In March 2013, more than 200 people died and 1000 became seriously sick in Pakistan after consuming contaminated cardiac medications. WHO visited the site of manufacturing and established that the manufacturing process of Isotab (isosorbide mono-nitrate, ISMN) was seriously contaminated with pyrimethamine [1]. This crisis exposes the issue of using poor quality drugs in countries where regulatory oversight is weak and patients are desperate for affordable medicine.

Despite many incidents of death secondary to counterfeit drugs, there is no consistent or universally agreed-upon definition of counterfeit drugs. According to the definition given by WHO, a counterfeit drug is a drug that has been deliberately and fraudulently mislabeled with respect to identity and/or source [2]. US FDA defines counterfeit drugs as “those sold under a product name without proper authorisation” [3]. So how do we identify these?

Why do we need to know about the bad of counterfeit drugs?


According to a WHO report, in 1995 during a meningitis epidemic in Niger more than 50,000 people were inoculated with fake vaccines resulting in 2500 deaths. Three years later in Haiti, 89 children died due to consumption of paracetamol cough syrup mixed in diethylene glycol (a toxic chemical used in antifreeze). In 2001, 38% of the 104 anti-malarial drugs on sale in pharmacies in South East Asia did not contain any active ingredient [5].

Counterfeit drugs are also a public health threat. Directly, they can threaten the well-being of the user with harmful ingredients (such as the case of the contaminated ISMN in Pakistan). Indirectly, they can contain inadequate or wrong ingredients with no curative/immunization power (such as the case of fake anti-malarial drugs in SE Asia). Collectively, the popular use of counterfeit drugs can case mankind to develop resistance to the drug, making diseases harder to be treated. It also destroys long-term innovation and development of new drugs since there is no incentives in making patented drugs anymore.

Problems caused by counterfeit drugs are real, and most prominent in countries where regulatory and legal oversight is the weakest, such as in third world countries. There is a need for pharmacists to understand the threats from these counterfeits since Singapore is at the crossroads of many transiting tourists and foreigners.

Identifying counterfeits


There are multiple ways to spot a counterfeit drug.

Source: Check the source of the drug. Does it come from registered pharmacies or roadside? Does it come from a pharmacist or from a friend who has no knowledge of medicine?
Price: If the price is too good to be true, it probably is.
Packaging: If the packaging looks suspicious (unusual fonts, wrong translation, spelling errors etc.) or looks tampered with, be wary. If the batch number on the cartoon and the blister pack is different, be wary.
Drug: If the drug is an unusual colour (it is uncommon to have indigo, teal, lilac, gold as drug colours), or the shape or the smell is different from what you are familiar with, be wary.

Popular counterfeits


Drugs which are difficult to get a prescription for, and drugs that patients are likely embarrassed to ask for are common drugs that can appear as counterfeits on the market [5]. For example, controlled drugs and painkillers (e.g. tramadol, anarex and ketoprofen) as well as lifestyle drugs such as Viagra (treatment of male erectile dysfunction), Propecia (treatment of male alopecia) and Xenical (treatment of obesity), commonly appear in the black market in the local setting. Counterfeits for prescription drugs for hypertension and antibiotics have also previously been seized in operations led by the Health Sciences Authority of Singapore [6].

National agencies such as the FDA and drug companies are already stepping up to tackle this issue. As pharmacists, we can play our part by educating patients on the consequences of purchasing as well as use of counterfeit drugs. MIMS

Read more:
Made in China: Cancer patients resort to DIY drugs for treatment
FDA clamps down on online sellers of potentially dangerous drugs
Viagra: The lowdown on the little blue pill
3 Chinese drugmakers probed over production practices

Sources
1. Deadly medicines contamination in Pakistan. World Health Organisation, March 2013. Available at: http://www.who.int/features/2013/pakistan_medicine_safety/en/. Last accessed on 10 October 2016.
2. Definitions of SSFFC Medical Products. World Health Organisation. Available at: http://www.who.int/medicines/regulation/ssffc/definitions/en/. Last accessed on 10 October 2016.
3. Counterfeit drugs questions and answers. US FDA. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm169898.htm. Last accessed on 10 October 2016.
4. Counterfeit medicines. Fact sheet. November 2006. World Health Organisation. Available at: http://www.wipo.int/edocs/mdocs/enforcement/en/third_global_congress/third_global_congress_ref_z3.doc.Last accessed 10 October 2016.
5. Making a Kill: The deadly implications of counterfeit drug trafficking. Roger Bate. Available at: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Industry_Engagement_Activities/APEC%20LSIF%20Anti-Counterfeiting%20Health%20Products%20Seminar/The%20Deadly%20Implications%20of%20Counterfeit%20Drug%20Trafficking.pdf. Last accessed on 10 October 2016.
6. $9.8m worth of fake, illegal medicine seized in major op. The Straits Times, 23 December 2015. Available at: http://www.straitstimes.com/singapore/courts-crime/98m-worth-of-fake-illegal-medicine-seized-in-major-op. Last accessed on 10 October 2016.