Quote of the day: On educating consumers on Generics Law

"There must be continuing education on Generics Law. Our consumers have yet to fully appreciate the value for money offered by generic substitutes. Our doctors and public health institutions must not negate the spirit of this law by failing to live up to their duty to inform their patients, particularly the poor, about generic substitutes."


- Senator Mar Roxas, on his sponsorship speech on Senate Bill No. 2263 to make the laws on patents, trade names and trade marks more responsive to the health needs of the Filipino people delivered at the Senate session hall on August 16, 2006.

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pinoypharmacist's comment:


Former BFAD Director, Quintin L. Kintanar, M.D., Ph.D., in recognizing the role of pharmacists, said that "Under the Generics Act of 1988, the pharmacist is not only a dispenser of drugs. He is also a teacher; he has been given the responsibility of informing the consumer what are the available generically-equivalent drug products and their prices."

He also said that "To discharge this responsibility properly the pharmacist himself must be professionally competent and must also be well-informed on the provisions of the Generics Act and the current developments in the pharmaceutical field."

Further, A.O. No. 63 series of 1989 requires drugstores, botica and other drug outlets "To inform the patient/buyer of all available drug products generically equivalent to the one prescribed with their corresponding prices. In so doing, the drug outlet shall not favor or suggest any particular product so that the patient/buyer may fully and adequately exercise his option to choose." (Section 3)

So, you see how confident and ready the government was about the role of pharmacists when they drafted the implementing rules of the Generics Act. It seems, however that WE WERE THE ONES WHO ARE NOT READY.

But wait... Although Michael Tan (in his article, Generics again) observes that " drugstores don't always inform consumers about the possible choices", he admits that he "sees some hopeful signs around generics" based on his own experiences in buying medicines.

Reference:
http://news.inquirer.net/common/print.php?index=2&story-id=53269&site-id25&col=81

Labeling our patients' medications

In giving orientation to new interns, I always emphasize the importance of labeling "loose tablets and capsules" properly and in accordance with the requirements of A.O. 63 series of 1989 (Section 3, no. 3.2) not only for the sake of compliance but because it is the right thing to do to ensure the safety of medications for our patients.

My lecture on the subject matter includes powerpoint presentation of drug labels improperly (read unprofessionally) done that were collected from community drugstores and hospital pharmacies.

In one of this orientation lecture, an intern revealed to us that the pharmacist in a community drugstore where she had her internship reprimanded her for completing the information on the label simply because it took her longer to fill the prescription order.

What a disgusting way to train our interns!!!

For not filling a violative prescription

In one of our meetings, a senior pharmacist in-charge of the outpatients pharmacy outlet informed us about an incident regarding a doctor who prescribes by writing only the brand name of the drug on the prescription pad.

The pharmacist did not fill the prescription and asked the patient to get a correct one. The doctor was irritated and told the pharmacist that if his prescriptions were to be returned to him just to make him indicate the generic name of the drug, he might as well instruct the patient to buy the medicines outside the hospital.

What does this mean?

It means that while some of us do our best to follow the provisions of the Generics Act, violative prescriptions are still being filled in many drugstores and pharmacies instead of being rejected and/or reported to the Department of Health, as required by law.

When the Generics Act was enacted in 1988, then Secretary of Health, Alfredo R. A. Bengzon, M.D., issued Administrative Order No. 63 series of 1989 whereby "associations of affected professionals are enjoined to promote compliance in order to achieve a smooth transition to the next phase of full implementation" of the law. (Section 9)

After almost 19 years since the enactment of the said law, I think that the Philippine Pharmaceutical Association (PPhA) and its affiliate organizations and societies have a lot more to do.

The PPhA's Code of Ethics states that "A pharmacist, in coordination with the government and other health professionals helps in the formulation and implementation of health care policies, standards and programs designed for the benefit of society."

I wish that like in the Philippine Medical Association (PMA),* the Code of Ethics for Pharmacists has implementing provisions against unethical and unprofessional conduct as grounds for reprimand, suspension or expulsion from the PPhA.

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Reference:

* http://www.pma.com.ph

A frontline pharmacist in action

One time I made a phone call to one of our outlets that serves the out-patients. I was put on hold for a while by the clerk who answered the call and while waiting for the pharmacist, I overheard her giving instructions to patients on the proper administration of their medicines.

As a trainer, I often wonder whether we are effective in giving encouragement and support to our frontline pharmacists so they may be able to provide drug information and patient counselling despite their heavy workload. So, you can just imagine my joy and excitement overhearing one of our frontline pharmacists counselling patients in action!

Surely, I made it a point that I let her know I am very pleased by what she does...

An inquiry for a dispensing doctor

One early morning just before office hours, a doctor inquired in our office about certain provisions in any law that prohibits doctors to sell medicines in their clinics, particularly vaccines. She told me this was an inquiry by a pediatrician friend of her.

I was the only pharmacist at that time and the only law I can think of is the Pharmacy Law (R.A. 5921) which states that "No medicine, pharmaceutical or drug of whatever nature and kind or device shall be compounded, dispensed, sold or resold, or otherwise be made available to the consuming public except through a prescription drug store or hospital pharmacy duly established in accordance with the provisions of this Act.

Pharmaceutical, drug or biological manufacturing establishments, importers and wholesalers of drugs, medicines, or biological products are authorized to sell their products only at wholesale to duly established retail drugstore or hospital pharmacies." (Section 25)

I also referred her to DOH Administrative Order No. 63 series of 1989 which states the "Rules and Regulations to Implement Dispensing Requirements under the Generics Act of 1988 (R.A. 6675)" (specifically, Section 1).

I learned from this experience that every pharmacist should maintain their familiarity and keep themselves updated with the laws, rules and regulations related to their profession.

The issue behind Senate Bill 1900

A few years ago, "An Act Regulating the Education and Licensure of Physicians and Their Practice of Medicine in the Philippines and for Other Purposes," otherwise known as Senate Bill 1900, caused a stir among pharmacists when an attempt to redefine the physician's roles was being "cooked" in the Senate.

If the bill passed the Senate, physicians will be allowed "to diagnose, treat, operate or prescribe and dispense any remedy for any human disease, injury, deformity, physical or mental condition."(1)

To air its position, the Philippine Society of Hospital Pharmacists issued an official statement for "A Call to Modify Senate Bill 1900." (2) The Drugstores Association of the Philippines also wrote the senate outlining its comments on the said bill. (3)

I suspect that maybe the reason why the word "dispense" found its way into Senate Bill 1900 is because of our failure to do properly what we are licensed to do.

For example, Dr. A.G. Romualdez, Jr. claimed that “here in the Philippines, until the advent of the Pharmacy Law…, most private Filipino patients obtained their medicines from the doctors who prescribed them. In most of the country, dispensing physicians were historically a big help in the distribution chain of drugs and they ensured that services were reasonably priced. Unfortunately, the practice has largely disappeared mainly because, under the Pharmacy Law, doctors were allowed to dispense only those medicines that they directly administered either by injection or inhalation or direct application to specific organs.” (4)

Now, this should be a wake up call to all of us...

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References:
1. http://www.inq7.net/globalnation/col_pik/2003/jul31.htm
2. http://www.pshp.org.ph/article.aspx?ID=5
3. http://www.dsap.org.ph/index1.php?fid=senate
4. Romualdez, A.G. Jr., MD. "Anti-poor conspiracies." Malaya 18 Aug. 2004.

Not a license to kill

"Lack of drugstore pharmacists kills patients." This is the title of an article written by David Dizon in 2002.*

It noted that "[p]harmacists play a crucial role in the process of dispensing safe and effective medicine to consumers" and that "they give valuable information that could mean life or death for patients."

Unfortunately, "some pharmacists actually 'rent out' their licenses and/or diplomas to drugstore owners while maintaining other jobs."

I don't know if we have improved already but I always tell my interns that their license is not a license to kill but a license to heal.

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* http://uw2.abs-cbnnews.com/images/news/microsites/onddot/DavidDizon08132002.htm

Quote of the day

"I am a survivor of a concentration camp. My eyes saw what no person should witness. Gas chambers built by learned engineers. Children poisoned by educated physicians. Infants killed by trained nurses. Women and babies shot and killed by high school and college graduates. So I'm suspicious of education. My request is: help your students to be human. Your efforts must never produce learned monsters, skilled psychopaths, or educated Eichmanns. Reading and writing and spelling and history and arithmetic are only important if they serve to make our students human."

- Anonymous

An inquiry regarding PITC's legal mandate

Last November 24 I wrote the Philippine International Trading Corporation (PITC) through pitc@pitc.gov.ph asking for clarification regarding its legal mandate.* In my letter, I asked the following:

"Isn't it that under Section 10 of the Generics Act of 1988, only raw materials and not finished drug products are to be imported 'during periods of critical shortage and absolute necessity' and that the government agency authorized under that law 'to import raw materials of which there is a shortage for the use of Filipino-owned or controlled drug establishments to be marketed and sold exclusively under generic nomenclature' is the Department of Health?"

Today, when I opened my mailbox, I found out I got a reply from Mr. Steve Francis A. Roldan, PITC's Legal Officer V, and this was his response:

Thank you very much for your e-mail dated November 24, 2006 expressing your support for PITC’s efforts in bringing down the prices of medicines to benefit the majority of our countrymen. In your e-mail, you seek clarification on PITC’s legal mandate, vis-à-vis Section 10 of the Generics Act of 1988.

In response to your query, please be informed of the following:

1. Under Section 11, Article XIII of the Constitution, the government is mandated to “…adopt an integrated and comprehensive approach to health development which shall endeavor to make essential goods, health and other social services available to all people at affordable cost …”

2. In order to “[r]educe by half the cost of medicines through increased and improved distribution importation through PITC and local sourcing, partnership with the pharmaceutical Industry, resolution of patent issues increased use of generic products, community based initiatives”[1] and consistent with the earlier quoted provision of the Constitution, the President issued Executive Order No. 442 on July 4, 2005, designating PITC as the lead coordinating agency to make quality medicines available, affordable and accessible to the greater masses of Filipinos.

3. PITC, as an agency under the Office of the President, is mandated under Section 1, EO 442, to “…establish retail outlets nationwide and supply these outlets with low priced quality medicines…”

As can be gleaned from the foregoing, while Section 10 of the Generics Act of 1988 authorizes the Department of Health to import raw materials for the use of Filipino-owned or controlled drug establishments to be marketed and sold exclusively under generic nomenclature during periods of critical shortage and absolute necessity, PITC’s mandate is distinct from, and is not precluded by, said Section 10.
We hope to have clarified matters.

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* http://www.pitc.gov.ph/mandates.html

Dr. Kenneth speaks

Quote of the day
"Imagine a doctor who made a mistake, and then there are no pharmacists to countercheck or provide warnings to patients and consumers."
- Dr. Kenneth Y. Hartigan Go
As quoted in the article "Dispensing doctors? A controversy in the offing."Medical Observer vol. 6 no. 6 June 1997:29-31.

Doctors prescribing Cytotec

Misoprostol (Cytotec), an unregistered drug product was featured last Saturday in the television show Imbestigador (Channel 7). Although the Bureau of Food and Drugs had already issued BFAD Advisory No. 02-02, * warning against dispensing/selling and using this drug product, there are still doctors who prescribe it and, sad to say, the illegal market still proliferates (Quiapo was identified in Imbestigador).

The BFAD Advisory enjoins all concerned parties "to report to BFAD... or police authorities any information that may lead to the apprehension of persons dealing with the subject drug."

You may report through these e-mail addresses:

ntlanuza@bfad.gov.ph and tmgutierrez@bfad.gov.ph.

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* To view the full text of this BFAD Advisory, visit the BFAD website at www.bfad.gov.ph (Click the heading "Advisory".)

MedExpress: changing the image of community drugstores

If there's one drugstore chain that is changing the image of community drugstores in the country, it is Med Express. This new retail drugstore chain "offers not only delivery and drive-thru pick-up but most importantly professional pharmacy services."*

"Medication safety issues [are] addressed by ensuring that only pharmacists will man all branches and call centers; strictly implementing a "No Rx, No Dispensing" policy; compliance packaging (patient's medication for a week is prepared in unit dose packaging); medication counselling; medication review; confidential medication profile system (a computer system that enables pharmacists to keep track of the patient's drug utilization and provide relevant pharmacist notes); and a patient compliance program (computer system that keeps track of the patient's supply of maintenance medications and enables pharmacists to monitor patient's adherence to medication regimen).

There are Med Express Drugstores in Ortigas Avenue, Mindanao Avenue and Filinvest Alabang.** Patronize this drugstore chain.

SAY NO TO DRUGSTORES WHO SELL PRESCRIPTION DRUGS LIKE CANDIES IN SARI-SARI STORES!

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Source:

* "MedExpress: A New Concept in Community Pharmacy Practice." The Hygeian. December 2005.

** http://www.manilatimes.net/national/2005/jul/19/yehey/life/20050719lif1.html

http://www.mb.com.ph/issues/2005/05/16/TECH2005051634854.html

http://www.mb.com.ph/issues/2005/06/12/HLTH2005061236258.html

Second lecture on counterfeit drugs

The second lecture on "Counterfeit Drugs" for our CE last Wednesday was given by Mrs. Maria Theresa M. Gutierrez, Food-Drug Regulation Officer IV, of the Bureau of Food and Drugs.

During the lecture, she mentioned that pharmacists who want to attend conventions, seminars and similar events which require them to be physically absent in the drugstores where they are hired to work, should file a leave of absence and have it received by the owners to protect themselves just in case the owners decide to run the business without a pharmacist on duty.

She was also very accommodating in answering our questions and I was very happy that she gave me her contact number and e-mail address just in case I have something to report to their office.

To report any malpractice or violation of existing provisions of the Pharmacy Law, Mrs. Gutierrez may be reached at (0919) 430-96-49 or at her e-mail address, tmgutierrez@bfad.gov.ph

Failure as guardians of the public health

You'll never know how easy it is to buy prescription drugs in community drugstores without a prescription from a medical doctor unless you have tried it. (You can even fake the name of the patient that the drugstore clerk writes on the receipt.) And you'll never know how severe the effects of drug misuse and abuse unless you have worked in a hospital...

It only means that the laxity in drugstores is a reflection of how we have failed as guardians of the public health.

Quote of the day

Will pharmacists be covered by the Medical Malpractice Act? Go to any drugstore today without a prescription and ask the person on the counter what is the best medicine for this and that and they will sell you something. While BFAD classifies a number of medicines as over-the-counter, every doctor knows that even aspirin taken for the wrong ailment can cause a patient to bleed to death or die of an acute allergic reaction.

Or if there should be a mis-dispensing of drugs at the drugstore,who shall be liable the doctor because of his handwriting, or the drugstore clerk? It is an open secret that many drugstores are running only on the 'borrowed licenses' of pharmacists. Only a few drugstores can produce the 'pharmacist on duty' on a bright and sunny day within one minute.

- Erwin L.Espinosa, MD on his article "Legislation and the law of unintended effect" dated September 16, 2002

Considerations in generic dispensing

Michael L. Tan had written an article entitled "Generics again."* Although it was written last year, I have read it only last September. Nevertheless, I still sent the editor my feedback on the article.

Here's my feedback:

Dear Sir,

While it is true that the Generics Act of 1988 requires that consumers be informed of the choices available to them in the selection of drugs with the same active ingredient (generic name of the drug), there are cases when the dispensing pharmacist should be cautious in doing so for reasons that may have undesirable effects to the patient.

This is because, based on bioequivalence studies, there are certain drugs made by different manufacturers that do not produce the same blood levels (bioavailability) and subsequent effects to the patient.

For example, here in the Philippines, Appendix T of the latest edition of the Philippine National Drug Formulary (vol. 1 6th ed., 2005) contains a list of "Drugs Requiring Stict Precaution in Prescribing, Dispensing and Use Because of Bioavailability Problem and Availability in Philippine Market in Several Brands/Manufacturers; Prescription Must be Filled According to the Specified International Non-proprietary Name (INN) and Brand Name (B)."

I would say that if a patient was already started with a certain brand of drug that is included in the list, it is safer to stick to that brand than to obtain varying levels and effects because of switching from one brand to another brand. It may be helpful also to consult first the prescriber before attempting to change brands.

Of course, an informed consumer can start with a cheaper and still effective drug if pharmacists provide the information required of them under the law.

Two of the drugs you mentioned in your aritcle (atenolol and propranolol) are included in Appendix T of the PNDF and better control of hypertension may be achieved if only one brand of those drugs is to be taken as maintenance therapy.

Also, R.J. Taylor (a pyschiatrist), in writing to the Australian Prescriber (vol. 28 no. 4, Aug. 2005)**, said that "we should remember that we are NOT just prescribing the active ingredient when we prescribe. There is the issue of varying particle size and varying excipients that may make a difference." As an example, he mentioned that "I once had a pyschotic patient with lactose intolerance and I had to work to identify which brands (or even which strengths of the same brand) of antipyschotics were lactose free." (Lactose is used as a base in some prescription drugs and over-the-counter medications.)

Indeed, there are excipients (and other pharmaceutical ingredients) added to the active component (the drug itself) to produce a drug product (i.e., drug + excipients) that sometimes make the difference. Some of these excipients may produce allergic reactions to susceptible patients which explain why some patients are "hiyang" to certain brands of drugs having the same active ingredient.

I am also in support of the Generics Act but these are two of the exemptions which I think should be remembered in choosing cheaper generic drugs over certain expensive branded drugs."

pinoypharmacist's note: I have limited knowledge in pharmacokinetics and biopharmaceutics. If there is anything that is not correct regarding my understanding of the subjects, kindly inform me. It shall be greatly appreciated.

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* http://news.inq7.net/opinion/index.php?index=2&story_id=53269
** http://www.australianprescriber.com/upload/pdf/articles/695.pdf

What's wrong with an official receipt and a piece of paper?

One of the drugstores that I have recently reported to the Regulation Division I of the Bureau of Food and Drugs had issued me an official receipt with a different address of the drug outlet (probably that of the other branch) for prescription drugs which I purposely purchased without a prescription. (This was not the first time I have encountered such malpractice.)

On another occasion, the same drugstore issued me just a piece of paper as receipt for my purchased medicines. So, aside from reporting this drugstore to the BFAD, I also reported to the Bureau of Internal Revenue through no-or-complaint@bir.gov.ph. This is where complaints on non-issuance of Official Receipts (OR) by business establishments are being reported to the BIR.

Quote of the day: On deterioration of pharmacy's social standing

"Regrettably, most of those who use pharmacy to advance their own aims and many pharmacists have as their mission the accumulation of wealth. Once taken up, that goal obscures every value the professional holds dear: standards of excellence are eased to accommodate profit potentials, the sense of responsibility to community and profession is undermined, rules of conduct are relaxed, efforts by management to ease entry into its educational system become apparent, and its social standing begins to deteriorate."

- R. David Anderson

Not without a prescription

I was on my way home from the supermarket last Monday morning when I met a kababayan along the way.

She asked me if I can buy a certain drug product for her hypertension in the hospital pharmacy where I work since the price there is cheaper.

I asked if she had a prescription and she replied, "Wala. Kilala ka naman doon."

I learned that the last time she had a check up and diagnosed with hypertension was 2 years ago. Since then, she has taken the drug product every time she feels dizzy which she thinks is due to hypertension.

I advise her to consult a doctor again and assured her of my assistance to buy her medicine if she already has the prescription.

Quote of the day: On implementing pharmaceutical care

"Are pharmacists willing to provide pharmaceutical care and do they have the capabilities to do so? In fact, many pharmacists have been providing elements of pharmaceutical care for years, but they may not have been consistent or systematic in doing so, or they may not have been documenting their patient care activities. Individually, each practitioner must address his or her own degree of willingness. Implementing pharmaceutical care is not easy, and pharmacists need to establish their own motivations for providing pharmaceutical care to their patients. This effort can be extremely challenging; yet by taking small steps forward, pharmacists can overcome many obstacles to converting their practices to the new philosophy."

- Randy P. McDonough

Source: Intervention to Improve Patient Pharmaceutical Care Outcomes.

Journal of the American Pharmaceutical Association. Vol. NS 36 No. 7

(July 1996) 453-466.

A forwarded message about MedExpress

This is a forwarded text message sent by one of our interns:

IT'S ALL ABOUT TIME!
Have your medicines delivered right at your doorstep!Just give us a call at (02) 6343333...
Our on-line licensed pharmacist will take your call...
Another first from MedExpress, the 3 in 1 drugstore!
Breakthrough services for your ultimate convenience...
Pls. pass this message and let your friends experience the MedExpress services...
MedExpress also offers the following services:
1. Patient compliance program
2. Confidential medication profile
3. Medication counselling
4. Daily dose pack

MedExpress also caters walk-in and drive thru customers, just give us a call at (02)6343333 and know more about us.

Quote of the day: On type of pharmacist of the future

"What type of a pharmacist do we want to graduate?... The pharmacist of the future should not only be knowledgeable, creative, and an effective communicator but also be a motivated professional ready to learn new concepts and function as a team player. Keeping these attributes in mind, we must think beyond time spent on education and training; quality not just the credit hours of our courses, should be evaluated. A teacher should demonstrate an enthusiasm and excitement for the subject, genuine concern for the student, and a process of learning the material. The students should learn how to raise and answer important questions. An intellectually stimulating session can produce larger payoffs than simple one-way transfer of facts. It is my experience that once students become enthusiastic about the subject matter, they work hard to learn both within and outside the classroom."

- Milap C. Nahata

Issues Facing Clinical Pharmacy Education for Undergraduate Students. DICP - The Annals of Pharmacotherapy Vol. 23 No. 3 (March 1989): 250 - 251.