Thursday, May 30, 2013

Louisiana Proposed Rule Changes: Some pharmacists concerned about proposed rule changes By Bill Lodge Advocate staff writer

Proposed changes in regulations could push some pharmacists out of the specialty medicine business in Louisiana, according to a Baton Rouge pharmacist with 37 years of experience.
Patricea Angelle, a compounding pharmacist in Baton Rouge, said the rule changes would impose an enormous cost burden on some compounding pharmacies and create serious problems for patients who depend on the medicines they provide.
Compounding pharmacies prepare medicines prescribed for patients with allergies or other negative reactions to some medications they need in order to recover from illness or injury.
Some of those special medicines may be needed by patients for whom other medications simply don’t work. Compounding pharmacists also prepare medicines that some physicians want to keep stocked at their offices.
Malcolm J. Broussard, executive director of the Louisiana Board of Pharmacy, said he hasn’t “heard from any pharmacies telling us the proposed rule would force them to close.”
If so, others will fill those gaps, Broussard said.
A public hearing on the pharmacy board’s proposals is scheduled for 1 p.m. Thursday at the board office, 3388 Brentwood Drive.
The proposed rule changes in Louisiana follow an incident late last year in which dozens of recipients of medicines from a compounding pharmacy in Massachusetts contracted fungal meningitis and died.
The Louisiana Board of Pharmacy declared an emergency in January, and members announced they planned to adopt a rule that would bar the state’s compounding pharmacists from deriving more than 10 percent of their business from the sale of medicines by purchase order to physicians for use at their offices.
“The quality and safety standards for products made pursuant to a purchase order are ordinarily more stringent than the quality and safety standards for preparations made pursuant to a patient-specific prescription,” Broussard, said in an email exchange this week.
“When pharmacies make products pursuant to purchase orders in compliance with the less stringent standards applicable to patient-specific prescriptions, there is a potential risk,” Broussard added. “The proposed rule is an attempt to mitigate that risk by limiting such activity to no more than 10 percent of a pharmacy’s activity.”
In Washington, D.C., Sarah Dodge, the International Association of Compounding Pharmacists’ vice president for government affairs, said such rules seem arbitrary.“That concerns us,” Dodge added.
Dodge explained that one proposed federal law calls for greater controls on compounding pharmacies that send sterile compounds across state lines to recipients who are not patients.
Inside one state’s boundaries, Dodge said, “What we prefer is that the state allow what has been usual for (physicians’) office use.” She said her organization does not support an arbitrary cap.
“The federal proposal is far more palatable than the Louisiana proposal,” Dodge said.
Broussard said, “In the event a pharmacy is currently preparing more than 10 percent of itsactivity pursuant to (physicians’) purchase orders, that pharmacy will need to make a business decision.”
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