In the pharmaceutical industry, reverse logistics is the process of moving drugs from their final destination, whether it be the shelves of a commercial pharmacy, a hospital, a clinic or even your home medicine cabinet, through the whole supply chain, back to the manufacturer.
This process includes both product returns and product recalls—each presenting its own challenges. In this blog post, we will specifically focus on recall management and how Track&Trace solutions can make it easier and more efficient.
WHAT IS A RECALL?
- A recall consists of removing a prescription or over-the counter drug from the market.
- A recall could be initiated by the marketing authorisation holder (MAH) or national and regional health authorities such as the U.S. FDA or the EMA.
- A recall is a serious process that requires fast and effective action to protect the public from harm.
RECALLS ON THE RISE
According to the U.S. FDA, about 4,500 drugs and medical devices, on average, are pulled from U.S. shelves every year. U.S. pharma-product recalls have significantly increased in recent years, reaching unprecedented numbers, according to the Regulatory Affairs Professionals Society (RAPS).
In the European Union and all over the world, pharmaceutical MAHs and other authorities are facing the same recall challenge. While automated vision systems can prevent or limit some recalls during the manufacturing process before the products go to market, others cannot be anticipated.
DID YOU READ THE NEWS THIS SUMMER?
This past July, the U.S. FDA issued a voluntary recall of drugs containing valsartan, an ingredient used to treat high blood pressure and heart problems, after an impurity linked to cancer had been detected. Authorities in more than two dozen countries around the world had already issued similar recalls. In response, the Chinese bulk manufacturer of valsartan said it would recall the product in the United States and halt shipments to the country. Affected companies included Teva Pharmaceutical Industries Ltd., Solco Healthcare and Major Pharmaceuticals.
In August, European and U.S. health officials expanded their recall of valsartan after the potentially cancer-causing substance N-nitrosodimethylamine (NDMA) was found in medications made by a second Chinese manufacturer and by one in India.
WHAT ARE THE 5 MAIN REASONS FOR RECALLS OF DRUGS AND MEDICINES?
- Manufacturing defects and deviations are the most common cause of recalls, primarily when oversized or undersized pills or capsules result in super- or sub-potent formulations. In the U.S., the FDA monitors drug manufacturers’ compliance with Current Good Manufacturing Practices (cGMP).
- Particulate contamination. This refers to contamination of inorganic materials such as glass, silicone and stainless steel for vials, syringes and IV bags. Contamination of packaging materials should not be underestimated. Several years ago, a variety of over-the-counter medications were recalled because of contamination believed to have come from the wooden pallets used to ship the drugs.
- Contamination of active pharmaceutical ingredients (APIs), i.e., an impurity encountered in the drug. This was the case in the valsartanrecall. Crystallization of the API in liquid formulations will also lead to recalls.
- Packaging defects such as sterility failure in injectable products due to cracks on the rim of vials. Sterility is the leading cause of medical-device recalls.
- Mislabelling. This was the case this past August with the massive voluntary recall of a popular blood-pressure medicine distributed by Accord Healthcare. This kind of recall could have been avoided by using automated vision-inspection solutions.
The list of reasons for recalls does not stop here.
Every year, hundreds of new drugs are put to market with approval from the appropriate regulatory health organizations. Unfortunately, some companies fail to properly test these drugs, which could result in serious side effects and complications.
WHY ARE RECALLS SO CHALLENGING?
It is not easy to recall a product once it is on the pharmacy shelf. All around the world, regulatory health organizations require that the smallest level of packaging of any drug be identified with a unique serial number. Some also require that units be aggregated.
Any break in the chain of custody means that the integrity of the item cannot be guaranteed and that MAHs lose track of their own products. MAHs need to gain complete visibility on their supply chains, from the wholesalers and distributors to the retailers and end customers.
HOW CAN TRACK&TRACE SOLUTIONS PREVENT DRUG RECALLS?
Recalls can be managed down to the individual unit thanks to serial numbers and traceability solutions. Through systematic, documented identification and recorded data, traceability allows you to verify and track the history, location and even the state or status of an item, regardless of where it is in the supply chain.
Furthermore, aggregation of individual products to a carton, bundle and pallet will simplify the handling of the products through the supply chain. While aggregation makes commissioning, decommissioning and recommissioning easier, faster and more accurate, it also helps ease and accelerate the process of recall management. Lot-level tracking through aggregation is highly improving the recall management process for all the actors in the pharmaceutical supply chain.
End-to-end traceability gives pharma MAHs the visibility they need in their supply chain; they can know in real time which product is where and call it back!
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