The state agency that oversees compounding pharmacies is still in disarray two years after a deadly meningitis outbreak, failing to inspect facilities, allowing dirty labs to stay open and rarely publicizing recalls of possibly tainted meds, a Herald review found.
Department of Public Health officials blamed the 2012 fungal meningitis outbreak on lax oversight of the now-shuttered New England Compounding Center (NECC), which produced contaminated steroid injections that killed 64 and sickened 751 in 20 states. Compounding pharmacies fill prescription orders for specially mixed medications.
State Rep. Jeffrey Sanchez (D-Jamaica Plain), then chairman of the Joint Committee on Public Health, called for spot checks on compounding pharmacies in the aftermath of the meningitis scare.
But the Herald review found no record that five sterile compounders had been inspected in more than 12 months. In fact, the majority of the 28 sterile compounding facilities currently licensed in the state have been inspected only about once a year since the outbreak, the review found.
State health officials also did little to publicize seven recalls of medications over safety concerns issued by compounding pharmacies since February 2013.
For instance, Johnson Compounding and Wellness in Waltham contacted the Board of Registration in Pharmacy last month to initiate a recall for an antiviral, topical medication over fears that an ingredient had been contaminated by the manufacturing supplier, company spokesman David Ball said.
However, the state never alerted the public and neither did the company, Ball said. “They reached every person who received the medication so there was no need to advertise,” he said, adding that no adverse effects were reported.
State inspectors also flagged deficiencies in sanitation and procedures at more than one-third of the compounding pharmacies inspected in the past two years, according to state inspection reports.
Two companies were cited for bacteria and mold contamination risks. The bacteria and mold found during inspections are naturally occurring on human skin and in the air.
“But you don’t want mold where you’re mixing intravenous medications,” said Allen Vaida, executive director of the Institute for Safe Medication Practices.
“From the consumer standpoint, if you put it in your bloodstream, you could get an infection,” Vaida added. “That was the problem with NECC — it was fungal and introduced into the spinal cord and that was the problem.”
The FDA and DPH opened a joint review into the Woburn offices of Central Admixture Pharmacy Services, (CAPS) a national company, in 2013 and 2014, but there are no records that the company, which is still operating, has been inspected in more than a year.
CAPS Woburn was cited for mixing cardioplegic solution — used in heart bypass surgery — with the wrong base, DPH records show. The company also was cited for simultaneously mixing a dialysis solution and an intravenous food replacement drug too close to a penicillin medication, which can cause serious allergic reactions in some patients, FDA and DPH records show.
“The bottom line of the whole thing is once again, they’re not following proper procedures,” Vaida said. “Cardioplegic solution — that’s a very serious solution to compound, obviously. There’s been cases where the wrong cardioplegic solution was fatal and they only found out later that the solution was wrong. It can be very dangerous.”
DPH officials said pharmacy board staff worked in collaboration with CAPS Woburn “to resolve all outstanding issues.” CAPS officials did not respond to requests for comment.
DPH also has issued 14 cease and desist orders to pharmacies over safety concerns since 2012, but many were given probation and remained open, while others voluntarily withdrew from the business.
DPH spokesman Scott Zoback said, “DPH will continue to take a close look at compounding pharmacies to make needed reforms going forward.”
Newly elected MASS Attorney General pledged to go after drug abuse… while apparently the Board of Pharmacy.. it has been business as usual in regards to the oversight of compounding pharmacies
