WASHINGTON -- (BUSINESS WIRE) -- In a health policy brief released today by the Institute for Patient Access (IfPA), a physician led non-profit policy research organization, state lawmakers were cautioned of the potential consequences to patient health if pharmacists are permitted to substitute biological medicines without notifying the prescribing doctors.
“Due to the exceptionally complex and unique nature of biological medications and the many ways that they differ from conventional drugs, there are important reasons for pharmacists to notify physicians when they consider substitutions,” said David Charles, M.D., a practicing neurologist and clinical researcher in Nashville, Tenn., and co-author of the health policy brief.
Legislation that would permit pharmacists to substitute biological medicines has been or will soon be considered in several states including California, Colorado, Delaware, Georgia, Illinois, Indiana, Maryland, Massachusetts, Pennsylvania, and Washington State.
“For patients with serious conditions such as multiple sclerosis, cancer, rheumatoid arthritis, and certain movement disorders, biological medications often produce substantial, life-changing improvements that are not seen with conventional drugs,” said Dr. Charles. “Like all treatments, biologics may be associated with side effects in some patients. If a patient experiences a side effect, physician notice of a pharmacist’s substitution allows the doctor to identify which product caused the adverse reaction so that the patient can be switched to a different biologic, if needed.”
Biological medications made from living cells or organisms are large, complex chemical structures. In addition, unlike conventional drugs, biologics are highly sensitive to their manufacturing methods. As a result of the substantial differences between biologics and conventional drugs, the two classes of products are regulated differently by the Food and Drug Administration (FDA).
While pharmacists can legally substitute generic conventional drugs for one another without physician notification, “therapeutically-interchangeable” biologics are not generics. Generic drugs have been chemically verified to contain exactly the same active ingredient as the name-brand drug.
“Physicians are committed to providing the safest and most effective treatments for their patients,” said Dr. Charles. “When prescribing treatments, doctors carefully weigh the expected benefits and risks, and take responsibility for treating side effects. Physicians must be able to track the exact biological medications associated with side effects so that they can be reported to the manufacturer and the FDA.
“If patients begin experiencing major side effects that can’t be traced to a specific product, manufacturing of all the biological medications in that class may need to be shut down until the problem can be identified. For patients with progressive conditions like multiple sclerosis and cancer, not having access to their biological medication could lead to permanent disability and even death.
“In a transparent healthcare system, patients and physicians have a right to know exactly which medication patients receive.”
For the full health policy brief, “Why Doctors Need to Know When Pharmacists Substitute Biological Medicines,” please visit www.InstituteforPatientAccess.org.
The Institute for Patient Access (IfPA) is a physician-led policy research organization dedicated to maintaining the physician-patient relationship for quality healthcare. To further its mission, IfPA produces educational materials and programming designed to promote informed discussion about patient access to approved therapies and appropriate clinical care. Established in 2012, by the leadership of the Alliance for Patient Access, IfPA is a 501(c)(3) public charity non-profit organization.