Inside This Issue - News
Questions on compounding arise in wake of outbreak
November 5th, 2012
BOSTON – As the investigation continues into the Massachusetts compounding center identified as responsible for the meningitis outbreak that, at presstime, left at least two dozen individuals dead, defenders of the longtime practice are attempting to convince the public that compounding has a history of being safe if properly conducted.
Gov. Deval Patrick said he’s requiring the state’s 25 compounding pharmacies to undergo unannounced inspections at least once a year. A state health department spokesman said the first such inspection was conducted in late October, but he refused to reveal the name of the facility and said results of the inspection were being reviewed.
As part of its investigation of the multistate outbreak, the Centers for Disease Control and Prevention (CDC) said it is assessing and revising guidance to clinicians involved in the management of patients who received injections with contaminated steroid products distributed by the New England Compounding Center (NECC). CDC analysis suggests the period of greatest risk for development of fungal meningitis among patients who received epidural or paraspinal injections with contaminated products is during the first six weeks after injection and that additional monitoring of such patients should be considered.
The compounding pharmacy blamed for the outbreak repeatedly failed to follow standard procedures to keep its facility clean and its products sterile, according to the state’s initial investigation. Reports reveal that the NECC shipped some orders of the drug implicated in the outbreak without waiting for final results of sterility testing. Although company records indicate the tests found no contamination, regulators have expressed skepticism of NECC’s methods.
Meanwhile, the International Academy of Compounding Pharmacists (IACP), which says it represents 2,700 compounding pharmacists, technicians and student pharmacists, issued a statement in which it said the “situation causes the academy and its entire membership great concern and empathy on behalf of all of the individuals involved.”
But as the investigation continues by the CDC, the Food and Drug Administration and boards of pharmacy in the six states in which cases of fungal meningitis have occurred, IACP stressed the need to clarify what it calls the role and nature of compounding pharmacy.
“Compounding is a traditional part of pharmacy practice. It involves the preparation of medications on prescription by physicians and other authorized prescribers who meet unique patient health care needs that cannot be met with commercially manufactured and marketed drug products. This might include providing different strengths, preparing a drug with different non-active excipients for which a patient may have an allergy, or creating dosage forms which are more palatable for a patient,” says the statement.
“Given the nature of the ongoing investigation, the first priority must be the identification and prompt treatment of any additional patients who may be at risk from medications compounded by the NECC. The academy will work with regulatory authorities to assist in determining whether or not the pharmacy in question failed to meet legal and professional standards of practice.”
Published reports indicate that in 2004 state regulators proposed a formal reprimand for the NECC but never delivered the legal document after the company protested that such action could be “fatal to the business.” The sanction by the Board of Registration in Pharmacy was included in a proposed consent agreement intended to resolve complaints against the NECC, based in nearby Framingham. The complaints included a failure to meet accepted standards for making the same steroid that has now been connected to the outbreak.
The agreement was among documents released by the state department of health that provide additional details about past incidents at NECC, which has now been shuttered.