Drug recalls can be extremely taxing for all parties involved. From making sure there is a temporary replacement to checking the supply of the replacement and its reliability, companies face many challenges. Along with this complex process, manufacturers must ensure recall is handled properly and the affected drug is removed from distribution. However, by not finding a proper substitute, negative effects can ripple down to consumers and the pharmaceutical industry will have more issues on their hands.
There are cases of one company being the sole manufacturer of a single drug, which becomes an issue for the company when recalls occur. If that company issues a recall on this drug, the sole producer is being removed from the market. In these cases, the only short-term solution is to find a substitute drug, which has its own difficulties associated with it. In recent years, the Food and Drug Administration (FDA) has become more active at trying to limit the effect of this situation and reduce the number of shortages.
The FDA prioritizes drugs classified as medically necessary, which means that it is used to treat or prevent a “…serious disease or medical condition for which there is no alternative, available in adequate supply, that medical staff has been determined to be an acceptable substitute.” The FDA looks at how all potential shortages will impact the public’s health and evaluates the overall risk that comes along with the potential shortage.
In the case of certain recalls, the FDA has implemented short-term policies to limit the overall impact of a shortage until the proper functions take place to remedy the problem. In some cases, original use dates of already stocked drugs (that are not being recalled) are extended on the basis that once the fixed shipments or replacement drugs arrive, they will be disposed of.
Communication is the number one way the pharmaceutical industry can get involved in aiding the solution of shortages and possibly preventing a shortage from occurring. With the implementation of the Food and Drug Administrative Safety and Innovation Act (FDASIA), pharmaceutical companies are required to notify the FDA when interruptions to manufacturing or changes in production can lead to supply changes or discontinuation of a drug.
Progress has been made in recent years with how the FDA and pharmaceutical industry are attacking drug shortages. In 2011, there were 251 shortages reported, with 191 being averted across all forms of drugs. In 2016, 23 were reported and 115 were averted, showing a decrease by 90.8% in 5 years in the number of drug shortages reported.
Still, the United States is facing drug shortages in mainly sterile injectables. This is partly due to the strict FDA regulations on these types of injections. These include chemotherapy, anesthesia, and other acute drugs. Still, there is serious potential that a recall could cause a shortage and make an already complex recall process even more challenging. Drug manufacturers should consider incorporating a shortage into their next mock recall to ensure they are prepared as possible.
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