Management Module 2: Formulary, Billing, Service

distribution, communication and collaboration, leadership and stewardship

drug coverage in canada can be either

federal

provincial

private

federal drug coverage include

Under Canada Health Act, prescriptions administered in hospitals are covered

Federal drug benefit programs for eligible groups (RCMP, First Nations)

canada does not have universal pharmacare

provincial drug coverage

provincial and territorial government manage and administer their own publicly funded drug plans

these plans determine what drugs are covered and the eligibility requirements for beneficiaries

private plans

private insurance companies

can be enrolled as an individual plan or through work place benefits

provincial drug plans are

income based programs

have specialized coverage for specific patient groups (seniors, recipients of social assistance, high drug costs)

plan sponsor

• employer organization that funds the benefit plan and offers it to the plan member

• usually employer of individual

benefits consultant

• works with plan sponsor, insurance company and PMB to find the best plan at the best pricing to suit the needs of the plan sponsor

insurance company

also known as carrier

sunlife, manulife, Desjardins

adjudicator (PBM)

• decides whether a claim will be paid

• receives, analyzes, and reimburses any claim submitted if applicable

• ESI, Telus Health (Assure), Green shield, ClaimSecure

who is the beneficiary/plan member

patient

drug formulary

• list of therapeutically effective drugs of proven high quality that have been approved for coverage under a drug plan

health technology agencies in Canada include

CDA (Canadas Drug Agency, formerly known as CADTH)

role of CDA in the formulary

• evaluates drugs and makes recommendations on whether they should be covered or not

• private plans conduct their own review and HTA

if there is a generic interchangeable product on the formulary, the ministry of health and LTC will reimburse pharmacists for the

lowest cost interchangeable drug

higher costs interchangeable drugs are only covered by the ministry when deemed medically necesarry

Limited Use Code

used for limited use drugs only when eligible recipients meet specific criteria

prescription has to have LU code on it

brand card allows patients to

stay on their brand name drugs at generic price

no monthly charges and valid in most canadian pharmacies

Ex: InnoviCares, RXHelpONE

off-formulary interchangeability (OFI)

• OFI is the application of interchangeable designations to drug products where the original products (brands) are not listed as benefits in the formulary

• Some OFI products may be eligible for coverage under ODB through EAP

EAP program

facilitates patient access to drugs and products not listed on the formulary or where no listed alternative is available

patients prescriber must submit a requesting document providing clinical rationale for requesting the unlisted drug and why covered benefits are not suitable

enteral nutrition products are eligible for coverage under ODB when prescribe by the physician or NP only if

this is the patient’s sole source of nutrition

for enteral nutrition coverage for ODB patients must meet one of the following

1. oropharyngeal or GI disorders resulting in esophageal dysfunction or dysphagia (head and neck surgery, neuromuscular disorder, cerebral vascular disease where dysphagia prevents eating

2. maldigestion or malabsorption disorder and/or significant gut failure where food is not tolerated (pancreatic insufficiency, biliary obstruction, short bowel syndrome)

3. for patients requiring the use of a chemically defined diet as a primary treatment of a disease where the therapeutic benefit has been demonstrated (crohn’s disease)

health network system

province wide computer system that links pharmacies directly to the ministry

• can identify drug interactions, duplicate prescriptions, double doctoring, frauds

• pharmacy charges you for your portion of the rx costs and dispensing fee

dispensing fee

flat fee set by the pharmacy for each drug dispensed that covers the cost of preparing and dispensing the drug

drug plans may limit or cap the amount that will be reimbursed for a dispensing fee

copay

an upfront fixed fee that the plan member must pay out of pocket for each prescription filled

deductible

fixed amount to be paid by the plan member out of pocket before the plan will begin to cover their drug expenses (usually charged annually)

coinsurance

• the percentage of a covered healthcare service (drug cost) that the employer or the patient pays after the deductible is fulfilled

• may be expressed from the perspective of the insurance company or the patient (if the patient has a 10% coinsurance, this means the plan pays 90%)

co-ordination of benefits

• a situation in which a plan member is covered under more than one public and/or private insurance plan and payment of the members covered medication must be coordinated between the plans and their respective payers

• prescription is put through the patients insurance first and then their spouse

max-cost exceeded

• a situation in which a plan member reaches the maximum amount that their plan will cover and must pay for all future expenses out of pocket

what determines the total prescription cost

• cost of drug + markup + dispensing fee

drug use evaluation (DUE)

• criteria based, ongoing, systematic quality assurance designed to ensure that drugs are used appropriately, safely, and effectively

• used to measure effectiveness

• to capture inappropriate prescribing patterns

who should be involved in the DUE process

prescriber, pharmacist, nurse, and administrator

how is DUE done

• either retrospectively or prospectively

• actual drug use is compared to standards (how the drug should be used)

• based on findings can provide prescribing education

• PDSA cycle (plan-do-study-act) is done to determine compliance with standard

What organization approves a drug for marketing and sale

Health Canada

who provides recommendations on whether a drug should be added to the formulary

CDA (Canada’s Drug Agency)

every new marketed novel drug needs to be reviewed by the CDA prior to submission for provincial formulary (exception: new generic drugs)

provinces review CDA recommendations and

make decisions based on resources available on whether to add a drug to their formulary

they do not have to follow the CDA recommendations

nursing home DUEq

• pharmacist consultant working with MD, RNs, to review medications and offer suggestions as medication experts

• academic detailing: pharmacists providing one on one education to other HCPs regarding drug use in elderly

third party DUE

• limited list of approved drugs and OTCs

• coverage driven by employers benefits

• focus is mainly on cost as opposed to clinical evidence

restrictive hospital formulary

• provide selected products and substitute drugs with a recommended alternative that is available

unrestrictive hospital formulary

all medications are covered

who makes the formulary decisions in hospitals

reviewed by the Pharmacy and Therapeutics (P&T) and approved by Medical Advisory Committee (MAC)

P&T is a subcommittee of MAC

what is the mission of the MAC and P&T

to promote safe, rational and cost-effective distribution, utilization and administration of drugs

role of MAC

• develop, review and revise policies and procedures about safe, cost-effective drug use and administration of medications

• review use of approved medications for unapproved indications and make recommendations

• complete drug utilization review of expensive drugs for effectiveness

how is drug use management in community conducted

• through patient monitoring for efficacy and side effects

• ensure that provincial formulary restrictions are followed

provinces compensate pharmacists for what roles in the community

• trial prescriptions, change in prescription dose, change in drug therapy due to intolerance, change in drug therapy due to inappropriate drug, refuse to fill prescription, smoking cessation, MedChecks

what is a pharmaceutical opinion

• Clinical intervention that occurs at the time of dispensing a prescription or when conducting a MedsCheck review in which a pharmacist identifies a potential concern that requires consultation with the prescriber

• can bill the government for a pharmaceutical opinion

minor ailment

• health conditions that can be managed with minimal treatment and/or self care strategies

• usually short term condition

• lab results usually not required

signs and symptoms of anaphylaxis

• urticaria, itchiness, angioedema (swollen lips, tongue, throat)

• respiratory distress (wheezing, shortness of breath, stridor)

• this usually occurs minutes or up to 4 hours after vaccination

naloxone is a

opioid antagonist that displaces opioids at their receptor sites temporarily

can temporarily reverse opioid overdose in minutes

nasal spray or injection

can be obtained without an rx from most retail pharmacies (offered free of charge in many provinces)

what are the signs of an opioid overdose

• pale and clammy skin

• extreme drowsiness or loss of consciousness

• unable to be woken up by shouting, shaking of shoulders or touch

• breathing that is very slow, irregular or has to be stopped

• slowed or no heartbeat

• pinpoint pupils

paxlovid criteria

• must be within 5 days of symptom onset to be effective

• must be positive COVID-19

• not-used for pre or post exposure prophylaxis or for treatment of severe/critical COVID-19 illness

• renal dosing available for those with renal impairment

• ritonavir is a inhibitor of CYP3A4