The problem of counterfeit drugs is considered nothing less than a plague in the medical world, as they are likely to be contaminated or contain wrong/no active ingredients. It is also possible that they may contain the right active ingredient but at the wrong dosage.

Regardless of whichever issue surfaces, counterfeit drugs have the potential to harm patients and hurt the reputation of the healthcare profession. Unfortunately, counterfeit drugs are widely available within the Asia Pacific region, including Malaysia. To combat such an issue, the relevant stakeholders, especially pharmacists, must have at least a basic understanding of the situation.

Prevalence of counterfeit drugs in Malaysia

A survey conducted in February 2013 indicated that one in twenty drugs sold in Malaysia was fake. The research team also found an increasing trend in the prevalence of counterfeit drugs, and that a large proportion comprised lucrative sexual stimulants. The most popular of these was none other than the "little blue pill": Viagra. In 2007, the Royal Malaysian Customs Department completed the largest seizure of counterfeit Viagra, worth USD4 million - equivalent to 1.4 million pills.

Similarly, the Pharmacy Enforcement Division of the Malaysian Ministry of Health, along with other international and government agencies, successfully conducted the largest internet-based operation targeting the syndicate behinnd the sale of fake medicines online. The operation, otherwise known as Pangea VIII, resulted in resounding success: USD $81 million worth of counterfeit drugs were seized globally. In Malaysia, just under 300 websites and social networking sites were closed down and legal actions were taken against the perpetrators. In addition to sexual stimulants, many unregistered slimming products and adulterated cosmetic products werefound during the operation too.

Serious concerns have been raised in the country, revolving around the fact that these counterfeit products have been very accessible, but the general sentiment about this has been indifference. On the heels of this is yet another greater problem that looms in the shadow: unregistered traditional medicinal products.

The ticking time bomb

In 2005, a WHO Global Survey estimated that the size of the Malaysian traditional medicines market was worth RM4.55 billion. This figure was four times larger than the total amount of drugs used in government hospitals and health clinics. The market was shown to have strong growth rates, between 8% and 15% annually.

Regulations for traditional medicines are significantly less stringent as compared to conventional pharmaceutical products. In fact, these traditional and herbal medicines often do not undergo any regulatory processes at all. The availability of traditional medicines further complicates the issue. For example, a study was conducted on the mercury content of the herbal remedy, Smilax luzonesis where it was found that 14% of the tested products did not meet the minimum quality requirements. Many of these “natural products” were also laced with western medicines, such as sibutramine, NSAIDs and steroids to enhance their purported effects.

Measuring up to the world standard

Malaysia is not the only country facing such an issue: Indonesia was reported to have a 25 per cent prevalence of counterfeit drugs, and other developing countries such as India and Mexico also reported similar figures. However, developed countries such as the United States and the United Kingdom have successfully reduced and contained the problem to less than one per cent.

Co-operation from all stakeholders, especially pharmacists who oversee the purchase and sales of medicine, must be sought to combat such problems. The nation can, and should, aspire to achieve zero prevalence in counterfeit drugs. With the appropriate pragmatic approach, this is definitely an achievable goal. MIMS

Read more:
A snapshot of the Malaysian pharmaceutical industry
Malpractice among pharmacists: Errors, negligence and abuse
Healthcare professionals: How can you spot counterfeit drugs?

Reference:
1. Zulkifli NW, Aziz NA, Hassan Y, Hassali MA, Bahrin NLZ, Ahmad A. Are We on the Right Track?: Overview of Unregistered Drugs in Malaysia. J Pharm Pract Community Med. 2016 Aug 1;2(4):107–15.
2. Pharmaceutical Service Divisions Malaysia. Unregistered medicines valued at RM 830, 663 seized in Malaysia during Operation PANGEA VIII 2015 [Internet]. pharmacy.gov.my. 2015 [cited 2017 Jan 17]. Available from: http://www.pharmacy.gov.my/v2/en/news/23-jun-2015/unregistered-medicines-valued-rm-830-663-seized-malaysia-during-operation-pangea-viii-2015.html
3. Harris J, Haja Mydin H, Stevens P, Morris J. Keeping it real: combating fake drugs in Malaysia. Kuala Lumpur; 2011.