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Volume 2
Pharmacy Reform
[ index ]
FY 2014 Budget Recommendation:
Issues in Brief
Deval L. Patrick, Governor
Timothy P. Murray, Lt. Governor
The Patrick-Murray Administration is committed to ensuring the integrity of the Commonwealth’s public health infrastructure and the ways in which the state responds to public health needs in Massachusetts. The Governor’s legislation, An Act Relative To Pharmacy Practice In The Commonwealth (H.D. 84), will strengthen oversight of compounding pharmacies while his budget for FY 2014 makes critical investments in state public health programs and services.
Under Governor Patrick’s leadership, the Administration has launched an aggressive series of policy and operational initiatives to ensure that the significant harms resulting from substandard sterile compounding are never allowed to happen again. The Governor’s FY 20 14 budget builds on recommendations made by the Commission on Pharmacy Compounding, which was appointed by the Governor to provide DPH and the Board of Pharmacy with the right tools to regulate this vital industry.
Improving Pharmacy Accountability
The Governor’s FY 2014 budget recommendations continue recent reforms to the Commonwealth’s oversight of the pharmacy industry. These efforts will ensure that patients and families receive safe and effective medications. For the last two months, DPH has conducted unannounced inspections of all sterile compounding pharmacies in the Commonwealth. At Governor Patrick’s direction, the Board of Pharmacy issued new regulations that require sterile compounding pharmacies in Massachusetts to report volume and distribution to the state for the first time. The new regulations also require all licensed pharmacies and pharmacists to report to the Board when they are the subject of a disciplinary action by any state or federal agency.
Investments in the Governor’s FY 2014 budget will enable the Board to increase inspections of all sterile compounding pharmacies in the Commonwealth to support the enhanced monitoring requirements and improve accountability. New staff resources will also allow the Board to continue its unannounced pharmacy inspection schedules. The Governor is also directing DPH to strengthen inspector training requirements. The new requirements will ensure that all inspectors are pharmacists with at least five years of clinical experience, with additional training requirements and specific expertise in sterile compounding for inspectors working in that area.
An Act Relative To Pharmacy Practice In The Commonwealth (H.D. 84)
Key legislative proposals in An Act Relative To Pharmacy Practice In The Commonwealth (H.D. 84) make patient safety paramount and will help fill the regulatory gaps in compounding pharmacy monitoring. The Governor’s legislation includes a series of innovative strategies to further protect the public:
- Tiered Pharmacy Licensure – The Board of Pharmacy will require a special license for sterile compounding that will help regulators to hold pharmacies accountable for their practices. The Board will continue its enhanced, aggressive pharmacy inspection schedules for compounding pharmacies.
- Fines for Violations and Whistleblower Protections – The Board and DPH will have the authority to invoke monetary penalties for Massachusetts-licensed pharmacies that violate Board policies, regulations, or statutes. Whistleblower protections and rewards for pharmacists and pharmacy staff are established.
- Regulating Out-Of-State Pharmacies – The Board will have the authority to regulate out-of-state compounding pharmacies by requiring licensure for out-of-state pharmacies that deliver and dispense medications in the Commonwealth.
- Enhanced Board Transparency and Composition – The Board will be reorganized to include more members who are not practicing in the industry they are responsible for regulating. The 11-member Board will be comprised of four pharmacists, one nurse, one physician, one pharmacy technician, one quality improvement expert, and three public members. Additionally, Board members will be subject to term limits, ensuring the continuous presence of new representation. The Board will update its website to ensure transparency and enable health care consumers and providers to have access to accurate, comprehensive information about Board actions.
By implementing these strategies and also continuing the important work that we have already begun, DPH and the Board of Pharmacy will be better positioned to achieve their primary missions – to prevent illness and injury and assure access to high-quality public health and health care services, and to promote wellness and health equity for all people in the Commonwealth.
Prepared by the Executive Office for Administration and Finance ·
www.mass.gov/budget/governor
For more information email: contactanf@massmail.state.ma.us (617) 727-2040
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