South African Pharmacy Council regulations

• These notes focus on health law and ethics, providing an overview of the South African Pharmacy Council (SAPC) and relevant legislation.

Terminology

• An Act is a document that brings change to the law or constitution of a country.
• A Bill is read and deliberated by the parliament, a vote is taken, and is then signed by the president to become an Act.
• Regulations provide support to new laws, are enforceable by law, and are signed by the minister.
• Rules provide more detail on how to implement the law and regulations.
• Acts are broad, rules are more specific.

Pharmacy Act No. 53 of 1974

• It was assented to on October 9, 1974.
• It commenced on February 21, 1975.
• It establishes the South African Pharmacy Council.
• This act defines the objects and general powers of the council.
• It extends the control of the council to the public sector.
• This act covers pharmacy education and training requirements.
• This act covers registration, the practice of pharmacy, and ownership of pharmacies.
• It covers investigative and disciplinary powers of the council.
• This act deals with matters connected to all the above.
• Updated to Government Gazette 23480 dated June 3, 2002.

Establishment of the South African Pharmacy Council, Its objects, General Powers and Functions

• Focuses on the establishment of SAPC, along with related objects, powers, and functions.

Establishment of South African Pharmacy Council

• The South African Pharmacy Council is a juristic person.
• A juristic person is a non-human legal entity recognized by the law and entitled to rights and duties in the same way as a human being.
• It succeeds the Interim Pharmacy Council of South Africa.
• The registrar convenes the first council meeting.
• The head office of the council is in Pretoria.
• SAPC is an independent statutory council.
• A registrar of the council is appointed in terms of section 4 (u) of this Act or a person lawfully acting in that capacity.
• The SAPC's mandate is to promote and maintain the health, safety, and wellbeing of patients and the public to ensure accessible quality pharmaceutical service in South Africa.

Objects of The Council

• The council assists in promoting the health of the population of the Republic.
• The council advises the Minister or any other person on pharmacy related matters.
• The council promotes providing pharmaceutical care which complies with universal norms and values, in both the public and the private sector, with the goal of achieving definite therapeutic outcomes for the health and quality of life of a patient.
• The council upholds and safeguards the rights of the general public to achieve universally acceptable standards of pharmacy practice in both the public and the private sector.
• The council needs to establish, develop, maintain and control universally acceptable standards.
• The SAPC must be transparent to the profession and the general public in achieving its objects and in performing its functions and executing its powers.
• The council maintains and enhances the dignity of the pharmacy profession and the integrity of persons practicing that profession.

Council Standards

• Standards for pharmaceutical education and training.
• Standards for registration of a person who provides services that form part of the scope of practice.
• The scope of practice defines the category in which such person is registered.
• The practice of the various categories of persons who need to be registered in terms of existing Act.
• Professional conduct required for those registered in terms of the Act.
• Control over registered persons by addressing complaints or accusations about their conduct.
• Includes Pharmacy Education, Pharmacy Practice, CPD & Registrations, Pre-registrations, Legal Services & Professional Conduct

Patient Responsibilities in a pharmacy

• Respect pharmacists and pharmacy staff.
• Know your pharmacy and the services offered.
• Provide accurate medical and medicine information.
• Inquire about medicine costs and arrange payment.
• Comply with prescribed treatments.

Patient Rights in a Pharmacy

• Right to quality pharmacy care.
• Right to personal professional service, regardless of background.
• Right to confidentiality and privacy.
• Right to ask questions and discuss pharmaceutical service prices openly.
• Right to pharmaceutical services in a clean environment.
• Right to expect cooperation with other health professionals.
• Right to access pharmaceutical services of personal choice, complain about service quality, and expect medicine availability.
• Have the right to talk to the pharmacist about their health.
• Have right to receive adequate medicine advice

General Powers of Council

• The council can print and publish copies of registers or supplementary lists showing amendments of the registers.
• The council can issue extracts from the registers.
• The council requires registered individuals to make annual fee payments.
• The council can remove or restore names to registers.
• The council can appoint examiners/moderators, conduct exams, and grant certificates.
• The council can approve the training of pharmacists.
• Subject to the provisions of this act, the council can register a person, inspect records and accounts or investigate the activities at a pharmacy, or require any person to submit such information.
• The act allows the council to suspend or cancel any registration entitling a person to carry on the profession of a pharmacist.
• The council can recognize qualifications, appoint committees, appoint/dismiss a registrar, set fees, require information, establish boards, and prescribe the scope of practice.

Constitution of Council

• Consists of 25 members.
• Includes 9 elected pharmacists and 9 pharmacists nominated by Members of the Executive Council responsible for health matters in the provinces of the Republic and appointed by the Minister.
• Includes 1 officer of the Department appointed by the Minister.
• Includes 2 pharmacists from a university training program, and 4 other persons appointed by the Minister, one with adequate legal knowledge.
• The council has a president and vice-president, with all members entitled to vote.
• Members hold office for five years and may be reappointed or re-elected for one more term

Vacation of Office and Filling of Vacancies

• A council member vacates his office if his estate is sequestrated, he is disqualified from his profession, he becomes a patient, he is convicted of an offense, he ceases to be a citizen, absent from meetings or the minister ends his membership.

Chapter II: Registration

• Concerns pharmacists and bodies corporate carrying on business as a pharmacist and maintenance of registers.

Registration

• Registration of persons, recording of licensed premises and maintenance of registers.
• Includes licensing, and ownership of pharmacies.
• Process include pre registrations
• Includes registration of individuals as well as professional conduct

Key Terms

• Registration
• Ownership
• Recording
• License
• Removal
• Penalty
• Appeal
• Restoration

Registration Process

• To become a Pharmacist, you need to finish an accredited bachelor of pharmacy degree
• Complete a internship at a training approved premises
• Perform community service
• People and Premises must have relevant registration.

Registration of Persons, Recording of Licensed Premises and Maintenance of Registers

• The requirements and conditions for registration, removal, restoration or reinstatement of the various categories of persons shall be prescribed.
• The council can require registration, keep records, and make changes as necessary.

Licensing of Pharmacies

• Involves registration and recording.
• Requires submission to the Director General and SAPC.
• Includes a license issuance after approval for the Director General.
• License issues can be appealed.
• The council has a right to inspect premises.

Ownership of Pharmacies

• Must be authorized.
• Can be state owned(Public), Sole Propriator, Partnership, closed corporation.
• Partnerships, closed corporations, and certain companies(Pvt) are all considered private pharmacies

Removal of Name From Register

• It happens if a pharmacist is absent from the Republic, failure to notify the registrar, and failure to pay the council.
• Is also possible if the pharmacist is removed from and other healthcare society

Related to Restoration:

• An appeal can be launched

Registration of Additional Qualifications and Specialities

• The council may recognize additional qualifications in the Gazette.
• The minister may prescribe registerable specialities.
• Any person who desires to have a degree, diploma or certificate other than the degree, diploma or certificate by virtue of which he has in the first instance been registered, or who desires to have a prescribed speciality contemplated in subsection (1), registered, must apply to the registrar.

Penalties for Professing to Be or Practising as Pharmacist While Unregistered

• Practicing as a pharmacist for gain without registration is an offense.
• Impersonating a registered pharmacist is an offense.
• Penalties may include a fine.

Permitted through permission from the minister:

• Authorities persons can keep medicine
• Can employ interns
• Handle / Supply medicine for armed forces personnel
• Provide medicine / supplies to hospitals

Penalties for False Representation Inducing Registration

• Procuring registration or certificates by false means.
• Making unauthorized alterations or removal of documents is an offense.
• Includes the destruction of documents as the action may induce registration
• Includes forgery as the action may induce registration
• Impersonating a registered person.

Chapter III: Control of Pharmaceutical Education

• The Pharmacy education and training qualifications institutions for students/learners are controlled here

Pharmacy Education and Training

• The Minister, with council consultation, makes related regulations.
• This includes setting standards for schools to apply for institute approval.
• The minister can authorize any institution.
• Make related rules

Relevant unit standards apply to registrations

Pharmacist's Education and Training

• Council recognizes qualifications, manages the number of trainees, and investigates institutions.
• Council conducts examinations/evaluations and awards certifications.
• Relevant for registration
• Recognises the need for people to "remain competent"- Continual Professional Development for those that are registered

Conduct of Pharmaceutical Practice

Deals with Authorizations for service provision Rules around pharmacy practices Business names as practices are restricted

Is also around restriction and suspension

Pharmacy Practice

Must be properly regulated

Restriction In Respect of Business Names

• Business names are restricted.
• Prevents the usage of names that is associated with previous practisers
• Exceptions include the inclusion of an individuals surname

Restriction in (Or Suspension From) Practice of Registered Person

• Applies if person is mentally disabled or unfit/addicted.
• Suspension or conditions may be imposed.
• Health Committee is relevant.

Actions Taken

May have to suspend the licence

Disciplinary Powers of the Council

• Includes power of officers and other persons.
• Inquiries into charges of misconduct and the procedure.
• Disiplinary action can be challenged
• Inquiries and charge procedures must be conducted fairly

Inquiry by the Council Into Charges of Misconduct

• The council can inquire into any matter of improper conduct.
• The council can consult with or seek information from any person for their inquiry.

Procedure for the Conduct of an Inquiry

• The council can take evidence, summon witnesses, and require document production.
• Refusing to attend or give evidence may be considered an offense.

Penalties the Council May Impose

• Penalties include reprimands, suspension, removal from the register, and fines.
• The outcome is published in the Gazette.
• A finding/penalty may be appealed.

Postponement of Imposition, and Suspension of Operation, of Penalty

• The council determine the execution of an imposed action.

Effect of Suspension or Removal From Register

• If the individual cannot carry out their profession if they are not registered.
• This can have effect regarding their license.

Regulations Pertaining Council

• Minister makes and lists regulations following proper consultation.
• This also included any potential amendments.