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Handling pharmaceutical recalls – protecting the public and the brand

Pharmaceutical products and medical devices are among the most-regulated and most thoroughly tested products in the world. In the UK, the MHRA (Medicines and Healthcare Products Regulatory Agency) is responsible for ensuring that all medicines and medical devices work correctly and are safe. However, despite thorough testing, there is always a chance that issues might develop and health and safety of consumers can be called into question. In this case, recalls may become necessary.

In 2012 alone, the total number of recalls increased by 26 per cent compared to the previous year, according to the RAPEX (Rapid Exchange of Information System). Whereas the number of pharmaceutical recalls has decreased in general, there has been a noticable rise in companies involved in multiple recalls. The RAPEX figures also show that an increasing number of recalls are being made on a voluntary basis. With customers more discerning than ever, companies are now choosing a more cautionary approach and will withdraw products before they are required to do so by public demand or national bodies. Last year, 31 per cent of all recalls were voluntary.

There are numerous reasons behind this development. Not only are consumers more critical but brand loyalty has declined significantly too. The consumer-brand-relationship is now more fragile than ever, leading companies to focus on enhancing brand image and put the overall customer experience at the heart of their operations. In addition to that, supply chains are getting longer and, often, operations are outsourced to subcontractors.

With more and more complex channels of supply, ensuring continuously high quality standards becomes increasingly difficult. Pair this with high costs for product development and testing as well as the pressure to retain margins and a slip in product quality becomes much more likely.

If a company has identified, or has been made aware of, a problem with a product and the decision to do a recall has been made, the concerned product must be removed from the market as quickly and efficiently as possible. In case of pharmaceutical recalls, preparation is key. This means either having an internal plan ready or having an external provider on standby.

As a first step in the recall process, all relevant channels and stakeholders need to be informed, including the local health authorities. Depending on the nature of the recall, the public needs to be made aware of the reasons and consequences of the recall as well as any harm associated with the product. Establishing lines of communication and assigning responsiblities beforehand ensures an efficient and comprehensive operation.

A particular challenge in recalling pharmaceutical products is the administrative and logistical element. As up to a hundred per cent effectiveness can be required, accurate and detailed documentation of production, testing, distribution and partners is key. This can save a lot of time, and ultimately money, as a recall will only then be deemed complete if the authorities are convinced that all regulations have been followed and all threats to public health and safety have been eliminated. Rigorous preparation, comprehensive documents and attention to detail help keep the possible negative implications of recall to a minimum.

It is not only legal and compliance elements to be taken into consideration, growing consumer awareness for environmentally friendly disposal of recall waste becomes an increasingly important factor too. Companies need to place utmost importance on demonstrating concern and commitment to being environmentally friendly.

Ultimately, effective recall management has one goal – protecting the public and the brand. As long as a recall is thoroughly planned and executed, it provides not only a chance to protect your brand image but also to enhance it.

Providing a positive customer experience, taking their concerns into account and showing commitment to resolving the situation can, in fact, help increase brand loyalty. It is the way the situation is handled by the company that can make or break a customer relationship.