How does the Board of Pharmacy protect the public?
As of June 30, 2017, the Michigan Board of Pharmacy is requiring accreditation and subsequent licensing with regards to sterile compounding. This mandate affects hospitals, infusion centers and compounding pharmacies.
The Michigan Board of Pharmacy has a rigid set of standards for compounding medications, such as chemotherapies, antibiotic infusions and all other infusions. Michigan is the first state to adopt this compounding licensure.
What prompted the Michigan Board of Pharmacy to mandate these stringent regulations for compounding medications?
It is the result of a fungal meningitis outbreak in the fall of 2012, in which 800 individuals were sickened, including 76 deaths. The New England Compounding Center had distributed contaminated products throughout a multi-state region.
The FDA and state authorities investigated the company and found they were in violation and had sent out drugs that were unsanitary or contaminated.
As a result of the investigation, company officials and employees were indicted on a host of federal charges. Several of the fatalities occurred in southern Michigan; prompting Michigan legislators to encourage the Michigan Board of Pharmacy to take action.
So, what does this mean for patients going forward? These newly adopted standards by the Michigan Board of Pharmacy ensure consistent sterile procedures for the safety of all patients. Pharmacies preparing sterile compounds for intravenous use undergo a rigorous survey to ensure the sterility of the products they are dispensing.
The compounding licensure process also takes into account the safety of pharmacy personnel preparing these sterile products. Sterile isolators are available to limit exposure to any medication that may be compounded.
These isolators are tested every six months to ensure their efficiency. Pharmacy personnel also must maintain appropriate sterile techniques to comply with guidelines of USP 797.
These guidelines provide standards for compounding sterile preparations to promote patient safety and prevent harm. These standards help ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency. These guidelines also describe a number of requirements, including responsibilities of compounding personnel, training, environmental services and monitoring, storage and testing of finished preparations.
So, the next time a medical professional accesses your vein to infuse a medication, remember your state and local healthcare organization are working together to ensure your safety.