New study alerts to the risks of poor quality medicines for diabetes treatment

A new study suggests that there are important but neglected issues with falsified and substandard medicines used to treat diabetes and that “no country is immune”.

Diabetes prick test

According to the World Health Organization, globally more than 415 million people have either type one or type two diabetes and rely on insulin, antidiabetic medication and supplies for self-monitoring of blood glucose (SMBG) to monitor and medicate their condition. The direct annual global cost of diabetes is estimated at $827 billion.

From the very limited available data, the IDDO and MORU Tropical Health Network scientists found about one tenth of medicines sampled were not up to standard. Researchers concluded, based on the global prevalence of diabetes, there was a potential global “great health significance”. The scientific data on SMBG were inexistent but recalls and seizures of substandard and falsified SMBG were described on four continents.

With insulin in the top ten best-selling medications globally (in terms of number of prescriptions and sales value), it, along with new oral antidiabetic medicines, are likely to be attractive targets for falsification and risk of substandard production.

Due to their vital role in diabetes management, poor quality antidiabetic medicines and SMBG supplies will inevitably have adverse health impacts for patients, both short and long term, and can be life-threatening. In China, deaths have been linked to falsified antidiabetic medicines.

The systematic review recommends improvements should be made to the current reporting system to facilitate evidence pooling to better understand the global burden of this problem and inform interventions.

Kartika Saraswati of the IDDO and MORU Medicine Quality team, said: “The global prevalence of diabetes mellitus is increasing alarmingly. However, the quality of vital medicines and medical devices used to treat and monitor diabetes remains uncertain but of potential great public health significance.”

Research scientist Dr Céline Caillet, of IDDO’s Medicine Quality team, added: “Our findings showed that, despite the scarcity of the data, there are important issues with the quality of medical products for diabetes that need to be tackled.

“If substandard or falsified medical products are used to treat diabetes, this negates the benefits of optimal treatment, increasing the possibility of developing complications in patients. In 2045, it is estimated that about one in 10 people aged 20-79 years old will be diabetic. Given the magnitude of diabetes, the public health risk of even a low prevalence of poor quality medical products used to treat diabetes would be considerable.”

The researchers found data on 674 samples in the literature and of these 10.8 per cent were falsified or substandard, but the sample size is small in relation to the vast global trade in antidiabetic medical products and firm conclusions about prevalence cannot be made. More accessible data from surveillance of diabetes medical products are needed.

The report warned the issue of poor quality medicines is a global problem with “no country immune”. However, the problem appeared more pronounced in financially poor countries where regulatory systems were often weak. Diabetes disproportionately affects low and middle-income countries, where about four in five people with diabetes live. This puts most of the burden of poor quality medical products for diabetes treatment in low and middle-income countries, and because the cost to treat diabetes is higher in low and middle-income countries, paying for treatment can cause financial hardship, impairing peoples’ lives and productivity. The problem is further compounded by the temptation to buy cheaper potentially substandard medication or use illegitimate sources such as unregistered physical and internet pharmacies.

The research highlighted that in some cases SMBG strips, which give blood-glucose readings, had been falsified or people were sold second-hand unused and potentially degraded glucose strips at reduced prices.

To read the full paper view here.


Notes for editors

Substandard medicines could have resulted from manufacturing errors or negligence, or poor practice in transportation and/or storage.

Falsified medicines are defined as deliberately or fraudulently misrepresenting their identity, composition or source, and result from criminal fraud.