Pharmaceutical Information Act

c t PHARMACEUTICAL INFORMATION ACT PLEASE NOTE This document, prepared by the Legislative Counsel Office, is an office consolidation of this Act, current to September 22, 2014. It is intended for information and reference purposes only. This document is not the official version of the Act. The Act and the amendments as printed under the authority of the King’s Printer for the province should be consulted to determine the authoritative statement of the law. For more information concerning the history of this Act, please see the Table of Public Acts on the Prince Edward Island Government web site (www.princeedwardisland.ca). If you find any errors or omissions in this consolidation, please contact: Legislative Counsel Office Tel: (902) 368-4292 Email: legislation@gov.pe.ca Pharmaceutical Information Act Table of Contents c PHARMACEUTICAL INFORMATION ACT Table of Contents Section Page 1. Definitions................................................................................................................................................ 5 1.1 Conflict with FOIPP Act .......................................................................................................................... 6 PHARMACEUTICAL INFORMATION PROGRAM 6 2. Pharmaceutical Information Program ...................................................................................................... 6 3. Requirement to record information .......................................................................................................... 6 ADVISORY COMMITTEE 7 4. Advisory Committee ................................................................................................................................ 7 PRIVACY, CONFIDENTIALITY AND USE OF INFORMATION 8 5. Confidentiality ......................................................................................................................................... 8 REGULATIONS 9 6. Regulations .............................................................................................................................................. 9 7. Liability .................................................................................................................................................. 10 8. Offence ................................................................................................................................................... 10 c t Current to: September 22, 2014 Page 3 PHARMACEUTICAL INFORMATION PROGRAM Pharmaceutical Information Act Section 1 c PHARMACEUTICAL INFORMATION ACT CHAPTER P-5.2 1. Definitions In this Act (a) “Advisory Committee” means the Advisory Committee appointed pursuant to subsection 4(3); (a.1) repealed by 2004,c.43,s.6; (b) “Director” means the Director appointed pursuant to subsection 2(4); (c) “drug” has the same meaning it has in the Pharmacy Act R.S.P.E.I. 1988, Cap. P-6.1; (d) “emergency situation” means any instance where health care must be provided to preserve life or prevent severe harm to a patient who is unable, owing to the circumstances of the emergency or owing to mental incapacity, to be cognizant of the context in which the health care must be provided and whose associate or substitute decision maker is not immediately available to make decisions on the patient’s behalf; (d.1) “hospital” means a hospital as defined in the Hospitals Act R.S.P.E.I. 1988, Cap. H- 10.1; (e) “Minister” means the Minister of Health and Wellness; (f) “pharmacist” means a pharmacist as defined in the Pharmacy Act; (f.1) “repealed by 2014,c.39,s.67(2); (g) “prescriber” means a prescriber as defined in the Pharmacy Act; (h) “professional body” means a professional body created by statute to govern (i) physicians licensed pursuant to the Medical Act, (ii) dentists licensed pursuant to the Dental Profession Act, (iii) pharmacists registered pursuant to the Regulated Health Professions Act R.S.P.E.I. 1988, Cap. R-10.1, and (iv) members of any other group of health professionals, if any members of that group are authorized under or pursuant to an enactment to prescribe a drug or class of drugs; (i) “Program” means the Pharmaceutical Information Program established pursuant to section 2; (j) “resident” means a resident as defined under the Health Services Payment Act R.S.P.E.I. 1988, Cap. H-2. 2000,c.18,s.1; 2004,c.43,s.1,6; 2007,c.10,s.1; 2010,c.31,s.3; 2014,c.39,s.67(2). c t Current to: September 22, 2014 Page 5 PHARMACEUTICAL INFORMATION PROGRAM Section 2 Pharmaceutical Information Act 1.1 Conflict with FOIPP Act If a provision of this Act or the regulations made under this Act is inconsistent with or in conflict with a provision of the Freedom of Information and Protection of Privacy Act R.S.P.E.I. 1988, Cap. F-15.01 or the regulations made under that Act, the provision of this Act or the regulations made under this Act prevails to the extent of the inconsistency or conflict. 2004,c.43,s.2. PHARMACEUTICAL INFORMATION PROGRAM 2. Pharmaceutical Information Program (1) The Minister shall establish a provincial computerized pharmacy network and database to be known as the Pharmaceutical Information Program. Purpose (2) The purpose of the Program is to (a) electronically link pharmacies, physicians’ offices, addiction centres,, emergency rooms, and other health facilities with a database which maintains patient medication records; (b) provide pharmacists and prescribers who participate in the Program with medication profiles of individual patients to assist in the patient’s care; (c) provide electronic information for the administration of government drug-benefit plans; and (d) provide information for approved health planning, evaluation, and research on the beneficial and adverse effects of medications used by residents of Prince Edward Island. Information to be collected and stored (3) The Lieutenant Governor in Council shall, by regulation, ensure that the uses of the information collected and stored by the Program are limited to those enumerated in this Act. Director (4) The Minister shall appoint a Director to manage and control the information collected and stored by the Program. 2000,c.18,s.2; 2007,c.10,s.2. 3. Requirement to record information (1) Every pharmacist shall, when dispensing any drug prescribed for any resident, record with the Program all prescribed information. Exception (1.1) Subsection (1) does not apply to any pharmacist who is dispensing a drug from a pharmacy in a hospital if the drug is to be administered to or taken by a person who is admitted to the hospital. Prescribers (2) The Lieutenant Governor in Council may make regulations governing the participation of prescribers in the Program. Page 6 Current to: September 22, 2014 t c ADVISORY COMMITTEE Pharmaceutical Information Act Section 4 Exclusion of participant (3) Where, in the opinion of the Minister, any person is not properly fulfilling the duties created by this Act and the regulations, the Minister may suspend or exclude the person from participation in and access to the Program, in accordance with the regulations. 2000,c.18,s.3; 2004,c.43,s.3,6; 2007,c.10,s.3. ADVISORY COMMITTEE 4. Advisory Committee (1) The Minister shall establish an Advisory Committee to (a) provide advice regarding the use of, access to, and protection of information in the Program; (b) provide advice respecting the development of regulations pursuant to this Act; and (c) perform other duties pursuant to this Act and the regulations as assigned by the Minister. Duties (2) The Advisory Committee shall (a) advise the Director on strategic directions and policies for appropriate research uses of the Program; (b) consider issues arising from the analysis of information in the Program; (c) monitor patterns of operation and use of the Program and recommend actions and policies regarding the operation and use of the Program to the Director; and (d) communicate direct observations regarding non-compliance with provisions of this Act, and other recommendations expressed to the Committee, the Director, or other appropriate person or body; and (e) submit to the Minister an annual report. Composition (3) The Minister shall appoint the Advisory Committee, which shall consist of (a) one person nominated by the Medical Society of Prince Edward Island; (b) one person nominated by the Prince Edward Island College of Physicians and Surgeons; (c) one person nominated by the Prince Edward Island Pharmacists Association; (d) one person nominated by the College of Pharmacists; and (e) three persons nominated by the Minister, at least one of whom shall be a layperson to represent the public. Tenure (4) Appointments to the Advisory Committee shall be for a maximum of three years. Maximum service (5) No person shall serve more than two consecutive terms on the Advisory Committee. c t Current to: September 22, 2014 Page 7 PRIVACY, CONFIDENTIALITY AND USE OF INFORMATION Section 5 Pharmaceutical Information Act Procedures (6) The Lieutenant Governor in Council shall, by regulation, specify the procedures by which the Advisory Committee shall operate and advise the Minister and the Director. 2000,c.18,s.4; 2014,c.39,s.67(3) PRIVACY, CONFIDENTIALITY AND USE OF INFORMATION 5. Confidentiality (1) All persons having access to information in the Program (a) shall ensure the privacy, confidentiality and security of information in the Program; and (b) shall not permit disclosure of information in the Program to any person not expressly authorized by this Act or the regulations. Disclosure (2) Information stored in the Program that identifies a person (a) shall be disclosed to the person, where the person has requested information regarding the person’s own prescriptions or the person’s other health information stored in the Program; or (b) may, with the consent of the person, be disclosed to (i) a pharmacist, (ii) a prescriber who is participating in the Program, or (iii) a health professional who is providing care, treatment or services to the person. Correction of inaccuracies (3) Where information disclosed to a person pursuant to clause (2)(a) is found by the person to be inaccurate, the information shall be amended as prescribed by the regulations. Disclosure without consent (4) Information stored in the Program that identifies a person may be disclosed without the consent of the person (a) to a health professional acting in an emergency situation; (b) to persons responsible for the administration of provincial drug-benefit plans, where the information relates only to drugs dispensed as benefits of the plans; or (c) to persons responsible for the technical support and maintenance of the Program. Disclosure of information (5) The Minister may permit disclosure of information stored in the Program where (a) the disclosure is for (i) the purpose of reports or planning, or (ii) the purpose of research which has been approved by a prescribed research ethics body. (b) the disclosure does not compromise the privacy, confidentiality and security of the information disclosed; (c) the disclosure is in the public interest; and Page 8 Current to: September 22, 2014 t c REGULATIONS Pharmaceutical Information Act Section 6 (d) the information is in an aggregate or non-identifiable form, and cannot be used to identify any person, pharmacist, or prescriber to whom the information relates. Research disclosure agreements (5.1) The Minister may, before permitting the disclosure of information stored in the Program to a person or a research entity pursuant to clause (5)(a), require the person or research entity to enter into an agreement containing such terms and condition as the Minister considers appropriate. Exception where consent (6) Notwithstanding subsection (5), the Minister may permit disclosure of information pursuant to subsection (5) that could be used to identify a person, pharmacist, or prescriber where the Minister has the consent of the person, pharmacist, or prescriber to whom the information relates. Exception for investigation (7) Notwithstanding subsection (5), the Minister may disclose information that could be used to identify a person, pharmacist, or prescriber, without consent of the person, pharmacist, or prescriber, in response to a request from a professional body for the purpose of an investigation regarding the drug dispensing or prescribing practices of a pharmacist or prescriber being carried out by the professional body. Consultation (8) The Minister shall consult with the Advisory Committee as necessary and report on the discharge of the duties imposed by this section. 2000,c.18,s.5; 2004,c.43,s.4. REGULATIONS 6. Regulations The Lieutenant Governor in Council may make regulations (a) to ensure the privacy, confidentiality, and security of information in the Program; (b) establishing security arrangements and procedures and confidentiality undertakings, including physical and electronic security arrangements and procedures, to be undertaken or completed by pharmacists and prescribers to ensure the confidentiality of information in, or intended to be in, the Program; (c) specifying the duties of pharmacists and prescribers who participate in the Program; (d) respecting the suspension or exclusion of a person from participation in the program pursuant to subsection 3(3); (e) respecting the disclosure to a person, or the correction at the request of a person, of information in the Program that identifies the person; (e.1) respecting the use of a personalized password by a person who has information in the Program that identifies the person for the purpose of authorizing the release of that information to a person referred to in clause 5(2)(b); (e.2) prescribing forms for the purposes of this Act, including forms for (i) applications by a person for the disclosure or correction of information in the Program that identifies the person, (ii) applications for a personalized password by a person who has information in the Program that identifies the person, c t Current to: September 22, 2014 Page 9 REGULATIONS Section 7 Pharmaceutical Information Act (iii) applications for the disclosure of information in the Program for a purpose referred to in clause 5(5)(a), (iv) confidentiality undertakings for pharmacists and prescribers who participate in the Program; (e.3) prescribing research ethics bodies for the purpose of subsection 5(5); (f) prescribing fees for information released pursuant to section 5; (g) defining any term not defined in this Act; and (h) generally, to carry out the purposes of this Act. 2000,c.18,s.6; 2004,c.43,s.5. 7. Liability The Minister, the Director, and any other person acting on their instructions or under the authority of this Act or the regulations are not personally liable for any loss or damage suffered by any person by reason of any act done by any of them in good faith in the exercise or purported exercise of their functions. 2000,c.18,s.7. 8. Offence Any person who violates any provision of this Act or the regulations is liable upon summary conviction to a fine of a minimum of $15,000 and a maximum of $50,000. 2000,c.18,s.8. Page 10 Current to: September 22, 2014 t c