When a contaminated batch of injectable steroids was linked to 541 cases of fungal infections this fall, causing 36 deaths, officials immediately looked for the source. Although no cases were reported in Missouri, people across the country wondered about the safety of the drug supply. Yet the contaminated steroids were not made by one of the major pharmaceutical companies. Instead, they were manufactured by the New England Compounding Center, a company that produced ‘compounded pharmaceuticals.’
For those not familiar with medication compounding, the recent headlines may have created the wrong impression of an important skill at the root of modern pharmacy practice, says Jake Wilson, president of Bellevue Pharmacy. “Because of these very unfortunate events, compounded pharmaceuticals may have been portrayed as some sort of rogue and untrustworthy substances created in a back room somewhere. That really couldn’t be further from the truth,” he says, adding the reality is that compounding medicines is what pharmacy has always been about. “The foundation of pharmacy practice is the relationship between the physician, the patient and the pharmacist, and our compounding pharmacists are passionate about taking care of patients. Only the advent of mass-produced pharmaceuticals has decreased compounding over time.”
Most prescription medications are mass-produced and dispensed as provided by the manufacturer. However, some individuals need prescriptions personalized to a dose or delivery method not available from major pharmaceutical companies. For example, individuals who cannot take pills may need a certain type of medication prepared in a liquid or topical formulation. Children may need a smaller dose than is typically available. Compounding pharmacists customize prescriptions to meet these kinds of special needs.
Hospital pharmacies often compound medications for patients. “Compounding can go from simple to extremely complicated,” says Patrick Berry, director of retail pharmacy services for Mercy St. Louis. “Certification is beginning to become available and more common. Being members of compounding organizations also provides a great deal of depth to the pharmacy practice. And, of course, experience is a major factor.”
Berry points out that Mercy has been compounding for 25 years with three of the six Mercy pharmacies each specializing in different areas. “We limit our practice to only those areas in which we have full confidence in the products we dispense,” he says.
Wilson also emphasizes experience and careful quality controls. Bellevue Pharmacy is one of two pharmacies in Missouri accredited by the national Pharmacy Compounding Accreditation Board (PCAB). Maintaining that accreditation requires periodic on-site inspections by PCAB surveyors, continuing education for staff, and the use of high-quality, sterile chemicals and equipment.
Wilson regularly sends samples of compounded products to Dynalabs, a St. Louis-based quality assurance and testing facility. “Accredited compounding pharmacies undergo continual quality control,” he says.
Having worked in retail and hospital settings, Wilson adds that "never have I been in a business where the relationships with patients are so positive. Patients come here because they have a need that we can meet. This is real pharmacy—doing what pharmacists do best since the beginning of the profession."