What is going to happen

I am very pleased with the appointment of Dr. Kenneth Y. Hartigan-Go as Director IV of the Food and Drug Administration on August 23, 2012. I guess I am a fan of this renowned toxicologist. 

Almost a year after his appointment, it is very obvious that the FDA has already taken giant steps under his leadership. I would like to think that the FDA is now on its way to be at par with its foreign counterparts in terms of regulating the local pharmaceutical industry. Unlike before, I am confident that the FDA is now more capable to do its job  efficiently and effectively.

Just to test that I am right with my assumptions, I have sent early today a complaint to the agency via eReport about a certain branch of a chain of drugstores where antibiotics are sold to the public without the need of a prescription. This is in relation to the DOH-FDA Advisory No. 2012-017 (Subject: ANTIMICROBIAL RESISTANCE) where "the public is... enjoined to report to FDA, either in writing or through telephone call... any drugstore dispensing antibiotics without the correct prescription..."

Let's wait and see what is going to happen...

Enslaved to the lure of wealth

Our profession was once again put in a bad light in one of the segments of the tv program "Imbestigador" when it featured in tonight's episode the 2 drugstores selling the unregistered drug misoprostol (Cytotec) in violation of the BFAD Advisory No. 02-02.

Nolee's Pharmacy in Calamba and Farmacia de Borja in Sta. Cruz (both in the province of Laguna) were positively found out selling the illegal drug.

The pharmacists in both drugstores were not present at the time when the "salesladies" were apprehended but it is more disappointing to learn from that segment that the owner of one of the drugstores is apparently a pharmacist.

If this is true, it seems that the guardian of the public health has gone enslaved to the lure of wealth.

Should empty vials of drugs be returned to the hospital pharmacy and destroyed by crushing prior to disposal?

On September 8, 1994, the Bureau of Food and Drugs (now the Food and Drug Administration) had issued Memorandum Circular No. 22 (Subject: Inventory, Proper Disposal and/or Destruction of Used Vials or Bottles) requesting the "conduct of a periodic inventory, proper disposal or destruction of used vials or bottles" by all concerned entities due to the "proliferation of adulterated, misbranded or counterfeit drugs" in the Philippines.

This was one of the measures taken by the Bureau to address the reports which reveal "that some unscrupulous persons are recycling used vials or bottles and fill it up with substances totally different in strength, quality, purity or potency from that previously contained in it."

On July 6, 1999, the Bureau of Food and Drugs amended BFAD Memorandum Circular No. 22 series of 1994 by the issuance of Bureau Circular No. 16 which defined "the responsibility of the Chief Pharmacists of government and private hospitals to conduct at least, a semestral inventory of the proper disposal and destruction of used vials or bottles, and to submit same to the Bureau within five (5) days fromt the date of inventory." The circular also directed the nurse administering the drugs to "be under strict instructions to return all empty vials to the hospital pharmacy for destruction on a quarterly basis" and that "all inventories and/or destruction shall be done under the supervision of a duly authorized representative of BFAD."

One of the accreditation standards of PhilHealth for health provider organizations (i.e. code 6.5.1.x.1) requires "the handling, collection, and disposal of waste [that] conform to relevant statutory requirements and codes of practice" and states the "presence of license/permits/clearances from pertinent regulatory agencies implementing among others the following: RA 9003, RA 6969, RA 9275, PD 1586, DOH Hospital waste management manual, RA 8749 (Clean Air Act)", as its core indicator.

This standard is consistent with the provision of the Joint DENR-DOH Administrative Order No. 02 series of 2005 (Subject: Policies and Guidelines on effective and proper handling, collection, transport, treatment, storage and disposal of health care wastes) which was also communicated, among others, to the president of the Philippine Health Insurance Corporation and directors of Bureaus under the Department of Health through the issuance of DOH Memorandum Circular No. 2005-0070.

The joint administrative order stipulates that the Department of Environment and Natural Resources-Environmental Management Bureau (DENR-EMB) "shall be the primary government agency responsible for implementing pertinent rules and regulations on the management of health care waste in the Philippines, particulary concerning the issuance of necessary permits and clearances for th Transport, Treatment, Storage, and Disposal of such wastes, as governed by RA 6969, RA 9275, RA 9003 and PD 1585." It also specifies that the "handling, collection, storage and transport of health care wastes shall be in accordance with the provisions of RA 8749, RA 6969, and RA 9003, and the DOH Health Care Waste Management Manual (Chapter 5)."

According to the DOH Health Care Waste Management Manual (2004), pharmaceutical waste "includes expired, unused, spilt, and contaminated pharmaceutical products, drugs, vaccines, and sera that are no longer required and need to be disposed of appropriately. This category also includes discarded items used in handling of pharmaceuticals such as bottles or boxes with residues, gloves, masks, connecting tubing and drug vials."

In this context, Chapter 5 of the Manual specifies that only "large quantities of obsolete or expired pharmaceuticals stored in hospital wards or departments should be returned to the pharmacy for disposal. Other pharmaceutical waste generated at this level, such as expired drugs or packaging containing drug residues should not be returned because of the risk of contaminating the pharmacy. It should be deposited in the specified container at the point of generation." It also states that "health care waste collection practices should be designed to achieve an efficient movement of waste from points of generation to storage or treatment while minimizing the risk to personnel."

Further, DENR Administrative Order No. 36 series of 2004, now requires waste generators to comply with the Waste Transport Record or Manifest System which include the declaration of the class, subclassification, and quantity of each hazardous waste, before it is allowed to store, recycle, reprocess, treat or dispose of hazardous waste at a facility outside its premises by contracting a DENR-accredited waste transporter and treater.

Therefore, policies and procedures on handling, collection, storage, transport and disposal of used pharmaceutical vials or bottles has to be aligned with the current regulatory and accreditation requirements. Ther repealing clause of the Joint DENR-DOH Administrative Order No. 02 series of 2005 which states that "all other issuances whose provisions of DENR and DOH Administrative Order, Memorandum Circulars or other issuances inconsistent [with it] are... repealed or modified accordingly", should also be considered.

Just an isolated case?

Two weeks ago I received a text message from my aunt asking me if I'll be interested in having my license rented by a doctor who owns a clinic somewhere in Cavite.

She told me that the doctor sells medicines in the clinic and to avoid being questioned by DOH surveyors during their inspections, he's offering Php 4,000 for the pharmacist's license. The pharmacist will just have to visit the clinic at least once a month and that's it!

I don't know if this scenario is rampant or just an isolated case, but the fact that it happened is something that pharmacists must not accept if the opportunity come their way.

We all know the reason why... some of us just pretend not to know. (You know!)

The grounds where sick people pass

She was half naked... face battered...
Her neck has hematoma... strangled... gang raped!


What kind of sickness had afflicted those who trampled upon your healing soul?
You've brought yourself to this remote land to cure.

And for what?


You ended up in the unwelcoming hands of some ungrateful brats.
They've even made witness to their crime the grounds where sick people pass.


Anger? Disgust? What's there to make you feel better?
What's left to get the rest of your kind to be out there?



______________
This post is dedicated to the volunteer nurse who was gang raped in South Upi, Maguindanao last September 25, 2010.

Amid dengue scourge

To hear news of ovepricing involving drugstores is no good news because it drags with it the pharmacist's name and reputation.

Such is the case of alleged overpricing in the sale of iv fluids "amid dengue scourge" in Cebu.

According to reports, those involved are pharmacies located outside Cebu City Medical Center and Vicente Sotto Memorial Medical Center.

I just hope that these reports are not true. Otherwise, those who were involved came short in "[helping] individuals protect themselves against diseases."




(Note: Posted first on the official website of the Philippine Pharmacists Association)

On ethics and self-regulation

Writing about the Medicines Transparency Alliance (MeTA) Philippines' series of round table discussions on the ethical promotion of pharmaceutical products, Dr. Alberto Romualdez in his article, "Finger-pointing on ethics" (Malaya, September 8, 2010), pointed out that "one of [the factors that influence the availability and accessibility of safe and effective medicines for sick Filipinos] is the continued misuse or overuse of ineffective, inappropriate, and often unsafe preparations for treatment of illnesses or enhancement of health."

According to him,"The irrational use of pharmaceutical products is a result of aggressive, often unethical, marketing and promotions practices of a highly competitive industry in a severely imbalanced market."

In his account of what has transpired in those round table discussions, he mentioned that "The health professional discussion group consisted of doctors and pharmacists who had the most extensive dealings with pharmaceutical marketing activities. These groups acknowledged that ethical problems existed but essentially laid blame on drug companies. The groups generally advocated for self-regulation in the form of existing or newly revised codes of ethical behavior. It was acknowledged however that mechanisms for monitoring compliance and imposing sanctions on violations were [woefully] inadequate."

In searching for any existing or newly revised codes of ethical behavior that may serve as basis for self-regulation, it is notable that the Code of Ethics of the Philippine Medical Association specifies the following:

"A physician is encouraged to report to the Philippine Medical Association or the Board of Medicine personal knowledge of any corrupt or dishonest conduct of the members of the profession." (Art. IV, Section 9)

"Generic names shall be used during the course of CME activities. However, after the lectures, the sponsoring entity may promote or indicate their branded products." (Art. IV,Section 15)

"Only gifts of reasonable value that primarily entail benefit to patient care or related to physicians' work may be accepted by a physician from a health product company." (Art. VI, Section 3)

On the other hand, the PPhA's code of ethics is more general in stating that "A pharmacist acts with honesty, integrity and professionalism in relationship with the patients and other health professionals."

Based on the above comparison, I hope that our code of ethics will be as specific as that of the PMA's. I also hope that this finger-pointing on ethics will stop soon. It's time we take the responsibility for our actions.

____________


(Note: Posted also in the official website of the Philippine Pharmaceutical Association.)