Analysis: medicine shortages are a complex and multi-layered problem, with overlapping and interconnected threads of causes
Ongoing geopolitical volatility, increased energy costs, and an array of post-pandemic issues are impacting negatively on global pharmaceutical industry supply chains, resulting in medicine shortages across the world. US hospitals are reporting supply problems with liquid ibuprofen, while a sudden increase in ADHD diagnoses has led to an unexpected shortage in the drugs used to treat it there. In Mexico, there have been chronic medicine shortages, while sudden supply drops across Asia were linked to disruptions in China and in Australia.
In Ireland, the Health Products Regulatory Authority (HPRA) publish and maintain an up-to-date list of a medicine shortages impacting the Irish market. According to HPRA, there are currently over 300 medicine shortages impacting the Irish market.
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From RTÉ Radio 1's Today With Claire Byrne, pharmacist Kathy Maher on the current shortage of insulin
Medicine shortages are not a new phenomenon and are recognised as a global problem by the World Health Organization. In June 2013, the International Pharmaceutical Federation held the first ever International Summit on Medicine Shortages. They concluded that the nature of medicine shortages is complex and multi-layered, with overlapping and interconnected threads of causes.
Within a highly complex global chain of supply, manufacturers are generally reliant on a single authorised supplier for key ingredients including active substances. Several manufacturers are supplied by one source and these sources are very often situated in only a few countries, such as India or China. Such reliance on very few sources is a risk factor, which can cause instability in the global supply chain. Many countries in the world are consumers of only a small percent of overall global consumption of medicines and hence do not have a viable domestic manufacturing industry for medicines.
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From RTÉ Radio 1's Morning Ireland, Thyra de Jongh from the Technopolis Group in the Netherlands on medicines shortages across the EU
In a comprehensive policy statement on medicine shortages issued in September 2020, the International Pharmaceutical Federation proposed six major recommendations, as well as specific recommendations for governments and supply chain stakeholders in the global pharmaceutical industry.
(i) Each country should establish a publicly accessible means of providing information on medicine shortages.
(ii) All global process to determine the list of critical/vulnerable products should be developed.
(iii) All procurers of medicines are urged to move towards active procurement processes that assure the continuity of supply of quality medicines.
(iv) All countries are encouraged to remove unnecessary variability of regulatory practices within and between countries.
(v) All countries should investigate the potential to establish a national body charged with gathering and sharing information about demand for, and supply of, medicines within their jurisdiction.
(vi) All countries are encouraged to develop evidence-based risk mitigation strategies which might include strategic buffer stockpiles, contingency plans, pandemic planning and capacity redundancy, appropriate to their national needs.
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From RTÉ Radio 1's Drivetime, Fianna Fail MEP Billy Kelleher and Azure Pharmaceuticals' Sandra Gannon on solving the medicine shortage
HPRA are aware that a medicine shortage represents an individual set of circumstances. The HPRA has established from industry information that over 60% of shortages relate to delays or breakdowns during manufacturing or a product quality issue. Manufacturing can also be delayed when an active substance or other ingredient is in short supply. Shortages in packaging materials can also lead to delays.
Unexpected demand can also cause certain shortages. This could be due, for example, to an unanticipated increase in prescribing of a particular medicine. Greater than anticipated levels of seasonal illness can also result in shortages of medicines needed to treat those illnesses.
The HPRA oversees a multi-stakeholder framework intended to address the issue of human medicine shortages in Ireland. The aim of the framework is to help avoid potential shortages from occurring in the first place and reduce the impact on patients when shortages do occur. Participants in the framework include marketing authorisation holders (companies that have an authorisation to market a medicine in Ireland), manufacturers, wholesale distributors, healthcare professionals, the HSE and patient representative groups.
Like the complex pharmaceutical supply chain, there is no quick fix or magic solution to providing access to medicines for all
We are all guilty to a greater of less extent of food waste by buying too much and over stocking our fridges with food. In recent years, there has been a similar tendency to over-prescribe medication. It is estimated, for example, that the UK's National Health Service loses as much as £300 million a year due to unused or partially used medication that cannot be recycled or re-used.
Ireland is the world’s third largest exporter of pharmaceuticals and will continue to have a role to play in ensuring a consistent supply of medicine to the world. The sector continues to evolve, expanding its capabilities to include innovation, digitalisation supply chain excellence and next-generation technologies. Leading industry names including Novartis, AbbVie, Janssen, Pfizer, Sanofi, Lilly, AstraZeneca, MSD, Bristol Myers, Stryker, Takeda and have significant operations here.
Like the complex pharmaceutical supply chain, there is no quick fix or magic solution to providing access to medicines for all. To achieve this goal the pharmaceutical stakeholders need to continue improving pharmaceutical supply chains through greater visibility and collaboration between pharmaceutical consumers, distributors, suppliers and manufacturers; improved resilience and embracing AI. They also need to encourage the increased production of generics and continue to invest in pharmaceutical research and development.
The views expressed here are those of the author and do not represent or reflect the views of RTÉ
