Certification, which is voluntary, may be required as a condition of eligibility for insurance reimbursement.
The Joint Commission is launching a new program to certify compounding pharmacies. The organization is taking action to support pharmacies facing strict rules issued by some state regulators in the wake of a fungal meningitis outbreak in 2012, which killed 64 people and sickened nearly 700 more in 20 states.
The co-owner and head pharmacist of the New England Compounding Center, (NECC) the Massachusetts compounding pharmacy linked to the 2012 outbreak, is on trial facing murder charges.
In court testimony this month, the company's former quality control officer said that mold, bugs, and human hair were found at the facility.
The case triggered congressional hearings, federal legislation, and lawsuits.
Certification, which is voluntary, may be required as a condition of eligibility for insurance reimbursement. In some cases, it can satisfy state regulatory requirements. Michigan is the first state to require certification and several other states are considering certification programs.
The Joint Commission to Certify Cardiac Care
The Commission's two-year certificates are designed to ensure the quality of staff training, products, and the pharmacy environment. Specifically the guidelines promote:
- Training – proper use of personal protective equipment and aseptic techniques
- Sterility – of base products and beyond-use dates and labeling
- Airflow – guidelines for cleaning and documentation, storage
The Joint Commission also certifies programs such as patient blood management as well as cardiac and perinatal care for accredited organizations.
At the trial last week, a former pharmacy NECC staffer testified that technicians, not licensed pharmacists, were compounding medicines, according to The Boston Globe. He also noted rusty equipment and chipping paint in a supposedly sterile production room.
Writing in The New England Journal of Medicine, Boston University Law professor Kevin Outterson said that the 2013 Drug Quality and Security Act fell short in responding to the case because FDA review of compounding pharmacies is voluntary.
He called on purchasers to buy sterile-compounded drugs exclusively from FDA-regulated outsourcing facilities. "This decision could also be included in accreditation standards and reimbursement contracts," he wrote.