The recent years have witnessed a significant upswing in the drug shortage problems of the US. FDA backorder drugs have pushed several health systems and hospitals into critical decision-making situations and have subjected medical practitioners to rationing of care
Drug shortage reasons are multi-factorial, thus making it more and more complex for the FDA to act upon the issue with enduring solutions. Read on to discover reasons behind this mounting industry trend.
Shortcomings in the manufacturing process
This is the foremost reason attributed for the shortage of drugs in the US. Manufacturing of drugs demands very high levels of precision and quality control measures. The slightest change in this complex manufacturing process can cause significant delays in delivering the products at the right time. Additionally, sourcing raw materials for the production of certain medicines relies on a steady supply in the global market, something that is subject to its own shortages cycle.
Sudden increase in demand
Unexpected increase in the demand of a particular drug can also lead to shortages. For instance, a geographical region may face a sudden breakout of a fatal disease like Anthrax and the drug used in the treatment of that particular disease can outrun supply within days or worse case even hours.
Voluntary product recalls
A drug manufacturer may recall a product for several reasons such as lack of financial returns, restricted distributions of the drug, potential safety concerns and so on. In such cases the FDA intervenes to conduct a necessity evaluation for the particular formula and the National Organization of Rare Diseases will find an alternative manufacturer for the drug-dependent patients. Such scenarios may cause temporary shortage of drugs.
Limited production capacity
This is very true in the case of injectables. Very few companies are involved in the manufacturing of sterile injectable drugs and any trouble in the manufacturing facility during the production phase will directly lead to drug shortages.
Supply chain issues
Hospitals and healthcare institutions in the pharmaceutical supply always carry very limited
inventory. The shortage in manufacturing of drugs is thus quickly realized as there is no buffer inventory to count.
Natural disasters affect drug supply by either damaging the manufacturing facilities or making the procurement of naturally occurring raw materials for drug development difficult.
Compliance and regulatory issues
The FDA may at times demand manufacturing companies to stop production if any discrepancy in compliance or regulatory issues is detected. Healthcare systems are subjected to strict regulations failing which, the safety of patients becomes questionable.
Apart from these reasons, research has indicated that a major chunk of the shortages in the US go unexplained. Drug manufacturing companies fail to come out in the open and disclose the specific reason behind a particular shortage problem. The reasons behind this trend may vary anywhere between legal to bad publicity. FDA backorder drugs () that are crucial to human life must be sourced through alternative and safer avenues at the earliest time to protect reputed hospitals from defamation.