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Jurisprudence Part 2 > DIDFA & ODBA > Flashcards

DIDFA & ODBA Flashcards

1
Q

What does DIDFA mean and is it a national or provincial act?

A

DIDFA = Drug Interchangeability and Dispensing Fee Act

This is provincial legislation

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2
Q

Does DIDFA apply to all pharmacies?

A

Does not apply to dispensing of a drug in a public hospital

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3
Q

How does DIDFA define an interchangeable product?

A

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 products

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4
Q

Who is the person who can designate products as interchangeable and what is their other role?

A

The Executive Officer

Must also ensure that only high quality, affordable drugs are listed as interchangeable

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5
Q

What are the two main purposes of the ODB dormulary?

A
  1. Provides listing of all products designated as interchangeable in Ontario
  2. Identifies all interchangeable products that are eligible for reimbursement under the ODBA
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6
Q

What is OFI?

A

OFI = off formulary interchangeability

it is the application of interchangeable designations to drug products where the brand names are not listed as ODB benefits

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7
Q

What conditions must a dispenser consider for all prescriptions (regarding interchangeability)?

A
  1. The patient has a right to choose an interchangeable product or ask for no substitution
  2. If the brand name is dispensed, the patient must be informed that there are interchangeable products
  3. Interchangeable product may be dispensed without informing the patient as long as the product is the lowest cost in inventory
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8
Q

What options are available to the patient and the dispenser when dispensing a “not a benefit” product?

A
  1. The patient could pay for the prescription
  2. If the patient cannot pay for it, the pharmacist can contact the prescriber to recommend an alternative that is covered
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9
Q

What is contained in section 4 of DIDFA?

A
  • 6 subsections with basic rules for interchangeability

- set of cascading principles where each subsection is dependent on the previous or next subsection

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10
Q

What does DIDFA subsection 4(1) indicate?

A

If a prescription says to dispense a brand name, the dispenser has the authority to change it to a designated interchangeable product

*interchangeability is allowed but not required

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11
Q

What does DIDFA section 4 (2) indicate?

A

The patient right to request an interchangeable product; the dispenser MUST do this

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12
Q

What does DIDFA section 4 (3) indicate?

A

Informing the patient; if the dispenser gives the brand name, the patient is entitled to know that there are interchangeable options

*this typically happens when an interchangeable product is not in the inventory

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13
Q

What does DIDFA section 4 (4a) indicate?

A

Exceptions to informing patients of their rights; subsection 3 does not apply if the brand name product is not more expensive than the lowest cost interchangeable product in the dispensers inventory

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14
Q

What does DIDFA section 4(4c) indicate?

A

Exceptions to informing patients of their rights; patient does not need to be told about interchangeable products if the product is a refill

*however, anytime a brand is switched, the patient must be informed

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15
Q

What does DIDFA section 4(5) indicate?

A

If a drug is not in the formulary, but there is an interchangeable product listed in the formulary (same API, dose and dosage form), it may be substituted

*normally happens with newly approved products available on the market

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16
Q

What does DIDFA section 4(6) indicate?

A

No substitutions request; a prescriber may indicate “no substitution” which cancels the requirements for interchangeability in the first three subsections and subsection 5

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17
Q

What does DIDFA section 5 indicate?

A

Dispensing generic drugs; for a prescription written without indication of brand or manufacturer, the dispenser must dispense an interchangeable product as listed in the formulary

*if there is none listed in the formulary, the dispenser can choose any product with the same API and the same dosage form

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18
Q

The regulations listed in DIDFA outline requirements surrounding which four things?

A
  1. Yellow signs
  2. Quantity dispensed
  3. Prescription receipts
  4. Purchase records
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19
Q

What are the two yellow signs that must be displayed in the pharmacy where patients can see upon presenting a prescription?

A
  1. Notice to patients

2. U & C dispensing fee

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20
Q

What information is displayed on the “notice to patients sign”?

A
  • patient right to request an interchangeable product
  • it is the patient’s choice to have the prescription as written or to have an interchangeable product instead and they must let the dispenser know
  • dispenser may choose an interchangeable product but the patient must be informed
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21
Q

What information is displayed on the “U&C dispensing fee” sign?

A
  • usual and customary dispensing fee of the pharmacy

- informs patients of the services that may be offered by the pharmacy and are included in the U&C dispensing fee

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22
Q

Who determines the U&C dispensing fee?

A

The owner of the pharmacy

*must be reported to the OCP and they must be informed of any changes

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23
Q

Can a pharmacy charge more than their U&C dispensing fee?

A

Yes but there must be a documented reason for the change and the patient must be informed of the reason and the total fee

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24
Q

What does DIDIFA require in respect to the quantity of drug dispensed?

A

The dispenser must give the entire quantity of drug prescribed (not including refills) unless the patient or patient’s agent requests a smaller amount

*if a smaller amount is requested, the patient must authorize this in writing

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25
Q

What are the exceptions to the DIDFA requirement to dispense the entire quantity as written?

A

Not in the best interest of the patient to give the whole quantity:

  1. Quantity prescribed may be dangerous
  2. Stability of the product may not warrant the prescribed quantity

OR

Agreements with insurance providers or plans require the dispensed amount to be less; in this case, the insurer is acting as the patient’s agent

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26
Q

What does DIDFA require to be included on the prescription receipt?

A
  1. Dispensing fee
  2. Cost of drug - including markup
  3. Total price of prescription
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27
Q

Is the pharmacist signature a requirement on the prescription receipt?

A

No but it is good practice

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28
Q

Are DIDFAs requirements applicable to non-prescription products?

A

No, only those pursuant to a prescription

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29
Q

How long must purchase records be kept in the pharmacy as regulated by DIDFA?

A

at least 2 years from the date when the invoice was first received

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30
Q

What are the amendments that were made to the DIDFA?

A
  1. financial cap removed on Ordinary Commercial Term (OCT) benefits
  2. Private Label Products can now be designated as listed drug products or interchangeable drug products in the formulary
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31
Q

What does ODBA stand for and what is it?

A

`Ontario Drug Benefit Act (ODB Act) –> provincial law and applies to the reimbursement of drugs under the ODB program and dispensing of medications in Ontario

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32
Q

Why was the ODBA introduced?

A

to ensure that drug benefits are available to those most at risk and to those who may not be able to afford drugs

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33
Q

Do pharmacy operators need to participate in the ODB program?

A

No, they are able to opt out

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34
Q

What is the Ontario Regulation 201/96?

A

The regulation to the ODBA which:

  • clarifies intent of act
  • clarifies role of the Executive Officer
  • introduces processes to implement the intent of the act
  • introduces a number of new definitions and concepts
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35
Q

What are the differences between DIDFA and ODBA?

A
  • DIDFA applies to every single prescription dispensed in Ontario
  • ODBA does not apply to the private or “out-of-pocket” sector of the healthcare system
  • ODBA ONLY applies to prescriptions receiving eligible drugs as listed in the formulary
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36
Q

What are the subgroups of Healthcare payments in Canada?

A
  1. Public sector: publicly funded by the government

2. Private sector: private insurance or paying “out-of-pocket”

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37
Q

What are the 5 principles that ODB Act is based on?

A
  1. Meet needs of Ontarians as patients, consumers and taxpayers
  2. Involve consumers and patients in a meaningful way
  3. Operate transparently to the extent possible for all persons with an interest in the system
  4. Consistently achieve value-for-money and ensure best use of resources
  5. Funding decisions are made on the best clinical and economic evidence available; openly communicated in a timely manner
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38
Q

Who is included int he list of persons interested in the ODB system?

A
  • patients
  • health care practitioners
  • consumers
  • manufacturers
  • wholesalers
  • pharmacies
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39
Q

Who establishes the pharmacy council?

A

Minister of health

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40
Q

Who are the co-chairs of the Pharmacy Council?

A

Representatives of the Ministry of Health and the Ontario Pharmacists Association

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41
Q

What does the Pharmacy Council do?

A
  • ensures involvement of pharmacists in the development of pharmaceutical health policy
  • allows pharmacists to provide advice to the Executive Officer and Minister of Health
  • involved in defining and implementing a pharmacist’s professional services
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42
Q

How is Executive Officer defined in the ODBA?

A

Executive officer replaces the Minister of Health in administering both ODBA and DIDFA –> extensive powers, some include:

  • designate products listed as drug products and substances
  • designate products as interchangeable with others under DIDFA
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43
Q

How does ODBA define designated?

A

–> designated in the formulary by the Executive Officer

44
Q

How does ODBA define interchangeable?

A

With respect to a drug product, interchangeable means a drug identified by a specific product name or manufacturer and designated under DIDFA as interchangeable with one or more other such products

45
Q

How does the ODBA define ‘listed drug product’?

A

Drug/combination of drugs in a particular dosage form and strength identified by a specific product name or manufacturer and designated as a listed drug product

46
Q

Who publishes and maintains the ODB Formulary/Comparative Drug Index?

A

The Executive Officer –> this formulary is only available online

47
Q

What is included in the ODB Formulary?

A
  • all drug products and substances for the purposes of the ODB plan and all that are interchangeable in Ontario
  • all of the prices ODB will pay for the purposes of the plan
  • coverage for many health products (including nutrition and diabetic testing products)
48
Q

What are the two main purposes of the ODB Formulary?

A
  1. List all drugs that are interchangeable
  2. List all the products that are benefits in the ODB plan
    - -> not all interchangeable products are benefits
49
Q

What is the eligibility criteria for ODB program?

A
  • must be eligible for OHIP coverage
  • 65 or older
  • receiving benefits under Ontario Disability Support or Ontario Works
  • those residing in Homes for Special Care or long-term care
  • those receiving professional services under Home Care Program
  • registrants in the Trilium drug program
50
Q

When do Ontario residents covered under OHIP qualify for drug benefits under ODB?

A

The first day of the month following their 65th birthday

51
Q

What is described in part 1 of the ODB Formulary?

A

Introduction –> quick glance at the entire formulary and information on how to use it, the Drug Benefit Network and information regarding reimbursement and billing rules

52
Q

What is described in part 2 of the ODB Formulary?

A

Preamble –> informs pharmacists and pharmacy technicians of the percentage markup allowed according to the ODB Act

53
Q

What is described in part 3 of the ODB Formulary?

A

Formulary Listings –> detailed formulary listings; list of benefits (Part III-A) and OFIs (Part III-B)

54
Q

What is an OFI?

A

OFI = off formulary interchangeability

This means that the product is not a benefit but is considered interchangeable for the purposes of DIDFA; prices listed in the formulary are supplied by the manufacturer and are for information only

55
Q

What is described in part 4 of the ODB Formulary?

A

Alphabetical Index of Drug products listed in Part III-B (OFI)

56
Q

What is described in part 5 of the ODB Formulary?

A

Index of Pharmacologic-therapeutic classification –> these are used in the formulary; examples include antihistamines, vitamins, hormones and substitutes ect.

57
Q

What is described in part 6 of the ODB Formulary?

A

Facilitated Access - HIV/AIDS and palliative care drug products —> specific drug products that are reimbursed through facilitated access when prescribed by an approved physician

58
Q

What is the purpose of part 6 of the ODB formulary?

A

Allows reimbursement for drugs that are not normally covered by ODB for ODB eligible persons treated for HIV/AIDS and/or under palliative care –> products are available to these patient populations through exceptional access program without need for submission of individual patient request

59
Q

What is described in part 7 of the ODB Formulary?

A

Trillium Drug Benefit Program –> provides benefits to patients with high drug expenses in relation to their income

60
Q

What is described in part 8 of the ODB Formulary?

A

Exceptional Access Program –> another mechanism to request coverage for products not listed as benefits under the ODB program; ODB does not cover every approved drug

61
Q

What is described in part 9 of the ODB Formulary?

A

Nutrition products/Diabetic testing agents –> other products under the ODB program for ODB eligible patients with a valid prescription

62
Q

What is described in part 10 of the ODB Formulary?

A

Abbreviations –> list of abbreviations for names of manufacturers and dosage forms

63
Q

What is described in part 11 of the ODB Formulary?

A

Section not in use; blank

64
Q

What is described in part 12 of the ODB Formulary?

A

Limited Use drug Products –> products listed in the formulary with specific clinical criteria for use; criteria outlines the conditions under which LU products are reimbursed by ODB

65
Q

What are the options a patient has when the product they were prescribed is listed as ‘not a benefit’?

A
  1. Pay for the drug; patient has the right to choose interchangeable or ask for ‘no sub’
  2. Cannot pay for the drug; pharmacist intervenes to ask physician for an alternative that is reimbursed under the plan
66
Q

In order to get ODB to reimburse a higher-cost interchangeable, what has to happen with the prescription?

A
  1. Prescriber must complete, sign and forward to the pharmacy a copy of the Canada Vigilance Adverse Reaction Reporting Form
  2. Prescriber must write ‘no sub’ on a written script or indicate ‘no substitution’ for a verbal prescription
  3. Pharmacist must mail/fax the completed and signed form to Health Canada’s Canada Vigilance Program and retain a copy of the completed and signed ADR form
67
Q

How does ODB administer billing privileges?

A

Pharmacy operators must apply to the Executive Officer who may:

  • grant or refuse any application
  • may require an agreement with conditions before granting these billing privileges
68
Q

How much time is required to notify the Executive Officer of an opt out of the ODB program and what happens when a pharmacy opts out?

A

90 days –> pharmacy operators would then no longer be able to bill or accept payment from the Executive Officer

69
Q

What happens if the Executive Officer believes that the pharmacy operator has breached any conditions of the agreement or act?

A

Suspension of billings or payments –> could affect all pharmacies owned by an operator if the operator owned more than one pharmacy

Depending on severity of breach, suspension may be rescinded or an agreement on conditions to operate the pharmacy must be reached by the Executive Officer and the operator

70
Q

What do the ODB site inspectors do?

A
  • examine pharmacy records related to ODB program and ensure compliance of the legislation
  • conduct routine site inspections
  • verify claims reimbursed under the ODB program by the inspection unit of the Ontario Public Drug Programs
71
Q

How are the ODB Site Inspectors related to the OCP?

A

They are completely separate.

They do site inspections on behalf of the ministry, not the OCP and these inspections are separate and unrelated to the OCP conducted pharmacy site inspections.

72
Q

How is the amount paid by the Executive Officer determined?

A

drug benefit price + markup + dispensing fee - co-pay = amount paid by Executive Officer

73
Q

What happens when a pharmacy has to pay more to purchase a drug product than what ODB will reimburse?

A

As long as invoices are kept secure to prove that more was paid, ODB has a plan in place to ensure pharmacies are reimbursed fairly

74
Q

How is the maximum dispensing fee determined on Ontario?

A

location of the pharmacy and the number of other pharmacies in the geographical area

75
Q

What are the limits on the quantity of medication that the Executive Officer will pay for at once/

A

The lesser of the maximum allowable quantity of a listed drug product:

  • either a 35 day supply for Ontario Works recipients (not applicable as of August 1st 2018)
  • 100 day supply for all others

Or, the entire quantity specified in the prescription (ex. prescriber wrote for 60 days)

76
Q

Why are people with Ontario Works only eligible for a 35 day supply? (this is no longer applicable as of August 1st 2018)

A

Persons qualifying for benefits under the Ontario Works act are generally only out of work temporarily and need assistance for a short time

77
Q

Who runs the Ontario Works program?

A

A municipality rather than the province

78
Q

What is the Trial Prescription Program?

A
  • makes a patient eligible for only a 30 day trial supply
  • eligible to any drug that the patient has never taken or has not taken in the last 12 months
  • if the drug is well tolerated, the remaining quantity can be dispensed
  • designed to eliminate wasted drug product
79
Q

In what situations could a pharmacist over-ride the Trial Prescription Program?

A
  1. If it is not possible for a patient to return to the pharmacy
  2. If the patient has tolerated a prior course (ex. samples from a physician)
80
Q

How long will ODB pay for programs with specific eligibility dates?

A

Maximum of 30 days beyond the end of the eligibility period

81
Q

What situations indicate that dispensing the full quantity of a drug is not in the patients best interest?

A
  1. Pharmacist believes that the person is incapable of managing the medication as a result of a physical, cognitive or sensory impairment
  2. The person agrees that the quantity should be reduced (need record of authorization from patient)

MUST BE DOCUMENTED

82
Q

If the dispenser provides a more frequent dispensing, how many dispensing fees will the Executive Officer pay for in one calendar month?

A

No more than 2 in one calendar month, even if the prescription specifies more than two intervals in that time

83
Q

What are the exceptions to the Conditions on Payment of Dispensing Fees?

A
  • narcotics
  • psychotherapeutics
  • eligible recipients that are residents in a long term care home or any other residential facility funded by the Government of Ontario specified by the Executive Officer
84
Q

What does the ODBA say about refusal to dispense?

A

Refusal to dispense is prohibited; pharmacy operators cannot refuse to supply a listed drug to avoid meeting the requirements of the act

85
Q

What is the exception for Refusal to Dispense?

A

If the pharmacist is concerned that the patient’s well-being is jeopardized in dispensing that product

86
Q

What is a co-payment?

A

A portion of the cost of prescription which the patient is expected to pay as determined by the drug plan; it is a form of cost sharing

87
Q

What are the two possible co-pays with ODB?

A

$6.11 –> higher income seniors

$2.00 –> other eligible recipients or the operator’s usual and customary dispensing fee, whichever is less

88
Q

What is a deductable?

A

Form of cost sharing where the patient must pay a certain amount towards their medication costs before becoming eligible to receive benefits

89
Q

What is the deductible payment for ODB?

A

deductible is determined by income and it is the first $100 or more for the specified class of seniors

90
Q

If a patient wanted more than a 100 day supply and did not fall under the rules of the exception, what does the pharmacist do?

A

Pharmacist is permitted to charge the patient for any additional quantity of drug and must explain the reasons and give the patient a choice –> this should be documented

91
Q

What is an extemporaneous preparation?

A

A drug or combination or drugs prepared or compounded in a pharmacy by prescription

92
Q

What are the conditions that must be met in order for an extemporaneous preparation to be eligible for reimbursement under ODB?

A
  1. A preparation cannot be equivalent to a manufactured product on the market
  2. A topical preparation must contain an ODB formulary listed drug product and no other active ingredients except those listed in the section for extemporaneous preparations such as menthol and camphor
93
Q

What is the difference between the calculation for a normal drug and an extemporaneous preparation for reimbursement?

A

Inclusion of compounding time; this is dependent on what is being compounded

94
Q

What conditions are there on “open benefits” drugs?

A

No restrictions in prescribing or dispensing

95
Q

What conditions are there on “limited use” drugs?

A

Outlined in part 12 of the formulary:

  • restricted to patients that meet specified criteria
  • reimbursement is limited to those specific indications
  • authorization for an LU is valid for the duration indicated in the criteria
  • prescriber is responsible for indicating the criteria by specifying the Reason for Use code (RFU) on the prescription
96
Q

If a drug is listed as limited use and the prescriber did not indicate that the patient met the clinical criteria or provide an RFU, what would happen?

A

Patient would have to pay; communication should happen between the pharmacist and prescriber

97
Q

Who is the EAP for?

A

Clinical situations where there are no formulary alternatives to treat conditions or diseases and the drugs are not covered

98
Q

How does one access the EAP?

A

Requires an application from a physician on behalf of a patient

99
Q

When authorized for EAP, what does this authorization include?

A
  • an expiry date that is dependent on the drug
  • it is for a product with a specific DIN
  • coverage requests are retroactive to the date the clinical decision was made to start the medication OR 30 business days before the date the request was received by the program (whichever is shorter)
100
Q

What is required to qualify for the Trillium program?

A
  1. Must present a valid Ontario Health Insurance card
  2. Must provide income tax returns for the previous year for all members in the household
  3. Must have expended all other health insurance benefits
101
Q

Is there a deductible associated with the Trillium program?

A

Yes there is a determined initial amount of drug costs every quarter, then a $2.00 co-pay is applicable

102
Q

What must happen for a nutritional product to be reimbursed by ODB?

A
  1. Prescribed by a practitioner as the sole source of nutrition for a patient
  2. Nutrition Product Form completed by the prescriber and pharmacist –> retained for 2 years
103
Q

How much will ODB pay for a nutritional product?

A

ODB pays only a maximum based on the listed price which may be higher than what the ministry will pay –> pharmacy may only charge the patient the difference as determined by ODB

104
Q

What is necessary in order to be eligible for diabetic testing agents?

A

Prescription

105
Q

What is the maximum number of blood glucose test strips that may be reimbursed in 1 year?

A

this is based on the recipient’s diabetic history

Jurisprudence Part 2 (2 decks)

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