* Drug used as painkiller in back injections
* Compounding pharmacies primarily regulated by states
* Company has suspended operations
(Updates with more details) By Tim Ghianni
NASHVILLE, Tenn., Oct 8 (Reuters) - U.S. health authoritiesscrambled on Monday to identify more cases of a rare form ofmeningitis, including enlisting local police to find people whomight be infected by tainted steroid injections that have so farkilled eight people.
The U.S. Centers for Disease Control reported 105 cases innine states on Monday, up from 91 cases on Sunday. The deathtoll rose by one overnight.
The widening outbreak has alarmed federal and state healthofficials and focused attention on regulation of pharmaceuticalcompounding companies like the one that produced the drugs, theNew England Compounding Center Inc in Framingham, Massachusetts.
The CDC believes that about 13,000 patients may have beenexposed to the three lots of the steroid methylprednisoloneacetate recalled from the NECC, said Curtis Allen, a spokesmanfor the CDC, in an e-mail.
In Ohio, health officials said Monday they are mobilizingcommunity resources, including sheriff's offices, to check onpatients who have received the injections.
"If that means knocking on doors, then that's what they willdo," said Beth Bickford, executive director at the Associationof Ohio Health Commissioners, in a statement Monday. The statehas so far reported one case of fungal meningitis likely causedby a tainted epidural steroid injection.
The company shipped 17,676 vials of the steroidmethylprednisolone acetate to 76 facilities in 23 states fromJuly through September, the Massachusetts Health Departmentsaid.
The steroid is used as a painkiller, usually for the back,and could have been injected in thousands of patients,authorities have said.
Meningitis is an infection of the membranes covering thebrain and spinal cord, and affected patients started showing avariety of symptoms from one to four weeks after theirinjections.
The company, which was previously the subject of complaints,has suspended its operations while an investigation proceeds andearlier recalled the three lots of the drug. It expanded itsrecall on Saturday to all products compounded and distributed atits Framingham facility.
A compounding pharmacy takes medications from pharmaceuticalmanufacturers and makes them into specific dosages and strengthsfor use by doctors.
Complaints against the company in 2002 and 2003 about theprocessing of medication resulted in an agreement withgovernment agencies in 2006 to correct deficiencies, theMassachusetts Health Department said.
LIMITED FDA AUTHORITY
In 2011, there was another inspection of the facility and nodeficiencies were found. In March 2012, another complaint wasmade about the potency of a product used in eye surgeryprocedures. That investigation is continuing, the state healthdepartment said.
The U.S. Food and Drug administration has limited authorityover the day-to-day operations of compounding pharmacies, whichare regulated primarily by state boards that oversee thepractices, licensing and certification of pharmacies andpharmacists.
Compounded products do not have to win FDA approval beforethey are sold, and the agency has no jurisdiction over how theproducts are manufactured or labeled for use. Instead, the FDAinvestigates cases of adulterated drugs in cooperation withstate regulators.
The FDA has tried to exert greater authority over compoundeddrug products under a section of the Food, Drug and Cosmetic Actthat covers new drugs. But those efforts led to federal courtchallenges that resulted in two separate and conflicting rulingsat the appellate level.
The nine states where fungal meningitis cases have beenreported are Florida, Indiana, Maryland, Michigan, Minnesota,North Carolina, Ohio, Tennessee and Virginia.
Tennessee, where the outbreak was first detected, accountedfor most of the cases, with 35, including four deaths. Manypatients there remain hospitalized, some in critical condition.
Michigan had 21 cases and two deaths. One person died inMaryland and another in Virginia, the CDC said.
Fungal meningitis is not contagious, the CDC said. Symptomsinclude fever, headache, nausea and neurological problems thatwould be consistent with deep brain stroke.
The steroid was sent to California, Connecticut, Florida,Georgia, Idaho, Illinois, Indiana, Maryland, Michigan,Minnesota, North Carolina, New Hampshire, New Jersey, Nevada,New York, Ohio, Pennsylvania, Rhode Island, South Carolina,Tennessee, Texas, Virginia and West Virginia, the CDC said.
A list of facilities that received vials from the infectedlots can be found via the website
(Reporting By Tim Ghianni; Writing by Mary Wisniewski; Editingby Greg McCune and Cynthia Osterman)
Keywords: USA HEALTH/MENINGITIS