Over the last few years, more and more stories have appeared in the news regarding compounded medications. Recently, the New England Compounding Center (NECC) came under scrutiny after more than 400 patients who received a medication from NECC contracted fungal meningitis. At the time of this post, 31 people had died from the infection.
In the wake of this tragedy, there has been some confusion among the public about the differences between medication manufacturing and compounding.
Manufacturing is defined as the preparation of large quantities of medication with a process that is approved and regulated by the U.S. Food and Drug Administration (FDA). Under this process, manufacturers must comply with federal quality and safety standards.
Compounding occurs when a medicine has to be created because the strength, concentration, or dosage form that is needed for a specific patient is not commercially available. Compounding is done under the oversight of a state board of pharmacy rather than the FDA. Although these quality standards are universal from state to state, oversight and enforcement of these standards varies.
Typically, when you think of a compounded medication, you think of the capsule, cream, or gel you can get at your local pharmacy. But compounded medicines also can be created as a liquid to be swallowed or injected into the body. Compounded medicines are often made in small quantities to meet the needs of specific or anticipated patients.
Many health care organizations have the facilities and resources to compound medications safely in-house. However, some health care organizations will turn to compounding companies either to prepare these patient-specific products or to obtain other medicines that are temporarily unavailable due to a drug shortage.
There are many guidelines available for pharmacy professionals to use when they are looking for a quality compounding supplier. The American Society of Health-System Pharmacists (ASHP), which operates www.SafeMedication.com, encourages hospitals and health systems to research compounding companies extensively and to make sure that the compounded preparations these companies provide are prepared in accordance with state and federal standards and applicable quality standards.
ASHP is working diligently with Congress and the FDA to ensure that the right changes are made to federal law and regulations to prevent an event like the one at NECC from ever occurring again.
It’s clear that there is a real patient need for compounded medicines. Hospitals and health systems that either compound medications or work with outside compounding companies ensure that their patients will receive the medicines they need in a timely fashion. But compounding must be done in a way that is safe and reliable.
Editor’s note: The views expressed in “Pharmacist’s Journal” do not necessarily represent the views of the American Society of Health-System Pharmacists.
By Susan Flaker, Pharm.D., Inpatient Pharmacy Supervisor, Barnes Jewish Hospital, St. Louis Mo.