Bill 44 — First Session, 27Th Legislature, 57 Elizabeth Ii the Legislative Assembly of Alberta Bill 44 Pharmacy and Drug Amendment Act, 2008 (Legislature 27, Session 1)

L27 S1 692

Alberta — Bills

2008 Bill 44 First Session, 27th Legislature, 57 Elizabeth II THE LEGISLATIVE ASSEMBLY OF ALBERTA BILL 44 PHARMACY AND DRUG AMENDMENT ACT, 2008 MR. DENIS First Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Second Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Committee of the Whole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Third Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Royal Assent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Bill 44 Mr. Denis BILL 44 2008 PHARMACY AND DRUG AMENDMENT ACT, 2008 ( A s s e n t e d t o , 2 0 0 8 ) HER MAJESTY, by and with the advice and consent of the Legislative Assembly of Alberta, enacts as follows: Amends RSA 2000 cP-13 1 The Pharmacy and Drug Act is amended by this Act. 2

Section 1(1) is amended (

a) by repealing clause (a.2) a nd substituting the following: (a.2) “community pharmacy” mean s a pharmacy with respect to which a community pharmacy licence is issued; (a.3) “community pharmacy service” means a pharmacy service provided to or for a patient for which the patient or patient’s agent attends to receive the service at the pharmacy; (

b) by adding the following after clause (b.2): (b.3) “compounding and repa ckaging pharmacy service” means (

i) compounding drugs, or (ii) repackaging drugs for a licensed pharmacy or institution pharmacy that dispenses or sells those drugs; 1

Explanatory Notes 1 Amends

chapter P-13 of the Revised Statutes of Alberta 2000. 2

Section 1(1) presently reads in part: 1(1) In this Act, (a.2) “community pharmacy” me ans a pharmacy with respect to which a community pharmacy licence is issued; (b.2) “compounding and repackaging pharmacy” means a pharmacy with respect to which a compounding and repackaging pharmacy licence is issued; (d) “dispense” means dispense as defined in

section 1(c)(

i) of

Schedule 7.1 to the Government Organization Act; (e) “drug” means a substance or combination of substances referred to in

section 31, 32 or 33 or defined as an emergency release drug or a special access drug and any combination of such a substance or substances with any other substance; (n.2) “mail order pharmacy serv ice” means dispensing drugs pursuant to a prescription where the patient or patient’s 1 Explanatory Notes

(

c) by repealing clause (

d) and substituting the following: (d) “dispense” means, with respect to a drug, any one or more of the following: (

i) evaluating a prescription for a drug; (ii) assessing the patient and the patient’s health history and medication record; (iii) packaging and labelling of a drug; (iv) providing a drug to or for a person pursuant to a prescription; (

d) by repealing clause (n.2) and substituting the following: (n.2) “mail order pharmacy service” means a pharmacy service provided to or for a patient for which neither the patient nor the patient’s agent attends at the community pharmacy to receive the service; (

e) by repealing clause (

q) and substituting the following: (q) “patient” means a recipient of a pharmacy service; (

f) by repealing clauses (

s) and (s.1) and substituting the following: (s) “pharmacy” means the premises or part of premises in or from which a pharmacy service is provided; (s.1) “pharmacy service” means the storing, compounding, dispensing or selling of drugs; (

g) by adding the following after clause (z): (z.1) “record” means the record s of a pharmacy, whether in written, photographic, magnetic, electronic or other form, and includes, without limitation, (

i) the records of the prop rietor of the pharmacy, the licensee, the regulated members engaged by the proprietor or any other person associated with the pharmacy, 2

agent does not attend persona lly at the pharmacy to receive the drugs; (q) “patient” means a recipient of pharmacy services from a pharmacy; (q.1) “patient’s agent” means, in respect of a patient, a member of the patient’s immediate family, an individual who has a close personal relationship with the patient or an individual who personally provides care to the patient; (s) “pharmacy” means the premises or part of prem ises in which drugs are stored, in which drugs are compounded, in which drugs are dispensed or sold or within which drugs are provided for sale; (s.1) “pharmacy services” means services within the practice of pharmacy and with respect to animals means compounding, dispensing, providing for sale and selling drugs; (z) “public area” means public area as defined in the regulations for the purposes of this Act; (bb) “satellite pharmacy” me ans a community pharmacy with respect to which a satellite pharmacy licence is issued; (bb.1) “satellite pharmacy serv ice” means the dispensing, compounding, providing for sale or selling of drugs at a satellite pharmacy; (dd) “specialized pharmacy services” means specialized pharmacy services as defined in the regulations for the purposes of this Act. 2 Explanatory Notes

(ii) any record required to be kept under this Act, the Health Professions Act, the Controlled Drugs and Substances Act (Canada) or the Food and Drugs Act (Canada) or the regulations or standards under those Acts, (iii) a record of all prescriptions the pharmacy receives, including an identification of the prescriptions that the pharmacy transfers to another pharmacy or pharmacist, (iv) a record of all drugs dispensed from or through the pharmacy, including the prescription, the name of the drug, the amount dispensed, the name and contact information of the patient and the name and contact information of the prescribing practitioner, (

v) a record of the pharmacy services provided, including the name of the person or persons who dispensed a drug, (vi) a record of the names and contact information of the patients to whom pharmacy services are provided, (vii) a record of the counselling services provided to a patient, and (viii) any other record created or received by a proprietor, licensee, regulated member engaged by the proprietor or other person associated with the pharmacy and the provision of pharmacy services; (

h) by repealing clauses (bb) and (bb.1) and substituting the following: (bb) “satellite pharmacy” means a pharmacy that is operated by a community pharmacy and with respect to which a satellite pharmacy licence is issued; (bb.1) “satellite pharmacy service” means a community pharmacy service provided at a satellite pharmacy; (

i) by repealing clause (dd) and substituting the following: 3

3 Explanatory Notes

(dd) “specialized pharmacy service” means a service other than a pharmacy service that is defined in the regulations as a specialized pharmacy service for the purposes of this Act. 3

Section 2 is amended (

a) by repealing subsection (4) and substituting the following:

(4) An individual who is authorized to compound or dispense a drug in the practice of a profession other than pharmacy under the Health Professions Act, another enactment regulating the practice of a health profession or the Veterinary Profession Act may compound or dispense a drug from premises other than a licensed pharmacy or an institution pharmacy, but only in accordance with that enactment. (

b) by repealing subsection (5)(

b) and substituting the following: (

b) provide a pharmacy service other than incidentally to the practice of the profession as authorized under the Health Professions Act, the other enactment described in subsection (4) or the Veterinary Profession Act. 4

Section 3 is repealed and the following is substituted: Licence required 3 Subject to

section 4 and the regulations, no person shall provide a pharmacy service unless the service is provided (

a) from a licensed pharmacy with an appropriate category of licence, and (

b) in accordance w ith this Act and any conditions imposed on the licence. 4

Section 2 presently reads in part:

(4) An individual who is authorized to compound, dispense, provide for sale or sell a drug in the practice of a profession other than pharmacy under the Health Professions Act, another enactment regulating the practice of a health profession or the Veterinary Profession Act may compound, dispense, provide for sale or sell a drug from a premises other than a licensed pharmacy or an institution pharmacy but only in accordance with that enactment.

(5) Nothing in subsection (4) authorizes an individual to (

a) use a word or phrase the use of which is regulated by

section 37, or (

b) compound, dispense, provide for sale or sell drugs other than incidentally to the practice of the profession as authorized under the Health Professions Act, other enactment described in subsection (4) or Veterinary Profession Act. 4

Section 3 presently reads: 3 Subject to

section 4, no person shall (

a) compound, (

b) dispense, or (

c) provide for sale or sell a drug from a pharmacy unless it is a licensed pharmacy with an appropriate category of licence. 4 Explanatory Notes

Section 4 is amended (

a) in subsection (1) by striking out “compound drugs for or dispense, provide for sale or sell drugs” and substituting “provide a pharmacy service”; (

b) in subsection (2) by striking out “, dispense, provide for sale or sell” and substituting “or dispense”; (

c) by repealing subsection (3) and substituting the following:

(3) Despite subsections (1) and (2), an institution pharmacy must be a licensed pharmacy with an appropriate category of licence (

a) if a pharmacy service provided from the institution pharmacy is provided to persons other than patients, or (

b) if persons are charged for a pharmacy service or drug provided from the institution pharmacy. 5

Section 4 presently reads: 4(1) An institution pharmacy is not required to be a licensed pharmacy to compound drugs for or dispense, provide for sale or sell drugs to (

a) patients of the hospital, nursing home, institution, facility or centre in which the institution pharmacy is located, (

b) patients of a hospital, nursing home, institution, facility or centre described in

section 1(1)(

j) that is affiliated with the hospital, nursing home, institution, facility or centre in which the institution pharmacy is located, or (

c) patients of a hospital, nursing home, institution, facility or centre described in

section 1(1)(

j) that has entered into an agreement with the hospital, nursing home, institution, facility or centre in which the institution pharmacy is located to provide for shared pharmacy facilities and services.

(2) An institution pharmacy is not required to be a licensed pharmacy to compound, dispense, provide for sale or sell (

a) a special access drug, (

b) a drug to be added to a home parenteral therapy preparation, or (

c) a drug required by an indivi dual who cannot readily obtain it from a community pharmacy or a satellite pharmacy.

(3) Despite subsections (1) and (2), an institution pharmacy must be a licensed pharmacy with an appropriate category of licence if (

a) it charges an insurance company for drugs that it provides to a beneficiary of the insurance company, (

b) it compounds drugs for or disp enses, provides for sale or sells drugs to any person other than a patient described in subsection (1), or (

c) it provides pharmacy services not described in or related to those described in subsection (2) to persons other than patients.

(4) For the purposes of this section, “patient” means an individual who receives a drug as part of a health service delivered by a 5 Explanatory Notes

Section 5 is repealed and the following is substituted: Licences 5(1) The following categories of licence may be issued under this Act: (

a) a community pharmacy licence; (

b) a compounding and repackaging pharmacy licence; (

c) a mail order pharmacy licence; (

d) a satellite pharmacy licence.

(2) A community pharmacy licence authorizes the provision of community pharmacy services from the community pharmacy that is the subject of the licence.

(3) A compounding and repackaging pharmacy licence authorizes the provision of compounding and repackaging pharmacy services from a compounding and repackaging pharmacy that is the subject of the licence, but does not authorize the dispensing or selling of a drug to or for a patient unless the licensee also holds a community pharmacy licence.

(4) A mail order pharmacy licence authorizes the provision of mail order pharmacy services from the community pharmacy that is the subject of the licence.

(5) A satellite pharmacy licence authorizes the provision of satellite pharmacy services by the community pharmacy that is the subject of the licence at the location stated on the licence.

(6) Only a clinical pharmacist may apply for a licence.

(7) An application to the registrar for a licence must be in the form required by the registrar.

(8) Only one licence in each category may be issued to a licensee with respect to a pharmacy, except that more than one satellite 6

hospital, nursing home, centre, institution or facility described in

section 1(1)(j)(

i) to (viii). 6

Section 5 presently reads: 5(1) A clinical pharmacist may apply to the registrar on the form set by the council for a licence.

(2) A clinical pharmacist may hold more than one category of licence but only one licence in each category, and the subject of all the licences must be the same pharmacy.

(2.1) Despite subsection (2), a clinical pharmacist may hold more than one satellite pharmacy licence and each satellite pharmacy licence may be issued with respect to a different satellite pharmacy.

(2.2) The registrar may issue licences in the following categories: (

a) a community pharmacy licence; (

b) a compounding and repackaging pharmacy licence; (

c) a mail order pharmacy licence; (

d) a satellite pharmacy licence.

(2.3) Subject to subsection (2.31), a community pharmacy licence authorizes the licensee to operate a pharmacy that compounds, dispenses, provides for sale or sells drugs in Alberta.

(2.31) A licensee who holds a community pharmacy licence shall not provide mail order pharmacy service or satellite pharmacy service unless the licensee also holds a mail order pharmacy licence or a satellite pharmacy licence.

(2.32) Despite subsection (2.31), a licensee who holds a community pharmacy licence is not required to hold a mail order pharmacy licence to operate a pharmacy that delivers drugs to a patient or the patient’s agent if the patient or patient’s agent normally attends the pharmacy in person to receive the drugs.

(2.4) A compounding and repackaging pharmacy licence authorizes the licensee to operate a pharmacy that compounds drugs for another pharmacy or repackages drugs for another pharmacy in Alberta that dispenses, provides for sale or sells those drugs. 6 Explanatory Notes

pharmacy licence may be issued with respect to a community pharmacy. Issuance of licences 5.01(1) The registrar may issue a licence referred to in

section 5 to an applicant if the registrar is satisfied that (

a) the applicant (

i) is a clinical pharmacist, (ii) meets the licensing requirements set out in the regulations, (iii) will personally manage, control and supervise the practice of pharmacy in the licensed pharmacy, and (iv) will comply with this Act, any condition imposed on the licence and any order made under this Act, (

b) the proprietor will act in accordance with this Act, (

c) the pharmacy (

i) meets the requirements set out in the regulations, and (ii) will be operated in compliance with this Act, any condition imposed on the licence and any order made under this Act, (

d) the pharmacy services will be provided without undermining patient safety, the quality of patient care or the integrity of the drug distribution system, (

e) the applicant has paid the fees, dues and levies prescribed in the bylaws and any arrears or penalties, and (

f) in the case of an application for a satellite pharmacy licence, the patients who are expected to attend the satellite pharmacy require a pharmacy service that cannot be effectively provided in a community pharmacy, or if there is another reason, satisfactory to the registrar, that makes it necessary for those patients to receive a pharmacy service at a satellite pharmacy. 7

(2.41) A licensee who holds a compounding and repackaging licence shall not operate a pharmacy that compounds, dispenses, provides for sale or sells drugs to or for a patient unless the licensee also holds a community pharmacy licence.

(2.5) A mail order pharmacy licence authorizes a community pharmacy licensee to operate a pharmacy that provides mail order pharmacy service to patients in Alberta.

(2.6) A licensed pharmacy may deliver drugs to a patient outside Alberta if (

a) the patient normally attends the pharmacy in person to receive drugs, or (

b) the patient is in another province or territory in respect of which there is an agreement between the college and the organization that regulates the practitioners of pharmacy in that province or territory to facilitate (

i) investigations of alleged misconduct of licensees, proprietors or pharmacists practising in licensed pharmacies, and (ii) the resolution of any comp laints made against licensees or proprietors or pharmacists practising in licensed pharmacies.

(2.7) A satellite pharmacy licence authorizes a community pharmacy licensee to operate a satellite pharmacy at the location stated on the licence that is not the location of the community pharmacy.

(2.8) An applicant for a mail order pharmacy licence or for a satellite pharmacy licence must hold a community pharmacy licence.

(3) The registrar may issue a community pharmacy licence or a compounding and repackaging pharmacy licence to an applicant if the registrar is satisfied that (

a) the applicant (

i) is a clinical pharmacist, (ii) meets the licensing requirements set out in this

section and in the regulations, 7 Explanatory Notes

(2) With respect to each application for a licence, the applicant and the proprietor must each (

a) provide a statutory decl aration stating whether the applicant or proprietor has been convicted of an indictable offence related to misconduct, fraud or commercial matters within Canada or a similar offence outside Canada, and (

b) if so convicted, provide evidence satisfactory to the registrar of effective rehabilitation.

(3) The registrar must consider an application, make a decision and give the applicant a copy of the decision as soon as reasonably possible.

(4) The registrar must state on the licence the category of licence, the name of the licensee and the name and location of the pharmacy with respect to which the licence is issued and the date on which the licence expires.

(5) The registrar must enter in the register under this Act (

a) the category of licence issued, (

b) the home address of the licensee, (

c) the business telephone and fax numbers and business mailing and e-mail addresses of the licensee, (

d) the name, mailing address and street address of the pharmacy in respect of which the clinical pharmacist is issued the licence, and of any proprietor of the pharmacy, (

e) the name of any pharmacist employed or previously employed to engage in the practice of pharmacy within the pharmacy described in clause (d), (

f) any conditions imposed on the licence, (

g) any other information required under the regulations, and (

h) the date on which the licence expires. 8

(iii) will personally manage, control and supervise the practice of pharmacy in the pharmacy, and (iv) will comply with this Act, any condition imposed on the licence and any order made under this Act, (

b) the pharmacy meets the requirements set out in the regulations and will be operated, and the proprietor will act, in accordance with this Act and any order under this Act, and (

c) the applicant has paid the registration fees, dues and levies prescribed in the bylaws and any arrears or penalties.

(3.1) A licensee who holds a community pharmacy licence may apply to the registrar on a form satisfactory to the registrar for (

a) one mail order pharmacy licen ce for the pharmacy in respect of which the community pharmacy licence is issued, and (

b) one or more satellite pharmacy licences for pharmacies that are operated in conjunction with the pharmacy in respect of which the community pharmacy licence is issued.

(3.2) The registrar may issue a mail order pharmacy licence if in the opinion of the registrar (

a) the applicant will comply with this Act, any condition imposed on the licence and any order made under this Act, (

b) the mail order pharmacy service is in the public interest, (

c) the mail order pharmacy serv ice will be provided without undermining patient safety, the quality of patient care or the integrity of the drug distribution system, and (

d) the applicant has paid the registration fees, dues and levies prescribed in the bylaws and any arrears or penalties.

(3.3) The registrar may issue one or more satellite pharmacy licences if in the opinion of the registrar (

a) the applicant will comply with this Act, any condition imposed on the licence and any order made under this Act, (

b) the patients who are expected to attend the satellite pharmacy require pharmacy services that cannot be effectively provided in a community pharmacy, or if there is another reason, 8 Explanatory Notes

(6) The registrar may impose conditions on a licence in accordance with the regulations (

a) at the time the licence is issued, or (

b) at another time if, in the registrar’s opinion, the conditions are necessary to protect patient safety, the quality of patient care or the integrity of the drug distribution system.

(7) A licence remains in effect for the term provided for in the bylaws. 9

satisfactory to the registrar, that makes it necessary for those patients to receive pharmacy services at a satellite pharmacy, (

c) the satellite pharmacy servic e will be provided without undermining patient safety, the quality of patient care or the integrity of the drug distribution system, and (

d) the applicant has paid the registration fees, dues and levies prescribed in the bylaws and any arrears or penalties.

(3.4) With respect to each application for a licence, the applicant and the proprietor must each (

a) provide a statutory declaration stating whether the applicant or proprietor has been convicted of an indictable offence related to misconduct, fraud or commercial matters within Canada or a similar offence outside Canada, and (

b) if so convicted, provide evidence satisfactory to the registrar of effective rehabilitation.

(3.5) The registrar must consider an application, make a decision and give the applicant a copy of the decision as soon as reasonably possible.

(4) The registrar must state on the licence the category of licence, the name of the licensee and the name and location of the pharmacy with respect to which the licence is issued.

(5) The registrar must enter in the register under this Act (

a) the category of licence issued, (a.1) the name and business address of the licensee, (

b) the name and address of the pharmacy and of any proprietor of the pharmacy in respect of which the clinical pharmacist is issued the licence, (

c) the name of any pharmacist employed to engage in the practice of pharmacy within the pharmacy described in clause (b), and (

d) any other information required under the regulations.

(6) The registrar may, in accordance with the regulations, impose conditions on a licence. 9 Explanatory Notes

Section 5.1(1) is repealed and the following is substituted: Review of a decision 5.1(1) If an applicant is refused a licence under

section 5.01 or the renewal of a licence under

section 7 or is dissatisfied with a condition imposed on a licence, the applicant may, by written request to the registrar within 30 days of being notified of the refusal to issue or renew the licence or the imposition of a condition on a licence, request a review of the registrar’s decision. 8

Section 6(2) is amended by striking out “5(5)” and substituting “5.01(5), except clause (

b) of that subsection,”. 9

Section 7(1) is amended (

a) in clause (

a) by striking out “section 5” and substituting “section 5.01”; (

b) in clause (a.1) (

i) by striking out “section 5(3.4)(a)” and substituting “section 5.01(2)(a)”; (ii) by striking out “section 5(3.4)(b)” and substituting “section 5.01(2)(b)”. 10

(7) A licence remains in effect for the term provided for in the bylaws. 7

Section 5.1(1) presently reads: 5.1(1) If an applicant is refused a licence under

section 5 or the renewal of a licence under

section 7 or is dissatisfied with conditions imposed on a licence, the applicant may, by written request to the registrar within 30 days of being notified of the refusal or the issuance of the licence, request a review of the registrar’s decision. 8

Section 6(2) presently reads:

(2) If a member of the public, during regular business hours, requests information on the register respecting a named licensed pharmacy, proprietor, licensee or pharmacist employed within a licensed pharmacy, the college must provide the information described in

section 5(5) with respect to the request. 9

Section 7(1) presently reads: 7(1) On application by the licensee, the registrar may renew a licence if the registrar is satisfied that (

a) the licensee and the licensed pharmacy continue to meet the requirements of

section 5, (a.1) the licensee and proprietor hav e, in the current application, complied with

section 5(3.4)(

a) and, if applicable, have provided satisfactory evidence under

section 5(3.4)(b), (

b) the information under

section 5( 5) pertaining to the licence is correct, (

c) the licensee has provided the information required by the regulations, and (

d) the licensee has paid the renewal fee, dues and levies prescribed in the bylaws and any arrears or penalties. 10 Explanatory Notes

Section 10(1) is repealed and the following is substituted: Obligations of licensee 10(1) A licensee must (

a) ensure that the licensed pharmacy operates in accordance with this Act, (

b) ensure that due diligence is exercised in the dispensing of drugs in accordance with the standards of practice under the Health Professions Act for the practice of pharmacy, (

c) comply with any conditions imposed on the licence, and (

d) ensure that (

i) all drugs dispensed to or for a patient are dispensed pursuant to a prescription that has been received by the pharmacy, (ii) counselling in respect of a patient is conducted in accordance with the standards of practice under the Health Professions Act for the practice of pharmacy, (iii) a patient or a patient’s agent is able, with reasonable ease, to contact a clinical pharmacist who is engaged by the pharmacy, (iv) all required records are created and maintained in accordance with this Act, (

v) the drugs being dispensed by or through the pharmacy meet the laws of Canada and Alberta, (vi) pharmacy services are provided by regulated members, and (vii) a pharmacist providing services within the practice of pharmacy does so under the management of the licensee.

(1.1) Records must be kept under the care and control of the licensee. 11

Section 10(1) presently reads: 10(1) A licensee must (

a) ensure that the licensed pharmacy operates in accordance with this Act, and (

b) comply with any cond itions imposed on the licence. 11 Explanatory Notes

Section 11 is amended by adding the following after subsection (2):

(3) A proprietor must ensure that all required records are created and maintained in accordance with this Act.

(4) If a proprietor knows or has reason to believe that a licensee is acting in contravention of the licensee’s obligations under

section 10, the proprietor must report the alleged contravention to the registrar. 12

Section 14(2) is amended by adding “clinical” before “pharmacist”. 13

Section 19(

a) is repealed. 14

Section 21 is repealed and the following is substituted: Inspection or investigation 21(1) Any record required to be created or maintained and any substance required to be kept under this Act, the Health Professions Act, the Controlled Drugs and Substances Act (Canada) or the Food and Drugs Act (Canada) or the regulations under those Acts must be available for inspection by a field officer.

(2) A field officer may, at any reasonable time, enter a licensed pharmacy and inspect the operation and records of the licensed 12

11 Obligations of a licensee and proprietor. 12

Section 14(2) presently reads:

(2) Despite subsection (1), if a licence is terminated under subsection (1)(a), (

b) or (

c) and the proprietor or the proprietor’s agent immediately places the pharmacy under the personal management, control and supervision of another pharmacist, the registrar may grant permission to the proprietor to continue to operate the pharmacy for the period of time prescribed in the bylaws. 13

Section 19(

a) presently reads: 19 In this Part, (a) “records” includes prescriptions and other information whether in written, photographic, magnetic, electronic or other form; 14

Section 21 presently reads: 21(1) Any record and substance required to be kept by a pharmacist under this Act, the Health Professions Act, the Controlled Drugs and Substances Act (Canada) or the Food and Drugs Act (Canada) or the regulations under those Acts must be available for inspection by a field officer.

(2) A field officer may, at any reasonable time, enter a licensed pharmacy and inspect the operation and records of the licensed pharmacy to ensure compliance with this Act and must report the findings to the registrar on the conclusion of each inspection. 12 Explanatory Notes

pharmacy for the purpose of determining whether this Act is being complied with.

(3) Where a field officer has reasonable grounds to believe that a person has committed an offence under this Act or the regulations, the field officer, or a person authorized by the registrar, may, at any reasonable time, enter any premises, other than a private dwelling place, to conduct an investigation.

(4) On entering a licensed pharmacy or other premises, a field officer must, on request, produce identification provided for by the regulations.

(5) In carrying out an inspection or investigation a field officer may, at any reasonable time, (

a) require any person to answer any relevant question and direct the person to answer the question under oath, (

b) demand the production for examination of any records that are relevant to the inspection or investigation, (

c) inspect and take samples of any substance in the licensed pharmacy or premises, (

d) on giving a receipt for them, remove records and substances that are relevant to the inspection or investigation for the purpose of examining them, performing tests on them and making copies of them, and (

e) make copies or take photographs of any record removed under clause (d).

(6) If a field officer removes any records or substances during an inspection or investigation, the field officer (

a) must give a receipt for the records or substances to the person from whom they were taken, and (

b) must return substances, if possible, and must return any records, within a reasonable time after they have served the purposes for which they were taken. 13

(3) On entering a licensed pharmacy, a field officer must, on request, produce identification provided for by the regulations.

(4) In carrying out an inspection a field officer may, at any reasonable time, (

a) require any person to ans wer any relevant question and direct the person to answer the question under oath, (

b) demand the production for examination of any records and substances that are relevant to the inspection, and (

c) on giving a receipt for them, remove records and substances that are relevant to the inspection for the purpose of examining them, performing tests on them and making copies of them.

(5) A field officer who removes any records under subsection (4) must return them to the licensed pharmacy from which they were removed within a reasonable time.

(6) A field officer who removes any substance under subsection (4) must return it, if possible, to the licensed pharmacy from which it was removed within a reasonable time.

(7) The registrar, on the request of a field officer, may apply to the Court of Queen’s Bench for (

a) an order directing any person (

i) to produce to the field inspector any records or substances relevant to the inspection in the person’s possession or under the person’s control, (ii) to give up possession of an y record described in subclause (

i) to allow the field officer to take it away to examine and copy it and perform tests on it and to return it within a reasonable time, and (iii) to give up possession of any substance described in subclause (

i) to allow the field officer to take it away and to allow the field officer to examine it and perform tests on it and to return it, if possible, within a reasonable time, and 13 Explanatory Notes

(7) On request, a field officer must provide a copy of any records removed during an inspection or investigation to the person from whom they were taken.

(8) The licensee or proprietor and any person engaged by the proprietor must co-operate with an inspection or investigation.

(9) The registrar, on the request of a field officer, may apply to the Court of Queen’s Bench for (

a) an order directing any person (

i) to produce to the fi eld officer any records or substances relevant to the inspection or investigation in the person’s possession or under the person’s control, (ii) to give up possession of any record described in subclause (

i) to allow the field officer to take it away to examine and copy it and perform tests on it and to return it within a reasonable time, and (iii) to give up possession of any substance described in subclause (

i) to allow the field officer to take it away to examine it and perform tests on it and to return it, if possible, within a reasonable time, and (

b) an order directing any person to attend before the field officer to answer any relevant inquiries the field officer may have relating to the inspection or investigation.

(10) An application for an order under subsection (9) may be made without notice if the Court is satisfied that it is proper to make the order in the circumstances. 15

Section 22 is amended (

a) in subsection (2) (

i) by adding “or conducting an investigation” after “an inspection”; 14

(

b) an order directing any person to attend before the field officer to answer any relevant inquiries the field officer may have relating to the inspection.

(8) An application for an order under subsection (7) may be made without notice if the Court is satisfied that it is proper to make the order in the circumstances. 15

Section 22 presently reads in part: 22(1) A field officer must notify the registrar, as soon as practicable, of any perceived or apparent misconduct on the part of a proprietor or licensee. 14 Explanatory Notes

(ii) in clauses (

a) and (

b) by adding “or investigation” after “the inspection”; (

b) in subsection (2.1) by adding “or investigation” after “inspection”. 16 The following is added after

section 27: Collection, use and disclosure of information 27.1(1) In this section, (a) “health information” m eans health information as defined in the Health Information Act; (b) “personal information” m eans personal information as defined in the Freedom of Information and Protection of Privacy Act.

(2) The registrar may collect and use information, including personal information and health information, acquired under this Act for the purposes of protecting or enhancing patient safety, the quality of patient care or the integrity of the drug distribution system.

(3) Information, including personal information and health information, may be collected from or disclosed to (

a) a body that regulates pharmacies in another jurisdiction, (

b) a body that regulates pharmacists in another jurisdiction, (

c) a body that regulates health professionals other than pharmacists in Alberta or in another jurisdiction, 15

(2) Within 90 days after completing an inspection, a field officer must (

a) give a report to the regist rar, licensee and proprietor setting out the findings of the inspection, (

b) decide and advise the registrar, licensee and proprietor whether or not the results of the inspection were satisfactory, and (

c) if the registrar has been notified under subsection (1), advise the proprietor and licensee of the notification.

(2.1) If the results of an inspection were not satisfactory, the field officer may direct the licensee or proprietor or both to undertake specified actions to ensure compliance with this Act. 16 Collection, use and disclosure of information. 15 Explanatory Notes

(

d) a law enforcement agency, (

e) the Government of Albe rta or any agency of the Government, or (

f) the government of Canada or of any province or territory of Canada or any agency of the government of Canada or of a province or territory of Canada for the purposes of protecting or enhancing patient safety, the quality of patient care or the integrity of the drug distribution system. Reciprocal agreements 27.2(1) The Minister may enter into agreements with any government, government agency or body referred to in

section 27.1(3) or any other person or group of persons that regulates pharmacists or pharmacies (

a) respecting any matter relating to the administration or enforcement of this Act, or (

b) respecting the reciprocal enforcement of this Act and legislation in another jurisdiction.

(2) The Minister may make regulations respecting reciprocal enforcement agreements that may be entered into by the college with a body that regulates pharmacies or pharmacists in another jurisdiction. 17

Section 28(1) is amended (

a) by adding the following after clause (a.2): (a.3) exempting a person, or an y class of persons, from the requirement of

section 3; (

b) in clause (

l) by striking out “22(2)” and substituting “22(2.1)”; (

c) by adding the following after clause (p): (p.1) respecting the creation an d maintenance of records for the purposes of this Act; 16

Section 28(1) presently reads in part: 28(1) The council may make regulations (

a) respecting licensing, except the term of a licence; (a.1) respecting requirements and applications for licences and renewal of licences; (a.2) respecting licences, includi ng limitations on a category of licence and the requirements that a pharmacy must meet; (

l) respecting specified actions under

section 22(2); 16 Explanatory Notes

(p.2) respecting the types of records that constitute records for the purpose of

section 1(1)(z.1); 18

Section 30 is repealed. 19

Section 36 is repealed and the following is substituted: Operation of a pharmacy without a licence 36(1) A person who operates a licensed pharmacy while the licence is suspended is guilty of an offence.

(2) Subject to

section 4(1) and (2) and regulations made under

section 28(1)(a.3), (

a) a person who operates a pharmacy but does not hold a licence, or does not hold the appropriate category of licence, is guilty of an offence; (

b) a person who operates a pharmacy but does not comply with the conditions of a licence is guilty of an offence. 20

Section 37 is amended by adding “, apothecary” after “drug store”. 21

Section 38 is amended (

a) by striking out “3(1)” and substituting “3”; (

b) by adding “11(4),” before “12,”. 17

(

p) defining words or expressions to be defined by the regulations and any other word or expression used in this Act that has not been defined in this Act; 18

Section 30 presently reads: 30 Drugs may be compounded, dispensed, provided for sale or sold only in a licensed pharmacy or an institution pharmacy. 19

Section 36 presently reads: 36(1) A person who operates a licensed pharmacy while the licence is suspended is guilty of an offence.

(2) Subject to

section 4(1) and (2), a person who operates a pharmacy but does not hold a licence or does not hold the appropriate category of licence is guilty of an offence. 20

Section 37 presently reads: 37 No person except a licensee or proprietor may use the word or phrase pharmacy, pharmaceutical dispensary, drug store or drug or any similar word or phrase, alone or in combination with other words, in a manner that states or implies that premises or a business is a pharmacy unless the premises or business is a licensed pharmacy or an institution pharmacy. 21

Section 38 presently reads: 38 A person who contravenes

section 2(2), 3(1), 10(2) or (3), 12, 30, 31(2), 32(2), 33(2) or (3) or 37 is guilty of an offence. 17 Explanatory Notes

Section 42(1) is amended by adding the following after clause (d): (

e) the Minister, an employee under the administration of the Minister, an agent of the Minister or a person contracted by the Minister. 23 This Act comes into force on Proclamation. 18

Section 42(1) presently reads: 42(1) No action lies against any of the following in respect of anything done or omitted to be done in good faith under this Act: (

a) the college or an officer or employee of the college, the members of the council or a field officer; (

b) a member of the council or of a committee or another person exercising powers or carrying out duties in accordance with this Act or under

Part 4 of the Health Professions Act with respect to a complaint under this Act; (

c) a person acting on the instru ctions of a person or entity referred to in clause (

a) or (b); (

d) a licensee who makes a report under

section 10(3). 23 Coming into force. 18 Explanatory Notes

RECORD OF DEBATE Stage Date Member From To Questions and Comments From To Stage Date Member From To Questions and Comments From To Stage Date Member From To Questions and Comments From To Stage Date Member From To Questions and Comments From To Title: 2008 (27th, 1st) Bill 44, Pharmacy and Drug Amendment Act, 2008

Document details

Collection	Alberta — Bills
Citation	L27 S1 692
Type	bill
Volume / chapter	L27 S1 692
Language	en
Format	json
Source	PROVINCIAL
Identifier	cb67e2a0732c968215c5244d2fa75623dc244686

Source file is stored in the law ingest library (json).