The time span of 2000- 2020 is primarily referred to as the drug shortage era, however the problem is still pertaining to the post-COVID-19 era. The frequency of drug shortages have caused numerous difficulties for clinicians, healthcare facilities, patients, and federal regulators in the recent years. The consequences of COVID-19 have further exacerbated the situation. Drug shortages are caused by many factors, including difficulties in acquiring raw materials, manufacturing problems, regulatory issues, supply chain discrepancies, and business decisions. They adversely affect patient care by causing the substitution of safe and effective therapies with alternative treatments, compromising or delaying medical procedures, or causing medication errors.
Although certain types of drugs are more vulnerable to shortages than others (such as generic cancer drugs), shortages of a variety of drugs have been reported, including heart drugs, pain medications, intravenous (IV) electrolytes, and many others. Drugs that have been around for decades are suddenly not available, which can significantly affect patient care. These include leucovorin, propofol, morphine, hydromorphone, furosemide, amino acids, and others. Shortages are estimated to extend to medical supplies, such as technetium-99m.
The problem of drug shortage extends to various regions, which cannot be essentially attributed to COVID-19. For instance, the unavailability of essential medicines has been reported for the region of Papua New Guinea, and the shortage is unrelated to COVID-19. As a result, the people of Papua New Guinea are facing a reduced quality of care and even some avoidable fatalities. Similarly, drug shortage in US have been pertaining for a decade and have included shortage of cardiovascular drugs like labetalol (C07A G01) and metoprolol (C07AB02), methyldopa (C02AB), pindolol (C07AA03), and ketoprefen (M01AE03).
Europe is also experiencing shortages of common medicines. In a survey of medicine shortages carried out between 14 November and 31 December 2022 by the Pharmaceutical Group of the European Union (EU), 100.0% of the 29 member countries reported experiencing shortages of medicines among community pharmacists and 76.0% said that shortages were worse than the previous year, 2021. These shortages include those of anti-infective, respiratory problems, cardiovascular and gastrointestinal issues.
Furthermore, the UK is also experiencing an HRT shortage. Supply problems are reported with liquid ibuprofen. In Mexico, chronic medicine shortages are so dire that many prescriptions couldn't be fulfilled in 2022, while across Asia, sudden supply drops were linked to disruptions in China and in Australia, as confirmed by TGA. It is anticipated that the rural areas would be worst affected.
Causes of Drug Shortage
Ideally, there should be an early warning system for impending drug product shortages that would provide ample opportunity to prepare for all implications of the shortage. However it is yet not statutorily defined, leaving the declaration decision to the manufacturer. Also, the manufacturer isn’t penalized in any way if it fails to provide the required notification.
In the US, manufacturers are required to notify the FDA of quality problems, however, drug shortages or discontinuations are often caused by a business decision or other factors that don’t require prior notification. Therefore, manufacturers either routinely don’t provide any notice of an impending drug shortage or provide little advance notice and no estimate of the projected duration.
If all manufacturers of a product are notified that a drug shortage is impending, they might be able to increase production to avert it. However, even with advance notice of an impending shortage of some agents, the manufacturing process for vaccines or antibiotics is so complex that shortages may occur even if alternative manufacturers are willing to produce the product to make up for the shortfall.
Distributors have also been inconsistent in providing information to health systems regarding drug shortages. Health systems are often unaware of drug shortages until it is no longer possible to purchase a product, causing considerable difficulty in developing an effective management strategy. Pharmacists need to have reliable and timely information to enable them to successfully manage drug shortages.
There may be occasions where the drug shortage occurs during manufacturing. Factors for this shortage might include antiquated equipment, a shift of a company’s resources from manufacturing to research and development, and loss of production and compliance personnel, to list a few.
Changes in a product’s formulation and limited production capabilities can also delay product availability. Also, the legislation approves a specific manufacturing line to produce a specific drug at a specific facility. Therefore, pharmaceutical manufacturers can’t just set up production of a drug in short supply somewhere else in a facility. Also, manufacturers also often use the same manufacturing equipment for many drug products, so it is difficult to increase the production of one product without causing manufacturing shortages and delays for another.
Sometimes it is possible to increase drug production only by buying more equipment or contracting with other companies to produce the drug. However, this isn’t an easy solution, because there is often a significant lag between a supply shortfall and a production increase at another facility. Antitrust laws may also prevent companies from sharing manufacturing information.
Astonishingly recently a social media has led to drug shortage. Semaglutide, a drug used to manage type 2 diabetes by stimulating insulin production is used to treat obesity. Social media platforms has hailed the drug as a miracle weight loss solution. In Australia, increased demand for the off-label use of the semaglutide resulted in shortages that began in April, 2022, with supply levels not expected to normalize until April, 2023. Unfortunately, this has meant that many people with type 2 diabetes faced stress in obtaining their medication.
Additionally, civil unrest such as the Russia-Ukraine war also impact the supply chains. These also results in high inflation and energy prices that hit the manufacturing industry including the generic drug manufacturers, who are sometimes subjected to hard pricing regulations.
Furthermore, to protect their limited medicine supplies, some countries temporarily block the parallel trade of medicines to other countries. Furthermore, once an over-the-counter drug shortage is announced on the news, consumers begin stockpiling, contributing to the issue.
Yet another issue is the misallocation of the drugs, with some areas of a country being over-supplied with a particular medicine and other areas experiencing shortfalls. The effective use of data and analytics is key to helping to improve access to medicines globally and better-managing supply and demand to pharmacies and individual patients.
Consequences of Drug Shortage
The increased demand was unmet, resulting in frantic illegal trades. Additionally, overseas-based family and friends sought out large quantities of antipyretic drugs, such as paracetamol, ibuprofen, and aspirin, to supplement the national crisis. In Singapore, customers stood in long queues outside courier companies to send medication to China, and pharmacies were sold out of essential pain relief. Similar situations were also observed in countries such as Japan and South Korea, where government warnings, purchasing limits, and price increases were implemented to manage the demand.
The health-care providers ration limited resources. Many patients need increased consultations with their health-care team to revise their management plans, which further burdens health-care systems that are already stretched to the brink. The increased human resources used to manage the shortage also lead to a more substantial economic burden on governments. The economic impacts also affect patients who face greater out-of-pocket costs in many instances, alongside the clinical implications for care. Drug shortages have been shown to cause an increase in errors, use of poor substitutions, and adverse events, including mortality.
Encapsulating, the problem of drug shortage can be accurately managed by streamlining the supply chain and introduction of new rules and regulations. Advance notifications and production management in terms of adequate availability of raw materials, demand forecast, human resources, and infrastructure for production and delivery should be ascertained. Thus, it is right to put that drug shortages can be both addressed and avoided with minor changes in the legislations and production systems.