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Pharmacy Questions A-05

Pharmaceutics:
1. Bulk powders are:
A. Insufflations
B. Douche powder
C. Dentrifices
D. A and B
E. All of the above
2. In the fusion method of making cocoa butter suppositories, which substance is most likely to be used
to lubricate the mold?
A. Mineral oil
B. Propylene glycol
C. Cetyl alcohol
D. Stearic Acid
E. Magnesium Silicate
3. Magnesium stearate is used in tablet manufacturing as:
A. Lubricant
B. Source of Magnesium

C. Binder
D. Disintegrant
E. Diluent
4. Which of the following preparations is a saturated solution?
A. Aromatic Water
B. Elixir
C. Emulsion
D. Solution
E. Extract
5. Gel belong to:
A. Dispersions
B. Emulsion
C. Solutions
D. Ointments
E. Creams

Today's Role of the Pharmacist in the Philippines


In the late 20th century pharmacist's function in the Philippines is simple and focuses on the needs of the
community and hospital. Among them are to compound and prepare prescription drugs which mainly their job.
Pharmacist kept and stocked chemical ingredients that will be used to prepare and make medicines. Today
pharmacists are dispensing manufactured drugs, which do not need to compound anymore, which are properly
packaged, labeled and/or in different kinds of dosage forms. Also a key role that attached to them is drug informant.
But today the revolution on their roles are changed. They have integrated and challenging in terms of work. Some of
them are in the community, hospital, distribution and laboratories. Mainly the pharmacist are involving much now
within the variance of jobs that may overlap sometimes with the other professions. These mean that the profession
is versatile and very alive.
Community Pharmacist Wherein the job of pharmacist is to supervise and manage a drugstore. It is a full time job.
He does procurement, ordering, receiving deliveries, inventories of the products, dispensing and a lot more. The
common job landed by a pharmacist is this. The pharmacist usually wages from 10k-20k, depending on the
drugstore's income. He must adopt to different functions within the drugstore that required by Food and Drug
Administration (FDA). Such of these are: 1) eight straight hour duty that may vary depending on the drugstore's
operation 2) filing filled and partially filled prescription orders, checking and removing expired drug or recalled
drugs. He is the nearest informant about drugs.
Ghost Pharmacist it is simply recognized as the leasing of one's license to a certain drugstore so that it can
operate. The pharmacist is not full time rather part time job which is illegal and unlawful. This is basically happened
when a drugstore is to start.
Hospital Pharmacist The setting is basically within the hospital premises. Pharmacist are ranked according to the
years of service, educational attainment and experience. The role is no difference with that of community
pharmacist; however, a very unique in this job is that of involvement in Pharmacy Therapeutics Committee (PTC).
This regards that the pharmacist is the secretary of the committee and has the action to choose among the bidders
and procure drugs that are appropriately stocked and dispensed in the hospital pharmacy.

Clinical Pharmacist This type of work is not much established yet. But because of the immediate evolving of the
function of pharmacists, it is been started to practice in the Philippines. St. Luke's Hospital is the pioneering
institution who practices and deploys clinical pharmacist in the country; moreover, other leading hospitals have
already adopted and practiced it. But because of the lacking of schools offering Clinical-Base-Pharmacist, the
hospitals are giving series of trainings and education, to enhance their knowledge and skills more, before they are
placed to the actual setting.
Liaison Pharmacist acts as a link between the company and Food and Drug Administration (FDA). It is an outdoor
work and not much on office base.
Production Pharmacist Laboratory base job. Function is to produce finished drug products which must be tested
before packaging, warehousing and consumption.
Quality Control Pharmacist Few are employed in this kind of job because they prefer chemists or chemical
engineers. But the function is to test if the finished drug product conforms to the standard, USP/NF or other
pharmacopoeias. Makes sure that the drug is safe, effective and standardized.
Warehouse Pharmacist Receiving placed orders, invoicing and dispatching drug products to be delivered in the
registered drugstore clients only.
Administrative Pharmacist/ Working under the Government
The different roles of pharmacist in the Philippines defines that continuing need of them in the society. I take
courage to say that in the years to come more jobs will be opened for them and focused more in the healthcare of
the people that need to be cured.

HowtoBecomeanefficientPharmacist?

Find a job that fits you and can be easily adapted to it.

Salary should be agreeable and compensated all your basic necessities and also your wants.

No overlapping of work within the work area.

Deserves respect and trust.

Be responsible and proficient on your career.

Do not instigate ranking among your co-workers. Remember that a good leader must have equality, integrity and credible.

Working hours must be affirmative and congruent with the salary rate, also subsequently with that of the number of working days.

Be an epitome to others.

Be eloquent and credible when giving advice and counseling patient regarding about their drugs.

Prepare everything you need before starting an activity. Being meticulous is worthy than being nasty.

Important of them all is putting your heart to your work which you giving your 100% in every time you are in it and embracing all the
shortcomings, problems and challenges that may develop in the future

MostProblemsthatEncounterbyPharmacists

Unanticipated visitation of Food and Drug Regulatory Officer ( FDRO)

Shifting schedules, especially at graveyard shift.

Unjustified salary rates

Extended hours of work or overtime.

Conflict with co-workers (for some)

A lot of Paper works.

Violation with regards to non-compliance to the Food and Drug Administration requirements.

Talking to the physicians regarding drug-drug interaction and other drug issues.

Unidentified prescription order that cannot be read by any pharmacist and other healthcare professionals which the prescribing physician
is only known it.

SemiAnnualReportingofDangerousDrugs
Are you new in submitting semi-annual reports of dangerous drugs in PDEA? Are you afraid that what you have reported and written in your
dangerous drug books are enough and non violative? I tell you, you do not have to worry about submitting your reports, because it takes minutes
to submit and check them. People there are very kind and approachable. I will tell you about the experiences I had before and until now.
Usually the dangerous drugs are inscribed in an official DOH prescription in which the doctors who hold S2-license or registered are authorized to
prescribe them.The official DOH prescription is known to be as "Yellow prescription". The yellow prescription is filed and written in the dangerous
drug book that contains the date sold, the information of the patient, the doctor, served quantity and balance, date of purchase of the DD and
where it came from, and the initial balance. These must be filled up and the information must be factual. The important thing in here is to check the
doctor's S2- license number. Violations are caught in here, for retailers, because of serving a yellow prescription which the S2-license of the doctor
is expired or unregistered. So, be careful on that and be vigilant. Also, I remind you to keep all yellow prescription for verification.
When reporting comes, that happens in January 1 - 15( reports covered from July to December of the previous year), and July 1 - 15 ( reports
covered from January to June of the current year), there is only one place to go for submission and that is in main office of PDEA in Quezon City.
Things to be brought are the dangerous drugs and the reports. I can say that in PDEA it is so organized and systematic. Before going to the
concern office, the information desk has to examine your papers first. When lacking, you do not need to pursue it, but to return when all the
documents are completed. When everything is sufficient you are to go to the next step.

Reporting and Submission Proper


When your are ready and everything of the requirements is with you ( the dangerous drug books and reports which must be in two copies), you are
to wait in the assemble hall located in the main building of PDEA. I was there sitting in line, moving to the next chair everytime one is being

checked his/her reports and dangerous drug book/s. Then it was my turn. The officer told me to open the dangerous drug book in the last page
(because in here he signs and dates implying the the DDB is checked). The reports are also signed and dated. The officer told me to find the
drugstore I employed so that I can sign, the date I submitted, write my contact no and how many DDB reviewed. The officers came from
compliance service department. Finally, the first copy is their file copy and the other is returned to me as a proof that the reports are received by
them and I have submitted my semi-annual reports. Always, when deadline is near, the submission is many and they need to issue counter
number to avoid confusion and chaos. I can say that the best time you submit your reports is in the first few days after the start of submission
because few submissions are being checked and you may take around 15 - 30 minutes to submit your reports.
I hope I help you in your problem regarding this matter and I hope I can see your their submitting too!

MakingaStandardOperatingProcedure(SOP)forPharmacy
Hi guys! Today I will impart to you how to write your own SOP. I know why are you here. I wonder if a FDA inspector have lately inspected your
office and looking for your SOP; however, you have nothing to provide, and he commanded you to create your pharmacy's own Standard
Operating Procedure or else it will turn out as a deficiency and violation.

What is SOP?
Standard Operating Procedure (SOP) according to FDA Philippines is a document that describes how to perform various routine operations that
contains step by step instructions. It is written by the individuals who perform the operation and who share some aspects of the operation. SOP is
needed to guide personnel when and why to perform a task, and what is the scope of the task. The SOP must undergo series of reviews and
approvals before it can be imposed. Individuals who can be knowledgeable to review the procedure and who can be higher up in the hierarchy of
the department are the possible reviewers and can approve the tentative manual.
In the previous blog, I showed you the format and the contents of SOP according to FDA Phil. By following it so, you can easily make your own
SOP of your Pharmacy. Usually the Pharmacist is tasked to make it and reserved the right to create according to the operations that he seems to
be applicable to his workplace. So that you can begin doing so, I will give you some tips and hints to make your own SOP.

Creating Your SOP

First you need to think of the important functions and tasks in your pharmacy other than the basic contents that required by FDA Phil. For example,
if your company is engaging in distribution you should create a SOP for Good Distribution Practice; moreover, in an instance of compounding
drugs there must be a SOP for Good Compounding Practice, so that each of the staff will sternly follow one procedure and operation, and
procurement of raw materials, pull-outs and returns and others need a SOP to harmonize the work and avoid mislead or errors. The language of
your SOP should be clear, in an active verb forms for procedural directives and should be direct to the point. Use language that can be easily
understood. You may use Filipino or other native dialects to reach those who cannot understand English much. Be considerate, remember that
almost all the tasks and operations are performed by employees that may not be eloquent enough to understand the manual in English. To start
with, the following are the main content of the SOP objective, scope, responsibility, procedure, quality records, forms and end of document.
1.

OBJECTIVE describes purpose of the goal and aim.

2.

SCOPE up to what extend can be the task performed

3.

RESPONSIBILITY who can be involved in performing the task.

4.

PROCEDURE the step by step action of doing a task

5.

QUALITY RECORDS how to do records and uphold them

6.

FORMS to where the records are written (Optional)

7.

END OF DOCUMENT can be used to place additional information and rationale

Sample of Standard Operating Procedure


I. OBJECTIVE: To provide proper guidelines in procuring of stocks.
II. SCOPE: Applied to all products
III. RESPONSIBILITY

Pharmacist

Owner/Manager
IV. PROCEDURE
1.

The procurer will make an order through phone, SMS, facsimile, sales representative and other media.

2.

There should be a copy or list of the products to facilitate checking of them when delivered.

3.
Upon delivery of the product, check the product's count, amount, batch no. and make sure that the expiry date is very far to make sure the
product is safe and effective.
4.

The procurer will pay the delivery man and ask for official receipt and copy of the sales invoice and filed them.

5.

The procurer will price the product through an acceptable price mark-up.

6.

The product will then display and ready to be sold.

V. QUALITY OF RECORDS:
The purchaser will file the invoice for future use and other cases.
VI. FORMS:
Logbook
VII. END OF DOCUMENT

Important Things to know!


Now that you have knowledge and skills in making SOP you can now start doing it. I just want you to remember other things about SOP. The
writer, reviewer and editor must affix their sign over their names when completed. Manual should be reviewed regularly and kept up to date. A

system of revision should be clear before any reform is made. All documentation should be made available on request of competent authorities, if
possible, all personnel encompassed are given a copy which become their personal guide. Records should be made at the time each operation is
performed so that in such a way all the significant activities are traceable. All records must be readily retrievable, stored and retained.

CounterfeitDrugs
Oureconomictodayissodynamicthatrepresentsagreaterchanceofeconomicgrowthandprogress.Industries,like
telecommunications,food,clothing,lifeinsurances,investments,pharmaceuticalandcosmetics,realtypropertiesandalike,arethe
majorentitiesthatcontributetotheadvancementoftheeconomy.Pharmaceuticalindustryisoneofthetopfiveleadingmarketsthat
contributestothegrowthofthePhilippineeconomy,notjustinourcountryalonebutalsointheotherpartsoftheworld.However,it
isnotalwaystosaythatthepharmaceuticalindustryisaperfectmarket.Therewillbeafraudulenceandblackmarketwithinit.
Usuallytheimportationofthesmuggledproductsthatdoesnotundergodueprocessisillegal.Also,themanufactureofdrugproducts,
devices,cosmeticsandfoodthatdonotmeetthestandardsandrequirements,maybeadulterated,andunregisteredarealsoillegal.
Thesemaybeclassifiedascounterfeitproducts.
Counterfeitdrugs/medicinesaccordingtoRepublicActNo.8203referstomedicinalproductswiththecorrectingredientsbutnotin
theamountsasprovidedhereunder,wrongingredients,withoutactiveingredients,withsufficientquantityofactiveingredient,which
resultsinthereductionofthedrugssafety,efficacy,quality,strengthorpurity.Itisadrugwhichisdeliberatelyandfraudulently
mislabeledwithrespecttoidentityand/orsourceorwithfakepackaging,andcanapplytobothbrandedandgenericproducts.Itshall
alsoreferto:
1)thedrugitselforthecontainerorlabelingthereoforanypartofsuchdrug,containerorlabelingbearingwithoutauthorizationthe
trademark,tradenameorotheridentificationmarkorimprintoranylikenesstothatwhichisownedorregisteredintheBureauof
Patent,TrademarkandTechnologyTransfer(BPTTT)inthenameofanothernaturalorjuridicalperson;

2)adrugproductrefilledincontainersbyunauthorizedpersonsifthelegitimatelabelsormarksareused;
3)anunregisteredimporteddrugproduct,exceptdrugsbroughtinthecountryforpersonaluseasandjustifiedbyaccompanying
medicalrecords;
4)adrugwhichcontainsnoamountoforadifferentactiveingredientorlessthaneightypercent(80%)oftheactiveingredientit
purportstopossessasdistinguishedfromanadulterateddrugincludingreductionorlossorefficacyduetoexpiration.
Buthowwouldyourdetermineifadrugs,devicesorcosmeticsarecounterfeit?Here,Iamgoingtogiveyousometipsonhowto
determinethemontheactualcircumstances.

Unknownsource(manufacturer,importerordistributor)
Unregisteredestablishmentsthatengaginginmanufacturing,distributing,importingorsellingdrugproductswithouttheFDA
approval
Peddlingorofferingspecialofferthroughdoortodoor
Theconditionofthemedicinesorproductswhentransferredarenonstable,easilytobreakandcheap,caking,donotsuspend
forsuspension,inconsistent,odorous,crystalling,crackedandotherconditionsthatidentifyundersubstandard.Butthereisan
exemption.ProductsthatregisteredtotheFDAbutdonotmeetthestorageconditioncausingsomeproblemsincontents.
NoBatchno.orLotno.
Nodrugregistrationno.(DR),deviceregistrationno.(DVR),orotherproductregistrationno.ispresentinthelabel/sthat
approvedbytheFDA.
NoManufacturingdateandexpirationdate
NoCertificateofRegistrationProductforimporteddrugs,devicesandcosmeticproducts.
Labelsandpackagingareauthenticbutthecontentisadulterated
Labelsandpackagingareauthentic,butcamefromsmuggling,slippingfromtheregisteredownerandusecommercially.
Counterfeitproductsareeasilyidentifiedbyobservingthelabelsandpackingthatareimitationoftheoriginal.

Sometimestheproductisingoodfate,passedthequalitycontrolandrightlabelsandpackaging,butdoesnotregisteredto
FDA,whichreportedbythepharmaceuticalcompanyasunregisteredandnotallowedtobesold.Thishappensduetoslippingof
productsfromregisteredcompanyanddistributeinthemarketillegally.
Smuggleddrugsanddevicesthatcirculateinthemarket.

DispensingDoctorsvs.Pharmacists
Every drugstores and pharmaceutical establishment is supervised by a registered and licensed pharmacist.
Irregardless of the educational attainment, pharmacists are hired for pharmaceutical businesses to operate and
transact on other pharmaceutical businesses and government agencies. Establishments that do not have employed
pharmacists are subjected for revocation of business permit and closure.
The rule of thumb, doctors and pharmacists are function to prescribe and dispense, respectively. To further discuss
this matter we must understand that the two professions are related and connected to each other.
When a doctor diagnoses a patient and found out the illness he will prescribe medicines to cure or mitigate the
disease. Then, the patient should go to the nearest drugstore who can dispense and fill his prescription. This
scenario is a typical and basic. In the Philippines, some doctors are illicitly dispensing medicines after they prescribe
without the presence of registered pharmacist. According to the Pharmacy Law, an act of selling of drug products,
compounding and manufacturing of drugs shall be under the immediate supervision of a registered pharmacist. It
means that dispensing in the clinic of pharmaceutical products is prohibited without the supervision of a pharmacist.
However, because of costly of salary that is paid to pharmacists, doctors chose not hire pharmacist anymore and
illegally dispense medicines by themselves.
My Opinion and Sentiments

I believe that all profession have their specific functions and works to do. We, pharmacists, one of our functions is
to dispense drugs in pharmacy setting. The function is very clearly tagged to us ever since the profession was born.
If that function is taken away from us and robbed by somebody else what will be our role in the community
pharmacy with regards of giving information about the drugs to the community. I strongly disagree to what the
doctors do regarding this matter. It is so unethical and unlawful. I hope that doctors ( physicians, veterinarians, and
dentists) respect other professions. We know that you have a lot of businesses that earn money comparing to us, we
are employed to serve one establishment and no other sidelines. We receive minimum wage that depends on the
income of the drugstore. By doing it so, you are competing small low income earner drugstores and killing their
business. I hope that you will help us to improve more the pharmacy profession in the Philippines and give us the
chance to work according to what is due to us. I hope that you will help us provide with work through employing us
in your clinics because dispensing with the presence of pharmacist is right . I hope also that the FDA will enhance
and strengthen their monitoring against this illegal acts of doctors and provide a strict ordinance to resolve this
issue.

DoctorsS2License
When dispensing regulated drugs an official DOH prescription or yellow prescription is needed to be able to fill the doctor's order. Pharmacists
should be meticulous on the validity of a doctor to prescribe regulated drugs. On contrary, pharmacists has no access to determine whether a S2
license of a doctor is valid, null or expired already unless it written. But because of that instances of confusion in S2 license the new yellow
prescription has added an information about the validity of the license. Usually a doctor must apply or renew for his S2 license at the compliance
service of PDEA bringing all the required documents. The doctors are given a temporary license which consists of nine alpha-numeral code that
can be used for a maximum of three months after the requisition of the ID. A valid S2 license ID must contain twelve alpha-numeral code making
the last three numbers as the control number, that temporary S2 # does not possess this.
Nowadays, the validity of the S2 license has been matched with the of PRC validity. The S2 license is only valid for three years as of the PRC ID,
and it unified to that of PRC validity to help doctors to renew their licenses at the same time and within a time frame. For more queries and

information, do not hesitate to call PDEA Compliance Service 920-8110.


To elaborate more of the S2 License alpha-numerical code here is the complete information for your guidance.

IsYourPrescriptionDrugPhasedOut?
Can you guess who is this well-known, multiple chained drugstore who rifts physicians' reputation because of their scheme of saying to customers
"phased-out from the market" whenever a prescription drug is not available in their shelves?
Yes guys you have read it out right! I know this has no effect to us pharmacists, but I am afraid it is a big deal for all physicians who prescribe
drugs knowingly that a certain branded drug is still and actively circulated in the market. The word "phased-out" means that a certain brand of a
product is already dismissed in the market and has no availability will be found anywhere because the owner of that registered product stopped
the production. I met medical doctors who were deeply distressed and frustrated because of this transpiration. An Ob-Gyne doctor had told me
once about her experience when she prescribed a certain brand of antifungal vaginal suppository tablet. Unfortunately, the patient called her
explaining that her prescription drug was not available in the market anymore. The doctor was alarmed about that incident, because she knows

that the drug is still in the market, and a medical representative of that branded drug is weekly visiting her to remind her to prescribe the drug,
though. Another doctor who is a friend of the Ob-Gyne doctor had the same incident happened. She prescribed a prenatal supplement brand to
her pregnant patient and highly confident that her prescription was been filled; however, it turned to be a bad sequel to her. The patient came back
to her telling that the drug she prescribed was already phased-out in the market and the patient thought that she had received an obsolete drug
prescription. So, the doctor called up to the drugstore branch the patient went. The moment she spoke to the phone attendant, she told her about
her case and asked the availability of the drug. The phone receiver told her that the drug she looking for is not available in that branch. Then the
doctor had realized the incident to be a scheme of that drugstore, which, if the product is not available, the drugstore would tell customers
"phased-out" rather than no stock / non carried product, because she knew that it has a name to protect and a reputation that "all branded drugs
are available in its stores". I know that a lot of doctors were experienced this already and wanted to talk about it.
I begun to realize the poor relationship system of physicians and pharmacies in the Philippines. Because of the thinking of the people that all drugs
can be obtained over-the-counter or prescription free, some sectors of drugstores abuse it. Is not it the right to receive prescription before
dispensing and filling up medicines? What happen today is the customer goes to the pharmacy counter asks for this drug and right away the
customer's demand is given. I think the excellent reforms that may apply are advising customer to visit a doctor first and be diagnosed and
comeback to fill up his prescription, and complete the whole treatment session to achieve optimum cure. Physicians are a tremendously help to
the community pharmacy business. They are the ones who prescribe and influence patient's treatment and choice. Without them pharmacy
business will be weakened and stopped. We must respect their authority about prescribing and help them to promote healthcare to the community.
I know that all drugstores are not capable to input all the branded drugs that available in the market, but I just want to open up my opinion and
sentiments about "Phased-out" issue. I hope that the community pharmacies will tell the truth with regards to the availability of their stocks and non
carried medicines. I hope they will be honest and truth by telling customers whenever a specific branded drug is not available. What is wrong by
telling " we do not have that medicine" and advising the customer to visit another drugstore nearby? In this statement, at least you have helped the
customer to find what he is looking for and helped other pharmacy to have sales. It is good to have a healthy competition, but there must be a
moment to supporting each other to achieve one goal to provide optimum healthcare to the community. By telling the truth, physicians are relieved
from the case of prescribing wrong drug or obsolete drug, securing their reputation and name.

I. OBJECTIVE: To provide proper action regarding Product Recall


To establish coordination with the supplier/s when a certain product is recalled.
II. SCOPE: All products that are subjected to be recalled under the DOH-FDA declaration.
III. RESPONSIBILITY

Pharmacist

Owner/Manager
IV. PROCEDURE

1.

The pharmacist is important person to accomplish this task.

2.
The distributor company will inform the drugstore about the product recall through a Product Recall Letter* containing the details of
product/s to be recalled.
3.
The pharmacist must be particular on the batch no or lot no of the product that is being recalled from the market to facilitate removal of
stock in the shelves and the store.
4.

After the batch no has been checked, see to it that the product is removed from the shelves so that it will not be sold anymore.

5.

Coordinate to the supplier when will be the product withdrawn.

6.

Wait for further pronouncement of the recall to be updated.

V. QUALITY OF RECORDS:
The letter and withdrawal form should be kept for further purposes.
VI. FORMS:
Logbook
VII. END OF DOCUMENT

Iamsafe!
Before a drug reaches the market and consumers, it undergone different stages from the identification of drug molecule to the approval of the USFDA. Clinical trials and its phases are very important in developing and achieving the excellent features and significance of the drug. The USFDA's approval for the new developed drug means the drug has passed all the requirements set by US-FDA to be sure that the drug has well
identified, physically and chemically studied, given its IUPAC name and non-proprietory name, passed the clinical trials, is safe to use and take,
established the use and mode of action and side effects, has dosage form and its mode of administration, storage condition, tests and
standardization, and etc. After completing the whole process the company who made the research and development has the sole authority to hold
the patent of the drug and market it universally under a registered name, until the time the expiration of the patent comes.

Herbal drugs however, are traditional and known to be alternative drugs that have not undergone series of elaborated studies and experimentation
including physically nor chemically and clinical trials and not proven by experts. But because of the likeness to cause cure, the different
government agency bodies around the world had considered them already to be safe to use by consumers as one of their choice of treatment for
their ailment.
Having the choice of treatment for your ailment, I strongly advice to choose drugs that have proven through research and development and
undergone clinical trials, because you can be assured that these drugs are safe and effec and specifically targeting the cause of illness to produce
mitigation or cure. Doctors would rather choose clinically proven drugs than herbal drugs that just used alternatively.
Lagundi leaves versus Carbocisteine drug
I seen contradicting commercials in the television in the past days that I realized the advertisements of Lagundi and Carbocisteine drug are
provoking consumer to " what must be the choice" for the treatment of their distressful cough. Each commercial claims the same use, mode of
administration, how the product has made and so on so forth. But, however, the Carbocisteine's commercial has caught my attention because it
depicted exquisite information needed by consumers on how the drug treats the cough, and enlightened them on how the drug really works in the
body and the effects that can be felt after it taken. Likewise, Carbocisteine has been proven long before and has established probable side effects
and still monitoring up to now for occurrence of adverse drug reactions and adverse drug events. It is also widely used here and abroad for the
treatment of cough producing phlegm and actively prescribed by doctors as one of the leading drug of choice for phlegmatic cough. Herbal drugs
can have a feasible plant constituent therein that can give good effect and can cure as very congruent to that of the ethical drugs. Unfortunately,
most of them are not much established yet with their effectiveness and safety. Because a certain part of the plant is being made into drug,
example the Lagundi leaves that are being processed into capsules or in syrup form, we are not sure that the drug cannot cause a much more
severe side effects that can lead to a stern disease or even death, because Lagundi has not yet studied much. The content, the active chemical
molecule, the effects and side effects and even the onset of time to reach blood serum and other pharmacokinetic study are not evaluated and
established. Moreover, there are a lot of ethical drugs and alternative drugs in the market today that are comparable because of their similarity in
effects and use such as: sambong leaf versus diuretic drugs, alkapulko plant versus antifungal drugs, garlic versus antihypertensive drugs, and
others.

GenericDrugProducts:AreTheySafe?

Nowadays, generic drug products are stapling in the pharmaceutical market and industrial world, because of the enacted laws which allow people
to choose and access generic products freely and should directly prescribe, introduce and suggest by health professionals.
Manufacturers and traders are to apply license to operate to FDA, and such, cGMP should be met and practiced before production is made. But
most of manufacturers are unknown or untrusted, others are from countries abroad.
Generic drug products are questionable in their safety, quality and efficacy, although, they can be very low cost and widely available in the market,
we cannot be sure about the risks they can bring to consumers' health.
Some of the issues facing of the generic drug products are the following:
1.
Substandard and adulterated active ingredients
2.

Easily to break, crack, chip, crystallize, cake, not suspending for suspension or unstable.

3.

Questionable drug active ingredient and quality of production.

4.

Pharmacokentically unresolved issues such as onset of time to reach blood plasma, half-life and elimination in the body.

5.

Slow drug's action and fast drug's elimination leading to short effect in the body and does not maintain in the blood plasma.

6.

Drug's action is compromised and desirable effect is not achieved compare to the branded drugs.

7.

Production does not meet the Current Good Manufacturing Practice and sanitary problem is raised.

8.

Physicians actually prescribe them but do not necessarily recommend them to their patients.

9.

When bioassay is done and FDA tests , they do not meet the USP/NP or other pharmacopoeias.

However, these drug products have licensed to distribute in the market to reach consumers and utilize for treatment of illness, but government
agencies assume that these are bioequivalently equal to the branded drugs, even though, they are not really evaluated much. There are three
kinds of drug products in the market that classifies them as branded, branded-generics and generic drug products. Branded as we know are
registered for their trade name and often costly because of some compensations for registration, taxation, high quality production and marketing
strategies. Branded-generics are products that do not have registered name but has to hold the manufacturer's name that identifies them and
market them easily. Example of these are Pharex products and Ritemed products. Lastly, the generic products which carrying the non-proprietary
name of the the drug and usually sold in the market at very cheap and low price.
We, pharmacists should be neutral regarding this issue, because we know how the production of drugs are and their other features. But
sometimes, we come to contemplate and realize that branded drugs are far more better that generic drugs. For an instance, a patient took a two

capsules of Mefenamic Acid 500mg and his headache does not relieve after 30 minutes, but when he takes a certain brand of Mefenamic Acid
500mg capsule, only one capsule, the relief is reached within 10-15 minutes and the effect reaches up to four hours which must be. This is also
the same with other branded drugs versus generic drugs.
I am not to branded drugs or to condemn the production and marketing of generic drugs, but I just want to emphasize that if we want to help
people to achieve wellness and optimum health, production of low cost generic drugs should be standardized, under the cGMP method, quality
and effective, safe, and most of them all is to manufacture for such gain while compromising others' health and life.

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