What Acts are under Federal Regulation (2)?

What Acts are under Federal Regulation (2)?

1) Food and Drugs Act

2) Controlled Drug and Substances Act

Food and Drug Acts Schedule F

(which is under part C of the Food and drug regulations)

1) How many parts ?

2) What are the implications of part 1? (3)

3) What are the implications of part 2?

Food and Drug Acts Schedule F

(which is under part C of the Food and drug regulations)

1) 2 parts

2) What are the implications of part 1? (3)

i) Prescription required

ii) has 'Pr' on the package

iii) Prescription must be stored for at least 2 years

3) What are the implications of part 2 of Schedule F (under part C of the Food and Drug regulations)?

Drugs may be sold without a prescription if it is in a form not suitable for human use, OR if it is labeled FOR VETERINARY USE ONLY by manufacturer

1)What is the purpose of the CDSA ?

2) Where is a controlled SUBSTANCE schedule (under which Act)?

3) What schedule are controlled Drugs ?

1) Controls import, export, production, distribution, and use of substances that alter mental processes or be harmful to health when distributed/used without supervision.

2) CDSA

3) Schedule G - controlled Drugs

1) Are Schedules I-VIII of the CDSA used in pharmacy practice ?

2) What are schedules I-VIII of the CDSA used for ?

1) NOT currently used in pharmacy practice

2) ARE currently used for penalties for illicit use, trafficking, manufacturing etc.

1) Definition of a Narcotic

2) Letter for a narcotic ?

1) Any substance included in the schedule, or anything that contains the substance in the schedule

2) N

1) What 3 groups are narcotics subdivided into ?

1) Subdivided into:

i) Straight Narcotics

ii) Verbal Rx Narcotics

iii) Exempted Codeine preparations

What makes it a Verbal Rx Narcotic ? (3)

clues: ingredient make up ? formulations not intended ? what it cannot contain ?

What makes it a Verbal Rx Narcotic ? (3)

i) Contains 2 medicinal, non-narcotic ingredients in addition to the narcotic. Must be in therapeutic doses.

ii) is NOT intended for parenteral use

iii) Does NOT contain diacetylmorphine (heroin), hydrocodone, methadone, oxycodone, or pentazocine.

(the ''5'' narcotics)

1) Straight Narcotic

 NO direct definition in legislation:

- Use 'Verbal Rx Narcotic' backwards, and if it doesn't qualify it is a straight narcotic

Exempted Codeine Preparations

1) tablet/capsule & liquid Requirements ?

2) do they require a prescription ?

3) What warning must be present ?

4) When shall a pharmacist not supply them?

Exempted Codiene Preparations

1) tablet/capsule - no more than 8mg codeine per tab/cap

liquid - no more than 20mg/30ml, PLUS two other medicial ingredients. The two medicial ingredients must be in a quantity not less than the regular single dose for one ingredient, OR half the regular minimum single dose for each ingredient

2) NO prescription required

3) "This preparation contains codeine and should not be administered to children except on the advice of a physician or dentist"

4) Shall not supply if have reason to believe they will be abused.

Definition of Double Doctoring

What is it ? What schedules does it pertain to ?

What is required of the person trying to obtain the drugs?

Definition of Double Doctoring

Double doctoring is seeing multiple practitioners to get multiple prescriptions. Persons trying to get a prescription/substance from schedules I,II,III, or IV must disclose to the practitioner the particulars concerning every schedule I,II,III, or IV drug they have had in the preceding 30 days including what it was, and who prescribed it.

1)What must be present on the prescription for the

pharmacist to despense the medication ?

2) What should be verified if the pharmacist does not recognize it?

3)May the pharmacist supply methadone to a dealer, hospital or pharmacist ?

1) Signature of practitioner and Date

2) Signature must be verified if unrecognized

3) YES, if the physician is authorized by the OCS and CPSO

The doctor can write the prescription for the FULL amount, but request that it be filled in parts/intervals.

Eg. Cannot write M:100, 4 refills

CAN write M:500, dispense in 100s every 30 days

Emergency Supply

How much of a narcotic can a pharmacist supply another pharmacy with?

1) Under what schedules are controlled drugs found ?

2) Under what parts are they subdivided ?

3) What is the symbol for a controlled drug on a stock bottle?

1) Controlled drugs are found under Food and Drug Regulations, Part G

2) subdivided into I,II,III

3) C

When can a pharmacist refill a controlled drug ?

clue: different for parts I, and II or III

A pharmacist can refill a controlled drug from part I if the prescriber has given a WRITTEN Rx that includes that the prescription be refilled, the # of refills, and the dates/intervals between refills.

A pharmacist can refill a controlled drug from part II or III if the prescriber has given a written or oral Rx that includes that the prescription be refilled, the # of refills, and the dates/intervals between refills.

Target Substances

1) Which Act schedules them ?

2) What can be the symbol on the bottle (2 possible)

3) How should Rx's be filed

1) CDSA

2) C / T

3) Filed as N/CD or Regular, doesn't matter as long as consistent.

When are the regulations for refills on Target Substances as outlined by the CDSA ?

Who can manufacture, import/export, sell, transport, send, deliver, or distribute a controlled substance ?

Who controls this?

Licensed dealers

1) What limits what they can sell ?

2) What must they maintain records of ?

3) What changes must they report ?

4) Who can they NOT supply to ? explain.

1) Their license has limits

2) Must maintain records of controlled substances received & sold

3) Must report changes in staff, premises, processes & conditions for manufacturing, & storing of controlled substances.

4) cannot supply to persons on NOTIFICATION - a restriction on a physician of pharmacist that specifically restricts them from prescribing or ordering controlled drugs or benzodiazepines.

Ordering of Controlled Substances

1) Who can do it ?

2) how can they do it ?

Ordering of Controlled Substances

1) Only an authorized pharmacist, appointed by the pharmacy owner and has notified OCP of who the narcotic signer is.

2) Can be ordered by written order, through computer from remote input device, or by verbal order ONLY for verbal prescription narcotic that specifies the name and quantity of the narcotic.

What does the CDSA - Narcotic control regulations 27 say concerning orders using a remote input device or verbal order ?

What if the licensed dealer does not receive what they need to ?

What does the CDSA - Narcotic control regulations 27 say concerning orders using a remote input device or verbal order ?

The Licensed dealer must receive receipt within 5 working days stating the name and quantity of narcotic, the date received, and the signature of the pharmacist who received the order.

If the dealer does not receive the receipt within 5 working days, they shall NOT supply the pharmacy on orders by phone or electronic remote input.

APPLIES TO ALL NARCOTICS AND CONTROLLED DRUGS & TARGET SUBSTANCES.

What must be entered according to the CDSA's Narcotic control regulations 38 concerning what must be entered for sales of narcotics excluding verbal narcotics and propoxyphene ?

2) What specific occurence must also be included in a sales report ?

- Pt. name & address

- Drug name, quantity& dosage form

- name, initials and address of prescriber

- name of pharmacist

- date supplied

- prescription #

2) If a prescriber writes a prescription for office or personal use it must be included in the sales report.

According to the CDSA's Narcotic control regulations 40:  How long are Narcotic prescriptions to be stored for ?

How are they to be arranged ?

Narcotic prescriptions are to be stored for 2 years, and are to be organized by date/rx #.

Also, controlled drugs are to be filed with narcotics

Narcotic, Schedule G, or target substance Destructions:

1) Who should be contacted ? How ?

2) What should be included ?

3) How will reply come ?

1) Health Canada should be faxed or mail

2) Should include Drug, quantity, lot #, expiry & reason

3) Will get reply by mail

1) Regulated Health professions Act

2) Drug and Pharmacies Act

3) Pharmacy Act

4) Drug interchangeability and dispensing fee act

5) ODB Act

Drug and Pharmacies Regulation Act Section 118 outlines practitioners dispensing directly to their patients.

Who can do so ?

Who CANNOT ?

Drug and Pharmacies act states who may describe drugs:

(7)

1) Physicians (MD)

2) Dentists (DDS)

3) Veterinarians (DVM)

4) Nurse practitioners (RN (EC)) - specific list

5) Midwives - specific list

6) Chiropodists (DC)

7) Podiatrists (DPM)

Drug and Pharmacies Regulation Act section 156 states what must be present on a prescription:

(8)

1) Pt. Name

2) Pt. Address

3) Drug name

4) Drug strength (if applicable)

5) drug quantity

6) directions of drug use

7) Name of prescriber

8) Address of prescriber

(2 pt, 4 drug, 2 doctor)

The Hardcopy must contain:

How long must a hardcopy be kept for ?

(SAME FIRST 8 AS A PRESCRIPTION)

1) Pt. Name

2) Pt. Address

3) Drug name

4) Drug strength (if applicable)

5) drug quantity

6) directions of drug use

7) Name of prescriber

8) Address of prescriber

9) drug manufacturer

10) signature of person dispensing

11) signature of person receiving oral order (if applicable)

12) Identification or other designation??

13) Date dispensed

14) Price charged

Hardcopy must be kept for at least 2 years

Not easily reproducible

Not erasable

More than a mark/initials

not a stamp

electronic signatures must be unique single use signatures?

Prescription label requirements

(13)

1) Rx #

2) Pharmacy name

3) Pharmacy address

4) Pharmacy phone #

5) Drug name

6) Drug strength

7) Drug manufacturer

8) drug quantity

9) Name of pharmacy owner

10) Date dispensed

11) Name of prescriber

12) Name of person for whom it was prescribed

13) Directions for use

Misrepresentation

 What is it , rules governing it ?

Drug and Pharmacies Regulation Act Regulation 545 states that child resistant packaging means:

Except in what events can non child resistant packaging be used ?

Drug and Pharmacies Regulation Act section 157

Concerning Rx copies to the patient/their agent:

Is a prescription copy valid authorization ?

Must a pharmacist provide a copy on request of a patient, agent, or pharmacist acting on the patient's behalf ?

A patient/their agent is entitled to have a copy of the prescription as long as it is marked as such, and as long as the prescriber  has given directions otherwise.

NO a copy is not valid authorization

YES a pharmacist must present a copy

Drug and Pharmacies Regulation  Act section 62

Requirements for a transfer

can transfer from out of province ?

Can the transferring pharmacy refill the prescription ?

Can the same prescription be transferred again?

Does the pharmacist transferring the prescription need to sign off on the transfer on the original prescription or the patients file ?

Can Schedule G or N drugs be transferred ?

Requirements for a transfer:

- must have remaining refills

- must make a note on original prescription or pt profile

YES, can transfer into ontario, from within Canada 

The transferring pharmacy cannot refill the prescription.

The prescription cannot be transferred again.

NO, schedule G or N drugs cannot be transferred.

The transferring pharmacist needs to sign off on the transfer, and needs to date it on the original prescription or in the patient's profile.

Rx Transfer from out of province

Allowed ? Under what conditions?

Allowed from the US ?

ODB formulary Comparative Drug Index (CDI)

What is the purpose of the formulary/CDI ?

Who is the onus on to provide evidence of interchangeability ? to who ?

What position designates or removes interchangeable status ?

A guide for professionals to prescribe, and dispense covered medication. Also confirms designation of drug products that are interchangeable under ontario legislation. Also is used to compare drug prices.

The manufacturer provides evidence of interchangeability to the Committee to Evaluate Drugs (CED)

An Executive Officer designates or removes interchangeable status.

DIDFA - Drug Interchangeability and Dispensing Fee Act

Purpose ?

Who does it not apply to ?

Makes it mandatory to offer the patient a lower priced medication alternative  if available.

Does NOT apply to dispensing of drug to a hospital.

DIDFA - section 4

If a prescription directs the dispensing of a

YES. The pharmacist must give the patient what they prefer, brand or generic, and the pharmacist MUST inform the patient the availability of a generic product.

You don't have to inform them if you give them a brand product and charge them the least available for an interchangeable, or if it is a refill and a brand was used in the first fill.

Is substitution into the formulary permitted ?

(If a prescription directs the dispensing of a

product that is

not designated as an interchangeable product and there is an interchangeable product that

contains a drug or drugs in the same amounts of

the same active ingredients in the same dosage form).

No sub, Pas de Rempl. , no substitution, or pas de remplacement.

or any other direction that there should be no substitution.