West Virginia free clinics face regulation by state pharmacy board

October 13, 2008

Free clinics in West Virginia dispense more than 500,000 prescriptions a year. Earlier this year they came under regulation by the state pharmacy board. Defenders argue that the board is trying to fix something that isn't broken. The board says that patient safety requires oversight.

Key Points

The West Virginia Board of Pharmacy and the West Virginia Association of Free Clinics are hammering out a deal to regulate free-clinic pharmacies. Free clinics dispense more than 500,000 prescriptions annually but were not regulated as pharmacies until earlier this year.

Representatives of free clinics said that the board was trying to fix something that wasn't broken.

Both sides charged that the other was putting profits before patients.

Free clinic spokespeople said that the board and the West Virginia Pharmacists Association were trying to drive more patients into pharmacies by shutting down free drug programs.

Pharmacists said that the free clinics were trying to safeguard the $3 co-pay they charged the 100,000-plus West Virginians who depend on free drugs.

"With over 500,000 scripts a year, it is inconceivable that there have been no errors," said WVPhA executive director Richard Stevens.

The disagreement surfaced after Gov. Joe Machin backed a mail-order prescription program called WVRx that is modeled on the state's free-clinic drug distribution programs. Clinics dispense a combination of physician samples and drugs donated by manufacturers to patients who do not have any form of health coverage, including Medicaid or Medicare.

Some free clinics have volunteer pharmacists to handle drug utilization review and dispensing, White said. Dispensing is more often handled by volunteer physicians, physician assistants, and nurses. Drug stocks are typically kept in a closet or separate storage area.

Free clinics do not accept, store, or dispense controlled substances, she said.As the state worked out the details for WVRx, regulators realized that free-clinic pharmacy programs were essentially unregulated, Stevens said. They operated like pharmacies but were not inspected by the Board of Pharmacy. Physicians who dispensed are regulated by the state medical board, but medical examiners did not deal with drug-dispensing issues.

The state legislature passed Senate Bill 722, which created a new class of pharmacy to include free-clinic operations.

These charitable clinic pharmacies would be required to have a pharmacist in charge who was on site for at least eight hours per month to oversee pharmacy operations.

The Free Clinic Association said the new rules would increase costs and put them out of business.

"The board didn't understand the kinds of quality controls and safety controls that were already in place," said free-clinic attorney Robert Gifford. "It was a heavily regulated environment under the control of the medical unit of the state Department of Health and Human Resources."

Stevens said that DHHS oversight occurred more in theory than practice.

"There have been too many reports to the association and the board of activities that appear to be in violation of federal law in terms of repackaging and distribution," he said. "With the approval of WVRx and no effective regulatory oversight, the state was opening itself up to tremendous liability potential."

Typical problems included multiple batches of physician samples being mixed together for dispensing, expired medications being mixed with unexpired products and given to patients, tablets being taken out of punch cards and dispensed in other containers, and coated tablets being split prior to dispensing.

The two sides met sporadically over the summer. In September the board revised draft regulations to clarify its acceptance of prescriber dispensing and volunteer pharmacists.

Final rules must be approved by a legislative committee in early 2009. Both parties predict that they will work out their remaining differences.