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Compounded Medicines: Safety and Regulation Issues

Compounded Medicines

What kind of drugs do you usually take: compounded or manufactured by a large pharmaceutical company? At first glance, it seems that in most cases doctors prescribe factory-supplied medicines. But in practice millions of US citizens use compounded drugs on a regular basis. And in the USA there are about 7,500 facilities making such medications.

What is a compounded drug?

Compounded medications are the ones that are made in pharmacies or clinics rather than at the factory. Such drugs may be similar to commercially available ones, but the formulas are altered in order to perfectly meet the needs of a particular patient.

When are such drugs used?

  • One needs a different dosage of some ingredient.
  • A patient is allergic to some ingredient that is not essential.
  • Kids do not want to take the medicine prescribed (in such cases pharmacists may change its form or add some yummy flavor).
  • A patient has some problems with swallowing (in such situations different forms are usually used).

As you can see, in a range of cases the use of compounded medications helps people to avoid serious problems and side effects associated with the consumption of factory-made products.

However, medicines from compounding pharmacies should not be used for no particular reason, since there are some safety risks.

Why are compounded drugs considered to be unsafe?

The first fact one should mention is that they are not approved by the FDA and, consequently, they are not considered to be as safe as factory-supplied products.

Sure, there are standards that compounding pharmacies should follow. Such facilities are supervised by the FDA and state boards of pharmacy, but in practice there are serious risks associated with compounded drugs.

Here are some of them:

  • insanitary conditions in a pharmacy;
  • the contamination of the products that are supposed to be sterile;
  • technology violations;
  • wrong doses of active ingredients.

According to the information from the website of the FDA, during the inspections of compounding facilities the representatives of this organization have repeatedly revealed such serious violations of the procedure as making sterile products with exposed skin, keeping pets in pharmacies, etc.

Furthermore, there are recorded cases when such violations have caused serious consequences. The most well-known one is the outbreak in 2012. It was caused by painkillers contaminated with a fungus. This product was produced by the New England Compounding Center. And, according to official statistics, the medicine mentioned killed over 100 people. In addition, over 750 patients got infections.

One should note that there was a whole bunch of factors that contributed to the magnitude of the accident:

  • The contaminated product was produced in the form of a suspension, and that’s why it could not be filtered in a proper way.
  • Since it was used for injections into a spine, no preservatives could be added, and, as a result, fungi got in the favorable environment.
  • The contaminated medication belonged to steroids, and this type of substances prevent an organism from fighting harmful microorganisms.
  • The drug was produced in bulk (although it was strictly forbidden) and was sent to 20 states, so about 14,000 of people got contaminated injections.
  • Due to the fact that the volume of sales was high enough, in some cases the medication was kept in store, and during the period of storage fungi could grow without any restrictions.

The people responsible for the tragedy were sentenced. Besides, in 2013 the Drug Quality and Security Act was issued. This document specified 77 outsourcing facilities that had the right to produce compounded drugs in large volumes.

However, the steps mentioned turned out to be less-than-adequate. For example, in 2016 17 cancer patients from New York got the fungal infection as a result of the intravenous injections of the contaminated medicines. In 2017 68 people from Texas suffered from the contaminated steroids for eyes. As a result, they lost their sight partially or completely. And this list of tragedies caused by low-quality compounded drugs is not complete. In fact, during the period from 2001 to 2017, the authorities registered over 50 accidents associated with the use of unsafe compounds.

Have compounded medicines got safer?

In view of cases of contamination and other accidents associated with the poor quality of compounded medications, Scott Gottlieb, the former FDA Commissioner, has come to the decision to initiate additional measures to increase the oversight of compounding. In 2018, he issued the Compounding Policy Priorities and held a public meeting. While explaining the reasons for such steps, he noted that there was a large amount of firms that produced large volumes of medicines, including sterile ones, with procedure violations under the shelter of pharmacy licenses.

It is important to mention that the International Academy of Compounding Pharmacists hasn’t approved the new policy of the FDA. It has formed a coalition with other compounding pharmacy groups, and they have turned to Congress for help and support. They want the FDA to reconsider some of the regulations introduced. For example, they raised concerns about the 5% cap on distributing drugs across the borders of the states. The representatives of the compounding industry claim that such restrictions may result in serious problems with getting access to the necessary drugs. A lot of patients buy their compounded medications from other states, since most pharmacists specialize in a particular type of products.

One should also note that the representatives of the coalition have highlighted that they realize that compounds should be produced in strict adherence to the standards and rules, but at the same time they understand that the impractical regulatory framework may lead to a range of problems that will affect patients in the first place.

As of today, the FDA is responsible for the oversight of the outsourcing facilities, but it does not check the quality of compounded drugs. Other drugstores work under the supervision of state pharmacy boards. But most states do not conduct routine inspections of the pharmacies that specialize in compounding. So, there are certain safety risks left. For example, there may be pharmacists that keep working in unsanitary conditions and producing large volumes of unsafe drugs.

Are there any other problems related to compounding medicines?

You have probably heard of the headline-making case of defrauding Tricare, haven’t you? In 2017 the representatives of one of the compounding pharmacies were found guilty of seizuring about $200 million. Earlier that year 8 people connected with 3 different pharmacies were convicted of defrauding the Office of Workers’ Compensation of $158 million. And these are only some of the evidenced cheating cases associated with compounded medications.

Such crimes are most frequently related to:

  • over-pricing;
  • refilling prescriptions without getting consent;
  • producing products that fail to achieve optimum effect or have no medical effect at all;
  • manufacturing drugs in large volumes with no individual prescriptions;
  • adding ingredients that are not allowed to be used within the territory of the USA;
  • making copies of the factory-manufactured drugs.

As you can see, at the moment, the compounding industry doesn’t seem to work properly and to abide the law. There are too many accidents that make experts and patients doubt the effectiveness of the current system of regulation. State authorities, as well as manufacturers and doctors, don’t seem to keep control of the quality of drugs patients get. It looks like it is high time to change the system and to implement new rules.

And the last thing we would like to discuss is the recommendations that will help you use compounds safely.

So, in case your doctor prescribes you a compounded drug, be sure to:

  • ask whether there is an FDA-approved alternative that will suit you;
  • find out whether the pharmacy has got the accreditation (however, the answer is not so crucial, that’s just for you to feel more comfortable);
  • check the accuracy and exhaustiveness of the information on the label;
  • ask about the requirements to the storage conditions.

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