Esomeprazole switching from Schedule II to Schedule III status in Canada

The National Drug Scheduling Advisory Committee (NDSAC) has approved the recommendation that esomeprazole or its salts be granted Schedule III status, when sold for the 14-day treatment of frequent heartburn (i.e., heartburn that occurs 2 or more days per week).The Schedule III status pertains to use of the drug at a 20 mg daily dosage, when sold in packages containing no more than 280 mg of esomeprazole (i.e., 1 tablet daily for 14 days). The National Drug Schedules will be revised to incorporate this change. Esomeprazole will continue to be a Schedule I (prescription) drug, except when the above conditions are met.Esomeprazole 20 mg for the 14-day treatment of frequent heartburn has been a Schedule II product since the fall of 2016. Schedule II products do not require a prescription, but are only available from a pharmacist and must be kept in an area of the pharmacy where there is no opportunity for self-selection. Its new status as a Schedule III drug means that it can be sold without a prescription from the self-selection area of the pharmacy; however, the pharmacist must be available to assist the patient with self-selection.The product monograph for Nexium 24HR (esomeprazole 20 mg delayed release capsules) notes that the product is not indicated for infrequent heartburn (i.e. ≤ 1 episode of heartburn per week) or for immediate relief of heartburn, as it may take one to four days for the drug to reach full effect. In addition, Nexium 24HR is not indicated for use in children 17 years of age or younger.The recommended dosage of Nexium 24HR (for adults ≥ 18 years of age) is one 20 mg capsule once daily for 14 days. No dose adjustment is required in patients with renal insufficiency or mild to moderate hepatic impairment. The daily dose of 20 mg should not be exceeded in patients with severe hepatic impairment.Nexium 24HR should not be taken for more than 14 days or more frequently than every four months unless directed by a physician. Patients should be advised to take the capsule with a glass of water before eating in the morning.Esomeprazole 20 mg/day for the 14-day treatment of frequent heartburn (in packages of no more than 280 mg) is the first proton pump inhibitor to be approved for Schedule III status in Canada. Omeprazole 20 mg/day for the 14-day treatment of frequent heartburn (in packages of no more than 280 mg) continues to have Schedule II status in Canada. All of the other proton pump inhibitors (including omeprazole and esomeprazole when sold for other indications and in other quantities) continue to have Schedule I (prescription) status in Canada.ReferencesNational Association of Pharmacy Regulatory Authorities. National drug schedules: final recommendations for esomeprazole 20 mg. November 13, 2018. https://napra.ca/nds-notice-board/national-drug-schedules-final-recommendations-esomeprazole-20-mg (accessed November 16, 2018).Pfizer Consumer HealthCare. Nexium 24HR (esomeprazole 20 mg delayed release capsules) product monograph. Mississauga, ON; September 21, 2018. https://pdf.hres.ca/dpd_pm/00047736.PDF (accessed November 20, 2018).

Esomeprazole switching from Schedule II to Schedule III status in Canada

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