Narrator: Why do drug shortages happen and how can we reduce them?

Drug shortages have been a problem for decades, but in the last few years it has reached a new level. An ongoing series of supply issues has disrupted the supply of essential medicines – from hormone replacement therapy (HRT), antibiotics and cancer chemotherapies, to drugs used to treat attention deficit disorder ( ADHD), as well as a new type of diabetes and obesity. loss treatments.

Some of those shortages have been reduced, as new supply lines come online, or quality problems are resolved. But others are more persistent. Some of the drugs on the current US shortage list have been around for almost a decade.

But what are the reasons behind this shortage and what is being done to ensure that patients get the medicines they need regularly?

What is a drug shortage?

A drug shortage describes a time when the demand or expected demand for a drug exceeds the supply. Drug shortages can occur for many reasons, including production and quality problems, delays and discontinuations.

How much of a problem is the drug shortage?

Medication shortages can compromise patient care by delaying treatment or diverting patients to different, inappropriate medications. They also put pressure on pharmaceutical groups trying to find the products they need, and put an economic burden on the health care system by raising prices.

During the first quarter of 2024, the American Society of Health-System Pharmacists (ASHP) – which monitors drug shortages in the US – along with the University of Utah Drug Information Service, tracked the ‘all time’ of 323 active shortages, surpassing the previous record of 320 deficits in 2014.

The ASHP said many of the shortages include low-cost generic drugs, particularly vaccines used in medical treatments and hospital procedures, such as cancer treatments and intravenous antibiotics. veins. Some of these drugs have no other treatment options, forcing hospitals and doctors to prescribe drugs or delay care.

The situation is no better in the UK. In November 2023, the trade body British Generic Manufacturers Association (BGMA) reported that drug supply problems had reached a peak with a reported 100% increase in drug shortages between January 2022 and January 2024.

Furthermore, the global nature of the supply of medicines means that shortages are often interconnected, meaning that shortages in one country often affect others.

Why do drug shortages occur?

The reasons are many – geopolitical factors such as Brexit, the Ukraine-Russia war and the Covid-19 pandemic have had a significant impact on supply, as have rising energy costs and inflation, commodity issues and availability of raw materials.

One of the main reasons for the acute shortage is the sudden and unprecedented increase in demand, for example, due to the rapid increase in the spread of diseases. In December 2022, an increase in cases of Strep A among children in the UK caused an increase in the demand for penicillin, amoxicillin and azithromycin, especially solutions, which caused shortages across the country and a significant increase in prices.

Emerging trends, such as the ‘Davina effect’ where an awareness campaign led by TV personality Davina McCall led to a sudden increase in demand for hormone replacement therapy (HRT) in the UK can add to the pressure of supply chains. As of 2022, Novo Nordisk is struggling to increase production of Ozempic (semaglutide), to keep up with public demand. Originally developed as a treatment for diabetes, demand for glucagon-like peptide-1 (GLP-1) receptor agonists increased after clinical trials showed that the drug could be used off-label as a weight loss aid and highly recommended by celebrities. social media.

Another reason for the shortage is a sudden drop in supply. This may be due to recalls or quality problems – as the Indian manufacturer Intas, the main seller of cisplatin and carboplatin cancer chemotherapies in the US, failed a US Food and Drug Administration inspection last year ago, causing shortages across the country. Or because the company makes a business decision to discontinue an unprofitable product, and there are not enough suppliers to supply the product. However, supply drops can also be caused by natural disasters – for example, in 2023, a hurricane hit the Pfizer plant in Rocky Mount, US, destroying part of the main production facility a quarter of the company’s sterile vaccines for US hospitals. .

Production problems, including shortages of raw materials or supply methods, issues with industry dynamics and volatility and distribution or supply problems, such as international trade disruptions due to trade disputes environment, can all contribute to the deficit. Refined vaccines are more vulnerable to shortages compared to solid oral dose medications due to their expensive and complex manufacturing process.

The risk of drug shortages also increases because there is space for the production of active pharmaceutical ingredients (API) in China and India; two of the world’s largest pharmaceutical manufacturers. In 2018, research found traces of potentially carcinogenic nitrosamines in batches of the blood pressure drug valsartan from a Chinese manufacturing plant, which was responsible for supplying the API to many drug manufacturers around the world. The findings prompted worldwide recalls from several manufacturers and raised concerns about the continued supply of the drug.

However, ASHP stated that the most severe and persistent shortages are driven by excessive price competition among manufacturers of conventional products, which undermines investment in manufacturing capacity, quality assurance, and supply chain reliability and leads to a lack of incentives to produce less profitable drugs. As a result, low-cost drugs are more likely to experience shortages.

What is the protocol when shortages occur?

Several countries have established national reporting systems so that deficits can be more easily reported. For example, in the US, manufacturers can notify the FDA’s Drug Shortage Staff through a direct web portal, and the list is updated daily with new and resolved shortages, as well as additional information received from suppliers. products in terms of production capacity.

When a shortage occurs, the FDA works directly with the drug manufacturer to resolve the shortage and other manufacturers to help ramp up production if they are willing to do so. In the event that the shortage cannot be resolved immediately and the shortage involves an important drug needed for US patients, the FDA may seek a firm willing and able to transfer the product to the US market to resolve the shortage.

In the UK, the Department of Health and Social Care (DHSC) will liaise with pharmaceutical manufacturers, generics and retailers to obtain additional supplies; providing medical advice from the NHS Specialist Pharmacy Service and national medical experts on the administration of alternative medicines; and contact essential medicines to identify possible sources of medicines.

In October 2019, severe shortage protocols (SSPs) were introduced as part of the “no-deal” Brexit preparations to allow entrepreneurs to offer an alternative product specified in the shortage protocol. Since then, DHSC has issued 61 SSPs, with the number of active protocols peaking at nine in July and September 2022.

The UK government has also banned the import and stockpiling of some medicines where there is evidence, or risk, of a large shortage that could adversely affect UK patients. This list is reviewed and updated regularly.

And, in 2020, DHSC established the National Supply Crisis Response Service to address supply issues involving medicines and other products.

Regulators, such as the Medicines and Healthcare Products Regulatory Agency, can also take various regulatory actions such as speeding up the review process for new marketing authorizations; providing temporary exemptions to drug labeling requirements so that drugs packaged for use in another country can be used; importing and testing licensed pharmaceutical groups; and considering manufacturers’ requests to import over-the-counter medicines to treat individual patients. Other jurisdictions have similar powers, but the details differ.

What is being done to reduce the deficit?

In December 2023, the European Medicines Agency published a list of more than 200 essential medicines to avoid possible shortages – it considers a medicine essential according to two main criteria: the severity of the disease it is targeting and the presence of other drugs. The list is scheduled to be extended through 2024 and updated every year.

At the end of April 2024, the EMA published recommendations to address deficiencies in the production and supply of medicines included in the list of EU essential medicines and to strengthen their supply chains.

As part of these recommendations, European retailers may be asked to take new measures such as stockpiling medicines; analyzing past shortages or back orders to help identify demand patterns; and increasing production capacity to avoid potential shortages of essential medicines in the supply chain.

There is currently little transparency about the actions of the DHSC in the UK in relation to decisions affecting supply chains and it is not clear whether the UK follows the same system as the EU. In 2023, organizations representing UK businesses called for changes to the systems used to deal with shortages – for example to help businesses change prescriptions to provide alternatives to patients when medicines run out. But, in January 2024, the government showed that it has no plans to present legal proposals of this kind and instead will continue to rely on the protocols of the great deficit to help entrepreneurs to change the instructions in each way.

In the United States, many policy solutions have been proposed, including stockpiles, and support for domestic and advanced production. The Biden administration has advanced funding for increased domestic production as a way to combat drug supply issues, with measures taken in 2021 and this year to encourage more production capacity.

In April 2024, the United States Department of Health and Human Services appointed a supply chain and shortage coordinator to lead efforts to strengthen medical supply chains and related shortages.

And, in May, the U.S. Senate Finance Committee drafted a bipartisan bill to reduce the deficit by making the federal health care provider Medicare pay bonuses to hospitals and doctors for contract procedures that ensure adequate supply of drugs – starting with undiluted vaccines and injected drugs, such as. chemical treatment.