Stakeholders Weigh In On Tougher Pharmacy Regulations
Stakeholders voiced support and suggested changes before state lawmakers this week for proposed regulations meant to tighten oversight of Massachusetts compounding pharmacies.
State officials, and representatives from the pharmacy and health care industries gave verbal and written testimony in a hearing Tuesday before the Joint Committee on Public Health.
Addressing Lapse That Led To Outbreak
The panel is considering three bills to address apparent lapses in the regulatory system that led to the fungal meningitis outbreak linked to Framingham-based New England Compounding Center (NECC) last fall.
Most of the legislation is proposed by Gov. Deval Patrick, and includes the following measures:
Requirement of a special license for sterile compounding companies subject to federal oversight;
• Allowing the Board of Pharmacy to levy fines against pharmacies that violate its policies;
• Establishing whistleblower protections for pharmacy staff that report non-compliance;
• Requiring licenses for out-of-state pharmacies that deliver compounded drugs here; and
• Reorganizing the Board of Pharmacy to include members from outside the industry.
Patrick has also proposed a $1 million line item in the fiscal 2014 state budget that would pay for unannounced inspections at compounding pharmacies.
A Call For Drastic Change
Lauren A. Smith, interim commissioner of the Massachusetts Department of Public Health (DPH), testified on the merits of Patrick's proposals Tuesday, saying the NECC case demonstrated the need for drastic changes in some segments of the compounding industry.
"The days when compounding pharmacies only served local patients who presented prescriptions written by local hospitals or physicians are shifting. Instead, we now see an industry where high volumes of medications are being shipped across state lines.
"Our state laws and regulations, while comparable to most states, need to be strengthened to address the changing realities of this industry," Smith said.
Historically, the state has had limited oversight of compounding pharmacies, and there was confusion over whether the state pharmacy board or the U.S. Food and Drug Administration was more to blame for failing to oversee NECC properly.
The Board of Pharmacy passed emergency regulations in the fall to allow for enhanced monitoring and inspection of compounders' operations in an effort to avoid another health crisis.
The Industry Weighs In
Though representatives from pharmacy and hospital organizations generally approved of the proposed regulations, they objected with Patrick's proposal to reorganize the Board of Pharmacy to include members from outside the industry.
Evan T. Robinson, dean of the College of Pharmacy at Western New England University, said in a letter that reducing the number of pharmacists on the 11-member board from seven to four, as the governor has suggested, is a bad idea.
"The Board of Pharmacy has broad-ranging responsibilities for the practice of pharmacy and to decrease the number of pharmacists to a minority position would … be counterproductive to both practice and patient care," Robinson wrote.
The Massachusetts Chain Pharmacy Council, which also submitted testimony, likewise recommended a majority of six practicing pharmacists serve on the board.
The Massachusetts Hospital Association (MHA), which also testified, said the creation of five board slots for members of the general public raises concern about keeping the board balanced with members that have appropriate clinical expertise. And, the MHA talked about the need for a system that allows hospitals necessary waivers to dispense drugs under a more regulated system, which the association said is necessary due to a nationwide drug shortage.
The regulations are still under the review by the Joint Committee on Public Health.
Image source: Freedigitalphotos.net
WBJ Web Partners
Most Recent
Most Recent
0 Comments