LECTURE 1 ***always think what is best for the pt!!!

***
Ethics:
Legal age of consent (for sexual activity) in Canada is 16 yrs
CAN refuse to give out a medication (e.g. if unsafe) or for Plan B can direct pt to another
pharmacy
Ethics = NOT what you think but what you do
Morals = right vs wrong, based on a set of values
Law = if you break these, there are consequences
Ethical Principles:
o Autonomy = pts right to choose what is done to them
o Paternalism = making decisions for others against their wishes with the intent of
doing them good (results in a limitation of autonomy) e.g. making pt buy condoms as
they have AIDS violating autonomy

o
o
o
o

o
o

When one fails to respect anothers autonomy & act with disregard to the individual rights.
Substitute their own beliefs, opinions & judgement to that of another, claim they acted in the
persons best interest

Beneficence = acting in the best interest of the pt (doing good), there is a risk of
paternalism
Non-maleficence = Do NO HARM to the pt - e.g. only use tx if medically necessary
Veracity (honesty) = pts have the right to the truth
Confidentiality = pt information is protected, ONLY shared in circle of care (i.e.
everyone involved in the care of the pt), outside authorities need appropriate
documentation (present a warrant e.g. officers)
Confidentiality still exists even if pt is dead
PHIPA (Personal Health Information Protection Act) to safeguard & protect
personal health information & ensure that medical records are retained, stored,
transferred & disposed of in a safe & secure manner
Justice = fair, consistent tx of pts (consistent use of rules/laws with everyone)
Fidelity = The right of pts to have practitioners provide services that are in the pts
BEST INTEREST

E.g. recommending vitamins ONLY when the pt needs (infidelity if recommending & the
pt DOES NOT need them)

Sexual Abuse & Dating:

o You CANNOT date a pt from your pharmacy and fill their rxs this constitutes sexual
abuse
o The RHPA (Registered Health Professional Act) outlines that sexual contact b/w a
pharmacist or pharmacy tech & a pt is prohibited, this includes a spouse
Drug Legislation: (OCP SUMMARY CHART)
NAPRA (National Association of Pharmacy Regulatory Authority) voluntary
organization, includes members from ALL provinces
o Aligned the provincial drug schedules so that the conditions for the sale of drugs would
be consistent across Canada
o National advisory committee (National Drug Scheduling Advisory Committee)
make scheduling placement recommendations to the provincial regulatory authorities
o Schedule 1 require rx
o Schedule 2 require professional intervention by pharmacist
1

o Schedule 3 pt self-selection in a pharmacy

o Unscheduled NO professional supervision, sold in ANY retail outlet (e.g. gas station)
Act = outlines what is to be done (or not done), more difficult to make changes
Regulations = more-detailed rules to be followed (how to...), more easily changed
Schedule = a list; may be found in an act or in regulations
Federal Drug Legislation: Food & Drugs Act (Schedules A, B, C, D)
o 1) Schedule A:
Diseases for which tx may NOT be promoted to the public
Advertising to consumers is restricted
o 2) Schedule B:
Publications describing official drug standards (e.g. pharmacopeia)
o 3) Schedule C:
Radiopharmaceuticals
o 4) Schedule D:
Allergenic substances, blood derivatives, drugs obtained by recombinant DNA
procedures, immunizing agents (vaccines), insulin & others
o (1) Food & Drugs Act (schedules A, B, C, D)
Food & Drug Regulations (Part C, D, E, G*, J)
Part C Schedule F (Parts I, II) ALL rx drugs in Canada
o

Schedule F Part I:
Rx reqd across Canada (Pr symbol on package)
NO addl sales reporting reqd (but must maintain rx file for 2 yrs)
Schedule F Part II:
Drugs may be sold WITHOUT rx if drug is in a form NOT suitable for
human use OR is labelled FOR VETERINARY USE ONLY by manuf.
(other rx is reqd)

Part G Schedule G (Parts I-III) = controlled drugs (i.e. overlap between 2

acts)
(2) Controlled Drugs & Substances Act (CDSA) (schedules I VIII) (any drug that can
alter mental status is included in CDSA)

Narcotic regulations schedule N

substance NOT controlled drugs

Controlled

Benzodiazepines & other Targeted Substances schedule

o Controlled substance = ANYTHING scheduled under CDSA
o Controlled drugs = schedule G items
Narcotic Drugs: (e.g. codeine, methadone, nabilone)
o 1 narcotic (e.g. morphine, codeine)
o 1 narcotic + 1 active non-narcotic ingredient (e.g. codeine + acetaminophen)
o ALL parenteral narcotics (i.e. all injectable narcotics)
o ANY containing these special 6: (H&M DOPe) straight narcotics
Hydrocodone, Methadone, Dextropropoxyphene, Oxycodone, Pentazocine,
hEroin
o Legal requirements:
Written or faxed rx reqd (NO verbal rx accepted) (re-authorization allowed for
narcotics)
Physician, Vet, Dentist can prescribe
Refills NOT allowed (part-fills allowed total qty to be dispensed & part-fill qty to
2

be given, interval NOT reqd for narcotics)

NO transfers at all
Purchase record: purchases to be registered in the narcotics & controlled drugs
register
Retain invoices in chronological order(for auditing purposes)
Record of sale in narcotic & controlled drug register to be maintained
Dextropropoxyphene (& propoxyphene) sale record NOT reqd
Orders must be either written or electronic, to be signed by an authorized
registered pharmacist
The receipt of electronic orders must be signed by the registered pharmacist
(Rph) who ordered & this receipt should be sent back to the dealer in 5 working
days
Records must be maintained for 2 yrs
Report any loss or theft to the office of controlled substances within 10 days
Narcotic Preparations verbal narcotics:
o 1 narcotic + 2 or more non-narcotic ingredients (e.g. codeine + caffeine +
acetaminophen) (excludes H&M DOPe & parenteral narcotics)
o Exempted codeine products
OTC 8mg of codeine per tablet/capsule or 20mg/30ml of liquids, with 2 nonnarcotic ingredients
All exempted codeine products would become verbal narcotic if called in by
physician (e.g. Tylenol #1 therefore need interval)
Exempted codeine product is ONLY: 1 narcotic + 2 non-narcotic, if 1 narcotic + 1
non-narcotic then it is a STRAIGHT narcotic
o Legal requirements:
SAME as narcotics, EXCEPT:
Written, faxed & VERBAL rx accepted (verbal rx can be received Rph,
intern or registered student under the supervision of the Rph)
NO record of sale to be maintained
Orders to dealer can be VERBAL as well
Controlled Drugs: (found in sch G of the Food & Drug Regulations (Part G), divided into
parts I, II & III)
o Part I: Secobarbital, Pentobarbital, Amphetamines, Methylphenidate
All straight controlled drugs
All combinations containing more than one controlled drug
Legal requirements:
SAME as narcotics EXCEPT:
o VERBAL rx is allowed, but NO repeats on verbal rx
o On written rx refills can be given, but MANDATORY to mention
intervals
o Part I Preparations:
All combinations containing only one controlled drug & one or more noncontrolled drug
Legal requirements:
SAME as in verbal narcotics
o Part II: Barbiturates (except Secobarbital & Pentobarbital), Butorphanol,

Chlorphentermine, Diethylpropion, Nalbuphine, Phentermine, Phenobarbital,

Thiobarbituric acid
Legal requirements:
SAME as part I CD, EXCEPT refills CAN BE taken VERBALLY, but intervals
are MANDATORY
o Part III: Anabolic steroids & derivatives Andriol, Depo-testosterone, Androderm,
Androgel, etc...
Legal requirements:
SAME as part II
BZD & Targeted Substances:
o Legal requirements:
Refills ALLOWED (DO NOT need intervals for BZD rx)
Rx valid for 1 YEAR from the date on the rx
Transfers permitted only ONCE (rx can be transferred from one province to the
next/narcotics & CD could NOT be transferred)
Record of purchase reqd
Sales recording NOT reqd
Reporting of loss reqd
Marihuana Medical Access Regulations: (Marihuana = controlled substances)
o Health Canada implemented the Marihuana Medical Access Regulations (under CDSA)
o Define circumstances which access to marihuana for medical purposes is allowed
E.g. End-of-life care, sx associated with the specified medical conditions:
Multiple sclerosis (severe pain &/or persistent muscle spasms)
Spinal cord injury (severe pain &/or persistent muscle spasms)
Spinal cord disease (severe pain &/or persistent muscle spasms)
Cancer, HIV/AIDS infection (severe pain, weakness, anorexia, wt loss &/or
severe nausea)
Severe forms of arthritis (severe pain)
Epilepsy (seizures)
o Applications must provide a declaration from a medical practitioner to support their
application
o Health Canada gets dried Marijuana & seeds from Prairie Plant Systems Inc.
(Saskatoon, Saskatchewan)
o Pts have to fill out an application form, specific to the type of access they need
Can accept verbal rx from Dr out of province
Dr can prescribe narcotic for self or family member, but this is NOT good practice (pharmacist
has right to refuse), can be done in emergency situation with other drugs (e.g. Lipitor), but
NOT narcotics
General Rx Rules: (from OCP Summary Chart)
o Narcotic drugs rx must be either written or faxed from prescriber (NO verbal)
Verbal rx allowed for narcotic preps, controlled drugs & BZD + targeted
substances
o Narcotic drugs & controlled drugs may NOT be transferred between pharmacies,
BZD & targeted substances may be transferred once (if rx is not expired)
o BZD rx is valid for 1 year from date on rx, controlled drugs & narcotics rx is valid
4

o
o

o
o

o
o
o
o

indefinitely (must use professional discretion to see if still appropriate)

Narcotics, controlled drugs & BZD + targeted substances must keep purchase record
in Narcotic & Controlled Drug Register
Narcotic drugs & controlled drugs part I sales record reqd in Narcotic & Controlled
Drug Register (dextropropoxyphene sales are NOT reportable)
Ordering: written or electronic (NOT verbal)
Narcotic drugs, narcotic preparations refills NOT permitted (part-fills allowed total
qty + fill qty must be given)
Controlled drugs part I & controlled drugs preps refills allowed on written rx, NOT on
verbal rx (part-fills on verbal rx allowed subject to professional discretion), intervals
MUST BE GIVEN (verbal rx refills allowed on parts II & III)
Controlled drugs parts I, II, III & preparations intervals MUST BE GIVEN on rx
All rxs must be kept for at least 2 yrs from the last date of dispensing
Rxs for narcotics, controlled drugs & preps of either may be filed together, but must
be separated from all other rxs
Rxs for BZDs & targeted substances may be filed in either the Regular or
Narcotic/Controlled Drug File (must be consistent within the pharmacy)

NOTES:
Rx from the USA, patient must go to an emergency clinic and get the Rx authenticated

LECTURE 2
NAPRA: (National Association of Pharmacy Regulatory Authorities)
Is an umbrella organization of Canadas provincial pharmacy regulatory bodies (e.g. OCP,
etc...)
Members of NAPRA: (1) Provincial & Territorial Pharmacy Regulatory Authorities (2) Canadian
Armed Forces
Mission of NAPRA: make sure that the public interest is always upheld by:
o Representing the interests of the member organisations (i.e. different colleges e.g.
OCP)
o Serving as national resource centre (e.g. promote the harmonization of legislation &
5

standards)
NAPRA developed a set of national competencies standards for entrance into the
profession
Provincial regulatory bodies (e.g. OCP), provide a guideline of practice for pharmacists (i.e.
NAPRA sets recommendations NOT laws)
7 main competencies set out by NAPRA:
o (1) Pt Care
o (2) Professional Collaboration & Teamwork
o (3) Ethical, Legal & Professional Responsibilities
o (4) Drug Therapeutic & Practice Information
o (5) Communication & Education
o (6) Drug Distribution
o (7) Management Knowledge & Skills
NAPRA definition of a registered/licensed pharmacist is:
o (1) Practices according with professional registration & licensure & professional
standards
o (2) Possess broad-based & pharmacy specific knowledge
o (3) Uses critical thinking, problem-solving & decision making skills appropriate to the
pharmacists role
o (4) Mentors pharmacists, students, interns, pharmacy techs or others
o (5) Takes responsibility for his/her own continuing professional development & commits
to life-long learning (e.g. looking up references to stay up to date)
The pharmacist is the one who runs, manages the pharmacy & is allowed to carry out ANY act
involved in the drug distribution process (e.g. counselling, dispensing, etc...)
What can a Pharm Tech do?
o Assisting the pharmacist in the preparation of prescriptions
Receiving a written rx or a request for a rx refill from the pt
Ensure completeness of info on rx
Prepare rx labels
Retrieve, count, pouring, weighing, measuring & mixing medications
Reconstitute medications
Selecting type of rx container
Placing rx & auxiliary labels to rx containers
Pricing rxs, filing rxs
Establish & maintain pt profiles
Repackaging & labeling of medications
Maintaining packaging & dispensing equipment, etc...
o Clerical activities (e.g. hospital printing MUR, hospital report) *questions regarding
medication, poisons & health matter MUST be handled by the pharmacist
Preparing & reconciling third party billings
Preparing receipts, invoices, letters & memos & general filing
Billing appropriate dept for medication
Receiving & sending electronic medication (e.g. faxing a refill request to the Dr
for the pt)
o Communication activities (e.g. speak with pt to create pt profile, receiving phone calls)
o Inventory management (e.g. hospital delivering medication to dif wards including
6

narcotics)
Monitoring stock levels
Prepare & place orders
Receiving & checking supplies purchased
Maintaining inventory records, including those for narcotics & controlled drugs
Rotating stock & monitoring expiry dates
Identifying expired products for disposal, destruction or return to manuf.
Pre-packaging of medications (including unit-dose packaging)
(Compounding tech must be under the supervision of the pharmacist to prepare
compounded products)
(Techs can prepare chemotherapy in hospital but under supervision of pharmacist)
(Clarification of rx b/c it is ineligible needs to be done by pharmacist)
Community Pharmacy WORKFLOW: (TEAM= pharmacist + pharmacy techs, assistants,
students, interns or cashiers)
o (1) Entry (where rxs are dropped off)
o (2) Filling (where the rx is filled)
o (3) Checking (the rx is checked for accuracy)
o (4) Therapeutic (pharmaceutical care)
ONLY pharmacist can do, tech can
do steps 1, 2 & 6
o (5) Counselling & interventions
o (6) Pick-up (end-stage)
Hospital Pharmacy WORKFLOW: (TEAM= dispensary pharmacist, clinical pharmacist +
pharm techs, students, interns) clinical pharmacist = follows Dr (works in team with Dr)
o Physicians orders (sent to dispensary)

o
o

Clinical pharmacist orders (ONLY under medical directive = HCP practices outside
their scope practice)

Filled (unit dosed)

Checked (by dispensary pharmacist or pharm tech)

tech check tech = ONLY under medical directive, repeat NOT checked by
pharmacist, one tech dispenses repeat & other tech checks before it goes to ward)

o Delivered in specific wards (placed in medication storage carts)

o Administration (by nurses, physicians, etc...)
(Medical directive varies from hospital to hospital therefore if cant generalize b/w
hospitals)
Documentation:
Why Document?
o To meet documentation standards that exists for ALL pt care practitioners
o To be effective & efficient at caring for the pts
o Limit legal liability (i.e. professional liability insurance)
o Obtain reimbursement (e.g. MedsCheck)
o Communicate with the pt & the pts other care providers (i.e. IMPORTANT in hospital as
working with many professionals & they ALL need to know what everyone is doing)
o Present pt cases for learning purposes & to have clinical experience on which to reflect
& convert to clinical knowledge
o Manage a practice
How do we Document?
7

2 forms by which we document: (1) paper documentation (2) electronic documentation

Paper Documentation:
Advantage
Efficient
Disadvantages
Time consuming to maintain
Difficult to retrieve the info
Access
o Electronic Documentation:
Advantages
More effective & efficient
Retrieval is easy
Access
Disadvantages
Takes time to learn the system
What should we Document? (Be timely, Be precise, Be concise, Be complete)
o (1) assessment
o (2) drug therapy problems
o (3) the care plan
o (4) follow-up evaluation
Drug Distribution:
What is Drug Distribution?
o Provide the RIGHT DRUG, in the RIGHT DOSAGE FORM, in the RIGHT STRENGTH,
to the RIGHT PATIENT, at the RIGHT TIME (5 Rights ALL have to be met for a
o
o

Parts
o
o
o
o
o

successful drug distribution to occur)

for the Prescription:

(1) Prescriber prescription pad (heading)
(2) Name of the pt
(3) Superscription
(4) Date rx was written on
(5) Inscription = body of rx including the name of the drug with strength + Sig (=
directions)
o (6) Subscription = M (= Mitte = Send), tells the dosage form & the amount to
dispense
o (7) Refills (authority to provide additional refills)
o (8) Prescriber signature (plus can include prescriber printed name & license #)
Translating rx on a rx label VERB:
o Tells the pt how to administer medication
o Apply, instil, inhale, take, give, place, insert, swish & swallow, etc...
o **Peridex swish & SPIT (DO NOT swallow)
o **Nystatin swish & swallow/or spit depending on infection location
Translating rx on a rx label the ROUTE:
o Tells the pt details of where to administer the medication (e.g. PO, vaginally, rectally,
IM, S/C, IV, etc...)
Translating rx on a rx label DOSE & DOSAGE FORM:
o Type of dosage form & how many/how much of it (e.g. 1 tab, 2 cap, 1 tsp, 1 drop, 2 inh,
8

etc...)
Translating rx on a rx label the FREQUENCY:
o How often & when to take the med (e.g. TID, QID, PM, QHS, Q4H)
Translating rx on a rx label ADDITIONAL DETAIL:
o Additional more detailed info to help pt understanding of taking medication (e.g. PRN,
for 10 days, with food, for pain, until finished)
Translating rx on a rx label the AUXILIARY LABELS:
o Additional info to pt NOT included on rx label (e.g. for external use only, take on empty
stomach)
Auxiliary labels in practice: *see auxiliary labels examples on pg 21-23*
o NOT more than 2-3 per vial
o Any information NOT included on the rx by the doctor, but is important for the pt
o WARNING: DO NOT exceed the dose prescribed by your physician. If
difficulty in breathing persists, contact your physician immediately.
Ephedrine (+ salts), epinephrine (+ salts), ethylnorepinephrine (+ salts),
fenoterol (+ salts), ipratropium (+ salts), isoetharine (+ salts), isoproterenol
(isoprenaline) (+ salts), metaproterenol (orciprenaline) (+ salts), salbutamol
(albuterol) (+ salts), terbutaline (+ salts)
(ALL are stimulants & can cause adverse reactions on the cardiac system)
o E.g. Didrocal (DO NOT need label: DO NOT lie down after taking this medication),
Nitrolingual pumpspray (DO NOT shake), Indapamide (INCREASE intake of bananas,
orange juice, etc... meds can cause HYPOkalemia), Hydrocan liquid (DO NOT
refrigerate, DO NOT need label: DO NOT shake), Epipen (DO NOT exceed
recommended dose as prescribed by your physician)
Prescription Label Requirements:
o (1) The identification number that is on the rx (rx #)
o (2) The name, address & telephone number of the pharmacy in which the rx is
dispensed
o (3) The drug name, strength, & its manuf. unless directed otherwise by the prescriber
(e.g. clinical trial where the pt is NOT supposed to know the name of the drug)

o (4) The quantity where the drug dispensed is in solid oral dosage form
o (5) The name of the owner of the pharmacy
o (6) The date the rx is dispensed
o (7) The name of the prescriber
o (8) The name of the person for who it is prescribed
o (9) The directions for use as prescribed
Compliance Packaging: (can be used in COMMUNITY & HOSPITAL pharmacy)
o Purpose: to help pts with their adherence of medications (especially if taking several
meds with complicated regimens)
o A tool to help reach therapeutic goals for special pt populations:
(1) Elderly (2) Cognitive impairment (3) Large # of chronic conditions
o Increase efficacy of administration
o E.g. single & multi-medication blister cards, strip packaging, etc...
o Generally, the package has little compartments or blisters representing each
administration (e.g. Morning (breakfast), Noon (lunch), Evening (supper), & Bedtime)
o Must meet the minimum labeling requirements (just like a vial!)
9

Should have documentation from the most responsible prescriber, patient, other family
members, etc...
o Also to acknowledge that the medications are dispensed in non-child proof packaging
o Each drug should be labelled with generic name and identifier (e.g. shape, colour,
relative size, unique markings of tab or cap)
o PRN medications must be dispensed in a separate container as they cannot be placed
in a compliance pack
Name of Medications on a Rx:
o Brand name = name for which the innovator company holds a patent (e.g. Lipitor,
Hydrazide, etc...)
o Generic name = non-patented name, usually includes drug chemical name (i.e.
active ingredient) (e.g. hydrochlorothiazide, atorvastatin, etc...) (APO-citalopram =
BRAND NAME, citalopram = GENERIC NAME)
o Trade name = both the brand names & generic names such as Avandia, Norvasc,
APO-Hydro, APO-Atorvastatin, etc... (Note: theres a difference in practice when you
hear generic, & the actual generic name of the medication)
What is a Generic Drug? (generally cheaper price)
o Products that contain the SAME MEDICINAL INGREDIENTS as the original brand
name drug
o Comparative Bioavailability Studies: (Mandated by Health Canada)
Compare the generic drug to the original brand name drug
The level of a medicinal ingredient in the blood of healthy human volunteers is
measured
Each volunteer receives the original brand name drug & the new generic drug
on 2 separate occasions
The generic drug must show that it can deliver the SAME AMOUNT of medicinal
ingredient at the SAME RATE as the original brand name drug
o DIDFA (drug interchangeability)
Definition of an interchangeable drug (MUST meet ALL 4 conditions for
interchangeability):
(1) SAME amount of the SAME active ingredients
(2) Comparable pharmacokinetics (Health Canada gives a range that is
o

acceptable, doesnt have to be identical PK)

NO

(3) SAME clinically significant formulation characteristics

(4) To be administered in the SAME way as the drug prescribed **
In practice, if the dispenser (pharmacist) gets a rx for an interchangeable
product, they may dispense in its place another product that is designated
(must see approved interchangeable drugs as per FORMULARY) as being
interchangeable with it (without contacting the Dr.)
SUB (= NO substitution)
Principles of interchangeability NO longer apply
For a written rx: no sub or no substitution MUST be in the doctors own
handwriting (MUST BE written, cant be stamped or type written)
For a verbal rx: the pharmacist must document the physicians request
Why would a prescriber write NO Sub?
10

Drug
o

Pt has severe intolerance or allergy to a generic product (e.g. excipients

(lactose))
Pt is enrolled in a study where a specific drug is part of the tx regimen
Can get abuse of this!!!
Administration:
Different formulations taken by mouth:
Tablets, capsules, solutions, suspensions, lozenges, wafers (placed on tongue &
is fast dissolving)
Different TABLET formulations:
(1) Sublingual tabs (AVOID 1st pass metabolism) (2) Effervescent tabs (i.e.
drop in water & bubbles) (3) Chewable tabs (4) Extended-release tabs (LESS
hard on stomach, LESS S/E) (5) Film-coated tabs (CAN split, coat does NOTHING
for mechanism) (6) Enteric-coated tabs (DO NOT split)
TOPICAL Medications: (cream, gel, ointment, lotion, etc...)
Advantages:
AVOID GI tract
AVOID 1st-pass metabolism (i.e. drug is metabolised by liver before being fully
distributed to the body)

Control of absorption
Availability of multiple application sites
Improve pt compliance
Disadvantages:
Potential for localized irritation
Time needed for diffusion through skin
Dosage limitations (cant put too much of drug)
Lack of standardized administration amongst pts
Change in skin physiology caused by: age, disease, diet, genetics, etc...
PARENTERAL Administration: (parenteral = AVOID the intestine (therefore
injection))
Important to use when:
The drug has a LARGE 1st pass effect
Life-saving drug is being administered
Need fast onset of action
Subcutaneous (S/C) Route - 45
Beneath the skin (under cutaneous or fatty tissue; above muscle & blood
vessels)
Sites: upper arm, lower abdomen, anterior surface of thigh
Used for intermittent (occasional) S/C injection (e.g. insulin)
Use for continuous S/C infusion (e.g. morphine)
Intradermal (ID) Route 10-15
Into the dermis (vascular layer of skin, under the epidermis, above S/C
site)
Site: anterior surface of the forearm (e.g. TB test)
Intramuscular (IM) Route - 90
Injection into the muscle
11

Sites: deltoid (upper arm), gluteal (buttocks), vastus lateralis (thigh)

Onset of action is SLOWER than IV but MORE RAPID than S/C (depot
drugs)
LESS risk & easier than IV route, MORE PAINFUL than IV route (longer
needle is needed) (e.g. vaccines)
IV administration & route (uses):
Maintain access to cardiovascular drugs
Administer drugs
Maintain fluid requirements (restore & replace)
Administer nutrition (TPN)
Advantages:
o Rapid onset (right into the blood), immediate access to the
cardiovascular system
o For drugs too difficult or irritating to administer via IM, S/C
o Can give drugs or fluids which cant any other way
Disadvantages:
o Rapid onset, therefore rapid onset of adverse reactions
o IRREVERSIBLE administration
o Risk of infusion of air, microorganisms, pyrogens, particular matter
o Risk of sepsis (infection), phlebitis (venous inflammation &
irritation), extravascular/infiltration (leaking outside the vein)
Fastest to Slowest ONSET of action: IV > IM > S/C (based on vascularisation)
Longest to Shortest DURATION of action: IM (depot drugs) > S/C > IV
IV administration sites:
Peripheral sites:
o Vein in hand or forearm; scalp or foot vein in infants, but a
CENTRAL IV site is PREFERRED in neonates)
Central IV sites:
o Subclavian vein, jugular, SVC; peripherally inserted central or PIC
line; umbilical vein in neonates
o A catheter is run along the subclavian vein, tunneling through
muscle, tissue to SVC
o Why give a drug centrally?
Larger vessel site (therefore larger volume of blood & more
drug can be given) + it dilutes the drug (minimizes S/E)
Bolus IV Injection: (i.e. one LARGE dose at a time)
IV push, IV bolus, direct IV injection
One time dose
Can be used as LOADING dose
Intermittent IV Administration:
Medication given from time to time
IV bolus at Y-site (i.e. 1 line but 2 drugs feed into the line) or heparin/saline lock

(lock prevents coagulation)

Medication given by piggyback minibag (i.e. usually give one drug, then flush the
line then give the other drug PIGGYBACK = give 1 drug, then give the other through the
same line without flushing the line in-between administration)

12

Continuous Infusion:
Constant therapeutic drug levels
Typically for drugs with short half-life
SLOW onset of action without a loading-dose
o Intrathecal:
Into the spine (specifically into the epidural space in the central cavity b/w the
dura matter & the vertebral column)
Used for pain control
o Epidural:
Into the brain (specifically into the subarachnoid space underneath the
arachnoid matter in the brain where there is CSF (cerebrospinal fluid))
Used for pain control
Precursor Control Regulation:
Precursor Control Regulation under the Controlled Drugs & Substances Act (CDSA)
Addresses concerns in monitoring & controlling access to precursor drugs
Two classes of precursors:
o Class A precursors = components of illicit substances (e.g. methamphetamine,
MDMA (ecstasy), cocaine, heroin, LSD & PCP) (pseudoephedrine precursor to crystal
meth)
o Class B precursors = mostly solvents & reagents used in clandestine manuf.
processes (e.g. acetone, sulphuric acid, etc...)
Pharmacies are considered retailers/end users who sell Class A precursors only in quantities
EQUAL or LESS than the thresholds (e.g. pseudoephedrine-containing products are limited to
3g per package size (NOT per tablet))
o LICENCE REQUIRED by pharmacy if they sell oversized products with MORE than 3 g
of pseudoephedrine per package
o Also if pharmacy sells or transfers quantities of product to another pharmacy or retailer
a licence will be REQUIRED since this is considered wholesaling
o Importing/exporting of any precursors would REQUIRE a licence as well
o Purchases of oversized products or quantities over the threshold will require End-Use
Declaration (EUD) to be signed (signed by the person acquiring the Class A precursor
BEFORE the transaction takes place, declaration is valid until the end to the calendar
yr from the date of the 1st transaction)
How do we Monitor Trends of Abuse?
o (1) Early refills
o
(2) Pt comes into pharmacy within 2-3 days to buy a second bottle of a 100 T1s (i.e.

recommended dose= 1-2 Q4-6H)

o (3) Buying large quantities of pseudoephedrine

o (4) Large quantities of syringes? (e.g. steroids) Diabetic!
o (5) Monitor inventory
o (6) Security videos
Drug Disposal:
Community pharmacy can accept expired meds from pts if they are our pts or not (can
accept drugs from any schedule)
Additional steps required when disposing narcotics, controlled drugs & targeted substances
13

compared to disposing other drugs

Drugs Disposal: Narcs/Controlled substances:
o For damaged, expired drugs (narcotics, controlled substances)
o Letter (or fax) sent to Office of Controlled Substances (Ottawa) (part of Health
Canada)
Ask permission for destruction
o Outline product name, exact quantity, lot number/expiry date & reason
o REPLY will be MAILED back (i.e. ONLY once have received letter back can proceed with
destruction)
o Witnessed destruction (i.e. by another HCP such as pharmacist or registered
pharmacy intern or a Field Representative from the OCP)
o Documentation (i.e. ask much info as possible e.g. date, quantity, manuf., strength,
DIN)
o Inventory of destroyed material is to be signed & dated by BOTH parties (i.e.
pharmacist + witness), it should then be placed in the narcotic rx file on the date
destroyed &/or stapled to the Pharmacy Narcotic & Controlled Drug Register for
Receipts
o NOTE: a request to destroy unusable BZD & other targeted substances is NOT reqd
but the quantities MUST be recorded & the destruction witnessed as done with narcotic
& controlled drugs
o If UNOPENED pack can SEND BACK to the manuf.
Drugs Disposal: BZD & Targeted Substances:
o The pharmacist records, before destruction, information with respect of the destruction
including the name, strength per unit & quantity of targeted substance to be destroyed
o The method of destruction conforms with federal, provincial & municipal environmental
legislation
o The DATE OF DESTRUCTION is recorded
o The destruction is WITNESS by a pharmacist or practitioner
o IMMEDIATELY after the destruction, the pharmacist & witness sign & print their names
on a joint statement, indicating that they witnessed the destruction & the targeted
substance destroyed has been altered or denatured to such an extent that its
consumption has been rendered impossible
o NO authorization or approval document issued by the Office of Controlled
Substance with respect to this activity
NOTES:
TIP for EXAM always pick the most SIMPLE option (go with your gut feeling 80-90% of
time correct)
Nitrostat tabs (NTG) PROTECT from light & humidity
Alvesco MDI (Ciclesonide) Auxiliary labels: DO NOT SHAKE, RINSE MOUTH, Warning! DO
NOT exceed...
Nasonex SHAKE WELL (NOT gently)
Miacalcin (Calcitonin) DO NOT SHAKE, store unopened bottles in fridge, FOR NOSE
o Store UNOPENED bottles in the fridge
o Store OPENED bottles at room temp for 30 days (then discard)
Estalis in fridge
14

NuvaRing once dispensed keep at room temp for up to 4 months (in pharmacy store IN
FRIDGE)
Oxsoralen lotion 1% (for PUVA bath) AVOID sun exposure (DO NOT need to shake or
refrigerate)
Need to keep at ROOM TEMP = clarithromycin, cotrimoxazole sus, azithromycin (can be
kept at room temp or fridge if kept in fridge will numb taste therefore taste better)

LECTURE 3
Storage Conditions:
Temperature 3 storage temps (room, refrigerated, freezing (e.g. vaccines))
Light medication that are photosensitive need to be stored in light protective containers or
vials
Medication to be kept in the ORIGINAL container: omeprazole, ARV (a lot of these),
ACCUTANE
Insulin if unopened then keep in fridge, if opened then leave outside for up to 28 days
HOSPITAL Drug Distribution:
Drug distribution definition (5 Rights) = Provide the RIGHT DRUG, in the RIGHT DOSAGE
FORM, in the RIGHT STRENGTH, to the RIGHT PATIENT, at the RIGHT TIME
All drug distribution systems in hospitals include:
o (1) Procurement (= to get from manuf.)
o (2) Preparation (e.g. preparation of antibiotics)
o (3) Administration of drugs (i.e. usually pharmacist NOT involved in this step, usually tell Dr or nurse

how to administer drugs)

As well as quality assurance & pt monitoring to safeguard the pt

Pharmacy can be:
o (1) Centralized = occupies one large area in the hospital & carries out all of the
hospital pharmacys activities
o (2) Decentralized = have satellites which are mini-pharmacies in several areas (e.g.
different pharmacy for a different ward cardiology, chemotherapy... AVOID confusion)
Two most common drug distribution systems used in Canada:
o (1) Unit dose
= medications are dispensed for a 24-hr period (e.g. 1 dose of each of pt meds)
All drugs are compounded & dispensed by pharmacy in a:
(1) pt specific, (2) individually labelled & (3) ready-to-administer form (e.g.
reconstitution is already done, nurse gets ready to administer form)

Unit dose = term used for ORAL meds

IV Admixture system = unit dose equivalent for PARENTERAL products
(2) Traditional
Medications are distributed as either:
(1) Wardstock = pharmacy orders meds for the ward, NOT pt-specific
(e.g. analgesics, laxatives, body lotions, etc...)
15

(2) Packed into vials with a supply for a fixed amount of period (e.g. 30 day
supply), pt-specific
Advantages of UNIT dose:
o (1) SAFER for the pt (i.e. LESS chance of overdose & since giving 1 dose at a time, can catch mistakes
o

easier, whereas if dispense for 30 days, wont catch mistake for 30 days)
(2) MORE efficient & economical for the institution (i.e. ready-to-administer form means MORE
time for nurses to spend with pts rather than mixing medication, etc...)
(3) Provides optimized use of human resources (i.e. REDUCE waste of meds)

o
Advantages of TRADITIONAL dose:
o (1) LESS time is spent as giving a LONGER day supply
o (2) LESS expensive for pharmacy in terms of staffing (i.e. DO NOT need to prepare
meds each day)
o (3) Initial start-up cost for unit dose is VERY HIGH (for traditional system NO start-up
cost)
Compounding:
What is MANUFACTURING? (DO NOT need rx)
o Bulk prodn follows GMP (i.e. Good Manuf. Practice) & FDA (Food & Drugs Act &
Regulations)
o Health Canada inspection (FEDERAL!)
o Manuf. maintains an ESTABLISHED licence
o Commercially available (for sale in pharmacy)
o Sale of product to an agent for sale has NO established PPP relationship
o More strict QA/QC testing than compounding
What is COMPOUNDING? (ONLY need rx if any of the ingredients require an rx)
o Professional pharmacy activity (based on a professional relationship pharmacistpatient-prescriber)
o Pursuant to a rx
o Customized service (medication is NOT commercially available)
o NOT for commercial sale i.e. compounded products will NOT be sold outside of the
defined PPP relationship
o Regulated by OCP (PROVINCIAL!)
Why COMPOUND? (Compounds = preparations = extemporaneous mixtures = extemporaneous preparations)
o Product NOT commercially available
o Allergic to the drug or excipients (e.g. lactose intolerant)
o Discontinued product (i.e. ONLY if drug was NOT a threat to a pt)
o Different dosage forms (e.g. tablet suspension)
o Improve palatability (i.e. taste)
o If medication is back-ordered & pt needs a medication then can compound drug
Policy on Manufacturing and Compounding Drug Products in Canada (2006)
o Health Products and Food Branch Health Canada
The professional practice of compounding must NOT be used to bypass the
drug review and approval system
Patients must continue to have access to individualized drug therapy, which
may require custom compounded medications
Drugs which are available in Canada must be safe, effective and of high quality
Pharmacists who provide compounded products must do so within an

16

established relationship (prescription/dialogue)

RECONSTITUTION is NOT compounding or manuf. (e.g. preparing amoxil sus. by adding water to the
commercially available dry powder )
Labelling requirements:
o Ingredients (ONLY active ingredients)
o Expiry (use SHORTEST expiry out of the ingredients)
If NO expiry dates then look at stability info in information resources
o Storage info
o Period of stability or safety
E.g. Amoxil sus. expiry date is for the powder, but once reconstituted the period of stability = 14
days

o AVOID abbreviations
o Include lot numbers (good practice, NOT required)
Pharmacists Role in Compounding:
o Prepare, check, document, and supervise! (i.e. check ALL ingredients, expiry dates, lot
numbers)
o Need to have sterile conditions/procedure?
o Recognize potential incompatibilities (E.g. if use water or mineral oil, etc...)
o Maintain inventory & proper storage
o Pt counselling & education
o Document & maintain accurate records
o Techniques levigation, trituration, pharmaceutical calculations, hazardous material
handling, etc...
Pharmacy Technicians Role in Compounding:
o Maintain inventory & proper storage
o Document & maintain accurate records
o Pharmaceutical calculations (i.e. calcs done by techs but checked over by pharmacist but NOT reqd to be
checked over by pharmacist)

Confirm the physiochemical properties of the ingredients

(usually pharmacist are responsible for

this & checking if ingredients are compatible, techs do ALL of the mixing)

Techniques levigation, trituration, hazardous material handling

Compounding area: clean/hygienic
is NEEDED to do compounding?
Personnel (e.g. techs), premises & space, appropriate compounding procedures &
instruction, ingredients, suitable equipment, labels & containers, accurate
documentation
Preparation of Compounds practical approach:
o Fill the rx in a way that LIMITS physical contact (i.e. AVOID/REDUCE contamination)
o Calculate the amount of each ingredient needed for the preparation
o Count/weigh the correct quantity
o Place in an appropriate container, secure lid
o Document the preparation, with complete information of all ingredients
o Label properly with expiry, stability
Common Sources of Compounding Error:
o Inaccuracy in weighing procedure
o Calculation error
o Failure to COMPLETELY dissolve the solute
o
o
What
o

17

o Inaccuracy in the final volume

o Failure to ensure homogenous mixing of the product prior to dispensing
Considering Physiochemical Properties:
o Even though you have a rx, doesnt mean compatibility has been ensured
o Have to ensure that the ingredient is soluble or able to be compounded with the base
o Also have to know which substance can be used in levigation or trituration
o Sources: Martindale or Remington
When mixing powders in solids:
o Reduce powders to a fine powder before adding to the base
o Gradually mix the powder into a small amount of the base to make a smooth paste
o Mix the remaining quantity of the base
o Some powders can be mixed with small amounts of mineral oil or glycerin
When mixing liquids:
o Use a graduated cylinder to measure the liquid & use a mortar & pestle to reduce the
particle size of powders
o Suspension compounds should be stirred well & a shake well label affixed
Weigh Ingredients: ELECTRONIC BALANCE:
o MORE accurate, LESS labor intensive, easier to use
o Bubble level (adjust the feet of the balance to get it level)
o First step taring or zeroing (place weighting paper on scale, tare it & then pour ingredient to
measure)

o Used to weigh accurately 1mg to 300g

Common ingredients: topical agents: (DO NOT need to memorize, just be aware of)
o Common bases:
Alpha keri oil, betamethasone cream, clotrimazole cream, Cetaphil, Eucerin,
Glaxal base, Micanazole cream, Moisturel, Uremol (urea cream/lotion), HC cream
o Solutions:
Isopropyl alcohol, coal tar distillate (LCD)
o Dry ingredients:
Crystals camphor, menthol, phenol, urea
Powders salicylic acid, erythromycin, clindamycin, HC, boric acid
Common techniques in compounding:
o Trituration reduction in particle size of solid, by rubbing (i.e. mortar & pestle,
spatula & ointment pad)
o Levigation particle size reduction of a solid to a fine state by trituration after
moistening it (e.g. water, glycerin, mineral oil)
o Pulverization by intervention reducing solid particle size by combining with a
solvent (e.g. alcohol, propylene glycol) which easily evaporates after pulverization (e.g.
menthol crystals & alcohol)
Use when solid RESISTS grinding
o Geometric dilution incorporating equal, increasing amount of 2 different
components (Doubling-up method)
Aseptic techniques:
o 2 methods of compounding:
(1) NON-sterile (usually oral/topical preparations)
(2) Sterile (e.g. parenterals, ophthalmics, otics, inhalants, topical)
18

Sterile preps must be made using aseptic technique (i.e. one that
prevents contamination, causing an infection (sepsis))
Compounded Sterile Products (CSP) defined:
Preparations prepared according to the manuf. labeled instructions & other
manipulations that expose contents to potential contamination
Preparations containing NON-sterile ingredients or devices that MUST be
sterilized before administration
Biologics, diagnostics, drugs, nutrients & radiopharmaceuticals that have either
of the above two characteristics
Sterile compounds:
Use aseptic methods under controlled conditions to produce a sterile
pharmaceutical dosage form
Sterile compounds MUST BE FREE of contamination (i.e. #1 source of
contamination = people)
Aseptic technique:
Minimize chance of contamination by M.O., particulate matter & pyrogens
Sources of contamination supplies, people & equipment
Compounding occurs in clean room
Access to work area is restricted
Personnel must wear protective clothing & taken precautions to prevent
contamination
Aseptic environment:
The compounding area should be clean, well lit & with limited access
Temperature monitor refrigerator for the sterile products storage
Ante-room (i.e. room BEFORE person enters clean room & gets dressed)
Sufficient air supply
Smooth, non-porous surfaces
Laminar air flow hood - should be operating continually, 24hrs/day NOT
feasible in a community setting should be turned on AT LEAST 30 min prior to
use
Work should be AL LEAST 15cm into the hood
Only ONE person should be working in the hood at any given time
Personnel Equipment:
Hair must be covered by hair-net/beard covers
Eye protection/goggles
Mask
Gloves
Gown/sterile scrubs
Shoe covers
The Compounding (Clean) Room:
Traffic must be LIMITED
Ample airflow & ventilation (air is continuously filtered to remove particles/dust)
Surfaces/walls/floors MUST be smooth to prevent dust from settling
Adequate storage space for drugs/supplies required at the time of preparation
MUST have a sink; sharp containers; fridge; disinfectant; preparation area (hood)
Anteroom is used for: hand-washing, dressing, order entry,
19

unpacking/sanitizing of supplies, labelling, storage

Packaging/boxes/food/drink MUST NOT enter the clean room
o Laminar Air Flow Hood:
Dual filtering system (i.e. Pre-filter & HEPA filter)
Pre-filter removes big contaminants (e.g. dust, lint)
HEPA filter removes fine bacterial contaminants (0.3 - will remove these
bacteria)
Types of Laminar Air Flow Hood (LAFH):
(1) Horizontal hood air flows from back to the front
(2) Vertical hood (Biological Safety Cabinet) air flows from top down
o For hazardous compounds/cytotoxics e.g. chemo drugs
(3) Glovebox isolator operator uses a glove system to compound
products inside a sealed chamber
o HORIZONTAL Air Flow:
Airflow is directed FORWARD (usually LESS expensive)
Work is performed in the hood & the product is protected
The operator is NOT protected from particles or fumes
o VERTICAL Air Flow: (used for cytotoxics)
The air flow is directed DOWNWARD & AWAY from the operator providing a safer
working environment
This is the PREFERRED hood for community pharmacies
Communication:
Communication b/w health professionals & pts helps in 2 ways:
o Ongoing relationship
o Exchange of information
5 Basic Elements of Interpersonal Communication: (DO NOT memorize)
o Sender
The person that sends a message to the other person (e.g. pt, pharmacist, etc...)
o Message
The element that is transmitted (sent)
Can be thoughts, ideas, emotions, information or other factors
Both VERBAL (talking) & NON-VERBAL (gestures, facial expressions, body
language)
Can be CONSCIOUSLY or SUBCONSCIOUSLY transmitted
o Receiver
Receives the message from the sender
Decodes the message & assigns a specific meaning to it, which may or may
NOT be intended of the sender
Consider both VERBAL & NON-VERBAL components of the message
o Feedback
The receiver communicates back to the sender their UNDERSTANDING of the
message
Receiver responds with their OWN verbal & non-verbal messages
Feedback loop! important to allow 2-way communication
o Barriers
Affect the accuracy of the exchange of information
20

There are several different types of barriers:

Environmental barriers, personal barriers, pt barriers, time, administrative &

financial barriers

Verbal vs Non-verbal Communication:

o Verbal (words) conveys ideas
o Non-verbal conveys attitude & emotions
Non-verbal Communication in Pharmacy:
o Body language, proximity to another person, your physical environment, expression,
body movements, appearance, behaviour
o NON-verbal communication may be the predominant form of communication especially
if speech impaired, deaf, blind, etc...
Barriers in Communication:
o Environmental Barriers:
Height of the rx counter
Glass wall b/w the dispensary & the pt
Crowded, noisy areas
Lack of private areas
Clerk or pharmacy tech who stands b/w you & the pt
o Personal Barriers:
Lack of confidence in ability to communicate effectively
Shyness, anxiety
Cultural differences
Lack of objectivity (emotional burden)
Pharmacists professional values
o Patient Barriers:
Pts perceptions of the pharmacist
Personal belief in the health care system
Their medical condition itself
Confidentiality & privacy
o Time, Administrative & Financial Barriers:
Lack of reimbursement of cognitive services, counselling, recommendations
Lack of education
3rd party insurance & billing issues
Lack of staff, even scheduling, technical support
Mechanics of dispensing process
Timing (small children, crying, physicians in a rush, etc...)
Removing Barriers:
o 2-step process:
1st have to be AWARE that a barrier exists (best way to find out is to put yourself in the
pts shoes)

2nd taking the appropriate steps to REMOVE the barrier

Pharmacists & the Communication Model:
o As a sender, have to ensure that the message is transmitted (sent) in the clearest form
o Ask for feedback!
o Language is easy to understand, fully understood by the receiver (the pt)
o That the environment is conductive for clear transmission & communication
o As a receiver, we have to listen to what is transmitted by the sender (the pt)
21

Provide feedback about what we have understood*** (or else misunderstandings can
occur)
Words & Misunderstandings:
o People give meaning to verbal & NON-verbal messages based on:
Past experiences, definitions, perceptions
o When 2 people DO NOT share the same past experiences MISUNDERSTANDINGS!
o E.g. take with plenty of water, take with food, OTC
o Prevent misunderstandings:
Different people assign different meanings to words & phrases (pharmacists need
o

to be aware of this)

Anticipate how other ppl may perceive or translate your message

Use feedback to check the meaning
E.g. Please demonstrate how you are going to use this device? How are
you going to take this medication?
What pharmacists can do:
o AVOID the use of ambiguous words (vague, having several possible interpretations)
o AVOID the use of jargon (medical terms, pharmacy terms, short forms, abbreviations,
etc...)
o Use simple examples, comparisons, scales, etc...
o LEARN about different cultures
Presentations & Health Promotion:
Definitions:
o Presentations = demonstration, lecture, etc...
o Seminars = class where students discuss their findings/research
o Orientation = guided introduction
o Clinic days = place for medical treatment/information for outpatients
Presentations (MAIN PARTS):
o WHO? (who are you presenting to?)
o WHY? (whats the point of the presentation?)
o WHAT? (what is the material Im going to present?)
o WHERE? (the location & place?)
o WHEN? (a mutually convenient time & date)
o HOW? (how are you going to present?)
Things to keep in mind...:
o Date & time
o Place of presentation
o How are you going to invite people? Invitations, posters, announcements, etc...
o What do you need to present the material? Laptop, projector, supplies?
o Seating, room set-up, etc...
Knowing your Audience:***IMPORTANT*** KEEP AUDIENCE IN MIND WHEN PRESENTING***
o Who is the audience (KEY question!)
Demographics (i.e. senior crowd, students)
Age, gender, race, language, cultural background (i.e. communication issues?)
Profession? (i.e. doctors, nurses, occupational therapists)
Education level
o What will be useful to them?

22

 What information can they use in their normal day or in practice

o What is the CURRENT level of understanding?
o How will the USE the information & content from my presentation?
Developing the Actual Presentation:
o What are the MAIN parts to an presentation:
Objectives
What information do you have?
Sift through the different sources, extract, organize, analyze, refine, synthesize
o Framework
Intro, body, conclusion
o Other things: material, language, visual
Things to include in presentations:
o It all depends on the specific disease/topics - *KEEP IT CONCISE AS POSSIBLE*
o Plus the target audience
***ESSENTIAL TO ADDRESS THE CONFLICT OF INTEREST FROM THE BEGINNING IF
THE INFORMATION IS SPONSORED (E.G. BY BAYER) OR NOT!!!*** (i.e. state where the
material is from)
Health Promotion:
Health promotion = giving the pt all of the information out there so they can take control of
their own health (e.g. diabetes awareness)
Health promotion activities a pharmacist can undertake:
o Community clinic days, immunizations, vitamins & minerals, etc...
o Hospital immunizations, how to administer meds correctly, how to dispose of
medications (e.g. used syringes), pandemic medication use (e.g. Tamiflu oseltamivir),
pandemic response (e.g. importance of handwashing)
Competencies for health promotion:
o (1) Managing, planning, evaluating
o (2) Communicating
o (3) Educating
o (4) Marketing & publishing e.g. leaflets, flyers
o (5) Facilitating e.g. talking about different community centres that the pt can be
referred to
o (6) Influencing policy & procedures i.e. influencing at the govt level to make changes
Health promotion & communication:
o Designing health promotion campaigns
o Important to understand health promotion psychology
Pharmacist & Health Promotion:
o Compliance = extent to which behaviour coincides to what they were told to do
Compliance means pts should be taking drugs 3x per day but instead is taking
them 2x per day, therefore they are compliant, but NOT 100% compliant (i.e.
varying degrees of compliance)
o Adherence = pt takes the right dose at the right interval, do you adhere to what was
told or not? (ABSOLUTE yes or no?)
Why do pts...
o STOP taking their meds?
o Make modifications to their regimens?
23

STOP filling their Rxs?

Feel like meds controlling their lives, finances, S/E, life-styles change, perception
about health & medication (e.g. feel like they might be addicted to drugs)
Important to understand difference between:
o (1) Health motivation e.g. Eat well = healthy *** always give pt positive
statement***
o (2) Fear e.g. if you dont eat well = sickness
Drug & Practice Information:
***ALWAYS ask for more information, as could poison pt if DO NOT have all of the information
o

(e.g. mother asking for Tylenol dose, but does not mention meds are actually for son unless you ask for more
information...)***

Receiving Drug Information (DI) questions:

o ALWAYS ask for more information *** (e.g. Tell me more...)
o Separate uncertain from certain details
o Understand the context of the question
o Appreciate the complexity of drugs & diseases
o What information is being requested? Understand & identify the type of question
Types of information requested:
o Pharmacology
Pharmacokinetics (i.e. what the body does to the drug ADME or LADME/L=liberation how

sustained-release drugs are released from the dosage form BEFORE it is absorbed)
Pharmacodynamics (i.e. what the drug does to the body)

Availability
Drugs approved in Canada
Foreign drug products
Formulations, strengths, excipients
Drug formulary (ODB, 3rd party, or hospital)
Recommending a drug
Drugs APPROVED for preventing or treating disease (i.e. NOT OFF-label use of
drug)
ON-label & OFF-label uses
ON-label = govt APPROVED uses of medication (indicated)
OFF-label = NON-govt approved uses of medication (NON-indicated)
E.g. What drugs can be used to prevent/treat a disease ON- & OFFlabel uses of drug
E.g. What drugs are APPROVED to prevent/treat a disease ON-label
uses drug ONLY

Dr responsible to know if prescribing a drug for OFF-label use (i.e. responsible for pt
safety), if clear OFF-label use, DO NOT need to contact Dr to make sure (unless really
OFF-label, BUT normally would go ahead with rx)

Prescribing considerations
C/I, precautions, warnings, dosing, procurement (= how to get a drug call
manuf? etc...)
Administration, adverse reactions, drug interactions, monitoring, cost, poisoning,
toxicology, pregnancy/breastfeeding
Types of References: ***
o

24

Primary
Up-to-date, LATEST information, in scientific journals
Trials, new studies
Secondary
Database of primary literature (i.e. collection of primary data in databases)
E.g. Medline, PubMed, EMBASE
Tertiary
OLDER information, text books, physically you can open
E.g. CPS, TC (i.e. electronic sources of CPS & TC are STILL TERTIARY BUT MORE UPTO-DATE than textbooks)

Process of looking up information:

o (1) Determine the type of information reqd
o (2) Start with tertiary source (i.e. tertiary is primary ALWAYS start at tertiary)
o (3) If needed, use secondary sources to identify primary sources for specific questions
o (4) Select primary source studies/articles & critique
SECONDARY sources: (Medline, PubMed, EMBASE, The Cochrane Library, Clinical Evidence)
o Medline (online source of index & abstracts)
U.S National Library of Medicine (NLM)
Database of citations & abstracts in various fields
Major source of biomedicine information going back to 1950s
Broad subject coverage
Biomedicine & health
Life sciences for biomedical practitioners
North America emphasis; majority English language publications
Available in 2 interfaces:
PubMed (more up-to-date & FREE!)
Medline Ovid (easier to search, subscription!)
Are PubMed & Medline separate? NO! Medline is part of PubMed (i.e. PubMed
is the door to these databases (+ its FREE)
o PubMed
Gives FREE access to Medline (+ it is North American)
National Library of Medicines (NLM) interface to Medline
Links to FULL-text articles
Search filters for clinical queries & special queries
Free service maintained by the National Centre for Biotechnology Information
(NCBI)
o EMBASE
Comprehensive online database
Provides data from OUTSIDE of North America
Provides articles NOT FOUND on Medline (i.e. some overlap...but very minimal)
Biomedical & pharmaceutical information (excellent for drug literature)
Product by Elsevier (science & health information publisher)
o The Cochrane Library (Collection of Databases)
Provides systematic reviews & meta-analysis, INTERNATIONAL database
(i.e. all over the world), INDEPENDENT, NON-biased information
Collection of 6 databases
25

Cochrane Database of Systematic Reviews

Cochrane Central Register of Controlled Trials
Cochrane Methodology Register
Database of Abstracts of Reviews of Effects
Health Technology Assessment Database
NHS Economic Evaluation Database

INDEPENDENT evidence & review (i.e. NON-biased)

Evidence-based medicine databases
Important for healthcare decision making
Available in 2 interfaces
Ovid
Wiley (MORE up-to-date)
o Clinical Evidence
INTERNATIONAL SOURCE of data for decision making
Under the British Medical Journal
Summarizes current knowledge & uncertainty about PREVENTION &
TREATMENT
Based on searches & appraisals of systematic reviews, RCTs,
observational studies
Comprehensive database includes systematic reviews, RCTs & etc...
(Cochrane ONLY systematic reviews & meta-analysis)
o PubMed is a SECONDARY resource & you look up clinical trials that are a PRIMARY
resource (found in journal articles journal is NOT a secondary resource) clinical
trials are a PRIMARY resource***
TERTIARY sources: (CPS, Martindale, USPDI, TC, PSC)
o Compendium of Pharmaceuticals & Specialities (CPS) Common Pharmacy
Stuff!
Information about drugs IN CANADA
APPROVED indications (ON-label uses) (i.e. NOT OFF-label uses)
Drug monographs prescribing considerations
Product identification (Brand Name)
Excipient information (e.g. lactose, gluten)
E-CPS has pt information (lay language, NOT in hardcopy of CPS)
CPS- What is contains:
Glossaries (abbreviated terms, etc...)
Discontinued products
Clinical Recommendations for DENTAL PROPHYLAXIS of
BACTERIAL ENDOCARDITIS
Brand & generic products
Therapeutic guide (i.e. topic or disease & a list of ALL drugs used in its tx)
Product identification section (i.e. product picture MOST times brand drug)
Directory (poison control, manufacturer info, Health Organization...)
Clinical information
Monographs (NO monograph for ALL medicines)
Appendices (Narcotic drugs, ADR forms, special access programme, Latin

sigs (short-forms), etc...)

26

Other important things it has:

Lilac pages: Drug & Food interactions, Drug & Grapefruit interactions,
Drugs containing lactose, Drugs containing sulphites
Immunization information
Lab reference values
Drugs in Pregnancy & Lactation
Drugs in Dentistry
What is the e-CPS?
Web access to CPhAs CPS
Current, up-to-date information (CPS physical book is published
ONCE a year!)
Health Canada health advisories
User friendly search (faster!) can search by drug
Information for pts (printable sheets, supplements counselling)
Martindale (updated EVERY 3 years)
INTERNATIONAL reference by Pharmaceutical Press
ALL NON-Canadian drug Qs + Canadian drug Qs
Brand names from other countries (foreign product inquiry!)
Directory of manuf. FULL name of maunf. &/or distributors, including address
where available
Drug monographs (complete drug reference includes herbal, etc...)
Part I chapters arranged by therapeutic use/action
o Each chapter contains monographs divided into sections:
ADRs & precautions, interactions & PK, uses &
administrations, preparations
Monographs include chemical data, storage,
incompatibilities, uses, doses & toxic effects
Part II short monographs arranged alphabetically
o May be on new drugs, obsolete drugs, herbals, toxic substances,
drugs that are difficult to classify
o Monographs may include same information as above where
available
Part III
o Alphabetically by proprietary name
o Includes manuf. or distributor (directory of WORLDWIDE drug
manuf.)
o Active ingredients (cross-referenced to drug monographs)
o Indication summary, includes preparations from a number of
countries
When to use Martindale: (UNIQUE features of Martindale)
(1) It contains pharmaceutical data (e.g. chemical formula, stability,
solubility, etc...)
CHEMICAL structure *** (also Remington, AHFS)
(2) Most chapters begin with a disease treatment review
(3) International drug proprietary names *** & OFF-LABELLED

27

drugs
Therapeutic Choices (CPS)
Basically gives information on how to handle certain disease/conditions
Comparison of different drugs (drug A vs. drug B) (e.g. TCAs vs SSRIs)
Used when the INDICATION IS KNOWN
Gives tx recommendations
Primarily MD authored
When to use TC:
When you KNOW THE DISEASE STATE & a particular recommendation
is to be given
Patient Self-Care (PSC)
Used to help pts on selecting OTC products, NON-drug measures (* NO
BRAND NAMES)
Pharmacist-authored
Addresses everyday issues community pharmacists are challenged with
Has pt information which can be photocopied & given out if wanted to
When to use PSC:
When need to look up MORE information on issues handles by
pharmacists
It essentially guides the pharmacists as to the assessment
questions (red flags) to be asked to the pt (i.e. when to refer
pt), in order to narrow down the pts condition & hence accordingly
recommend an appropriate tx/referral
United States Pharmacopoeia Dispensing Information (USPDI)
TWO volumes:
Volume I DRUG information for HCP, clinical information (similar
to CPS); ***AMERICAN information*** labelling, AUXILIARY
labels***
Volume II advice for the pt, NOT intended for HCP, helpful
for counseling on rx drugs
Volume II is used when want to look up lay language terms &
lay language counselling points for drugs (EASY TO
Understand Language)
Volume III Provide info on packaging, labeling, storage of
medications & also therapeutic equivalency info along with legal
requirements for dispensing of drugs pertaining to USA
(e-CPS, PSC & USPDI-vol II can ALL be used for pt advice in lay
language)
Drugs in Pregnancy & Lactation (Briggs, Freeman, Yaffe) QUARTERLY updates
Preg & lactation Q this source + Motherisk are VERY good since CPS is
published by the manuf.
Gives practical information about the use of drugs in pregnancy & breastfeeding
Known/possible effects on the fetus
Known/possible movet of drugs into breast milk
Uses FDA Risk Factory scale (A, B, C, D, X pregnancy categories)
28

Drugs, herbals, nutritional supplements

Pediatric Dosage Handbook
Detailed information about pharmacotherapy in pediatric population
Dosing & dosage regimen information***(important since children have
different PK)
Updates on drug monographs
Information on neonatal (NEW born) drug management/dosing
Drug Interaction Facts updated ANNUALLY (supplements sent quarterly in looseleaf format)
Detailed information
Explains the mechanism of the drug interaction
Evidence based drug/drug, drug/herbal & drug/food interactions
Rating scale of the clinical significance/severity of the interaction
Documented effects & management options
Stedmans Medical Dictionary of the Health Professions & Nursing
Good source for general information on MEDICAL TERMS
Definitions of diseases, symptoms, anatomical & biomedical terms
Diagrams on select terms
54,000 entries
American Hospital Formulary Service (AHFS) - updated ANNUALLY
Published by the AMERICAN society of Health System Pharmacists (ASHP)
Evidence-based, peer-reviewed
NO bias from industry, drug insurers, etc...

**EXCELLENT** different from CPS in terms of clinical information as CPS

information is provided by the manuf. (may make their drugs look better) AHFS is
EVIDENCE-based information

Contains monographs (detailed information) of drugs from the US!!!

Drug interactions, adverse reactions, cautions, toxicity, pharmacology,
PK, laboratory test values, dosage, uses, etc...
Chemical structure (Remington, Martindale & AHFS give information
on chemical structure) ***
The ONLY info that AHFS DOES NOT provide is pt counselling info, interactions
with herbals, auxiliary labels, investigational drug info, orphan drugs &
availability in other countries OUTSIDE of USA
ONLY 2 references that give OFF-label uses: ***
(1) USPDI used for auxiliary labels & OFF-label uses in Canada
& USA(for Canadian & NON-Canadian uses)
(2) AHFS lists OFF label uses ONLY in America (NO
differentiation b/w Canadian & NON-Canadian OFF-label uses)
Motherisk (The Hospital of Sick Children) website (www.motherisk.org) + phone
service
EXCELLENT resource for pts & HCP for:
Drugs & pregnancy
Drugs & breastfeeding
MORE current info than Briggs ***
Public helplines

29

Publications also (tertiary & primary)

Dr. Gideon Koren gives information on evidence-based drug use
RX Files ***NOT an approved resource NEVER pick RX Files from options***
Academic detailing for HCP (i.e. differences b/w drugs)
Based in Saskatoon, Saskatchewan
Evidence-based & clinically relevant drug comparison charts
Good, concise, practical information
Supplement to learning from TC
Drug Information & Research Centre (DIRC)
Pharmacist operated (run by the OPA)
Annual subscription
Call in drug information questions, where you have a live agent look up the
answer for you
Also access to online databases, resources, etc...
Health Canada (website) go to the website!!!
Drugs & Health products
Advisories, warnings, recalls
Biologics
Compliance & enforcement
MedEffect Canada (adverse effects)
Medical devices
Natural Health Products
Vet drugs
Special access to drugs

Often meant for pharmacists to give to pts e.g. Yamin, Crestor, Xalatan, Lipitor

E.g. directions of use, common S/E, etc...

Manufacturers Leaflet
Often, the information included in boxes or bottles of medication

NOT really considered a resource or reference

Often a supplement to pharmacist counselling & intervention

Manufacturers leaflet vs Drug monograph (by manuf.)

Drug Monograph (MORE comprehensive than leaflet, found in CPS from manuf.)
As per Health Canada regulations
Guidance document
What is a product (drug) monograph?
Factual, scientific document on the drug product submitted by
the manuf.
NO promotional material
Describes: properties, claims, indications, conditions of use, etc...
Basically, EVERYTHING needed for the safe & effective use of the drug
Uses & limitations
Main components of a Drug Monograph 3 parts: I, II, III
Part I Health Professional Information (found in CPS)
o Pharmacology, indication & clinical use, C/I, warnings & precautions, adverse reactions, drug interactions,

dosage & administration, overdose, storage & stability, dosage forms, composition, packaging

Part II Scientific Information (clinical trials info)

o Pharmaceutical information such as structure, molecular weight
o Clinical trials, efficacy & safety study, pivotal comparative F studies, detailed pharmacology (animal
testing, teratogenicity, etc...)

30

o Microbiology, toxicology, references

Part III Consumer Information
o NO copyright laws for this part (therefore can copy)
o General disclaimer about this medication
o Warnings & precautions, interactions, proper use, S/E & what to do with them, storage, reporting
suspected S/E

Canadian Pharmacists Letter

Established in 1868
Professional development
Peer-reviewed research
Published 6x/year with additional supplemental topic articles & information
Subscription through Canadian Pharmacists Association (CPhA) membership
More for continuing education, rather than a reference
Pharmacy Practice
Publication through Pharmacy Gateway
Online source of pharmacy publications
Rogers Publishing product
Information on diverse clinical, business, management topics for both
community, hospital & industry
Offers CE lessons
More for continuing education, rather than a reference
The Merck Manuals* (i.e. NOT 1 book, but several books)
Created by Merk & Co., Inc. (American Pharmaceutical Company)
Meant as an aid for physicians & pharmacists
There are SEVERAL books:

The Merk Manual of Diagnosis & Therapy ***what we are concerned about***
The Merk Manual of Pt Symptoms
The Merk Manual of Geriatrics
The Merk Index (Chemists) information on chemicals, drugs, biologics
The Merk Veterinary Manual (Veterinarians)
The Merk/Merial Manual for Pet Health (Pet owners)
The Merk Manual Home Edition (pts)
The Merk Manual of Health & Aging (pts)

The Merk Manual of Diagnosis & Therapy (aka The Merk Manual)
Medical information for HCP
Comprehensive (every major body system & disease states)
PATHOPHYSIOLOGY ***
Merk Manual: information on pathophysiology, clinical presentation, diagnosis,
treatment options
Merk Index: contains info about chemical properties & compounding
Remington* updates every 5 years
Information on:
Pharmacochemical properties of drugs (solubility, chemistry, PK)
CHEMICAL STRUCTURE ***
Manuf. considerations & formulas for certain drug products***
Measurement units
Capsule size (unique)
Can be helpful when trying to determine compatibilities & compounding
considerations

31

***Other resource for compatibilities is Martindale***

***Manuf. drugs IMPORTANT for compounding pharmacy to have***
Natural Medicines Comprehensive Database* updates ANNUALLY
UNBIASED information on complementary, alternative & integrative therapies
From the makers of the Canadian Pharmacists Letter
Excellent information on herbal products
Names (scientific & common)
Mechanism of action
People use this for (all known uses without regard for effectiveness)
Uses & its evidence
Drug interactions
Charts on therapeutic efficacy (list of potential efficacious drugs by
indication)
Compendium of Self-Care Products
The CPS of schedule II, III products on the Canadian market
Companion reference to patient self-care
Published by CPhA
Comparative tables
With ingredients, conc.
Organized by therapeutic area e.g. acne, analgesic products,
etc...
Product monographs on several items (ONLY in past versions)

NOTES:
Drug Product Database (DPD) (Health Canada)
o ALL licensed drugs approved in Canada (does NOT tell you about the availability of
drugs... CPS, USPDI & Martindale are used for availability of drugs in Canada)
o Includes human pharmaceutical & biological drugs, veterinary drugs & disinfectant
products
o Information available in the database include:
Brand name, description field, DIN, company, drug statuses, status date, class, active

ingredient(s), strength, route of administration, pharmaceutical form(s), product monograph (PM),

schedule, therapeutic classification, active ingredient group (AIG) number, veterinary species

Mircomedix
o American version of e-CPS (updated often every 3-4 days)
o Tools to identify drugs by shape, colour, embossing (Identidex); section on toxicology
(Poisondex)
o Pt education leaflets for both rx & dietary supplements
Clinical Practice Guidelines
o Up-to-date, specific guidelines in treating specific diseases or indications
o (E.g. use when need the tx for a particular disease, with up-to-date information in
hospital)
Clin-Alert
o Reference book of adverse drug reaction events reported
Drug Facts & Comparisons
o It is a loose leaflet binder that offers MONTHLY updates to provide the most RECENT
FDA approved & OFF-LABEL information for both rx & OTC medications
32

o Also has the brand names of Canadian drugs

o NO info on physical & chemical properties, monitoring, availability in other countries
Drug Interactions Facts
o Loose-leaf edition provides DRUG-DRUG & DRUG-FOOD interaction info
Physicians Desk Reference (PDR)
o Compilation of drug package inserts
o ONLY FDA approved indications & dosages are present in PDR
o NO info on availability in Canada b/c it is purely an American reference
o There is a section on product identification (similar to CPS); there is information on
chemical structures, molecular weight, solubility, half-life, etc... (all info can be
obtained in this reference similar to what is present by the manuf. in the package
inserts)
Lexi-Complete Drug Reference Handbook
o Canadian & US brand names
o Information on orphan drugs, OFF-LABEL indications, investigational drugs, PK,
pregnancy risk factors, drug interactions, C/I, dosage adjustment in renal/hepatic
impairment & dosage forms
Red Book
o Pharmaceutical prices described in this book
o Useful tool when inquiring about dosage forms, package sizes, average wholesale price
& manuf. contact information
RENAL Dosages
o CPS, USPDI
Pt LAY LANGUAGE
o USPDI Vol II OR e-CPS pt info sheets
Drug Availability in Canada
USPDI- Vol 1
Martindale
CPS
Health Canada (NOC Notice of Compliance)
Drugs Manufacture in the US
USPDI Vol 1
The American Drug Index (updated annually)
Drug Facts & Comparison (updated monthly & bound
annually)
Drug Topics Red Book (release monthly & bound
annually)
Physician Desk Reference (PDR) (updated annually)
AHFS
Drugs Manufactured in
Martindale
FOREIGN Countries
Index Nominum
USP Dictionary
USAN (for nomenclature)
For Investigational Drugs
Medline (UNAPPROVED drugs)
Martindale
Lexi-Complete Handbook
Drug Facts & Comparison
33

For UNKNOWN drugs (try to

identify by physical
characteristics e .g. special
marks, colour, shape, etc...)
Side-effects

Drug-Drug Interactions

Drug-Lab Test Interactions

Drug-Food Interactions

Drug-Herb Interactions Lawrence

Compounding or Extemp
Characteristics of Specific
Chemicals/Drugs

Pediatrics

Poisoning & Toxicology

Doses & Drug Administration

Formulas for Compounding

FDA website
USPDI- Vol 1
The PDR (USA)
Drug Facts & Comparison

CPS
USPDI Vol 1
Clin-Alert
Meylers S/E & Drugs
AHFS
Drug Interaction Facts (Tatro) more specific
CPS
Clin-Alert
Books with Drug Interactions in title
AHFS
Effects of Drugs on Clinical Laboratory Tests
Drug-Laboratory Test Interactions
Drug Interaction Facts
USPDI Vol 1
Reference Guide to Drug & Nutrient Interactions
Database of Natural Product
Herbs: Everyday Reference for Health Professionals
Remington
Merk index
The Merk Index
Martindale
Remington
The Pharmaceutical Codex
Handbook on Injectable Drugs (Trissel) for stability
Nelson Essentials for Pediatrics
Nelsons Textbook of Pediatrics
Pediatric Dosage Handbook
Refer to poison control centres YELLOW pages of CPS
Clinical Management of Poisoning & Drug Overdose (3 rd
Ed -1998)
Physician Desk Reference
Drug Facts & Comparison
Martindale
USP-NP (United States Pharmacopeia National
Formulary)
British Pharmacopoeia Vol 2
Contemporary Compounding Compendium

34

LECTURE 4
Evidence Based Medicine (EBM):
EBM = integration of best research evidence with clinical expertise & pt values
How do we practice EBM: 5 steps
o (1) Define the Q
o (2) Collect the evidence to answer the Q
o (3) Critical appraisal = formal evaluation of the evidence gathered (i.e. see if valid, from
good-source & NON-biased)

o (4) Integration of information in daily practice

o (5) Evaluation of process & improvement for the future
(1) Defining the question: PICO (4 steps)
o P = pt/population (your pt)
o I = intervention (drug A)
i.e. comparing drug A to drug B
o C = comparison intervention (drug B)
o O = clinical outcome (consequence or results)
o Structuring a PICO question:
If NOT sure of the comparator then the comparator could either be the CURRENT
standard of care or could even be nothing (i.e. is it better to do nothing than to
use the intervention?)
Sources of Evidence: (general understanding ONLY)
o Evidence Pyramid [in DECREASING importance of clinical decision making]
(1) Systematic reviews, meta-analysis (VERY powerful)
(2) RCTs
35

(3) Cohort studies

(4) Case-control studies
INCREASE in significance,
importance & strength of data
(5) Cross-sectional surveys
(6) Case studies
(7) Case reports
Important Definitions & Term:
o Baseline charactertistics = a set of characteristics or variables collected or
measured before the trial intervention is started (i.e. collecting study subjects
characteristics)
o If a trial is controlled = the tx group is compared to another group
o
Placebo-controlled = the tx group is compared to a group receiving inactive tx

(i.e.

everything looks the same but the active ingredient is NOT there)

o Active-controlled = the tx group is compared to the tx already in practice

o Arms of the trial = the study group are split into 2 different groups or arms
Sources of Evidence
o Systematic Review
Formal method to review articles in literature on a particular topic (VERY
specific)
Published & UNPUBLISHED trials (look at unpublished trials to reduce bias &
get the entire picture)
o Meta-analysis
Combine several RCTs to get a single numerical estimate of results
(takes little RCTs & combines these making a sample population LARGER
can combine studies if same pt characteristics & same medication compared,
b/c of larger sample size, get LESS variability & a better representative sample)
o Randomized Control Trials (RCTs)
Gold standard
Ideal for assessing relative effects of drugs
Have control & treatment groups
(RCTs tests for efficacy & NOT effectiveness as NOT real-life conditions as
drug NOT yet on the market & we have controlled our pt population. Whereas
once in population then cant control pts & we see the drugs effectiveness)
o Cohort Studies
Observational, over long periods of time
To detect complications, new events
Follow 2 groups & observe
PROSPECTIVE - looking-forward (e.g. follow ppl for 3 months) IMPORTANT
when trying to analyze risk factors
o Case Control Studies
Selecting pts with a specific disease
Looking at PAST data to find causation
Takes SHORTER time period to complete
RETROSPECTIVE studies (e.g. lung cancer & tobacco smoking)
o Case Series & Case Reports
Bottom of pyramid due to very small sample sizes e.g. looking at pt medical
36

notes
Cases series = a series of similar case reports
Sources of error: (3 sources of error in ANY type to study)
o (1) selection of study participants
o (2) classification & measurement
o (3) comparison & interpretation
Important to Keep in Mind:
o Accuracy = lack of error, getting the correct result
o Bias = systematic error independent of study size (e.g. testing a drug in ONLY a specific
type of pts & NOT the others)

o
o
o
o
o
o
Bias:
o
o

Error = discrepancy b/w the observed result & the true value
Precision = absence of random error
Reliability = repeatability of a measure
Validity = absence of bias (or absence of ALL error)
The smaller the sample size = INCREASE in random error in the population
The larger the sample size = REDUCES the random error in the population

Bias = preconceived notion about what should happen

Different sources of bias:
(1) Selection bias = systematic differences b/w comparison groups in
prognosis & responsiveness to tx (i.e. leave out certain ppl)
Random allocation with adequate concealment of allocation protects
against selection bias (i.e. blinding)
(2) Publication bias = ONLY take the trials with a positive result to publish,
leaving OUT negative results (over-representation of positive studies in
systematic reviews may mean our reviews are biased toward a positive result)
o *Systematic reviews: publication bias is the MOST difficult type of bias to overcome
in this study design***
P-value:
o P-value = statistical significance
o P<0.05 = indicates TRUE DIFFERENCE b/w the 2 arms = statistically significant result
o The smaller the P-value (e.g. P<0.001), the more likely the result is NOT due to chance
o P>0.05 = NO difference b/we the 2 arms; any difference may be due to chance
Confidence Interval
o Confidence interval (CI)= the precision of the results; used with ARR, RR, RRR &
NNT
o The WIDER the CIs, the LESS precision there is in the results
o Practitioner must decide if it is clinically significant
Results:
Event Rate:
Experimental
Controlled
- EER = EE/ES
Group (E)
Group (C)
E = Events
EE
CE
- CER = CE/CS
N= NONEN
CN
events
S = Total
o ARR = CER EER
=EE + EN
=CE + CN
Subjects
Percentage of
37

subjects treated with the intervention SPARED the adverse outcome compared
with control
o RR = EER/CER
Amount of risk REMOVED by the intervention compared to the control
o RRR = (1-RR) x 100%
Reduction in adverse outcomes in the tx group relative to those in the control
o NNT (or NNH) = 1/ARR
o Odds Ratio = (EE/EN)/(CE/CN)
(odds ratio >1 = event MORE LIKELY to happen, odds ratio <1 = event LESS
LIKELY to happen)
o NNT = # of ppl the drug needs to be given to, to see a benefit
o RRR = amt by which the risk is reduced by the drug compared to the controlled group
(i.e. proportion of risk REMOVED by the tx)
Null Hypothesis:
o To test whether a pattern exists in a set of data, you propose a NULL HYPOTHESIS that
the pattern does NOT exist
(1) An assumption where an observed difference between two samples of a
statistical population is purely accidental & NOT due to the tx
(2) The hypothesis to be investigated through statistical hypothesis testing so
that when argued against, it indicates that the alternative hypothesis is true
Statistical Errors: ***MEMORIZE***
o Type I error (ALPHA):

false positive (i.e. say there is a difference b/w the 2 groups when there isnt)
Incorrectly rejecting the null hypothesis in favour of the alternative
o Type II error (BETA):
false negative, opposite of a Type I error (i.e. say there is NO difference b/w the 2 groups
when there is)

False acceptance of the null hypothesis

Professional Collaboration:
Collaborative Care:
o Physicians, pharmacists & other providers using complementary skills, knowledge &
competencies & working together
o To provide care to a common group of pts based on trust, respect
o An understanding of each others skills & knowledge
o Advantages:
(1) IMPROVE access to care
(2) Enhance the quality & safety of care
(3) Enhance the coordination & efficacy of care
(4) Enhance provider morale & reduce burnout with health professionals
IMPORTANT factors recognized for collaborative care:
o Patient Centered Care
Models of collaborative care must:
Be designed to meet the needs of pts
Enhance the quality & safety of care provided to pts
It is the pt who ultimately must make informed choices about their care
o Mutual Trust & Respect
38

Collaborative & respectful interaction among HCPs

Members understand & respect the professional responsibility, knowledge &
skills that come with their scope of practice
o Clear Communication
Members of the team communicate effectively to provide safe & optimal care
Team members ensure that the pt is receiving timely, clear & consistent
messaging
EFFECTIVE & EFFICIENT communication
Should be supported by CLEAR DOCUMENTATION that identifies the author
Common, accessible pt record in collaborative care settings is desirable (e.g.
electronic records)
To ensure appropriate communication b/w HCP
To PREVENT duplication, coordinate care, share information & protect the
safety of pts
o Clarification of Roles & Scope of Practice
Roles & responsibilities of each HCP on the team be clearly defined &
understood
The pt should also have a clear understanding of the roles & scopes of practice
of their providers
o Clarification of Accountability & Responsibility
Providers MUST be accountable & responsible for the outcome of their individual
practice
Individual responsibility is reqd so that pts can be assured that their well-being
is protected & that the team is working toward a common goal
Collaborative Care Example:
o Family Health Team (FHT):
Primary health care that brings together different health care providers to coordinate highest quality of care for the pt
FHT consists of: doctors, nurses, pharmacists & other HCP
Regulated Health Professionals Act (RHPA):
o Regulates the HCP in the interest of the public
o ALL regulated HCP must have standard of practice
o The colleges were established under Regulated Health Professions Act, to
protect publics right to safe, competent & ethical health care
o Each college ensures that its members uphold the standards of practice by holding its
registered HCP accountable for their conduct & practice
Definitions:
o Practitioner = a person registered & entitled under the laws of a province to practice
medicine, dentistry or veterinary medicine
CAN DISPENSE medication to their own pts (DPRA)
Practitioner vs prescriber
Practitioner registered under 3 fields: medicine, dentistry, vet
o Narcotics can ONLY be prescribed by practitioner & NOT prescriber
(must prescribe within scope of practice e.g. dentist cant
prescribe cholesterol meds)

39

Prescriber can prescribe if have authority under MEDICAL DIRECTIVE

(e.g. chiropodist, podiatrist), can prescribe other things like wheelchair,
hearing aids, etc...

Audiologists:
o Concerned with the prevention, identification, assessment, treatment & rehabilitation
of hearing difficulties in children & adults
o IN ONTARIO ONLY, they (along with physicians) can prescribe hearing aids
o DO NOT need a referral from a family physician for access
Speech Language Pathologists:
o Concerned with the prevention, identification, assessment, treatment & rehabilitation
of:
Communication disorders
Swallowing disorders in children & adults
DO NOT need referral for access
Podiatrists:
o Focuses on preventing, diagnosing & treating foot & ankle conditions by medical,
surgical or other means
o DO NOT need referral for access
o For DIABETIC FOOT, need to go Dr 1st then podiatrist as the podiatrist wont
understand how diabetes works
o Podiatrists vs Chiropodists go regarding any foot problems
NO clear distinction b/w the titles either title can be used by the trained
HCP
Within the profession it is widely becoming accepted that Chiropody is used for
palliative foot care & Podiatry is used for more advanced work such as minor
surgery (however, NOT legislated)
Chiropractors:
o Experts trained in the neuro-musculoskeletal system
o Diagnose & treat disorders of the spine & other body joints by adjusting the spinal
column or other corrective manipulation
o Advise pts on corrective exercises, lifestyle & nutrition
o DO NOT need referral for access
Dental Hygienists:
o Registered & certified health professionals who specialize in PREVENTING oral health
problems & diseases
Dieticians:
o Professionals for food, diet & nutrition information
o Work in hospital, industry, community, government & education
o Nutritionist is NOT A PROTECTED title in all provinces
o TPN is when dieticians works with a pharmacist
Medical Radiation Technologists (MRTs):
o Perform diagnostic imaging examinations & administer radiation therapy treatment
Medical Laboratory Technologists (MLTs):
o Perform sophisticated medical tests on blood, body fluids & tissues
o For lab work need a requisition from a Dr for it to be covered, if walk in then will need
to pay for it
40

Midwifery:
o The assessment & monitoring of women during pregnancy, labour & the post-partum
period & of their newborn babies
o Provision of care during normal pregnancy, labour & post-partum period
o Conducting spontaneous normal vaginal deliveries
Nursing:
o Includes both promotion of health, prevention of illness & the care of ill, disabled &
dying people
o Perform controlled act of administering a substance by injection or inhalation,
performing a prescribed procedure below the dermis or mucous membrane, putting an
instrument, hand or finger into body openings
o Registered Nurses (RNs), Registered Practical Nurses (RPNs), Registered Nurses in
Extended Class (RN(EC)) & Nurse Practitioner
o RN(EC)s or NPs can order certain drugs (NOT controlled substances...only Dr, Vet &
Dentist), lab tests & diagnostic tests (e.g. x-ray, ultrasound, ECG, mammography,
spirometry)
Occupational Therapists: DO NOT require referral
o Enable individuals, families, groups, communities, organizations or populations to
develop the means & opportunities to identify & engage in the occupations of life
o To enable ppl to participate in the activities of everyday life (i.e. help ppl to do their
day-to-day activities)
o Enabling people to do things that will enhance their ability to participate or by
modifying the environment to better support participation
o Can PRESCRIBE wheelchairs***
Optician:
o HCP who designs, fits & dispenses lenses for the correction of a persons vision
Optometrist:
o Specializes in the examination, diagnosis, treatment, management & prevention of
disease & disorders of the visual system, the eye & associated structures
Physiotherapists:
o Goal is to restore, maintain & maximize your strength, function, movement & overall
well-being
o Prescribe personalized therapeutic exercises, & provide essential education about the
body
Social Work:
o Concerned with helping individuals, families, groups & communities to enhance their
individual & collective well-being
o Work in general & psychiatric hospitals or community health centres
o Provide a link b/w interprofessional team & the family as well as with community
services
o ***REFER pt to social worker if cant pay for drugs***
Pharmacists: (Medication Experts)
o Custody, compounding & dispensing of rx drugs, the provision of non-rx drugs, health
care aids & devices & the provision of information related to drug use
Hospital Pharmacy Management & Practice:
41

Important to know what hospital pharmacists do:

o (1) Medication experts within the multidisciplinary health care team
o (2) Have access to pt-specific information, such as laboratory test results &diagnoses
o (3) Have access to colleagues to share information/expertise
o (4) Document their activities & findings in the pts health record
Hospital pharmacists can provide Drug Use Evaluation (DUE) = evaluate the prescribing
patters of Drs to specifically determine the appropriateness of drug therapy (to ensure
medicines are used appropriately)
o E.g. monitor how drugs are used, how often & in what popn
Medication Use Evaluation (MUE) = similar to DUE but emphasizes improving pt
outcomes & individual quality of life; will assess clinical outcomes (cured infections,
decreased lipid levels, etc...)
The goal of DUE or MUE is PROMOTE optimal medication therapy & make sure drug
therapy meets current standards of care
Types of Hospitals: (depending on type of hospital will change your role in hospital)
o Acute Care can be classified as primary, secondary, or tertiary depending on types of
services avail at each hospital

Primary serves pts with common disorders

Secondary serves pts referred for specialty care
Tertiary provides VERY specialized care to complex pts transferred from other
two levels of care
o Rehabilitation, Long-term Care (complex continuing care), Teaching vs NonTeaching, Speciality Hospitals (psychiatric, paediatric)
Role of the Hospital:
o (1) Patient Care: involves the diagnosis & tx of illness & injury, preventive medicine,
rehabilitation, etc...
o (2) Education: educating staff to provide better care, pts to care for their ailments &
educating HCPs in order to train them to be competent professionals
o (3) Research: for the advancement of medical knowledge against disease &
improvement of hospital services
o (4) Public Health Promotion: assisting the community in reducing the incidence of
sickness & to increase the wellness of the popn (e.g. poison control centres)
Pharmacoeconomics:
o Specific branch of health economics used to identify, measure & compare costs &
consequences of pharmacy products & services
o Used to help make decisions about formulary inclusions, drug-use policies, clinical
practice guidelines, reimbursement & individual pt therapies
o Situation: ADDING to the formulary:
Pharmacy & Therapeutic Committee (P&T) will have a large part in this

Some factors to help decide this: efficacy, safety, research/evidence (EBM), the
workload associated with its use, cost, place in therapy, etc... (depends on TYPE of

hospital & type of SERVICES provided)

Especially important when the drugs have the SAME efficacy, then these other
factors, like COST, have a larger impact therefore pick the least costing drug
(i.e. must also consider S/E)

E.g. Drug A vs Drug B SAME efficacy as a drug already on the formulary (both in same class

42

PPIs), if Drug A is OD x 20 days & Drug B is BID x 10 days & the cost per tab is the SAME then
ADD DRUG B since duration of therapy is SHORTER (workload associated with therapy) (i.e. need
to think beyond cost & efficacy)

Pharmaceutical Care:
o A relationship b/w the pt & the pharmacist in which the pharmacist accepts
responsibility for drug use control functions & provides those services governed by
awareness of, & commitment to, the pts interests
o Shift focus from products to pts
o Improve pt quality of life
o 3 steps:
(1) Assessment: collect pt, drug & disease information (identify any DRPs)
(2) Care-plan: resolve DRPs
(3) Follow-up: monitoring
Role of Technician in Providing Pharmaceutical Care:
o Help the pharmacist in drug distribution duties
o First doses usually checked by the pharmacist
o Pharmacist also checks IV & chemo drugs
o Tech check Tech ALL refill orders
o Technician helps with filling of incident reports for mistakes outside the pharmacy,
discrepancy reports discovered in pharmacy & audits
o Technicians help to make sure workflow is efficient & effective
o Dispensing & certified to double check unit dose & some IVs Delegated
o Certified to prepare injectable products in a sterile environment including
chemo/TPN, IV admixtures
o Packaging of unit dose
o Purchasing & inventory control
o Narcotic distribution
Hospital Pharmacy Policies & Procedure:
o Policy general statement & guideline
o Procedure describes in DETAIL how the policy will be carried out
o Policies & procedures are management tools for clearly outlining in logical order the
step by step details or method of carrying out those functions to allow the department
to run efficiently
o Written in manual for ALL pharmacy staff to use
o IMPORTANT!!! as provides standardization of practice
o Valuable for training NEW pharmacy personnel or in distributing information dealing
with pharmacy service to other departments
o Procedures are up-dated constantly
o Also provides standards for rest of hospital staff to follow & to ensure continuity &
consistency in practice
o Policies & Procedures answer:

(1)
(2)
(3)
(4)
(5)
(6)

What needs to be done?

What is the purpose?
When should it be done?
How should it be done?
Where should it be done?
By whom should it be done?

Hospital Organization:
43

Board of trustees, comparable to the Board of Directors, governs the hospital

They establish the vision of the hospital & principles/strategies of care
The board is the Executive body of the hospital & is responsible for the
establishment of the hospitals by-laws & policies
The board also accepts responsibility for the enforcement of The Public
Hospitals Act
The Role of the Board:
Hire a CEO
Appoint medical staff
Approve operating budget
Ensure that suitable funding is available
Raise funds
Oversee pt safety
Board is expected to have the knowledge & expertise to supervise &
assess the medical staff directly & is responsible for making decisions of
the corporation
Medical Advisory Committee (MAC)
The Public Hospitals Act requires that the medical staff organize itself into a
system of committees for regulatory & supervisory functions the chief once
being the MAC
MAC is RESPONSIBLE to the GOVERNING BODY of the hospital
It consists of elected members of EACH major section of the medical staff (i.e.
dif wards/dif depts.)
It also appoints various medical staff to other standing pr special committees
which report DIRECTLY to the MAC e.g. P&T committee, The Quality
Assurance Committee, etc...
Recommendations from the committees MUST be REFERRED to the
Board of Trustees for action & implementation
MAC receives, considers & acts upon reports & recommendations from each of
its sub-committees
MAC makes RECOMMENDATIONS to the Board of Directors concerning
matters prescribed by the Public Hospitals Act E.g.
Quality of care provided in hospital by professional staff
Clinical & general rules regarding professional staff
Privileges granted to each member of professional staff
Dismissal, suspension or restrictions of privileges of any member of
professional staff
Roles of MAC:
Advise board on matters of the quality of care being provided to pts
Reqd to supervise the practice of medicine in the hospital & report to the
board
Pharmacy & Therapeutics Committee (P&T Committee)
Also called the Drug & Therapeutics Committee in some hospitals
Sets a forms line of communication b/w the medical staff & the pharmacy dept
of the hospital
44

Open lines of communication about therapy to physicians & nurses

Composition & operation might vary from hospital to hospital, but general
guidelines apply
Usually composed of at least 3 physicians, a pharmacist & a
representative of the nursing staff
Larger hospitals may have MORE members & MORE representations from other
depts. e.g. infection control, etc...
Committee members are appointed by the governing unit (i.e. MAC)
It reports to the MAC (***P&T committee appointed by MAC, so they report to
MAC***)
Role of the P&T committee:
(1) Evaluates & standardizes medication use within the hospital
(2) Sets standards for drug use
(3) Evaluates the ongoing use of drugs for effectiveness
(4) Maintains the hospital formulary***
(5) Serve in the advisory capacity to the medical staff & hospital
administration in ALL matters pertaining to the use of drugs, including
investigational drugs
(6) Establish or plan suitable educational programs for the hospitals
professional staff on matters related to drug use
(7) To study problems related to the distribution & administration of
medicines, including medication incidents
(8) To start &/or direct drug utilization review programs & studies
(9) Make recommendations concerning drugs to be stocked in hospital pt
care area
Hospital Formulary:
o Purpose: improve the quality of care & to restrain health care costs
o List of drugs pts in the hospital are ELIGIBLE to receive (that is paid for by the hosp &
avail in the hosp)
o Informs physicians, pharmacists & other HCP as to policies & procedures associated
with the availability of drugs in the hospitals (assists in prescribing)
o NON-formulary drugs are drugs that are commercially available but NOT included in
the hospital formulary
o NON-formulary drugs will NOT be dispensed unless the doctor orders the
NON-formulary drug for a specific pt by use of a special NON-formulary drug
request form
o To obtain the drugs, the prescribing doctor must provide information to the pharmacist
regarding the pt receiving these drug(s) & the reason for use
o Alternatively, the pts family may buy the medication for the pt & bring it to the
hospital

Hospitals work in local networks with a number of hospitals therefore if a drug is NOT available at one
hospital then can request/borrow from another hospital (*pt always comes 1st*)

Hospital formulary must be APPROVED FOR USE by the Medical Advisory

Committee on recommendation from the P&T Committee
Hospital formulary BENEFITS:

45

Therapeutic: provides the GREATEST benefit to the pt & the physician in that
the MOST effective & efficient products are listed & therefore available
Economic: eliminate duplication, reducing inventory duplication & increasing
the opportunity for volume purchasing
Educational: contains information for prescribing & drug use (i.e. a lot of
formularies will include an explanation of WHY it is on the formulary (to
EDUCATE others))
o Things to consider for placing drugs on formulary: cost, S/E & cost of managing
S/E, effectiveness, admin cost, pt convenience
Hospital Committees:
o P&T; Patient Safety; Medication Safety; Hospital Accreditation; Health Records;
Pandemic Planning; Management Network; Informatics; Inter-professional; Hospital
Councils or Programs; Clinical Teams
Purchasing of Pharmaceuticals:
o Why is the pharmacist involved? Knowledge of product quality, assurance of supply, control

of dating

Group purchasing:
Group decides on products to be tendered
Tenders are sent to selected supplier
Sealed bids are received by group
Group reviews bid & decides on supplier based upon a number of criteria
o Contract purchasing:
Purchasers agree to buy specific volumes over a given period of time at a fixed
price
Price reductions for committed volumes
Used by large chains, banners & hospitals
Includes rx, OTC & other front shop items
o Sources of Supply:
Manufacturers, wholesalers, distributors, other pharmacies, hospitals
Common Drug Policies in Hospitals:
o Therapeutic Substitution: is a medical approved policy that provides for automatic
dispensing of a particular drug in place of a therapeutically but similar drug product (i.e.
o

can substitute entire drug for another drug e.g. hospital only gives 1 PPI NO matter what PPI you come in hosp with,
exception = ONLY 1 PPI by IV = pantoprazole)

interchangeability*
Auto-STOP Policy: policy where the therapy of certain drug classes are
automatically STOPPED after a fixed duration, in order for the doctor to reassess if the
pt still needs it or not of if the pt needs a new drug to be substituted or added to the
current regimen

*different than therapeutic

E.g. antibiotics may have an auto-stop policy of 3 days (safety reasons)

Amox TID in community pharmacy need quantity to dispense, in hospital automatically give
therapy with a STOP-policy of 7 days therefore can reassess pt & limit medication over-use & waste

Perpetual Inventory: a perpetual inventory system provides information regarding

the balance on hand of any narcotic & controlled drug stock. A perpetual inventory
sheet is completed each day. The balance at the end of the day is the same as the
starting balance for the following day. At any time, a physical inventory of stock in
46

hand in the pharmacy & on the nursing units MUST tally with the amount of each drug
listed in the perpetual inventory sheets

Allows for an ACCURATE record of the inventory & amount of narcotic &
controlled drugs being issued
o
Night Cupboard: as a requisite of accreditation, NO person, other than the
pharmacist, is allowed in the pharmacy after regular hours. A night cupboard is
provided within the hospital for emergency supplies of medication & the pharmacist
on call, if necessary, will RETURN to the hospital
Medical Directives:
o Method to delegate a CONTROLLED ACT from health professional to another (i.e.
can provide care outside normal scope of practice ONLY under medical directive (e.g.
diabetic nurse starting insulin, pharmacist adjusting warfarin for pt at warfarin clinic)

Common in hospitals, but can now be outside hospitals as well

In order to delegate or to accept delegation, pharmacists MUST ensure that the
following principles are met:
The procedure being delegated is clinically appropriate & in the pts best
interest
The delegator (authorizer) & the delegate (implementer) have the competency
(knowledge, skills, judgement) to perform the acts or tasks
In assessing the performance readiness, the authorizer & implementer need to
ensure that the procedure will be performed competently (i.e. safely, effectively
& efficiently) & that the outcomes will also be managed appropriately
Both the authorizer & the implementer are accountable to the pt for
their decisions & actions
Pt must consent to receive care by the delegate, under the medical
directive
Directives MUST be approved by MAC
Why is Hospital Pharmacy Management Important?
o 1 pharmacist per 100 beds
o Increasing staffing complements
o Increasing work complexity
o Increasing costs of providing the service as well as the cost of drugs
o Increasing demands for accountability including risk management & pt safety
Total HEALTH Expenditure: (1) Hospitals (2) Drugs (INCREASING) (3) Physicians (4) Other
professionals
Prescribed drugs account for the MAJORITY (85%) of total DRUG spending in Canada,
increasing at MORE than DOUBLE the rate of NON-prescribed drugs in 2009
Definitions:
o Adverse Drug Reaction (ADR) = unintended & undesired effect of a drug , which
occurs at doses used in humans for prophylaxis, diagnosis or therapy
EXCLUDES: therapeutic failures, intentional/accidental poisonings, drug abuse,
medication errors in administration (too much/little drug), drug interaction, NONcompliance
o Adverse Drug Event (ADE) = ADR in addition to medication errors (errors in
prescribing, dispensing, pt adherence & monitoring)
o
o

47

Drug Related Problems (DRP): pharmacists NEED to identify potential DRPs

o Untreated indication, improper drug selection, sub-therapeutic dosage, failure to
receive drug, over-dosage, adverse drug reaction, drug interaction, drug without
interaction
ADEs are PREVENTABLE!
o Different stages at which ADEs can occur:
(1) prescribe (2) transcribe (3) dispense (4) administer (5) monitor
Patients at Risk of ADEs:
o Elderly:
Tend to receive MORE medications
Illnesses tend to be treated with high-risk medications
Drug interactions occur due to polypharmacy
Poor compliance
Altered PK/PD
o Multiple Medications:
5% (1-2 meds) 10-20% (>5 meds) 50% (>10 meds)
o Particular Drug Classes: Cardiovascular drugs (1st), Antibiotics (2nd), Diuretics (3rd), NONopioid analgesics (4th)

How do you PREVENT ADE:

o (1) Communication
o (2) Policies & Procedure
o (3) High alert drugs
o (4) Recognize pt populations most at risk
o (5) Recognize drug classes
REDUCING ADEs:
o Medication Reconciliation: a formal process of
Obtaining a complete & accurate list of each pts current home medications
including name, dosage, freq, & route = BEST POSSIBLE MEDIATION HISTORY
(BPMH)
Comparing the physicians admission, transfer &/or discharge orders to that
BPMH list
(1) ADMISSION compare: BPMH vs admission medication orders (to identify &
resolve any discrepancies)
(2) TRANSFER compare: BPMH & the Transferring unit medication
administration record vs transfer orders (to identify & resolve any discrepancies)
(3) DISCHARGE compare: BPMH vs the Last 24 hrs medication administration
record + new medication started upon discharge (to identify & resolve any
discrepancies & prepare the Best Possible Medication Discharge Plan (BPMDP))
Also medication reconciliation process on surgical PRE-admission
o >50% of ALL hospital medication errors occur at interfaces of care
o A common error is an OMISSION of a regularly used medication (46.4%)
o Medication Reconciliation helps to DECREASE adverse drug events by 15% &
medication errors by 70%
Hospital Management is all about:
o Medication safety: effective, evidence-based
o Patient safety: medication systems, technology
48

o Public health: promoting wellness & prevention

o Accountability
Technology & Patient Safety (via drug distribution):
o The unit-dose drug distribution system is the method of choice b/c it provides
improvements in:
Medication safety
Overall system efficacy
Job satisfaction & effective use of human resources
Technology & Patient Safety (via drug administration):
o The process to administer a drug safely to a pt is complex & involves many health care
disciplines working towards the common goal of high quality, safe, efficient drug
administration
o This process typically consists of these main phases: prescribe, transcribe, dispense,
administer & monitor (i.e. processes occur at DIFFERENT parts of hospital & with
DIFFERENT people)
o Bar coding:
Part of safe medication system
Added to unit-dose packaging & prepared doses in pharmacy
Can be used at the patients bedside to automate bedside medication
administration & increased pt safety
By scanning bar codes on unit-dose medications, pt wristbands, & staff ID
badges, staff can automate cognitive checks of right pt, right drug, right dose,
right route & right time before administering medications, & also sign off the
administration of the drug
Eliminates a number of manual steps & reduces the chance of error
Technology & Patient Safety (some machines/programs):
Automated dispensing cabinets (ROBOT)
Bar-coding
Centralized intravenous admixture
Computerized Physician Order Entry (CPOE)
Electronic Medication Administration Records (eMAR)
Unit dose
Reporting Medication Errors:
o Hospital Pharmacy Dept

ANYONE can report nurse, janitor (e.g. pt falling) reporting is VOLUNTARY

ISMP Canada

o
o

Canadian Society of Hospital Pharmacy (CSHP)

National System for Incident Reporting (NSIR)

Has information of common medication errors & how to fix them

Government based, operated by CIHI (Canadian Institute of Health Information GO TO

website, tells you most frequent drug trends in Canada e.g. Most dispensed)
NSIR is used by Canadian hospitals to share & discuss medication/IV incidents (e.g. omitted
dose, wrong quantity, wrong pt) participation is VOLUNTARY

Reporting in hospital pharmacy is VOLUNTARY

Should report to at least 1 to prevent the incident in the future NO order of
preference on who to report to
ISMP (Institute of Safe Medication Practices):
o
o

49

Founded in early 2000, FIRST NATIONAL reporting system in Canada (NO national
reporting system existed in Canada before this) (sister organization in US)
o INDEPENDENT, NON-PROFIT organization
o Collects & analyzes medication error reports & the development of recommendations
for the enhancement of pt safety (i.e. prevention of harmful medication incidents)
o It is a VOLUNTARY practitioner reporting system
Goals of Reporting Medication Errors:
o REDUCE avoidable AEs
o REDUCE mortality & morbidity
Morbidity = the rate of disease or proportion of diseased persons in a given
locality, nation
Mortality = measure of the number of deaths (in general, or due to a specific
cause) in some popn
Pharmacys Responsibility to Administration:
o Annual Reports are prepared & submitted to the administrator of the hospital to keep
him/her informed of the activities & achievements of the pharmacy dept
o A typical report to the administrator:
Financial reports, staffing, workload monitoring, supplies, adverse drug
reactions, medications incidents/errors, activity reports, quality assurance,
accreditation
Hospital Pharmacy: Role of the MANGER:
o Within the DEPT:
Human resource management (i.e. staffing), risk management, pt safety, resource
management (i.e. where the pharmacists work within the hospital), resource security,
supplies procurement, policies & procedures, education & research, standards of
practice & legal issues
o Within the HOSPITAL: (i.e. responsible for the WHOLE hospital & NOT just the dept)
Budget & fiscal responsibility, risk management, accountability for resources, pt
care support, pt safety, policy development, committee participation & support
(e.g. P&T committee), standards of practice & legal issues
o Financial accountability, workload measurement, HR related accountability, external
accountability, public relations, annual reporting
Financial Accountability:
o Budgeting, variance reporting, inventory management, purchasing & inventory control
Hospital Funding:
o INCOME: Ministry of Health (81%), pts (2%), preferred accommodation (2%),
commercial services (5%), other income & recoveries (7%), amortization of
contribution for equipment (3%)
o EXPENSES: salaries (56%), benefits (12%), general supplies & expenses (17%),
medical & surgical supplies (5%), drugs (6%), amortization of equipment 94%)
Budgeting:
o Staffing, drug costs, other supplies & expenses, capital environment, renovations
o

o
o

Dept are reqd to predict their budget status at year end to assist in the budget process

If the original budget is TOO HIGH, then reductions need to be made

If reductions have to be made , then the implications of the reductions have to be

50

stated (i.e. increased in drug cost if # of pharmacists are reduced)

o Budget is the established & monitored on a monthly basis
o Operating expenses: drugs, staffing, other supplies (IV admixture, med-surg supplies, gloves, gowns)
o Operating revenues
o Capital equipment: emergency replacement
Budget Variances:
o Manager is required to explain variances either over or under & predict costs &
revenues at year end
Purchasing & Inventory Control:
o Contract administration: role of buying groups
o Purchasing procedures
o Receiving product & documentation
o Inventory control procedures: dating of product, returns
Workload Management: (i.e. how much time is spent with 1 pt doing a specific activity helps tell what pharmacists are
doing most & what is the most demanding time spent)

Drug Distribution:
Raw counts # of drugs dispensed
Standard time measurement
o Clinical activities
Raw counts med reconciliation, pt counselled
Actual time counts
Management tools around resource allocation
Justification tool for added resources
o Should provide the following information:
(1) the workload demands placed on the pharmacy dept
(2) the amount of time (input) spent on various dept activities (e.g. drug
distribution, management)
(3) the index of pharmacy productivity
(4) the optimum number of employees that are needed in the dept
Medication Safety:
Adverse Reactions (AR):
o UNINTENDED & UNDESIRABLE effects secondary to health products (drugs, medical
devices, natural health products)
o Could cause malformations, hospitalization, disability or death
o Post-market surveillance is reqd based on Food & Drug Act & Regulations
How are ARs detected?
o Pts, HCP, manuf., regulatory bodies
o Reporting:
Reporting is VOLUNTARY
Post-marketing surveillance by manuf.
o MedEffect Canada for reporting ARs (part of HEALTH CANADA)
By consumers, industry, professionals
Via fax, writing, online, telephone
Can subscribe to reports
MedEffect Canada: (part of HEALTH CANADA) GOVT ORGANIZATION
o MedEffect Canada provides consumers, pts, HCP with easy access to:
(1) Reporting an ADVERSE REACTION or S/E
o

51

 (2) Obtain new safety information

(3) Understand the importance of reporting
Institute of Safe Medication Practices (ISMP):
o INDEPENDENT, NON-PROFIT
o Collaborates with healthcare community (i.e. pharmacists, doctors, nurses, etc...),
regulatory agencies/policy makers, industry, & the public
o ERROR PREVENTION from occurring
o Systems-approach instead of individual fault (i.e. errors occur due to systems, process & NOT
due to an individual)

VOLUNTEER practitioner reporting system

Analyze MEDICATION INCIDENT & NEAR-MISS reports, identify contributing
factors & causes & make recommendations for the PREVENTION of harmful
medication incidents
o Promote safe medication use & SYSTEM strategies for reduction of adverse drug events
How do we analyze an incident? (e.g. dispense incorrect insulin to pt & they end up in HYPOglycemic state)
o Root Cause Analysis (RCA) = framework designed to provide a standardized
approach to analysis of critical incidents & near miss events in healthcare
environments (understand... DO NOT memorize)
Why is there a need for RCA?
o Errors occur at ALL levels of healthcare
o All staff, even the most experienced & dedicated professionals can be involved in
preventable adverse events
o Accidents result from a sequence of events & tend to fall in recurrent patterns
regardless of the personnel involved
GOALS of Root Cause Analysis: THREE QUESTIONS:
o (1) What happened? (2) Why did it happen? (3) What can be done to reduce the
likelihood of a recurrence?
A Team-based Process:
o Multi-disciplinary process (i.e. pharmacist, tech, student, manager, etc...)
o Those with DIRECT knowledge of the event processes
o Those responsible for change
Multidisciplinary Approach: Key Benefits
o Detailed examination by team often discovers NEW information NOT previously known
by individual team members
o Invaluable to involve frontline staff
Staff understand key processes
Participation creates greater visibility & acceptability for the recommendations
Why did it happen? (e.g. dispensed NOVORAPID (rapid-acting insulin) rather than NOVOLIN (intermediate +
o
o

short-acting insulin))

Reasons for incidents are MULTI-FACTORIAL (i.e. # of factors involved that produced error)
o Need to consider: system/process design, workflow, individual accountability e.g.
workarounds (shortcuts)
Workarounds At-Risk Behaviours: (i.e. when people do this they put the whole system at risk)
o Natural tendency to take SHORTCUTS to make completion of tasks easier or increase
efficiency
o Workarounds occur when a procedure or action does NOT fit with the workflow
o

52

Why did it happen?

o Need to review if it happened before? Does it occur with certain meds more than
others? Where is pharmacy did it occur? Speak with pt, on duty pharmacist, techs,
manager, etc...
o The WHOLE-TEAM should participate in RCA (NOT just the person at fault)
A lot of techs NOT aware of the CONSEQUENCES of the error, therefore need to
EDUCATE them***
Is this a Root Cause?
o If the factor was eliminated or corrected would there be a real chance to PREVENT a
similar event from happening?
o If so, need to redesign the system to REDUCE the likelihood that this could happen
again
Safety Strategies:
o Eliminate REMOVE the hazard
o Control provide safeguards (to PREVENT from happening again)
E.g. of safe-guarding tall-man lettering to help differentiate b/w 2 drugs
(HYPOglycemia vs HYPERglycemia)
Accept NOT an option (if a serious hazard is identified, then minimum safety strategy is a
CONTROL measure)

How can we REDUCE the likelihood of a recurrence? ***MEMORIZE***

o (1) Forcing functions or constraints (e.g. scan EACH box)
HIGHEST level
strategy (MOST effective)
o (2) Automation/computerization
o (3) Simplification/standardization
o (4) Reminders, checklists, double checks
o (5) Rules & policies
o (6) Education & information (e.g. educate staff)
LEAST effective
strategy
o HIGHER level strategies:
Use technology
Implement barcode scanning of EVERY item dispensed
Enhance differentiation:
REVIEW storage option separate short, intermediate & long-acting
insulins in fridge
Consider warning labels
o LOWER level strategies:
Educate staff about high-alert medications & the need for additional safeguards
with these items
BUT still tech may NOT have knowledge to prevent error as A LOT to remember
Failure Mode & Effects Analysis (FMEA):
o FMEA is team-based systematic & PROACTIVE approach for identifying
Way that a process or design can fail
Why it might fail
How it can be made safer
o

(Different that RCA as assumes error is GOING TO happen i.e. will PREDICT an error will
happen before it happens (PROACTIVE APPROACH))

53

o FMEA focuses on how & when a system will fail, NOT if it will fail
FMEA vs RCA (when to use):
o FMEA = Future (preventative, proactive)
o RCA = Retrospective (after the event or close call)
FMEA Steps: (DONT memorize, just understand)
o (1) Select process & assemble the team
o (2) Diagram the process
o (3) Brainstorm potential failure modes & determine their effects
o (4) Identify the causes of failure modes
o (5) Prioritize failure modes
o (6) Redesign the processes
o (7) Analyze & test the changes
o (8) Implement & monitor the redesigned processes
3 ways to IMPROVE safety:
o (1) Mitigate the harm
o (2) Reduce or eliminate failures that cause error
o (3) Make error MORE visible
Medication Reconciliation:
o = accurate list of pts HOME medications are compared at transitions of care
o Discrepancies are identified & reconciled with the doctor
o Intended to minimize potential harm from unintended discrepancies
To PREVENT use of unnecessary medication at home, PREVENTS errors
o Medication reconciliation occurs from admission to discharge (i.e. at each transition of
care) to identify any discrepancies
Admission: Best Possible Medication History (BPMH) vs Admission Medication
Orders
Transfer: BPMH & the Transferring Unit Medication Administration Record vs
Transfer Orders
Discharge: BPMH & the Last 24 hr Medication Administration Record + New
Medications started up discharge
Notes:
Difficulty swallowing REFER to speech language pathologist
Nurse CANNOT perform diagnostic imaging exam (can INTERPRET lab values & order meds)
Speech language pathologist DO NOT need referral
Family Health Care Team is NOT insured by the govt
Occupational therapist CAN prescribe wheelchairs
Biggest health care costs in Canada = Hospitals/Biggest rising cost = Drugs
Auto-stop policy applied to warfarin, cephalexin (NOT zopiclone, aliskiren & meperidine)
Drug Expenditure in Canada:
o Hospital (29.9%)
o Drugs (17.5%)
o Physician (12.8%)
o Other professionals (10.7%), other institutions (9.9%), other health spending (6.1%),
public health (5.5%), capital (4.2%), administration (4.1%)

54

LECTURE 5
The Canadian Health Care System & Health Canada:
Fiscal transfer = FEDERAL govt transfer money to the province & it is up to the province to
budget that money
Canada is a federal nation: National (federal) govt & provincial/territorial govt
o There is INDEPENDENT authority
o Division of legislation & power b/w 2 main levels of govt (national & provincial)
Pharmaceutical Jurisdiction: FEDERAL ***MEMORIZE***
o DOES NOT purchase for general public (EXCEPT for specific groups)
o Control over intellectual rights (e.g. patents)
o Approval & labelling of pharmaceutical products
o Overall competitiveness of pharmaceutical market (i.e. which companies can come into
Canada & market drugs)

Upholds the Canada Health Act (i.e. makes sure healthcare all over Canada is harmonized
(equal) in terms of services)

Pharmaceutical Jurisdiction: PROVINCIAL ***MEMORIZE***

o Buys medications for drug plans (e.g. ODB)
o Sets prices & decide on what drugs will be included in the formulary
o Decide on drug coverage (who is covered)
o Provinces have to address issue of rising drug expenditures & limited health budgets
Canada Health Act:
o Defines the principles that govern our health care system
o Criteria & conditions provinces & territories must meet to get funding from the federal
govt Canada Health & Social Transfer (mechanism)
o The Canadian health care system is universal health care, this means that ALL citizens
& immigrants will have access to health care regardless of their ability to pay. ALL
Canadians are insured on equality basis & offered health in ALL 10 provinces & 3
territories
o 5 Principles of the Canada Health Act: ***MEMORIZE*** CAPPU
(1) Comprehensiveness
55

Insure ALL medically necessary services given by hospitals,

physicians
(2) Accessibility
Provide access to insured hospital & physician services without barriers
(NO economic barriers to medically necessary services)
(3) Portability
Residents are entitled to coverage when they move to another province,
etc...
(4) Public Administration
Health-care insurance is to be administered on a NON-profit basis by
public authority (i.e. NOT private)
(5) Universality
ALL insured parties are entitled to equal access to insured services
What are insured health care services under the act?
o Medically necessary hospital, physician & surgical-dental services
ALL medically necessary in-patient & out-patient services provided in a
hospital
Standard or public ward accommodation; nursing services; laboratory,
radiological & diagnostic procedures such as blood tests & X-rays
Medically or dentally required surgical dental services requiring a hospital
for proper performance
Drug administered IN HOSPITALS
Canada Health Act DOES NOT Cover:
o Services delivered by health-care professionals other than doctors, particularly
OUTSIDE of hospitals (some provinces DO cover these services, but are NOT obligated
to do so under the CHA)
o Services in sectors OUTSIDE the hospital. These include long-term care facilities &
home-care. Pharmaceuticals, rehabilitation & dental care are also NOT covered when
provided OUTSIDE of hospitals
Which groups are COVERED by the FEDERAL govt & NOT provincial? ***MEMORIZE***
o Canadian Forces (military)
o Veterans (via Veterans Affairs) (i.e. members of military that have went to war & now retired)
o First Nations & Inuit (Aboriginal, Native Indians)
o Officers of the Royal Canadian Mounted Police (RCMP)
o Inmates of federal penitentiaries (prisoners) & some former inmates on parole
o Certain designated classes of migrants (refugee)
o (NOTE: seniors over 65 yrs, social welfare recipients & disabilities are NOT eligible
for FEDERAL drug benefit programs)
Canadas Health Care System:
o PUBLIC funding & PRIVATE delivery (i.e. pharmacists, doctors are NOT part of the govt) ***
(compared to the US which is PRIVATE funding & PRIVATE delivery)
o 13 different provincial/territorial health care insurance programs, cost shared with
FEDERAL govt
o FUNDING is dealt with by govt & DELIVERY of services is dealt with by HCP
Health Canada: (VISIT WEBSITE www.hc-sc.gc.ca)
56

o
o
o
o

FEDERAL dept for helping Canadians maintain & improve their health, while respecting
individual circumstances & choices
9 branches, divisions, units
FEDERAL MINISTER of HEALTH responsible for the laws/regulations that run Health
Canada
Health Protection Branch (HPB) of HEALTH CANADA
Responsible for drug quality, safety & efficacy
It regulates drugs imported into & manufactured for sale in Canada
Health Products & Food Branch (HPFB)
Manage the risks/benefits of health products & food
Evaluates & monitors the safety, efficacy & quality of human & veterinary
drugs, medical devices, natural health products & other therapeutic products
available to Canadians
As well as the safety & quality of food in Canada
Promoting Canadians to make HEALTHY choices & giving information
Therapeutic Products Directorate (TPD)
Special Access Program (SAP) ***
Access to drugs NOT approved on the Canadian market yet
Emergency/other therapies have FAILED
Therapeutic Products Directorate (TPD)
Part of Health Canada HPFB
Regulation of pharmaceutical drugs, medical devices, other therapeutic products
in Canada
Rx & NON-rx products
Also NEW indications for ALREADY authorized drugs
BEFORE anything comes onto the market, there must be evidence & testing
Post-marketing surveillance
Marketed Health Products Directorate (MHPD) (part of Health Canada)
Post-marketing surveillance of drugs & natural health products
Monitors adverse events & investigates complaints
Takes appropriate action from informing the public & health care community of
new product safety information, to REMOVING the product from the market
Natural Health Products Directorate (NPHD)
Regulates natural health products vitamins/mineral supplements & herbal
products - when a therapeutic claim is made
Each natural health product approved to be marketed is assigned a Natural
Product Number (NPN) or Homeopathic Medicine Number (DIN-HM)
Special Access Program (SAP) ***
Provides access to drugs NOT on the Canadian market
Options in serious & life-threatening clinical situations, when conventional
therapy has FAILED, UNSUITABLE or UNAVAILABLE
SAP allows a manuf. to sell a drug NOT authorized on the Canadian market
Includes pharmaceutical, biologic, radiopharmaceutical products
Practitioner starts the request by filling out a Special Access Request
(SAR) form
SAP under Health Canada HPFB
57

If in-patient HOSPITAL will pay for the drug

If out-patient, the PATIENT will pay for the drug (or 3rd party insurance if prior agreement)

Common Drug Review (CDR):

o Involves a single process to access new drugs for potential coverage by participating
federal, provincial & territorial drug benefit plans
o The Canadian Agency for Drugs & Technologies in Health (CADTH) develops EVIDENCEbased clinical & pharmacoeconomic reviews to assess a drugs cost-effectiveness
o These reviews are used by the Canadian Expert Drug Advisory Committee (CEDAC) as
the basis for its recommendations on what drugs to include in the formularies of
the participating drug plans
o Federal, provincial & territorial govts (except Quebec) examine the CDR
recommendations but still have the FINAL say over which drugs to include in their
respective formularies
Patent:
o Exclusive rights to manuf. a innovative product
o Patents have expiry date
o Currently, drug patents have an ACTIVE LIFE of 20 years from the date of filing in
Canada
This is the minimum patent cycle allowed under our international trade
obligations
o A 20 year patent cycle DOES NOT mean 20 years of market exclusivity

It may take 8 to 12 years for a new drug to reach the market in Canada therefore
ONLY 8 yrs to make profit

Patented Medicines Prices Review Board (PMPRB):

o Made in 1987 2 roles:
(1) to ensure that prices charged by manuf. are NOT excessive

(i.e. price at which

the patentee sells the patented medicine to wholesalers, hospitals & pharmacies & others)

o
o

o If excessive, can order patentee to REDUCE it

(2) report annually on trends of ALL medicines & R&D spending
Reports to the FEDERAL govt
PMPRB SETS & CONTROLS the prices of PATENTED medication (i.e. patented rx
drugs)
NOT NON-patented drug prices (e.g. generic medication)
Has a patented medicine prices index (i.e. compared prices across 7 different countries)
Existing patented drug prices CANNOT increase more than the Consumer Price
Index (CPI)
PMPRB DOES NOT regulate the prices of generic drugs

Price of generic is LESS in US than Canada (patented Canadian rx are LESS expensive
in Canada than the US)

o OTC prices is set by pharmacist/pharmacy manager

Who REGULATES generic prices?
o NOBODY!!! the market controls the prices (i.e. generic price is about 50% of brand)
Drug Discovery Process in Canada:
Why does Drug Discovery Continue?
o (1) Market Need
Dissatisfaction with current products (i.e. efficacy, safety) or medical need

58

o
o

Ideas
o
o
o

(2) Viable business

HIGH risk, but HIGH returns (shareholder value for about 8-10 years of patent)
(3) Intellectual curiosity
ALL drugs have benefits/drawbacks
Research to improve molecules; betterment of mankind/goodwill
of NEW Drugs:
Internal research (R&D)
Exclusive partnerships with start-up companies; collaboration with universities, etc...
4 MAJOR Sources of a New Drug:
(1) Synthetic novel chemical or new biotechnology product
(2) Natural substance found in humans, that has activity as a drug
(3) Natural substance NOT found in humans, as a drug
(4) Old drug found to have NEW uses (e.g. sildenafil can be used for pulmonary
hypertension)

Pre-clinical Testing/Trials - ANIMALS: (3-5 years) (i.e. tissue testing in lab & on animals, testing NOT
done on humans yet)
o Primary pharmacodynamics (i.e. look at MOA of how drug is causing the desired therapeutic effect)
o Secondary pharmacodynamics (i.e. ANY other effect than the desired effect following the same
MOA)

Safety pharmacology
PK/toxicokinetic (blood conc. knowledge of the toxic effects of the drug; LD50 (in
animals))
Toxicology
Mutagenicity (any mutations; genomic damage; heritable effects)
Carcinogenicity (risk of cancer, for short term or chronic use)
Reproduction/teratology (birth defects; effect on fertility)
Studies that investigate potential undesirable effects on physiological function,
in relation to exposure
Important to investigate effects of new drug on vital functions (cardiovascular,
respiratory, CNS)
o Pharmacokinetics: assessment of ADME
Clinical Testing - HUMANS:
o Safe guards
o Must submit Clinical Trial Application (CTA) BEFORE clinical trials on humans
Health Canada approval required
CTA includes: test results, drugs ingredients, dosage forms, MOA, toxic effects ,
etc...
o ALL studies involving humans reviewed by Health Canada: ALL must follow Good
Clinical Practices (GCP)
o Reviewed by Institutional Review Board (IRB), Independent Ethics Committee
(IEC); get pt consent
o Also Data Monitoring Committee
Phases of Clinical Testing:
o Phase 1 tolerance, pharmacodynamics, pharmacokinetics
o Phase 2 dose-finding
o Phase 3 Establishment of efficacy & safety
o

59

Phase I: (6-9 months)

o HEALTHY Human volunteers
ADME
Systems that may be affected
Doses tested (i.e. still dont know optimal dose)
Single Ascending Dose (SAD) or Multiple Ascending Dose (MAD) (keep
increasing until intolerable)
SAD = whole popn gets the SAME dose & INCREASE depending on tolerance
MAD = entire pt popn receive multiple doses & INCREASE depending on tolerance

Bioavailability & Bioequivalence

Rate, equivalence, absorption of different formulations

Bioavailability = amount of drug that reaches systemic circulation to undergo the desired therapeutic effect
Bioequivalence = if 2 drugs give the SAME PK within acceptable limits

Phase II: (6 month 3 years)

o Give to pts WITH DISEASE (i.e. the target disease trying to treat)
o To establish acceptable dose range (i.e. OPTIMAL DOSE)
o Understand & find the efficacy with acceptable toxicity
Phase III: (1-5 years)
o LARGE scale trials with doses from Phase II (i.e. optimal dose found in phase II); ANY PATIENTS
(i.e. look at different pts from HEALTHY & DISEASED pts but trying to focus on DISEASED pts)

LARGE sample size

Could be against historical controls (e.g. placebo or standard of care)
Placebo, or comparator GOLD STANDARD clinical trial
Randomized, double-blind, comparative phase III study
Phase IV:
o Also known as Post-Marketing Surveillance Trial
Involve the safety surveillance of a drug after it receives the approval for
marketing
I.e. look at long-term effects of drug use & adverse effects (rare S/E)
AFTER drug has survived Clinical Testing:
o NEW Drug Submission (NDS) to Health Canada for approval
NDS includes: test data, disease treated, type of pts that could benefit, length of
tx & goal (e.g. cure)
o Notice of Compliance (NOC) Drug has complied to Food & Drug Act & Regulations
ONLY then the drug with receive a DIN
o Notice of NON-Compliance (NONC) Drug does NOT follow the Food & Drug Act &
Regulations
Must RE-START from the beginning (can appeal decision & provide further
evidence)
If the drug is still under testing, it can be obtained through the Special Access Program
(emergency release)
Data Safety Monitoring Boards (DSMB):
o Independent committee
o Reviews data while clinical trial is in progress may recommend that a trial be
stopped if there are safety concerns (e.g. serious expected/unexpected ADRs)
Gaining Market Access:
o
o
o

60

Approval to market a drug based on assessment of benefit/risk ratio (Health Canada)

Approval of prices
FEDERAL legislation
Patented Medicine Prices Review Board (PMPRB)
Governing Bodies: ***
o BEFORE Market Authorization (i.e. BEFORE drug is on the market) Health Canada
o AFTER Market Authorization various organizations monitor advertising to drug
products (including Health Canada)
Advertising Agencies:
o Agencies that provide advisory opinions on messages directed to consumers for
prescription drugs & on educational material discussing a condition or disease
o (1) Advertising Standards Canada
Agencies that have notified Health Canada that they have publicly self-attested
to meeting Health Canadas recommended criteria for the pre-clearance of
advertising material of NON-rx drugs & natural health products directed to
consumers
o (2) Pharmaceutical Advertising Advisory Board (PAAB)
Agency recognized by Health Canada for advertising material for ALL health
products directed to health professionals (e.g. doctors, pharmacists, etc...)
BEFORE the drug reaches the market it CAN NOT be marketed
AFTER the drug reaches the market YES it can be done
o BUT DTCA (Direct to Consumer Advertising) can NOT be done in Canada (e.g.
TV)
Limits of Advertising:
o PROMOTION of rx drug limited to name, price, quantity***
o Any drugs that related to schedule A disease can NOT be advertised (i.e. treat specific
o
o

disease the drug can NOT be marketed but can market just the drug name)

o
o
o

OTC can be advertised ***

DTCA of rx drug can NOT be advertised
Herbal products are given NPN & are NOW regulated (DO NOT need to go through
clinical testing)

Pharmaceutical Calculations: (SEE Reconstitution Calculations***)

Co-pay = a specific amount or percentage of the total amount the cardholder needs to pay
along with third party
Deductible = an amount ($) that needs to be paid by cardholder BEFORE benefits kick-in
Professional fee cap = Third-party puts a cap on MAXIMUM professional fee it will pay,
beyond that cardholder needs to pay (e.g. dispensing fee)
Total yearly cap = The MAXIMUM dollar value per year that third party will cover. When
exceeded, cardholder needs to pay the exceeding amount
Pharmacy Management Principles:
Management Expectations for Pharmacists:
o GENERAL apply knowledge, skills, principles of management with the intention of
improving pt care & interprofessional collaboration
o THE DETAILS

61

 Supervise personnel, delegate functions, meet standards

Manage workflow, management principles
Other functions, advanced roles
Regulations of Pharmacy Management:
o NAPRA gives details of what is IMPORTANT in terms of management in pharmacy
o Ontario
OCP Standards of Practice for Pharmacy Managers
Drug & Pharmacies Regulation Act (COMMUNITY ONLY)
o

(NAPRA INDEPENDENT organization that gives GUIDELINES regarding pharmacy, but NOTHING regulated (i.e. DO
NOT get inspectors going to pharmacies)/OCP (provincial govt) regulate pharmacists for the province)

Pharmacy Management - Community & Hospital:

o Professional services, advancement of the profession, dispensing functions (Drug
distribution!), financial management, human resource management, security,
customer service (hospital?), planning, marketing, legal & ethical obligations,
teaching/research
PLANNING - pharmacy:
o 1st step involves vision, goals, objectives
Vision = how the organization views itself in the future (e.g. achieve global impact)
Mission statement = why the organization exists, who does it serve
o Strategic planning: operations of the pharmacy, organization of the pharmacy
o Marketing pharmacy services
SWOT Analysis: (important for decision making)
o To get an idea what position we are in for future strategic planning
o Organizations use it for future planning & projects
o Why is it important? pharmacies can use it to enhance the services they provide &
remain competitive
o STRENGTHS what we are good at, what do we do well
o WEAKNESSES have to find & define these areas
o OPPORTUNITIES assess the environment on a local, geographic, national level
Current economic climate, legislation changes (e.g. Meds Check)
o THREATS by competitors, government policy, etc...
ORGANIZING - pharmacy:
o Members of a pharmacy team: pharmacists, pharmacy techs, assistants, students,
interns
o Structure of the organization:
Triangle HIERARCHY, pharmacy managers (TOP) staff pharmacists
techs (BOTTOM)
Rigid as following orders, good for emergencies & when things need to be
done
Flat ONE LEVEL, all members on SAME level
E.g. a project that is NEW & everyone is learning together

DECISION MAKING:
o DO NOT follow the same thought process for every decision being made, depends on
the situation
Decisions are more important if they impact FUNDING
o Stakeholder everyone involved in pts care

62

Making a decision STEPS:

(1) What is the situation (outline it)
(2) Collect the data needed (information)
(3) Develop alternatives (different options)
(4) Pros & cons of the alternatives (eliminate the ones that DO NOT make sense)
(5) What is the best alternative (have agreement)
(6) Implement this alternative
(7) Reflect & follow-up (what is a good alternative?)

Community Pharmacy Management & Practice:

How can we make our Pharmacy Grow?
o GOOD management, GOOD people, GOOD marketing
o In both community AND hospital as in hospital have budgets, therefore need to market to get funding
for certain services at board meetings

Managerial Mistakes!
o Things a pharmacy manager should NOT do:
Failure to delegate (i.e. manager does everything!)
Failure to keep learning
Lack of accountability
Lack of knowledge of the business
Lack of vision (i.e. need a vision to have direction & plan for the future, need to know trends)
Cant build teams
Failure to make decisions
What makes a BAD Manager?
o Bias
o Secrecy (i.e. when pharmacist DOES NOT talk to other pharmacists & staff about their performance)
o Oversensitive (i.e. afraid of offending someone)
o Stuck on procedure (e.g. procedure outlines pt call back at 1pm, however, easier to reach pts at 5:30
pm)

o Suck on trivia
o Select weaker candidates (i.e. DOESNT pick the right person for the job)
o Missed deadlines
o Delays decisions
o Hesitant in hiring former employees
o Works long hours
Business Structures:
o How do you determine what structure is best for you?
Owners needs, legislation (provincial e.g. taxes), expected profits, liability
protection
Forms of Business Organization 3 TYPES:
o Sole Proprietorship ONE person owns it & usually manages it
o Partnership when 2 or MORE people involved as co-owners
o Corporation (private/public) a legal entity separate from the owners
Sole Proprietorship:
o Legally, the owner (proprietor) is the SAME as the business (one in the same)
UNLIMITED liability

63

o
o
o

Responsible for ALL debts & obligations

Therefore creditor can make a claim against you assets (personal or business)
Profits are yours!
PROS:
Easy & inexpensive to start (only need to register the business name
provincially)
Direct control AUTONOMY!
LESS working capital needed (i.e. need less money than corporation)
You get ALL the profits (NO partners or shareholders involved)
CONS:
UNLIMITED liability
You & the business are one
Have to use personal assets to pay off business debts, if needed
(therefore owners transfer assets to their loved ones or others)
The profit from business, if goes towards personal incomes, taxed at a HIGHER
rate
Lack of continuity (i.e. succession plan hard to continue if next gen in family DO NOT want to
be a pharmacist)

Hard to raise funds on your own

Partnerships:
o Good option if you want a partner & you DO NOT want to incorporate yourself
o EASIER to raise funds (combined financial resources)
o Partnership agreement
o Get a SHARE of the profits
o 2 types of partners: general & limited
o Limited liability partnerships (LLP) ***
DONT have the same control & privileges as a general partner, but ONLY liable
to the amount they invested (i.e. LLP DO have a say in management)
o Partnership agreement:
VERY important to have a firm & clear agreement BEFORE starting the business,
able to protect interests
A plan to divide profits, losses, how to expand, buy-out, sell ones share of the
business, how to dissolve, dispute resolution, etc...
o The components of the partnership agreement:
Has to be written, drafted by a lawyer
Terms of the partnership (i.e. how much each person will bring into the business to start)
Sharing of profits
Who is responsible for what, that is management duties
Succession mechanism with death or retirement, life insurance
o PROS:
Easy to start, relatively
Can distribute or share the costs with your partner
Profits go to owners
Can have EQUAL share in profits/assets
Better tax rate (i.e. LOWER tax rate)
Easier to manage (2 people or more to help to run the business)
64

CONS:
UNLIMITED liability (just like in sole-proprietorship) LLPs are better for this
HARD to find your soul mate
Need a suitable partner, who complements your thinking & management
style
Financially youre liable, even if a partner break contract
May be difficult or complex to dissolve
o Some QUESTIONS to ask yourself BEFORE partnership:
What will be the role & responsibilities of the partners?
How will the parties involved divide profits, losses & ownership?
Decision making in the business?
Communication channel for important information?
How much will each partner work?
Where do you see the partnership in a few years?
Corporations:
o To incorporate yourself
o Done on FEDERAL or PROVINCIAL level
o The business (or corporation) is a SEPARATE legal entity - separate from the
owners/shareholders
o As a shareholder, you are NOT liable personally DONT have to use your personal
assets
o Can be public (i.e. on the stock market) or private (i.e. limited amt of shareholders) (crown = corp.
owned by govt)
o Can be on the big or small scale
o PROS:
LIMITED liability
Can TRANSFER ownership shares (just selling & buying shares)
Easier to continue the life of the business
SEPARATE legal entity
Ease of raising capital (i.e. sell MORE shares therefore raise MORE money)
Tax advantages
Attract specialized skills & management
o CONS:
More regulation (red tape)
More EXPENSIVE to incorporate
Complicated to start & regulate
Conflicts b/w shareholders & board of directors
Have to please the shareholders (i.e. by making MORE money)
Cooperatives: (e.g. Pharmasave)
o The business is OWNED by its members an association
o LEAST common form
o Appropriate when you want to put ALL your resources in the same pot
Common needs are fulfilled, like delivery, sale, employment
o Managed by board elected by the members
o

E.g. Pharmasave need to pay a certain amount of money to use name (a fee or royalty),
but then can use banner Pharmasave & get their buying power, etc...

65

PROS:
Owned & controlled by its members
Voting system (i.e. vote if you want to do something or NOT) one member = one vote
LIMITED liability
Profits are distributed amongst members
o CONS:
Conflict b/w members (ppl have different views)
Decision-making process can be LONGER
Need the members to participate
Profits are distributed
May feel less incentive to reinvest back into cooperative
Franchise: (e.g. Shoppers Drug Mart)
o The company gives you the right or a license, to run a business under their name
(brand)
o There are ESTABLISHED operating rules & methods (i.e. NOT a lot of decision making
o

power)

o
o
o

Theres a fee (royalty fee)

Its a style, NOT a form of ownership
E.g. Shoppers Drug Mart (SDM)
Still a corporation on a whole, individual stores are FRANCHISED out
SDM = franchisor
Associate (a PHARMACIST) = franchisee
Use the SDM brand, promotional material, advertising, floor plan, store layout, everything!

PROS:
Provides resources (the company does the work for you!)
Site, lease, negotiation, design, pricing, policies & procedures, buying
power (bulk), monitors inventory as well
Can rely on an established name & reputation, customer recognition
Access to consumer data & research
o CONS:
The fees! (royalties or a percentage of sales)
Lack of proper support from the franchisor
May be forced to pay for promotional material or activity
Forced to take on the reputation of other locations
Intrusion!
Lack of autonomy (non-entrepreneurial) NOT for everyone, have to be a
team-player
Are you really an owner? NO!
Financial Statement Analysis:
o Need to assess the performance of the business periodically
o Monitoring the cash flow into & out of the business
o Monitor the growth of the business by comparing data from the current year to
previous years & industry averages (benchmarks)
o We are ALL working towards a profit
o Various statements & reports which can give important data on the health of the
business
Importance of Records:
o

66

Provides information!
Progress, ups or downs
Catch & fix the problem before it gets worse
o Banks & lenders want information
To help decide whether to lend or not
If youll be viable enough to pay back the debt
o Tax purposes
o Auditing
o Valuation of a practice
Financial Statements:
o 2 basic financial statements: (1) Balance Sheet (2) Income Statement
Balance Sheet:
o Picture of the financial position of a business in a point in time (at a particular date)
o Major components include:
Assets including fixed assets, current assets & goodwill
Liabilities
Owners/shareholder capital (Owners Equity)
o Fundamental equation: Assets (A) = Liabilities (L) + Owners Equity
(owners/shareholders capital)
o Assets = things owned by the business
o Liabilities = debts of the business
o Owners Equity = personal capital contributed by the owners + accumulated
earnings of the business
o Balance Sheet:
ASSETS
Cash + Accounts Receivable + Inventory + Pre-paid expenses = total
CURRENT assets
Fixtures/equipment = FIXED assets
FIXED assets + total CURRENT assets = TOTAL assets
LIABILITIES
Accounts payable + Notes payable (<1 yr) + expenses = total CURRENT
liabilities
Notes payable (>1 yr) = LONG-term liabilities
LONG-term liabilities + total CURRENT liabilities = TOTAL liabilities
Fixed/Current Assets & Liabilities:
o Fixed assets hard assets e.g. equipment, furniture, machines, etc...
o Current assets What you own & expect to turn into cash (liquidate) in 12 months
o Long-term liabilities debts which take >12 months to pay
o Current liabilities must be paid within 12 months
Working Capital:
o = current assets current liabilities
o Amount needed to pay current liabilities as they come due
o The amount needed to finance daily operations
o Working capital is influenced by inventory & inventory turnover
Financial Ratio:
o

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Quick Ratio/Liquidity Ratio

The financial ratio is also known as acid ratio b/c it is the most stringent ratio to
measure companys strength & liquidity
o It measures companys ability to come up with hard cash instantly
Return on Equity Ratio:
o The return on equity is a VERY popular financial ratio
o It reveals how much profit a company earned in comparison to the total amount of
shareholder equity on the balance sheet
Income Statement:
o Shows the change in retained earnings from one balance sheet to the next
o Shows profit earned & contribution to the owners equity
Basic Income Statement:
o
Sales
o Cost of Goods Sold (COGS)
o
Gross Marin
o Expenses
o
Profit (before tax) aka Net Income
Gross Margin:
o Also known as SUM of profits & expenses
o Must be LARGE enough to cover expenses
Price, Sales & Profit:
o Profit & Loss statement is usually measured over a period of time (usually 1 year)
o Major components includes:
o
o

Gross sales
Net sales (Gross Sales tax goods returned)
Cost of goods
Gross margin (Net sales cost of goods)
Expenses (fixed & variable)
Profit (gross margin expenses) (aka profit BEFORE interest & tax)
Interest & tax
Net earnings

Expanded Income Statement:

o 4 variables that can affect PROFIT unit price, unit volume, unit cost, expenses
o Sales = Units price x Unit volume
o Cost of Goods Sold = Unit volume x Unit cost
o Gross Margin = Sales Cost of Goods Sold
o Profit = Gross Margin Expenses
o % Gross Margin = [(Sales Cost of Goods Sold)/ Sales] x 100%
o A 10% HIGHER price = 100% INCREASE in profit (if can affect profit exponentially)
many factors affect profitability
Ordering Opening Inventory:
o Some things that help you decide WHAT TO ORDER?

New or established practice differences?

Type of pharmacy
Demographics
Location (strip mall, neighbourhood, etc...)
Health institutions or clinics surrounding you
Specialization of your pharmacy

68

Shelf space
Investment available
Availability of drugs

Inventory Control:
o Inventory control is important for pt care
o If inventory is OUT of control, people feel frustrated
Inventory Turnover (TO):
o Shows you how well you are managing your pharmacy inventory (quantitative
measure)
o Inventory Turnover = how many times, in a specified time frame, is your total
inventory (all of the drugs in your pharmacy, on your shelves) is replaced (so a rate)
Often over the course of 1 YEAR
o Turnover = relationship b/w cost of drugs (goods) sold & inventory
o TO = Cost (of goods sold)/Average inventory (at cost) ***MEMORIZE***
COGS found on income statement, actual cost of drug bought from the manuf.
Average inventory average of the beginning & ending inventory of the time
period (e.g. past yr)

E.g. If the opening inventory for a pharmacy is $100,000 & the expected sales is $400,000, and
the target TO is 3, what should be the closing inventory?
3 = 400,000/average inventory Average inventory = 400,000/3 = 133,000
Average inventory = (opening inventory + closing inventory)/2
(133,000 x 2) opening inventory = closing inventory
Closing inventory = 166,000

What is the IDEAL TO rate?

o HIGH TO rate (e.g. 10-12 per yr) will RUN OUT of stock, patient NOT served
o LOW TO rate (e.g. 2 per yr) taking up space, money could have been used
elsewhere, expiry
o IDEAL TO rate = 3-4 per year***
On average the drug inventory should sell out every 3 months therefore
approx TO rate of 4
How to manage pharmacy drug inventory:
o Importance of inventory 2 reasons
You need product to sell to make a profit
You need drug therapy for pts, in order for you to provide pharmaceutical care &
fulfill professional & legal responsibilities as a pharmacist
o LARGEST investment in your pharmacy = DRUG INVENTORY (therefore need to take
care of it)
o If have TOO much inventory:
Takes up shelf space, unattractive, out of date, damages, requires energy/time
to maintain
o If have TOO little inventory:
Pts cant get their drugs, lose business, reputation goes down, not optimizing
growth opportunity
Way of Inventory Control:
o Monitor in units or dollars
o

E.g.

Can monitor by physically counting the number of pills of a particular drug (units)

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Can monitor the TOTAL cost to date of a certain drug (dollars)

Traditional vs Contemporary methods E.g. can simply count or electronic inventory

management using UPC

Taking Inventory:
o Inventory is counted on scheduled basis minimum once per year
o Pre-printed stock lists with price per unit are used record the actual counts
o The value of inventory is determined by multiplying the price X count per unit
o Process is audited by accounting firm
o Cycle counting = correct inventory based on your counts regularly through the yr
(i.e. up-date computer)
Ratio Indicating Liquidity & Solvency:
o Liquidity = pharmacys ability to meet its current liabilities with little or no
interruption in the regular conduct of business
o Solvency = pharmacys ability to meet current liabilities with moderate change in the
composition of current assets
MCQ Preparation: (Look at lecture for further detail) + 360 Review Class
Identify KEY words in the MCQ
o Circle or underline these words; will help focus & clarify the question & stem
NEGATIVES none, not, neither
SUPERLATIVES most, best
QUALIFIERS usually, often, generally, may
Other: least, except
o Be aware of ABSOLUTE terms, like always, never, every for this option to be
correct it has to be an INDISPUTABLE fact
Read the question first, BEFORE looking at the options, think about an answer in your head,
then see if its in the options
Process of Elimination
o Increases the probability of finding the key by eliminating options that are incorrect or
distracters
o Always do this first, then think more about the options left over
If left with 2 options, give yourself pros & cons for each answer justify the most appropriate
answer (the key)
BEWARE of more than one true option
o Just because its true, DOESNT mean its the KEY (it can be a distracter)
o Therefore have to COMPLETELY understand the stem (should known what they are
asking)
o Have to think about the MOST appropriate response or option, SPECIFIC to
that stem or question
Frequent, intense reviews REPETITION will form MORE memory points, therefore easier
to recall
Make a list of main topics that youre going to cover/study
Have study/summary notes/readings ready near the exam, should NOT be making or
compiling any notes, only reviewing
KEY MESSAGE ALWAYS keep pt specific factors in mind
Notes from Emails from SolRx:
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Public drug spending for seniors INCREASED 5 of 10 seniors being treated for
CARDIOVASCULAR conditions
The MOST common drug class used by seniors is STATINS
Interdisciplinary team (i.e. team of pharmacist, physician, nurse, etc...)
o NO leader in the interdisciplinary team
o Each HCP must respect & use the expertise of others
o The teams interest in the betterment of the pt
1. A deceased patient's wife recently brought the patient's unused narcotic medications
to my pharmacy. Do I have to obtain authorization from Health Canada before I can
destroy these narcotics?
Yes. When patients return controlled drug substances (including narcotics) to a pharmacist, the
pharmacist accepts the legal responsibility for the drug and must, therefore, request a destruction
authorization from the Office of Controlled Substances (separately from the pharmacists own
inventory) before proceeding with the destruction of the controlled drug substances. The
pharmacist must record the amount of narcotic / controlled drug to be destroyed, ensure the drugs
are rendered unusable and witness the destruction.
In the case of a deceased patient, the estate executor is the legal guardian of the controlled drug
substances. Prior authorization from the Office of Controlled Substances to destroy the controlled
drug substances is not required. The drugs should be destroyed in the presence of the estate
executor and a pharmacist. A complete and detailed list of the controlled drug substances to be
destroyed must be prepared, and the estate executor and the pharmacist must date and sign as
witnesses confirming the destruction took place.
Prior authorization is not required for the destruction of benzodiazepines and other targeted
substances.
2. I have a patient with cancer who wants to receive medical marijuana. What does the
patient need to do to?
The patient must apply to Health Canada's Office of Cannabis Medical Access. Application forms are
available online at Medical Use of Marihuana, by telephone toll-free 866.337.7705 or by mail:
Office of Cannabis Medical Access
Drug Strategy and Controlled Substances Programme
Healthy Environments and Consumer Safety Branch
Health Canada
Address Locator 3503B
Ottawa, Ontario K1A 1B9
3. A patient brought in a prescription for two drugs, Amoxil and Tylenol with Codeine
No.3, written on the same prescription form. The patient only wants me to dispense
one of these drugs and wants another pharmacy to dispense the other drug. What do I
need to do?

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The process you need to follow is different, depending upon which drug you dispense.
Amoxil dispensing (non-narcotic) - you need to return the original prescription to the patient:
Process the prescription for Amoxil.
On the original prescription, indicate that you have dispensed the Amoxil and note your
pharmacy name, your initials, and the date.
Photocopy the original prescription for your records.
On the photocopy, make a note that the original prescription was returned to the patient.
Return the original prescription to the patient. The patient can then have the undispensed
narcotic prescription dispensed at the pharmacy of his/her choice.
Tylenol with Codeine No.3 dispensing (narcotic) - you need to keep the original prescription:
Process the prescription for Tylenol with Codeine No.3.
Log the prescription for Amoxil.
Photocopy the original prescription for your records.
On the original prescription, indicate that you have dispensed the Tylenol with Codeine
No.3 and logged the Amoxil. Note your pharmacy name, your initials, and the date.
You may photocopy the original prescription and provide the photocopy to the patient. Be
sure to note your pharmacy name and telephone number on the photocopy so that the other
pharmacy can contact you to transfer the Amoxil prescription.
4. We were working on a prescription for 100mL of Tussionex suspension. As the
technician was attaching the label to the bottle, it tipped over and the contents spilled
onto the counter and floor. What should I do?
As required by the Regulations to the Controlled Drugs and Substances Act, you should report the
loss (or theft) of controlled drugs and substances directly to the federal Office of Controlled
Substances within ten days of discovery. You can order loss and theft reporting forms from:
Compliance, Monitoring and Liaison Division
Office of Controlled Substances
Health Canada
Address Locator: 3502B
Ottawa, Ontario K1A 1B9
Cost-Benefit Analysis (CBA)
o Cost of providing a program/treatment & comparing those costs with the benefits that
results
o Expressed as: Benefit to Cost ratio = Benefits ($$)/Costs ($)
o Outcome measured: dollars
o Ratio to be AT LEAST 1 to be considered worthy, higher the better
o Disadvantage difficult to assign dollar values to NON-financial benefits e.g. benefits
of the program that may improve a pts life

Cost-Effective Analysis (CEA)

o Used to compare different tx options with cost measured in $ & outcome measured in
units of therapeutic objective
o Cost to Effectiveness ratio = Cost ($)/Therapeutic effect (units)
o Outcome measured is healthcare related rather than financial e.g. blood pressure
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(mmHg), blood glucose

o The LOWER the value the better the tx option is
Cost-Minimization Analysis (CMA)
o When 2 or more interventions are examined & assumed to be equivalent in terms of a
given outcome
o Cost associated with each intervention may be examined & compared
o E.g. comparison of cost of 2 calcium-channel blockers, which produce the same blood
pressure reduction
Cost-Utility Analysis (CUA)
o An economic tool that measures the consequences in terms of outcome of the program
in terms of quality & quantity of life QALY
o Outcome measure: cost per QALY (quality adjusted life year)
o Objective is to compare a GOLD STANDARD intervention that already has the cost per
QALY, QALY is calculated by multiplying the utility value obtained for the specific health
condition with quantity of life year spent in that specific health condition
o It is very important for evaluating new therapies
Health Related Quality of Life (HRQOL)
o QALY focuses on ALL aspects of life, HRQOL ONLY focuses on pt NON-clinical
information such as functional status, well-being, perception of health, return to work
from illness & other outcome that are affected by illness
Canada Vigilance Program: (MedEffect Canada)
The Canada Vigilance Program is Health Canadas post-marketing surveillance program
that collects & assesses reports of suspected Adverse Drug Reactions (ADRs) to health
products marketed in Canada
Canadas Food & Drugs Act & Regulations require manuf. to report ALL adverse drug
reactions to Health Canada
Post-marketing surveillance allows Health Canada to monitor the safety profile of health
products once they are marketed to ensure the benefits of the products continue to outweigh
the risks
The Canada Vigilance Program provides a variety of tools for health professionals &
consumers to report suspected adverse reactions reporting can be done online, by phone or
by submitting the Canada Vigilance Reporting Form by fax or mail
Red FLAGS that signal Physician REFERRAL:
Blood in vomiting/urine/stools
Fever NOT responding to appropriate measure
Yellowing of skin or eyes
Severe pain (i.e. described as the WORST pain I have ever had)
Fever, vomiting, headache, confusion, difficulty in bending neck
Signs of infections (fever, abscess (pus), swelling, redness, tenderness, heat)
Spontaneous bleeding or bruising
Chest pain
Pain on urination
Under 2-yr old child
Eye pain, blurred vision, blepharitis
Duplication of Therapy:
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Acetaminophen products (concern is overdose)

TWO NSAIDs (concern is GI bleeding)
TWO Antidepressants (concern is serotonin syndrome)
Drugs + herbal products (ginseng + warfarin bleeding concern, St. Johns wort + SSRI
serotonin syndrome, Niacin + statin myopathy)

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