Backorders.  The number one complaint from clinicians, pharmacists, pharmacy technicians, patients and federal regulators.  The HUGE pain in every pharmacist, technician and pharmaceutical provider’s sides.  So, let’s talk about it.  They say knowledge is power and can only make us stronger, so here are some of the facts. 

Drug shortages are caused by a wide array of different factors, such as difficulties acquiring raw materials, manufacturing issues, business decisions, regulatory issues, and disturbances in the supply chain.  These kinds of shortages adversely affect patient care and wellbeing, which is why the FDA and the Drug Shortage Task Force are working to get ahead of the supply game.  

Let’s break it down even further. Raw materials in the pharmaceutical industry are divided into three categories; API (Active Pharmaceutical Ingredients), expecients, and packaging. The API is chemical composition, substrate, or element of the drug that produces the intended action or treatment.  Expecients may also be called drug carriers, which are generally solvents that are responsible for carrying the drug to the intended treatment site in the body.  Packaging raw materials include glass, plastic, aluminum foil, polymers, papers and paper boards. When these materials are not available, there’s not much a manufacturer can do but wait.  This kind of shortage can also be caused by natural disasters.  In 2017, Hurricane Maria devastated Puerto Rico, where 49 different pharmaceutical plants (FDA-approved) were grown.  Over half of all manufacturing done on the island is pharmaceutical.  

Your typical manufacturing issues are quality control, cleanliness monitoring, audits, paper-based manufacturing, and even communication.  Business decisions, such as allotments, discontinuations, increased competition, product liabilities, and even the opioid crisis have an impact on the pharmaceutical industry.  Regulatory issues could be anything from bioequivalence to patents, or from labeling requirements to compliance. 

The FDA offers a database of all known shortages, however, manufacturers are only required to report a shortage to the FDA if it is a single sourced “medically necessary” or life-saving drug that is being discontinued.  The Drug Shortage Task Force is working with the FDA to incentivize manufacturers to produce more drugs that are less profitable and to create or invest in quality management systems. There are also numerous legislative proposals for the 2020 budget, to improve data sharing, risk management, lengthening expiration dates and streamlining pharmaceutical guidelines.  

Because there are so many layers within the pharmaceutical industry, we must work together to preserve availability.  AvKARE is working to improve all aspects of our manufacturing and packaging roles.  Forecasting is one of the most important things we can do to maintain our inventory and we ask all buyers to submit usage requests to their wholesaler to ensure we can supply the demand.  Disturbances in the supply chain, and recalls for that matter, go hand-in-hand with the previously mentioned factors.  

Here at AvKARE, we are doing our best to prevent drug shortages… are you?


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