The U.K. Medicines and Healthcare products Regulatory Agency recommends retailers restrict sales of nonprescription pain relievers to two packs per transaction to reduce the risk of overdose - a strategy an FDA working group rejected.
The U.K. health care regulator also discourages retailers from promoting sales of more than one pack at a time, such as by offering buy-one-get-one- free deals, according to the guidance released Dec. 10. However, MHRA says it is not opposed to retailers reducing the price for single packs.
MHRA explains in the best practice 1 guidance that the changes strike "a reasonable balance between meeting a customer's immediate need for pain relief while helping to minimize stockpiling and accidental or impulsive overdose."
The agency adds though that the nonprescription pain relievers "are effective and acceptably safe when used according to the label instructions."
The move is a logical next step after the agency's success at reducing overdoses of painkillers by limiting the number of tablets or capsules to 16 per pack, or 32 when sold under a pharmacist's guidance. It also is illegal to sell more than 100 tablets of paracetamol - acetaminophen - or aspirin in a single retail transaction, MHRA notes.
Within one year of restricting the package size in 1998, acetaminophen overdose cases fell 21 percent and the number of monthly referrals to the liver transplant list fell to an average of two from 3.5, according to published research.
MHRA says it drafted the guidelines with help from the British Retail Consortium and the Association of Convenience Stores. Both trade groups say the guidance will reinforce the current generally accepted practice at stores.
The regulatory agency encourages compliance by using till bars that prevent access to more than two packs; training staff about the restrictions and how to respond to consumers who want more packs; and placing notices on stores shelves and in the payment area to alert consumers and remind staff.
FDA Working Group Rejected The Strategy
Despite MHRA's success reducing acetaminophen related overdoses with package restrictions and its recommendation to restrict sales, an FDA joint advisory committee meeting rejected sales restrictions as a way to reduce overdoses in the U.S.
A joint FDA advisory panel of nonprescription and anesthetic drugs and drug safety and risk management experts voted 20 to 17 against restricting OTC acetaminophen package sizes at a meeting June 29-30. The meeting was held to discuss how to reduce the risk of liver damage from acetaminophen (2 'The Tan Sheet' July 6, 2009).
The advisory committee argued pack-size restrictions would unduly hinder access to people who appropriately use acetaminophen for chronic pain and it would drive up costs.
Panelists also said limiting pack size without limiting sales of packs would not stop consumers from buying multiple packs, which is one reason why MHRA took its latest step to restrict sales.
Similarly, an FDA working group previously cited cost and access concerns when it rejected restricting sales in U.S. (3 'The Tan Sheet' June 1, 2009).
The group noted sales restrictions may not address the problem of unintentional overdoes as effectively as suicides by acetaminophen overdose, which are more prevalent in the U.K.
In addition, the working group questioned whether FDA has the authority to limit sales without legislation enacted by Congress, according to materials prepared for the June meeting.
[Editor's note: This story was contributed by 4 'The Tan Sheet,' your source for nonprescription pharmaceutical and nutritional industry news. For more information call 1-800-332-2181.]
- Elizabeth Crawford (5 e.crawford@elsevier.com)
