State boosts pharmacy checks, uncovers more reg violations
State regulators stepped up pharmacy inspections and found more violations in the year that followed a nationwide meningitis outbreak stemming from tainted drugs, according to a new state report.
Regulators have inspected more than 900 pharmacies since February 2014, according to the recent report by the Board of Registration in Pharmacy.
But a large portion of the inspections were done at retail chain and independent community pharmacies, not compounding pharmacies like the one responsible for the outbreak, according to the report which details complaints, investigations and disciplinary actions taken by the board between Dec. 1, 2013, to Dec. 1, 2014.
The pharmacy regulators reported:
• Inspectors doubled the number of retail pharmacy checks last year, which officials reported was due in part to contracting of additional investigators in late 2013.
• The number of pharmacy investigations pending, closed or done in conjunction with outside agencies jumped from 482 in 2013 to 616 last year.
• Cases resulting in disciplinary action increased by 45 percent — rising from 51 to 74 cases over the oneyear period.
Complaints that were investigated included:
• Failure to fill prescriptions properly.
• Drug violations such as improper use or distribution by pharmacists.
• Confidentiality violations.
• Failure to report drug reactions or improper dosages.
The report, posted on the agency’s website last month and filed with the House Clerk last week, highlighted changes the state pharmacy board made in the wake of the 2012 meningitis outbreak, including updated guidelines for investigations and handling evidence and a new weekly critical incident report.
A Herald review in April found the state was inspecting most compounding pharmacies only about once a year and several hadn’t been inspected in more than 12 months — despite calls for more random spot checks after the meningitis scare.
The Herald also found DPH regulations don’t require all compounders to use the most rigorous tests for contamination risks of bacteria and fungus.
Fungal-tainted steroid injections mixed at the now-closed New England Compounding Center in Framingham were responsible for a meningitis outbreak that killed 64 and sickened 751 nationwide.
In Massachusetts, only “high-risk” compounders mixing non-sterile ingredients are required to conduct the maximum level of testing, despite the fact that the majority of compounding pharmacies in the state are classified as low- or medium-risk facilities.
An agency spokesman had no immediate comment on the report or whether the board is considering tightening regulations or increasing inspections of compounders.