FDA warns against improper medicine dispensing amid Bell-Kenz mess

The Food and Drug Administration (FDA) on Monday has warned medical practitioners against the improper dispensing of medicines following the alleged involvement of some doctors in pyramiding-like marketing scheme involving pharmaceutical company Bell-Kenz.

The FDA's public warning issued on 15 May reiterated the public warning against accessing drug products from medical doctors, unauthorized clinics, and other health facilities.

Under Republic Act (R.A.) No. 10918, dispensing was defined as "the sum of processes performed by a pharmacist from reading, validating. and interpreting prescriptions: preparing; packaging; labeling; record keeping; dose calculations; and counseling or giving information, in relation to the sale or transfer of pharmaceutical products with or without a prescription or medication order. Dispensing is an exclusive activity of a pharmacist, to be conducted only within a licensed establishment."

Following R.A. No. 3720, as amended by R.A. No. 9711, the Department of Health (DoH) has issued Administrative Order No. 2020-0017 requiring all establishments that sell or offer for sale drug products to first secure appropriate License to Operate (LTO) or authorization from FDA prior to engaging such activities.

Medical doctors, as part of their practice, utilize drug products, the FDA said.

However, several doctors procure, store, sell, and offer for sale drug products to their patients without proper authorization issued by FDA, which is a violation of R.A. No. 3720 as amended by R.A. No. 9711;

FDA added that doctors procure, store, sell and offer for sale drug products to their patients without the supervision of a pharmacist, which is a violation of R.A. No. 10918: without issuing receipts, which is a violation of existing trade and revenue regulations; and without observing good distribution and storage practices, which is a violation of standards implemented by FDA.

Likewise, the FDA reiterated that all licensed drug manufacturers and distributors are not authorized to sell to unlicensed retail outlets, including clinics of medical doctors.

The FDA also advised the public not to avail medicines from clinics of doctors unless the abovementioned requirements are met.

This is the latest of a series of issuances that the FDA and the Department of Heath (DoH) released since the Bell-Kenz controversy broke out in April.

The DoH and its attached agencies, like the FDA, said they are prepared to answer queries from the senators on possible government neglect that led to the alleged pyramiding of medicines during the Blue Ribbon Committee hearing on Wednesday (22 May).

“Out of our respect for the Senate and knowing the public nature of its proceedings, the DOH will present its positions and answer all questions at the hearing itself,” Dr. Albert Domingo, a senior official from DoH, said when asked to comment on the scheduled hearing.

The Senate Blue Ribbon Committee, otherwise known as the “Senate Committee on Accountability of Public Officers and Investigations,” is the Senate committee tasked to investigate alleged wrongdoings of the government, its officials, and its attached agencies, including government owned and controlled corporations.

Article VI, Section 21 of the 1987 Constitution, states that the committee’s purpose is to pursue its inquiries in aid of legislation in accordance with its duly published rules of procedure. The rights of persons appearing in or affected by such inquiries shall be respected.

The Senate Committee calendared the hearing on Wednesday as a follow up to the inquiry conducted last month where senators grilled the officials of Bell-Kenz pharma for allegedly engaging in pyramiding and other unethical marketing practices involving doctors and pharmacies.

Some doctors that incorporated Bell-Kenz themselves are reportedly practitioners at the Philippine Heart Center (PHC).

The PHC, during last motnh's hearing, assured it will cooperate with the Senate probe.

During the said hearing in April, cardiologist and Bell-Kenz chief executive officer Dr. Luis Raymond Go and other company officials were under senators’ scrutiny, particularly on their alleged grant of lofty incentives to doctors who are prescribing their medicines on a monthly quota.

Go then admitted Bell-Kenz only had partial compliance with the reporting requirements on the company’s financial relationships with doctors.