Medicinal Product Recalls: What, Why and How

Product Recalls: Why are they necessary?

Medicinal products are subject to strict quality and safety standards and regulations to ensure that they are effective and do not pose unacceptable risks to patients and the public.

However, sometimes medicinal products may be found to be defective, counterfeit, falsified or otherwise unsafe after they have been placed on the market. This may be due to various reasons, such as manufacturing errors, packaging defects, labelling mistakes, contamination, tampering, storage or distribution problems, adverse reactions, or new scientific information. When this happens, the medicinal products may need to be recalled from the market to protect public health.

What is a medicinal product recall?

A medicinal product recall is a process of removing or correcting a defective or unsafe medicinal product from the market. A recall may affect all or part of the supply chain, from the manufacturer to the end user. A recall may be initiated by the manufacturer, the distributor, the marketing authorisation holder (MAH), the competent authority (such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK) or any other stakeholder who becomes aware of a quality or safety issue with a medicinal product.

The report of this should be made to the Yellow Card website. The Defective Medicines Report Centre (DMRC) will ensure that all parties involved throughout the supply chain are made aware as quickly as possible. 
(They would also assess the risk to public health and advise relevant bodies involved in the supply chain accordingly).

This sequence of events could be triggered by a pharmacist or GP reporting a serious side effect of a medicinal product that has been prescribed to a patient.

A recall may be classified into different levels depending on the degree of risk posed by the defective or unsafe medicinal product:

 

• Class I recall: when there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
• Class II recall: when the use of or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III recall: when the use of or exposure to the product is not likely to cause adverse health consequences.

Why is a medicinal product recall important?

A medicinal product recall is important for several reasons.

First, it protects patients and the public from potential harm caused by defective or unsafe medicinal products.

Second, it ensures that only high-quality and safe medicinal products remain on the market and that they comply with the applicable regulations and standards.

Third, it helps to identify and correct the root causes of the defect or safety issue and prevent its recurrence.

Fourth, it maintains trust and confidence in the medicinal products and their manufacturers, distributors and regulators.

How is a medicinal product recall conducted?

A medicinal product recall is conducted according to specific guidelines and procedures that vary depending on the type of product, the nature and extent of the defect or safety issue, the level of recall and the country or region involved.

However, some general steps can be outlined as follows:

• Detection: The defect or safety issue with a medicinal product is detected by anyone working within the supply chain through various sources, such as quality control testing, post-marketing surveillance, adverse event reporting (e.g, patient, GP or Pharmacist), customer complaints, inspections or audits.

• Assessment: The defect or safety issue with a medicinal product is assessed usually by the manufacturer or MAH) in terms of its impact on quality, safety and efficacy of the product and its risk to public health. The level and scope of recall are determined based on this assessment.

• Notification: The defect or safety issue with a medicinal product is notified to the relevant competent authorities (such as MHRA in UK, notably the Yellow Card or the DMRC) and other stakeholders in the supply chain (such as distributors, wholesalers, retailers, healthcare professionals and patients). The notification should include information such as the identity of the product, the batch number(s), the reason for recall, the level and scope of recall, the actions to be taken by each party within the supply chain and contact details for further information.

• Implementation: The defect or safety issue with a medicinal product is resolved by implementing appropriate actions by each involved party in accordance with their roles and responsibilities. These actions may include stopping distribution or sale of affected batches, quarantining or segregating affected batches from unaffected batches, safe and correct quarantine and destruction of the goods, returning affected batches to the manufacturer or MAH for inspection if requested, informing customers and end users about recall and advising them on how to handle affected batches (such as returning them for replacement or refund), checking inventory records and tracing affected batches throughout supply chain.

• Verification: The effectiveness of recall is verified by monitoring and evaluating its progress and outcome by each party within the supply chain. This may involve confirming receipt of notification by all parties involved in recall, verifying completion of actions by each party within specified timeframes, collecting data on quantity and disposition of affected batches (such as number returned, destroyed or reworked), conducting follow-up inspections or audits if necessary.

• Closure: The recall is closed when all actions have been completed satisfactorily by all parties involved in recall and when there is no further risk to public health from affected batches. A final report on recall is prepared by the manufacturer or MAH summarising its cause, extent, actions, outcome and corrective and preventive measures taken to prevent recurrence. The final report is submitted to relevant competent authorities (such as MHRA in UK).

Assistance, Training and Support