Screening tool to spot falsified medicine harm is road-tested

A tool designed to spot when patients have been exposed to falsified medicines has been put through its paces by scientists in Europe.

The "decision-aid" tool – developed by the European Directorate for the Quality of Medicines & Healthcare (EDQM) – consists of a questionnaire referring to a watch-list of falsely-labeled and falsified (counterfeit) medicines (FFCs) that have been identified in Europe, including symptoms of their use and individual risk factors, and a scoring form.

The pilot zeroed in on 56 'watch list' medicines in seven therapeutic classes that are frequently falsified and intercepted in Europe, including central nervous system drugs, therapies for obesity, erectile dysfunction and cardiovascular disease, and anabolic steroids, as identified by the EDQM's official medicines control laboratories (OMCL) network.

In a first phase, the tool was trialled in 105 self-reported users of watch-list medicines, and then validated in 371 patients in real-world conditions – either in out-patient clinics or in-patient facilities in six European countries. The doctors participating in the study scored patients and their risk of harm as either 'unlikely' or 'probable' depending on the risk factors uncovered by the tool.

In three out-patient sites which recruited 180 patients, the tool was considered to have correctly classified five patients as harmed by falsified medicines, according to the researchers, who have published their work in the journal BMC Health Services Research. There were no cases identified among 190 in-patients enrolled in the study.

The five patients included an Armenian who had been treated with the antibiotic Rocephin (ceftriaxone) – known to have been targeted by counterfeiters in the country—as well as a Croatian who developed liver damage after taking a dietary supplement adulterated with the anabolic agent oxandrolone, and three Italians who had experienced side effects after taking anabolic products.

"FFCs are produced or distributed illegally and can harm patients," say the researchers. "Although the occurrence of FFCs is increasing in Europe, harm is rarely reported."

There were some limitations. All physicians considered manual scoring as required by this preliminary version of the tool as too time-consuming for medical practice, and the intention is to develop a digital version.

"The tool can be integrated into routine patient questioning, diagnosis and treatment planning," write the authors, who suggest it could be of particular use in areas where there is a high level of contamination of health systems by falsified medicines, e.g. 10-20 per cent penetration.