Study: Best standards for compounding drugs not adopted by Pa. and N.J.

Pennsylvania is one of 22 states that has not adopted "best practice" quality standards for compounding sterile drugs, a study has found.

New Jersey has adopted some of the standards "but not in their entirety," according to Pew Charitable Trusts, which performed the study, commissioned after a deadly 2012 outbreak traced to a Massachusetts compounding facility.

After tainted steroid injections from the New England Compounding Center caused a fungal meningitis outbreak that killed 64 people and sickened more than 750, state and federal officials reexamined laws and regulations governing drug compounding - the traditional pharmacy practice of creating custom medicines to meet individual needs of a patient.

While the Food and Drug Administration regulates pharmaceutical manufacturing, states primarily regulate pharmacies and pharmacy compounding - the combining, mixing, or altering of a drug's ingredients tailored to a specific patient.

Following the meningitis outbreak, Pew began to look at state trends and policies on compounding human drugs, and found significant variation in states' oversight.

More than half the states, including Pennsylvania and New Jersey, inspect pharmacies that perform sterile compounding at least every year, and New Jersey monitors all in-state sterile compounding. Pennsylvania does not, Pew said.

Pennsylvania and New Jersey are among 28 states that allow traditional pharmacies to compound without a patient-specific prescription, which may conflict with new federal law, the study said.

The Pennsylvania State Board of Pharmacy adopted draft regulations in July to conform compounding to U.S. Pharmacopeial (USP) quality standards. The rules are currently under regulatory review, a spokeswoman said.

The New Jersey State Board of Pharmacy said its pharmacies doing sterile compounding must have "prior approval" and "pass a rigorous inspection." The board said it is revising its regulations to ensure that pharmacies comply with the 2013 law. "In some instances, state regulations call for more stringent standards than set by the USP."

Pennsylvania has 3,736 pharmacies, including 1,759 that do compounding work. New Jersey has 2,167 pharmacies, and 1,236 do compounding.

"Our report offers a snapshot of where states are today," said Elizabeth Jungman, Pew director of public health programs. The next step is for states to set up mechanisms to track compounding activities, ensure compliance, and hold out-of-state compounding pharmacies that ship in-state to high standards to prevent contamination or substandard products.

"There is certainly a need for compounding - if a patient is allergic to an ingredient, or needs a liquid, and the pharmacist makes a liquid out of a tablet," said Michael R. Cohen, president of the Institute for Safe Medication Practices in Horsham.

"On the other hand, there are people who abuse it - compounding things that are not available on the U.S. market and that have never been tested. It's a very loosely regulated industry, even to this day," Cohen said.

One form of compounding that has raised patient safety concerns is custom-mixing medications in bulk and supplying them directly to hospitals and doctors who dispense to patients.

"Because these medications are often made at large scale, any error would affect more doses," Jungman said. "Also, there may be more time between when the product is compounded and when it is used, giving a chance for a fungal contamination to grow."

That's what happened in 2012 when the New England Compounding Center distributed three lots of tainted injections to dozens of health-care centers from New York to Florida and west to California.

Two Pennsylvania health-care facilities, in Altoona and Jefferson Hills, received contaminated injections, as did seven medical centers in New Jersey, including two in Vineland. One meningitis case showed up in Pennsylvania, and 51 cases including joint and spinal infections were reported in New Jersey, according to the Centers for Disease Control and Prevention. No one died in those two states.

In response to that outbreak, a new federal law in 2013 required compounders preparing drugs without a prescription to register with FDA as "outsourcing facilities" and meet the FDA's Good Manufacturing Practices that govern drug manufacturers.

Pew identified more than 25 reported compounding incidents associated with 1,076 cases of "adverse events" or patient harm, including 90 deaths, since 2001 nationwide. Contamination of sterile products was the most common error, but some were the result of pharmacists' and technicians' miscalculations and mistakes in filling prescriptions.

lloyd@phillynews.com

215-854-2831 @LoydLinda