External Assessment Specifications Document

Transcription

1 External Assessment Specifications Document Curriculum Code: Qualification Title: Occupational Certificate: Pharmacy Technician NQF Level: Pharmacy Technician External Assessment Specifications Page 1 of 14

2 Table of content 1. ASSESSMENT STRATEGY ASSIGNMENTS TO BE EVALUATED EXTERNALLY CRITICAL ASPECTS OF THE INTERNAL ASSESSMENTS TO BE ASSESSED EXTERNALLY CRITERIA FOR THE REGISTRATION OF ASSESSORS FOUNDATIONAL LEARNING ELIGIBILITY REQUIREMENTS FOR THE EXTERNAL ASSESSMENT Pharmacy Technician External Assessment Specifications Page 2 of 14

3 1. ASSESSMENT STRATEGY 1.1 Assessment Model An external integrated summative assessment, conducted through the relevant QCTO Assessment Quality Partner is required for the issuing of this qualification. The external integrated summative assessment will focus on the exit level outcomes and associated assessment criteria. The external integrated summative assessment will be a combination of two assessments; one an open-book and one a closed book at a registered assessment site. Assessors registered with the Assessment Quality Partner will conduct the external integrated summative assessment. 1.2 Qualification Purpose The purpose of this qualification is to prepare a learner to operate as a Pharmacy Technician. This occupational qualification is intended to equip the learner with the knowledge and skills required as Pharmacy Support Personnel (PSP) at the level of a Pharmacy Technician. The occupational certificate will allow for two part qualifications, Pharmacist s Assistant Basic at NQF 4 and Pharmacist s Assistant Post Basic at NQF 5, thus fulfilling the need for different levels of well-trained PSP. This occupational qualification will improve learner access to PSP qualifications and provide an opportunity to those learners who do not wish to pursue the academic (CHE) Pharmacy Technician qualification and/or wish to remain in the workplace while achieving the qualification. Successful completion of this qualification, and each of the part qualifications, may enable the learner to register in the relevant PSP category with the South African Pharmacy Council (PSP). Learners exiting with the Pharmacy Technician qualification will be able to assist with: medicine supply management; manufacturing of medicines; dispensing (supplying) of medicine to patients; providing patient care; managing pharmacy resources; apply health and safety regulations, human rights, relevant medical and pharmaceutical law and ethics in the performance of their pharmaceutical duties and housekeeping and administration relative to pharmaceutical services. A Pharmacy Technician is a generalist who can operate in the four categories of pharmacy (community, institutional (private or public), manufacturing and wholesale). While the Pharmacy Technician works under the direct personal supervision of a pharmacist in a pharmacy they may also work in a primary health care clinic or any other facility approved by Council under the indirect personal supervision of a pharmacist. A qualified learner will be able to: Manage medicine supply Manufacture, package and repackage medicines and scheduled substances Compound, manipulate and prepare extemporaneous preparations Dispense medicine to patient Manage pharmacy resources 1.3 Assessment Standards Assessment Standards for the Qualification Integrated Assessment Focus Area 1 Apply scientific knowledge to provide technical support in delivering pharmaceutical services (20%) Associated Legislation related to the relevant scope of practice in pharmaceutical services is explained in the South African context Ethical and professional conduct related to the relevant scope of practice is demonstrated in the provision of pharmaceutical technical support services Basic pharmaceutical terms and concepts are explained in relation to sterile and non-sterile drug delivery systems and their routes of administration Basic pharmaceutical terms and concepts are explained in relation to non-sterile and sterile drug delivery systems and their routes of administration Basic scientific principles are explained and applied to sterile and non-sterile and sterile pharmaceutical preparations Pharmacy Technician External Assessment Specifications Page 3 of 14

4 Basic concepts of anatomy, physiology and patho-physiology are explained in the context of common, acute and chronic conditions Basic principles and concepts of pharmacology and biopharmaceutics, as applied to the management of common acute and chronic conditions, are explained Screening tests are performed in accordance with GPP Integrated Assessment Focus Area 2 Provide technical support for the ordering, managing, despatch and disposal of medicines, scheduled substances, medical supplies and devices in compliance with GWDP and legal requirements (15%) Associated The principles of GWDP are explained in relation to the management of stock Ordering and receipt of stock of medicines, scheduled substances, and medical devices are organised and managed in accordance with cgmp, GPP and GWDP Stock is organised, managed and secured in accordance with legal requirements, including cgmp, GPP and GWDP Despatch of medicines, scheduled substances, medical supplies and devices are organised and managed in accordance with cgmp, GPP and GWDP. Disposal of expired and unwanted medicines, scheduled substances, medical supplies and devices is managed according to current relevant legislation and guidelines. Documents are completed and records maintained in accordance with applicable legislation, process documentation and SOPs Supervision of ordering, managing, despatch and disposal processes is managed according to procedures Integrated Assessment Focus Area 3 Provide technical support for the manufacture, packaging and re-packaging of sterile and non-sterile medicines and scheduled substances in compliance with GMP guidelines under the supervision of a Pharmacist (15%) Associated Pharmaceutical and GMP principles are explained and applied to the manufacture, packaging and/or re-packaging of sterile and non-sterile medicines and scheduled substances. Resources, materials and equipment for the preparation of specific medicines are organised and prepared in accordance with relevant SOPs and process documentation Line clearance is signed off according to procedure The manufacturing process is maintained and controlled in accordance with cgmp, process documentation and relevant SOPs. Medicines and scheduled substances are re-packaged in accordance with cgmp, ethical principles, relevant legislation, process documentation and SOPs and authorised by a pharmacist Packaging processes are checked and signed-off by appropriate personnel (PB and PT) Manufacturing processes are checked and signed-off by appropriate personnel (PT) All documents are completed and records maintained in accordance with cgmp guidelines. Supervision of manufacturing and packaging is managed according to procedures (PT) Integrated Assessment Focus Area 4 Provide technical support for the compounding, manipulation and preparation of sterile and nonsterile medicines and scheduled substances (extemporaneous compounding) in compliance with standards as described in the GPP rules and GMP guidelines under the supervision of a Pharmacist (15%). Associated The principles of GPP are explained in relation to compounding, manipulation and preparation of sterile and non-sterile medicines Pharmacy Technician External Assessment Specifications Page 4 of 14

5 Sterile admixtures are compounded, manipulated and prepared following relevant SOPs and process documentation, using aseptic techniques and the principles of cgmp and/or GPP for specific patients Non-sterile medicines are compounded, manipulated, prepared and packed following relevant SOPs and process documentation, in accordance with cgmp and/or GPP for specific patients Records are generated for each of the preparations produced in accordance with legal requirements and organisational policies and procedures Supervision of compounding is managed according to procedures (PT) Integrated Assessment Focus Area 5 Provide technical support to dispense prescriptions and to sell Schedule 0, 1 and 2 medicines in compliance with legal requirements, including GPP (20%) Associated Communication with patients/caregivers is conducted in a professional manner with sensitivity to patients needs and diversity Prescriptions are dispensed in accordance with current legislation, GPP and organisational procedures In the case of Schedule 0, 1 and 2 medicines, relevant information and history are obtained and a suitable course of action is decided in consultation with a pharmacist Medicines and/or appropriate advice is/are provided according to GPP Patient and/or prescription is/are referred to a pharmacist for further management as needed Relevant records are maintained in accordance with current legislative requirements, including GPP The concepts of health and wellness are explained in terms of disease and disability. (PT) Socio-economic factors that contribute to poor health and wellness dysfunction are identified and described with the aid of relevant examples. (PT) Preventative measures and lifestyle modification options are explained in relation to the identified condition. (PT) Supervision of dispensing is managed according to procedures (PT) Integrated Assessment Focus Area 6 Provide technical support in the management of pharmacy resources (15%) Associated Pharmacy resources are managed according to operational and legal requirements, including GPP (PT only) Principles of staff supervision are explained and applied in the context of the practice of pharmacy (PT only) Financial aspects of the pharmacy-related facility are explained and applied in the practice of pharmacy Pharmacy-related facility operations are explained and applied in the practice of pharmacy (PT) Principles of time management are explained and applied in the practice of pharmacy (PT) Principles of team building and diversity are explained and applied in the practice of pharmacy (PT) Effective lines of communication are established and maintained to facilitate supervision in the workplace Assessment Standards for Phases None Assessment Standards for Part Qualifications Yes Pharmacy Technician External Assessment Specifications Page 5 of 14

6 2. ASSIGNMENTS TO BE EVALUATED EXTERNALLY None 3. CRITICAL ASPECTS OF THE INTERNAL ASSESSMENTS TO BE ASSESSED EXTERNALLY None 4. CRITERIA FOR THE REGISTRATION OF ASSESSORS As per SAPC s requirements 5. FOUNDATIONAL LEARNING Yes, for the Pharmacy Assistant ( 6. ELIGIBILITY REQUIREMENTS FOR THE EXTERNAL ASSESSMENT In order to qualify for the external summative assessment learners must have a copy of a completed and signed Statement of Work Experience as well as proof of successful completion of the following subjects and modules or alternative programmes where applicable. 6.1 Qualification Knowledge Modules Number Title NQF Level KM-01 KM-02 KM-03 KM-04 KM-05 KM-06 KM-07 KM-08 Introduction to the pharmaceutical environment Stock distribution and control ( Stock management (Post Supply chain management Non-sterile medicine manufacture ( Non-sterile and sterile medicine manufacture (Post Medicine manufacture Compounding of 4 3 non-sterile extemporaneous preparations ( Pharmacy Technician External Assessment Specifications Page 6 of 14 OR Alternative Programmes Credits Number Title NQF Level Credits

7 Knowledge Modules Number Title NQF Level KM-09 KM-10 KM-11 KM-12 KM-13 KM-14 KM-15 KM-16 KM-17 KM-18 PM-01 Compounding of 5 4 sterile and nonsterile extemporaneous preparations (Post Compounding of sterile and nonsterile extemporaneous preparations Dispensing (Post Dispensing Screening and testing patients Managing pharmacy resources General housekeeping ( Administration and housekeeping (Post Body systems, disorders and commonly used medicines (Post Pharmacological 6 18 and nonpharmacological management of common communicable and noncommunicable disease states and conditions Distribute and 4 4 control stock as per current legislation ( OR Alternative Programmes Credits Number Title NQF Level Credits Pharmacy Technician External Assessment Specifications Page 7 of 14

8 Knowledge Modules Number Title NQF Level PM-02 PM-03 PM-04 Manufacture nonsterile medicines ( PM-05 PM-06 PM-07 PM-08 PM-09 PM-10 PM-11 PM-12 PM-13 Manage stock, as per current legislation (Post Manage supply chain Manufacture nonsterile and sterile medicines (Post Manufacture nonsterile and sterile medicines Compound nonsterile extemporaneous preparations ( Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Post Compound sterile and non-sterile extemporaneous preparations, as per current legislation Dispense medicines Dispense medicines (Post Perform general housekeeping and administrative tasks in the pharmacy ( Perform general housekeeping and administrative tasks in the OR Alternative Programmes Credits Number Title NQF Level Credits Pharmacy Technician External Assessment Specifications Page 8 of 14

9 Knowledge Modules Number Title NQF Level PM-14 PM-15 PM-16 PM-17 PM-18 pharmacy (Post Conduct screening tests Manage pharmacy resources and self-development Identify anatomical structures (Post Conduct practical activities to optimise therapy for patients Operate computers and computer software ( And Statement of Work experience 6.2 Phase 1 No Phase Tests applicable 6.3 Part Qualification Part Qualification 1: Title: Pharmacist s Assistant (, NQF Level 4, Credits 62 OR Alternative Programmes Credits Number Title NQF Level Credits Purpose: The purpose of this part qualification is to prepare a learner to operate as a Pharmacist s Assistant (. This part qualification is the first in the trajectory for becoming a Pharmacy Technician. A Pharmacist s Assistant ( performs a range of assistive tasks in the various categories of pharmacy. Applicable Modules (Rules of Combination) Knowledge Modules: KM-01, Introduction to the pharmaceutical environment, NQF Level 4, Credits 10 KM-02, Stock distribution and control (, NQF Level 4, Credits 4 KM-05, Non-sterile medicine manufacture (, NQF Level 4, Credits 6 KM-08, Compounding of non-sterile extemporaneous preparations (, NQF Level 4, Credits 3 KM-15, General housekeeping (, NQF Level 4, Credits 2 Total number of credits for Knowledge Modules: 25 Practical Skill Modules: Pharmacy Technician External Assessment Specifications Page 9 of 14

10 PM-01, Distribute and control stock as per current legislation (, NQF Level 4, Credits 4 PM-04, Manufacture non-sterile medicines (, NQF Level 4, Credits 6 PM-07, Compound non-sterile extemporaneous preparations (, NQF Level 4, Credits 5 PM-12, Perform general housekeeping and administrative tasks in the pharmacy (, NQF Level 4, Credits 2 PM-18, Operate computers and computer software (, NQF Level 4, Credits 4 Total number of credits for Practical Skill Modules: 21 This qualification also requires the following Work Experience Modules: WM-01, Processes to distribute and control stock, as per legislation (, NQF Level 4, Credits 5 WM-04, Processes to manufacture non-sterile medicines (, NQF Level 4, Credits 4 WM-07, Processes to compound non-sterile extemporaneous preparations (Pharmacist s Assistant -, NQF Level 4, Credits 5 WM-12, Processes to perform general housekeeping and administrative tasks in the pharmacy (, NQF Level 4, Credits 2 Total number of credits for Work Experience Modules: 16 Assessment Standards and for Part Qualification: Assessment Qualification Standard 1: Apply basic scientific knowledge to provide technical support in delivering pharmaceutical services Legislation related to the relevant scope of practice in pharmaceutical services is explained in the South African context Ethical and professional conduct related to the relevant scope of practice is demonstrated in the provision of pharmaceutical technical support services Basic pharmaceutical terms and concepts are explained in relation to non-sterile drug delivery systems and their routes of administration Basic scientific principles are explained and applied to non-sterile pharmaceutical preparations Assessment Qualification Standard 2: Provide technical support for the receiving, storing, picking, packing and distributing orders and to perform stock counts and participate in stock taking in compliance with GWDP and GPP requirements Distribution and control of stock of medicines, scheduled substances, and medical devices is conducted according SOPS, and in accordance with cgmp, GPP and GWDP Orders for medicines or scheduled substances are picked, packed and secured in accordance with all requirements and checked orders are despatched according to SOPS Documents are completed and records maintained in accordance with applicable legislation and SOPs Stock counts are performed accurately and assistance is rendered in stock taking Assessment Qualification Standard 3: Pharmacy Technician External Assessment Specifications Page 10 of 14

11 Provide technical support for the manufacture, packaging and re-packaging of non-sterile medicines and scheduled substances in compliance with GMP guidelines under the supervision of a Pharmacist Pharmaceutical and cgmp principles and legislative requirements are complied with in the manufacture, packaging and/or re-packaging of non-sterile medicines and scheduled substances. Resources, materials and equipment for the preparation of specific medicines are organised and prepared in accordance with relevant SOPs and process documentation Materials are handled with due regard for environmental and storage conditions, and transport and security requirements Relevant manufacturing processes for non-sterile medicines and scheduled substances are conducted according to procedures Medicines and scheduled substances are packed and re-packaged in accordance with cgmp, ethical principles, relevant legislation, process documentation and SOPs, and authorised by a pharmacist All documents are completed and records maintained in accordance with cgmp guidelines. Assessment Qualification Standard 4: Provide technical support for the compounding, manipulation and preparation of non-sterile medicines and scheduled substances (extemporaneous compounding) in compliance with standards as described in the GPP rules and GMP guidelines under the supervision of a Pharmacist. The principles of GPP are complied with in relation to compounding of non-sterile medicines and substances A simple solution, suspension and semi-solid is compounded following instructions (formulas), relevant SOPs and process documentation, using the principles of cgmp and/or GPP for specific patients Records are generated for each of the preparations produced in accordance with legal requirements and organisational policies and procedures Equipment is checked and cleaned according to SOPs Housekeeping activities are performed according to SOPs Personal computer is operated to generate documents and spreadsheets Pharmacy Technician External Assessment Specifications Page 11 of 14

12 Part Qualification 2: Title: Pharmacist s Assistant (Post, NQF Level 5, Credits 130 Purpose: The purpose of this part qualification is to prepare a learner to operate as a Pharmacist s Assistant (Post. This part qualification is the second in the trajectory for becoming a Pharmacy Technician. A Pharmacist s Assistant (Post performs a range of tasks in the various categories of pharmacy. Applicable Modules (Rules of Combination) Knowledge Modules: KM-03, Stock management (Post, NQF Level 5, Credits 4 KM-06, Non-sterile and sterile medicine manufacture (Post, NQF Level 5, Credits 6 KM-09, Compounding of sterile and non-sterile extemporaneous preparations (Post, NQF Level 5, Credits 4 KM-11, Dispensing (Post, NQF Level 5, Credits 12 KM-16, Administration and housekeeping (Post, NQF Level 4, Credits 3 KM-17, Body systems, disorders and commonly used medicines (Post, NQF Level 5, Credits 15 Total number of credits for Knowledge Modules: 44 Practical Skill Modules: PM-02, Manage stock, as per current legislation (Post, NQF Level 5, Credits 6 PM-05, Manufacture non-sterile and sterile medicines (Post, NQF Level 5, Credits 8 PM-08, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Post, NQF Level 5, Credits 6 PM-10, Dispense medicines (Post, NQF Level 5, Credits 14 PM-13, Perform general housekeeping and administrative tasks in the pharmacy (Post, NQF Level 5, Credits 3 PM-16, Identify anatomical structures (Post, NQF Level 5, Credits 15 Total number of credits for Practical Skill Modules: 52 This qualification also requires the following Work Experience Modules: WM-02, Processes to manage stock as per legislation (Post, NQF Level 5, Credits 8 WM-05, Processes to manufacture non-sterile and sterile medicines (Post, NQF Level 5, Credits 5 WM-08, Processes to compound sterile and extemporaneous preparations (Post, NQF Level 5, Credits 6 WM-10, Processes to dispense medicines (Post, NQF Level 2, Credits 15 WM-14, Processes to conduct screening tests, NQF Level 6, Credits 2 Total number of credits for Work Experience Modules: 36 Assessment Standards and for Part Qualification: Assessment Qualification Standard 1: Apply basic scientific knowledge to provide technical support in delivering pharmaceutical services Legislation related to the relevant scope of practice in pharmaceutical services is explained in the South African context Pharmacy Technician External Assessment Specifications Page 12 of 14

13 Ethical and professional conduct related to the relevant scope of practice is demonstrated in the provision of pharmaceutical technical support services Basic pharmaceutical terms and concepts are explained in relation to sterile drug delivery systems and their routes of administration Basic scientific principles are explained and applied to sterile pharmaceutical preparations Basic concepts of anatomy, physiology and patho-physiology are explained in the context of common, acute and chronic conditions Assessment Qualification Standard 2: Provide technical support for the ordering and management of stock of medicines, scheduled substances and medical devices in compliance with GWDP and GPP requirements The principles of GWDP are explained in relation to the management of stock The ordering and management of stock of medicines, scheduled substances and medical devices appropriate to the scope of a post basic is conducted according SOPS, and in accordance with cgmp, GPP and GWDP Stock counts are performed to determine needs for stock replenishment. Stock holding is assessed for slow moving, expired, discontinued and short-dated stock Documents are completed and records maintained in accordance with applicable legislation, process documentation and SOPs Expired, damaged, recalled medicines and medicines received from patients are quarantined and made ready for safe disposal, according to SOPS Assessment Qualification Standard 3: Provide technical support for the manufacture, packaging and re-packaging of non-sterile medicines and scheduled substances in compliance with cgmp guidelines under the supervision of a Pharmacist Pharmaceutical and cgmp principles and legislative requirements are complied with for and in the manufacture, packaging and/or re-packaging of sterile medicines and scheduled substances using aseptic techniques Environmental and storage conditions for materials are monitored and controlled, according to SOPs Procedures to quarantine products and materials are selected and implemented Legal and special requirements for scheduled substances are applied under guidance of a PT or pharmacist Materials (including packaging material) are controlled and issued, according to procedure In-process control testing and in-process checks are performed Labels and over-printed material are appropriately secured and unused, damaged or rejected labels are discarded according to SOPS All documents are completed and records maintained in accordance with cgmp guidelines. Assessment Qualification Standard 4: Provide technical support for the compounding, manipulation and preparation of non-sterile medicines and scheduled substances (extemporaneous compounding) in compliance with standards as described in the GPP rules and GMP guidelines under the supervision of a Pharmacist The principles of GPP are complied with in relation to compounding of non-sterile and sterile medicines and substances Calculations are performed to determine quantities of ingredients An emulsion and a suspensions are compounded following instructions (formulas), relevant techniques, SOPs and process documentation, and according to the principles of cgmp and/or GPP Records are generated for each of the preparations produced in accordance with legal requirements and organisational policies and procedures Pharmacy Technician External Assessment Specifications Page 13 of 14

14 Equipment is checked and cleaned/sterilised according to SOPs Housekeeping activities are performed according to SOPs Assessment Qualification Standard 5: Provide technical support to dispense prescriptions and to sell Schedule 0, 1 and 2 medicines in compliance with legal requirements, including GPP Communication with patients/caregivers is conducted in a professional manner with sensitivity to patients needs and diversity Prescriptions are prepared and dispensed in accordance with current legislation, GPP and organisational procedures In the case of Schedule 0, 1 and 2 medicines, relevant information and history are obtained and a suitable course of action is decided in consultation with a pharmacist Medicines and/or appropriate advice is/are provided according to GPP Patient and/or prescription is/are referred to a pharmacist for further management as needed Relevant records are maintained in accordance with current legislative requirements, including GPP Basic hygiene, infection control and healthy lifestyle are promoted Pharmacist Initiated Therapy (PIT) is performed according to SOPs Pharmacy Technician External Assessment Specifications Page 14 of 14