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Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Apo-Alendronate/Vitamin D3 · DIN 02454467 Manufacturer: Apotex Inc.; listing date 2016-09-29 Health Canada: Marketed since 2016-07-21 · brand APO-ALENDRONATE/VITAMIN D3 · ATC M05BB03 ALENDRONIC ACID AND CHOLECALCIFEROL, M05BB03 ALENDRONIC ACID AND CHOLECALCIFEROL · form Tablet · route Oral · ingredients VITAMIN D3 (CHOLECALCIFEROL) 2800 UNIT, ALENDRONIC ACID (ALENDRONATE SODIUM) 70 MG · company Apotex inc · schedule Prescription

DIN 02454467: Apo-Alendronate/Vitamin D3 Raw flags: chronicUseMed=Y, sec3=Y Item: 920000544; group id 892; item number 2142; lccId None; manufacturer id APX Source form: Tab; strength: 70mg & 70mcg Recorded listing: General benefit; chronic-use medication (100-day supply rule, dispensing-fee limit) Source prices (unrounded): $2.4348; ministry $2.4348 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02454467 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94104 Therapeutic Notes (formulary) Note: The recommended dose of Vitamin D for osteoporosis prevention and treatment in adults over 50 years old is at least 800 IU/day, in conjunction with calcium. This product does not provide the total recommended daily intake of Vitamin D; supplemental Vitamin D may be required. The appropriate dosage of ALENDRONATE & CHOLECALCIFEROL must be determined by the physician based on the patient's vitamin D requirement.

Interchangeable products

Fosavance · DIN 02276429 · $2.4348 Jamp Alendronate/Vitamin D3 · DIN 02519828 · $2.4348

Shortage status: resolved shortage (ended 2026-02-26); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02454467

Shortage record checked 2026-09-13T08:10:21.292534+00:00