Monday, June 18, 2018

Pharmacy in meningitis outbreak flouted rules, officials say

BOSTON — The compounding pharmacy responsible for a deadly national meningitis outbreak repeatedly failed to follow standard procedures to keep its facility clean and its products sterile, Massachusetts officials said Tuesday, painting a harrowing picture of a company that flouted crucial rules as it hurried to ship drugs around the country.

One finding in particular stands out: The pharmacy, New England Compounding Center, shipped some orders of the drug implicated in the outbreak without waiting for the final results of sterility testing. And while company records indicate that the tests found no contamination, regulators said they were skeptical of the company's methods.

Records suggest that the company failed to sterilize products for "even the minimum amount of time necessary to ensure sterility," said Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department.

The findings raise questions about whether the outbreak could have been averted, or reduced in magnitude, had proper procedures been followed.

"This was preventable," said Eric Kastango, president of Clinical IQ, a consulting firm that counsels compounding pharmacies. "They failed to properly sterilize this medicine that had to be sterilized. That's huge."

Mats used to trap dust and dirt just outside the company's clean rooms were "visibly soiled with assorted debris," according to a report released Tuesday by the state's Board of Registration in Pharmacy, and hoods in the sterile compounding area were not properly cleaned. A leaking boiler next to a clean room "created an environment susceptible to contaminant growth," Biondolillo said during a news conference at the state House.

Investigators are also looking into "the environmental conditions surrounding the business," she said, including a recycling center on the same property in Framingham, Mass., and owned by the same family. At the same time, the state and the Food and Drug Administration are investigating two related drug companies, Ameridose of Westborough and Alaunus Pharmaceutical of Framingham, which have many of the same owners.

New England Compounding has suspended operations and laid off most of its employees.

The meningitis outbreak has been tied to three lots of a steroid, methylprednisolone acetate, produced at New England Compounding that were contaminated with a fungus. In all, it shipped more than 17,000 vials of the suspect drug, which was used mainly for spinal injections aimed at easing back and neck pain.

So far, 304 people in 17 states, including Florida, have contracted meningitis, and 23 have died.

Biondolillo stressed that the root cause of the outbreak has yet to be determined

Gov. Deval Patrick, speaking at the news conference, said he had directed the state pharmacy board to "immediately start periodic, unannounced inspections of compounding pharmacies that prepare sterile and injectable medication."

Although the FDA can inspect compounding pharmacies and issue warnings, the agency says states have ultimate jurisdiction.

Patrick said the state was moving to permanently revoke the licenses of New England Compounding and its three principle pharmacists.

Comments
Forecast: Hot and humid across Tampa Bay, with potentially wet weekend

Forecast: Hot and humid across Tampa Bay, with potentially wet weekend

Summer officially doesn’t start for another three days, but that won’t stop the searing temperatures and stifling humidity from making for a hot and sticky week across Tampa Bay. Temperatures will climb well into the 90s — and feel...
Updated: 12 minutes ago
Clearwater and Tampa want to turn flushed water into drinking water. Is it safe?

Clearwater and Tampa want to turn flushed water into drinking water. Is it safe?

Twenty years ago some people called it "Twerp." Others, wrinkling their noses, called it "toilet-to-tap," or something more vulgar. In 1998, Tampa tried to boost its drinking water supply by supplementing it with treated wastewater, calling the prog...
Updated: 28 minutes ago
A sports story that we all can love

A sports story that we all can love

When we think of sports — hard-nosed, competitive sports — what words immediately come to mind? Tenacity. Grit. Guts. Perseverance. Courage. Intensity. Determination. You get the idea. Sports are usually cutthroat, give no quarter, sho...
Updated: 2 hours ago
Rays journal: Adeiny Hechavarria returns and plays short, but now what?

Rays journal: Adeiny Hechavarria returns and plays short, but now what?

NEW YORK — The Adeiny Hechavarria situation is going to be interesting for the Rays. The veteran seemed destined to be traded or even released as he completed his recovery from a hamstring strain rather than play again for the Rays after last ...
Updated: 2 hours ago
The Daystarter: Are Democrats nervous about Nelsonís chances versus Scott?; neo-Nazi leaderís video from prison causes concern;

The Daystarter: Are Democrats nervous about Nelsonís chances versus Scott?; neo-Nazi leaderís video from prison causes concern; "toilet-to-tap" makes comeback; plus St. Pete Pride this weekend

Catching you up on overnight happenings, and what to know today.ē Itíll be partly cloudy with scattered showers and thunderstorms during the afternoon, with highs in the upper 80s to lower 90s, according to the National Weather Serviceē Keep these l...
Updated: 2 hours ago
A St. Pete church opposes its own land deal. Will council go along?

A St. Pete church opposes its own land deal. Will council go along?

ST. PETERSBURG ó The Rev. Manuel Sykes wouldnít say last week whether he wanted City Council to reject a rezoning proposal that would let a developer build a drive-thru restaurant on his churchís land.He wouldnít mind, though, if a little divine inte...
Updated: 2 hours ago
At 61, he made his professional wrestling debut to help son cope with motherís death

At 61, he made his professional wrestling debut to help son cope with motherís death

A 16-foot wrestling ring and 150 rental chairs were set up on the basketball court of the Police Athletic League of St. Petersburg. Concessions were prepared in slow cookers.It was as far from the limelight as it was in distance from Madison Square G...
Updated: 2 hours ago
Rays leave New York with a smile after beating Yankees 3-1

Rays leave New York with a smile after beating Yankees 3-1

NEW YORK – You had seen this game before. So had the radio guys, the coaches, the manager, the players and, certainly, the bosses. The Rays grab an early lead over the Yankees. They look like they are headed to a rare win in the Bronx. And th...
Updated: 2 hours ago
Tampa police seek driver who struck pedestrian and fled scene

Tampa police seek driver who struck pedestrian and fled scene

TAMPA ó Police are seeking the publicís help in locating the driver who fatally struck a pedestrian before fleeing the scene on Sunday night.Police say the driver struck an unidentified woman near the intersection of N Nebraska Avenue and E Linebaugh...
Updated: 2 hours ago
Colombia's president-elect seeks unity after polarizing vote

Colombia's president-elect seeks unity after polarizing vote

Colombia's President-elect Ivan Duque is appealing for unity after winning a runoff election over a leftist firebrand whose ascent shook the country's political establishment and laid bare deep divisions over the nation's peace process
Updated: 9 hours ago