JURIS FINAL - DEC 2024 PDF
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This document discusses the goal of Canada's healthcare system, which is to provide all Canadians and permanent residents with access to necessary medical services free of charge. It also details the funding sources for healthcare, both public and private, and the core values of equity and fairness.
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MODULE 3 - HEALTH CARE SYSTEM What is Canada's healthcare system goal? - all Canadians and PR of Canada are to have access to medically necessary hospitals, physician, diagnostics and nursing services free of charge at the point of service Canada’s healthcare systems are funded by whom? - public...
MODULE 3 - HEALTH CARE SYSTEM What is Canada's healthcare system goal? - all Canadians and PR of Canada are to have access to medically necessary hospitals, physician, diagnostics and nursing services free of charge at the point of service Canada’s healthcare systems are funded by whom? - publicly funded - privately delivered —> to these: dr office, hospitals and labs What are the two core values of Canada’s HC system? - equity & fairness What is equity? - access to the sources they need - being treated the same way regardless of age, race and gender What is fairness? - get what they need depending on their situation What are the sources of funding? - private: 28% - private insurance and out-of-pocket - public: 72% - provincial and federal government FUNDING OF HEALTHCARE - PUBLIC SECTOR FUNDING What are the sources of funding for the federal government? - The Canada Health Transfer (CHT) - they cover services for certain groups What are the sources of funding for the provincial government? - HC premiums, copayment, payroll taxes, sales tax - but they CAN NOT be a barrier to accessing healthcare for those who CAN NOT pay the premium What is the sources of funding for a private fund? - private insurance and out-of-pocket services - covers the basic services during the wait period - after the wait period, it supplements, no duplication, no substitution Most of the money from the PUBLIC sector goes where in order? - hospitals, physicians and drugs What is the ranking of spending in the PRIVATE sector? 1. prescription drugs 2. dental care 3. other institutions - hospitals 4. non-prescription 5. vision care SERVICES AND PAYMENTS PROVINCIAL Coverage: Provincial Basic services: covers most residents of the province (Canadians and PR) Supplemental services: may pay for some services for certain groups (drugs for seniors, vision care) FEDERAL Coverage: Federal Basic services: prisoners in federal institutions, serving members of the Canadian forces, resettled refugees through the Interim Federal Health Program (IFHP) Supplemental services: prisoners in federal institutions and serving members of the Canadian forces, aboriginals (NIHB), refugees (IFHP), RCMP officers, MPs, federal judges and veterans (PSHCP) PRIVATE Coverage: private insurance or out-of-pocket Basic services: new immigrants (or those returning after an extended absence) while waiting for the provincial coverage, physicians and hospital services that are not covered by the provincial program Supplemental services: cover supplemental services for those who do not receive coverage for these services under the provincial or federal health programs What are basic services? - covered and paid by the provincial government - medically necessary hospitals, physicians, nursing, diagnostics and medically necessary ambulance services - provincial government (residents of the province) - federal government (certain groups) - RCMP - private fund (during the wait period) What are supplementary services? - uncovered drugs - prescription drugs, dental care, vision, ambulance, home care, LTC and services offered by allied health professionals - private funds - provincial government (optional coverage) - federal government (certain groups) What are the types of care? - primary care (entry-level care) - secondary care (specialized care) - tertiary care (highly specialized care) - quaternary care (investigational/experimental treatments) What is the more common kind of care offered in the hospital? - secondary care - with the exception of the ER What are factors that affect spending in healthcare? - aging populations (baby boomers from - health-sector inflation 1946-1964) - defensive medicine - better diagnostics/early diagnosis methods - longer life spans - newer, more effective/more expensive drugs - apply effective disease prevention strategies - drug commercials from US channels (vaccines) - patients’ knowledge about newer agents - better diagnostics/early diagnosis methods - rising income Who is involved in delivering healthcare? - government (federal and provincial) - healthcare agencies - healthcare settings - healthcare professionals What is the role of the federal government? - funding the provincial health programs - ensuring the compliance of provincial health programs with CHA principles - covering certain services for certain groups - providing services through federal agencies and federal programs What is the role of the federal government regarding basic and supplementary services? - active members of the Canadian armed forces - prisoners in federal institutions - resettled refugees: cover the basic services until they are covered by the province. Supplementary services are covered for up to 1 year by the Interim Federal Health Program - IFHP covers refugee claimants, asylum seekers, victims of human trafficking and detainees What is the role of the federal government regarding supplementary services? - refugees for up to 1 year (IFHP) - after 1 year, get a job, learn the language, support yourself - public service health care plan = RCMP offices, MPs, federal judges and veterans - non-insured health benefits: native Canadians What is IFHP - Interm federal health program - covers the cost of healthcare services for resettled refugees, protected persons, refugee claimants, and asylum seekers - victim of human trafficking and detainees What is PSHCP - public service health care plan What is NIHB - non-insured health benefits - native Canadians - supplementary services What is SAP - special access program - facilitates access to drugs used for the diagnosis, treatments and preventions of serious and life-threatening conditions when conventional therapies failed, unsuitable or unavailable in Canada What is the role of the federal agencies - Health Canada? - sets the principles of the Canadian healthcare system by administering the Canada Health Act - issue drug establishment license (DEL) and medical devices establishment license (MDEL) - monitor the safety and efficacy of the marketed health products by different directorates - collect and share data concerning ADR (Canada Vigilance, health product info watch, Med Effect Canada) - they collect ADR - approve new drugs (issue notice of compliance = NOC) What is the role of the public health agency? - disease prevention and control - vaccines and immunizations - emergency preparedness and response - food safety monitoring, poisoning and recalls - educate the public on healthy living - traveler health What is the generic drug approval? - abbreviated new drug submission - drug is compared to a Canadian reference (NOC - includes the brand name to which it is interchangeable) - there are 4 criteria for the approval of new generics: bioequivalence, pharmaceutical equivalence, same route of administration and same indications What is NOC? - letter from Health Canada noticing the drug is approved - notice of compliance What is bioequivalence? - making sure the drugs behave the same way in the body - they have 100 healthy volunteers to test the drug - but what can be different? the fillers - what is least important? - the dosage form - 80%-125% of the brand name and the AUC is the amount that is absorbed in the body What is the drug approval process? - bioequivalence - pharmaceutical equivalent - same route of administration - used for the same indications What is pharmaceutical equivalence? - same active ingredients, same strength and comparable dosage forms - identical active ingredient (s) - in the same amount - formulated in a comparable dosage form (least important) - fillers don’t matter What are biosimilar drugs? - biological drugs - not identical to the brand name and not interchangeable - studies should demonstrate that the biosimilar drug has: highly similar physical/chemical/biological properties/purities to the brand name && a similar safety, efficacy and pharmacological profile to the brand name What is the role of Public Health? - prevention and control of infectious and chronic diseases (WHIMIS / food poisoning happens at a restaurant) - developing plans to respond to public health emergencies when needed (quarantine and food poisoning) - prevention of occupational injuries (make sure staff are trained to prevent injuries - helmets, shoes, ladders) What is the role of the Patented Medicine Price Review Board - PMPRB - federal agencies? - sets the ceiling price for patented medicines (rx and non-rx) - review drug prices promptly - reports drug sales and price trends in Canada - regulates prices (FACTORY GATE PRICES) from innovators to hospitals, wholesalers and pharmacies ONLY What does the PMPRB not control? - they do not control prices from manufacturer to provincial drug plans (pan-Canada Pharmaceutical Alliance negotiation) What is the role of the CADTH - Canadian agency for Drug and technologies in Health - federal agencies? - provide evidence-based reviews about health technologies - CADTH common drug review (CDR) or CADTH drug reimbursement review process - accepts submissions from manufacturers and review evidence about new drugs - make recommendations to decision maker, as to which drug to consider for coverage and about terms of reimbursement What is the role of the provincial government? - administer health plans in compliance with CHA (Canada Health Act) - they define medically necessary services (all Canadians and PR) - may fund additional services to certain groups (drugs for seniors, ambulance, vision care to diabetics) - negotiate service fees with providers - fund hospitals and other healthcare facilities - plan and execute health initiatives - they establish an independent employer-funded compensation plan for workers injured on the job What are health care clinics? - privately owned and operated - physicians get paid on fees for service basis or per capita basis What are healthcare hospitals? - funded by the provincial government and offer primarily secondary care services What are LTC facilities? - funded by the provincial government +/- copayment - offer 24/hr access to medical care - regulated by the provincial health authorities What are hospice homes? - offer end-of-life/palliative care - funded by the provincial government +/- copayment - regulated by provincial health authorities What is a home for special care? - offer 24-hour support and supervision for patients with severe mental illnesses - funded by the provincial government +/- copayment - regulated by the provincial health authorities What are group homes? - offer care for patients under 18 who have health, behavioural issues (aggressive behaviour, eating disorders and suicidality) or social issues (neglect, domestic violence or parental divorce) What is home care? - necessary care that is delivered to patients who are stable in their homes - and funded by the provincial government What are retirement homes? - paid by the residents with optional fee for service - less regulated What is assisted living? - funded by the provincial government for those who qualify - for patients with complex needs (pt with physical disabilities, persons with acquired brain injury), those who live at home and require a higher level of personal support THIRD PARTY What is managed care? CPhA defined - - quality care that uses only the most cost- effective treatments and encourages preventative health strategies - considered a cost-containment approach - the role of pharmacists: counselling, drug therapy monitoring, clinical services, prescribing and promoting preventative health strategies (vaccines, lifestyle modifications) What are the usual cost containment measures? - formulary (drug listing) - pricing strategies - preferring generics - excluding certain classes - excluding coverage for certain drug classes (drugs for erectile dysfunction or drugs for pre-existing conditions) - raising deductibles, copayments and coinsurance to shift more cost to patients - setting criteria for drug coverage such as prior authorization and step therapy - rising cost-sharing (copayment and deductibles) - limiting the quantity of drugs dispensed, such as dollar limits and trial quantities - removing drugs with insufficient evidence of efficacy from the formulary - delisting drugs with less evidence - identifying and responding to patterns of inappropriate utilization What are innovative cost containment measures? - PPN (preferred provider network) - limiting dispensing fees - using innovative pharmacy models - strict pre-authorization process FEDERAL ACTS AND REGULATIONS INTRO TO LEGISLATIONS Why do we need laws? - we can interpret the laws and determine what they mean - we can apply laws to everyday pharmacy practices What is legislation? - both act (enacted by the legislature) and regulations (made by a person or body whose authority to make them is set out an act) BILL —> ACT —> REGULATIONS LEGISLATION = ACT + REGULATION What is a bill? - a proposed act that is before parliament for consideration - for a bit to be enacted and become and ACT, it must receive 3 readings to be passed by the legislative assembly and then receive royal assent What is an act? - (difficult to read, difficult to change, doesn't give details) - it is a bill that is passed by parliament after its 3rd reading - the term ‘statute’ and ‘act’ are interchangeable (act=statute=law) - acts outline ‘what is to be done or not’ What is a regulation? - a description of the procedures to be followed in carrying out the provision to the act - they define the application and enforcement of legislation - they serve as rules of the act and explain how to follow the act - the process for amending a regulation is usually shorter than the process for amending the Act Reading the legislation order - title (full legal name), short title (abbreviated title), part (like chapter), section, subsection, clauses schedule (formal list) What are ways to regulate the profession? - legislation - policy - by-laws - guidelines - standards of practice What is a by-law? - rules established by organizations or associations How are bylaws practiced in the pharmacy? - enable various pharmacy regulatory authorities to regulate the profession and make changes/updates quickly - provincial and territorial governments give pharmacy regulatory authorities the authority to enact by-laws What is a standard of practice? - describe the specific activities that must be performed to meet the requirements of the regulations - they are accepted consensus of practice by members of the profession - they describe the existing, generally accepted, standard on recurring/significant issues - they are published to assist practitioners in staying current and to promote best practices - example: model standards of practice for pharmacy technicians Pharmacy techs gather, review, enter and or update the information required to create and/maintain patient records including - patient demographic, health history, allergies and drug and medical device use What is a policy? - outlines the position of the publisher of the policy on a specific practice situation - example: loyalty points and rx for out-of-country What is a guideline? - suggestions of voluntary behaviour that might assist practitioners; they are not intended to be mandatory - they are recommendations on how members can adhere to policies and standards of practice - they serve as a ‘word to the wise’ - they do not have to force of law or a regulation CANADA HEALTH ACT What is the CHA? - enacted by the HC in ’84 and represents the cornerstone of the Canadian health care system - ensures that all eligible residents of Canada have reasonable access to medically necessary HOSPITAL AND PHYSICIAN SERVICES, without direct charges at the point of service - and provides for criteria and conditions that the provinces and territories must fulfil to receive the full federal cash contribution under the Canada Health Transfer (CHT) What are the Canada Health Act principles? - public administration, comprehensiveness, universality, accessibility and portability What is public administration? - must be carried out by a non-profit/by public authority. - must be auditable What is comprehensiveness? - all necessary services must be insured /covered What is universality? - all persons insured must receive uniform coverage What is portability? - insured services must be maintained when an insured person moves or travels for a minimum waiting period What is accessibility? - services that must be unimpeded by financial or other barriers - providers must be compensated fairly Public Administration Example: A public health insurance program must be managed by a government agency, not by a for- profit private insurer. For instance, in Canada, provincial health plans like OHIP in Ontario are managed by provincial health ministries. This ensures transparency and allows for public audits to ensure that funds are being used effectively. Comprehensiveness Example: All medically necessary services—such as doctor visits, hospital care, and surgeries—must be covered under a health insurance plan. If someone needs an essential medical service, it should be included. For instance, if a patient requires surgery after an accident, the entire cost should be covered by their public health insurance plan. Universality Example: Every insured individual in a country should have the same access to covered medical services, regardless of age, income, or location. In Canada, this means all citizens and permanent residents are entitled to the same standard health coverage under their provincial plans, ensuring everyone has access to the same services. Portability Example: If a resident of Ontario temporarily moves to another province or travels internationally, their health insurance coverage should continue for a specified period. For instance, if an Ontario resident is in another province for a short-term job, they should still receive insured services without needing a new health plan, at least for a certain waiting period. Accessibility Example: Health care services should be available to everyone without prohibitive costs. For instance, an emergency room visit or primary care consultation should not come with out-of-pocket expenses that could prevent individuals from seeking care. In addition, doctors and other healthcare providers must receive fair compensation to maintain service availability and prevent shortages in care access. FOOD AND DRUG ACT What is the FDA? - health Canada is responsible for establishing standards for the safety and quality of all foods and drugs sold in Canada - the department exercises this mandate under the authority of the FDA and pursues its regulatory management under the food and drug regulations What is FDA: Schedule A? - a list of disorders, diseases and abnormal physical states for which treatments may not be promoted to the public - allowed types of drug advertisements - Health Canada is the regulator of drug advertisement What is FDA: schedule B? - a list of all established sources on drug set of standards for drug purity What is FDA: schedule C? - list of drugs, other than radionuclides, sold or represented for use in the preparation of radiopharmaceutical - also includes information about manufacturing and labeling requirements What is FDA: schedule D? - list of allergenic substances used for the treatment of diagnosis of allergic or immunological diseases What does FDA reg: PDL consist of? - part C: contains the PDL - does not include medicinal ingredients listed in the CDSA - and contains information of the manufacturing and labeling requirements What are PDLs two parts? - list of products for human use - list of products for vet use - sold in a form that is not available for human use What is FDA reg part D? - deals with vitamins, minerals, and amino acids and describes the amounts which may appear in food and daily intakes - NPH regulations must be read in conjunction with part D What is an establishment licence? - certification issued by Health Canada for drug manufacturing and whole-selling What is FDA reg part J? - deals with restricted drugs - use of these drugs is restricted to licensed dealers, qualified research investigators and law enforcement officials Who is authorized to prescribe from the PDL? - physicians/surgeons (MD) - veterinarians (DVM) - optometrists - dentists - midwives - naturopaths - nurses (NPs and RN) - chiropodists and podiatrists - pharmacists Pharmacists are authorized to sell RXs drugs under the following conditions: - with a prescription - to all patients who present a prescription signed by a prescriber authorized in a Canadian jurisdiction - with a prescription - drug manufacturers: wholesalers and pharmacists - hospitals: government departments (after receiving an order signed by the minister or delegate) KEY INFORMATION FROM FDA REGULATIONS - prescription retention for 2 years - reporting to ADR - mandatory to marketing - authorization holder - it is voluntary for healthcare professionals - mandatory for the manufacturers - allowable limit of active ingredients in dosage forms >90% and $25,200 - senior couple whose income >$41,500 will pay - the first $100 in prescription cost every year starting August 1st - after paying the $100 deductible, they will pay $6.11 for every prescription - seniors making less than the limits above will pay $2 for each prescription dispensed (no $100 deductible) APPLICATION IS REQUIRED - copay is determined by MOH when a claim is processed What is the cost-sharing for trillium recipients? - according to the household income, recipients will have to pay the cost of their prescriptions up to a certain $ value (divided by 4 quarters - August, November, February and May) - after satisfying the deductible, a copay of $2 applies - residents of special care facilities, recipients of the Ontario Social Assistance program, and people receiving professional services under the home care program will pay $2 copay - OHIP+ and residents of LTC facilities $0 SCENARIO: - Mr. Smith is 75 years old, ODB patient - he has a Rx for Norvasc 5mg and there is an interchangeable generic available - the dr wrote on the rx NO SUB - can we give Mr. Smith the brand name? - We call the dr, do the ADR form and if they still want the brand - they pay the difference Medically necessary- NO SUB - ODB recipients - ODB will pay the higher cost (for the brand/generic) - sign an ADR form (minimum of 2 interchangeable generics) - the PHYSICIAN MUST - complete, sign and send to the pharmacist (ADR form) and write NO SUB on the RX - can be written or verbally NO SUB for ODB recipients - upon receiving the ADR report form the pharmacist must - note on the form that is it an ODB no sub - fax or mail the completed ADR forms - retain a copy of the completed form on file - form does NOT need renewal but NO SUB must be written on the RX - BUT WHAT HAPPENS IF THE PHYSICIAN REFUSES TO GIVE MR. SMITH THE ADR REPORT FORM AND MR SMITH STILL WANTS THE BRAND NAME OF THE DRUG? - he will have to pay the brand and generic cost difference SCENARIO: - Mr Taylor is an ODB patient & tried several antihypertensive drugs but do not appear to work - there is a new drug called: Edarbi (Azilsartan) but it is not listed in the CDI and it is expensive - is there any way for this to be covered under ODB? - YES the exceptional access program What is the EAP? - reserved for clinical situations when a disease can cause severe disability and the treatment is not covered under the ODB and other provincial programs - DRUGS COVERED UNDER THIS PROGRAM ARE - expensive (cheaper alternatives are available) - drugs may not have traditional evidence of efficacy/safety but meet specific clinical need - expensive drugs with risk of usage outside approved indications Who can make the EAP request? - physicians and nurse practitioners - the request outlines the patient's medical condition and why the patient cannot take ODB COVERED products known as icr (individual clinical review) - the request is submitted to ODB Who reviews the request for EAP? - the committee to evaluate drugs (CED) - CAN TAKE 6 WEEKS - the ministry will send a response to the physician to confirm if the request is approved or denied - physicians will fax the approval to the pharmacy - the pharmacy does NOT have to keep it on file EAP approval process - the approval is specific to the particular drug name, strength and dosage form - and has effective and has an expiry date (can be extended if the physician requests a renewal but can also take 6 weeks) - the pharmacy can now submit the claims to ODB for edarbi and will be covered now SCENARIO: - Ms. Martin is an ODB patient and has a prescription for Celebrex - the pharmacist contacts the physician to inquire whether or not she qualifies for a LU code. What is a limited-use code? - some products are considered inappropriate for being a general benefit and thus are listed as limited-use products - they are usually: very expensive, can be used for off-label indications and are effective but have the risk of severe adverse reactions What is the criteria for LU drugs? - very expensive (cheaper alternative available) - can be used for off-label indications - effective but have risk of severe adverse reactions How does a patient quality for an LU code? - the patient must meet specific criteria - the physician must verify the patient is qualified by providing a 3-digit reason code “reason for use” RFU code - the rx for LU drugs must have the physicians licence number (it can be taken verbally) How can RFU codes be communicated? - handwritten on the Rx - electronically - verbally during a verbal order - verbally when Rx is being transferred What is a defined authorization period? - each RFU has a defined authorization period (some are indefinite) and a new RFU should be obtained for coverage to continue - refills and new RX (without new RFU) can be dispensed within the authorization period How long can LU codes be kept on file? - 2 years What happens when a patient does not meet the LU criteria? - recommend something else - and have them pay full price because Celebrex is not covered with ODB SCENARIO: - Mr Walter is an ODB patient and has a prescription for Ramipril 5mg caps - the pharmacist only dispensed 30 capsules, not 100 - why did the pharmacist reduce the quantity? - the patient requests less - the insurance doesn’t cover all of it - the RX is not safe What is a ODB trial program? - for new Rx (never had the drug before or in the last 12 months), ODB recipients will receive an initial trial quantity of 30 days supply EXCEPT insulin - the program can be overridden (dispense the full quantity) by the pharmacy staff in 3 cases - the patient had the product in the last 12 months (the drug was covered by a private 3rd party and had a sample from the physician for at least 2 weeks or had the rx in the hospital - the patient is unable to return to the pharmacy in 30 days - the drug form is not splittable (inhalers) CONTINUED SCENARIO - Mr. Walter accepted 30 capsules and he is back 15 days to refill the rx. he was shopping in the store and thought to pick it up instead of making another trip. is it okay to refill the rx 15 days early? - no because he has more than 10 days of supply When is it okay to do an early refill? - when we submit a claim to ODB more than 10 days prior to the end of the previous supply, the HNS will give us a warning ‘REFILL TOO SOON’ - even though we must comply, the pharmacist can use their judgment - the reason for an early refill should be documented SCENARIO: - Dalton has a rx for Lipitor 20mg and the quantity to dispense is 200 tablets. he wants the full quantity, is there a problem with that? - dispense 100 tabs because of the 100-day supply rule What is the maximum quantity to dispense? - for most ODB patients, pharmacists must dispense the lesser of: - the entire quantity prescribed - 100 day supply - FOR PEOPLE RECEIVING SOCIAL ASSISTANCE - the max qty is 35 days - why? bc these people should be trying to find a job - once they find a job, the program stops - FOR TRILLIUM: the lesser of 100 days supply or a qty sufficient to extend to 30 days after the end of the eligibility period (calculated by HNS) - possible OSPE question How many max qty dispensed for those on the Ontario social assistance program? - 35 days supply How many max qty dispensed for those on trillium? - 100-day supply or a qty sufficient to extend to 30 day after the end of the eligibility period CONTINUED SCENARIO - the pharmacist dispensed 100 tabs of Liptor 20mg, dalton explained that he will be going on vacation and will not be able to come back for a refill - now what? - only give 100 days supply What is the vacation supply for ODB patients? - ODB recipients travelling outside of the province for between 100-200 days may obtain an early refill of a max of 100 days supply - patients must provide evidence of travelling - insurance document, write a letter to the pharmacist - pharmacist must keep the letter on file (do not attach to rx but on a separate file) for 24 months - 2 years What is the vacation supply for trillium recipients? - the benefits year starts august 1st - from august 1st to january 31 - an early refill of vacation claim of 100 days may be allowed (documentation required) - no vacation claims allowed between feb 1 and july 31 - pt must pay and submit the claims for possible reimbursement SCENARIO: Mrs Zole, wants to get her medications in a weekly blister pack. Can we bill the medications weekly and get a dispensing fee? - odb only pays a max of 2 dispensing fees per 28 days - max dispensing fee is 5 per patient per year - applies to 15 commonly used CHRONIC-USE drug categories - after the max ODB will pay the cost + markup - the counting of 5 claims will start after satisfying the deductible - the new max applies to the trillium program What are the exemptions for the limit on dispensing fees? - OW - Ontario Works recipients - residents of LTC facilities or other publicly funded care settings - for extemporaneous preparations of chronic-use medications - drug products specified by the executive officer (narcotics and controlled drugs, psychotherapeutic medications, and palliative care drugs What if a patient needs to receive weekly meds? - the pharmacist may decide to dispense more frequently due to physical, cognitive or sensory impairment or complex medication regimen - dispenser must notify the prescriber of the rationale of their decision of more frequent dispensing - the authorization is valid for 1 year and the patient's condition must be assessed annually What about other medications that do not fall under the 15 categories for dispensing fees? - maximum of 2 dispensing fees every 28 days SCENARIO: the pharmacist wants to maximize the outcome of the medscheck program. What is that and what can the technician do to help with the program? - patients can have a meeting with the pharmacist to go over the medications that the patients take and take safety - Annual: $60/pt/yr, $25/follow up - Diabetes: $75/pt/yr, $25 follow up - Home med check: $150/pt/yr What is med check? - one on one meeting between the pharmacist and patient - making sure the patient is getting the most benefits out of their drugs - ODB will pay the pharmacists for this Who qualifies for medscheck? - Ontario residents - valid OHIP - taking at least 3 prescription drugs for chronic conditions What is a pharmaceutical opinion? - problems that can put the patient at risk (high dose, lose dose, drug-to-drug interaction, allergy) - when the pharmacist identifies a concern about the patient’s therapy (medscheck, dispensing new/refill RX) —> make recommendations to the physicians —> physicians may change the RX, do not change the RX or direct pharmacists NOT to dispense the medications - $15 per intervention per prescription (When the pharmacist finds a problem) - the physician may change the RX, keep the RX unchanged, to direct the pharmacist to NOT dispense the medication - when submitting a pharmaceutical opinion claim, the pharmacist is the prescriber and there must be a clear reference to the prescriber's name and the prescription number What does the pharmaceutical option NOT APPLY TO? - Out-of-stock situations - too soon/too late refills - completing /clarifying the RX - changing the drug to a covered one NARCOTIC SAFETY AND AWARENESS ACT + PATCH 4 PATCH Why was NSAA enacted? - to enable the Ministry of Health to monitor the prescribing and dispensing of prescriptions narcotics and other controlled substances as well as to identify the uses of multiple medications, multiple pharmacies or visiting multiple physicians - helps us identify the use of multiple drugs, multiple pharmacies and seeing multiple physicians - enacted the NMS - narcotic monitor system What additional information is required for narcotic and controlled drug prescriptions under NSAA? - prescriber registration number - CPSO - the NUMBER and TYPE of approved form of patient ID (does NOT have a photo) - COMPUTER-GENERATED or HANDWRITTEN - RX can be dropped, faxed or verbal Who is exempted from having their ID recorded on the Rx? - hospital in-patients and doses given upon discharge - young person in a youth custodial facility - inmate in a correctional facility - if the Rx was issued by a vet What happens if the patient does NOT have an ID? - prescriber professional judgement - reasons why the patient needs the medication before having an ID - the prescriber must tell the patient to pick up the prescription in person to receive it from the pharmacy delivery service in person - the pharmacist must keep records of the Rx Is ID required for prescription re-authorization? - YES, renewal reauthorization = new Rx and must meet all requirements - the physician does not have to ask the patient to go to the office to review their ID unless it is necessary Do the requirements apply to prescriptions for a child? - yes - the child's information must be recorded not the parents What should the pharmacy staff do when prescribing an Rx for a monitored drug? - process the RX as usual - with prescriber registration and number and type of ID When the patient comes to pick up their prescription do I need to see an ID? - no, but may do so if the dispenser has a concern What happens when someone else comes to pick up the prescription? - yes but record who - name, address of the agent and number of type of agent ID - this applies to the taxi driver assigned by the patient or nurse - can be recorded on Rx Rx is ready but the patient did not pick it up. Instead, the patient's spouse (or designated agent) arrived to collect it. Can the rx be given to the spouse? - yes but ensure to record the following - name and address of the agent - number and type of agents ID (no specific ID requirement, but an ID to verify identity such as Employee ID, billing statement, drivers licence, or Ontario photo card) - this also applies to a taxi driver assigned by the patient or a nurse receiving the medication to a long- term care facility or retirement home - documentation can be recorded on the prescription or elsewhere as appropriate What if the RX does not have an ID, can we still process it? - yes but the patient must pick up the RX themselves - if the RX will be delivered - it must be delivered by the pharmacy delivery - it must be picked up by the patient, not the agent Can we get the patient's ID and prescriber registration number over the phone or fax? - yes from the prescriber or delegate - you can not just write it if you have it, must be verified Does the driver have to verify? the patient’s ID before dropping the prescription? - if the rx is received by - the patient = no ID is not required - patients agent = the driver must record the name and address of the agent, the type and number of an ID that verifies the name and address of the agent What happens if you receive a prescription from the dentist for 30 tablets of a monitored drug for office use - do we still need ID? - no, for office use are exempted from ID - prescriber registration number is REQUIRED What is a narcotic monitoring system? - an electronic database that collects and stores data on the prescribing and dispensing of monitored drugs in ontario - data submitted by the dispenser - used to identify inappropriate patterns of prescribing, dispensing or using monitored drugs - alert pharmacists for multiple drugs, pharmacies of early and late refills What data does the pharmacy submit to NMS? - prescriber registration ID number - pharmacist ID - patient info = name, ID number DOB, Rx # - date on which the monitored drug is dispensed - drug info: DIN, QTY and day supply SAFEGUARDING OUR COMMUNITIES ACT - P4P What is P4P? - started in Guelph and Wellington county - OBJECTIVE: to reduce the abuse of fentanyl patches What is the role of the prescriber for P4P? - name and address of the pharmacy of where it will be dispensed - the physician to notify the pharmacy that an Rx was issued - ‘first RX’ if the physician did not prescribe fentanyl What do you do when you dispense p4p? - confirm the rx meets the requirements and the pharmacy name address and notification - dispense the patches in exchange of the returned patches - use judgment if there is a discrepancy - notify the physician of the received and dispensed patches - examine, document and secure How do you handle returned patches? - examine, document and secure (secure: keep them in a safe place until they are disposed of and away from the public) - HPSA can dispose of them What are the exceptions when dispensing patches? - authentic prescriptions from another province - another pharmacy was documented by the dispenser on the prescription and no patches were dispensed - to institutionalized patients (LTC, inpatients and correctional facilities) - as long as the policy is in place and the pharmacy has a copy of the policy What does the patient have a right to when getting dispensed patches? - the right to choose the pharmacy - must comply with the program - secure use of patches, return used patches and unused patches to the pharmacy What should the pharmacist do? - when the patient returns no patches or fewer patches = use judgment or have a right to refuse - what if this happens often? = Do not give/police report - what if the patient claims that patches were lost? = Do not give / or use professional judgment - what if the patient requests more than the patches returned because of travelling? = as long as there is proper documentation MODULE 4 - PART 3 - DIDFA and Regulations (drug interchangeability and dispensing fee act) DIDFA & regulations provide for: - mandates of dispensing an interchangeable generic - def. of interchangeable product - ‘no sub’ - professional fee - quantity to dispense - rules of interchangeability - receipts of requirement - retention of invoices - health network system What is the purpose of DIDFA? - to make it mandatory to offer the patient a lower-priced medication alternative (interchangeable) if available - ensure the quality of interchangeable generic product - sets rules for handling prescriptions for interchangeable/non-interchangeable drugs What is an interchangeable drug? - “a drug or combination of drugs identified by a specific product name or manufacturer and designated as interchangeable with one or more of such products” - drug products manufactured by more than one manufacturer - contain the same ingredient in the same strength and same dosage form - provide equivalent action in the body - the manufacturer has to provide evidence of interchangeability - committee to evaluate drugs and executive officer - the interchangeable drugs appear in the Ontario Drug Benefit Formulary and comparative drug index SCENARIO 1 - Mrs. Thompson is in the pharmacy with a prescription for Lipitor and she wants to get the brand name. Can we do that? - yes the patient has the right to ask for the brand name - she has to sign on the prescription that she wants the brand name and we can give her the brand - if she is a cash payer: if the brand cost $100 and the generic cost $15, she will pay $100 - has to sign - if she has private insurance: we need the doctor to handwrite no sub on the rx, the insurance will pay - if the doctor says no to no sub (no point of giving her brand bc generic works the same way) and she has private insurance but still insists on brand name: get her to sign, give the brand name, she will have to pay the difference between generic and brand No Substitution - this does not apply to ODB patients - it applies to private insurance and cash payers ONLY - the brand name should be dispensed if: - the prescriber HANDWRITES ‘no sub’ or ‘no substitution’ - if the patient requests a brand name product (patient may pay the cost difference) Pharmacy Professional Fee - each pharmacy establishes its own fee - fee filed with the OCP registrar - appropriate sign displayed showing the ‘usual customary dispensing fee’ charged for each prescription (signs are available through OCP) - the SIGN MUST BE CLEAR AND SEEN BY ALL PATIENTS - the fee may be changed (the owner notify the registrar and waits for confirmation before changing the fee) What are the services covered under the professional fees? - maintain accurate and detailed patient records - counsel on Rx and OTC drugs - offer cost-effective alternatives when possible - check Rx for accuracy and completeness, allergy, and potential drug interaction - communicate prescriber/third party on behalf of the patient to solve problems - provide educational materials and advice on healthy lifestyle What is not covered under the professional fees? - delivery fee & rx transfer What happens if the patient requests to dispense less than prescribed? - pharmacist may dispense a quantity less than what the prescriber specified IF - lesser quantity is requested by the patient/agent (spouse) PRIOR to dispensing in WRITING - the professional judgement of the dispenser requires so - if the quantity exceeds the quantity paid for by the insurance What if the patient wants to be dispensed more? - we can not give more than what the prescriber prescribed DRUG INTERCHANGEABILITY - if its a brand name, check for interchangeability on generics - ‘no sub’ is only for those who have no insurance and/or they’re paying cash RULES FOR DRUG INTERCHANGEABILITY - the pharmacist may dispense the BRAND NAME without notifying the patient about the availability ty of the interchangeable generic AS LONG AS the pharmacist charges the patient the cost of the lower-priced interchangeable generic - because the brand name is expiring - if the rx has originally been filled for BRAND NAME, the pharmacist may refill the prescient without notifying the patient of the availability of cheaper interchangeable generic - whenever the several interchangeable generic may be dispensed, the patient has the right to request any specific generic NOTICE TO PATIENT SIGNAGE - when dispensing your prescriptions, your pharmacist may select an alternate brand of the same drug where permitted by Ontario law - you have the right to request an interchangeable product (alternative brand of the same drug) - ask your pharmacist if a lower-priced drug is being used to dispense your prescriptions - please feel free to consult your pharmacist about your prescription RECEIPTS - itemized receipt must be issued for all rxs - (show cost + professional fee + total price) - does not apply to non-prescription drugs - mark up is included in fees RETENTION OF INVOICES - every operator of a pharmacy must retain - for 2 years - each invoice and purchase record that relates to the purchase by the pharmacy of drug products to which the Act applies HEALTH NETWORK SYSTEM - links dispensaries to MOHLTC (or claim processor - insurance or adjudicator) computer systems - online claim processing - improve care by identifying - drug interactions - duplicate prescriptions - potential double doctoring - use of multiple pharmacies - inappropriate use of the system - too soon, too late refill How to use the ODB formulary and CDI - not a benefit = ODB does not pay ODB formulary and CDI used to - confirm a product is eligible benefit - guide pharmacist to change interchangeable stock - guide pharmacist regarding conditions for payment - confirm a drug is interchangeable under ODB - guide professional committees in hospital in selecting pharmaceutical products - compare price LU code: - if a patient has a limited use code and the patient wants a brand and the doctor says the patient does not qualify - they will have to pay the difference between brand and generic price - indefinite: valid only once REGULATED HEALTH PROFESSIONS ACT (RHPA) What is the RHPA framework intended to do? - better protect and serve the public interest - be a more open and accountable system of self-governance - provide a more modern framework for the work of health professionals - provide consumers with freedom of choice - provide mechanisms to improve the quality of care What are the key features of the RHPA? - health professional procedural code - Health Professions Regulatory Advisory Council - controlled acts - scope of practice - a statement that described what the profession does What is the definition of the scope of practice? - a statement that describes what the profession does What are health regulatory colleges? - a corporation that governs each regulated health profession responsible for regulating the practice of the profession and governing its members according to RHPA What is the health profession’s appeal and review board? - an independent third party with a mandate to review registration and complaints decisions of the health regulatory college - when a pt complains to the college about a dispensing error a pharmacist made What is the health professionals’ procedural code? - sets out the practical rules for the colleges regarding - registering members & handling complains - conducting investigations & carrying out discipline hearings - handling fitness to practice hearings - quality assurance programs - patient relations programs (OCP has a yt channel so they can communicate to their patients) - mandatory reporting - funding for victims of sexual abuse by members - appeal processes regarding registration and complaint decisions To achieve the objectives of the college the code mandates each college and they establish 7 DIFFERENT STATUTORY COMMITTEES (know these 7 - very important) - Executive committee - registration committee - inquiries, complaints and reports committee - discipline committee - fitness to practice committee - quality assurance committee - patient relations committee What is the Health Professions Regulatory Advisory Council? - independent advisory body to the Minister of HLTC - members appointed by the lieutenant governor in council What is their mandate? - advise the minister of a number of items related to the regulation of health professions such as - whether unregulated health professions should be regulated - whether regulated professions should no longer be regulated - amendments to the RHPA, a health profession act or a regulation under those acts - quality assurance and patient relations programs in Ontario health regulatory colleges What are RHPA-controlled acts? - only those who are trained can do the activity - procedures or activities which may pose a risk to the public if not performed by a qualified practitioner - no person shall perform a controlled act set out in subsection (2) in the course of providing health care services to an individual unless - the person is a member authorized by a health professional act to perform the controlled act - the performance of the controlled act has been delegated to the person by a member described How is the controlled acts term different than the term authorized acts? - Controlled Acts: High-risk activities identified by the RHPA that are restricted to certain regulated health professionals. - Authorized Acts: The subset of controlled acts that a particular health professional is permitted to perform within their scope of practice as defined by their regulatory college. SCENARIO - I help my father who has Parkinsons’ to check his blood glucose level by pricking his finger with a lancet, is this considered against the law because this is a controlled act? - if there is an emergency, it is acceptable - if there is no other option PHARMACY ACT (PA) - a specific health profession act - applies to RPh and RPhT What is provided by the Pharmacy Act? - scope of practice - authorized acts - classes of registered members - protected titles - college council - accreditation committee - advertising - quality assurance program - professional misconduct What is the practice of pharmacy? - the custody, compounding, dispensing and prescribing of drugs - the provision of health care aids and devices - the provision of information and education related to the use of anything mentioned clauses - the promotion of health, prevention, and treatment of diseases, disorders and dysfunctions through monitoring and management of medication therapy SCENARIO: - a friend is a pharmacist and I asked him to work a relief shift at my pharmacy, but he told me that is a part b pharmacist. what does that mean? - class A - can do all - pt care - class B - they don't offer patient care - only teaches What are the classes of registered members? 1. Pharmacists - A and B 2. pharmacy technician 3. registered pharmacy student 4. pharmacist and pharmacy technician intern What is a protected title? - no person other than a member shall use the title ‘apothecary’, druggist, pharmacist, pharmacy technician, pharmaceutical chemist or any other variation or abbreviation What is a representation of qualification? - no person other than a member shall hold themselves out as a person who is qualified to practice in Ontario as a pharmacist or a tech What is the process of P.Tech registration process? - create an account with the college - register as an intern technician - practice assessment of competence at entry - PACE - Juris, ethics and professionalism exam - PEBC exam - 1 and 2 - final application for a certificate of registration as a pharmacy technician What is the college council? - a pharmacy act that provides for the STRUCTURE of the council of OCP - RHPA and DPRA provide for the power and mandates of the college council - the council acts as a policy-making group and functions as a board of directors What is the accreditation committee? - in addition to the statutory committee mandated under the RHPA - the PA requires that the college must have an accredited committee - professional misconduct of the pharmacist or tech is referred to as the discipline committee - practice issues related to pharmacy is referred to the accreditation committee What is it called when there is a complaint against the pharmacist? - discipline committee What is the practice of issues related to pharmacy called? - complaints to the actual pharmacy setting - accreditation committee How many committees does OCP have? - 8 = statutory committees (7 in RHPA and 1 in PA) What are standing committees? - know this one - its a test question (except question) - professional practice committees - communications committees - finance committees What are other OCP-established committees? - standards of practice committee - pharmacy technicians working group What is PA advertising? - regulating the advertisement by the member while DPRA regulates advertisement by the pharmacy What is professional misconduct? - PA provides for the practices that are considered professional misconduct - members who commit professional misconduct are subjected to disciplinary actions by OCP What are some examples of professional misconduct? - failing to maintain a standard of practice of the profession - abusing a patient, verbally or physically - practicing the progression while the member's ability to do so is impaired - dispensing or selling drugs for an improper purpose - returning to stock or again selling or dispensing a drug previously sold or dispensed and delivered - we can refund, but not return - providing a prescriber with prescription blanks, a professional diary, an appointment book or other gift - you cant give a gift in exchange for a prescription business - offering or distributing, directly or indirectly, a gift or rebate DRUG AND PHARMACY REGULATION ACT (DPRA) What does it regulate? - certain aspects of PHARMACY operation and DISPENSING of drugs in an environment that is safe to the patient - it does not apply to drugs compounded, dispensed or supplied by a hospital or a health or custodial institution (jail) Gives OCP the authority to: (to regulate hospital pharmacies) - licence and inspect the pharmacies within public and private hospitals, in the same manner it currently licences and inspects community pharmacies - enable the college to enforce licensing requirements with regard to hospital pharmacies - allow the college to make regulations to establish the requirements and standards for licensing, operation and inspection of hospital pharmacies What does the DPRA regulate for rx & dispensing? - prescribing authority - vials requirements - rx requirements - rx copies - record of sales dispensing - rx transfer - label information - misrepresentation - warning labels - remote dispensing What does DPRA regulate for the pharmacy? - record-keeping - protected titles - pharmacy construction - delivery systems - lock and leave conditions - opening pharmacies - inspection - closing pharmacies - advertisement Who can prescribe drugs in Ontario? (all drugs, not only narcotics) - physicians (MD) - dentists (DDS) - vets (DVM) - nurse practitioner (they should show their CNO #) (NP) - registered nurse - midwife (from a list) - Chiropodists (DC) and podiatrists (DPM) may prescribe within their scope of practice - optometrist What are the characteristics of a signature? - not easily reproducible - unique (include electronic signature) - no stamp, no pencil, no initial or marks Where would find information about what appears on the record of dispensing? - the drug and pharmacy act What is an OCP policy for labelling single-entity drugs? (blister packs) - when the drug is a single entity drug, the label must show: the generic name and name of the manufacturer What is the OCP policy for labelling blister packs? - the label must show the description of the drug - ex ‘ramipril white pill’ SCENARIO: - some elderly patients have asked us to dispense their medications in easy open vials (snap vials), why do they need to sign a form for that? - a ‘child-resistant package’ means a container that meets the standards and approved by the ministry - the law: “Every person who fills a prescription shall dispense the drug in a child-resistant package that is certified and designated by the CANADIAN STANDARDS ASSOCIATION” What are the exceptions for easy-open prescriptions? - the prescriber or the person who presents the prescription to be filled directs otherwise (EASY OPEN VIAL is labelled) - the pharmacist's judgement that is advisable not to use a child-resistant package (ex-drug to be dispensed in original container) - the child-resistant package is not suitable for the drug - THE CHILD-RESISTANT PACKAGES ARE NOT AVAILABLE (NOT IN REGULATION) SCENARIO: - Yesterday, after filling a new rx, the patient asked whether he could get a copy of his rx. can we give a copy? - every person in respect to whom a rx is presented to a pharmacist to be dispensed is entitled to have a copy - the pharmacist MUST provide a copy and mark it as COPY - the copy is not a valid authorization - EXCEPTION: if the prescriber directs otherwise SCENARIO: - the patient transferred her rx to Sudbury because she was on vacation there. Now she is back in Brampton, and she wants to transfer the rx back. Can we do that? - the rx transfer is between pharmacies NOT pharmacists - should be done in a timely manner upon the patient's request - does federal schedules affect rx transfer? - must have refills remaining - rx must be marked as transferred - once transferred the rx can not be refilled or transferred further at your pharmacist (UNLESS TRANSFERRED BACK IF PERMITTED) - rx can be transferred out of Ontario and into Ontario (from Canadian provinces only) What is misrepresentation? - no person shall knowingly sell any drug under the representation or pretense that is a particular drug that is not or contains any substance that does not it - we can not make the patient think we are giving them a brand when its really a generic - we can not make them think that there is a combination in the drug where there is not DPRA & PHARMACY What is record keeping? - what is considered patient records? - rx, electronic profiles, signed dispensing records, med checks, pharmaceutical opinion (finding DRP), documentation of dialogue (counselling) and consents (easy only vials) How long can we keep records? - IMPORTANT - whichever longer of - 10 years from the last recorded service - example: pt filled an RX in 2010 till 2032.. then they died - keep all till 2042 - 10 years from the day on which the patient turns 18 years old - child was 2 years old in 2024.. till 2050 (2024+16years = 2040.. then 10 more years) RECORD KEEPING - records must be available and retrievable whenever needed (upon inspection) - destruction requires the registered permission - records must be secure, backup daily, recoverable, backup must be kept off-site or fireproof, theft resistant - records can be sold to another pharmacy upon closure and inform patients and give them a choice (can be returned to the college) What is a certification of registration? (accreditation) - OBJECTIVE: The pharmacy operates according to the standards - inspection is done before the pharmacy opens - a new certification of accreditation with a new number is issued for - a new pharmacy location or new owner - more requirements if the pharmacy will operate a remote dispensing - an accreditation committee may ask the member to submit a written response in their defence within 30 days SCENARIO - the pharmacy manager held a staff meeting and informed us that there will be an inspection coming soon and wanted us to prepare for the inspection. what can we do? - the act outlines the power and responsibilities of inspectors who are appointed under the act to MONITOR COMPLIANCE WITH ALL REGULATIONS What does the OCP mandate to in regards to inspections? - quality assurance and ensures competency of pharmacists - inspection ensure pharmacy meets standardized criteria How many inspections are there? - 4 inspections - accreditation, routine, re-inspection, OCP ordered by the accreditation committee When does OCP inspect a pharmacy? - accreditation inspection: when the pharmacy opens - inspection when the pharmacy relocations or is the acquisition - routine inspection: every 3 years also known as a practice visit - pharmacy identified (3 years since last inspection) - re-inspection - if the routine inspection reveals deficiencies (only happens if during the routine inspection reveals need to be inspected) - inspection ordered by the accreditation committee (pt complaint to OCP is against the pharmacy, OCP will have to do an inspection) What are the areas of inspection? - personnel - pharmacy area - equipment and cleaning - labels that meet legal criteria - mediations are stocked in areas that ensure conditions of sales as per NAPRA - lock and leave criteria - computer systems - documentation - the library has the necessary references - system is in place to ensure the removal and disposal of expired drugs - proper filing and record keeping During an inspection process, the accreditation committee may: - conclude the matter - request another re-inspection with costs - requests an interim suspension of the certificate of accreditation - request a revoke of the certificate of accreditation (if false info is provided or continuing deficiencies) - refer the owner/designated manager/direction to the Discipline committee to recommend action What happens when the committee refers the owner to the discipline committee to recommend actions? - when pharmacies do not comply with operation standards - violate terms and conditions - proprietary misconduct (the regulations make all owners and operators responsible) What does the inspector usually look for during an inspection? - DM/Owner names - pharmacist must be physically present - the name or the licence of the manager must be clearly and publicly displayed - at least 200sq = 18.6m^2 all must comply by may 2012 - the rx lab at least 9.3m2 and with at least 12 sqft counter - enough shelving and drawers to store drugs and herbals - clean and designed in a way to ensures proper cleaning - free from risks/hazards - system for filling rx (computer software) - store records - secure - ID staff members - able to generate reports with speed and audit trials - separate lockers/rooms for apparel - hot/cold water supply - washing and toilet facilities - fridge exclusive for rx (2-8 degrees clean with no public access - library requirements - storage fixures - balance, compounding, dispensing equipment, distilled water, vials, labels - displays (certification of accreditation, name and license of the manager What are the lock and leave conditions for inspections? - the area where medications are dispensed/stored must be inaccessible when the pharamcist is not on premises - lock and leave design What does a lock and leave pharmacy have to have? - a barrier must be at least 2.33 metres (8 ft) in height - cannot be more than 15cm from the floor - all products must be at least 1m from the barrier - n-c-t and sched 1-2-3 must not be sold where the pharmacy is closed - phone must not be answered during the absence of an on-duty pharmacist - compounding equipment is in the drug and pharmacy act - REQUIREMENTS FOR A LOCK AND LEAVE - The pharmacy surface area 200sqft and half is behind the counter - 12 sqft for a dispensing counter - the area where medications are dispensed/stored must be inaccessible when the pharmacist is not on the premises What is the point of care symbol? - highly visible, indicates quality of care - used by pharmacies only - must be posted at least one public entrance to the pharmacy SCENARIO - the pharmacy where I work is closing. What do we do with the rx and drugs we have? - must inform the patients Closing a pharmacy - notify register within 7 days of closing - remove all signage that indicates that this place is a pharmacy - within 30 days of closing, the pharmacy must complete and file a closing package from OCP with the college of the registrar - name/location of the pharmacy owner, DM, date closing, where the drugs are going including narcotic and controlled substances - whereabouts of the prescription records What happens when you want to open a pharmacy? - pharmacy must be owned and operated by a pharmacist - the majority of shares is held by pharmacists - all owners are accountable for the actions of the corporation Who can own a pharmacy? - the majority of directors must be a pharmacist What happens when the owner is deceased? - 4-year period to get affairs in order *** DRPA and regulations provide for the advertisement by pharmacies (the Pharmacy Act provides for the standards of advertisement by the pharmacists) ADVERTISEMENT ACTIVITY 1. “We will fill your rx as if your life depended on it” 2. “the only real discounts at ‘discount pharmacies’ are in the inferior service you receive” 3. “voted as Torontos best pharmacy in 2002” 4. “our dispensing fee is the lowest in the neighbourhood and our service cannot be matched” 5. “no $2 copay charged here!” 6. “seniors and welfare pay only $2 medication fee” 7. “We waive the $2 copay for ODB recipients” 8. “low-income seniors and Ontario works (ODB copay 2) pay $0 - high-income seniors (odb copay $6.11) you pay $4.11) 9. “students insured under the Sheridan plan will not be charged up to $2 copayment” SCENARIO - a new store opened nearby and it is named “natural medicine dispensary”- what do you think about this name? - no person shall in connection with the retail business use any of the following designations - UNLESS THE BUSINESS IS AN ACCREDITED PHARMACY - drug store - service de pharmacie - drug mart - pharmacien detaillant - drug sundries - comptoir de - pharmacy - remedies divers medicaments - pharmacie - drug or drugs - medicines - drug department - medicaments - remedes SCENARIO - Ms. Walter is a patient are our pharmacy and she calls the pharmacy today to refill her rx. she will be at work will late so she wants us to deliver the medication to her home and that the drive leaves the rx in the mailbox, can we do that? - patient or patient agent must sign when the rx is received - the system must be auditable and traceable - the delivery log must show exactly what is delivered (rx #, number of rxs) so the patient sign for exactly what was sent - pharmacists know where the patient's rx is all the time (ideally the driver should go directly to deliver the rx) - best practice: daily signatures, keep records for 3 months SCENARIO - Mr. Smith saw his physician today and got a new rx for his blood pressure meds. he still has refills on the previous rx and wants us to put the new rx as ‘unfilled’ and to refill his previous rx. Can we do that? - this is called piggybacking - adding new authorization to the original remaining repeats is NOT ALLOWED - the old repeats remaining are invalid and must be released - HINT: THIS IS WHEN YOU COPY OVER THE PREVIOUS RX - COPYING OVER PREVIOUS RX INACTIVATES OLD REPEATS AND KEEP THE LATEST RX ACTIVE