A drug shortage can happen for various reasons. Quality or manufacturing problems, discontinuation, and delays can create drug shortages. In most cases, only manufacturers deliver information about drug shortages to the FDA.
The FDA always tries to reduce the impact of drug shortages and manage the situation. 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?
According to the Federal Food, Drug, and Cosmetic Act, when the demand for drugs exceeds the supply of the drugs for a period in the United States, it can be called a Drug Shortage. 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. In this situation, the manufacturer cannot fulfill the projected or current demands.
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. The FDA can not order a company to keep making drugs it wants to discontinue.
There are multiple reasons that can cause drug shortages.
- A company can stop drug production of quality-related problems with the drug-making process.
- Natural disasters or other emergencies can prevent some companies from making and shipping their drugs.
- The manufacturer or the company may need help arranging active ingredients or containers like 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 drug 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 injectable.
- After the shortage started, drug prices for the substance hardly ever increased.
What Can Be Done During a Drug Shortage?
FDA has taken multiple actions to manage and improve the situation of drug shortages.
- FDA work with scientists, task force committee, economists, health care providers, and the public to identify the root cause of drug shortages
- They work with the industry to resolve different manufacturing problems so the medication can return to the market.
- They try to explain the review of different pharmaceutical manufacturing lines.
- 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 can obtain different critical drugs from some foreign plants that can meet the FDA quality standard.
- 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 the year 2021, around 114 new drug shortages were reported. This was the lowest drug shortage report 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 healthcare 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 you with that same medication. If it is impossible, they always provide you with 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, they have certain limitations.
- FDA does not have any authority to force a company to supply some drug if they decide to stop making
- FDA cannot force a company to increase the production of some drugs
- FDA cannot force a company to change its drug supply and distribution
- FDA cannot decide for a company where or to whom they can distribute the drugs
A drug shortage can create several problems in the healthcare department. It can create several medical errors and interrupt the treatment process of chronic or acute health conditions and diseases. The FDA takes different measures to prevent any drug shortages. However, they have certain limitations in their area of work. FDA also plays a significant role in managing the situation during a drug shortage.