Ever directed your patient to a compounding pharmacy: Is it really safe?

Reepa Agrawal
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19 Dec, 2018

Traditional compounding pharmacies tailor made drugs for patients with specific needs which is not met during their mass production. Such pharmacies using different tools and methods can change the formulations from solid to liquid, prepare exact small doses especially for infants, remove allergic components as per patient requirements and even make few drugs more palatable. These pharmacies run by trained pharmacists have always helped the community at large. Many clinicians especially paediatricians are highly dependent on their local compounding pharmacies to customise drugs especially for the accurate doses according to weight of the infants and children. Equally essential for compliance is the palatability of medicines. The palatability of medicines can be improved by compounding process, in which stable flavouring agents are added and by careful fractionation, allergens can be removed thereby reducing the risk of allergic reactions. In USA, doctors can check whether the said pharmacy is accredited by PCAB (Pharmacy Compounding Accreditation Board) or not.

In most of the countries including India, pulverisation (to convert drugs into powder form) of drugs is done by either mortar and pestle manually, automated grinders or even by intervention that is by dissolving first in a solvent and then letting it evaporate to get the desired powder formulation. Precision at every level is needed especially to preserve the active ingredients. Compounding can be done in sterile or non sterile environment depending upon the drugs. Sterile compounding is essential for drugs to be used via parental routes.

Nowadays the line between large scale compounding pharmacies and actual drug manufacturing units is fading and is definitely a matter of concern. There are estimates that its market worth is billions of dollars. At the same time, when profits are not made, mass production of drugs are stopped by the pharmaceutical companies. These are especially seen with pediatric formulations like antiretroviral pediatric formulation where manufacturing was suddenly stopped In India due to lesser demand in the market. Hence, this leads to pulverisation of adult formulations to tailor to the pediatric population. During the process of compounding; errors, contamination can happen which poses a health risk. Also if the drug is a fixed drug combination, the process of pulverisation may lead to improper dosing in each powdered formulation.

One cannot forget the tragedy that took place in 2012 where fungal meningitis outbreak occurred due to fungal contamination of compounded drug (methylprednisolone) shipped throughout United States by NECC and causing 60 deaths and 750 cases. Following this dreadful negligent act NECC (New England Compounding Centre) located in Massachusetts faced several lawsuits. The quality standards are monitored by the respective States in the U.S but when large scale drugs compounding is done FDA governs them. There are now strict laws in place especially to prevent contamination at each level and also to keep a check on the production of drugs not approved by FDA.

All said and done, the health care sector is made of inter-dependent subsectors and each needs to work with utmost caution and honesty for the benefit of patients and not lucrative market gains.
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