DIDFA

• DIDFA


  Drug Interchangeability and Dispensing Fee Act
• DIDFA - Overview


  • Provides requirements and guidance for dispensing all prescriptions in Ontario community pharmacies
  • Does not apply to the dispensing in a public hospital pharmacy
  • DIDFA clarifies interchangeability and insures the quality of interchangeable drug products
  • The act explains the conditions under which the products are considered to be interchangeable
  • The manufacturers need to apply to have their products approved as interchangeable
• DIDFA - Overview


  • Regulates dispensing of interchangeable drug products
  • Works together with Ontario Drug Benefit Act
  • Many principles and regulations of both acts are overlapping
  • Ontario Drug Benefit Formulary contains the list of interchangeable drug products that applies to all prescriptions – not just those for ODB recipients
  • Regulates establishing and changing of dispensing fees
  • Outlines dispensed quantities and prescriptions receipts
• DIDFA


  • Objectives
  • Interchangeability/ Formulary
  • Quantities dispensed / Receipt
  • Invoices / Records
  • Fee (U & C Dispensing Fee)
  • Regulations to DIDFA
  • Notifying patients
  • Professional Allowances / Code of Conduct
• Designated


  Means designated in the Formulary
• Formulary


  Means the Formulary that the executive officer is required to keep, maintain and publish under the Ontario Drug Benefit Act
• Interchangeable product


  Means a drug or combination of drugs in a particular dosage form and strength identified by a specific product name or manufacturer and designated as interchangeable with one or more other such products
• Interchangeability


  • Applies when the drug(s) are listed in the ODB formulary
  • A product becomes interchangeable with another product on the effective date of its being designated as interchangeable with that product
• Requirements for Interchangeability


  • A product is designated as interchangeable with another product if it contains a drug or drugs in the same amounts of the same or similar active ingredients in the same or similar dosage form as the other product
  • Interchangeable drugs are pharmaceutical products that are manufactured by more than one manufacturer and contain the same or similar active ingredient in the same strength and same or similar dosage form and listed in ODB Formulary
• Substitution where named product

  1. If a prescription directs the dispensing of a specific interchangeable product, the dispenser may dispense in its place another product that is designated as interchangeable with it

  2. If a prescription directs the dispensing of a specific interchangeable product, the dispenser, on the request of the person for whom the product was prescribed or the person presenting the prescription, shall dispense in its place another product that is designated as interchangeable with it

  3. If a prescription directs the dispensing of a specific interchangeable product, the dispenser shall not supply that product without informing the person for whom the product was prescribed or the person presenting the prescription, in the manner prescribed by the regulations, of the right to request an interchangeable product
• Exceptions


  Subsection (3) does not apply if, the amount to be charged for supplying the product specified in the prescription is not more than the least amount that would have been charged for supplying a product that is interchangeable with it and available in the dispenser's inventory; the product is being supplied pursuant to a repeat of the prescription
• Selection of interchangeable product


  If a prescription directs the dispensing of a product that is not designated as an interchangeable product and there is an interchangeable product that contains a drug or drugs in the same amounts of the same active ingredients in the same dosage form as the product prescribed, the dispenser may dispense the interchangeable product
• Exception


  Subsections (1), (2), (3) and (5) do not apply to a prescription that includes, in the case of a written prescription, the handwritten words "no sub", "pas de repl.", "no substitution" or "pas de replacement"; or in any other case, a direction recorded by the dispenser that there be no substitution
• Dispensing generic drug


  If a prescription directs the dispensing of a drug for which there are interchangeable products without identifying a specific product name or manufacturer, the dispenser shall dispense an interchangeable product of that drug
• DIDFA - simplified


  • When a presented prescription is for an interchangeable product, the pharmacist may dispense an interchangeable product that is available
  • The pharmacist must inform a patient that an interchangeable product is available and the patient has a right to select the specific interchangeable product
  • The pharmacist may select any the least expensive interchangeable product available in stock
  • The pharmacist must dispense the specified product if a prescriber indicated "no substitution"
  • If a patient selects the more expensive brand, the patient must initial or sign the Rx order
• DIDFA - Example


  • Prescriber wrote Rx: Prozac 20mg, Pharmacy may dispense APO-fluoxetine 20mg
  • Prescriber wrote Rx: Prozac 20mg no sub, Pharmacy dispenses Prozac 20mg
  • Prescriber wrote Rx: Fluoxetine 20mg, Pharmacy may dispense APO-fluoxetine 20mg
• Maximum dispensing fee


  • Every operator of a pharmacy shall set a single specific amount as a usual and customary dispensing fee and shall file a statement with the Registrar setting out that fee
  • An operator of a pharmacy may change the usual and customary dispensing fee by filing a statement with the Registrar setting out the new fee
• Usual and Customary Dispensing Fee (U&C Fee / Dispensing Fee)


  • Must be registered with the OCP
  • Any change to fee is reported to OCP
  • If raising U&C fee on a Rx – patient must be informed PRIOR to dispensing the drug
  • Provided to the inspector on new openings & confirmed during visits
• Quantity dispensed


  1. Every person who dispenses a drug pursuant to a prescription shall dispense the entire quantity of the drug prescribed at one time unless before the drug is dispensed the person presenting the prescription in writing authorizes the dispensing of the drug in smaller quantities

  2. Pharmacy may dispense less than the entire quantity prescribed if: professional judgment of the pharmacist, a provider of health care services (insurance) pays for a lesser quantity, when a lesser quantity is being paid ODB
• Receipt


  1. Every person who dispenses a drug pursuant to a prescription shall provide with the drug, in the manner prescribed by the regulations, particulars of the amount charged

  2. A person who dispenses a prescription drug shall provide a receipt to the patient at the time of dispensing that shows the amount being charged as followed: a dispensing fee, the cost of the drug, the total price of the prescription
• Notice to Patients


  • What does this mean?
  • How are patients notified?
  • What are the notified about?
• Invoices


  • Must retain invoices and purchase records including any record of price reductions... in the form of rebates, discounts, refunds, or free goods.... received... that relates to the purchase by the pharmacy of drug products to which the ACT applies
  • Retain 10 years/ 7 years ?
• Rebates from Manufacturers


  • Manufacturers are not allowed to provide rebates (deals, discounts, currency) for any interchangeable product to wholesalers or pharmacies
  • A minimal amount is allowed
  • This amount must be recorded as professional allowances towards patient care activities: CE programs, clinic days, education days, etc.
  • No wholesaler, operator, company, director, officer, employee or agent shall accept a rebate, either directly or indirectly
• Formulary


  • The Ontario Drug Benefit (ODB) formulary = Comparative Drug Index (CDI)
  • A list of drugs, arranged in comparative categories and groupings according to the therapeutic use, strength and dosage form of the drug
  • The formulary serves two purposes: Drug coverage + Interchangeability
  • Guide to the prescriber & pharmacy staff to confirm a product as an eligible benefit
  • Guide to the pharmacists in stocking interchangeable products for dispensing
  • Guide to other third party plans
  • Guide to the professional therapeutics committees (hospitals/ institutions) in selection of products
• Not all drugs approved for sale in Canada are included in the formulary
• When determining whether to include a drug in the formulary, the executive officer of the ODBP may consult the Pharmacy Council
• The formulary also includes non drug items for example certain nutritional products, vitamins and diabetic testing agents that are eligible for coverage
• Once a product is listed in the formulary, the manufacturer is required to comply with the rules of ODB and DIDFA
• Formulary - Parts


  • Part 1 – Introduction – background, how to use, reimbursement / processes / information / contacts
  • Part 11 – Preamble
  • Part 111-A – Benefits / drugs (ODB / CDI)
  • Part 111-B – OFI
  • Part 1V – not in use
  • Part V – Pharmacologic -Therapeutic Classification
  • Part V1 – Facilitated Access Drugs
  • Part V11 – Trillium Program
  • Part V111– Exceptional Access Program (EAP) – Individual Clinical Review
  • Part 1X – Nutritional products / Diabetic testing
  • Part X – Abbreviations, Tables, Sample forms
  • Part X1 – currently not used
  • Part X11 – Limited Use Products
• Off-Formulary Interchangeability (OFI)


  • The application of interchangeable designations to drug products are not listed as ODB benefits
  • Created for the principles of interchangeability only
  • Drug product prices, as reported by the respective manufacturers to the ministry, have been listed for each product for information purposes only
  • Provides a choice for lower priced interchangeable drugs for private plans and cash-paying sector
• Interchangeable Products


  Drug or combo of drugs in a particular dosage form & strength identifies by a specific product name or manufacturer & designated as interchangeable w/ one or more other such product
• Interchangeable Products


  • Products have same or similar active ingredients in same or similar dosage forms
  • Two products are considered interchangeable if active or therapeutic components of the products are the same
• Executive officer


  Responsible for designating products as interchangeable or removing designation, and ensuring only high quality drugs are listed as interchangeable
• Interchangeability process


  Allows dispenser to dispense lower cost interchangeable product without needing to contact prescriber for specific drug selection
• Rules for Interchangeability (Section 4)


  • Authority of Dispenser to substitute
  • Pt's Right to Request Interchangeable Product
  • Inform the Pt
  • Exceptions to Informing Pts of their Rights
  • Selection of Interchangeable Product
  • No Substitution Requests
  • Dispensing Generic Drugs
• Formulary


  • Provides listing of all products designated as interchangeable in Ontario
  • Identifies all interchangeable products that are eligible for reimbursement under ODBA
• Off Formulary Interchangeability (OFI)


  Application of interchangeable designations to products where original (brand name) is not listed as ODB benefits in formulary
• Notices, Receipts & Records

  1. Yellow Signs

  2. Quantity Dispensed

  3. Prescription Receipts

  4. Purchase Records
• Doesn't apply to public hospitals under Public Hospitals Act
• May be confused w/ ODBA due to overlapping principles