Senator: Drug Recall Affirms Need for Closer Government Regulation

Andrew Kitchenman | March 20, 2013 | Health Care
Compounding pharmacy in Monmouth County suspends operations amid probe for possible contamination

Sen. Jeff Van Drew (D-Atlantic, Cape May, and Cumberland).
A New Jersey compounding pharmacy has recalled its products while it is being investigated for potential contamination, leading a state senator to say the incident points to the need to more closely regulate such businesses.

Med Prep Consulting of Tinton Falls temporarily halted all operations on Friday and voluntarily recalled magnesium sulfate products, after a Connecticut hospital identified some of company’s products as being potentially contaminated with visible particles. No infections have been linked to the Med Prep Consulting products.

All pharmacies need to do some compounding, in which a pharmaceutical product is created to fit the needs of individual patients, such as taking a medication manufactured in solid form and turning it into a liquid.

But compounding pharmacies that mass-produce sterile, injectable products have become more common in order to meet the needs of hospitals that face frequent drug shortages – however, those types of products pose the greatest risk of contamination.

Contamination of compounding pharmacy products has been in the public eye since September, when an outbreak of fungal meningitis was traced to a Massachusetts pharmacy, the New England Compounding Center. The outbreak led to 722 infections and 50 deaths through March 11, including 49 infections in New Jersey.

Sen. Jeff Van Drew (D-Atlantic, Cape May and Cumberland) has proposed the Compounding Pharmacy Quality Assurance Act S-2365, which would require all compounding pharmacies to follow a set of nationally recognized regulations.

Van Drew, a dentist, said the Med Prep Consulting case underscored the need for tighter regulation of the industry. He expressed frustration that Congress has failed to pass legislation that would apply federal drug regulations to compounding pharmacies, whose operations are more similar to pharmaceutical manufacturers than they are to traditional pharmacies.

“These pharmaceutical compounding companies have sprung up and they’re really manufacturing companies,” Van Drew said. “Most of them are good but some of them are not as good as they should be.”

New Jersey has 41 pharmacies that perform sterile compounding, in addition to pharmacies located in hospitals, according to Neal Buccino, a spokesman for the Division of Consumer Affairs in the Department of Public Safety.

State Board of Pharmacy regulations require regular training and testing of all personnel involved in sterile compounding, Buccino said. In addition, the state performs routine, unannounced inspections of compounding pharmacies, he said.

Van Drew said he has heard from anesthesiologists in South Jersey about the potential danger of some compounding pharmacy products. Some compounding pharmacies have increased production to meet the need caused by shortages of some pharmaceuticals.

Van Drew described federal regulation “as the real and best answer” to the need to regulate the industry.

“We should deal with it,” he said. In the absence of federal action, he added, “All we can do is state-by-state, try to ensure that the live up to standards.”

While the current version of the bill would require that all compounding pharmacies be accredited by the Pharmacy Compounding Accreditation Board, a national organization, Van Drew said he plans replace any reference to the organization with requirements that compounding pharmacies follow a set of regulations.

Van Drew said he was “disgusted” by the negligence shown by the New England Compounding Center.

“This is something that is very fixable,” he said.

Michael R. Cohen, president of the Institute for Safe Medication Practices, a Pennsylvania-based pharmacy monitoring organization, said the lack of federal regulation has led to many questions about safety practices of compounding pharmacies.

State inspections of compounding pharmacies can be costly, according to Cohen, speaking at the Association of Health Care Journalists annual convention on Friday in Boston.

State and federal investigators are investigating the Med Prep Consulting products. The company has agreed to halt its operations at least through at Friday. It agreed with the state Board of Pharmacy to stop producing and shipping medications until more information about its products can be analyzed, Attorney General Jeffrey S. Chiesa said in a statement on Friday. State health authorities have recommended that healthcare facilities that received Med Prep products remove them from use.

A woman who answered the phone at Med Prep Consulting declined to comment on the issue.