Amid global drug shortage, patients and healthcare professionals are looking at compound pharmacies to get the medications they need. Compound pharmacies formulate prescribed medications for patients based on their disease specifics, age, sex, and other needs. 

In this article, we will understand how compounding pharmacists is resolving the rising issue of drug shortage.

How serious is the current drug shortage situation?

The FDA defines drug shortage as “When the demand for the drug exceeds the supply of the drug.”

According to Shawn Hodges, CEO of Revelation Pharma, the problem of drug shortage continues to grow, impacting the entire pharmaceutical industry. As of September 2024, around 277 drugs are on FDA’s drug shortage list, and many essential drugs remain scarce. This can be largely attributed to:

Hodges says pharmacies, oncology clinics, or infectious disease clinics have found alternative methods to treat their patients.

In addition, the following statistics underscore the seriousness of drug shortage worldwide:

There is much more to this.

Compound pharmacies emerging as part of the solution

Hodges says pharmacy compounding can be an indispensable part of the solution to the problem of drug shortage. Generally, the shortage is caused by manufacturing and supply chain issues, economic factors, and regulations. This is the void that compounding pharmacies can fill.

Compounding medicines are primarily meant for patients who cannot fulfill their medicinal needs with standard drugs available on the market. Compounding pharmacists can also combine or change ingredients to meet the specific needs of patients. So, drug shortage seems like a boon to the compound pharmacy industry. Large-scale compounders are making extra efforts to fulfill the demand for crucial drugs, including pain medicines, respiratory treatments, and anaesthetics such as lidocaine and ketamine hydrochloride.

Compounding is allowed under the FD&C Act (Federal Food, Drug, and Cosmetic Act) in certain circumstances. For instance, a prescriber does not find an appropriate FDA-approved medication for a patient. In this situation, they can prescribe custom medications that are commercially unavailable. Another situation is when the FDA-approved drug is appropriate but is unavailable. In such instances, compounds can create copies of FDA-approved drugs that are currently on the FDA drug shortage list.

Are compounded medications safe?

As mentioned above, compounding is allowed for medicines listed on the FDA drug shortage list. However, unnecessary use of compound medicines or when these are incorrectly compounded, things can turn risky and even life-threatening for patients. For instance, the FDA earlier revealed illegally marketed semaglutide products online and drugs containing different salts of semaglutide without being tested for safety and efficacy.

The good news is that the FDA has recently issued a safety alert for the distribution of compounded drugs. The Agency has issued a warning regarding compounded drugs distributed by Fullerton Wellness, LLC in California. The Agency discovered that the facility used non-sterile ingredients for injectable products and paid no attention to health risks often resulting from the lack of sterilization.

Generally, compounded medicines are safe when purchased from a reputable and licensed compounded pharmacy, online or physical stores. Patients and healthcare professionals should know that poor compounding can result in inaccurate dosage or contamination, leading to injuries or even death.

Finding the best compounding pharmacy

Check if the pharmacy is licensed and accredited by concerned authorities. The pharmacists must be well-trained to provide effectively formulated for patients’ specific needs and conditions. Additionally, ask about the pharmacy’s batch testing process to ensure every ingredient used for the medicines meets safety and quality standards.

Moreover, as a patient, you should also inquire about the quality practices followed by the pharmacies. A reputable and genuine compounded pharmacy will proactively provide all information transparently and clearly.

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