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Provincial Principles
Legislation • Meet needs of patients, consumers and
Ontario Drug Benefit taxpayers in Ontario
• Involve consumer and patients in a
Act meaningful way - Accountability
and • Operate transparently to fullest extent for
Regulations all who have an interest in the system
• Ensure best use of resources, value for
money and cost-effectiveness
Gregory Ujiye, R.Ph., B.Sc., • Utilize best clinical and economic
Professional Practice evidence for funding decisions for drugs
Advisor/Inspector
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Ontario Drug Benefit Act Ontario Drug Benefit Act
The Formulary The Formulary
• ODB Formulary/Comparative Drug Index 12 “Parts” or sections
commonly referred to as the Formulary serves
a dual purpose and identifies: • Part I – Introduction
– all “listed drug products” and “listed substances” – Background, How to Use, Dispensary
eligible for reimbursement by the ODB program
– all products that are interchangeable for the purposes Reimbursement/Procedures,
of DIDFA Information/Contacts
– drug benefit prices
• Part II – Preamble
• Products and prices effective the date
published in the Formulary (or ceases when • Part III – Formulary/Comparative
removed) Drug Index (CDI)
• Any other information necessary for
administering the ODB program Continued…
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Ontario Drug Benefit Act Ontario Drug Benefit Act
Billing Restrictions: Section 4 “No Substitution” by “patient”
• No operator of a pharmacy or a • Patient choice protected in the ODB Program,
physician can charge or accept same principle as DIDFA
payments from anyone except the EO • Brand or more expensive listed interchangeable
for the purposes of this Act drug product is requested by patient, i.e. no
substitution
• Allows for collection of the co-payment • “May charge” or collect the difference between
from the patient the more expensive interchangeable product
• Can collect from the patient only what and what ODB will pay
the Act allows • s. 4(5) provides formula for calculating the
difference
• Collection of co-payment is not
• Document
mandatory – “pharmacist may charge…”
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Ontario Drug Benefit Act Ontario Drug Benefit Act
Amount Executive Officer to pay
Amount Executive Officer to pay
Where dispensing fee is less than the co-
payment prescribed, the lower High Acquisition Cost
dispensing fee also becomes the co-
payment • Acquisition cost higher than drug
benefit cost
(DBP + MU + DF) – (co-pay) = payment • Mechanism to recover the
(10.00 + 0.80 + 4.99 – 4.99) = 10.80 difference from the EO provided in
(phm’t collects $4.99 copay)
the Act
• Pharmacist responsible for collecting co-
payment (must maintain documentation for
proof, i.e. invoice)
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Ontario Drug Benefit Act Ontario Drug Benefit Act
Administration: s.11.4 - s.11.6 Administration: s.12 – s.15
• Process for pricing listed drug • Agreements, confidentiality, collection of
personal health information, inspections,
products by manufacturers etc.
• Rebates by manufacturers • Requirement for manufacturers and
• Enforcement and penalties by EO pharmacies to provide information other
than personal health information
• Defines “rebates” (s. 11.5 (18)) • Inspections and powers of inspectors
• EO establishes “Code of Conduct” – broad powers to examine any records
relating to the business practices relating to
(s 11.5 (15)) for provision of the Act
“professional allowances/rebates” • Offences and penalties
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Ontario Drug Benefit Act Ontario Drug Benefit Act
Regulation 201/96 Regulation 201/96
Professional Allowances s. 1(10): Professional Allowances:
1. Continuing education programs that 4. Education days provided by
enhance scientific knowledge or pharmacists for health protection and
professional skills if held in Ontario promotion days, targeted to general
2. Continuing education programs for public
specialized services or specialized 5. Compliance packaging assisting
certifications if held in N. America patients with complicated medication
3. Clinic days provided by pharmacists to regimes
disseminate disease or drug related 6. Disease management and prevention
information to the general public initiatives
Continued… Continued…
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Ontario Drug Benefit Act Ontario Drug Benefit Act
Regulation 201/96 Regulation 201/96
Trillium Program: Requirements Extemporaneous Preparations/Compounds*
• Insured under the Health Insurance Act, – Cannot be equivalent to a manufactured product
i.e. a valid Ontario Health Insurance – For internal consumption and contains a solid dosage
Card form of a listed product and no other active ingredient
– For topical or dermatological use and contains a listed
• Total household unit have collectively drug product and no other active ingredient other
spent amount determined by the than those listed in the regulations e.g. menthol,
regulations camphor etc.
– For injection and prepared under direct supervision of
• Application to the executive officer a pharmacists registered in Ont. (some restrictions)
• All forms of health insurance expended – For specific ophthalmic preparations
– Maximum of 5 minutes compounding time paid
continued…
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Ontario Drug Benefit Act Ontario Drug Benefit Act
Regulation 201/96 Regulation 201/96
Limits on Amounts paid by executive officer
Co payments: s.20.1/20.2
“30 day program”
• Introduces co-payments and new
• On all new prescriptions or prescriptions that
patient has not had in previous 12 months definitions such as:
• Limits the initial Rx to a 30 day quantity – Deductible amount, allowable drug costs,
regardless of quantity authorized Fiscal period (Aug 1 – July 31)
• Allows a person to try medication and allows • Introduces concept of a “deductible”
physician to monitor for efficacy – amount that must be paid initially in order for
• Designed to reduce waste an eligible person to receive benefits from a
• Provides for exceptions if patient cannot come drug plan
back in 30 days (document reasons) – Different from co-pay – cost sharing on each
• Administered through adjudication system prescription
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Ontario Drug Benefit Act Ontario Drug Benefit Act
Nutritional Products Additional Benefits Part IX Diabetic Testing Agents: Additional Benefit Part IX
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ODBA, Regulation 201/96 ODBA, Regulation 201/96
Code of Conduct: Schedule 3 Code of Conduct: Schedule 3
• Guidance document governing use of • Prohibition of Professional
professional allowances Allowances:
• Principles – Advertising or promotional flyers
– Payments from manufacturers to pharmacies (exception: clinic days as defined)
in the form of professional allowances must
only be used for defined activities – Entertainment, social or sporting
– All persons involved in the drug distribution events
system must act transparently – Meals and travels not directly
– All suppliers and operators of pharmacies associated with defined programs
must commit to abide by the Code of – Convention displays
Conduct
Continued…
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Ontario Drug Benefit
Ontario Drug Benefit Act
Phone Numbers
Pharmacist Help Line
1-800-668-6641
Seniors Info Line
1-888-405-0405
Trillium Drug Program
Questions?
1-800-575-5386
(416)-326-1558 (Toronto)
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