Department of Public Health Announces Changes at Board of Pharmacy; Provides Update on Unannounced Pharmacy Inspections

BOSTON — Department of Public Health Interim Commissioner Dr. Lauren Smith today announced changes at the Massachusetts Board of Pharmacy and provided an update on the unannounced inspections of and enhanced regulations for compounding pharmacies that Governor Deval Patrick called for in wake of the NECC meningitis outbreak.

Three new members who work across diverse health care settings will fill seats on the Board of Pharmacy. They are: Patrick Gannon, Vice President and Chief Quality Officer for Southcoast Health System; Jane Franke, Senior Director of Performance Improvement Innovations at Blue Cross Blue Shield of Massachusetts; and Edmund Taglieri, Jr., Executive Director of the Beaumont Rehabilitation and Skilled Nursing Center.

Gannon will replace Sophia Pasedis, whose term expired last week. Taglieri will replace George Cayer, whose term has also expired and Franke will fill a vacant public seat on the 11-member Board.

“These respected health care professionals will use their experience to bring change to the Board of Pharmacy to enhance our oversight of this industry,” said Interim Commissioner Smith. “We expect additional changes to the Board after the Commission on Pharmacy Compounding issues its recommendations to Governor Patrick at the end of the month.”

The Commission has been meeting regularly and is looking at best practices in other states and exploring changes to the law to help address the regulatory gray area surrounding compounding pharmacies. The Commission is also examining the statutory structure of the Board to ensure a better balance of oversight that includes more members who are not practicing in the industry they are responsible for regulating. Finally, the Commission is examining a licensing requirement for out-of-state pharmacies that distribute medications into the Commonwealth and additional reviews of local pharmacies’ out-of-state operations.

Unnanounced Inspections Continue

More than a dozen pharmacies have been inspected since Governor Patrick directed the Board of Pharmacy to begin checks of compounding pharmacies that produce sterile injectable medications. These inspections have identified problems in three pharmacies for which new cease and desist orders have been issued:

• Oncomed Pharmaceuticals – The Board of Pharmacy issued a cease and desist notice to OncoMed Pharmaceuticals in Waltham on November 21st due to issues with the storage of chemotherapy drugs. The Board is actively working with OncoMed on a corrective plan to resolve these issues.
• Pallimed Solutions – On November 27th, the Board of Pharmacy issued a partial cease and desist notice to Pallimed Solutions Pharmacy in Boston to halt the production of sildenafil citrate. Inspectors found that the pharmacy had prepared and distributed sildenafil citrate using improper components.
• The Whittier Pharmacist – The Board of Pharmacy also issued a partial cease and desist notice to The Whittier Pharmacist, Inc. in Bradford on November 28th, after identifying violations in the pharmacy’s sterile compounding operations. The cease and desist notice is in effect until changes are made to bring the pharmacy into compliance with USP 797 standards.

All pharmacies compounding sterile medications in Massachusetts were required to sign affidavits attesting to compliance with related laws and regulations. Each of these three pharmacies signed attestations. The Board of Pharmacy will pursue any means necessary to ensure that those who place the public at risk are held accountable, including referring cases to the Attorney General.

Other pharmacies that have been inspected have come back with minor deficiencies that have since been corrected, or are currently being addressed. Unannounced inspections of compounding pharmacies that produce sterile injectable medications will continue until all have been inspected.

Stringent Regulations Advance

This week, the Board of Pharmacy held a public hearing on emergency regulations that were put in place by the Patrick-Murray Administration to enhance monitoring and scrutiny of the compounding industry.

“These regulations greatly advance our ability to monitor the sterile compounding industry,” said Interim Commissioner Smith. “These new tools stem from lessons learned during the meningitis outbreak and will help us ensure that something like this never happens again.”

The new regulations require sterile compounding pharmacies in Massachusetts to report, for the first time, volume and distribution figures to the state. This would alert the Board of a pharmacy that is acting like a manufacturer, which requires an FDA license.

The regulations also require all licensed pharmacies and pharmacists to report to the Board when they are the subject of any disciplinary action by any state or federal agency. This will allow the Board to know when other entities have identified issues with Massachusetts licensed pharmacies. The Board will schedule a vote within the next month on making the emergency regulations permanent.

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