Chapter 1: Healthcare System in Canada
Pharmaceutical Marketing and Advertising
Regulations are set in Schedule F of Food Drug Act (FDA)
Canadian Healthcare System
Universal healthcare system. All citizens and immigrants have access to healthcare regardless of ability to pay.
Drug and Pharmacies Regulation Act
A provincial act about accreditation of pharmacies
Portability
A series of obligations on provinces which essentially guarantee any Canadian resident (after 3 months of being a resident) access anywhere in Canada on the same basis of local residents
Medicare
Canada's national health insurance program. Designed to ensure all residents have reasonable access to medically necessary hospital and physician services.
Accessability
Charges or other obstacles must not impede access to insured services
Coordination of Benefits
-Incase of 2 plans, decides which plan is billed first -Government plan is prime carrier -In case of 2 private plans (husband and wife both insured), whoever's birthday comes first, their plan should be billed first
Canadian Agency for Drugs and Technologies in Health (CADTH)
-1989 -An independent, not-for-profit agency funded by Canadian governments. -Its mandate is to deliver reliable, timely, evidence based information to Canada's health care leaders -Provides drug formulary reccomendations -Provides suggestions to existing public drug health plans -Answers questions about newly approved drugs (how does it compare to alternatives, who will it benefit, is it of good value)
Adjudicators
-Assure -Greenshield -Emergis -ESI -ClaimSecure Track components of a drug plan
Components of a Drug Plan
-Beneficiaries -Coordination of benefits -Payment rules -Deductibles/ co-payments -Drugs covered (formularies, interchangeability, prices, rules for coverage)
Drugs Covered
-Described by a formulary (can be an actual list of drugs or description of drugs) -Interchangeability -Plan may cover brand/generic -Prices vary in each province -Markup (adjudicator sets limits)
Problems with Claim Payments
-Drugs and products not covered -Deductible or copayment changes -Fee caps -Asking for extended month supplies
Product Identification
-Drugs identified by 8-digit drug identification number (DIN) -Diabetic supplies, medical supplies identified by product identification number (PIN) or pseudo-DIN -Natural health products identified by natural product number (NPN)
Rules for Coverage
-Generic -Special circumstances -Maintence, trial drugs -Exclusions -Reference based drug pricing
Third Party Prescription Drug Plans
-Great West life -Maritime Life -Canada Life -National Life -Telus Health -Manulife
Access to Cannabis for Medical Purposes Regulation (ACMPR)
-Licensed Producers can only provide dried cannabis to patients -Product label will indicate percentage of THC and CBD for that lot of cannabis -Medical cannabis CANNOT be sold with additives -Medical cannabis CANNOT be sold in dosage forms such as pre-rolled cigarettes, capsule, edibles or oils
Direct to consumer advertising (DTCA)
-Limited to posting of drug name, price and quantity ads and ads for the prevention or treatment of a specific disease listed in FDA -Provisions of free drug product samples to physicians is a key promotional activity for pharmaceutical companies
CHA covers
-Medically necessary hospital services -Medically required physician's services -Medically or dentally required surgical dental services requiring a hospital for proper performance
Public Health Agencies (PHA)
-Prevent and control chronic diseased and injuries -Prevent and control infectious diseases -Prepare for and respond to public health emergencies -Serve as central point for sharing Canada's expertise with rest of world -Apply international research to Canada's public health programs
5 Principles of CHA
-Public Administration -Comprehensiveness -Universality -Portability -Accessibility
Responsibilities of Provincial Government
-Regulate healthcare services, professions, and drug distribution -Establishes standards for pharmacy practice and registration of pharmacist -Areas not included under CHA (public health, pharmaceuticals, mental health) -Financing hospitals, physicians, other healthcare professionals, and drugs for seniors and those on social assistance
Responsibilities of Federal Government
-Regulates new drug approval, manufacturing, Canada Health Act, Controlled Drug and Substances Act -Fiscal Role -Steering role, national standards, portability -Leadership/coordination role -Special Groups
Drug Interchangeability Dispensing Fee Act (DIDFA)
-Relates to drug interchangeability and requires that drugs that are considered interchangeable be listed in formularies. -Reimbursement of products is based on a lowest cost policy meaning pharmacists are required to dispense the lowest costing product in a category of product
Provincial Drug Benefit Programs
-Seniors over the age of 65 -Social welfare recipients -Persons with disabilities
CHA does not cover
-Services offered by healthcare professionals other than doctors, particularly outside of hospitals -Services in sectors outside of hospital: longterm care, pharmaceuticals, rehabilitation services, and dental care (provided they are outside of hospitals)
Federal Hospital Insurance and Diagnostic Services Act
1959
Canada's First Medicare System
1962
Royal Commission on Health Services
1965
Bill 227
1966. Creates national Medicare program. Federal government agrees to pay 50% of provincial health costs
Established Programs Financing
1977. Federal government replaces 50:50 funding with a 5-year block funding to give provinces more control over health expendatures
Canada Health Act
1984. Act passed in parliament with adherence to the 5 principles. To protect, promote and restore the physical and mental wellbeing of Canadians
Canada Health and Social Transfer (CHST)
1995. Replaces transers for a) social assistance and social services and b) for health and post-secondary education
National Forum on Health calls for medicare to be extended to cover homecare and pharmacare
1997
Universality
All insured parties are entitled to equal access to insured services
Pharmacy Act
Authorizes pharmacies to administer a list of vaccines for preventable diseases, compounding, promotion of health and treatment of diseases, disorders, drug monitoring
Federal Public Drug Benefit Programs
Federal Government oversees drug benefit programs for the following: -First Nations -Veterans -Canadian Forces -Certain designated classes of migrants (refugees, inmates, inmates on parole)
Constitution Act
Formed in 1867. Determines roles of Federal, Provincial and territorial healthcare services
Public Administraiton
Healthcare insurance to be administered on a non-profit basis by a public authority responsible to the province and subject to audit
Comprehensiveness
Insurance must cover all insured services; get essential services, supplied by hospitals, medical practitioners and dentists. Each province determines which services are insured
Deductibles
Must be applied first, either as annually or quarterly -Can be calendar year or arbitrary period
Beneficiary
Person who is eligible to be covered by the drug plan (employee, spouse, dependants) -Tracked by birthdate -
Veteran Affairs Canada (VAC)
Provide pensions for disability or death, economic support in the form of allowances, healthcare benefits, and services to: -Canadian Forces -Merchant Navy from WWI, WWII, Korean War -Civilians who had wartime service -RCMP survivors
Non-Insured Health Benefits (NIHB)
Provides coverage for a limited range of these goods and services when they are not insured by provinces, territories or other private insurance plans
Decentralized Healthcare
The healthcare system is owned and operated by provincial governments