Drug Recall

Introduction

Product recall is a process taken by the manufacturer, importer or wholesaler to remove or withdraw a particular products from all links of distribution.

  • The removal or withdrawal may be due to critical quality defects discovered or serious adverse drug reactions reported which might cause health risks to users of the products.

In general, a drug recall can be seemed as a way to protect the public from a defective or potentially harmful product. It may be conducted on

  • Voluntary recall: A manufacturer/distributor's own initiative or
  • Direct recall: by the Director of Pharmaceutical Services, Ministry of Health Malaysia's request.



Classification

Drug recalls can be classified to:

3 degrees based on the severity of quality defects and adverse reactions of the products

  • Degree I: Products with major health risks that might cause serious injuries or death. Should be under an embargo within 24 hours.
  • Degree II: Products with minor health risks or are substandard. Should be under an embargo within 72 hours.
  • Degree III: Products with other reasons for recall. Should be under an embargo within 30 days or as specified.

3 levels of drug recalls based on the nature of problem, extent of the product distribution and degree of hazard involved.

  • Level A: To all consumers (end-users)
  • Level B: To all points of sales (i.e. hospitals, pharmacies, clinics, specialists centers)
  • Level C: To all sub-distributors (wholesalers)



Public Notification

Not all drug recalls are announced through NPRA press releases statements.

  • However, when a product that has been widely distributed or poses a serious health hazard is recalled, NPRA may do so if the agency determines it is necessary to protect consumers.

On the other hand, patients may learn about medication recalls from the drug manufacturer directly or their health care professional (doctor, nurse and pharmacist).



Experience Sharing

Thus far, the drug recalls that I have encountered are mostly level B and twice level A.

Upon receiving a level B product recall notice, we should take immediate action to stop dispensing all affected medications (identified by batch number) and quarantine them for safe collection by the distributor company.

For level A product recalls, achieving complete user notification can be challenging as some products may have already been dispensed.

  • In these instances, we prioritize comprehensive public awareness efforts, such as newspaper announcements by drug company.



Summary

When product recalls occur, in addition to quarantining these products, it is essential for pharmacists to identify alternative sources or medications to facilitate a smooth transition for affected consumers.



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