Pharmacy Legislation Lecture Notes PDF

Pharmacy Legislation Lecture 2 Legislation ▪ Under the Westminster system, an item of primary legislation is known as an Act of Parliament after enactment. Legislation ▪ Proposed Acts are called Bills. Most Bills are drafted by the PCO. Bills are categorised as Government Bills, Members' Bills, loca...

Pharmacy Legislation Lecture 2 Legislation ▪ Under the Westminster system, an item of primary legislation is known as an Act of Parliament after enactment. Legislation ▪ Proposed Acts are called Bills. Most Bills are drafted by the PCO. Bills are categorised as Government Bills, Members' Bills, local Bills, and private Bills. Proposed amendments to a Bill may be set out in a document known as a Supplementary Order Paper (SOP). ▪ More information: http://www.pco.parliament.govt.nz/aboutlegislation/ The following Act and Legislation as applicable to pharmacy technician: Health and Disability Commissioner Act 1994 Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996 Privacy Act 2020 Health Information Privacy Code 2020 Health (Retention of Health Information) Regulations 1996 Health Practitioners Competence Assurance Act 2003 Health (Needles and Syringes) Regulations 1998 Health and Safety at Work Act 2015 Health and Safety in at Work Regulations 2016 Medicines Act 1981 Medicines Regulations 1984 Pharmac (Pharmaceutical Management Agency) - rules, regulations, and subsidy requirements Privacy Act 2020 ▪ The Privacy Act 2020 came into force on 1 December 2020, replacing Privacy Act 1993. ▪ Privacy Act 2020 is applicable to all agencies that collect personal information about living individual. ▪ Patient information includes the DOB, full name, residential/home address, contact phone number(s). ▪ The Privacy Act 2020 is based on 13 privacy principles that govern how you should collect, handle and use personal information. Health Information Privacy Code 2020 ▪ This code sets specific rules for agencies in the health sector. It covers health information collected, used, held and disclosed by health agencies and takes the place of the information privacy principles for the health sector. Health Information Privacy Code 2020 The Health Information Privacy Code applies to the health information about identifiable individuals and applies to: All agencies providing personal or public health or disability services such as primary health organisations, district health boards, rest homes, supported accommodation, doctors, nurses, dentists, pharmacists and optometrists; and Some agencies that do not provide health services to individuals, but which are part of the health sector such as ACC, the Ministry of Health, the Health Research Council, health insurers and professional disciplinary bodies. Privacy Act 2020 (useful links) ▪ https://www.privacy.org.nz/ ▪ https://www.privacy.org.nz/privacy-act-2020/codes-ofpractice/hipc2020/ ▪ https://www.health.govt.nz/about-site/privacy-and-security Health Practitioners Competence Assurance Act 2003 ▪ The Health Practitioners Competence Assurance Act 2003 (the Act) provides a framework for the regulation of health practitioners in order to protect the public where there is a risk of harm from professional practice. ▪ All health professionals must hold a valid (current) annual practicing certificate (APC) Health Practitioners Competence Assurance Act 2003 ▪ In New Zealand, the following health professionals must be registered and hold current APC in order being able to practice legally: ▪ All Medical Doctors (Medical Practitioners) must be registered with a Medical Council of New Zealand ▪ Registered Nurses (RN’s) must hold APC from the Nursing Council of New Zealand ▪ All Pharmacists must be registered with Pharmacy Council of New Zealand Health Practitioners Competence Assurance Act 2003 ▪ APC must be renewed every 12 months. ▪ Other registered health professionals include: dentists and dental therapists, dietitians, midwifes, occupation therapists, optometrists, physiotherapists and medical laboratory scientists. Health Practitioners Competence Assurance Act 2003 Each Council will set up their own rules and regulations ▪ Each health professional has his/her scope of practice defined (i.e., prescribing rights) ▪ Proof of ongoing professional development is required in order to renew APC. The specifics of that are set by those Councils. ▪ Each Council has the power to suspend or cancel registrations. May also put some restrictions on the scope of practice (i.e., Medical Practitioner may not be permitted to prescribe Controlled Drugs) ▪ Health Practitioners Competence Assurance Act 2003 ▪ Having one legislative framework allows for consistent procedures and terminology across the professions now regulated by the Act. The principal purpose of protecting the health and safety of the public is emphasised and the Act includes mechanisms to ensure that practitioners are competent and fit to practice their professions for the duration of their professional lives. Medicines Act 1981 ▪ The Medicines Act 1981 regulates medicines, related products and medical devices in New Zealand. The Act ensures that the medicines and products used in New Zealand are safe and effective (MOH, 2022). Medicines Act 1981 ▪ The Act: defines what a medicine is sets out: requirements for the approval, classification, manufacture, sale, distribution, advertising, prescribing and dispensing of medicines licensing requirements for the medicines’ distribution chain, including wholesalers and pharmacies requirements for the approval of related products post-market controls on medicines and medical devices. For instance, Covid-19 BioNTech, Pfizer vaccine has been approved by MedSafe under appropriate section in Medicines Act 1981. Medsafe will only recommend a medicine is approved to use in New Zealand if it meets these standards. If approval is granted, it will either be full approval under section 20 of the Medicines Act 1981, or provisional approval under section 23. Medicines Act 1981 Medicines Act 1981 Legal requirement of prescribing under the Medicines Act 1981 Note: optometrists and dietitians can also prescribe within their scope Legal requirement of prescribing under the Medicines Act 1981 Legal requirement of prescribing under the Medicines Act 1981 ▪ A veterinarian may only prescribe a prescription medicine that is for the treatment of an animal under a veterinarian’s care. ▪ In addition to standard information, we must also have the full name & physical address of the animal’s owner. ▪ A pharmacy may contact the Veterinarian Council of NZ if there is any doubt about the prescription. Legal requirement of prescribing under the Medicines Act 1981 ▪ NOT all prescribers have the same prescribing rights, and it has to do with their scope of practice. ▪ For examples, Optometrists have no prescribing rights for controlled drugs. ▪ Registered Dietitians can prescribe a limited range of items. Prescribing | Dietitians Board Master-Product-List-for-Dietitan-Prescribers-updated-December2022.pdf (dietitiansboard.org.nz) Legal requirement of prescribing under the Medicines Act 1981 Note: Tramadol is now included Legal requirement of prescribing under the Medicines Act 1981 ▪ Midwives Limit on supply (prescription medicines) ▪A maximum of 3 months (90 days) is permitted ▪Oral Contraceptive (OC) can be prescribed for up to 6 months (180 days) ▪Legally, all prescriptions are valid for 6 months (180 days). ▪Prescription for OC is valid for 9 months. ▪HOWEVER, the subsidy will lapse after 90 days (3 months) from the date on which prescriptions have been written* *Pharmac rules and have nothing to do with legislation as such). Medicines Act 1981 ▪ Medicines Act 1981 No 118 (as at 01 July 2022), Public Act Contents – New Zealand Legislation Legal Requirements of a Prescription Form under Medicines Regulations 1984 ▪ Medicines Regulations 1984 (SR 1984/143) (as at 22 December 2022) 41 Form of prescription – New Zealand Legislation Dispensing of prescription medicines – (clause 42) Medicines Regulations 1984 Medicines Regulations 1984- Schedule1 ▪ Prescription ONLY medicine ▪ Restricted or Pharmacist ONLY medicine ▪ Pharmacy ONLY medicines ▪ Medicines Regulations 1984 (SR 1984/143) (as at 28 May 2021) Schedule 1 Prescription, restricted, and pharmacy-only medicines – New Zealand Legislation *Please note that general sale medicines are not regulated by Medicines Regulations. Medicines not listed in the classification schedules are referred to as general sale medicines. These medicines may be sold from any outlet. Pharmacist-Only Medicines (Restricted medicines) ▪ What are the Pharmacist-Only medicines? ▪ What record must be kept? ▪ Can consumers/customers self-select? ▪ Pharmacist Only Medicines (medsafe.govt.nz) Group discussion Pharmacy mistakes Pharmacy mistakes: What happens when drug stores mix up meds (CBC Marketplace) – YouTube What are your thoughts? Self-directed activity ▪ Please complete all Canvas activities. ▪ Revise everything we have covered so far.