The production of counterfeit or substandard anti-infective drugs is a widespread and under-recognized problem that contributes to morbidity, mortality, adverse drug reactions, drug resistance, enormous financial consequences for companies producing the genuine product and loss of confidence in the health care systems and the drug regulatory authorities. Counterfeit drugs particularly affect the most disadvantaged people in poor countries, like the Philippines. A wide array of different counterfeit types based on packaging, sophisticated fake holograms styles on blisterpacks and spurious tablets that contain no active drug have been found in Southeast Asia.
To counter such threats, simple field tests and advances on Forensic Analysis and Chemical Characterization of counterfeit and substandard anti-infectives can be done. Among of which are High Performance Liquid Chromatography (HPLC); Gas Chromatography coupled with optical, electrochemical or mass spectrometric detectors; Thin-Layer Chromatography (TLC); and Colourimetry.
There can be no simple solution to the problem of counterfeit drugs. A comprehensive, pragmatic plan of action, linking various organizations, health workers, industry, and civil society is essential. The increasing evidence that the trade in counterfeit drugs is linked to transnational organized crime presage the necessity to harmonize definitions and penalties between countries, apply strict police and customs action, intensify inspection and drug regulation, increase public awareness, and reinforce a strong political will and openness among countries.
But, vigilant doctors can help detect and report counterfeit medicines.
BFAD does not have specific guidelines on how to detect counterfeit drugs since these drugs are almost the same in appearance compared to the genuine ones. What they usually advice the consumers to do is to buy only from licensed drug stores. The problem is that some drug stores source their drug supply from unlicensed and suspicious traders and importers.
Republic Act No. 8203 also known as Special Law on Counterfeit Drugs, Section 3, states that:
“Counterfeit drug/medicine refers to medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients, without active ingredients, with sufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength or purity. It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products. It shall also refer to:
1) the drug itself or the container or labeling thereof or any part of such drug, container or labeling bearing without authorization the trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person;
2) a drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used;
3) an unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records;
4) a drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss or efficacy due to expiration.”
Hence, a substandard quality medicine is a counterfeit medicine by definition.
For the internist, the following can be indicators for fake drugs:
• Patients are not getting well or getting sicker– therapeutic failures. We have observed quite a few cases of attempted suicides with benzodiapezines, taking as much as over 50 tablets without any toxic effects. These drugs were sourced from undisclosed drug stores or from the streets. Hence, no active ingredients, patient do not get well or deteriorates and there is delay in treatment.
• Patient may report unusual side effects that are not known in current literature. Ask the patients where they had sourced their medicines. If they hesitate or refuse, suspect that the source is not from a legal channel. Please remember that even legal channels (i.e. licensed drug stores sometimes source medicines from illegal channels). Counterfeit medicines may contain nothing of the original active principles but something else (e.g. branded antihypertensive drugs were used, patients developed bleeding, while the diagnosis might be hypertensive bleed, the differential may be coumarin chemicals). Hence, wrong active ingredients can kill.
• The packaging is not in its original package, they do not have the requisite BFAD registration numbers andexpiry dates, printing is misaligned, labels easily destroyed or removed, discoloration of the package, no package inserts, tablets crumble, parenteral or bottle for reconstitution is tampered (i.e. needle holes seen in the rubber stopper) and the contents cannot be dissolved easily, evidence of contamination, foreign particles.
What the doctors must not do:
• With knowledge of substandard or fake drugs and of less than active ingredients, the doctor must not double the dose.
• Refusal to share information with other colleagues and hence missed out on patterns.
• Refusal to consider substandard drugs or counterfeit medicines as differentials to deterioration of patien conditions.
• Refusal to cooperate with the concerned drug industry in the investigation of counterfeit drugs.
• Buy drugs from questionable sources or abroad on their own and sell these in their clinics.
Newton PN, Dondorp A, Green MD, et.al. Counterfeit artesunate antimalarials in Southeast Asia. The Lancet. 2003; 362:169.