State Board Stepping Up Pharmacy Inspections

In the long wake of a deadly meningitis outbreak from tainted drugs distributed by a compounding pharmacy in Massachusetts, state regulators have been increasing their inspections of pharmacies with complaints.

The Massachusetts Board of Registration in Pharmacy recently released its 2014 annual report on investigations and disciplinary actions against retail chain, independent community, and compounding pharmacies. In it, regulators reported a “noticeable field presence” with an increase in investigative staff and greater interest in keeping tabs on sterile compounding pharmacies.

Massachusetts Department of Health and Human Services spokesman Scott Zoback told Pharmacy Times that the state’s objective was create to a strong presence in the pharmacy community and incorporate new staff.

“While still focusing on sterile compounding, board staff also focused on outreach and education in non-sterile compounding and retail pharmacy practice,” he said.

According to the report, the board closed more cases in 2014 than the previous year. In 2013, it closed 151 cases, whereas 2014 saw 284 case closures.

Of the complaints investigated in 2014, 74 resulted in disciplinary action, 78 resulted in non-discipline, 120 were dismissed, and 12 were opened in error. This contrasts with the 51 discipline cases, 26 non-discipline cases, 69 dismissals, and 5 cases that were opened in error in 2013.

The most common complaint dockets involved a failure to fill prescriptions properly (162 in 2013 and 229 in 2014). Drug violations and serious reportable events were the next most common complaints investigated in 2014.

The board said its investigators spent the majority of their time in 2013 inspecting and following up with sterile compounding facilities, which led to staffing limitations. The board corrected this problem in obtaining contract investigators later that year.

On behalf of the board, pharmacy inspectors from the Office of Public Protection conducted 1032 inspections in 2014, according to Zoback.

Zoback told Pharmacy Times that those 1032 inspections were broken into the following categories:

• 937 retail compliance inspections (149 independent pharmacies, 788 chain pharmacies)
• 53 sterile compounding inspections (including 8 site visits, which are not full compliance inspections)
• 35 non-sterile compounding inspections (8 chain pharmacies, 27 independent pharmacies)
• 7 wholesale distributor inspections

The number of retail inspections in 2014 nearly doubled from 2013, as well. Staff members maintained that this underlined the board’s interest in maintaining quality assurance systems and reducing medication errors.

Following the fungal meningitis outbreak that stemmed from the New England Compounding Center (NECC) in 2012, the board made several changes such as setting priorities for complaint investigations, updating guidelines for handling evidence, establishing a sterile compounding pharmacy inspection log, and instituting a weekly critical incident report. It also developed new policies for managing communication of abnormal test results and handling reports for theft or loss of controlled substances.

In April 2015, Massachusetts regulators inspected most compounding pharmacies about once a year, though several had not been inspected in more than 12 months, The Boston Herald reported. The paper noted that many had called for “random spot checks” into compounding pharmacies following the NECC incident.

Responding to the Herald report, Zoback pointed to highlights in the board’s report, namely its improved processing time of complaints and investigations and increased closures of complaints and investigations with more board meetings and Delegated Complaint Review sessions. He also underlined the discussions within the report about the different complaint types and how ongoing inspections, increased oversight of reporting, and changes in internal policies and procedures affected the handling of those complaints.