Counterfeit contraceptives found in South America

http://www.eurekalert.org/pub_releases/2014-04/giot-ccf041714.php

PUBLIC RELEASE DATE: 18-Apr-2014

Contact: Brett Israel
Georgia Institute of Technology

Counterfeit contraceptives found in South America

More than a quarter of emergency contraceptives were falsified or substandard

A survey of emergency contraceptive pills in Peru found that 28 percent of the batches studied were either of substandard quality or falsified. Many pills released the active ingredient too slowly. Others had the wrong active ingredient. One batch had no active ingredient at all.

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Drugs are considered fake or falsified when someone makes a pirate copy of copies a patented drug, with criminal intent. Recent research has found that falsified drugs are a major problem in developing countries. Falsified emergency contraceptives have been reported in Nigeria, Ghana, Kenya, Angola, South America and even the United States. Fake drug manufacturers will copy everything from the pill to the package.

Just as concerning as counterfeit medications are other poor quality medications, such as degraded or substandard drugs. Degraded drugs were once good quality, but 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 they don't contain the right active ingredient, contain less active ingredient than they should, or might not dissolve properly. These pills either result from factory error or negligence.

Falsified drugs are the most worrisome, because they may not contain the expected active ingredient, or they may contain the wrong ingredients, including toxic compounds.

In the survey of emergency contraceptives from Peru, the researchers found that seven of the 25 batches analyzed had inadequate release of the active ingredient (levonorgestrel). One batch had no detectable level of the active ingredient.

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"Many fakes are very sophisticated. They have the right active ingredient and they may even have the right amount, but the excipients or coatings may not be the right ones," Fernandez said.

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