Why are recalls and drug alerts necessary?
Drug alerts and recalls are carried out to protect patients from the harm that may be caused to them by defective medicines.
A defective medicine is one that is likely to be harmful under normal conditions of use, one that does not comply with its marketing authorisation (its registered specification), one that is lacking in therapeutic efficacy or one that has been manufactured other than in accordance with accepted standards of good manufacturing practice.
Recalls are usually carried out by the marketing authorisation holder, the manufacturer or the importer, and are normally intended to inform distributors, healthcare professionals and others that particular batches of a product should be withdrawn from the distribution chain and, where necessary, from patients and their carers.
Manufacturers, importers and distributors are obliged to inform the UK medicines and medical devices regulator, the Medicines and Healthcare Regulatory Agency (MHRA), of any suspected quality defect in a medicinal product that could or would result in a recall or a restriction on supply.
Healthcare professionals also have a responsibility to inform the MHRA of any matter coming to their attention that the agency might reasonably conclude relates to a quality defect.
Patients or members of the public who have reason to believe that their medicine is not of an acceptable quality should, in the first instance, consult their doctor or a pharmacist who may then decide to refer the matter to the MHRA.
Reports to the MHRA
All reports of defective or suspected defective medicines made to the MHRA are referred to the agency’s defective medicines report centre (DMRC).
The DMRC provides an emergency assessment and communications system between suppliers of medicinal products, the regulatory authorities and the users. It does this by receiving and assessing reports of suspected defective medicines, monitoring and advising, and directing appropriate actions by the responsible organisation. It communicates the details of this action with the appropriate urgency to recipients of the products and other interested parties in the UK and elsewhere by means of drug alerts.
In many cases, the DMRC will issue a drug alert to recipients (healthcare professionals) within and outside the NHS to support a recall. However, not every substantiated defect results in a drug alert. Some organisations are able to identify every customer (patient) whoreceived the defective product – for example, with some hospital-only products – and, where the MHRA has assurance that all customers can be reached, the DMRC may decide not to issue a drug alert to support the recall.
However, the MHRA must be advised of any defect that could result in a recall and organisations must not undertake a recall without first discussing it with the DMRC.
Drug alerts are classified into four categories, depending on the potential of the defective medicine to cause harm and the speed with which action should be taken by the recipient.
A class I alert is issued when a defect is potentially life-threatening or presents a serious risk to health. Class I alerts are also issued for counterfeit products because of their unknown composition and therefore their potential to cause harm. The response to a class I drug alert should be immediate on receipt.
A class II alert (action within 48 hours) is issued when a defect could cause illness or mistreatment, but which is not class I. A class III alert (action within five days) is one that, although not posing a significant hazard, nevertheless requires action.
Where a defect poses no threat to patients, or is unlikely to impair product use or efficacy, the DMRC may issue a class IV, ‘caution in use’ alert.
The MHRA is always alert to the possibility that a recall may have a significant impact on the availability of products and, if this is the case, the DMRC consults with the Department of Health and the NHS Purchasing and Supply Agency before a final course of action is decided.
In addition to national distribution, class I and class II alerts are sent by way of an established rapid alert system to medicine regulators in other countries.
Drug alerts and recall notices normally include instructions to the recipient and what to do to ensure that the defective batch of product is removed from the supply chain and how to return it to the recalling organisation.
It is important that the product is removed from all locations and nurses can assist in this by checking any ward stocks when they receive notification.
It can be difficult to reach all patients who may have received a defective product because a recall or drug-alert notice will normally go only as far as the healthcare professional or pharmacy. If a patient-level recall is required, a notice will be posted in newspapers and, in extreme cases, it will be reported on radio and television.
A busy section of the MHRA
The DMRC receives about 600 reports of suspected defective medicines each year, of which normally fewer than 10% are substantiated.
Reports received during 2008 resulted in 35 drug alerts, of which only one was at class I. Packaging, labelling and patient information leaflet errors continue to comprise the highest incidence of defects resulting in recall.
All drug alerts are followed up by the DMRC to ensure that defective products have been withdrawn from the supply chain and that appropriate action has been taken by the manufacturer or importer to prevent a recurrence of the defect.
The MHRA encourages everyone in the supply chain to be vigilant, in particular pharmacists, nurses, doctors and patients, and the agency treats all reports of suspected defective medicines as potentially serious in its primary role of protecting public health.
John Taylor, CChem, FRSC, is quality and standards manager, Medicines and Healthcare products Regulatory Agency