Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

Story appears at Ocala.com:

Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

By Carlos E. Medina
Correspondent

Published: Saturday, June 2, 2012 at 7:16 p.m.

Last Modified: Saturday, June 2, 2012 at 7:16 p.m.

The recent recalls of sterile products made by Franck's Pharmacy in Ocala, as well as its position as a high-volume drug maker, are aspects of the compounding pharmacy business that has troubled federal regulators for years.

The Federal Drug Administration, which is tasked with ensuring the safety of drugs in the nation, has limited oversight over compounding pharmacies like Franck's because of a 74-year-old law that allows pharmacists to “compound,” or create unique variations of existing drugs for patients.

But that law, and the FDA's lack of authority over the practice of compounding, may draw new scrutiny in the wake of a well-publicized mistake at Franck's that killed two dozen prized polo ponies in 2009 and the production of contaminated solutions that reportedly damaged the vision of 33 eye surgery patients in recent months.

Compounding pharmacies make medications and other medical preparations from scratch. They cannot make straight copies of commercially available medications and can only make medications when they are ordered by a doctor.

These pharmacies fine tune drugs to a patient's need, whether that means creating a specific dosage not offered by a manufacturer or a liquid form of a drug only available in pill form.

Historically, compounding was the way most people got their prescription medicines. As recently as the 1960s pharmacists routinely ground and mixed compounds in their stores to make the medicines prescribed by local doctors.

The age of mass-produced drugs is a phenomenon of the last fifty years. The availability of those mass-produced drugs eventually led most pharmacies only to dispense ready-made medicines.

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Recent Report Projects that Compounding Pharmacies Will Experience Growth

IBISWorld Inc recently issued the following report:

The Compounding Pharmacies industry is expected to experience annualized revenue growth of 5.5% to $1.8 billion in the five years to 2012. During that time, the industry has benefited from increased awareness of pharmaceutical options among consumers and a growing number of senior citizens. The industry has also gotten a boost from an increasing number of mass manufactured drugs that are in short supply. However, the industry was not entirely unaffected by the recession. Revenue growth slowed during the recession due to a sharp increase in the unemployment rate, which reduced the number of people with private health insurance. Furthermore, the recession hurt per capita disposable income. According to industry analyst Kevin Culbert, “this factor slowed growth because a larger proportion of industry products are paid for out of pocket by consumers compared with traditional pharmaceuticals.”
Luckily for the Compounding Pharmacies industry, there has been no shortage of demand in recent years. In 2012, revenue is expected to grow 7.9%, largely due to a steadily aging US population and an increase in physician visits. In the five years to 2012, the number of adults aged 65 and older is expected to grow 2.4% annually to about 42.7 million people. People aged 65 and older are a major market for this industry because they tend to require more prescription medication than the rest of the population. Consequently, growth in the market has boosted industry demand during the past five years. According to Culbert, “drug shortages can also cause doctors and patients to use compounding pharmacies because operators purchase chemicals in bulk and make medicines on-site.” During the past five years, the number of prescription drug shortages has increased, rising from 61 in 2005 to more than 280 in 2012.
In the five years to 2017, IBISWorld estimates that revenue will increase. During that time, a growing number of doctors and patients will likely turn to compounding pharmacies to prepare medications with alternate doses and strengths. Rising demand will ultimately bring more operators into the industry. IBISWorld projects that the number of firms operating in this industry will increase at an average of 2.3% annually to 178 in the five years to 2017.
For more information visit IBISWorld’s Compounding Pharmacies in the US industry page
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This industry includes stores that make and sell compounded medications. Compounded medications are prescriptions that are written by physicians and prepared by pharmacists for individual patients. These medications are not commercially available; rather, they are prescribed by physicians and prepared by pharmacists to meet unique needs.
IBISWorld industry Report Key Topics