Several states have decided to reclassify over-the-counter (OTC) ephedrine products as prescription drugs, following reports of ephedrine-caused illness and death. Missouri and Florida have designated ephedrine and ephedrine-combination drugs as prescription medications, while Ohio now requires ephedrines to be placed behind a counter staffed by a pharmacist. Ephedrines have been prescribed to young people for improved athletic abilities and weight loss. Industry sources say that pseudo-ephedrines are replacing ephedrines as OTC products and may be just as harmful.
Spurred by reports of abuse and even deaths from overdoses, three states have joined a national move to take over-the-counter ephedrine products off the shelves and put them back behind the pharmacy counter.
Florida recently reclassified ephedrine and ephedrine-combination products as prescription drugs. Missouri redesignated such products as Schedule IV drugs. Ohio put them in the Schedule V category so that, while they are still OTCs, they can be sold only by a pharmacist from stock stored behind the pharmacy counter. Such reclassifications mean that the targeted products can no longer be sold in outlets that do not have licensed pharmacies.
A jump in ephedrine-related emergency room visits and the recent death of a teenager from an overdose led to Ohio's reclassification. An autopsy found that the ephedrine the teenager ingested created a toxic dose in his kidneys and a lethal dose in his bloodstream.
Ohio originally put pseudoephedrine OTCs in Schedule V but later exempted them through an amendment sponsored by the Nonprescription Drug Manufacturers Association, said Frank Wickham, pharmacy board executive director. In addition, some ephedrine products were exempted, and manufacturers can petition the board for exclusion of their products.
"Now pseudoephedrines are being added to a lot of products," Wickham told Drug Topics. "Pseudoephedrines have been involved in just as many deaths as ephedrine. Apparently, ephedrine products are being promoted to young girls for weight loss and to young men for improving athletic performance."
Street drugs, appetite suppressants, and pep pills may be the problem, but manufacturers marketing ephedrine products for FDA-approved uses are "caught in the same sweep," said Kevin Kraushaar, NDMA director of state government relations. "We're asking states to exempt products being marketed in a manner consistent with the Food, Drug, & Cosmetics Act, as was done in Ohio, Oregon, and Washington."
Ephedrine abuse is a problem that "has never gone away," said Carmen Catizone, executive director, National Association of Boards of Pharmacy. "As soon as the states and the DEA have tried to pass regulations, either by scheduling ephedrine or by making them prescription drugs, the manufacturers of these products switch to a different form to avoid it. It's a big problem for the states. We're seeing some deaths from ephedrine abuse."
The problem goes beyond OTC ephedrine products being used as "uppers," often by long-haul truckers fighting to stay awake and teenagers hoping to shed extra pounds. Most clandestine street drug laboratories use ephedrine as a precursor for the production of methamphetamine (Speed) and methcathinone (Cat).
Unlike Ohio, Florida's legislation does not provide for any exceptions to the regulation transferring ephedrine-only and ephedrine-combination OTCs into the prescription category. There is, however, reportedly a legislative move afoot to amend the rule.
Regulatory personnel in the pharmacy services division of the Florida department of health and rehabilitative services are responsible for seeing that licensed pharmacies have moved the reclassified products to the prescription drug area. They are also checking to see that retail outlets without pharmacy licenses have removed ephedrine products from their shelves.
STATES RESTRICTING EPHEDRINE PRODUCTS Ephedrine-only Ephedrine-combination State products products Arizona Schedule V No Florida Rx drugs Rx drugs Idaho Rx drugs Rx drugs Michigan Rx drugs* Yes Missouri Schedule IV Schedule IV New Mexico Rx drugs Rx drugs North Dakota Rx drugs No New Jersey ** No Nevada Schedule III No Ohio Schedule V Schedule IV Oklahoma Schedule V No Oregon Rx drugs No*** Washington Rx drugs Schedule IV Wisconsin Schedule IV Schedule IV * Possession of more than 4 gm requires an Rx. **50 mg is Rx only; less than 50 mg is OTC. ***OTCs exempted on case-by-case basis. Source: National Association of Boards of Pharmacy survey.