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Stabroek News

PHARMACY TODAY - So many drug recalls
published: Wednesday | July 4, 2007


Ellen Campbell-Grizzle

We are hearing more now about drug recalls than ever before. Products are now being taken from the market in the full glare of public scrutiny. While we know that medicines continue to save many lives, the evaluation of benefit versus harm does help to achieve the ultimate goal of the safe use of medicines.

For example, the recent recall of the antiretroviral drug, Nelfinavir (Viracept) supplied by Roche, is well documented. Problems with certain batches of the drug were detected. The recall covered all batches and formulations for several markets except the United States of America, Japan and Canada. A release from the Global Fund stated that a toxic chemical (methane sulfonic) appears to have contaminated the active ingredient. This chemical is known to have cancer-causing effects and may be of particular concern to children and pregnant women. Readers may view the recall notice from Roche at http://www.roche.com/med-cor-2007-06-06b.

The World Health Organisation (WHO) in its statement issued on June 8, 2007, provided additional instructions. The release advised adults or children to continue to take their antiretroviral medication and see their doctor as soon as possible to change from Nelfinavir to a suitabl The WHO suggested some options for the guidance of prescribers.

Be an alert consumer

Consumer activism is critical to effective post marketing surveillance, an important stage in ensuring the safe use of medicines. Pharmacists know that the Jamaican consumer has a critical role to play in this process. Patients should report any untoward medical occurrence that may be present during treatment with a medicine.

There is no doubt that the information collected before a drug is marketed may be incomplete, especially with regard to Adverse Drug Reactions. Information about rare but serious adverse reactions is often not available until many persons have used the drug. Herbal remedies can interact with some medication. Genetics, diet and tradition cause important differences in the outcomes of therapies across diverse countries. Counterfeit or substandard products can be identified as a consequence of consumer reporting. Astute and alert patients have helped to save lives.

The public interest

There is a public health responsibility to acknowledge and explain the inherent uncertainty of the risk and uncertainties associated with medication use. The Erice Declaration of 1997 highlighted the role of consumers, health professionals, media, governments, academics and researchers in developing effective communication strategies. The declaration encourages transparent systems that promote general confidence and trust. Against this backdrop, cooperation is the key.

If you are taking medication, make sure you are adequately informed about your treatment.

Know what your medication is treating.

Understand how your medication works.

Rehearse your dosage while you are in the pharmacy.

Ask your pharmacist about expected side effects.

Take your medication as instructed.

Store your medication as instructed out of the reach of children.

Remember, report any untoward effects to your pharmacist, doctor or healthcare provider. Your vigilance in observing and reporting adverse drug reactions will help to ensure the safer use of medicines.


Ellen Campbell-Grizzle, president, Caribbean Association of Pharmacists; director, Information & Research, National Council on Drug Abuse; email: yourhealth@gleanerjm.com.

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