Pharmacy Expert: Play the Compounding Game

Adding compounding services to a pharmacy relies on understanding the rules of the game, said Nayan Patel, PharmD, CEO of Central Drugs Compounding Pharmacy, during his presentation at the 2015 Pharmacy Development Services conference.

“Stop fighting the [pharmacy benefit managers]. Stop fighting the government. Stop fighting everybody,” Dr. Patel said. “Learn the rules, learn the game, and play the game…If you do that, I can assure you, this industry is about to explode.”

At the time Dr. Patel began compounding, very few pharmacists in his area offered the service, despite its roots in traditional pharmacy. Since then, compounding has come back in vogue, providing options to patients who cannot take traditional, mass-produced medications due to allergies or health complications.

Those nuanced patient needs will help drive growth for drug compounding, as will marketing the service directly to prescribers, Dr. Patel said.

“Doctors today are realizing compounding today is a necessity,” he said. “…The manufacturers are not going to fulfill a need for us. We have to go after it.”

Expanding pharmacy services to include compounding relies on infrastructure and leadership, as well as an adaptable business model.

“Think outside the box,” Dr. Patel said. “You cannot have a pharmacy in a box, and put a compounding pharmacy in that pharmacy. You have to customize it.”

Although the 2012 meningitis outbreak at the New England Compounding Center led to negative connotations for compounding, it brought regulation and safety to the practice’s forefront. It makes safety a well-known standard among compounding pharmacists, and the new documentation standards allow pharmacists to prove that they are medication experts in this field, Dr. Patel said.

Compounding safety measures associated with the outbreak include the Drug Quality and Security Act, which established registration requirements for compounding pharmacy facilities and created an adverse event reporting system and risk-based inspection procedures for facilities with numerous adverse event reports.

Future safety regulations likely to affect compounding pharmacy practice include the FDA’s new 503A and 503B regulations, as well as USP <800> regulations.