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Counterfeit and illicit medicines

Counterfeit medicines

The World Health Organisation estimates that globally one in ten of all prescription only medicines are fake or counterfeit. Although there have been few counterfeit medicines or medical devices identified in the UK, rigorous surveillance is required. All healthcare professionals and suppliers must all continue to be vigilant as trade in counterfeit medicines is expected to increase. 

Recently four Class 1 Medicine Recalls have been issued by the Medicines and Healthcare Products Regulatory Agency, which has highlighted the need for a greater emphasis on controlling and auditing the supply chain. QCWM has been regularly involved with this, including visiting manufacturing sites, auditing documentation, working with wholesalers and laboratory testing.

The Association of the British Pharmaceutical Industry stated in 2005:

"Two possible weak areas in the system are internet pharmacies, which often operate from centres outside the UK, and through parallel trading, where medicines are not only shunted backwards and forwards across Europe by the traders but are often opened up and repackaged.

"All medicines should reach the patient in the manufacturer's original packaging - product integrity must be maintained. The simpler the system, the less likely it is to provide opportunities for criminals."

Illicit medicines

As well as counterfeit medicines which try and mimic approved pharmaceutical products there is an increasing problem with Illicit medicines which either market themselves as alternatives to the approved pharmaceutical product (API) or as a "herbal preparation". Common areas for this are:

• Eczema and psoriasis preparations which have been laced with steroids
• Natural remedies for pain which contain analgesics
• Diet pills which contain amphetamines
• Natural remedies for common conditions such as diabetes which contain APIs

The role of Quality Control West Midlands

The laboratory provides a full analytical service to healthcare professionals in primary and secondary care across the region as well as to the private sector. As a result of this we have become increasingly involved in the problems associated with counterfeit and illicit medicines.

The laboratory's first major involvement in this area was with the Dermatologists at Birmingham Children's Hospital who were concerned at the number of patients arriving with wonder creams for their eczema or psoriasis. The laboratory worked closely with them and developed a screening method for these preparations. Results of this study were published in the Archives of Disease in Childhood 2003;88:1056-1057. This revealed a huge problem and the laboratory worked closely with MHRA - exchanging methods with their own test laboratory and direct liaison with enforcement inspectors.

The laboratory has extended its screening methods and now routinely screens preparations which are thought to be illicit or counterfeit sharing information directly with the MHRA.