Boston Herald

State boosts pharmacy checks, uncovers more reg violations

- By ERIN SMITH — erin.smith@bostonhera­ld.com

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.

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