5078-HPA_Bylaws_Community v2023.1.docx Effective 2023-04-17 (Posted 2023-04-17)
College of Pharmacists of BC Community Pharmacy Standards of Practice
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Health Professions Act BYLAWS
SCHEDULE F
PART 1 - Community Pharmacy Standards of Practice
Table of Contents
1. Application
2. Definitions
3. Patient Choice
4. Community Pharmacy Technicians
5. Pharmacy Assistants
6. Prescription
7. Transmission by Facsimile
8. Prescription Copy and Transfer
9. Prescription Label
10. Dispensing
11. Patient Record
12. Pharmacist/Patient Consultation
13. Schedule II and III Drugs
14. Sole Pharmacy Services Provider
15. Prohibition on the Provision of Incentives
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Application
1.
This Part applies to all registrants providing pharmacy services in a
community pharmacy.
Definitions
2.
In this Part:
“community pharmacy” has the same meaning as in section 1 of the
bylaws of the college under the Pharmacy Operations and Drug Scheduling
Act;
“drug therapy problem” means a potential or actual adverse consequence
of drug therapy that interferes with achieving the goals of the drug therapy;
“final check” means ensuring that:
(a) the prescription product and the prescription product label match
the prescription information and the information on the
manufacturer’s label with respect to:
(i) drug,
(ii) dosage form,
(iii) strength,
(iv) quantity, and
(v) drug identification number;
(b) the prescription product label matches the prescription
information with respect to the matters set out in section 6(2)(a) to
(g);
(c) the drug has not expired and will not expire within the duration of
use; and
(d) a pharmacist has completed a clinical assessment of the
prescription after reviewing the patient profile.
incentive” means money, gifts, discounts, rebates, refunds, customer loyalty
schemes, coupons, goods or rewards;
“patient representative” means a person who is authorized to act on a
patient’s behalf;
“personal health number” means a unique numerical lifetime identifier used
in the specific identification of an individual patient who has any interaction
with the BC health system;
“prescription copy means a copy of a prescription given to a patient by a
registrant for information purposes only;
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“prescription transfer” means the transfer via direct communication from a
registrant to another registrant of all remaining refill authorizations for a
particular prescription to a requesting community pharmacy;
“refill” means verbal or written approval from a practitioner authorizing a
registrant to dispense additional quantities of drug(s) pursuant to a
prescription;
“renewal” means authorization by a full pharmacist to dispense additional
quantities of drug(s) pursuant to a previously dispensed prescription, in
accordance with section 25.92 of the Act;
Residential Care Facilities and Homes Standards of Practicemeans the
standards, limits and conditions for practice established in Part 3 of this
Schedule.
Patient Choice
3.
Registrants, owners and directors must not enter into agreements with
patients, patient’s representatives, practitioners, corporations, partnerships, or
any other person or entity, that limit a patient’s choice of pharmacy, except as
required or permitted under the bylaws.
Community Pharmacy Technicians
4.
(1)
Pharmacy technicians in a community pharmacy may prepare, process and
compound prescriptions, including
(a) receiving and transcribing verbal prescriptions from practitioners,
(b) ensuring that a prescription is complete and authentic,
(c) transferring prescriptions to and receiving prescriptions from other
pharmacies,
(d) ensuring the accuracy of a prepared prescription,
(e) performing the final check of a prepared prescription, and
(f) ensuring the accuracy of drug and personal health information in the
PharmaNet patient record.
(2)
Despite subsection (1), a pharmacy technician in a community pharmacy may
dispense a drug but must not
(a) perform the task of ensuring the pharmaceutical and therapeutic
suitability of a drug for its intended use, or
(b) do anything described in
(i) sections 6(5), 6(10), 10(2), 11(3), 11(4), 12, 13(2), 13(3) or 13(4)
of this Part, or
(ii) Part 4 of this Schedule
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(c) dispense a drug pursuant to HPA Bylaws Schedule F, Part 5
(3)
A pharmacy technician must identify his or her registrant class in any
interaction with a patient or a practitioner.
Pharmacy Assistants
5.
A registrant may delegate technical functions relating to the operation of the
community pharmacy to a pharmacy assistant if the registrant directly
supervises the pharmacy assistant and implements procedures, checks and
controls to ensure the accurate and safe delivery of community pharmacy
services.
Prescription
6.
(1)
A registrant must ensure that a prescription is authentic.
(2)
A prescription must include the following information:
(a) the date of the prescription;
(b) the name of the patient;
(c) the name of the drug or ingredients and strength if applicable;
(d) the quantity of the drug;
(e) the dosage instructions including the frequency, interval or maximum
daily dose;
(f) refill authorization if applicable, including number of refills and interval
between refills;
(g) in the case of a written prescription, the name and signature of the
practitioner;
(h) in the case of a written record of a verbal prescription,
i. the name of the practitioner and the identification number from
the practitioner’s regulatory college; and
ii. the name, college identification number and signature or initial
of the registrant who received the verbal prescription.
(3)
For the purpose of subsection (4), “prescription” includes a new prescription, a
refill, a renewal or a balance owing.
(4)
At the time of dispensing, a prescription must include the following additional
information:
(a) the address of the patient;
(b) the identification number from the practitioner’s regulatory college;
(c) the prescription number;
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(d) the date on which the prescription was dispensed;
(e) the manufacturer’s drug identification number or the brand name of the
product dispensed;
(f) the quantity dispensed;
(g) written confirmation of the registrant who
(i) verified the patient identification
(ii) verified the patient allergy information,
(iii) reviewed the personal health information stored in the
PharmaNet database in accordance with section 11.4;
(iv) performed the consultation,
(v) performed the final check including when dispensing a balance
owing, and
(vi) identified and addressed a drug therapy problem, if any.
(5)
A full pharmacist must
(a) review prescriptions for completeness and appropriateness with
respect to the drug, dosage, route and frequency of administration,
(b) review patient personal health information for drug therapy problems,
therapeutic duplications and any other potential problems,
(c) consult with patients concerning the patient’s drug history and other
personal health information,
(d) consult with practitioners with respect to a patient’s drug therapy
unless s.25.92(2) of the Act applies, and
(e) take appropriate action respecting a drug therapy problem.
(6)
A registrant may receive a verbal prescription directly from a practitioner or
from a practitioner’s recorded voice message.
(7)
A registrant must make a written record of a verbal prescription containing the
applicable information in section 6(2).
(8)
A registrant must not dispense a prescription issued for more than one patient.
(9)
For refill authorizations, a registrant
(a) may accept a refill authorization for Schedule I drugs from a
practitioner’s agent if confident the agent consulted the practitioner and
accurately conveyed the practitioner’s direction, and
(b) must
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(i) cancel any unused refill authorizations remaining on any
previous prescription if a patient presents a new prescription for
a previously dispensed drug,
(ii) advise the other pharmacy of the new prescription if unused
refills are at another pharmacy, and
(iii) create a new prescription number.
(10)
If a full pharmacist authorizes a prescription renewal, he or she must
(a) create a written record,
(b) assign a new prescription number, and
(c) use his or her college identification number in the practitioner field on
PharmaNet.
Transmission by Facsimile
7.
(1)
Prescription authorizations may be received by facsimile from a practitioner to
a pharmacy, if
(a) the prescription is sent only to a pharmacy of the patient’s choice,
(b) the facsimile equipment is located within a secure area to protect the
confidentiality of the prescription information, and
(c) in addition to the requirements of section 6(2), the prescription includes
(i) the practitioner's telephone number, facsimile number and
unique identifier if applicable,
(ii) the time and date of transmission, and
(iii) the name and fax number of the pharmacy intended to receive
the transmission.
(2)
Prescription refill authorization requests may be transmitted by facsimile from
a pharmacy to a practitioner, if the pharmacy submits refill requests on a form
that includes space for
(a) the information set out in section 6(2),
(b) the name, address and 10 digit telephone number of the pharmacy,
and
(c) the practitioner’s name, date and time of transmission from the
practitioner to the pharmacy.
(3)
A registrant must not dispense a prescription authorization received by
facsimile transmission for a drug referred to on the Controlled Prescription
Drug List, except in a public health emergency declared by the provincial
health officer. In a public health emergency, the pharmacy must receive
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a completed copy of the Controlled Prescription Program form transmitted by
facsimile prior to dispensing the medication.
(4)
Prescription transfers may be completed by facsimile transmission if
(a) the transferring registrant includes his or her name and the address of
the pharmacy with the information required in section 8(4), and
(b) the name of the registrant receiving the transfer is known and recorded
on the document to be faxed.
Prescription Copy and Transfer
8.
(1)
If requested to do so, a registrant must provide a copy of the prescription to
the patient or the patient’s representative, or to another registrant.
(2)
A prescription copy must contain
(a) the name and address of the patient,
(b) the name of the practitioner,
(c) the name, strength, quantity and directions for use of the drug,
(d) the dates of the first and last dispensing of the prescription,
(e) the name and address of the community pharmacy,
(f) the number of authorized refills remaining,
(g) the signature of the registrant supplying it, and
(h) an indication that it is a copy.
(3)
(3.1)
Upon request, a registrant must transfer to a pharmacy licenced in Canada a
prescription for a drug if
(a) the drug does not contain a controlled drug substance, and
(b) the transfer occurs between a registrant and another registrant or an
equivalent of a registrant in another Canadian jurisdiction.
Despite section 3(a), a registrant may transfer a prescription for a controlled
drug substance if the transfer is permitted under a section 56 exemption to the
Controlled Drugs and Substances Act.
(4)
A registrant who transfers a prescription to another registrant under
subsection (3) must
(a) enter on the patient record
(i) the date of the transfer,
(ii) the registrant’s identification,
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(iii) identification of the community pharmacy to which the
prescription was transferred, and
(iv) identification of the person to whom the prescription was
transferred, and
(b) transfer all prescription information listed in subsection (2) (a) to (f).
(5)
A registrant must make prescriptions available for review and copying by
authorized inspectors of Health Canada.
Prescription Label
9.
(1)
All drugs dispensed pursuant to a prescription or a full pharmacist-initiated
adaptation must be labeled.
(2)
The label for all prescription drugs must include
(a) the name, address and telephone number of the pharmacy,
(b) the prescription number and dispensing date,
(c) the full name of the patient,
(d) the name of the practitioner,
(e) the quantity and strength of the drug,
(f) the practitioner’s directions for use, and
(g) any other information required by good pharmacy practice.
(3)
For a single-entity product, the label must include
(a) the generic name, and
(b) at least one of
(i) the brand name,
(ii) the manufacturer’s name, or
(iii) the drug identification number.
(4)
For a multiple-entity product, the label must include
(a) the brand name, or
(b) all active ingredients, and at least one of
(i) the manufacturer’s name, or
(ii) the drug identification number.
(5)
For a compounded preparation, the label must include all active ingredients.
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(6)
If a drug container is too small to accommodate a full label in accordance with
subsection (2),
(a) a trimmed prescription label must be attached to the small container,
(b) the label must include
(i) the prescription number,
(ii) the dispensing date,
(iii) the full name of the patient, and
(iv) the name of the drug, and
(c) the complete prescription label must be attached to a larger container
and the patient must be advised to keep the small container inside the
large container.
(7)
All required label information must be in English, but may contain directions
for use in the patient’s language following the English directions.
Preparation of Prescription Product
9.1
(1)
A registrant who prepares a prescription product must ensure that:
(a) the prescription product label matches the prescription information and
the information on the manufacturer’s label with respect to:
(i) drug,
(ii) dosage form,
(iii) strength,
(iv) quantity,
(v) drug identification number;
(b) the prescription product label matches the prescription information with
respect to the matters set out in section 6(2)(a) to (g);
(c) the drug is not expired and will not expire within the duration of use;
and
(d) his or her identity is documented in writing.
(2)
A pharmacy manager must ensure that the record in paragraph (1)(d) is
readily available and is retained for at least three years from the date on which
the prescription product was last dispensed.
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Compounding
9.2 A registrant must comply with the National Association of Pharmacy Regulatory
Authorities standards as approved by the board from time to time.
Dispensing
10.
(1)
A registrant may adjust the quantity of drug to be dispensed if
(a) a patient requests a smaller amount,
(b) a manufacturer’s unit-of-use standard of package size does not match
the prescribed quantity,
(c) the quantity prescribed exceeds the amount covered by the patient’s
drug plan, or
(d) a trial prescription quantity is authorized by the patient.
(2)
A full pharmacist may adjust the quantity of drug to be dispensed, if
(a) he or she consults with a practitioner and documents the result of the
consultation, and
(b) if
(i) a poor compliance history is evident on the patient record,
(ii) drug misuse is suspected, or
(iii) the safety of the patient is in question due to the potential for
overdose.
(3)
If a registrant doubts the authenticity of a prescription, the registrant may
refuse to dispense the drug.
(4)
All drugs must be dispensed in a container that is certified as child-resistant
unless
(a) the practitioner, the patient or the patient’s representative directs
otherwise,
(b) in the registrant’s judgment, it is not advisable to use a child-resistant
container,
(c) a child-resistant package is not suitable because of the physical form
of the drug or the manufacturer’s packaging is designed to improve
patient compliance, or
(d) child-resistant packaging is unavailable, or
(e) the drugs are prescribed for medical assistance in dying.
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(5)
A registrant
(a) must not dispense a prescription more than two years from the prescribing
date, and
(b) despite paragraph (a), must not dispense a prescription for a
benzodiazepine or other targeted substance more than one year from the
prescribing date.
(5.1)
Despite subsection (5), a registrant may dispense a prescription for a
benzodiazepine or other targeted substance up to two years from the
prescribing date, if permitted by a section 56 exemption to the Controlled
Drugs and Substances Act.
(6)
(7)
Before dispensing a prescription product, a registrant must perform a final
check and record his or her identity in writing.
A pharmacy manager must ensure the record in paragraph (6) is readily
available and retained for at least three years after the last date on which that
prescription product was last dispensed.
Patient Record
11.
(1)
A patient record must be established and maintained for each patient for
whom a Schedule I drug is dispensed.
(2)
For purposes of subsection (1), the patient record must include
(a) the patient’s full name,
(b) the patient’s personal health number,
(c) the patient’s address,
(d) the patient’s telephone number if available,
(e) the patient’s date of birth,
(f) the patient’s gender,
(g) the patient’s clinical condition, allergies, adverse drug reactions and
intolerances if available including the source and date the information
was collected,
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(h) the date the drug is dispensed,
(i) the prescription number,
(j) the generic name, strength and dosage form of the drug,
(k) the drug identification number,
(l) the quantity of drug dispensed,
(m) the intended duration of therapy, specified in days,
(n) the date and reason for discontinuation of therapy,
(o) the directions to the patient,
(p) the identification of the prescribing practitioner,
(q) special instructions from the practitioner to the registrant, if
appropriate,
(r) past and present prescribed drug therapy including the drug name,
strength, dosage, frequency, duration and effectiveness of therapy,
(s) the identification of any drug therapy problem and the description of
any action taken,
(t) the description of compliance with the prescribed drug regimen, and
(u) Schedule II and III drug use if appropriate.
(3)
If a full pharmacist obtains a drug history from a patient, he or she must
request and if appropriate record the following information on the patient
record:
(a) medical conditions and physical limitations,
(b) past and current prescribed drug therapy including the drug name,
strength, dosage, frequency, duration and effectiveness of therapy,
(c) compliance with the prescribed drug regimen,
(d) Schedule II and III drug use.
(4)
A full pharmacist must review the patient’s personal health information stored
on the PharmaNet database before dispensing a drug and take appropriate
action if necessary with respect to any concern regarding the appropriateness
of the drug or any drug therapy problem.
Pharmacist/Patient Consultation
12.
(1)
Subject to subsection (2), a full pharmacist must consult with the patient or
patient’s representative at the time of dispensing a new or refill prescription in
person or, where not practical to do so, by telephone.
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(2)
Where a patient declines the consultation, the full pharmacist must document
that the consultation was offered and declined.
(3)
The full pharmacist must conduct the consultation in a manner that respects
the patient’s right to privacy.
(4)
The pharmacist/patient consultation for a new prescription must include:
(a) confirmation of the identity of the patient,
(b) name and strength of drug,
(c) purpose of the drug,
(d) directions for use of the drug including the frequency, duration and
route of therapy,
(e) potential drug therapy problems, including any avoidance measures,
and action recommended if they occur,
(f) storage requirements,
(g) prescription refill information,
(h) information regarding
(i) how to monitor the response to therapy,
(ii) expected therapeutic outcomes,
(iii) action to be taken in the event of a missed dose, and
(iv) when to seek medical attention.
(i) issues the pharmacist considers relevant to the specific drug or
patient.
(5)
The pharmacist/patient consultation for a refill prescription must include:
(a) confirmation of the identity of the patient,
(b) name and strength of drug,
(c) purpose of the drug,
(d) directions for use of the drug including frequency and duration,
(e) whether the patient has experienced a drug therapy problem.
(6)
If a drug therapy problem is identified during patient consultation for a new or
refill prescription, the full pharmacist must take appropriate action to resolve
the problem.
(7)
If an adverse drug reaction as defined by Health Canada is identified, the full
pharmacist must notify the patient’s practitioner, make an appropriate entry on
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the PharmaNet record and report the reaction to the appropriate department
of Health Canada.
Schedule II and III Drugs
13.
(1)
A registrant must not attribute a new prescription or refill for a Schedule II or
Schedule III drug to a practitioner without the authorization of the practitioner.
(2)
A pharmacist must offer to consult with the patient or the patient’s
representative regarding the selection and use of a Schedule II drug at the
time of purchase.
(3)
The pharmacist/patient consultation for a Schedule II drug must include
potential drug therapy problems, including any avoidance measures, and
action recommended if they occur.
(4)
A pharmacist must be available for consultation with a patient or patient’s
representative respecting the selection and use of a Schedule III drug.
Sole Pharmacy Services Provider
14.
The manager of a pharmacy may enter into an agreement with another person
to be the sole provider of pharmacy services in a premise or part of a premise,
if
(a) pharmacy services are provided in a manner that is consistent with the
Residential Care Facilities and Homes Standards of Practice,
(b) patient therapeutic outcomes are monitored to enhance patient safety,
and
(c) appropriate provision has been made for safe and effective distribution,
administration and control of drugs.
Prohibition on the Provision of Incentives
15.
(1)
A registrant must not provide or distribute, or be a party to the provision or
distribution of, an incentive to a patient or patient’s representative for the
purpose of inducing the patient or patient’s representative to
(a) deliver a prescription to a particular registrant or pharmacy for
dispensing of a drug or device specified in the prescription, or
(b) obtain any other pharmacy service from a particular registrant or
pharmacy.
(2)
Subsection (1) does not prevent a registrant from
(a) providing free or discounted parking to patients or patient’s
representatives,
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(b) providing free or discounted delivery services to patients or patient’s
representatives, or
(c) accepting payment for a drug or device by a credit or debit card that is
linked to an incentive.
(3)
Subsection (1) does not apply in respect of a Schedule III drug or an
unscheduled drug, unless the drug has been prescribed by a practitioner.