Drug shortages can have a profound negative effect on patients, as they disrupt both their treatment and wellbeing. There are many circumstances which can result in drug shortage ; generally, they can appear across the whole supply chain, as the road of a medicine from a factory to the shelves of a pharmacy is quite long. If you are wondering what specific supply chain issues cause drug shortages, read on.
Manufacturing issues
Manufacturing issues are the most common problems that contribute to drug shortages. They can arise due to numerous factors including technical challenges, resource constraints, regulatory compliance issues, or unexpected events. Many things can go wrong during the manufacturing process and addressing them requires careful oversight and robust quality assurance processes, as well as effective risk management strategies across the whole supply chain.
Raw material shortages or disruptions in their supply can halt production and lead to delays. Equipment failures such as breakdowns or malfunctions of manufacturing equipment are a preventable, but frequent issue that can significantly disrupt drug production. These delays in drug manufacturing can, in turn, cause shortages.
Drug contamination during the manufacturing process is another complication that can lead to shortages. It can render whole batches of medicine unstable, which requires correction and causes delays. This is partially why quality assurance is extremely important – inadequate testing and inspection procedures can cause batches to be recalled or rejected, which once again leads to delays and requires correction.
Another thing that can halt or even shut down production are regulatory challenges such as having to obtain approvals, changes in regulatory requirements or non-compliance with regulations.
Distribution problems
After manufacturing, the drugs are ready to be distributed, and this is where a new set of challenges arises.
Logistical challenges, such as transportation issues (including accidents or strikes), can delay drugs from reaching their intended destinations. Proper planning and inventory management is crucial, as inadequate forecasting and overstocking can lead to both shortages and excesses of drugs.
Many drugs need specific storage conditions. Therefore, warehousing issues such as problems with inadequate storage capacity, improper temperature control and hygienic conditions, as well as security issues can lead to the drugs getting damaged or spoiled.
Supply chains can be quite complex when it comes to drugs – they can involve multiple intermediaries, distribution channels and geographic locations. This increases the risk of distribution problems such as lack of coordination, miscommunication, or inefficient logistic processes.
Regulations can also come to play, as there are various licences and permits that need to be obtained in time when importing or exporting drugs to foreign countries. Restrictions can also be in place.
Market dynamics
Market dynamics play a vital role in shaping supply change decisions, and they can worsen the existing challenges.
One of the most common challenges is fluctuating demand. Doctors and patients can change their behavior based on market trends or prescribing patterns, which causes demand to fluctuate. If the supply chain cannot react to these changes swiftly enough, it can result in shortages.
Fluctuating raw material prices, changes in drug reimbursement and regulations can impact the profitability of drug manufacturers, which in turn either impact the drug’s price or availability.
Market competition including the entry of generics or introduction of new therapeutic alternatives impacts manufacturer decisions – they can choose to prioritize more profitable products, which can also lead to shortages.
Last but not least, natural disasters and public health emergencies also affect drug availability, as we saw a few years ago during the global COVID-19 pandemic.
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