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Serious reactions to medicines 'should be' reported to MoH

DUBAI - Hospitals, doctors and pharmacists are expected to report serious reactions to medicines to the UAE Ministry of Health.

The Adverse Drug Reaction reporting form is now available at the MoH web site that can be downloaded.

Quality defect

The form has been designed to include all necessary information. When completed, this form should be sent to the Director of Drug Control at the MoH.

A quality defect is when a medicine is not made available in the approved form. The tablets may be crushed, capsules open or precipitate may be visible in an oral liquid. Labelling of the medicine may be incomplete or wrong. Some defects may manifest themselves as adverse reactions.

Quality defects should first be reported to the pharmacist who supplied the medicine. If a quality defect is thought to be a risk to the patient's health, or if a supplier has not responded efficiently to a complaint then the defect should be reported to the MoH.

Reactions rare

Serious adverse reactions to medicines are rare. Many are not easily predicted and some are the result of unusual interactions with other medicines or food. An adverse reaction may also be due to a product defect. These types of reaction only become clear after a product has been approved for use in the market. Therefore, monitoring the safety of medicine in the market is essential.

MedWatch role

MedWatch is the Food and Drug Administration's (FDA) programme for reporting serious reactions and problems with medical products (in the US), such as drugs and medical instruments. A list of recent warnings and drug recalls is available on the MedWatch web site in the '2003 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements' section. Warnings are at times directed at medical professionals, at times to consumers and at times to both.

Among the products that are posted on the site included Viga and Viga for Women tablets, both marketed as dietary supplements and contain the unlabelled drug ingredient sildenafil, which may pose possible serious health risks to some users. The interaction between nitrates and sildenafil can result in profound and life-threatening low blood pressure. The use of nitrates in any form is an absolute contraindication for sildenafil users.

The CYPHER stent was approved in April 2003 for patients undergoing angioplasty procedures. Since the product's introduction, it is estimated that over 50,000 patients have received a CYPHER stent. To date, FDA has received 47 Medical Device Reports (MDRs) of stent thrombosis occurring at the time of implantation or within a few days of implantation.

In January this year, Herbsland Inc. recalled all 100 tablet bottles of Ancom Anti-Hypertensive Compound Tablets, an unapproved new drug labelled to contain several prescription drug ingredients, including reserpine, diazepam, promethiazine, and hydrochlorothiazide. The sale of a product with this combination of ingredients poses possible serious health risks including sedation, depression, and potentially life-threatening abnormalities of the blood.

Important task

The Pharmacy and Drug Control Department at the MoH believes that it is the responsibility of all health professionals in UAE to report adverse drug reactions. This is especially true of 'serious' ADR's, classified as reactions that lead to hospital admission, require patient resuscitation or lead to death.