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Pharmaceutical Manufacturing and Packing Sourcer

Total Recall

The number of product recalls in Europe is continuing to rise. According to RAPEX, in 2012, the total number of alerts amounted to 2,278 – an increase of 26 per cent. This increase was mainly due to enhanced market surveillance by the European Commission and member states. Top affected categories for consumer products were toys, electrical appliances, automotive and fashion. The Rapid Alert System for Food and Feed, the European Union’s (EU’s) alert mechanism for consumables, confirms that within this sector the number of alerts has also risen substantially. There is no similar alert system for medial devices and pharmaceuticals in the EU, but data is available through national regulatory bodies.

Based on this data, it is clear that the total number of pharma recalls has decreased; however, there has been a notable increase in individual pharma companies becoming involved in more than one recall situation. Combined, more than 10 million units were affected in 2012. These recalls are not just a logistical nightmare for the company involved, but also pose a financial and environmental challenge. This is especially important within the pharma sector, where proper disposal of unwanted medication is imperative to avoid harm to humans, animals and the environment.

With an increasingly discerning customer base, companies are approaching product withdrawal much more prudently, thus increasing the number of voluntary recalls. In 2012, 31 per cent of all recalls were completed on a voluntary basis, rather than companies being forced to by authorities.

Recall Procedure

The starting point for a recall or withdrawal of pharma products, whatever the industry, is when the health and safety of human – or any other – life is threatened. The issue could be for a variety of reasons, ranging from a simple labelling error to external tampering with the product. Regardless of the source of the threat, the outcome is always the same: the product must be removed from the market, quickly and efficiently.

For this to be possible, a plan is essential. In order to manage a recall effectively, every company must have a plan in place prior to the notification. In the case of medical or pharma recalls, preparation is everything. This means either having an internal plan ready or having an external recall provider on standby.

Establish the Situation
The first step in managing a recall is to assess the extent of the issue, its impact on consumers and the appropriate actions for handling the situation. There are three classes of product recall: Class 1 is applied where the use of the product could lead to serious harm or death; Class 2 could lead to treatable health consequences; and Class 3 is for situations that have no effect on health and safety.

Once a company has decided that they are going to proceed with a recall, an appropriate strategy has to be devised. Based on the classification of the recall, a company will know the severity of the situation, and also how deep it has gone into the distribution chain. All relevant channels and stakeholders then need to be informed – including the local health authorities – to identify the reasons for and consequences of the recall. This must be done as quickly as possible. Establishing lines of communication and responsibilities beforehand ensures an efficient and comprehensive operation. If necessary, the public needs to be made aware of the recall, as well as any potential harm associated with the product.

The next step within the recall lifecycle concerns the logistical side. As pharma recalls can require up to 100 per cent effectiveness, accurate documentation of the volume of distributed products, involved partners and the information on product distribution is key to a successful recall.

As companies have to alert local and often national health authorities – which have the ultimate objective of ensuring public health and safety – there will be checks on the effectiveness of recall management. It is therefore crucial to be able to demonstrate that not only have the stringent regulations been followed, but also that every effort has been made to remove affected products from the market in good time.

It is worth keeping in mind that a recall can only be deemed complete when the authorities are confident that the affected products have been successfully removed in compliance with regulations. Therefore, rigorous preparation, thorough handling and detailed documentation help to prevent a poorly handled recall.

Disposal of Products

Once all products involved in a recall have been removed from the market and collected, they must either be destroyed or recycled. The disposal of pharmaceuticals and their components are controlled by both national and local regulations and laws. Those applied in each case will depend on the volume and specific type of waste being handled. Regulations are strict and complex, and thus hard to navigate – again, having a plan in place or an expert at hand can help make this situation as painless as possible.

In addition, increasing consumer awareness results in pressure to dispose of unwanted products in both a safe and environmentally friendly way. As recalls are as much a logistical challenge as they are a battle to save the brand-customer relationship, companies must place the utmost importance on demonstrating concern and commitment to being environment-aware.

An important step is the separation of recyclable components and materials that must be destroyed or disposed of in accordance with strict regulations. The sorting and emptying of tablet packages, pill bottles or boxes has to be completed in a very careful and thorough manner to avoid mistakes. Individual elements have to be carefully sorted into liquid and solid components before being disposed of.

Possible Processes

There are several processes currently in practice for medical waste. The most prominent point for each is that safety must come first – this is nonnegotiable. Environmentally-friendly disposal will always take a backseat to secure disposal – but these are not mutually exclusive and the ideal outcome is for both to be achieved.

Some of these waste management practices include high or medium temperature incineration, or even burning in open containers, followed by disposal in open, uncontrolled, unengineered dumps. Waste immobilisation, including encapsulation and inertisation, involve immobilising pharmaceuticals in another substance.

For encapsulation, the pharmaceuticals are placed into a plastic or steel drum and then filled with a cement mixture. Inertisation involves the removing of all packaging materials, grinding the pharmaceuticals and mixing them with a cement paste. Both procedures involve disposing of the drums and cement paste in engineered landfills, which possess features that protect against a loss of chemicals into the aquifer. They are therefore to be prioritised over burning or ordinary landfills.

The third form of disposal is via highly engineered sanitary landfills, which offer a relatively safe disposal of solid wastes. Protection of the aquifer is the top priority. Engineered landfills allow the disposal of waste into a pit that has no access to watercourses and is above ground-water level. Fresh waste is covered with soil each day to maintain sanitary conditions.

Customer Care

Effective recall management and compliant, environmentally-friendly disposal both have the same goals: protecting the public, the environment and, ultimately, the brand. As long as a recall is thoroughly planned and executed, it offers not only a chance to protect your brand image, but also to enhance it. Providing a positive customer experience, taking end-user concerns into account and showing commitment to resolving the situation can, in fact, help to increase brand loyalty.

No company wants to recall one of its products, and there is always a chance that elements can go wrong – but the way such a situation is handled can make or break a reputation.

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Farzad Henareh is the Director of Business Development at Stericycle ExpertSOLUTIONS. He has been with Stericycle for five years, and is an expert in brand value and crisis management to ensure minimal impact of a product recall. Farzad joined the ExpertSOLUTIONS business unit within Stericycle in 2012. Since that time, he has helped transition the company into a global market leader for brand protection and enhancement by expanding services into recall management, consultancy and marketing services.
Farzad Henareh
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