Outline Creating new mid-level workers in South Africa • • • • • • • • Hlonelikhaya Masiza Senior Manager: Professional Affairs South African Pharmacy Council Year 2000 Regulations • Categories registerable in terms of the Act     • Pharmacist’s assistant (learner basic) Pharmacist’s assistant (basic) Pharmacist’s assistant (learner post-basic) Pharmacist’s assistant (post-basic) Scope of practice of all 4 categories prescribed in regulation History of Mid-level worker in Pharmacy History Year 2000 Regulations • Lessons learnt New Categories of Mid-level Workers • In 1987 regulations published in terms of the Pharmacy Act to allow for training of mid-level workers in pharmacy Three categories  Trainee pharmacist’s assistant  Qualified pharmacist’s assistant  Unqualified pharmacist’s assistant Development of the scopes of practice Scopes of Practice Training of mid-level workers Conclusion LESSONS LEARNT • • • • • Need for a clear scope of practice with clear distinction between pharmacist and mid-level worker Training in the workplace can have a negative impact on service delivery Scope of practice, unit standards (competencies) and training programmes must be well aligned Quality assurance of providers and training programmes must be rigorous Must have appropriate posts, remuneration and career path LESSONS LEARNT (cont.) • Re-look the training model  Contact time between learners and providers  Sites for practical learning  Criteria for tutor approval  Address discrepancies between training courses Career progression in pharmacy Specialist My Pharmacy career Pharmacist B. Pharm Degree plus 2 years as registered pharmacist post CSP Gr 12 with Science & Maths Pharmacy Technician Pharmacy Technician Pharmacy Technical Assistant Registered Pharmacy Technical Assistant B. Pharm Degree (4 years) Advanced Higher Certificate (1 year) Gr 12 with Science & Maths Pharmacist Assistant Post-Basic Pharmacy General Assistant M Pharm/ MSc Pharm Degree (2 years) Gr 12 with Science & Maths Literacy Higher Certificate (1 year) Further Education Certificate (1 year) New Categories of Midlevel Workers NQF Level 9 NQF Level 8 HET HET NQF Level 6 HET NQF Level 5 HET NQF Level 4 Pharmacy y Technical Assistant Student Pharmacy P acy Technical ec Assistant Trainee Pharmacy Technical Assistant Pharmacy harmacy Technician Student P Pharmacyy Technician Trainee Pharmacy Technician DEVELOPMENT OF THE SCOPES OF PRACTICE • • • • Pharmacy harmacy General Assistant (Learner) Pharmacy General Assistant P Scope of was developed by experts Approval by SAPC for narrow consultation stakeholders Narrow consultationdifferent participated - this include different categories of pharmacy, private and public sectors, providers of pharmacy education and training Approval by SAPC for wider consultation where it is published in the Government gazette FET Pharmacist Assistant Basic DEVELOPMENT OF THE SCOPE OF PRACTICE (Cont.) • • • • Comments were received in writing and oral presentations were made where required. Amendments were made where necessary Approval by SAPC to amend the Regulations and sent to the Minister of Health Minister of Health to publish regulations for comments and implementation SCOPE OF PRACTICE MID-LEVEL WORKERS SCOPE OF PRACTICE MID-LEVEL WORKERS Applies to PGA, PTA and PT Applies to PTA and PT only Scope Community and Institutional Manufacturing and wholesale General housekeeping and administrative task in the pharmacy as specified by the responsible pharmacist Yes Yes Assist with packaging and re-packaging of Schedule 0 to Schedule 5 (excluding Specified Schedule 5) medicines Yes Yes Picking, packing and dispatching of orders for Schedule 0 to Schedule 5 medicines provided that orders that contain schedule 5 medicines are validated by a pharmacist prior to release thereof Yes Yes Assist with the management of stock of Schedule 1 to Schedule 5 medicines : Provided that orders that contain medicines which fall into schedule 5 are validated by a pharmacist Yes Yes Assist with the compounding, manipulation, preparation and manufacturing of non-sterile Schedule 1 to Schedule 5 medicines ; provided that the pharmacy general assistant is not involved in the planning of the production process, interpretation and evaluation, validation and quality assurance Yes Yes Scope Community and Institutional Manufacturing and wholesale The checking of orders containing Schedule 1 to 4 medicines in closed packs, prior to the packing and dispatch thereof, which have been picked by a pharmacist’s assistant, as well as the supervision of such persons: Provided that this function may only be performed in a manufacturing pharmacy, wholesale pharmacy or bulk store of an institutional pharmacy Yes Yes Assist with the manufacturing, compounding, manipulation or preparation of sterile medicine or scheduled substance, in accordance with the Medicines Act Yes Yes Assist with the selection or preparation of a Schedule 1 to Schedule 5 medicine or scheduled substance prescribed by an authorized prescriber and the labelling of an appropriate container, following the interpretation and evaluation of the prescription by a pharmacist Yes No SCOPE OF PRACTICE MID-LEVEL WORKERS Applies to PT only Scope Community and Institutional Manufacturing and wholesale The provision of information to a patient, caregiver or the agent of a patient to optimize therapeutic outcomes resulting from the use of medicines which have been dispensed at a pharmacy and sent to the primary health care clinic for supply to the patient or the patient’s agent or caregiver Yes No The ordering and receipt of Schedule 1 to Schedule 5 medicines : Provided that orders that contain schedule 5 medicines are validated by a pharmacist; Yes Yes The sampling, or supervision of the sampling of medicines accordance with Good Manufacturing Practice No Yes Supervision of pharmacy support personnel as specified by the responsible pharmacist Yes Yes The provision of technical support in the provision of screening tests provided that where an interpretation of results is required this is done by a pharmacist Yes No in Scope Training of Pharmacy Technicians Training of Pharmacy Technical Assistants SCOPE OF PRACTICE MID-LEVEL WORKERS Applies to PT only The packaging and re-packaging of Schedule 0 to Schedule 5 (excluding Specified Schedule 5) medicines , in accordance with the Medicines Act, provided that the functions of the pharmacy technician may include – • checking and signing the identity of the bulk product and printed packaging material in accordance with the Batch Manufacturing Document and in compliance with standard operating procedures; • start-up line clearance and opening of the packaging line in accordance with the Batch Manufacturing/Packaging Document and in compliance with standard operating procedures; and detailed checklist, provided that the pharmacist has provided the necessary signed authorisation thereof; • in process control during packaging and re-packaging of Schedule 0 to Schedule 5 (excluding Specified Schedule 5) medicines , provided that the pharmacist does periodic checks in accordance with standard operating procedures and that final line closure is signed off by the pharmacist. Community and Institutional Manufacturing and wholesale Yes No One year full time programme - Higher Certificate (Students will register with Council) Graduation PTA Trainee (6 months) Graduation PT Trainee (6 months) Questions Thank you One year full time programme - Advanced Certificate (Students will register with Council) Thank you Thank you Registered PT PT Trainee (6 months) Thank you Thank you Thank you Graduation PT (Advanced Cert) Thank Thank you you Thank you Thank you Thank you
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