Pennsylvania has no authority to halt tainted steroid shots from Massachusetts

License not required here for out-of-state drug manufacturers

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If a Massachusetts pharmacy had not halted its shipment of steroid shots that have killed five people, Pennsylvania could not have stopped the distribution.

Pennsylvania, Georgia and Massachusetts are the only states that don't require out-of-state drug manufacturers to be licensed before they ship drugs within their borders.

The realization became apparent as the U.S. Centers for Disease Control and Prevention, the Food and Drug Administration, the Allegheny County Health Department and state Department of Health investigated recalled lots of the tainted pain medication -- methylprednisolone acetate -- a steroid that went to 75 facilities in 23 states, including Allegheny Pain Management in Altoona and South Hills Pain & Rehab Associates, which has facilities in Jefferson Hills, Bethel Park, Monessen and Brentwood.

The CDC said Friday that the outbreak of the rare fungal meningitis linked to the steroid shots now involves seven states. So far, no cases of illness related to the drug -- 47 sickened in addition to the five deaths -- have been identified in Pennsylvania.

"The results are real simple: The Pennsylvania Board of Pharmacy that protects citizens of the state does not have any regulatory authority of pharmacies that ship medicines into Pennsylvania," said David Miller, who is based in Philadelphia and heads the International Academy of Compounding Pharmacists.

"A guy in Pittsburgh who sells [prescription] drugs across the line in Ohio must be licensed in Ohio, but the guy in Ohio doesn't have to be licensed in Pennsylvania to sell drugs here," Mr. Miller said. "It's important in Pennsylvania that stuff is coming in from out of state and you would expect states to regulate those pharmacies."

The state Board of Pharmacy in the Department of State referred questions about drug-manufacturer licensing to the Health Department, which reported that the state Drug Device and Cosmetic Act requires that only out-of-state businesses with sales representatives within the state register with the health department if they distribute drugs or medical devices throughout the commonwealth. Those companies with no sales reps in the state can register voluntarily.

But out-of-state companies are required to be registered or licensed in the state in which they are located if they want to distribute prescription drugs here.

On Wednesday, the New England Compounding Center near Boston ceased production and initiated recall of all drug products prepared for injections in and around the spinal cord. In addition, the CDC and state health departments have released the names of facilities in the 23 states that received the contaminated product.

The 47 infections and five deaths identified to date were associated with a rare form of fungal meningitis (brain infection) and stroke. Of the total number of cases, 29 -- including three deaths -- occurred in Tennessee.

The infections have been linked to two fungi, aspergillus and exserohilum, which are not usually harmful to healthy people. However, the fungi are suspected of causing meningitis after being injected into the spinal column of some patients getting pain treatment, The Associated Press reported. That provides a rapid way for the fungus to cause a serious infection, particularly serious for people on chemotherapy or those with suppressed immune systems. The infection does not spread person to person.

"All patients who may have received these medications need to be tracked down immediately," Benjamin Park, medical officer of CDC's Mycotic Disease Branch, stated Friday. "It is possible that if patients with infection are identified soon and put on appropriate antifungal therapy, lives may be saved."

The Allegheny County Health Department is working with state and federal investigators to identify and contact patients who received the drug through the South Hills facility.

Ron Voorhees, acting director of the county Health Department, said three lots of the drug have been recalled, with two of those lots containing traces of fungus. The third recalled lot was used at the South Hills facility, but to date no one is known to have been infected from doses from that lot.

Of the 56,000 pharmacies in the United States, 7,500 are compounding pharmacies that actually produce tailored drugs for specific medical cases. They can include patients who are allergic to inactive ingredients such as fillers, who cannot swallow pills and must have the medicine in liquid form, or who require drug potencies different from mass-produced doses.

About 3 percent of all prescribed drugs come from compounding pharmacies. Western Pennsylvania has 19 compounding pharmacies that are licensed and regulated, as are all pharmacies. Large pharmacies also do some compounding work, Mr. Miller said.

The New England Compounding Center was manufacturing drugs in bulk and selling them without any prior prescriptions. About 17,000 injectables of the drug in question were manufactured and distributed.

"Everyone is upset that this one pharmacy has done something that's clearly outside the tradition of compounding pharmacies, unfortunately putting unnecessary scrutiny and criticism on the profession that is doing the right thing by working with physicians, filling prescriptions and taking care of patients," Mr. Miller said.

The Massachusetts pharmacy may have been operating legally, he said, but it does not hold accreditation from the Pharmacy Compounding Accreditation Board. Accreditation is particularly important, he said, when a compounding pharmacy is producing sterile medications that are injectable, or are inhaled or used as eye drops. The pain medication drug that the Massachusetts pharmacy produced is not the epidural medication that mothers receive when giving birth.

"Why go to Boston when the product is available commercially from a drug manufacturer?" Mr. Miller said. "Why would a clinic or doctor's office purchase drugs from a pharmacy that does not have accreditation when that drug is available in your neighborhood pharmacy?"

health

David Templeton: dtempleton@post-gazette.com or 412-263-1578. The Associated Press contributed. First Published October 6, 2012 12:00 AM


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