What happened to all the antibiotics?

 Across the world, there are reports of shortages of common antibiotics. Ben Hargreaves examines why these shortages are happening and what is being done in the background to return supply to normal.

In many countries across the world, there are shortages of common antibiotics. The problems have been reported across many countries in Europe, in the US, Canada, and Australia. Though the shortages have been more widely reported in more economically developed countries, the reality is that supply is likely limited globally. This poses significant issues for healthcare systems in those countries, as those in the Northern Hemisphere are dealing with infectious diseases that commonly occur in winter. At a time when COVID-19 is still putting a strain on health services, the more severe cases of infectious diseases that could arrive with antibiotic rationing would be an unwelcome addition.

The supply issues appear to be broadly impacting a number of different antibiotics, including amoxicillin, penicillin, and ceftolozane, among other products. As a result of the shortages, pharmacists have resorted to substituting alternative antibiotics, and dispensing alternative formulations. The supply constraints have also led some countries to approve companies sourcing antibiotics from outside of the country to ease demand, such as Health Canada’s decision to approve Juno Pharmaceuticals’ move to import 100,000 bottles of amoxicillin powder.

What is behind the shortages?

The current shortages have been spurred by a number of issues, some short-term and many long-term, that have plagued the manufacture and development of antibiotics. One of the reasons is the most evident: the winter months often lead to greater need for antibiotics, and that can lead to shortages. Moreover, more than any other medicine, antibiotics are more likely to face insufficient supply, with analysis by the US Pharmacopeia suggesting they are 42% more likely to be in shortage compared to all other drugs.

For its part, the US Food and Drug Administration (FDA) posted its drug shortage list, which contains various formulations of amoxicillin that are limited in supply. Three of the suppliers (Aurobindo, Hikma Pharmaceutical, and Teva Pharmaceuticals) posted their own reasons behind the shortages, which they stated had been due to an increase in demand for the products.

Seeking more detail on how these shortages occur, pharmaphorum reached out to the European Medicines Agency (EMA). A spokesperson for the agency stated, “Shortages can have multiple causes, including manufacturing problems causing delays or interruption in the production, shortages of raw materials, increased demand of medicines, distribution problems, labour disruptions, and natural disasters.”

More specifically on the current situation, they added, “Recently, shortages have been exacerbated by geopolitical events or trends, such as the war in Ukraine, the energy crisis, high inflation rates, as well as the recent surge of COVID-19 cases in China.”

Indeed, China plays a crucial role in the supply of antibiotics. According to Statista, the country accounts for approximately 42.2% of global antibiotic exports by value. This became an issue during the pandemic, as lockdowns limited some of the operations of facilities in the territory, and the recent rise in COVID-19 cases in the country means that a shortage of workers could be disrupting operations.

Finding a temporary fix

Different countries have reacted to the shortfall in antibiotic products in different ways. As mentioned, Health Canada has authorised the importation of certain products to alleviate shortages. The UK has expanded the list of medicines that cannot be exported or hoarded by wholesale dealers, in an attempt to ensure supply remains available.

In terms of what the European Union (EU) is doing to counteract the issue, the spokesperson stated, “EMA’s Medicines Shortages Single Point of Contact Working Party (SPOC WP) is taking a proactive approach to monitoring and reporting events that could affect the supply of medicines in the EU in accordance with the Regulation on EMA’s Reinforced Role (Regulation (EU) 2022/123). The group is continuously gathering information from Member States and industry associations to identify signals of availability issues as early as possible.”

They added, “In the light of recent potentially critical shortages of medicines, e.g. antibiotics, EMA and the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) are encouraging the national competent authorities in the Member States to consider the use of some of the available flexibilities, as foreseen by the EU regulatory framework for pharmaceuticals. These include allowing the exceptional supply of certain medicines that may not be authorised in a particular Member State or granting full or partial exemptions to certain labelling and packaging requirements to address severe problems in respect of the availability of some medicines.”

Looking to the long-term

However, despite the issue being exacerbated by geopolitical factors, the challenge is a broad one that requires a long-term strategy to navigate. As a ready solution that could improve reaction time to potential shortages, the FDA is advising companies to warn the agency when they notice demand spikes for products, alongside the current requirements to notify the agency when supply disruptions occur. The production of antibiotics takes months, and therefore any boost to production has a delayed ability to alleviate any disruption to supply. As a result, any earlier warnings can help regulatory agencies and countries prepare ahead of problems.

Larger questions remain around the way in which to support manufacturers to invest in production capabilities for antibiotics. With the production of generic medicine being concentrated in China and India, the ability to flexibly influence the supply of generic medicine, which most antibiotics are, is relatively limited. This is crucially tied to remuneration for the products themselves – despite being vitally important to global health, developing and manufacturing antibiotics is not a lucrative business.

As such, new strategies have to be devised to encourage continued investment into the area. The UK government recently attempted something along these lines when it launched a ‘Netflix-style’ payment model for antibiotics. This model will see the NHS in England pay a fixed annual fee for access to certain antibiotic medicine, calculated on the value to the service, rather than how many units are used to treat patients. Such innovative solutions may be the future of ensuring both that new antibiotics are developed, but also in creating a secure supply of these medicines.

https://pharmaphorum.com/views-and-analysis/what-happened-to-all-the-antibiotics/