Mix That Medicine, But Do No Harm

A mortar and pestle were once standard equipment for the neighborhood druggist. A pharmacist would prepare a prescription powder, liquid or ointment according to the specifications of a patient’s doctor. On-site compounding of prescription medications went into decline when pharmaceutical manufacturers begin producing large quantities of drugs in varying strengths. That relegated pharmacists to pill counting — albeit very carefully.

But on-site compounding has made a comeback in recent years. It’s almost always done by small, independent pharmacies, because it’s not profitable for the big drug chains. Compounding pharmacies fill a medical need. They can prepare small, personalized batches of medications that are customized for individual patients and can fill prescriptions for drugs whose manufactured versions are in short supply.

On-site compounding is not subject to the same level of regulation as the manufacturing process. The federal Food and Drug Administration strictly monitors pill factories but doesn’t police compounding pharmacies. Compounding falls under the jurisdiction of state pharmacy boards, which say they lack the funds to adequately enforce quality control.

That has to change, as was tragically demonstrated by the August death of a Pinehurst woman, Mary “Ginny” Scyster, who was a victim of fungal meningitis. State health officials say she contracted the disease from a tainted steroid that was injected at FirstHealth Moore Regional Hospital. The anti-inflammatory drug, methylprednisone, which was being used to treat Scyster for pain, was compounded by Urgent Care Pharmacy in Spartanburg, S.C.

Officials at Moore Regional responded quickly and effectively when the cause of Scyster’s death was determined and when two other cases of fungal meningitis were diagnosed in patients who had received doses of the contaminated drug — including one at Moore Regional. As many as 500 patients at Moore Regional’s Pain Clinic may have been injected with the steriod, and the hospital has sent letters to them, alerting them to the situation. Quantities of the tainted batch were shipped to North Carolina and four other states, where authorities are investigating the case along with the FDA and the federal Centers for Disease Control.

Medical officials in North Carolina believe that enough time has passed since patients received the drug that no more meningitis cases will occur. Even so, those who were treated with the steroid should contact their physicians if they experience severe headaches, fever, stiff neck, vomiting and back pain.

Given the trend toward compounding, the General Assembly should consider licensing pharmacies to prepare certain medications that are potentially hazardous. That way, state regulators would know which pharmacies are compounding and which ones should be periodically monitored. The legislature should also give the N.C. Board of Pharmacy the funding it needs to carry out that responsibility.