What is DOH A.O. 2015-0053?

Let’s take a break from the medical posts and discuss something related to practice!

I’ve heard of stories on how the pharmas have influenced the doctor-patient relationship. I recall one story shared by Dr. Tony Dans (circa 2003?) of how prescriptions for a drug changed  in relation to an out-of-town launch (on a cruise, if I’m not mistaken). Peaks in prescriptions were observed when the news came out, when invitations were sent, the days leading to the launch and for several days afterwards. Amused as I was, I didn’t pay much attention then as  that story happened abroad. I recall commenting also that probably what happened was an exception rather than a common occurrence.

But recently, Dejong C, et al. (JAMA Internal Medicine 2016; 176 (8): 1114.) posted an analysis exploring once again the relations between industry and physicians. The authors compared prescriptions for promoted drugs compared to others in the same drug class following receipt of an industry-sponsored meal. Not surprisingly,the study found that the receipt of a single industry sponsored meal was associated with an increased rate of prescribing brand name medication that was being promoted (odds ratio ranged from 1.18-2.18, all reaching statistical significance). More so, additional meals given and receipt of meals costing >US$20 also resulted in higher relative prescribing rates. I guess there’s no denying this now even if the study didn’t happen locally.

Department of Health Adminstrative Order 2015-0053, signed during Christmas break, is the implementing guideline on the local adoption of the Mexico City and Kuala Lumpur Principles in the promotion and marketing of medicines and medical devices. The AO intends to prescribe ethical standards in the relations between industry and stakeholders (doctors, patients, etc.). Through it, proponents hope that medical decisions become less influenced by industry activities and are made based on the best available evidence and with patients’ interests in mind.

The guideline has specific prescriptions on most activities of industry ranging from their interactions and activities with HCPs, support given to doctors, product sampling and even the training and recognition of medical representatives by the Board of Pharmacy. 

The document is 25 pages long. And while it is mostly concerns industry, it would be in the HCP’s interests to know what is permitted under the AO.

The following, I believe, should be known by all doctors practicing in the Philippines:

Coverage of Doctors and Provision of Product Samples

  • Information provided on medical products and devices by med reps should be limited to evidence-based scientific data.
  • Information and educational materials provided should discuss benefits and harms of drugs and devices, Pk and Pd data, indications and contraindications to use of the product, adverse events and drug interactions.
  • The following are prohibited in promotional and marketing materials: (a) one sided, inadequate or truncated evidence to support claims; (b) superlatives, exaggerations and comparatives without supporting data; (c) unsupported comments about competitors; and, (d) unspecified and unreferenced claims on efficacy and safety. Also prohibited are claims that products are non toxic and have no side effects.
  • Samples are allowed and receipt should be acknowledged by the doctor. These cannot be given by the health rep to the general public or any member of the doctor’s family.
  • In case a substantial amount of samples are given for indigent patients, the receiving doctor shall execute a statement that these will be used for its intended purpose and not for financial gain.

Support / Grants given to Doctors 

  • Grants, scholarships, support, consulting contracts and educational or practice-related items shall not be offered to doctors in exchange for recommending and prescribing products.
  • Support given during symposia and congresses should be modest and shouldn’t  include recreational activities . All of these should be well documented.
  • Textbooks, subscriptions to medical journals and anatomical models may be given in support of educational needs of doctors.

Scientific Programs, Symposia and Continuing Professional Development

  • Companies are prohibited from paying for travel, meals and other expenses of accompanying persons, guests or family members.
  • There are conditions on sponsoring doctors to events involving foreign or local travel.
  • Doctors sponsored to local and overseas symposia have an obligation to transfer knowledge in the medical community.
  • Doctors attending  symposia involving international travel as participants can be sponsored by a company only once during any given calendar year. Exempted from this are speakers, presenters, meeting organizers, etc.
  • Entertainment during activities shall not include expenses for recreational items such as tickets to movies, concerts or sporting events, sporting equipment or vacation trips.

Others

  • Healthcare professionals shall not be contracted to promote, advertise or endorse any medical product or device in mass, print, audio, visual and social media
  • Health reps shall not communicate directly to either patients or their families in the promotion of their products

While failure to comply with these guidelines translate to sanctions on industry, physicians are enjoined to respect, abide and align their  code of ethics to be consistent with the order.

Hopefully, I’ll never come across a study painting an unfavorable picture of industry-physician relations in the Philippines.

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