Why Is There A PrEP Shortage?

By Nick Hurley, 2nd December 2024.

Many people worry about the recent PrEP shortage. ³ PrEP is a vital drug that helps prevent HIV. ¹ This article will explain why there’s a shortage and what’s being done about it.

Read on to learn more about this pressing issue. ²

Key Takeaways

• Manufacturing problems have caused PrEP shortages lasting until March 2025 for some products, affecting both bottled and blister pack versions of tenofovir tablets.
• Commercial changes and viability issues have contributed to the shortage, prompting the Therapeutic Goods Administration to approve importing PrEP from other countries.
• The shortage threatens HIV prevention efforts, potentially undoing progress that led to a 64% drop in HIV diagnoses among Australian-born gay and bisexual men.
• The Australian government has taken swift action, including temporarily listing a US brand on the Pharmaceutical Benefits Scheme and expecting tens of thousands of PrEP units to be available by early November 2024.
• Efforts to secure future supplies include better reporting from manufacturers, early parts procurement, and more efficient transportation to prevent similar shortages and support the goal of ending HIV transmission by 2030.

Causes of the PrEP Shortage

The PrEP shortage stems from complex issues in the drug supply chain. Manufacturing problems and changes in the market have led to a lack of this vital HIV prevention medication.

Manufacturing Issues

Manufacturing problems have caused a major shortage of PrEP medication. ² These issues affect both bottles and blister packs of tenofovir tablets.

Experts predict some shortages may end by September 2024. Others could last until March 2025. These delays in production have led to less PrEP being available. This scarcity impacts HIV prevention efforts worldwide.

Commercial changes and viability challenges have also played a role in the current shortage.

Commercial Changes and Viability Challenges

Commercial shifts have played a big role in the PrEP shortage. Some suppliers face issues that make it hard to keep products available. ⁴ These problems affect how much PrEP people can get.

The Therapeutic Goods Administration (TGA) has taken steps to help. They approved bringing in PrEP tablets from other countries to fill the gap. ³

The TGA has also shared dates for when supply problems might end. For some PrEP brands, shortages could last until March 2025. This long timeline shows how serious the issue is. It affects many people who rely on PrEP to prevent HIV.

The TGA’s actions aim to keep PrEP available during this tough time.

Impact of the PrEP Shortage

The PrEP shortage has caused worry among those who rely on it for HIV prevention. Many people now face challenges in getting their usual doses, which puts them at higher risk of HIV infection.

Effects on HIV Prevention Efforts

PrEP shortages have slowed down HIV prevention efforts. In Australia, PrEP has played a key role in reducing HIV cases. A study found a 64% drop in HIV diagnoses among Australian-born gay and bisexual men.

Professor Andrew Grulich linked this decline to treatments like PrEP. In 2023, Australia saw record numbers of PrEP prescriptions for HIV prevention. ⁶

These shortages put at-risk groups in danger. Without PrEP, people may face a higher chance of getting HIV. This could undo progress made in recent years. To stop HIV spread, experts stress the need for PrEP access. ⁵ They say it’s vital for all at-risk groups, including overseas-born gay and bisexual men, to have PrEP.

Challenges for At-Risk Communities

The PrEP shortage hits at-risk communities hard. These groups often face health disparities and limited access to healthcare. The scarcity of this vital HIV prevention drug puts them at greater risk.

Many patients now struggle with higher costs and travel burdens to get their medicine.

Dr Higgins points out the extra strain on both doctors and patients. He states: The shortages create additional burdens on GPs and patients, including cost, travel, and administrative impacts. ⁷

Measures to Address the Shortage

The government and industry are taking steps to fix the PrEP shortage. They aim to secure future supplies and ensure people can access this vital HIV prevention drug.

Government and Industry Actions

The Australian government has taken swift action to address the PrEP shortage. These measures aim to ensure continued access to this vital HIV prevention medication . ⁸

1. Temporary PBS listing: The US brand Laurus Labs’ PrEP medication was added to the Pharmaceutical Benefits Scheme on 1 October 2024.
2. Supply boost: Tens of thousands of PrEP units are expected to be available by early November 2024, helping to ease the shortage.
3. Ministerial commitment: Health and Aged Care Minister Mark Butler stressed the importance of PrEP for those at risk of HIV . ⁹
4. Long-term goal: The government reaffirmed its pledge to eliminate HIV transmission in Australia by 2030.
5. Public health focus: These actions highlight the government’s dedication to disease prevention and medication access.
6. Industry collaboration: The government worked with pharmaceutical companies to secure alternative PrEP supplies.
7. Quick response: The swift action taken shows the government’s ability to address urgent public health issues . ⁸
8. Policy adaptation: Health policies were quickly adjusted to allow for the temporary listing of an alternative PrEP brand.

Securing Future Supplies

Planned deliveries aim to meet ongoing demand for PrEP. The TGA has warned GPs about limited stocks of tenofovir/emtricitabine tablets. To avoid future shortages, better reporting from makers is key.

Firms can take steps to secure supplies and manage risks. ¹⁰

Proactive moves can help keep PrEP in stock. These include buying parts early and making truck trips more efficient. Such actions can smooth out bumps in the supply chain. Next, we’ll look at how these efforts impact HIV prevention.

Conclusion

The PrEP shortage stems from complex issues in manufacturing and supply chains. These problems have led to limited access to vital HIV prevention drugs. Swift action from governments and drug makers aims to solve this crisis.

New suppliers and alternative brands offer hope for those who need PrEP. Efforts to secure future supplies will help prevent similar shortages and support the goal of ending HIV transmission.

References

1. ^ https://www1.racgp.org.au/newsgp/clinical/new-national-shortage-of-prep-part-of-concerning-t
2. ^ https://pmc.ncbi.nlm.nih.gov/articles/PMC8299364/
3. ^ https://www.theguardian.com/society/article/2024/sep/04/australia-prep-hiv-prevention-drug-shortage-tga
4. ^ https://clinic365.com.au/prep-medication-shortage-in-australia-how-long-will-it-last/
5. ^ https://www.aidsmap.com/news/jan-2022/big-increase-recent-prep-users-among-new-hiv-cases-largest-uk-clinic-reports(2022-01-24)
6. ^ https://pmc.ncbi.nlm.nih.gov/articles/PMC7467490/
7. ^ https://www.tht.org.uk/about-us/what-we-do/our-campaigns/ensuring-equitable-access-prep
8. ^ https://cpe.org.uk/our-news/call-for-government-action-to-tackle-medicines-shortages/
9. ^ https://www.pharmacymagazine.co.uk/profession-news/rps-calls-for-government-action-to-tackle-medicines-shortages
10. ^ https://www.toolsgroup.com/resources/winning-planning-strategies-to-combat-supply-shortages/