What is a Drug Shortage? - Grants for Medical

A drug shortage can happen for various reasons. Quality or manufacturing problems, discontinuation, and delays can create drug shortages. Manufacturers are required to notify the FDA about potential drug shortages, but healthcare providers and patients can also report shortages.

The FDA actively mitigates drug shortages through various strategies, including expediting regulatory reviews and facilitating importation from international sources when necessary. Medications are important to control different health conditions. A medication error or unavailability of medicines can cause severe health problems.

What is a Drug Shortage

The definition of a drug shortage involves more than just demand exceeding supply and includes factors such as production problems and regulatory issues, as recognized by the FDA. The FDA can track this shortage at the national level. They receive information from the manufacturer about their drug supply in the market.

When the supply of commercially available products can not fulfill the current demand, it can be considered a drug shortage. The manufacturer cannot fulfill the projected or current demands in this situation.

The Causes of Drug Shortage

What is a Drug Shortage – The Causes of Drug Shortage

Drug shortages can happen due to some manufacturing quality problems. Conditions like delayed production or a late supply of raw materials can cause drug shortages. Discontinuation can also be a significant reason for it.

Sometimes, companies can discontinue their old drugs. Although the FDA cannot force a company to continue producing a discontinued drug, it can facilitate efforts to ensure alternative supplies or encourage other manufacturers to produce the drug

Multiple reasons can cause drug shortages.

Quality-related issues can lead companies to halt production temporarily to address these problems.
Natural disasters or other emergencies can prevent some companies from making and shipping their drugs.
The manufacturer or company may need help arranging active ingredients or containers, such as syringes or glass vials, to make their drugs.
Different companies or manufacturers can make business decisions to stop the production of a specific drug.
Some product mergers made by two different companies can cause a drug shortage.

The FDA task force conducted numerous studies to understand the reasons behind drug shortages. They have gained insight from the healthcare community and patients.

Between 2013 and 2017, they analyzed 163 drugs that were part of a shortage. They compared these drugs to some similar products without shortage. After in-depth research, they finally identified some important facts about drug shortages.

A drug shortage can happen when a company discontinues making a drug due to low prices or other commercial and business reasons.
During a shortage, the protection of that particular drug did not increase enough to achieve the pre-shortage level.
Sterile injectable products are more likely to be affected by shortages.
Drug shortages can sometimes lead to increased prices, depending on the market and the specific circumstances surrounding the shortage.

What Can Be Done During a Drug Shortage?

FDA has taken multiple actions to manage and improve the situation of drug shortages.

FDA works with scientists, task force committees, economists, health care providers, and the public to identify the root cause of drug shortages
They work with the industry to resolve manufacturing problems so the medication can return to the market.
They review and assess pharmaceutical manufacturing processes to identify and resolve issues contributing to shortages.
They try to shorten the review process to reduce the supply time of the required products from the manufacturers.
They help several manufacturers to find new resources for raw materials.
They facilitate importing critical drugs from foreign facilities that meet FDA quality standards to alleviate shortages.
They extend the expiry date of the drugs, which can confirm safety and effectiveness after checking their pharmaceutical data.
They can develop long-term strategic actions to help drug manufacturers prevent future drug shortages.

Which Drugs Have Been in Shortage in Recent Years?

People report hundreds of drug shortages every year. However, in 2021, around 114 new drug shortages were reported, the lowest number in the last ten years.

More than 60% of these medications were injectable, and 24% were sole source products. However, more than 200 drug shortages were reported.

Some of these drugs are –

Zoledronic acid injection
Vitamin K (Phytonadione) injection
Vitamin A injection
Verapamil extended-release tablets
Vecuronium Bromide Injection
Varenicline tablets (Chantix)
Vancomycin Hydrochloride Injection
Valsartan tablets
Valsartan and Hydrochlorothiazide tablets
Valproate sodium injection
Tropicamide 1% ophthalmic solution

What Are the Effects of Drug Shortages?

Healthcare institutions and professionals work extremely hard to keep their patients healthy and safe. When a drug is in shortage and unavailable in the market, healthcare providers always try to find other ways to provide the same medication. If this is impossible, they always provide similar medicines with the same purpose.

Drug shortages can cause complications, inadequate medical care, and errors.

Here are some common effects of a drug shortage –

Medical procedures can be delayed
Drug shortages can raise some ethical concerns
Shortage can involve some sole-source drugs with no alternatives
It can interrupt the treatment of some acute or chronic conditions
It can create some medical errors

What are the limitations of the FDA in case of drug shortages

Although the FDA plays a significant role in preventing drug shortages, it has certain limitations.

The FDA lacks the authority to compel a company to produce or continue producing a specific drug but works within its capacity to address shortages
FDA cannot force a company to increase the production of some drugs
FDA cannot force a company to change its drug supply and distribution
While the FDA cannot dictate distribution specifics to companies, it can issue guidelines to prioritize distribution during shortages

Conclusion

A drug shortage can create several problems in the healthcare department, including medical errors and interruptions in treating chronic or acute health conditions and diseases. The FDA takes different measures to prevent drug shortages. However, it has certain limitations in its area of work. The FDA also plays a significant role in managing the situation during a drug shortage.