VOL. 128 | NO. 60 | Wednesday, March 27, 2013
Shortages Impact Compounding Pharmacies
By Jennifer Johnson Backer
In recent years, the U.S. Food and Drug Administration has reported an increase in the number of drug shortages and discontinuations.
The number of drug shortages reported to the FDA gained 41 percent to 251 shortages in 2011, compared to 178 shortages reported in 2010. The agency says it continues to see an increasing number of shortages, including drugs used to treat cancer, anesthetics used for patients undergoing surgery, drugs needed for emergency medicine and injectable drugs. The FDA also has reported a spike in the number of medications that have been discontinued.
Brett Wright, the owner of Benevere Pharmacy in Collierville, says he’s noticed an increase in the number of his clients requesting medications that are no longer commercially available.
Wright, who is a pharmacist by training, opened Benevere Pharmacy in May. The pharmacy specializes in custom-making medications that are tailored to meet the medical needs of an individual patient. Sometimes compounding is needed because a patient may be allergic to a certain dye, or an elderly patient may need a medicine in a liquid or suppository form that is not available. In other cases, compounding is necessary because a drug has been discontinued altogether.
Antonio Anderson mixes compounds at Benevere Specialty Pharmacy & Diabetic Supply. Benevere is a compounding and specialty pharmacy company serving Collierville and the surrounding areas. (Daily News File Photo: Lance Murphey)
Bellamine is a drug used to relieve symptoms related to menopause. It’s a drug frequently requested at Wright’s pharmacy. That’s because the drug was discontinued recently, and can only be made by compounding pharmacies.
“Menopause can be a challenging experience for many women,” Wright said. “We can take the original ingredients and compound them into a capsule.”
Midrin, a medication used to treat headaches, is also a popular request, Wright says. The medication has been discontinued within the last year because its manufacturer decided it was no longer commercially profitable.
Drug shortages can occur because of quality and manufacturing issues. Some facilities, particularly those that make older, sterile injectables, are limited by the number of drugs they can make at their facilities for safety and sterility reasons. In other cases, drug manufacturers decide to stop making a particular drug in favor of newer, more profitable drugs.
“If there isn’t a large patient group using the drug, it can impact a manufacturer’s desire to make the drug,” Wright said. “It may only be viable for a specific patient at a smaller pharmacy.”
The FDA does not approve drugs made by compounding pharmacies; instead, a compounding pharmacy is licensed by its state’s board of pharmacy. Unlike traditional drug manufacturers, compounding pharmacies are not required to tell the FDA what drugs they are making. Compounding, particularly sterile injectables have fallen under the scrutiny of the FDA because of a string of recent health emergencies.
In 2012, an outbreak of fungal meningitis was linked to an injectable steroid that infected hundreds of people across the U.S. The outbreak resulted in serious injuries and deaths and was tied to a firm in Framingham, Mass. In 2011, contaminated injectable eye medications also resulted in serious health problems.
Most of those problems have been tied to the emergence of firms with pharmacy licenses making and distributing drugs in a way that’s outside the bounds of traditional pharmacy compounding. Many of those pharmacies mass produce injectables for hospitals and larger clients – which is different than a traditional retail compounding pharmacy like Wright’s Benevere Pharmacy.
While many compounded medications are covered by insurance, Wright says it can still be a challenge for some patients. Pricing is based on the average wholesale price of the medication – which can sometimes be cheaper if there is no price that a pharmacy has to match in cases where a medication has been discontinued.
“The biggest challenge we face is payment,” he said. “We want to make sure that we can make it affordable for our patients.”
Wright says he’s also seen a boost in patients who have requested specialized thyroid medications that can provide more precise dosing than commercially available thyroid medication.
“We are focused on providing care to specific patients and their needs,” Wright said. “We are a retail pharmacy, but we can do that on an individualized basis for each patient. That’s what makes our pharmacy unique.”