7/15/2014

Massachusetts Society of Health-System Pharmacists

Westford, MA

Best Practice: Crisis Management

In 2012 a sterile compounding tragedy led to an outbreak of fungal meningitis, resulting in more than 60 deaths. The contamination was caused by a tainted corticosteroid injection prepared by the New England Compounding Center (NECC) in Massachusetts. The incident also affected hundreds of other patients and led to product recalls and plant closures. As you can imagine, this rapidly became both a national public health and drug shortage crisis, with potential high economic and human impact. Media attention surrounding this event demanded pharmacists’ immediate attention.

In response to the incident, Massachusetts Governor Deval Patrick appointed the Governor’s Special Commission on Compounding, which was charged with developing recommendations for preventing similar occurrences over a two-month timeline. MSHP was the only professional organization represented. The commission made 25 recommendations to improve pharmacy oversight in general and sterile compounding, specifically.

In February of 2013 the Pharmacy Sterile Compounding Summit took place in Washington, D.C. This event, sponsored and supported by Pew Charitable Trusts, ASHP and AHA, included discussions on scope and risk factors of current sterile compounding, sterile production quality standards, and oversight by federal and state agencies.

Key recommendations include directing the Massachusetts Board of Registration in Pharmacy (BORP) to actively and continuously monitor the practice of compounding to minimize patient risk and allow for a quick response to problems that may arise. It also recommended granting the BORP authority for oversight of free-standing pharmacies, hospital-based pharmacies, and physician offices, and the authority to establish content-specific expert advisory groups to address specialized areas of pharmacy practice.

Primary Intended Outcome(s)

Immediate changes in BOP composition, inspector experience and training, and process transparency
Evidence-based standardized assessment process tools (e.g. “cGMP) with an approved scoring format, specific to the setting
Clear definitions and jurisdictional delineations between and among oversight bodies with an emphasis on “compounding”, large vs. small scale and tradition vs. non-traditional
Restructured licensing fees and differentiated license types could create new funding options

Key Elements for Success

MSHP collaborated with primary regulatory agencies and associations in an attempt to manage the crises which includes:

Board of Registration in Pharmacy: attestations and emergency regulations and drafted testimony
Massachusetts Hospital Association: conference calls, testimonials and email campaign
Massachusetts Medical Society: special meetings on drug shortages
DPH collaboration: temporary central compounding waiver for “IDS” pharmacy

Outcomes/What Will Change?

Since the initial NECC crisis, there has been a great deal of activity on both the state and federal levels and MSHP has been involved every step of the way. Three bills were filed in Massachusetts during the 2013-2014 legislative session, which among other things, could impact CE requirements, licensure, compliance and BoP composition and authority.

On the federal side several bills were filed in the House and Senate. Congress recently passed HR 3204, The Drug Quality and Security Act. The bill, signed on November 27, 2011, allows compounding facilities to register with the FDA. Those registered facilities must adhere to specific guidelines set forth by the regulatory agency.

MSHP continues its involvement and has taken an active role in ensuring that its members are well-informed and engaged.

Suggestions for Other State Affiliates

It’s difficult to prepare for any crisis but as an organization there are several things you can do before any crisis occurs:

Create a crisis management plan that incorporates an organizational strategy. This can include a media relations plan, member communications and any grassroots advocacy that may be involved.

Prior to the onset of any crisis, make sure that members have established relationships with local, state and federal policymakers. Having a key Director of Pharmacy contact list was critical to MSHP for pushing out information and organizing calls on short notice as events unfolded on a daily basis.
Develop a clear and concise message regarding key issues and do not deviate from key message points. MSHP communicated with members what they should and should not say and provided suggestions on how to approach various interview approaches. The society also made the conscious decision not to take a finger-pointing approach but instead chose to take a solution’s-based approach to this crisis.
Build coalitions with other organizations. This expands the reach and scope of your messaging.
Make yourself available to members, lawmakers and the media. This will give your organization the opportunity to get your key messages across.