Medication shortages 50 times higher for patients on generic brands

Pharma News: Medication shortages are a public health issue in Australia. An estimated 90% of medicines in Australia are imported, making the nation heavily reliant on international supply chains, and vulnerable to drug shortages during global events such as the COVID-19 pandemic.

A first large-scale Australian study of shortages in oral antiseizure medications for epilepsy and other conditions, aimed to estimate the association between shortages and brand or formulation switching, and patient adherence. The rate of patient-level shortages was approximately 50 times higher for patients on generic antiseizure brands versus originator brands.

Of the 97 sponsor-reported shortages, 90 (93%) were generic shortages of oral antiseizure medications. Levetiracetam experienced the greatest number of shortages (24), followed by pregabalin (15), gabapentin, and topiramate (14). The sponsor-reported reasons for the shortages included “manufacturing” in 47 (48.5%), “commercial changes” in 19 (19.6%), “unexpected increase in demand” in 19 (19.6%), and “other” in 21 (21.7%).

The sponsor-reported shortages during the pre-COVID period were estimated to impact 156,269 patients compared with 174,583 patients during the COVID period. Of the 97 sponsor-reported shortages during the study period, 64 occurred during the pre-COVID period, representing a median shortage duration of 129 days. A total of 33 sponsor-reported shortages were reported during the COVID period, representing a median shortage duration of 101 days.

According to the study authors “In light of the disruption seen in global supply chains during the COVID-19 pandemic, it is important for policymakers to prioritise further understanding the vulnerabilities of pharmaceutical supply chains, and develop strategies to improve supply chain resilience.

“Solutions may include developing redundancy in manufacturing and supply, holding additional stock or production capacity, holding ‘buffer’ stock, or increasing domestic manufacturing capacity. For medications with low profit margins, which are predominantly genericised medicines, penalties for failure-to-supply, and increasing drug prices have also been proposed to incentivise manufacturers to maintain continuity of supply.”

In Australia, the importance of continuity of supply was addressed in the 2021 Strategic Agreement between the Commonwealth of Australia and both Medicines Australia and the Generic and Biosimilar Medicines Association. According to the agreement, sponsors will be required from July 2023 to hold 4–6 months of stock in Australia to minimise the risk of shortages impacting patients, recognising that ‘just in time’ supply chain practices were contributing to shortages in Australia.

However, the results of this study suggest that even mandating a buffer of 6 months of stock may not eliminate all antiseizure medication shortages, as approximately one in three sponsor-reported shortages continued beyond 180 days.

This study found that a higher number of sponsor-reported antiseizure medication shortages were reported for generic brands. This finding may be partly explained by the presence of multiple generic brands available for a number of different antiseizure medications, where there is only one originator brand. For example, in the case of lamotrigine and levetiracetam, there were 5 and 7 generic brands that reported shortages respectively, compared with one originator brand.

However, when taking into account the number of person-years of exposure to each brand, patients taking generic brands were far more likely to experience an antiseizure medications shortage on a generic antiseizure medications brand compared with an originator antiseizure medications brand. These findings suggest that supply chain management is an area in need of improvement, particularly for manufacturers and sponsors of generic antiseizure medications to ensure continuity of supply for patients.

Recognising the increasing issue of antiseizure medication shortages, the International League Against Epilepsy (ILAE) recently published recommendations for the management of patients in the event that switching between different antiseizure medication and brands is unavoidable.

However, the American Epilepsy Society (AES) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) state that the changes in the preparation of the medication may contribute to changes in patient adherence and subsequently adverse patient outcomes. They caution against switching the brand, or discourage brand switching in patients with well-controlled seizures, or in any patient with epilepsy without consultation between the Neurologist, patient, and/or caregiver.

This study was funded by UCB Pharma in Australia, the sponsor of the originator brand of Keppra (levetiracetam).

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