The term ‘down and dirty’ best describes those peddling in fake medicines.
The World Health Organisation (WHO) defines counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products, and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging”.
Various factors foster the counterfeiting of medicines.
According to WHO, they include lack of political will and commitment; lack of appropriate drug legislation; absence of or weak drug regulation; weak enforcement and penal sanctions; corruption and conflict of interest; demand exceeding supply; high prices of medicines; inefficient cooperation between stakeholders; lack of regulation by exporting countries and within free trade zones; and trade through several intermediaries.
The Emerging Markets Health Network reported that Health Ministry studies found that 5.2% of medicines sold over-the-counter are fake. In 2006. Pfizer (Malaysia) found that 4.8% of its prescription medicines – Viagra, Norvasc and Lipitor – were fake.
In 2005, the Pharmaceutical Association of Malaysia found that 5% of prescription medicines were fake, including eye drops, inhalers and medicines for erectile dysfunction (incidence was 8.5%).
According to Business Monitor International, the value of medicines consumed in Malaysia was RM6.06bil in 2012.
The Health Ministry seized more than 40,000 unregistered products worth more than RM23.5mil in 2012, with the majority being medicines for erectile dysfunction. The value of the seized counterfeit medicines is miniscule compared to the estimated value of the fake medicines sold.
Consequences of fake medicines
There are various serious consequences of fake medicines.
Patients’ morbidity and mortality are increased because of inappropriate treatment and adverse effects or even harm from toxic substances in the fake medicines. The toxic substances include heavy metals (e.g. aresenic) and additives (e.g. steroids).
Drug resistance develops to antimicrobial medicines, especially antibiotics, anti-malarials and anti-retrovirals.
The workforce’s productivity will be affected, with economic losses for some patients.
Fake medicines will lead to an erosion of confidence in the health system, with the public less likely to seek treatment when ill.
Legitimate pharmaceutical manufacturers, who have made costly investments, may withdraw supply of high quality medicines because it is not economical for them to compete with fake medicines.
Distinguishing genuine from fake medicines
There are several ways of ensuring that your medicines are not fakes. For example:
• Always seek advice from a doctor when ill.
• Obtain or purchase medicines from a public healthcare facility, licensed or registered private healthcare facility, or a licensed pharmacy.
• All genuine medicines sold would have been registered by the Health Ministry’s Drug Control Authority. All registered products contain registration numbers with the alphabetical code “MAL”, followed by eight digits, and then by either “A” for controlled medicines, “T” for traditional medicines and “X” for non-poison or over-the-counter (OTC) medicines. These medicines have a hologram label with 10 digits and the alphabets “KKM”.
• Medicines of Pfizer have an additional security feature, i.e. a Patient Authentication for Safety via SMS (PASS) system. There is a 15-digit verification code hidden behind the label authentication code. This enables consumers to check against the hologram label found in the medicines. The genuineness of the medicine can be verified instantly by sending the verification code by mobile phone (SMS) to 33488, after which they will receive a reply.
• Inspect the packaging of the medicine. All genuine medicines have high quality packaging or boxes. The name of the medicine is spelt correctly and the print is strong.
• All genuine medicines have indented batch numbers/dates and expiry dates. The indentation can be felt by running a finger over the package or strip.
• Most genuine medicines in boxes come with an information leaflet of high quality paper. Many will be written in more than one language.
• Do not accept blister packs with faded, wrongly spelled and cheap looking foil backs.
• Many high quality medicines have logos or names indented on the tablet itself.
• If the tablets inside the blister packs are misshapen, cracked or swollen, it is probable they are not genuine or their packaging quality is suspect.
• Avoid obtaining or purchasing medicines that are bottled individually from large bottles.
• A substantial difference in the price of the medicine should always ring a warning bell.
Public education about the dangers of fake medicines on long-term health and negative impacts on society is essential, with the media having an important role to play.
As the punishment for those found guilty of producing or distributing fake medicines is nothing compared to the potential profits, stronger deterrents are necessary.
Enforcement is currently carried out by the Health Ministry and Domestic Trade and Consumer Affairs Ministry. This has to be streamlined, with a reduction in bureaucracy.
Concomitantly, concerted efforts at enforcement should be efficient and effective, which cannot be said to be so currently.
Malaysia recognises and deals with the infringement of intellectual property in the music and film industry. Similarly, effective efforts are necessary to address the problems in the pharmaceutical industry.
Technology could be the key to control fake medicines. Although the hologram is a useful start, foreign reports of fraudulent production of the hologram are of concern.
The fact that one multinational pharmaceutical company has introduced an additional security system raises questions.
Currently, traditional medicines are not subject to the same stringent regulations as the medicines manufactured by pharmaceutical companies. Stricter regulation and monitoring of the traditional medicine industry is also necessary to protect consumers.
Although it is the right of individuals to choose the medicines needed, choice can only be rational when sufficient information is available.
¦ Dr Milton Lum is a member of the board of Medical Defence Malaysia. This article is not intended to replace, dictate or define evaluation by a qualified doctor. The views expressed do not represent that of any organisation the writer is associated with. For further information, e-mail firstname.lastname@example.org. The information provided is for educational and communication purposes only and it should not be construed as personal medical advice. Information published in this article is not intended to replace, supplant or augment a consultation with a health professional regarding the reader’s own medical care. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.