Customized Drugs

Before the days of Pfizer, GlaxoSmithKline, and other pharmaceutical giants of today, prescription drugs were produced in much smaller quantities through compounding. This is the process of combining, mixing, or altering ingredients to form a drug product and is performed by a licensed pharmacist.

In the earlier days of medicine, drug compounds were often derived from crude substances like opium, chrysanthemum, foxglove, and Nux Vomica. The process itself was not as sophisticated as well. For instance, Foxglove's effectiveness was determined by measuring the quantity needed to kill a cat. The activity of chrysanthemum on the other hand was measured by the number of flies that were killed over a specific time period while exposed to the substance.

The unnecessary demise of cats and flies were dispensed with when pharmaceutical studies progressed in the 19th and 20th century. In the 1930s and 1940s, about 60 percent of medications were still compounded. It was only in the mid-1900s that mass production of drugs went underway. Today, drug compounding is still practiced by specialized pharmacies but the process makes up only around 1 percent of the total output of medications.

Compounding is done nowadays mainly to meet the needs of specific patients when an Food and Drug Administration-approved drug can't fit the prescription. For individuals who are allergic to certain dyes or preservatives, medications without these non-active ingredients are prepared for them. Compounded drugs are also produced for children who are unable to swallow pills, need lower dosages, or simply can't take bad-tasting medications. Compounding is also done when a certain drug is temporarily unavailable from the manufacturers or is not produced commercially.

Although drug compounding has its uses, the process also carries a number of risks. For one, it is not under FDA oversight which means that the quality control is not as stringent as the production process of FDA-approved drugs. The mixing or alteration of ingredients could result in reduced effectiveness or contamination, making it harmful to the patient.

A severe case of drug compounding gone wrong involved the deaths of three patients. The fatalities were caused by contaminated solutions which were used to paralyze the heart during an open-heart surgery. In another incident, two people were blinded and several others suffered from eye damage when a compounded solution used in a cataract surgery was contaminated with bacteria.

In 1997, the pharmacy compounding law was passed, thereby establishing limits in legitimate compounding. The law requires that compounded medications must be specifically prescribed to an identified patient and the medication used in the process must be an FDA-approved drug or listed as an acceptable substance for compounding. Drugs which were previously declared as ineffective or unsafe and substances which are difficult to compound should not used for compounding, the law says.

To ensure safety in taking compounded medications, consumers are advised to check with the pharmacist if he or she is familiar with the compounding process of the particular drug that they need. Consumers must also be aware of the proper usage and storage of compounded drugs.