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PEBC Study #5
5. Health Canada, CDSA & Laws
| Question | Answer |
|---|---|
| What part of the Food and Drugs Act is for Regular Drugs? | Part C |
| What part of the Food and Drugs Act is for controlled drugs? | Part G |
| What part of the Food and Drugs Act is for vitamins, minerals and amino acids? | Part D |
| What part of the Food and Drugs Act is for restricted drugs? (Not used in pharmacy practice) | Part J |
| What class on the OCP regulation chart is buprenorphine | Narcotic drugs |
| What class on the OCP regulation chart is codeine | narcotic drugs |
| What class on the OCP regulation chart is fentanyl | narcotic drugs |
| What class on the OCP regulation chart is hydromorphone | narcotic drugs |
| What class on the OCP regulation chart is ketamine | narcotic drugs |
| What class on the OCP regulation chart is Lomotil | narcotic drugs |
| What class on the OCP regulation chart is methadone | narcotic drugs |
| What class on the OCP regulation chart is meperidine | narcotic drugs |
| What class on the OCP regulation chart is morphine | narcotic drugs |
| What class on the OCP regulation chart is nabilone | narcotic drugs |
| What class on the OCP regulation chart is oxycodone | narcotic drugs |
| What class on the OCP regulation chart is Percocet | narcotic drugs |
| What class on the OCP regulation chart is teva-lenoltec No. 4 | narcotic drugs |
| What CDSA classification is described as all products containing only 1 straight narcotic | narcotic drugs |
| What CDSA classification contains all narcotics for parenteral use | narcotic drugs |
| What CDSA classification is described as narcotic compounds containing 1 narcotic and 1 non-narcotic active ingredient | narcotic drugs |
| Narcotic drugs are automatically classified under this category if they contain any of the following 5 narcotics | diacetylmorphine (heroin), hydrocodone, methadone, oxycodone, pentazocine |
| Which two CDSA classifications CANNOT have refills on prescriptions? (but can have part fills with total authorized quantities) | Narcotic drugs & narcotic preparations |
| What CDSA classification is described as all combinations for non-parenteral use, containing only 1 narcotic and 2 or more non-narcotic ingredients | narcotic preparations |
| What class on the OCP regulation chart is Robitussin AC | narcotic preparations |
| What class on the OCP regulation chart is Teva-lenoltec No. 2 | narcotic preparations |
| What class on the OCP regulation chart is teva-lenoltec No. 3 | narcotic preparations |
| What are the ingredients and strengths of Teva-lenoltec No. 1 | 300mg acetaminophen, 15mg caffeine, 8mg codeine |
| What are the ingredients and strengths of Teva-lenoltec No. 2 | 300mg acetaminophen, 15mg caffeine, 15mg codeine |
| What are the ingredients and strengths of Teva-lenoltec No. 3 | 300mg acetaminophen, 15mg caffeine, 30mg codeine |
| What are the ingredients and strengths of Teva-lenoltec No. 4 | 300mg acetaminophen, 60mg codeine |
| How much codeine (solid and liquid forms) can exempted codeine preparations contain? | up to 8 mg/solid oral dosage form, or 20 mg/30mL of liquid |
| What CDSA classification is described as preparations containing codeine (up to 8 mg/solid oral dosage form, or 20 mg/30mL of liquid)and 2 or more active non-narcotic ingredients | exempted codeine preparations |
| What schedule are exempted codeine preparations? | Schedule II |
| ADHD medications and stimulants are part of what class of the OCP regulation chart? | Controlled drugs Part I |
| What CDSA classification is described as all products containing only 1 controlled drug (‘straight’ controlled drugs) and all combinations containing more than 1 controlled drug | Controlled drugs Part I |
| What class on the OCP regulation chart is amphetamine | Controlled drugs Part I |
| What class on the OCP regulation chart is dextroamphetamine | Controlled drugs Part I |
| What class on the OCP regulation chart is methylphenidate | Controlled drugs Part I |
| What class on the OCP regulation chart is butorphanol | Controlled drugs Part II |
| What class on the OCP regulation chart is barbituates | Controlled drugs Part II |
| What class on the OCP regulation chart is nalbuphine | Controlled drugs Part II |
| What CDSA classification is described as all combinations containing 1 controlled drug in Part II and 1 or more non-controlled ingredient(s) | Controlled drug preparations part II |
| What class on the OCP regulation chart is Tecnal | Controlled drug preparations part II |
| What class on the OCP regulation chart are anabolic steroids and derivatives | Controlled drugs Part III |
| Can pharmacists adapt/renew prescriptions for controlled substances to facilitate continuation of treatment? | Yes, after the CDSA s56(1) exemption |
| What 3 categories of drugs are included in "controlled substances" | narcotics, controlled drugs, and targeted substances |
| Difference between a controlled drug and a controlled substance | a controlled drug is an item listed in Schedule G of the FDA regulations, a controlled substance is a product that can be abused or cause harm when distributed or used without supervision |
| Who can prescribe narcotics according to the CDSA? (Name 6) | physicians, dentists, nurse practitioner, veterinarians, midwives and podiatrists |
| What two main identification pieces must be included on a narcotic prescription? | patients HC number, physicians license number |
| How long are narcotic/controlled substance purchase records to be kept | 2 years |
| Who should a pharmacy report to if controlled substances are lost or stolen? What is the time requirement for this report? | To Health Canada within 10 days |
| Signed receipt of a narcotic order must be returned to the licensed dealer within how many days after sale? | 5 business days |
| What part of the prescription is the Subscription? | instructions for the pharmacist (i.e. how much to dispense etc.) |
| What part of the prescription is the Signa or Signatura? | Directions for the patient on how to use the medication to be put on the vial label |
| What part of the prescription is the Superscription? | The symbol "RX" |
| What part of the prescription is the Inscription? | details the medications & strengths prescribed |
| Difference between a Signature and Signatura | the signature is the prescriber's signature/initials, whereas a signatura details the instructions for the patient on the prescription |
| What strength of codeine is in Mersyndol? | 8mg codeine |
| What is the federal legal age to smoke cannabis? | 18 years |
| How many grams of cannabis can someone possess in public? | 30 grams |
| How many cannabis plants are individuals allowed to grow without a medical license? | 4 plants |
| A cannabis product label must include what limit? | THC limits |
| What does the Health Canada National Principle of Public Administration detail? | Health care insurance plans must be administered by a public agency on a not-for-profit basis |
| What does the Health Canada National Principle of Comprehensiveness detail? | Health care insurance plans must cover all medically necessary health care services provided by hospitals, physicians, or dentists |
| What does the Health Canada National Principle of Universality detail? | Health care insurance plans must insure all residents |
| What does the Health Canada National Principle of Portability detail? | Health care insurance plans must cover all residents when they travel within Canada (limited coverage outside of Canada) |
| What does the Health Canada National Principle of Accessibility detail? | Health care insurance plans must provide all residents with reasonable access to medically necessary services on uniform terms and without financial charges or other barriers. Health care plans must pay compensation to health care providers and hospitals |
| What does the Code of Ethics principle of Beneficence mean? | To benefit our patients |
| What does the Code of Ethics principle of Non-Maleficence mean? | do no harm and, whenever possible, prevent harm from occurring |
| What does the Code of Ethics principle of Respect for Persons/Justice mean? | respect our patients’ vulnerability, autonomy and right to be self-governing decision makers in their own healthcare. Justice requires that we fulfill our ethical obligation to treat all patients fairly and equitably |
| What does the Code of Ethics principle of Respect for Accountability mean? | To act in the best interests of patients and not our own |
| If a police officer comes to the pharmacy asking about a patient's meds, you should: | ask them for a warrant or court order, and not disclose anything without one |
| Who can take a verbal prescription for a narcotic? | Pharmacists and pharmacist interns only |
| Can technicians authorize narcotic transfers? | No, only pharmacists and pharmacist interns |
| Who is able to delegate controlled acts in the pharmacy | pharmacist only |
| Who is able to ACCEPT deligation of a controlled act? | Pharmacists, technicians, and interns |
| Who is able to supervise a pharmacy or the part of the pharmacy where drugs are kept? | pharmacist only |
| Which injections can a technician administer? | Influenza, Covid-19, and RSV |
| Can an intern technician administer injections? | no |
| What is schedule I | prescription only |
| What symbol is on schedule I products? | Rx |
| What is schedule II | behind the counter, no public access |
| Which schedule II products can be visible and which cannot? | any non narcotic can be visible, narcotics have to be hidden |
| What is schedule III | products available for self-selection in the pharmacy |
| how far from the dispensary counter can schedule III products be? | 10 meters or less, and has to be visible to the pharmacist |
| What are unscheduled products | products sold without professional supervision, can be sold anywhere |
| What symbol is on narcotic drugs | N |
| which two classes in the CDSA cannot have refills but require part fills | narcotic drugs, narcotic preparations |
| What is required for a "part-fill" of a narcotic on a prescription | total authorized quantity, part fill amount, interval between fills |
| How long do original prescriptions need to be kept | 2 years |
| Scanned hard copies of prescriptions dispensed need to be kept for how long? | 10 years or 10 years after the patient turns 18 |
| How often is a narcotic count required | every 6 months |
| does a forgery need to be reported even if it is not filled? | yes |
| Where do you have to get authorization from before destroying narcotics? | health canada |
| Do benzos and targeted substances require prior authorization to destroy? | No |
| Who can witness narcotic destruction? | pharmacist and technician |
| How soon do you have to report to OCP that the pharmacy is dispensing methadone | within 7 days of dispensing |
| How do carries of methadone need to be dispensed? | in individually labelled bottles of each dose |
| How often does methadone training need to be updated | every 5 years |
| In the patient agreement for methadone, it states that methadone may be withheld if ...? | they appear intoxicated |
| In the patient agreement for methadone, it states that missed, lost, stolen, or wasted doses will not be replaced unless...? | there is a new prescription |
| What key details must be present on a methadone label? Name 6 | - "drink entire contents" - qty of methadone - dates of all doses - how many carries/witnessed doses - fridge sticker - methadone auxiliary label |
| What two pieces of information are required on a methadone prescription that defers from a narcotic prescription | - intended pharmacy - intended dose dates/length of treatment |
| What is methadone diluted with and why? | orange tang, so that it cannot be injected |
| To pickup a narcotic, patients must supply the pharmacy with...? | a valid form of canadian ID |
| If an Rx comes from another province, can it be filled? | yes, if it does not align with our provincial laws the pharmacist may use professional judgement |
| If an Rx comes from outside of Canada can it be filled? | No |
| Can we transfer Rx's to anywhere in Canada? | Yes |
| Can we transfer Rx's to the U.S.? | Yes, but we cannot transfer it back |
| As of 2012, what piece of equipment is required in the pharmacy? | Scanners |
| Are auxiliary labels required? | No, but encouraged |
| PRN medications cannot be dispensed how? | In blister packs |
| Can you give back a copy of a prescription to a patient? | Yes, but only if it says "COPY" |
| Can you mail a prescription? | Only by registered mail that can be tracked, and must be signed at receiving |
| How long can a pharmacist extension be of a medication? | 6 months maximum, or no longer than the original prescription given |
| Who has to be notified after a pharmacist extends a medication? | the prescriber or primary healthcare provider |
| What 2 main things need to be on a compounding label that defers from a normal Rx label? | - Beyond use date (BUD) - storage instructions |
| When closing a pharmacy, how many days does the "Notice of Intent" have to be received by OCP ahead before closing? | 7 days |
| How long does the pharmacy have after closing to file a "closing statement" | 30 days |
| What has to be removed from the outside of the building after a pharmacy closes? | the signs and symbols for pharmacy and point-of-care |
| what 3 steps need to be taken prior to opening a pharmacy? | - submit application minimum 45 days prior - submit floor plan - Schedule inspection |
| What cutback does Ontario Works require for prescriptions | 35 days |
| When would ODB cutback to 30 days? | On first medication fill or if it hasn't been filled in 12 months |
| When would a nutritional product that is a non-formulary benefit be covered by ODB? | If it is sole source of nutrition & criteria is met, nutrition form can be filled out and submitted |
| How many test strips are covered for a patient every 365 days while on insulin? | 3000 |
| How many test strips are covered for a patient every 365 days while on a high risk diabetic medication? | 400 |
| How many test strips are covered for a patient every 365 days while on a low risk diabetic medication? | 200 |
| For test strips to be covered for a patient, they need two things: | a prescription, and to be on a diabetic insulin/medication |
| When would you submit a manual claim? | If the drug was dispensed 7 days (or more) before |
| When would you submit a claim reversal? | If the original submission was 7 days (or more) before |
| What does DIDFA stand for | Drug Interchangeability and Dispensing Fee Act |
| What drugs can be interchanged according to the DIDFA? | drugs on the interchangeable list, never biosimilars |
| If a brand is suggested on the prescription, but there is no "NO SUB" note, what must be dispensed? | lowest cost generic brand |
| When would you dispense the brand name instead of the generic? (name 2 reasons) | if the Rx says "no sub" OR the patient requests the brand name and agrees to pay the difference |
| if the Rx suggests a specific generic brand of medication (ie. Apo-apixaban), what can be dispensed? | any generic brand |
| What must be visible on the "yellow sign" in the pharmacy? | The pharmacy's dispensing fee, and the DIDFA information |
| When does ODB not cover patients if they already have private insurance? | When they are on OHIP+ (under 25) |
| How can a brand name drug be covered by ODB? (name 2 ways) | doctor writes "no sub" on Rx and submits an Adverse Reaction Form, OR all generics are unavailable with intervention code "MI" |
| What is an EAP? | Exceptional Access Program |
| What does an EAP cover, and who applies for it? | It covers non-formulary/unlisted drugs for special cases, the physician must apply for the patient |
| When do ODB seniors benefits activate after their birthday? | The 1st day of the month AFTER the month of their 65th birthday |
| Who is trillium for? | low-income people under 65 with high drug costs |
| How many installments of deductibles are there for trillium per year | 4 |
| What is the trillium copay after the deductible is met? | $2.00 |
| What main room requirements are there for a pharmacy to be open? (Name 6) | - 200 sqaure feet minimum - 2 sinks - consultation room - fridge - scanners - internet access |
| Who needs to be present for the pharmacy to be open | Pharmacist |
| If a pharmacist's license has been suspended, can they still own and operate a pharmacy? | yes |
| Who can be a designated manager? | Anyone in Part A of the register (part A pharmacist or technician) |
| What 5 signs must be visible to the public in the pharmacy? | - OCP point of care symbol - Dispensing Fee sign - DIDFA interchangeability sign - Designated manager's name and certificate of registration - Time-delayed safe sign |
| What 4 titles of people are governed by OCP? | - pharmacists - registered pharmacy technicians - pharmacy interns - registered pharmacy students |
| How many elected members are on the OCP council? How many technicians? How many hospital staff? | 9-17 members 2-4 technicians minimum 1 hospital technician and 2 hospital pharmacists |
| What does the OCP council do? | discuss member views, make regulations for approval by provincial government |
| What are Controlled Acts according to OCP? | tasks that hold potential harm if not done correctly by a competent person |
| Who can perform uncontrolled acts? | anyone, including unregulated workers |
| Falsely using a title protected by OCP can lead to what? | a fine of $25,000 on first offense and $50,000 on every next offense |
| a medication can only have the final check done and dispense if...? | a pharmacist is present |
| Pharmacy technicians can provide information and education to patients if...? | it is NOT clinical or therapeutic |
| What is the age minimum of patients where pharmacists can administer injections? | 5 years or older |
| Who can be a preceptor/assessor for interns and students? | a registered pharmacist or pharmacy technician who has taken the preceptor training from OCP |
| What is the liability insurance policy reguirement for all OCP registrants? | $2 million |
| Can pharmacists adapt controlled substance prescriptions? | yes |
| What are the 4 domains of NAPRA's Model Standards of Practice for pharmacy technicians? | 1. Expertise in medications and medication use 2. Collaboration 3. Safety and quality 4. Professionalism and Ethics |
| How long are patient records retained? | forever |
| When a pharmacy is sold, what happens to patient records? | if the pharmacy is bought the records are transferred to the new owner, if it is not bought but closes, the previous owner is responsible for having records are transferred to another pharmacy |
| What happens when a pharmacist is morally or religiously opposed to dispensing a product? | They dont have to dispense it, but they must refer the patient to another pharmacist or pharmacy |
| Can OCP registrants refuse to dispense a prescription? | yes, using professional judgement and based on the circumstances |
| What are the 4 key factors of applying professional judgement for making a decision? | 1. patient best interest 2. Registrants' knowledge and expertise 3. Decision is reasonable 4. Documenting rationale and actions |
| If a registrant has been found guilty of or charged with any offence in any jurisdiction, they must: | report it to OCP immediately |
| According to PHIPA, when is a patient's consent 'implied' referring to the sharing of their health information? | When sharing information within the patient's 'circle of care' |
| What is PHIPA | Personal Health Information Protection Act |
| What is the ICRC | Inquiries, complaints and reports committee |
| If witnessing another registrant that is incompetent or incapacitated, you must: | report to the college immediately |
| A drug is any substance or preparation containing anything...? | referred to in the NAPRA schedules I, II, III or the FDA Schedules F, G, N |
| what does NAPRA stand for? | National Association of Pharmacy Regulatory Authorities |
| Which class in the CDSA can normally have refills but not if it is a verbal prescription? | Controlled Drugs I |
| Controlled drugs have what symbol on the bottle? | C |
| Targeted substances have what symbol on the bottle? | T/C |
| what is NMS and what does it do? | Narcotic Monitoring System, tracks narcotics dispensed to patients by health card number, and tracks narcotics prescribed by doctors |
| If a patient is on insulin, how many freestyle sensors are covered per year? | 32 |
| How many dispensing fees are there for chronic medications (without a frequent dispensing form)? | 5 |
| for non-chronic medications, what is the maximum number of fees that can be charged per year? | 24 |
| What two pieces of information are required to be dispensed with any opioid prescription by Health Canada? | Opioid warning sticker, opioid information sheet |
| What drug schedule is naloxone? | Schedule II |
| Who has to recieve training for methadone dispensing? | the designated manager within 6 months of dispensing, and one staff pharmacist within the year |
| what is required on a fentanyl prescription different from other narcotics? | name of intended pharmacy, and if it is the "first prescription" |
| what must be dispensed with fentanyl patches? | patch return booklet for next refill and exchange of old patches |
| What is the minimum time delay requirement for time-delayed safes? What are the rules on override codes/keys to bypass the time-delay? | 5 minutes, bypassing the time-delay is strictly prohibited in any circumstance |
| A signature is required upon delivery of a prescription, can a patient sign a waiver to request that the prescription be left at the door/in mailbox, etc.? | No, it must always be signed for at time of receipt |
| What information needs to be added to a compliance pack label that is different from a regular prescription vial label? | description of the medication, and time of day that it is taken |
| What is required for a schedule I sample to be given out? | a prescription from a doctor |
| When dispensing a schedule I sample, what can be charged to the patient? | a professional fee, never a charge for the sample |
| What are the rules for giving out samples of schedule II products? | Schedule II products can be given out as samples as long as they are non-narcotic. Narcotics cannot be given out as samples. |
| When can a schedule III products be given as samples? | Schedule III sample can only be provided to patients within a pharmacy when a pharmacist is present |
| What does veracity mean? | accuracy, conforming to facts |
| what is fiduciary duty? | a legal and ethical obligation to act in the best interests of another party, placing their interests above your own |
| What are the OCP Values? Hint: Acronym ICARE | Integrity Customer First Accountability Respect Excellence |
| What is the minimum countertop space required in a pharmacy? | 1.23m^2 |
| True or false: medicines is a protected title | yes, it cannot be used by non-pharmacy businesses |
Created by:
ella.brennan
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