The intent of these standards is to have the pharmacy organised in such a way that its services and processes contribute to the highest quality of pharmaceutical care. The pharmacy plans the development and implementation of its goals and evaluates its effectiveness in achieving them.
| (a) | The responsible pharmacist must demonstrate a high standard of professionalism and a commitment to quality development. |
| (b) | The management structure of the pharmacy should be documented with a clear allocation of duties and responsibilities established and properly recorded. |
| (c) | The responsible pharmacist must ensure that all regulations covering the operations of the pharmacy are complied with. |
| (d) | The pharmacy operation must comply with all relevant legislation rules, regulations, codes, standards and guidelines of the South African Pharmacy Council. |
| (e) | The responsible pharmacist must review his or her level of professional knowledge and expertise continually and documents an appropriate self-development plan. |
| (f) | The responsible pharmacist must participate regularly in continuing professional development programmes. |
| (g) | The extent and content of any documentation of pharmacy structures and processes will vary with the size and complexity of the pharmacy operation. |
| (h) | Quality service will be best achieved if all pharmacy staff are aware of the total commitment of the pharmacy owner and the responsible pharmacist to quality improvement. |
| (i) | A collection of all legislation and guidelines relevant to the pharmacy must be maintained in a current state and be accessible by all pharmacy staff. |
| (j) | Procedures must exist to ensure that pharmacy staff are informed of any changes to legislation or other relevant codes or regulations. |
| (k) | Documented procedures must be in place to ensure that pharmacy staff are aware of relevant legislation, and apply this to the handling, sale and required record keeping of medicines available for sale in the pharmacy. |
| 4.2.1.1 | Pharmacy planning |
The pharmacy, having established its mission and/or purposes should engage in ongoing planning to achieve its strategic objectives.
| (a) | The pharmacy's mission statement and/or statement of purposes should be documented, regularly reviewed and understood by all staff. |
| (b) | Business and quality objectives should be established, documented and form the basis of the pharmacy business plan. The objectives and plan should be reviewed at least annually. |
| (c) | Contracts should be established between the pharmacy and the health care provider being served which specify the terms of the relationship and the services provided. |
| (d) | The responsible pharmacist must be responsible for the preparation of the mission statement and/or statement of purposes, the pharmacy strategic plan, contracts for the supply of services and the pharmacy's client profile and client expectations. |
| (e) | The mission statement and/or purpose statement should encapsulate the basic purpose of the pharmacy and include the vision, values and principles being followed in the pharmacy. It must encompass the services being offered, by whom the services are provided, the clients and the pharmacy's intended impact on the community. |
| (f) | The pharmacy's mission should be consistent with the principles of pharmaceutical care and the quality requirements of the appropriate health care purchasers. |
| (g) | Through the planning process, the pharmacy staff should evaluate its mission and/or purposes. It should decide how these are to be met and assess progress, if necessary revising its goals, objectives, products and services. |
| (h) | A suitable planning process will allow for input from staff, clients and other groups or organisations involved with the pharmacy. |
| (i) | The planning process will incorporate research on pharmacy effectiveness, patient outcomes, demographics and other relevant areas. |
| 4.2.2 | Quality standards for pharmacy |
The pharmacy's quality objectives should reflect the need for both the provision of customer-focused services and the continuous improvement of quality.
The planning process will identify the human, financial and physical resources required for the pharmacy. This will influence the acquisition of resources and their allocation.
| 4.2.2.1 | Quality management |
The pharmacy provides high quality service to its clients. Its management pursues continuous improvement in service quality through its assessment and improvement efforts. The process of quality improvement should include monitoring the activity, assessing how well the activity is being carried out, establishing the areas where improvement is possible, taking action aimed at achieving improvement, evaluating the effectiveness of the action and the outcome.
| (a) | The Quality Improvement Plan should detail: |
| (i) | the quality standards for services supplied by the pharmacy; |
| (ii) | processes that operate in the pharmacy and the resources devoted to them (including staff); |
| (iii) | how customer feedback will be obtained for services provided; |
| (iv) | how other evidence supporting the achievement of quality standards will be obtained and recorded; |
| (v) | how resources and training relevant to the quality management responsibilities of each staff member are allocated; |
| (vi) | the frequency of assessment of the plan to ensure that it is producing a continuous improvement of service. |
| (b) | The responsible pharmacist should develop, documents and approves the quality improvement plan for the pharmacy. This provides a systematic plan for each of the service areas in the pharmacy. |
| (c) | The quality improvement programme should be assessed regularly. |
| (d) | A documented risk management system should be integrated into the quality improvement process. |
| (e) | Standard Operating Procedures must be developed, documented and used in the pharmaceutical and retail activities of the pharmacy and be reviewed on a regular basis. |
| (f) | Documentation of all pharmacy standards, procedures, policies and guidelines should be comprehensive, current and readily available to all pharmacy staff. It is reviewed regularly. |
| (g) | Pharmacy staff should be trained in the aspects of service quality management which are relevant to their work responsibilities. |
| (h) | All quality improvement planning, implementation and auditing must be appropriately documented. |
| (i) | Pharmacy staff should be involved to the maximum extent possible in the development and execution of the quality improvement plan and should be given regular feedback on the outcomes being achieved in quality improvement. |
| (j) | Pharmacy documentation must cover: legislative and professional requirements applicable to the operations of the pharmacy, Standard Operating Procedures, contractual details and supply of goods and services. |
| (k) | All staff must be trained in the use of Standard Operating Procedures. |
| (l) | The responsible pharmacist must ensure that standards for the operation of pharmacy services are established and that performance against these standards is monitored. |
| (m) | The proper management of risk and the effort made to reduce risk levels, will contribute to the pharmacy's operation as a high-quality enterprise. |
| (n) | Staff training in the quality area should be aimed at establishing familiarity with the quality improvement cycle, and confidence in its use. |
| 4.2.2.2 | Pharmacy effectiveness |
The pharmacy should evaluate how well it is accomplishing its purposes and uses the results of these evaluations as a basis for broad-based continuous planning and development.
| (a) | Pharmacy management should monitor client satisfaction and analyse the degree to which it is being maintained. |
| (a) | Contracts with third parties should specify a system of monitoring and review which is aimed at ensuring that the terms of the contract are met. |
| (b) | The responsible pharmacist and appropriate staff should participate in regular professional audit activities to review the standard of clinical and non-clinical services. From the review process strategies should be developed, documented and employed to improve performance. |
| (c) | Information from business, quality and outcome monitoring should be utilised in the assessment of pharmacy effectiveness. |
| (d) | Client satisfaction should be assessed from a variety of sources including complaints mechanisms, satisfaction surveys, outcome monitoring, informal feedback and indicators of service efficiency. |
| (e) | Lines of communication should be clearly specified between the pharmacy and health care providers which have a contractual or less formal relationship. |
| (f) | The pharmacist(s) should participate in any clinical review and audit carried out by health care providers with whom the pharmacy has a contractual relationship. |
| (g) | Data on the content and frequency of use of the services being provided by the pharmacy should be recorded and available for analysis. |
| (h) | Systems must be developed to enable the pharmacy to collect reliable and valid data on health outcomes resulting from the pharmacist's clinical observation. |
| 4.2.3 | Ethics and professional standards |
A system should be in place which enables staff to be kept informed about pharmacy business performance and developments in the economic and political environment, which could impact significantly on the pharmacy. The pharmacist and staff members should carry out, or participate in, research activities aimed at improving the effectiveness and efficiency of the pharmacy and the further development of pharmaceutical care.
| 4.2.3.1 | Inter-professional relationships |
The pharmacist should maintain good working relationships with other health care professionals in the healthcare team and participates in activities involving the effective supply of pharmacy services.
| (a) | The pharmacist should participate in medicine utilisation reviews, medical audits, medical care evaluations and clinical studies of medicines. |
| (b) | The pharmacist should ensure that other health care professionals are provided with medicine information and information concerning prescribing and dispensing practices. |
| (c) | Pharmacists should seek opportunities to provide information to other health care professionals and groups on developments concerning medicines, the general role of pharmacists, contents, packaging and processing of medicines, and the ancillary services offered by the pharmacy. |
| (d) | A major emphasis of inter-professional teamwork should be the development of more effective and rational prescribing policies. The pharmacist has a major role in influencing such policies. |
4.2.3.2 Closure of pharmacies
When a pharmacy is closed the following information must be made available to members of the public—
| (a) | the contact details of a pharmacist practising in the pharmacy in question; |
| (b) | information as to alternate facilities where pharmaceutical services can be obtained in an emergency; |
| (c) | details relating to when the pharmacy will be opened/closed. |
| 4.2.3.3 | Standard Operating Procedures |
A Standard Operating Procedure (SOP) is that set of instructions or steps which must be followed in order to complete a specific job or task safely, with no adverse impact on the environment, and in a way that maximises operational and production requirements. SOPs can be written for virtually any task undertaken in a pharmacy that has to be performed regularly and in a pre-determined way.
The responsible pharmacist is responsible for the existence of SOPs in a pharmacy and must be involved in the compilation of SOPs.
SOPs must—
| (a) | provide personnel with all the safety, health, environmental and operational information necessary to perform a job properly; |
| (b) | ensure that operations are performed consistently to maintain quality control of processes and products; |
| (c) | ensure that processes continue uninterrupted and are completed timeously; |
| (d) | ensure that no failures occur that could harm anyone; |
| (e) | ensure that approved procedures are followed in compliance with legislation; |
| (f) | serve as a training document, e.g. pharmacist interns or pharmacist's assistants; |
| (g) | serve as a historical record of the how, why, when of steps in an existing process; |
| (h) | serve as an explanation of steps in a process so they can be reviewed in incident investigation. |
The following SOPs are required to be in place:
| 4.2.3.3.1 | Community pharmacy— |
| (a) | good housekeeping (cleaning procedures, etc.); |
| (b) | daily routine and working hours; |
| (c) | enquiry or complaint procedure; |
| (d) | pest (insects, rodents, etc.) elimination; |
| (e) | effective stock rotation; |
| (g) | disposal or removal of S1-S6 expired, damaged and/or contaminated stock as required in regulation 27 published in terms of the Medicines Act; |
| (h) | obsolete or unusable stock; |
| (i) | product types requiring special storage or handling instructions; |
| (j) | separation and handling of goods returned from patients; |
| (l) | delivery of medicines; |
| (m) | receiving of medicines; |
| (o) | procurement of medicine; |
| (p) | handling of product complaints; |
| (q) | pre-packing (including quality assurance procedures) (where applicable); |
| (r) | procedures for a locum or relief pharmacist(s) (where applicable); |
| (s) | handling of S5 and S6 medicines; and |
| (t) | cold chain management (including procedures to be followed in the event of a refrigerator power failure). |
| 4.2.3.3.2 | Institutional pharmacy: |
| (a) | good housekeeping (cleaning procedures, etc.); |
| (b) | daily routine and working hours; |
| (c) | enquiry or complaint procedure; |
| (d) | pest (insects, rodents, etc.) elimination; |
| (e) | effective stock rotation; |
| (g) | disposal or removal of S1-S6 expired, damaged and/or contaminated stock as required in regulation 27 published in terms of the Medicines Act; |
| (h) | obsolete or unusable stock |
| (i) | product types requiring special storage or handling instructions; |
| (j) | separation and handling of goods returned from patients, wards, clinics etc.; |
| (l) | delivery of medicines; |
| (m) | receiving of medicines; |
| (o) | procurement of medicine; |
| (p) | handling products complaints; |
| (q) | handling of S5 and S6 medicines; |
| (r) | procedures for a locum or relief pharmacist(s) (where applicable); |
| (s) | cold chain management (including procedures to be followed in the event of a refrigerator power failure); |
| (t) | pre-packing (including quality assurance procedures) (where applicable); |
| (u) | compounding operations (including quality assurance procedures); |
| (v) | preparation of TPN/large volume parenterals (including quality assurance procedures) (where applicable); |
| (w) | oncology mixing (including quality assurance procedures) (where applicable); |
| (x) | preparation of IV additives (including quality assurance procedures) (where applicable); |
| (y) | control over medicine kept in places other than the pharmacy, e.g. wards, theatres, etc. (including controls over issuing ward stock and medicine per patient to the wards). |
| 4.2.3.3.3 | Wholesale pharmacy— |
| (a) | good housekeeping (cleaning procedures, etc.); |
| (b) | daily routine and working hours; |
| (c) | enquiry or complaint procedure; |
| (d) | pest (insects, rodents, etc.) elimination; |
| (e) | effective stock rotation; |
| (g) | disposal or removal of S1-S6 expired, damaged and/or contaminated stock as required in regulation 27 published in terms of the Medicines Act; |
| (h) | obsolete or unusable stock; |
| (i) | product types requiring special storage or handling instructions; |
| (j) | separation and handling of returned goods; |
| (l) | delivery of medicines; |
| (m) | receiving of medicines; |
| (o) | procurement of medicine; |
| (p) | procedures for locum/relief pharmacist(s) (where applicable); |
| (q) | handling of S5 and S6 medicines; |
| (r) | cold chain management (including procedures to be followed in the event of a refrigerator power failure); |
| (s) | pre-packing (including quality assurance procedures) (where applicable); |
| (t) | handling of product complaints. |
| 4.2.3.3.4 | Primary health facility— |
| (a) | good housekeeping (cleaning procedures, etc.); |
| (b) | daily routine and working hours; |
| (c) | enquiry or complaint procedure; |
| (d) | pest (insects, rodents, etc.) elimination; |
| (e) | effective stock rotation; |
| (g) | disposal or removal of S1-S6 expired, damaged and/or contaminated stock as required in regulation 27 published in terms of the Medicines Act; |
| (h) | obsolete or unusable stock; |
| (i) | product types requiring special storage or handling instructions; |
| (j) | separation and handling of goods returned from patients, |
| (l) | receiving of medicines; |
| (n) | procurement of medicine; |
| (o) | handling products complaints; |
| (p) | handling of S5 & S6 medicines; |
| (q) | cold chain management (including procedures to be followed in the event of a refrigerator power failure). |
The following policies must be available in all pharmacies:
| (d) | Post exposure policy (where applicable) |
