Vous êtes sur la page 1sur 187

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

PM604: Session 1: Rational Use of Medicines

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Objectives
y Define Rational Use of Medicines (RUM) y Explain the importance of RUM y Describe the different types of irrational use of medicines y Discuss the factors influencing the use of medicines y Consequences of irrational use of medicines

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Session Outline
y Definition and dimensions of RUM y Components of the Drug Use Cycle y Importance of RUM y Different aspects of irrational use of medcines y Consequences of Irrational Use of Medicines y Factors Influencing the Use of Medicines

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Buzz session
y The term appropriate/rational drug use means different

things to different people. What does the term mean from the perspective of: y Patient y Prescriber y Dispenser y Health Service Manager

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Rational Use of Medicines


The rational use of drugs requires that patients receive medicines appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and the community. World Health Organization, 1988

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Dimensions of Rational Use of Medicines


y Appropriate indication y Appropriate drug y Appropriate administration, dosage,

and duration y Appropriate patient y Appropriate patient information y Appropriate evaluation (estimate or cost)

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Components of the Drug Use System Supply


Manufacture, Registration Procurement, Supply Drug Imports Local Manufacture

Provider & Consumer Interaction

spital Centre Ho

Public & Private Health Facilities Epidemiology, Care Seeking Access, Affordability
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Private MDs/ Other Providers

Pharmacies/ Drug Sellers

Consumers

Demand

WHY RATIONAL USE OF MEDICINES?

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Importance of Rational Use of Medicines 1


y Irrational Drug Use can destroy all the benefits of careful, cost

effective selection, procurement and distribution of drugs.


y Resources spent on procurement are lost if the correct drugs are

not prescribed and dispensed to the patient, who in turn uses them in a correct manner

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Importance of the Rational Use of Medicines 2


y Medicines constitute the largest household expenditures

in most developing countries


y A major percentage (at least 30%) of the budget on

health care is spent on medicines


y Medicines make health care delivery credible

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Common Patterns of Irrational Use of Medicines


y The use of drugs when no drug therapy is indicated y The use of wrong drugs for a specific condition requiring drug therapy y The use of drugs with doubtful or unproven efficacy y The use of drugs of uncertain safety status y Failure to prescribe available, safe, & effective drugs y Incorrect administration, dosages, or duration
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Problems of Irrational Drug

Use

11

The Medicine Use Process

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines Diagnosis (1)


y Inadequate examination of client/patient y Incomplete communication between client/patient

and doctor y Lack of documented medical history

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines Prescribing 2a


Under-prescribing:
Needed medications are not prescribed. Dosage is inadequate. Length of treatment is too brief.

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines Prescribing (2b)


Incorrect prescribing
Medication is given for incorrect diagnosis. Wrong medication is selected for diagnosis. Prescription is prepared improperly. Adjustments are not made for coexisting medical, genetic, environmental, or other factors.

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines Prescribing (2c)


Extravagant prescribing:
Less-expensive medication provides comparable efficacy and safety. Symptomatic treatment of mild conditions diverts funds from treating serious illness. Brand-name medicine is used when less expensive equivalents are available

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines

Prescribing (2d)
Over-prescribing
Medication is not needed. Dose is too large. Treatment period is too long. Quantity dispensed is too great for current course of treatment.

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines Prescribing (2e)


Multiple prescribing
Two or more medications are used when fewer would achieve same effect. Several related conditions are treated when treatment of primary condition would improve or cure the other conditions.

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines (3)


y Dispensing
y Incorrect interpretation of the prescription y Retrieval of wrong ingredients y Inaccurate counting, compounding, or pouring y Inadequate labeling y Unsanitary procedures

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines (4)


y Packaging

y Poor-quality packaging materials y Odd package size, which may require

repackaging y Unappealing package

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines (5)


y Labeling/Counseling

y Poor labeling y Inadequate oral instructions y Inadequate counseling to encourage adherence y Inadequate follow-up or support of

clients/patients y Treatments or instructions that do not consider the client s/patient s beliefs, environment, or culture
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Problems with Irrational Drug Use: Poor Compliance

Compliance is the degree to which the patient follows the physician s instructions on how to take the prescribed drug and treatment.
Many studies about outpatient compliance carried out in developing countries indicate that only about 50% of patients follow the instructions given by the physician

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Problems with Irrational Drug Use: Poor Compliance


Causes of poor compliance include: 1. Improper labelling
Neither the name of the patient, nor the name of the drug is on the container labels when dispensed. If two nor more drugs are dispensed together, the patent does not know which drug he/she is taking

2. Inadequate instructions:
The instructions on dosage frequency must be written on the drug label, or the patient could forget how to take it when he/she arrives home and becomes involved in other activities
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Problems with Irrational Drug Use: Poor Compliance


3. Treatment /instructions that do not consider the socio-

economic and cultural aspects of the patient


For example, in cases where the patient does not know how to read, proper instructions would include graphic symbols of how to take the drug. For a treatment of three days, for example, you could number the days 1 to 3, and then below each day, make a mark for each time the drug must be taken that day
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Some Examples of Drug Use Studies

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

% Prescribed as Generics
Public Sector Indicator Studies, 1990 1994
Sudan Zimbabwe Tanzania Nigeria Cameroon Ghana Uganda Mozambique Swaziland Indonesia Nepal Ecuador Guatemala El Salvador Jamaica East. Carib.
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

0%

25%

50%

75%

100%

% Receiving Antibiotics
Public Sector Indicator Studies, 1990 1994
Sudan Malawi Zimbabwe Tanzania Cameroon Ghana Uganda Nigeria Yemen Indonesia Bangladesh Nepal Ecuador Guatemala El Salvador Jamaica East. Carib.
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

0%

25%

50%

75%

% Receiving Injections
Public Sector Indicator Studies, 1990-1994
Uganda Sudan Malawi Zimbabwe Tanzania Cameroon Ghana Mozambiqu Swaziland Nigeria Yemen Indonesia Bangladesh Nepal Ecuador Guatemala El Salvador Jamaica East. Carib.
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

0%

25%

50%

75%

f P ti ts K T k Dr gs
P lic S ct r I ic t r St
Malawi Indonesia Bangladesh Tanzania Nigeria Nepal Eastern Caribbean Ghana 0%
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

i gH
i s, -

25%

50%

75%

100%

% of ey Drugs in Stock
Public Sector Indicator Studies, 1990-1994
Malawi Tanzania Nigeria Nepal Ecuador Cameroon Ghana El Salvador Guatemala Jamaica 0%
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

25%

50%

75%

100%

Impact of Inappropriate Use of Medicines


Reduced quality of therapy Waste of resources

Risk of unwanted effects

Psychosocial impacts patients rely on unnecessary drugs

morbidity mortality

reduced availability increased cost

adverse reactions bacterial resistance

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Use of Medicines


Policy, legal, and regulatory framework

Prescriber, dispenser, and their workplaces

Rational use of medicines

Client/patient and community

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Pharmaceutical supply system

Factors Influencing the Rational Use of Medicines: Pharmaceutical Supply System


 Pharmaceutical quality problems  Unreliable suppliers  Poor forecasting/poor quantifications  Inadequate inventory management (expired

medicines, shortages, and so forth)  Pressure and lobbying from industry (promotional activities and misleading claims)
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines: Drug Regulation


 Non-formal prescribers

 Lack of regulation enforcement  Non-essential drugs available

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines: Prescriber


          

Inappropriate role models Lack of objective pharmaceutical information Limited experience Outdated knowledge Lack of skill or conscientiousness Unlicensed practitioners Inadequate pharmacology training Inappropriate prestige over-prescribing Fear-induced prescribing ( uncertain diagnosis ) Misleading beliefs about drug efficacy Incorrect generalizations from experience

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines: Dispenser


 Inability to read or interpret prescription  Outdated knowledge about drugs  Inadequately trained dispensers  Poor attitude about dispensing  Poor attitude about packaging

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines: Workplace


        

Lack of adequate laboratory capacity Lack of equipment or facilities No packaging materials Adequate packaging thought to be too costly Lack of continuing education Pressure to prescribe Pressure to dispense Insufficient staffing Inadequate supervision of practitioners

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines Economic Motivations of Providers and Consumers
 Provider preference to earn more money
 salaries independent of services provided  payment according to non-drug services provided (consultation fees, per

capita payment)  profit from drug sales (dispensing doctors, dispensing pharmacist fees)

 Patient preference to pay less for drugs


 overuse of free drugs versus decreased access with full payment  Reimbursement of essential drugs and treatments compliant with guidelines

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines Drug Financing Systems


y Public financing through central revenues
y

good drug selection and quality control, but danger of limited access if govt. budget insufficient

y Health Insurance - sharing payment risk


public compulsory y private voluntary (community pre-payment, HMO)
y

y User fees - money paid by patients for drugs


revolving drug funds run by govt. or community y private purchase y co-payments in insurance systems
y
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines Drug Financing Systems


 Public financing through central revenues
y

good drug selection and quality control, but danger of limited access if govt. budget insufficient

y Health Insurance - sharing payment risk


public compulsory y private voluntary (community pre-payment, HMO)
y

y User fees - money paid by patients for drugs


revolving drug funds run by govt. or community y private purchase y co-payments in insurance systems
y
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines Sales profits and pricing policies
 Lower prices for essential drugs & higher prices for non-essential drugs

should lead to greater use of essential drugs, but:


 higher prices for non-essential drugs may lead to their greater use by dispensing

prescribers who are motivated by profit less effective

 patients may prefer more expensive drugs if they feel that the cheaper drugs are

 dispensing fees that are % of the price of a drug may encourage the sale of

more expensive drugs

 flat dispensing fees irrespective of drug prices lower the cost to patients of

expensive medicines but may lead to price increases for cheaper drugs

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines Health Systems 1


 Prescribers that sell drugs usually:
 prescribe more drugs and less appropriately

 Increased cost sharing is associated with:


 reduced patient access to drugs and health care  reduced appropriate and inappropriate drug use with higher

fees  reduced inappropriate use only with lower fees

 Increased drug availability associated with increased

use
 availability of non-essential drugs leads to their use
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines Health Systems 2


 Flat fees per prescription are associated with drug

overuse and polypharmacy  Charging per drug item is associated with prescription of fewer drug items  Charging variable fees may lead to:
 reduced use of expensive drugs, and  increased use of cheaper drugs

 Strategies to promote rational use can be built into

insurance systems and reimbursement


MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines Clients/Patients and Community


Misinformation about medications Misleading beliefs Client/patient demands or expectations Complex diseases or problems No labeling or labels clients/patients cannot understand Inadequate oral instructions Clients /patients misunderstanding of medicines and their use  Conflict between cultural values and therapy  Lack of client/patient trust  Poor client/patient doctor communication
      
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Conclusions
y The promotion of RUM generally is crucial to maximize the

impact of health care delivery


y There are many challenges to RUM at the diagnosis, prescribing,

dispensing, and client/patient-use levels.


y All stakeholders have key roles to play in promoting RUM at all

levels.

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

PM604-Session Two: Investigating Drug Use In Health Facilities


MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Session Objectives
y Describe a model for defining and changing drug use

patterns y Identify the importance of drug use indicators y Know steps to implement an indicator study y Understand different methods of sampling and data collection y Understand how to analyze a situation using indicators y Identify & evaluate sources of data for indicator study y Introduce qualitative research methods
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

An Overview of the Process of Changing Drug Use


1. EXAMINE Measure Practices (Descriptive Quantitative Studies) 4. FOLLOW UP Assess Changes in Outcomes (Quantitative & Qualitative) Qualitative) Im rove diagnosis 2. DIAGNOSE Identify Problems & Causes (In(In-depth Quantitative & Qualitative Studies) Studies)

Im rove Intervention 3. TREAT Design and Implement Interventions (Collect Data to Measure Outcomes)

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Changing Drug Use Problems:


1. Examine
y Identify drug use issue of interest
Highest clinical risk? y Widely used or expensive drugs? y Easiest to correct?
y

y Collect data to describe practices


In all groups of interest y Most important prescribers? y High-risk patients?
y

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Changing Drug Use Problems: 2. Diagnose (dii)


y Describe problem in detail y Specific problem behavior y Define important providers or patients y Identify determinants of the problem y Knowledge and beliefs y Cultural factors or peer practices y Patient demand and expectations y Identify constraints to change y Economic constraints y Drug supply y Work environment

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Changing Drug Use Problems: 3. Treat


y Select target and design intervention
Which behaviors can be changed? y Feasible interventions? y Cost-effectiveness? y Personnel required?
y

y Pilot test
Acceptability y Effectiveness
y

y Implement in stages
y y

Collect process and outcome data Evaluate impacts

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Changing Drug Use Problems: 4. Follow Up


y Evaluate success in relation to intended outcomes
y y y

Was the intervention implemented as planned? What changes occurred Was the intervention cost-effective? Transferable?

y Consider unintended negative outcomes y Feed back results


y y y

To managers and policymakers To staff To providers and consumers

y Use results to plan future activities


MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Selecting Methods to Study Drug Use


y Depends on y Nature of the problem y Objectives of collecting data y Resource availability y Time available

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Methods to Study Drug Use .


y Quantitative Methods
y What? or How much? y Counts y Rates y Classifications

y Qualitative Methods
y Why? or How strong? y Opinions y Descriptions y Observations

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

DRUG USE INDICATOR STUDY

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Purpose of Drug Use Indicator Studies


y Measure current medicines use practices y Comparing the performance of individual facilities or

prescribers.
y Periodic monitoring of specific medicine use behavior to

assess change over time.


y To evaluate impact of intervention impact

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

57

Types of Indicators
y Prescribing y Patient Care y Facility Indicators

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

58

Prescribing Indicators
Measure performance of prescribers in the several key dimensions of appropriate use as per indicators listed below: 1. Average number of medicines prescribed per patient encounter 2. Average number of medicines prescribed by generic name 3. Percentage of encounters with antibiotic prescribed 4. Percentage encounters with injections prescribed
Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study
MUHIMBILI UNIVERSITY

59

Patient Care Indicators


1. These measure what patients experience in the HF and how long it takes to be prepared to take the prescribed pharmaceuticals 2. They do not capture quality of examination or RX

Example 1. Average consultation time 2. Average dispensing time 3. Percentage of prescribed medicines actually dispensed 4. Percent adequately labeled 5. Percentage of patients who could correctly explain on how to take the prescribed medicines. Implementing a Drug Use
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

60

Facility Indicators
y Availability of national standard treatment guidelines y Availability of key medicines

Complimentary indicators Percentage of medicines prescribed in consistence with standard treatment guideline

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

61

Steps in an Indicator Study (oim gst pcff)


y Specify objectives y Define indicators to be used y Develop Methods for measuring indicators y Select geographic area y Select sample of facilities

Select and train personnel Pilot test and revise procedures Collect data Feedback to facilities and managers y Decide on follow-up studies
y y y y

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

62

Scope of the Indicators Study


y Depends on:
information needs of managers y capabilities of record system y types of providers y resources available
y

y Minimum sample
20 facilities and 30 prescriptions / 30 patients per facility for crosssectional study y 100 prescriptions per facility if facilities will be compared
y

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

63

Preparing for a Survey (1)


Prescribing Indicators
y Select a sample of facilities y Decide on a source of data for prescribing encounters y Define types of encounters to include y Define drugs to be counted as antibiotics y List drugs to be classified as generic
Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study
MUHIMBILI UNIVERSITY

64

Preparing for a Survey (2):


Patient Care Indicators
y Observe logistics of patient care y Determine how consulting and dispensing times will be measured y Define criteria for adequate patient knowledge y Describe procedure for evaluating patient knowledge
Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study
MUHIMBILI UNIVERSITY

65

Preparing for a Survey (3):


Facility Indicators
y Determine if national EDL

or STG exists
y Prepare a short list of key

drugs to test availability

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

66

Indicator Sampling Methods


y Selection of Facilities y Simple Random / Systematic y Useful to Stratify -Government / Mission y Retrospective Prescribing Data y Systematic y Random sampling y Prospective Patient Encounters y Convenience
Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study
MUHIMBILI UNIVERSITY

67

Where Can We Find Useful Data for calculating Indicators?


y Administrative offices, medical stores y Clinical treatment areas and medical record departments y Health facility pharmacies y Private pharmacies and retail outlets y Households?

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Where Can We Find Useful Data for calculating Indicators? Data Available at Health Facilities
y Retrospective
y Patient registers y Treatment logs y Pharmacy records y Medical records

y Prospective
y Observation of clinical encounters y Patient exit interview y Inpatient surveys
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Data from Drug Encounters


y FACILITY y PATIENT y PROVIDER y INTERACTION y DRUGS
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

y ID, characteristics, equipment, drugs y y

available ID, date, age, gender, symptoms knowledge, beliefs, attitudes qualification, training, access to information, knowledge, beliefs, attitudes exams, history, diagnosis, time spent, explanation about illness, explanation about drugs brand, generic, strength, form, quantity, duration, if dispensed, how labeled, cost, patient charge

Undertaking the Survey: Field Activities


y Select a sample of encounters y Fill in encounter forms y Observe consultation and dispensing times y Collect patient knowledge and dispensing

information
y Fill in facility summary forms y Present results to staff
Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study
MUHIMBILI UNIVERSITY

71

10 11

Simple Prescribing Indicators Form


1 1 1 1 1 1 1 1 0 1

PRESCRIBING INDICATOR FORM


Date:

Location: Investigator:

Seq. # 1 2 3 0 4 5 6 7 8 9 10 11 12 13

Type (R/P)

Date of Rx

Age (yrs)

# Drugs

# Generics

Antib. (0/1)

Injec. (0/1)

# on EDL

Diagnosis (Optional)

Tot

XXXXXXXX

XXXXXXXXXXXXXX XXXXXXXX XXXXXXXX XXXXXXXX XXXXXXXX XXXXXXXXXXXXXX % of tota l drugs of ca se s % % of tota l ca se s % XXXXXXXXXXXXXX of tota l drugs

Av

g nt g

XXXXXXXX XXXXXXXX

* 0=No 1=Yes

Implementing a Drug14 Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study 15
16

MUHIMBILI UNIVERSITY

72

Detailed Prescribing Indicators Form


Detailed rescribing Indicators orm
Loca ion: Inves i a or: Da e:

ID# Heal h roblems 1 2 3 Dr s 1 2 3 4 5 6 7 8, 9

Da e Heal h

ame roblem Descri ion

e Code

ex

rescri er

ame and

rength

Code

Q antity

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

73

Prescription 1

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

74

Prescription 2

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

75

Prescription 3

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

76

Prescription 4

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

77

Prescription 5

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

78

Prescription 6

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

79

Patient Care Indicators Form


PATIENT CARE FORM
Locat on: Invest ator Pat ent Identifier (if needed) Consult ng D spensing # Drugs Time Time Pre(mins) (secs) scribed Date: # Drugs # AdeKnows Disquately Dosage pensed Labelled ( )

Seq. #

Count Total Average Percentage

XXXXXX XXXXXX XXXXXX XXXXXX XXXXXXXX XXXXXXXX XXXXXX % % %

* 0=No 1= es

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

80

Health Facility Summary Form


Loca ion

In es iga or

ontact

Proble s or o plaint

# Cases

Essential Drug Li t/For ular a ailable at facilit ? (0/1

e Drug in Stock to Treat I portant Condition

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

81

% in tock thi facilit

Retro pecti e Pro pecti e Patient Care


co ering dates co ering dates co ering dates

In Stock (0/1

Fro



F CILITY SU

RY F RM
ae

To

Facility Indicator Reporting Form


F
Lo In ti n tig t r te

ility Indi

t r

rting For

mments

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

MUHIMBILI UNIVERSITY

Signatures

82

! 

A e rage u ber drugs rescribed Percentage drugs rescribed by generic names enc unters with an antibi tic rescribed Percentage Percentage enc unters with an injecti n rescribed Percentage drugs rescribed n ssential rug List nsulting Time A e rage A e rage i spensing Time Percentage drugs actually dispensed Percentage drugs adequately labelled d sage Percent c rrect patient nowledge A a ilability essential drug List r Formulary Percentage a a ilability e y indicat r drugs
' % % ! ! ! ! "! & ! ! ( "! % ( % % ! ! "! $ "! "! "! "! "! "! "! !# ! ' ) $ $ $ $

# "!

u ber

a ses

Prescribing Patient a re % % % % mins secs % % % Yes / % % % % % mins secs % % % % %



F


  

Thi ility


ti n l tandard

Indicators Consolidation Form


Indicator
ocation:
01

onsolidation For
Date:

Av . dr Date Facility
0

Percent

Percent

Percent

Percent on EDL

Consult tim e

Dispense tim e

% Drugs dispensed

% Adequate label

%Adequate know ledge

Im partial

% Drugs

Prescribed

generics antibiotics Injections

Inform ation in stock

Mean Maximum MUHIMBILI UNIVERSITY Implementing a Drug Use Minimum OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

83

Graphs of Indicators Data (1)


Sample-Wide Distribution of Antibiotic Use
NUMBER OF FACILITIES

12 10 8 6 4 2 0
Under 30% 30% - 40% 40% - 60% Over 60%

Percentage Antibiotic Use


MUHIMBILI UNIVERSITY

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

84

Graphs of Indicators Data (2)


Sample-Wide Distribution of Consulting Times
NUMBER OF FACILITIES

8 7 6 5 4 3 2 1 0
Under 2 2-3 3-4 Over 4

Average Consulting Time (mins)


MUHIMBILI UNIVERSITY

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

85

Graphs of Indicators Data (3)


Facility-Specific Antibiotic Use
Percentage of Patients

80 70 60 50 40 30 20 10 0
U0 U1 U3 U3 U5 U6 U7 U8 U9 R0 R1 R2 R3 R4 R5 R6 R7 R8 R9

Urban Rural

Health Facility
MUHIMBILI UNIVERSITY

Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study

86

Graphs of Indicators Data (4)


Facility-Specific Consultation Times
AVERAGE TIME (MINS)

7 6 5 4 3 2 1 0
U0 U1 U3 U3 U5 U6 U7 U8 U9 R0 R1 R2 R3 R4 R5 R6 R7 R8 R9

Urban Rural

Health Facility
Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study
MUHIMBILI UNIVERSITY

87

Conclusion
y Undertaking a Drug Use

Indicators Study is possible in nearly all environments y The more attention to detail the greater the value and accuracy of the survey.
Implementing a Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY Indicators Study
MUHIMBILI UNIVERSITY

88

PM604: Session Three: Qualitative Methods

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Session Objectives (2)


y Identify four methods used to investigate reasons

underlying drug use and prescribing behavior


y Understand use of qualitative methods to identify why

documented drug use problems occur

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Session Outline (2)


y Introduction y Applying qualitative methods to drug use studies y Qualitative methods
y Focus group discussions y In-depth interviews y Structured observations y Structured questionnaires

y Activities y Summary
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Introduction
y Quantitative study methods identify presence of drug

use problems
y Indicator studies y Aggregate data: DDD, ABC, VEN y Record review and DUE

y What else do we need to plan an intervention? y We need to know why the problem exists: i.e.,

qualitative methods
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Introduction (2)
y Four qualitative study methods:
y Focus group discussions y In-depth interviews y Structured observations y Questionnaires

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Applying Qualitative Methods


y Complement results of a quantitative study y Explore a topic about which little is known y Provide background data prior to developing training

materials for a planned educational intervention and for developing managerial and regulatory interventions.

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Applying Qualitative Methods (2)


y Example of the use of qualitative methods
y Prescribing by brand name was very popular at the district

hospital. Despite numerous interventions including face-toface discussions, in-service education, policy and procedures changes, physicians continued to prescribe by brand name.
y Utilizing qualitative methods it was discovered that physicians

were receiving educational benefits from drug companies in exchange for their prescribing of branded products. This problem was then corrected once the reasons for the drug use behavior became known.

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Focus Group Discussions (1)


y A short discussion (1-2 hours) led by a moderator in which a small groups of respondents (6-10) talk in depth about a list of topics of interest. y A trained moderator leads the discussion and encourages participants to reveal underlying opinions, attitudes, and reasons for the problem being studied y The discussion is recorded and analyzed to identify key themes and issues

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Focus Group Discussions (2)


y 6-10 homogeneous participants i.e. they should share similar characteristics (e.g., age, gender, type of work) y Local convenience to participants y Number of focus groups discussions should be sufficient to gain the views of all the various target groups involved in the drug use problem

y Moderator and recorder must be skilled and trained

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Focus Group Discussions (3)


y Advantages
y Relatively cheap and easy to organize y Identifies a range of beliefs and ideas

y Disadvantages y Group may not represent the larger population y Success depends on the skill of the moderator

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

In-depth Interview (1)


y An extended discussion between a respondent and an trained interviewer (who is knowledgeable about the topic) based on a brief interview guide that usually covers 10-20 topics y The interview is flexible and often unstructured y The questions are open ended to encourage the interviewee to talk at length on the topic of interest y 5-10 interviews with each important subgroup, often opinion leaders and key informants

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

In-depth Interview (2)


y Advantages y Can develop trust between interviewer and interviewee y Possible to probe deeper and therefore gain unexpected insights or new ideas y Disadvantages
y Generates lots of data and analysis may be difficult y Interviewees may give answers they think the

interviewer wants to hear y time consuming

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Structured Observation (1)


y Systematic observations by trained observers of a series of encounters between health providers and patients y Observers record behaviors and impressions they witness during the encounters in structured manner or they record a score for each observed interaction y Data may be recorded as coded indicators and scales or lists of behaviours and events, and then frequency of behaviours may be calculated

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Structured Observation (2)


y To prepare for the study the observer should

introduce a non-threatening explanation and spend time blending in


y At least 30 encounters should be observed to

calculate the frequency of behaviours


y At least 10 sites should be visited to observe

behaviour
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Structured Observation (3)


y Advantages
y Best way to study the complex provider-patient interactions,

including patient demand and quality of communication y Can learn about provider behaviour in natural setting
y Disadvantages
y Observed providers may modify their behavior because of

observer s presence y requires skilled patient observers y inappropriate for infrequent behaviours
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Structured Questionnaire (1)


y A fixed set of questions asked to a large sample of respondents selected according to strict rules to represent a larger population y The questions have a fixed set of responses or options in order to collect the desired information in a standard way from all respondents y The questionnaire may be administered by an interviewer or filled out alone by the respondent
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Structured Questionnaire (2)


y At least 50-75 respondents from each target group y Respondents should be chosen randomly y Training and supervision of interviewers required y Questions always asked in a standardized way, with no leading questions y Useful for attitudes, beliefs and opinions as well as facts

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Structured Questionnaire (3)


y Advantages
y Best for measuring strength & frequency of attitudes,

beliefs, knowledge, and population characteristics y Can generalize to a wider population


y Disadvantages
y Do not uncover the unexpected y Sensitive to the way questions are phrased leading to

possible bias and respondents may answer even when they have no true opinion y Large surveys are expensive
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Summary
y Before an intervention can be designed to correct poor practice or irrational use of drugs, we need to know why that behavior is occurring y Qualitative methods should be used to investigate the behaviour from different perspectives and with regard to different actors (patients, staff, etc.) y Triangulation of results using different methods should be done to identify the major reasons underlying a particular behaviour.
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

PM604-Session IV: Drug Use Evaluation

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Session Objectives 1 (DUE)


y Understand the concept of drug use evaluation (DUE) y Understand the process for implementing and

performing a DUE
y Discuss the use of a DUE program for improving drug

therapy

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

ey Definition:

Drug use evaluation (DUE)


y Ongoing, systematic, criteria-based program of drug criteriaevaluations that will ensure appropriate drug use. Interventions are necessary when inappropriate therapy is identified. y A DUE will:
y Define appropriate drug use (by establishing criteria) y Audit criteria against what is being prescribed y Give feedback to prescribers on all identified problems y Monitor to see if criteria are followed and prescribing is

improved
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Drug Use Evaluation (DUE)


y When drug use problems are identified, corrective

action with providers will be necessary and required to optimize drug therapy

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Objectives of a DUE
y Ensure that drug therapy meets current standards y Promote optimal medication therapy y Prevent medication-related problems y Identify areas in which further evaluation is needed y Create criteria for drug use y Define thresholds for quality of drug use below which corrective action will be undertaken y Enhance accountability in drug use y Control drug costs
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Indicators suggesting need for DUE


y Over-use or under-use of medications y Problems indicated from WHO/MSH indicator studies y High number of adverse drug reactions y Signs of treatment failures y Excessive non-formulary medications used y Use of high-cost drugs where less expensive alternatives exist y Excessive number of drugs within a therapeutic category

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Stepwise Approach to DUE


1. Establish responsibility

2. Develop scope of activities 3. Establish criteria and Thresholds for the DUE 4. Collect data and organize results 5. Analyze data 6. Develop recommendations and plan of action 7. DUE follow-up
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Step 1 Establish Responsibility


y Drug and Therapeutics Committee is a logical choice y Multidisciplinary committee dealing with all facets of drug therapy has the necessary expertise y Subcommittees of the DTC y Must include representation of practitioners whose drug prescribing will be assessed

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Step 2 Develop Scope of Activities


y Identify drug therapy problems to be addressed
y

Using ABC/VEN analysis, ADR reports, AMR reports

y Concentrate on drugs with highest potential for problems


y y y y y y y y y

High volume Low therapeutic index High ADR rate Expensive drugs Critically important drugs Antimicrobials Injections Drugs used for non-labeled indications Drugs used for high-risk patients

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Step 3 Establish Criteria and thresholds defining correct drug use (using evidence-based medicine)
y y y y y y y y y y y

Appropriate drug for medical condition Correct dose Quantity to be dispensed Preparation for administration Monitoring is appropriate (e.g. lab test) Contraindications Drug interactions Drug administration (especially for injections) Patient education (written and oral instructions) Patient outcomes (e.g., blood glucose, Glyosyl.Haem.) Pharmacy administrative indicators (correct cost, billing)

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Step 3 Establish Criteria and Thresholds (2)


y Define and establish thresholds or benchmarks for

quality of drug use below which corrective action will be undertaken

y Thresholds define the expectations or goals for

complying with the criteria (e.g. 90% of prescriptions for 3rd generation cephalosporins are for predefined serious infections).
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Example: Ciprofloxacin DUE criteria & thresholds (1)


Criteria Use
y y y y y y

Threshold 90%

Complicated, chronic, or relapsing UTI, Gonorrhea Resistant respiratory tract infections Bone and joint infections Prostatitis GI infections

Dose
y y y y

95%

Complicated or recurring. infections: 500-750mg bid GI infections: 500mg bid Gonorrhea: 250mg in 1 dose renal disease decrease as follows:

Creatine Clearance 30-50ml/min 5-29ml/min Hemodialysis


MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

250-500 q 12 h 250-500 q 18 h 500mg q 24 h

Ciprofloxacin DUE criteria & thresholds (contd.)


Criteria Duration
y y y y

Threshold 95%

Complicated UTI 10-21 days Respiratory 7-14 days Osteomyelitis 4-6 weeks GI 5 days

Contraindications
y y

100% 90% 90%

Pregnancy Children less than 18

Drug interactions
y y

Theophylline, antacids, iron, sucralfate, probenecid Food: decreased absorption with milk

Outcome
y y

Negative cultures Improved symptomatology

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Step 4 Collect Data


y Prospective evaluation
y done as drug is prepared or dispensed to the patient y pharmacist can intervene at the time the drug is dispensed

y Retrospective evaluation
y requires access to medical records

y Sources of data
y patient charts, medical records, prescriptions, laboratory files y manual systems versus computerized systems y needs minimum of 50-75 records

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Step 5 Analyze Data


y Tabulate results for each indicator y Analyze to see what % of prescribing episodes comply with the criteria and whether the threshold is met, e.g.:
y 70% of patients prescribed 3rd generation cephalosporins

were given it for predefined criteria threshold

20% short of

y Determine why thresholds (benchmarks) are not met y Analyze data quarterly or more frequently

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Step 6 Develop Recommendations and Plan of Action


y Recommendations to address

Inappropriate drug use y Unacceptable patient outcomes y Interventions to resolve any drug use problems
y

y Interventions to resolve drug use problems


y y y y y

Education Drug order forms Prescribing restrictions Formulary manual changes STG changes

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Step 7 DUE Follow-up


y Check to see that recommendations have been

implemented
y Re-evaluate DUE to see if problems with drug therapy

have been resolved

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Problems that can arise in DUEs


y Lack of authority y Poor prioritization of drug use problems y Poor documentation of findings y Inadequate follow-up y Overly intrusive data collection and evaluation y Failure to obtain buy in from medical staff
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Summary (1)
y DUE is an audit and feedback intervention where drug use can be reviewed against approved criteria and thresholds y Requires establishing criteria and thresholds and then reviewing drug use to determine if therapy is appropriate y Feedback to prescribers is necessary to improve prescribing (educational, managerial, regulatory interventions may be required)

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Summary (2)
DUE will help improve drug use by
y Ensure that drug therapy meets current standards y Promote optimal medication therapy y Prevent medication-related problems y Identify areas in which further evaluation is needed y Create criteria for drug use y Define thresholds for quality of drug use below which corrective action will be undertaken y Enhance accountability in drug use y Control drug costs
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

INTERVENTIONS STRATEGIES

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Decision Making for Rational Use Interventions: Objectives


y To review intervention strategies y Choose between interventions y Develop a plan to undertake an

intervention

Decision Making for RDU OF HEALTH AND ALLIED SCIENCES SCHOOL OF InterventionsPHARMACY

MUHIMBILI UNIVERSITY

129

Developing Strategy
y Identify the problem & recognize the need for action-

meet consensus about the problem y Identify underlying causes and motivation factors using posters to promote generic prescribing will fail if doctors don t know generic names y List possible interventions educational, managerial and regulatory y Assess resources available for action- who will implement? Do they have enough time? y Choose an intervention or interventions to testeffectiveness, costs, sustainability y Monitor the impact & restructure the intervention
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Choosing Strategies
y Expected magnitude of impact y Likelihood of success y Risk of unintended effect y Political and cultural feasibility y Technical feasibility y Cost (economic feasibility) y Potential for donor support

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Decision Making for RDU Interventions 131

Framework for Intervention Studies


FORMA IVE S UDIES
. D fin
Drug U ro l rn wi h
lprescribing ldispensing lpatient use linformational leconomic lsocial, cultural lsupply logistics leducational lmanagerial lregulatory lcultural acceptance llikelihood of success lpotential impact lfeasibility

. Id n ify Mo i ing Factors/Und rlying Caus s

IN ERVEN ION S UDIES

. List ossibl Interventions . Choose Intervention s) to test 5. Conduct controlled study of Intervention s)

FOLLOW U
IMPLEMEN
cost effective interventions on a MUHIMBILI UNIVERSITY Decision Making larger scale for RDU OF HEALTH AND ALLIED SCIENCES SCHOOL OF InterventionsPHARMACY 132
Source: Quick et al. 1991.

REVISE & RES UDY


partially effective or costly interventions

DROP
ineffective, uneconomical interventions

Selecting an Intervention
Stage 1: Choosing a Target
y Characterize situation (indicator study) y Clarify problem (follow-up quantitative studies) y Investigate underlying factors (qualitative studies)
motivations of prescribers y patient expectations y constraints of system
y

y Synthesize data to choose targets


key behaviors to change y target group
y

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Decision Making for RDU Interventions 133

Selecting an Intervention
Stage 2: Choosing an Intervention

y List possible interventions y Consider available resources


y financial y human y administrative structure

y Choose an intervention (or interventions)


y feasibility y likely to change target behaviors y no absolute constraints

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Decision Making for RDU Interventions 134

Types of Study Design


y Post Only:
y

Not Recommended Not Recommended

after the event before and after


Recommended

y Pre-Post
y

y Randomized Trial
y

random assignment of study & control group


Recommended

y Time Series
y

multiple measures before and after


Decision Making for RDU Interventions 135

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Principles of Good Intervention Testing


y Use a relevant comparison group
y randomly assigned if possible y data collected like study group

y Measure outcomes at multiple time points


y before and after intervention y time series?

y Focus on key outcome measures


y behaviors targeted by intervention y feasible to measure

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Decision Making for RDU Interventions 136

Choosing Useful Outcome Measures


y Focus on key behaviors to be changed y Consider likely substitute behaviors y Focus on several important outcomes, not all changes y Choose outcomes:
that can be clearly defined y that can be reliably measured
y

y Measure more than one dimension, for example


changes in knowledge y changes in prescribing y changes in patient knowledge
y
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Decision Making for RDU Interventions 137

Issues and Sampling Methods


Uni S mp n y i m iz m b b n in h b mp in b in . xp h n

y Simple Random Sampling y Systematic Sampling y Stratified Sampling y Cluster Sampling y Multistage Sampling

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Decision Making for RDU Interventions 138

Using Samples to Collect Data


y A sample should be typical of the overall group of

interest.
y The accuracy of a study depends on the sample size. y If sample units are drawn in clusters, the size of the

clusters should be small, and the number of clusters should be large.


Decision Making for RDU Interventions 139

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Involving Decision Makers at Design Stage


y By involving decision makers at design stage increases

chances of implementation if the intervention is successful y Opportunities for involving decision maker should be actively sought y Asking for input at the design stage increases chances of cooperation and success

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Decision Making for RDU Interventions 140

Planning an Intervention
y Decide what kind of study to use to test the intervention y Define study and control groups y Define sampling process and size y Define outcome variables to measure success y Plan how to collect data y Decide who will analyze the data, how, and when* y Plan how to present the data, and to whom y Decide how to monitor the project

* R m mb : i y n n yz by h n , I y n' , mp nym k hin


Decision Making for RDU Interventions 141

mp w !

m y h p.

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Conclusion
Which Method to Use
y Best method depends on:
nature of the problem y objectives of collecting data y available resources and time y local capacity and experience
y

y Use multiple methods


quantitative + qualitative y triangulate findings y each method can look at different aspects of a problem
y

Decision Making for RDU Interventions


MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

142

Conclusion 2
Points to Consider when Developing Strategy
y Specific intended changes in behavior y Possible unintended outcomes due to the intervention y How both intended and unintended changes will be measured y Choice of intervention (or combination of interventions) y Why this is likely to achieve desired changes y Other information needed to design the intervention

Decision Making for RDU Interventions


MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

143

General Recommendations to Improve the Rational Use of Medicines

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Reference:
y TEN RECOMMENDATIONS TO IMPROVE USE OF

MEDICINES IN DEVELOPING COUNTRIES RO LAING,1 HV HOGERZEIL2 AND D ROSS-DEGNAN3


1Boston

University School of Public Health, Boston, USA, 2 World Health Organization Action Programme on Essential Drugs, Geneva, Switzerland and 3Harvard Medical School and Harvard Pilgrim Health Care, Boston, USA

HEALTH POLICY AND PLANNING; 16(1): 13 20 Oxford University Press 2001

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

-1-

Establish procedures for Developing, Disseminating, Utilizing and Revising National (or hospital-specific) Standard Treatment Guidelines

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

-2y Establish procedures for developing and revising an

Essential Drug List (or hospital formulary) based on treatments of choice

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

-3y Require hospitals to establish representative Pharmacy

and Therapeutics Committees with defined responsibilities for monitoring and promoting quality use of medicines

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

-4y Implement problem-based training in pharmacotherapy

in undergraduate medical and paramedical education based on national STGs

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

-5y Encourage targeted, problem-based in-service educational

programmes by professional societies, universities and the Ministry of Health


y Require regular continuing education for licensure of health

professionals

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

-6y Stimulate an interactive group process among health

providers or consumers to review and apply information about appropriate use of medicines

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

-7y Train pharmacists and drug sellers to be active members

of the health care team and to offer useful advice to consumers about health and drugs

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

-8y Encourage active involvement by consumer

organizations in public education about drugs, and devote government resources to support these efforts

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

-9y Develop a strategic approach to improve prescribing in

the private sector through appropriate regulation and long-term collaborations with professional associations

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

-10y Establish systems to routinely monitor key

pharmaceutical indicators in order to track the impact of health sector reform and regulatory changes

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Conclusions
y The promotion of RUM generally and in the context of

Antiretroviral Treatment is crucial to maximize the impact of health care delivery


y There are many challenges to RUM at the diagnosis, prescribing,

dispensing, and client/patient-use levels.


y All stakeholders have key roles to play in promoting RUM at all

levels.
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

PM 604: Module 2 Intervention to Promote Rational Use of Medicines

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Learning About Factors Underlying Drug Use

Use qualitative methods to identify motivations and incentives of prescribers and patients

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices 159

Components of the Drug Use System


Drug Imports Local Manufacture

The Drug Supply Process

Provider and Consumer Behavior

+
Private Physician or Other Practitioner Pharmacist or or Drug rader

Hospital or Health Center

Illness Patterns
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Public Public

160

Changing a Drug Use Problem:


An Overview of the Process
1. EXAMINE Measure Existing Practices (D ip iv Q n i iv S i ) 4. FOLLOW UP Measure Changes Changes in Outcomes n i iv & Q i iv Ev i n) improve diagnosis . DIAGNOSE Identify Specific Pro lems & Causes (In- p h Q n i iv In& Q i iv S i )

(Q

improve intervention

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

3. TREAT Design & Implement Interventions (C D M O m )


161

Strategies to Improve Drug Use


Educational: to inform or persuade inform or persuade

Managerial: to structure or guide decisions

Regulatory: to restrict or limit decisions

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

162

Educational Interventions
GOAL: to inform or persuade
y Training

changes in formal education in-service training seminars face-to-face persuasive outreach clinical supervision or consultation y Printed Materials y clinical literature and newsletters y formularies or therapeutics manuals y persuasive print materials y Media-Based Approaches y posters y audio tapes, plays y radio, televisions
y y y y
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

163

Prescriber Training
y WHO has produced a

Guide for Good Prescribing y Developed in Groningen y Field tested in 7 sites y Suitable for medical students, post grads & nurses
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

164

Printed Educational Materials


y Cover range of materials including journals, newsletters, adverts, STG s etc y Most useful when combined with other methods y Should include key messages and have attractive graphics
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

165

Face to Face Education


y Very effective method in both developed and

developing countries
y Need to target prescribers y Have key messages to convey y Should reinforce messages

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

166

Yogyakarta Diarrhea Study


A Comparison of Two Educational Interventions y Study Design y Randomized controlled trial y 2 districts randomly assigned to each of 3 study groups y 15 random health centers per district

y Study Groups y Face to face training in health centers (staff from single unit) y Large training seminar at district office (120 per seminar) y Control group with no training

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices 167

Yogyakarta Diarrhea Study


A Comparison of Two Educational Interventions

Data Collection Pre-post knowledge test Pre Retrospective prescribing audit 3 months pre vs. 3 months post Outcome measures Knowledge about diarrhea % receiving ORS % receiving antibiotics % receiving antidiarrheals
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices 168

Yogyakarta Diarrhea Study


Impact of Targeted Training on Health Worker Knowledge
Imp
10

T inin

nH

hW k

Kn w

Knowledge Score

Significant increase pre vs. post

Pre Post

0
MUHIMBILI UNIVERSITY Framework for Changing Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL Practices OF PHARMACY

Face to Face

Seminar
169

Yogyakarta Diarrhea Study


Impact of Targeted Training on Prescribing of ORS
% Cases Receiving ORS 100

Di m n i ni i

n n n

80

60

Pre Post

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Face to Face

Framework for Changing Drug Use Practices

Seminar

Control

170

Yogyakarta Diarrhea Study


Impact of Targeted Training on Prescribing of Antibiotics
% Cases Receiving Antibiotics 100

80

Si ni i n y i n m n , p<0.001
Pre Post

60

40

20

0 Face to Face* Framework for Changing Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL Practices OF PHARMACY 171
MUHIMBILI UNIVERSITY

Seminar*

Control

Yogyakarta Diarrhea Study


Impact of Targeted Training on Prescribing of Antidiarrheals
% Cases Receiving Antidiarrheals 100

80

Si ni i n y i n m n , p<0.001

60 Pre Post 40

20

0
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Face to Face*
172

Framework for Changing Drug Use Practices

Seminar*

Control

Impact of Small Group Training on ORS Sales in Kenyan Retail Pharmacies


Percentage Prescribing ORS 100

Phase 1 Nair bi
80

60

Phase 2 Other Cities

40

20
Intervention Control

0 Pre
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Post
173

Pre

Post

Framework for Changing Drug Use Practices

Impact of Patient-Provider Discussion Groups on Injection Use in Indonesia PHC facilities


Percentage Prescribing Injections 0

60

40

Pre Post

20

0
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices Intervention Control 174

Effects of Opinion Leader on Choice Antibiotic for Prophylaxis in a Teaching Hospital


Perce t f all 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 -secti s

Discussi with hief f Obstetrics

! ! ! !

! ! ! !
-- Cefaz li rec mme ded

, , , ,

, , , , , , ! , ! , ! , , ! ! ! !

! ! ! ! ! ! ! ! ! !

Cef xiti t rec mme ded

, ! ! ! ! ! !
Jan Apr

, , , ,
Jul 85

!
Jul 84

, ! !
Oct Jan

,
Apr

, , , , , , , , , , , , ,
Oct Jan Apr 86 Jul Oct

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices 175

Managerial Strategies 1
GOAL: to structure or guide decisions

y Changes in Selection, Procurement, Distribution


essential drugs lists y morbidity-based quantification y kit system distribution
y

y Changes Aimed at Prescribers


utilization review (audit) and feedback y diagnostic and treatment guidelines y structured drug order forms y peer group monitoring
y
Framework for Changing Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL Practices OF PHARMACY 176
MUHIMBILI UNIVERSITY

Managerial Strategies 2:
GOAL: to structure or guide decisions

y Changes Aimed at Dispensers y allowing generic substitution y improved labeling y course of therapy packaging y Changes in Economic Incentives y patient cost-sharing y revolving drug funds y cost controls
MUHIMBILI UNIVERSITY

Framework for Changing Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL Practices OF PHARMACY 177

Standard Treatment Guidelines


y STG s lead prescribers to most cost-effective treatments y Particularly useful for low level workers y Can be used for training, examinations and audit y Used for procurement

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

178

Prescribing Audits plus "Feedback" to Prescriber


Esta lish Criteria & Guidelines for Review

AUDIT (COLLECT DATA ON) RESCRIBING

NOTIFY RESCRIBERS OF RESULTS Individuals or Groups Letters or atient Notes or in erson


MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

AUDIT (COLLECT DATA ON) RESCRIBING Comparison with Guidelines Comparison with eers

179Framework for Changing Drug Use Practices

Rational Use of Medicine Indicators: 1--Prescribing indicators


y Average No. drugs per encounter y % drugs prescribed by generic name y % encounters with antibiotic prescribed y % encounters with injection prescribed y % drugs prescribed from EDL or formulary
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Regulatory Options
GOAL: To Restrict Decisions
y Market Controls y Limiting Drug Registration y Banning Previously Registered Drugs y Rx - only to OTC y Controlling Content in Drug Advertising y Prescribing and Dispensing Controls y Limiting Drugs Supplied in Public Sector y Restricting Specific Drugs to Higher Levels of Care y Required Generic Prescribing y Allowing Generic Substitution y Limits on Number or Quantity of Drugs per Patient
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

181

Framework for Changing Drug Use Practices

I t rv

ti

Str t gy

Pr scri i g f r Ac t Di rr

i M xic City

% cases treated in line with algorithm 100 After Workshop After Peer Review (n = 20)
37/52 79/115

Stud Ph sicians Control Ph sicians

80

60

Baseline Stage (n = 20) 42/82

1818-months Follow -up Follow-

40
25/102 20/84 16/70 11/46

31/110

20

0 Framework for Changing Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL Practices OF PHARMACY 182

MUHIMBILI UNIVERSITY

Impact of Training on Use of Diarrhea Treatment Algorithm in Three Mexico Settings


Intervention given by: "Experts" in 2 clinics (San Jeronimo) "Leaders" in 18 clinics (Coyoacan) "Coordinators" in 124 clinics (Tlaxcala)
S : M n z, , np b i h (1993)

Prescribers

Baseline % 24.5%

Post % 71.2%

Change % +46.7%

31

65

17.7%

43.4%

+ 25.6%

157

24.7%

31.2%

+ 6.5%

Framework for Changing Drug Use OF HEALTH AND ALLIED SCIENCES SCHOOL Practices OF PHARMACY 183

MUHIMBILI UNIVERSITY

Conclusion: Interventions to Change Drug Use


y Best evidence in PHC area y Focused, problem oriented repeated training y Supervision or self monitoring with simple indicators y Peer group oriented guideline development y Evidence lacking for : y Private sector, adults, and chronic diseases

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices 184

Conclusion: Interventions to Change Drug Use (2)


y Few interventions in hospitals in developing

countries but based on experience in developed countries great potential exists for hospital interventions to be successful
y Consumers need to be involved. Experience is

lacking but interactive, context specific programs using a mix of communication channels are likely to be effective
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices 185

Conclusion: Interventions to Change Drug


Use (3)
y Drug retailers sales practices can be improved! y Studies on impact of economic and drug sector policy changes sorely lacking y Need for more indicators for adequacy of diagnosis, guideline compliance, quality of care, cost, inpatient drug use, success of P&T committees and community programs

MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices 186

Characteristic of effective intervention


y Identify key influence factors: why people behave the way they do qualitative methods y Target individuals/group with worst practices y Use credible information sources: decision makers, authoritative materials y Use credible communication channel y Use personal contact whenever possible: face to face y Limit the number of messages & repeat key message using different media y Provide better alternative: encourage people to do something: treat diarrhea with ORS. Antidiarrhea not necessary
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY

Vous aimerez peut-être aussi