Gov. may seek changes in Mass. pharmacy board

November 28, 2012, 11:24 am

BOSTON (AP) — Gov. Deval Patrick says the state board that oversees pharmacies is too heavily dominated by people who are pharmacists themselves and he might seek a change in the panel's makeup.
The state Board of Pharmacy has come under scrutiny in the aftermath of a national fungal meningitis outbreak that has claimed 36 lives and sickened hundreds of others. The outbreak has been linked to a steroid produced by Framingham-based New England Compounding Center, which is regulated by the board.
Patrick said Wednesday he has become concerned that 10-member board is largely made up of pharmacists and he'd like to see a "different blend of talent."
He told the "Ask the Governor" program on WTKK-FM that he expected to file legislation when state lawmakers return to Beacon Hill in January.

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The benefits and risks of compounding pharmacies

• Infectious Disease News, November 2012
  Edward A. Bell, PharmD, BCPS

As of the end of October, 28 deaths resulting from the use of poorly prepared compounded medications by a Massachusetts-based compounding pharmacy have been reported. These deaths have focused increased attention on the role and safety of compounded specialized medicines and dosage forms in the United States.

Pharmaceutical compounding is defined as the combining or mixing of pharmaceutical ingredients to create a customized medication product for a specific patient by a prescriber’s order or prescription. Inherent in this definition is the notion that the final product is not tested for safety and efficacy by data that the FDA normally uses to assess a product. Because pharmacy school curriculums include training in the science and art of compounding, pharmacists are generally well trained in how to compound many medicines. More advanced training is also available for post-graduate pharmacists and pharmacy technicians, by organizations such as the Professional Compounding Centers of America. Although most independently owned and chain pharmacies (eg, Walgreens) do not prepare many compounded products, specialized compounding pharmacies are available that do prepare many compounded products.

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Florida's Mandatory Pharmacy Compounding Survey, FAQ, and Emergency Rule

Mandatory Pharmacy Compounding Survey
FAQs for Pharmacy Compounding Survey - (pdf- 36kb)
Emergency Rule 64B16ER12-1
With the recent nationwide fungal meningitis outbreak caused by contaminated compounded products, the Florida Board of Pharmacy adopted Emergency Rule 64B16ER12-1, Florida Administrative Code This Emergency Rule requires all Florida licensed pharmacy permit holders, including non-residents, to complete a mandatory survey to inform the Board of its compounding activities. The goal of this mandatory survey is to determine the scope of sterile and non-sterile compounding within Florida licensed pharmacies --whether physically located in or out-of-state.

Failure to timely complete the mandatory survey is grounds for disciplinary action; however the goal is not to discipline, only to obtain critical data. Your cooperation in this matter is important to the department’s public protection mission.

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Maryland: Headline mischaracterized Board of Pharmacy's stance

November 26, 2012

On behalf of the Maryland Board of Pharmacy, we are writing to commend Sun reporter Andrea Walker for a fair and honest reflection of information discussed during her interview with board executive director LaVerne Naesea and board commissioner David Chason about the board's monitoring of sterile compounding pharmacies and addressing potential gaps in oversight. The article's on-line headline, "Maryland pharmacy of board says it can adequately monitor compounding pharmacies — Board beefed up standards in recent years" (Nov. 18), accurately indicated the thrust of the interview.

However, as sometimes happens when a story isn't quite spicy enough, an editor may decide to change the headline to increase sales or perhaps raise controversy. The board suspects something like this may have occurred when the referenced article was published on the front page of The Sun's print edition on Monday, Nov. 19, under the headline, "Maryland board resists U.S. role in regulation of pharmacies."

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American Society of Health-System Pharmacists-Pharmacy Group to Address Compounding Disaster

By Nancy Walsh, Staff Writer, MedPage Today

Published: November 30, 2012

LAS VEGAS -- Interest is expected to be high at next week's meeting of the American Society of Health-System Pharmacists, where a late-breaking session will address the ongoing meningitis outbreak caused by contaminated products from the New England Compounding Center, highlighting the role of health-system pharmacists in preventing such events in the future.
The session, entitled "A Compounding Tragedy -- A National Response," will feature a speaker from the FDA, a representative of ASHP, and a member of the National Association of Boards of Pharmacy.
"We plan to present the advocacy efforts we have undertaken so far and highlight what still needs to be done," said JoAnn Harris, RPh, who directs the ASHP's educational services division.
Among the measures the society has put in place is the creation of a members' checklist for sterile compounding services, with instructions for reviewing all existing contracts with compounding facilities and assessment of adherence to quality control policies and state and federal requirements for licensure.
The ASHP checklist also calls for members to "work with organizational executives and other departments within the health system to ensure that the pharmacy department is involved in all decisions through the health system in regard to procurement and use of drug products obtained from external compounding facilities."
Another highly anticipated event at the meeting will be a keynote address given by former President Bill Clinton.
In "Embracing our Common Humanity," Clinton will describe the growing challenges of globalization and interdependence, and outline his vision for "a common future based on shared goals and values."
The meeting "will have something for everyone -- students, pharmacy managers, clinical specialists, and front-line pharmacists, and will have all-time record attendance," Harris said.
"ASHP is no longer simply a hospital pharmacy group. We represent all types of ambulatory care pharmacists, including those who work in clinics, accountable care organizations, and long-term care facilities such as nursing homes," she told MedPage Today.
Other important topics that will be featured at the meeting include the role of the pharmacist in reducing hospital readmissions and optimizing medication safety.
Sessions also will be devoted to general pharmacy-related topics such as stroke prevention in patients with atrial fibrillation, the emergence of resistance to gram-negative infections, and the use of neutraceuticals for pain management.
The meeting begins on Monday morning and continues through Thursday.