Illegal Medicine Threatens Patient Safety

Illegal Medicine threatens lives across Asia

Black market supply of pharmaceutical drugs poses numerous threats to public safety. The threat is dependent on the type of illegal medicine.

Counterfeit medicine is highly dangerous for patients. The key risk arises from substitution of active ingredients with cheap and dangerous alternatives. As reported in various consumer warnings and reports, harmful ingredients found in counterfeit medicine have included substances such as boric acid, leaded highway paint, floor polish, heavy metals, nickel, arsenic and brick dust.

Counterfeit products may also have the incorrect amount of active ingredient, making it difficult to achieve the required therapeutic dose. Counterfeit products may also have no active ingredient, rendering them useless in treating life-threatening conditions. As just one example, one study estimated that counterfeit medicine for malaria and tuberculosis was responsible for 700,000 deaths.

Expired medicine is also dangerous for patients. Expired medicine is legitimately manufactured, but has been retained in the supply chain beyond its intended life. At this point, the potency of the active ingredients is declining. The active ingredients may become unstable and potentially dangerous degradation products may emerge in the medicine. Owing to the product’s extended age, expired medicine is also more likely to become contaminated.

Unregistered medicine is legitimately manufactured, but has entered the country illegally. The medicine is not registered for sale in that country, and has not been subject to local monitoring by the Department of Health or relevant government agencies. As a result, unregistered medicine cannot be sold legally and enters the illegal supply chain.

Counterfeit, expired and unregistered medicine is typically sold in these illegal supply chains, where its common that storage conditions are inadequate, persons are unqualified and necessary supply chain controls are absent.

The risks posed by illegal medicines in illegal supply chains are cumulative, resulting in threats to consumers from defective or ineffective products, with lower chances of achieving the intended therapeutic benefit and higher risks of adverse reactions. From a long-term perspective, antibiotics supplied and distributed through the illegal supply chain are contributing to the emergence of “super bugs”: bacteria resistant to common and advanced antibiotics.

An upcoming report by SMCS Risk will provide further information on the detection and seizure of illegal medicine in Cambodia. The pharmaceutical industry must remain on the front-foot in controlling the illegal manufacture, sale and distribution of its products, but the lessons learned are also applicable to the cosmetic and food industries.