Drug Shortages in the Age of Uncertainty
Words by Kirstie Turner
2020 has brought with it an excess of unprecedented events that will have a lasting impact on a global scale. The UK’s departure from the EU, along with the COVID-19 pandemic, are just two examples that have brought uncertainty to many aspects of our lives, including drug availability. Medicine shortages are a huge concern for patients who rely on treatments to manage their conditions. Whether these are caused by manufacturing issues, delays, discontinuations, or regulatory uncertainty, it is critical that shortages are addressed imminently, with minimal disruption to the patients we serve, wherever they may be.
The pharmaceutical industry is a complex, highly regulated environment and, therefore, drug shortages can occur for a multitude of reasons. “Despite the best efforts of all concerned, supply problems can happen for unforeseen reasons such as manufacturing problems; availability of raw materials (active pharmaceutical ingredients), or other medicine or pack components; and unexpected demand,” explains the Association of the British Pharmaceutical Industry (ABPI).
Many of these issues can be heightened by situational complexities, as highlighted by Brexit. Layla McCay, Director of International Relations, NHS Confederation, says: “There is some uncertainty because the UK’s future relationship with the EU is currently undecided. This is incredibly important because it will establish the ease with which we can trade, including levels of border checks, tariffs, quotas, or regulatory controls.” Ambiguity leading to an impact on ease-of-trade can have a knock-on impact on supply capability.
However, patients must still be served, regardless of the political climate. Forward planning for drug supply, for multiple outcomes, is critical in uncertain times. McCay explains: “Significant time and effort from industry, government, and the NHS went into contingency planning for a possible no-deal scenario last year to ensure an uninterrupted supply of medicines and medical devices for patients. Plans would need to be resurrected at speed should a similar scenario recur.”
Companies take their responsibilities very seriously and are accountable to UK regulators should supplies of their products become unavailable
The COVID-19 pandemic is similarly causing fears of drug shortages but differs as there was minimal forewarning. In situations like this, pharma companies must call upon their business continuity plans to act appropriately. A spokesperson for Johnson & Johnson explains their approach: “We have robust business continuity plans in place across our global supply chain network to prepare for unforeseen events and to meet the needs of the patients, customers, and consumers who depend on our products. These steps include maintaining critical inventory at major distribution centres away from high-risk areas and working with external suppliers to support our preparedness plans.”
Along with activating business continuity plans, continual monitoring is also critical in times like these: “We are closely monitoring product demand and supply levels across our global network to ensure adequate and effective distribution,” comments Johnson & Johnson.
An open flow of communication between pharma and governing bodies can also help to mitigate drug shortages. “Industry could share further their plans to work closely with the government to ensure they are able to prepare for whichever scenario is reached at the end of the year. It will likely be helpful to continue establishing where we have a significant reliance on imported drug types and putting in place measures to ensure patients and healthcare professionals can access the adequate supply across scenarios,” advises McCay.
When it comes to the responsibility of providing their products, pharma remains vigilant. “Companies take their responsibilities very seriously and are accountable to UK regulators should supplies of their products become unavailable,” concludes the ABPI. In times of political uncertainty and global health pandemics, pharma must be the guiding light as we navigate these unprecedented times together, to ensure the quality of life of those who rely on medicines is not impacted.