The art of compounding medications has been around as long as pharmacies have existed. In fact, every pharmacy was a compounding pharmacy before the inception of large drug manufacturers. Even though compounding pharmacies are less common nowadays, they still play an important role in the manufacturing of drugs for hospitals and individuals.
This kind of a pharmacy is utilized for a couple of reasons. This first reason is the most typical use of such a pharmacy where a patient may have an allergy to the binder that is used in a drug that is manufactured on the large scale. A pharmacy that compounds can create a pill using a binder that does not cause an allergic reaction. In some cases, a custom dose, whether small or large, needs to be created for a patient. Compounds of creams is also another common role of this pharmacy.
Recently compounding pharmacies have taken on a new role that has been met with some controversy. It has become common place for there to be drug shortages of drugs that are used frequently. When such shortages began to happen, it was with less frequency. Major manufacturers would ask for small compounding pharmacies to help fill the gaps in inventory as an emergency measure until production volumes increased.
This measure was acceptable when it was mitigating an emergency shortage. However, as shortages became more frequent, emergency production by smaller pharmacies also became more frequent, even common. The controversy in using this stop gap is the difference in regulations and safety requirements for manufacturers versus pharmacies. The pharmacies do not have to conform to the strict regulations in place for large drug manufacturers.
These regular shortages for commonly used drugs have led many hospitals to bypass manufacturers all together. Many hospitals will have a compounding pharmacy they turn to instead of a major drug manufacturer. This choice allows a hospital to be more in control of inventory levels of crucial medications.
Ensuring inventory levels of crucial drugs is important, but it comes at a cost. The safety and sanitary standards for a pharmacy is much different than it is for a major drug manufacturer. This difference in standards creates an unwanted risk for hospital patients. What makes matters worse is many people who are administered drugs made by a compounding pharmacy are not aware of this fact.
With all the recent news of drugs recalled for impurities, it is certain that drug shortages will continue to be a problem. It is also worth mentioning that with these recent issues from overseas drug makers, consumers are warming to the idea of smaller compounding pharmacies in their own countries and sometimes even cities.
Increased need for these types of pharmacies is creating a demand for new standards and regulations. These standards and regulations will increase the responsibility of the pharmacist to maintain sanitary and safe conditions for the creation of medications that mirror those of large manufacturers.
Without these changes in regulations and standards the drug industry is in for some shaky times. Shortages in supplies and recalls due to impurities in overseas manufacturing is increasing the need for safe, reliable, and regulated alternatives to large scale manufacturing.
There has been resistance in placing such regulations because of the complications involved. However, it is a measure that would ensure the safety of hundreds of thousands of people at a time when they desperately need confidence in the drug industry. The inconvenience in seeing these regulations put in place is a small price for the safe manufacturing of crucial medications.