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Counterfeit Contraceptives Rife in South America

By HospiMedica International staff writers
Posted on 30 Apr 2014
A survey of emergency contraceptive pills (ECPs) in Peru has found that 28% of the batches studied were either of substandard quality or falsified.

Researchers at the Georgia Institute of Technology (GATech; Atlanta, USA), The University of Oxford (United Kingdom), and other institutions developed an analytical strategy to assess ECP medicine quality in Peru. For the study, samples of ECPs were purchased at 15 pharmacies and distributors in Lima (Peru). The tablets were collected from 25 different production batches (60 tablets each), encompassing 20 brands labeled as manufactured in nine countries (Argentina, Chile, China, Colombia, Hungary, India, Pakistan, Peru, and Uruguay).

The researchers used a tiered multiplatform approach to examine the tablets. First, ambient mass spectrometry was used to obtain a real-time signature of the tablet's chemical composition. They then examined the presence, identity, and amount of the active ingredient, and tested if the tablet dissolves properly. Since sophisticated fakes might pass all these tests, the researchers also examined excipients, such as lactose and cellulose. In all, 7 different batches showed inadequate release or improper amounts of the active ingredient, levonorgestrel, and one batch was found to contain a wrong active ingredient. The study was published on April 18, 2014, in PLoS One.

“A woman who does not want to get pregnant and takes these emergency contraceptives will get pregnant,” said study author Prof. Facundo Fernández, PhD, of the GATech school of chemistry and biochemistry. “We detected that the active ingredient was not there in one batch, instead those samples had a drug called sulfamethoxazole. It's a very common antibiotic. It can cause serious adverse reactions in some patients.”

Falsified drugs are a major problem in developing countries, and have been reported in Nigeria, Ghana, Kenya, Angola, South America, and even the United States. Just as concerning are other poor quality medications, such as degraded or substandard drugs. Degraded drugs are those that lost their efficacy over time, for example after prolonged exposure to the sun in an open air market. Substandard drugs are made by an approved factory, but do not contain the right active ingredient, contain less active ingredient than they should, or might not dissolve properly.

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