Using a compounder? Do your research
Tips to ensure compounding pharmacy safety
Scores of people have died in an outbreak of fungal meningitis that has been linked to steroids compounded by the New England Compounding Center (NECC). The incident is shining a light on an area of business that many in the healthcare world use, but which has not been closely monitored in the past.
“Many hospitals are asking themselves if they used NECC,” says Christian Hartman, PharmD, MBA, FSMSO, president of the American Society of Medication Safety Officers, director of clinical quality and patient safety at Wolters Kluwer Health, and a partner at Lucian Metrics in Boston. Hartman, a former medication safety officer at UMass Memorial Health System in Worcester and pharmacist at Brigham and Women’s Hospital, is heading up commission created by Massachusetts Governor Deval Patrick to look into compounding pharmacies and recommend any regulatory changes necessary to ensure its safety going forward.
“And if they did not use that one, then they are asking who they used, because compounding pharmacies are commonly used by hospitals,” he says, noting that this compounding business has taken off in the last six years.
Hospitals use them for several reasons. They use them to make up for drug shortages, like the shortage of methotrexate that hit the country’s cancer patients last year. “If the drug manufacturers are unable to meet the patient needs then compounding pharmacies have filled the gap in many cases.” Hospitals may tap compounders because they don’t have the capability themselves to compound what the hospitals need using the standards they demand. “Many hospitals don’t have the infrastructure, the appropriate policies, or testing capabilities to sterile compound appropriately,” he explains.
Another impetus for that growth is that healthcare is trying to standardize as much of what it does as possible. “That way, we can minimize risk. And if a compounder can produce a compound using safe practices and standards in a more efficient manner than hospitals can achieve, then the industry is here to stay.”
It’s a tough spot to be in, he says. “There is a need for these organizations, but we need to ensure they are safe to use.” The kind of compounders that hospitals use, who create large batches of a product and distribute it in bulk, are licensed by the FDA. The first thing you should do when looking for a compounder is to determine whether they are licensed. If they aren’t, don’t use them.
Second, Hartman says to look on the FDA website (http://www.fda.gov/ICECI/EnforcementActions/default.htm) to see if regulators have taken any actions against them. If they have a clean record, make sure they are using known standards around manufacturing. The FDA refers to Good Manufacturing Practices (GMP), and US Pharmacopoeia uses the 797 standards.
If possible, travel to the site. Take your head of pharmacy and see what the business looks like. “If you are going to look at working with a high-risk sterile compounding practice, you should go there and see it for yourself,” Hartman says.
While state regulations differ, you can also check the state board of pharmacy website to see if any state actions were taken. The recent tragedy has already led state boards of pharmacy to make some big changes, including tracking how much compounders are making and distributing, requiring them to report if they are subject to any investigation by a state or federal agency, and implementing financial penalties for organizations that don’t obey the rules.
Even if your state board of pharmacy doesn’t have a database, give it a call and see if anyone has any information on the business you are looking to use. “Do all the fact checking you can,” Hartman says.
- Association of Health System Pharmacists: http://www.ahsp.org
- International Journal of Pharmaceutical Compounding: http://www.ijpc.com. They have a great gap analysis tool available — http://www.ijpc.com/USP/IJPC%20USP%20797%20GAP%20Analysis.pdf
- CDC Multistate Outbreak Investigation: http://www.cdc.gov/HAI/outbreaks/meningitis.html
- NECC Customer List: http://www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325467...
- USP 797 QA Management System: http://www.pharmacyonesource.com/applications/simplifi797/
- USP 797 State Requirements: http://www.clinicaliq.com/797-state-survey
For more information on this story, contact Christian Hartman, PharmD, MBA, FSMSO, President American Society of Medication Safety Officers, Boston, MA. Email: firstname.lastname@example.org.