OCP Pharmacy Ontario Jurisprudence Exam

What does DIDFA stand for

Drug Interchangeability and dispensing fee act

What is DIDFA?

provincial law drug and interchangeability and dispensing fees

- is applied in addition to the other laws that govern the dispensing in Ontario

- regulations on OCP website

- provides requirements and guidance for dispensing meds in ON

- clarifies interchangeability

Does DIDFA apply to dispensing of a drug in a public hospital

NO - under Public Hospitals act

Why was interchangeability introduced?

encourage the use of high quality, generic drugs and to help reduced the costs to the public for medications

What is an interchangeable product?

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

Specific product name

proprietary name or registered name that the manufacturer assigns to a product such as Prozac or Apo-Floxetine

- both generic and brand name

Similar active ingredients

having the same therapeutic moiety but of possibly different salts, esters, complexes or solvates

What is the Executive officer responsible for in terms of interchangeability?

- designating products as interchangeable or removing the designation

- ensuring high quality, affordable drugs are listed as an interchangeable

Who publishes the ODB formulary / comparative drug index?

Execuetive office of the Ontario Public Drug Programs

What are the purposes of the formulary?

1) provides a listing of all products that are eligible for reimbursement under the ODBA

2) identifies all the interchangeable products that are eligible for reimbursement under ODBA

Why the formulary useful for pharmacies?

- decide which drug to keep in their inventory

- helps hospitals and other drug plans with making decisions for their programs

The formulary is divided into ____ parts

12

Part 3 A of the formulary

web link to for the formulary search which provides a searchable products that are benefits under ODB

Part 3 B of the formulary

contains a listing of "off formulary" interchangeable products. There products are NOT benefits under ODB

Off Formulary Interchangeability

the application of interchangeable designations to drug products where the original (brand name) products are not listed as ODB benefits in the formulary

OFI vs Not A Benefit

OFI is when neither brand or generic are covered and Not a Benefit is referring to a specific brand that is not covered (but the genetics are)

Are interchangeability and reimbursement the same?

no - separate

Who ODBA apply to? Every prescription?

No, not every prescription. Only the prescriptions for eligible recipients receiving listed drug products

What starts the process of interchnageability?

authority of the dispenser to substitute for a named product

Upon receiving a Rx for a SPECIFIC interchangeable product, the dispenser has the choice to (if the patient has not stated a preference):

1) dispense the brand product specified on the prescription (after notifying the patient about other interchangeable products available)

2) substitute it with an interchangeable product

Upon receiving a Rx for a SPECIFIC interchangeable product and the patient/patient agent has requested an interchangeable product, the dispense has the choice to:

NO choice, when a patient requests an interchangeable product, the dispenser no longer has the choice and MUST dispense an interchangeproduct

Upon receiving a Rx that directs the dispensing of a specific interchangeable product, what must the dispenser do?

it is mandatory that the dispenser inform the patient of the option available

Upon receiving a Rx that directs the dispensing of a specific interchangeable product, what can the patient choose after being notified about the options available?

patient has right to choose:

- have Rx dispensed as written

- have an interchangeable product dispensed instead

Upon receiving a Rx that directs the dispensing of a specific interchangeable product and you do not have an interchangeable product in your inventory, what must you tell the patient?

- there is an interchangeable products available

- it is their right to choose

Upon receiving a Rx that directs the dispensing of a specific interchangeable product and you do not have an interchangeable product in your inventory, what can the patient choose to do?

1) take the brand specified Rx

2) take their prescription elsewhere for an interchangeable

3) have the pharmacy order the interchangeable product to fill the Rx

What are the two exceptions which excuse the dispenser from being required to inform the patient of their right to request an intechangeable product?

1) when dispensing the product on the prescription is not more than the least amount that would be charged for supplying an interchangeable with it

2) the product is being supplied pursuant to a repeat of a prescription (if Rx is refill and they have specified brand before, you can continue refilling this without informing them until refills are done)

If a patient has had a specific brand drug before and the dispenser may switch the brands in the middle of the series, what happens now??

- DIDFA principles apply now (refills are switching)

- documentation is important since the medication dispensed has changed

- Auro to Apo to Teva must be counselled due to the appearance being different and different medication dispensed

- helps maintain trusting relationship

- when drug is interchanged, patient should be full aware of the subsitution even if it is between different generic products

You receive a Rx for a product that is not designated as an interchnageable. However, there is an interchangeable product that contains a drug or drugs in the same amounts of the same API in the same dosage form as the product prescribed. Can you dispense the interchnageable product?

- You can dispense the product the prescription is described for

- OR you can dispense the interchangeable product. This is called "interchanging into the Formulary"

Ex; example with RX for C.E.S but give Premarin instead

When do DIDA 4 subsections 1,2,3, and 5 not apply to a prescription?

- Rx is written has "No Sub" by prescribers

- patient requests No Sub (document!!!!!)

What does the No Sub request do?

- maintains the right to choose for both a patient and the prescriber

- this request cancels any requirements for interchangeability in the first three subsections

Section 4 of DIDFa addresses

the dispensing of a SPECIFIC interchnageable product - a prescription for a specific product name (brand or manufacturer)

Section 5of DIDFA addresses

dispensing when a prescription is provided for a non specific product (prescribed by the chemical name or generic name)

You receive a Rx for a drug written by generic, chemical name. What can you do as the dispenser?

- dispense an interchangeable product of the drug

1) only dispense an interchangeable product listed in the formulary !!!!!!!!!!!!!

If there are no interchnageable products, then any product with same API in same dosage form may be dispensed.

lowest price must be charged.

EX: Zestril is in the formulary and is listed as interchnageable "Yes". Dispenser can do/consider the following:

1) may dispense Zestril as prescribed (DIDFA 4.1)

1B) if dispense another specified brand product, must inform patient about interchangeables (4.3)

2) patient has right to request interchnageable (4.2)

3) may dispense interchnageable product and charge same price as lowest cost (no need to inform patient)

You receive a prescription written by generic drug name, what can you ONLY do?

- Can only dispense a brand that is listed in the Formulary as interchangeable

Which yellow signs must be posted in a pharmacy?

- Notice to Patients

- U&C Dispensing Fee

Notice to Patients

a patients right to request an interchangeable product. It is the patient's choice whether to have a the prescription dispensed as written or to have an interchangeable product instead.

- sign promotes patients to discuss with their pharmacist about their medication

Usual and Customary Dispensing Fee

- the services, in addition to the dispensing of Rxs that are included in the U&C fee

- fee that a pharmacy normally charges when dispensing a Rx

- set by the owner of the pharmacy based on their business model

- pharmacies are required to report their U&C fee to the OCP

- must tell OCP when they change their fee

- you can change to a hgiher fee, but must be explained to patient in advanced. They can accept or decline and go elsewhere. Important to document this

DIDFA's Quantity Dispensed Requirements

dispensing the entire quantity of the drug prescribed (quantity) not including any repeats, as indicated on the prescription unless the patient or patient's agent requests a lesser quantity

When a lesser dispensing quantity is requested, ___________

the patient must authorize the reduced quantity in writing, The act ensures the right of the patient to make choices.

What must a dispenser do if they provide a lesser quantity based on their professional judgement?

documentation is expected when professional judgement is used

What are some examples when providing a lesser quanity is in the best interest of the patient?

- the quantity prescribed may pose a danger to the person

- stability of the product may not warrant a large quantity as prescribed

- Insurance covers lower quantities (best interest of pt)

- Covoid only 30 days is an example

Does the insurers or employer groups act as the patient's agent through formal agreements ??

YES

According to DIDFA, what is required on community pharmacy PRESCRIPTION receipts?

- dispensing fee

- cost of the drug (including mark up)

- total price of the prescription

Is a pharmacist signature required on a community pharmacy receipt?

No, it is good practice but not required

What are the requirements in reagrdsto purchase records?

- the regulation requires every operator of a pharmacy to retain each invoice or purchase record

- including: any record of manufacturer or wholesaler price reductions that may have been granted to pharmacy

According to DIDFA, how long do all invoices or records must be retained by the operator in the pharmacy or be readily retrievable?

2 years from the date when that invoice or record was RECEIVED

Fees for Professional Pharmacy Services Policy

policy sets out College exceptions when pharmacists charge fees for professional services outside of the usual and customary dispensing activities

DIDFA is ______ law

provincial

Specifically, what are the 3 things DIDFA outlines in a general sense ?

1) interchangeability

2) additional prescription requirements

3) dispensing fees

As of Jan 1 2020, what happened to the Orindary Commercial term (OCT) benefits?

regulatory amendments to remove the financial cap on these benefits

ODBA is ___ law

provinical

ODBA is _______________

provincial law that governs the ODB program, which is one of the largest drug plans in Canada.

- it was introduced by ON ministry of Health to ensure that drug benefits are available to those most at risk and those that may not be able to afford drugs

Does OCP adminsiter the ODB plan?

NO

What are the 6 publically funded drug programs?

- ODB

- Trillium Drug Program

- Special Drugs Program

- New Drug Funding Program fro Cancer Care

- Inherited Metabolic Disease Program

- Respiratory Syncytial Virus Prophylaxis for High Risk Infants Program

The ODBA applies to:

1) the reimbursement of drugs dispensed under the ODB program

2) the dispensing of medications in ON (in addition to other laws governing dispensing)

Are pharmacy operators obligated to partcipate in the ODB program ?

No, they can opt out

What does a pharmacy have to do to participate in the ODB program?

must sign an agreeement stating they accept all terms and conditions of the ODB program

List all the places the ODB program formulary can be found?

only available online

When is the ODB formulary updated?

throughout the year

Does ODBA apply to private or out of pocket sector of the health care system?

NOOOO

The Pharmacy Council is established by:

the Minister of health

The Pharmacy Council includes:

- co chair representatives of the Ministry of Health and OPA

Purpose of Pharmacy Counsil

- allows pharmacists to provide advice to Executive officer and Minister of Health

- ensures involvement of pharmacists in the development of pharmaceutical health policy

- implementing pharmacists professional services

Purpose of the Executive Officer

replaces the Minister of Health for the purposes of administering both the ODBA and DIDFA

- powers given to the EO are extensive and carry huge responsibility

- designate products listed as drug products

- designate as interchangeable

- publish and maintain formulary

Listed Drug Product

drug or 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

Under DIDFA, the formulary ______________________________

lists all the products that are defined as interchnageable in Ontario

WHO is elgible for ODB

- must be eligible for OHIP coverage

- people over 65 years old

- those w benefits under the Ontario Disability Support Program

- people residing in Homes for Special care or long term homes

- people receiving services under Home care program

- registrants in the Trillium drug plan

Trillium Drug Program

provides benefits to eligible recipeints who have drug expenses in relation to their income. It is an annual provincial government plan.

Exceptional Access Program

ODB does not cover every approved drug,. EAP is another mechanism to request coverage for products not listed as benefit under the ODB program

Formulary provides

- drug interchangeability and ODB program info

What does it mean when a patient is under the ODB plan and the drug is NOT of benefit?

- it does NOT mean you cannot dispense the durg, rather that ODB does not reimburse the pharmacy for this specific brand of drug

ODB drug plan and NO Sub by prescriber

- ODB will provide reimbursement of a HIGHER cost interchangeable product where a patient has experienced a significant adverse rxn with a lower cost interchangeable drug product.

What must be provided when ODB provides reimbursement of a HIGHER cost interchangeable product where a patient has experienced a significant adverse rxn with a lower cost interchangeable drug product

1) a signed copy of Canada Vilgiance Adverse Reaction Reporting Form

2) No Sub or Written Rx or Indicate No Sub for verbal prescription

What does the pharmacist do after receiving a Canada Vilgiance Adverse Reaction Reporting Form from a prescriber?

1) mail/fax the completed and signed copy form to Health Canada's Viligance Program

2) retain a copy of the complete and signed adverse drug rxn form

ODB drug plan and NO Sub by patient

- the act allows the pharmacy to collect the difference between the Drug benefit price and higher cost of the bran.

- the formula and process for charging the difference is found in the ODBA.

- no requirement to sign the prescription requesting bran needed

Pharmacy operators must _____ to the EO for billing privledges.

apply

When a pharmacy wants to opt out of the program, they must notify the EO ______________-

with 90 days notice

where can a drug benefit price be found?

listed in the formulary

ODB dispensing fee is determined by

- location of the pharmacy

- number of pharmacies in the geographical location

List two limits on the quantity of medication that the EO will pay for at one given point of time?

- the lesser of the maximum allowed quantity of a listed drug product: either a 35 day supply for Ontario Works for 100 day supply for all others

- or entire quantity listed on the prescription (60 day ie)

When will ODB pay for two claims of 100 days provided criteria is met?

those leaving the province

Ontario Works Act are entitled to what day supply

35 day course of treament

- temporarily out of work and need assistance

Is Ontario Works managed municipality or by the province

municipality

The Trail Prescription Program - ODB

- designated to eliminate wasted drug products

- applies to any eligible drug the patient has taken or has not taken in the last 12 months and limits the patient to a 30 day trail supply

- if tolerated, remaining quantity can be dispensed

- over rides can be used (for professional judgement)

What is the Trillium benefit co pay after the deductible is met

$2

What is the deductible for low income seniors?

$0

What is the deductible for higher income seniors (over 19,000)

$100

When is more frequent dispensing allowed under ODB?

- professional judgement in regards to med management and patient agrees to quantity being reduced

- documentation must be available

- example blister packs

- patient only pays $4.11 every 90 days not every 2 weeks

The EO should not pay more than __ dispensing fees for the supply of a listed drug product in one calendar month even if doctor specifies these intervals for billing more than __times in a month?

2

What are two exceptions for limiting dispensing fee?

- eligible recipients in long term homes

- any other residental facility funded by the governemnt of Ontario specified by EP

The EO does or does not pay for every extemporaneous preparation?

does not

LU drugs are restricted to

patients that meet the specified criteria

(good clinical evidence that they improve patient outcomes for certain situations)

How long can a LU last

duration indicated (weeks, days, foever...)

Whos is responsible for indicatinf LU criteria

prescriber - with Reason for Use code on the prescription

If a patient does not meet the criteria for a LU code, can the patient still get the drug>

yes but it wont be reimbursed by ODB

What is EAP reserved for?

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

Does EAP require an application from a patient?

No - it is an application from a physician on behalf of the patient

What does an authorization of an EAP have?

1) expiry date dependent to that drug

2) be for a specified DIN

3) may or may not be covered

Is there an age or income restriction for Trillium drug program?

no