Edited by: Jean-Marie Boeynaems, Université libre de Bruxelles, Belgium
Reviewed by: Varsha Bangalee, University of KwaZulu-Natal, South Africa; Mohamed Izham Mohamed Ibrahim, Qatar University, Qatar
*Correspondence: Elmien Bronkhorst,
This article was submitted to Pharmaceutical Medicine and Outcomes Research, a section of the journal Frontiers in Pharmacology
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
The profession of pharmacy is maturing as a clinical profession in South Africa and has experienced significant development over the past 10 years. The development of clinical pharmacy in Southern Africa started in the late 1980s. The Director-General of Health and Welfare requested an expansion of the pharmacist’s role in Southern Africa, in 1988, when he challenged pharmacists to be “more than just dispensers.” South Africa experience human resource challenges in terms of healthcare service delivery and the shortage of pharmacists has been acknowledged. Due to the human resource shortage, it is very difficult to allocate pharmacists to work in a clinical unit on a daily basis. This document serves to set out practice guidelines for clinical pharmacy in South Africa, and to indicate areas where clinical pharmacist should concentrate to build practice.
The profession of pharmacy is maturing as a clinical profession in South Africa and has experienced significant development and growth over the past 10 years. It is presently well positioned to transform itself from a product-orientated (including procurement, preparation and evaluation of drug products), to a patient-oriented profession (
The American College of Clinical Pharmacy (ACCP) in 2006 defined the primary difference between clinical pharmacists and general registered pharmacists by clinical pharmacists’ ability to interact with patients and the fact that they can recommend specific drugs and patient specific drug dosages to improve patient well-being (
The development of clinical pharmacy in Southern Africa started in the late 1980s. In 1987,
The process of pharmacists joining ward rounds to monitoring medication in South Africa, has already been explored by
Therapeutic drug monitoring
Adverse drug reaction monitoring
In-service training for the nursing and medical staff
Providing drug information
Monitoring drug usage
During the early 1990’s, the South African Pharmacy Council called for a shift to a more professional health-care service from pharmacists, based on specific expertise of the pharmacists. The SAPC used the terms “primary care drug therapy” or “pharmacotherapy” to potentiate this expanded role (
The concept of pharmaceutical care has evolved into “comprehensive medication management” as part of clinical pharmacy. Medication management has expanded as a result of medication regimens becoming more complex and specialized, particularly in more complex patients, who may have as many as five comorbidities and take an average of eight medications concurrently. To achieve better outcomes with medication-therapies in such patients, the systematic and comprehensive management of medications is necessary.
South Africa face challenges regarding human resources in terms of healthcare service delivery (
According to
Due to the human resource shortage, it is very difficult to allocate pharmacists to work in a clinical unit on a daily basis. This document serves to set out practice guidelines for clinical pharmacy in South Africa.
The objective is to advocate the rational and appropriate use of medicines through the practice of clinical pharmacy and pharmaceutical care, in the interest of promoting health and well-being for the people of South Africa. All activities directly or indirectly, should be patient-oriented.
A secondary objective is to standardize the quality of pharmaceutical care offered by pharmacists across different institutions in both the public and private healthcare sector in South Africa.
“Clinical pharmacy is an area of pharmacy involved with the science, practice, activity and service to develop and promote the rational and appropriate use of medicines and pharmaceutical care, in the interest of the patient and the community”. During the Hoechst-Marion-Roussel lecture at the School of Pharmacy at the John Moores University in Liverpool, Strand explained that practice in pharmaceutical care has to be built up on one patient at a time, by first assessing the patient’s needs; developing a care plan and then monitoring the plan (
The Pharmaceutical Care Process.
The practice guidelines will outline the process, as perceived in the South African context of:
Assessment: Drug therapy evaluation and the process of identifying drug therapy problems
Patient Care Plan Development, while resolving, identifying and preventing drug therapy problems
Evaluating and monitoring the Patient Care Plan and recording and evaluating the actual patient outcomes and reassess for new problems
For clinical pharmacy to succeed in South Africa, it should be supported by the statutory body, management structures within the workplace, professional societies and funding structures.
Specially trained pharmacists in the area of clinical pharmacy to practize in direct patient care environments (
Clinical pharmacy is
According to the ACCP (
Direct patient care can be defined as “the direct observation and evaluation of the patient’s medication-related needs and include the introduction of new medication, modification or discontinuation of existing therapy as well as the ongoing monitoring of patient outcomes in cooperation with other health professionals”. It involves specific activities to improve pharmacotherapy (
Comprehensive medication management is defined as: “the standard of care that ensures every patient’s medication (including prescription, nonprescription,
Clinical pharmacists in South Africa, adopts the following set of pharmaceutical care medication-evaluation interventions, as developed by the American Society of Hospital Pharmacists (
These activities will serve to optimize the use of medicines, decrease potential drug interactions and side effects, and monitor therapeutic outcomes.
Evaluation of medication usage.
Function | Explanation | Monitoring/Outcome measure |
---|---|---|
|
Drugs without medical indications, unidentified medications, or untreated medical conditions, including any which required drug therapy. | Drugs discontinued, or introduced |
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Comparative efficacy and safety, and appropriateness for the individual patient | Limit side-effects or adverse drug reactions |
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Inappropriate dose, dosing frequency, dosage form, route of administration (considering efficacy, safety, and convenience), or duration of therapy | Optimize dosing regimen including dose frequency, form, and route of administration |
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Treatment of any conditions with more types of medication than necessary. | Improved patient outcomes with reduced adverse drug effects |
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To any medicines, and method used to alert health care providers to the allergy/intolerance. | Avoided hypersensitivity reaction |
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Any possibly drug-related symptoms or medical problems, and the likelihood that the problem was drug related | Identify and stop offending medicine |
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Drug-drug interactions, drug-disease interactions, drug-nutrient interactions, and drug-laboratory interactions | Identify interaction and discontinue/replace identified drug |
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Smoking or alcohol |
Identify problem caused by social drug use |
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Reasons such as system errors or any other factors that could hinder achievement of therapeutic efficacy | Ensure availability of medicine supply to patients |
Clinical pharmacists are required to uphold the highest standards of integrity and honesty, always working in the best interest of patients. They have to commit to lifelong learning, self-assessment, and self-development, as well as to provide professional education to other healthcare professionals (
Clinical pharmacists must use health delivery systems to optimize care of individual patients and participate to develop processes to improve medication use, applying knowledge of pharmacoeconomics (
Clinical pharmacists are required to communicate effectively with patients, caregivers, and other health professionals, providing clear, concise consultations, in a language appropriate to the level of understanding of their audience (
In 2015, the National Department of Health (NDoH) published the White paper on National Health Insurance (NHI), toward universal health coverage (UHC) (
Furthermore, the NDoH published their Quality Standards for Healthcare Establishments in South Africa in 2011, (
Clinical pharmacists should support the goals of the NHI (2015) aligning themselves with the National Core Standards to play a crucial role in the aim of NHI.
Clinical pharmacists should participate in procuring and supplying essential drugs to all citizens and should subscribe to the policy of the Standard Treatment Guidelines as pertaining to Public Health Care. According to the National Drug Policy, essential drugs are described as drugs that treat the majority of conditions that are prevalent in the country and have been selected by an Essential Drug Selection Committee as the most cost-effective. Clinical pharmacists should partake in the selection of these committees.
Clinical pharmacists commit to partake in lowering the costs of drug use in both the private and public sector by promoting rational drug use and cost effective drug choices. The use of scarce resources can be optimized by promoting the establishment of partnerships between the private sector and the public sector, especially within the light of National Health Insurance.
Establishing clinical pharmacy practice as new area of specialization in South Africa will be accomplished through:
Providing leadership and expertise in the field
Hosting regular symposia, workshops and an annual conference
Membership of the society which provides access to informative monthly branch meetings and society driven activities
Lobbying regulatory bodies, health care funders and service providers
Young and upcoming clinical pharmacists will be developed and supported
Provide support to practicing clinical pharmacists
To partake in training, advanced-level clinical pharmacists should be able to register at the South African Pharmacy Council as specialists, contribute to new knowledge in the field of clinical pharmacy and create specialists in the field of pharmacy for the development of health care in South Africa. Clinical pharmacists should participate in training of undergraduate pharmacists, in association with the Institution at which the undergraduate pharmacists are training. A mentorship program should be established between clinical pharmacists and the undergraduate pharmacist, but also to mentor new qualified clinical pharmacists.
To establish and coordinate the provision of pharmaceutical care and support for post graduate and independent research in clinical pharmacy, in order to increase the post graduate through-put and publications. This could also serve as a coordinating and collaborating platform for interdisciplinary research within and between the private and public sector.
The specific objectives are as follows:
To facilitate and strengthen teaching and supervision of postgraduate students between the Private Health Care sector and academia.
To teach, train and supervise postgraduate students at Post Graduate Diploma, Master’s, and Doctoral level in clinical pharmacy.
To coordinate the teaching of research and clinical training within the clinical environment and provide community-based service training.
To provide training in the form of workshops, symposia or short courses to staff by the clinical pharmacists in the hospital and clinic environment.
To support clinical pharmacy as a learning component in undergraduate teaching.
To achieve these competencies, clinical pharmacists must be prepared to complete the education and training and must commit to continued professional education to maintain competence through ongoing professional development.
To establish and maintain interdisciplinary and collaborative research projects to address relevant problems of healthcare needs in South Africa
To produce research outputs (as articles, reports and congress presentations) of internationally recognized quality in clinical pharmacy
To develop young researchers in clinical pharmacy, with particular emphasis on future clinical pharmacists
To provide an interdisciplinary forum at which researchers can present protocols, progress reports and research reports to colleagues and receive feedback in a supportive environment
The various levels of development during training will be assessed using competency standards developed in the UK. The General Level Framework (initially developed in the UK 2003), will be adapted for the South African Training and Practice Environment.
These tools will be utilized for assessment of the competence of a pharmacist and to identify areas for development, in the various stages of training. A peer, who will typically be a more experienced/senior clinical pharmacist, will do the assessment. The assessor has to be validated by another assessor/and or the South African Pharmacy Council.
The aim for clinical pharmacy in South Africa and other African countries is to promote advanced practice:
Advanced level pharmacists that are able to deliver specialized practice should be supported by relevant societies.
Currently, in the South African setting, there is a gap between general pharmacists and advanced level pharmacists for the general hospital/retail pharmacist interested in clinical pharmacy, but not necessarily at an advanced level. The society supports the development of a post-graduate certificate in clinical pharmacy, that can be developed using distance based education. The general level pharmacist (with a BPharm degree or equivalent) will be able to enter into this program, either to enroll in all modules to obtain the certificate, or only one module to receive a continuous professional development (CPD) certificate. See
Development of advanced level pharmacists.
The South African Pharmacy Council, as well as the Department of Health, will determine registration of a clinical pharmacist in South Africa and the qualifications necessary. However, the South African Society of Clinical Pharmacy proposes to support the idea that a clinical pharmacist can only practice with a relevant postgraduate Master’s degree or higher degree in clinical pharmacy. The idea of a board certification or pre-registration examination will also be supported.
The top barriers to pharmaceutical care provision perceived by pharmacists include inconvenient access to patient medical information and a lack of staff and time constraints. The limited human resources in South Africa are one of the limitations of implementing clinical pharmacy services in hospitals. Pharmacists also expressed concern over not learning to communicate effectively with medical professionals. They have concerns regarding a lack of confidence to talk to medical professionals without undermining their professional judgment, and felt that their role was not valued by other health professions without any appreciation of their role within the health care team. Since the profession of clinical pharmacy is still a novel concept in South Africa, the lack of mentorship make this barriers more pronounced. With clear outcome measures and adequate education, these barriers can be overcome.
Documentation of interventions and recommendations should be dictated by evidence-based practice and should only be done to promote and contribute to the welfare of the patient.
South Africa as a healthcare setting is diverse and the pharmacist providing services broadly classified and divided into the following must be documented:
Patient related demographical details – for the pharmacist database
Medication related consumption – for the pharmacist database and to monitor adherence and rational prescribing
Laboratory values – to monitor disease progression and medication related side effects for the pharmacist database and monitoring parameters
To assess drug therapy on a daily base according to the eleven categories
Monitoring outcomes should be part of the clinical pharmacist’s initial assessment and clear pharmaceutical goals should be set
Documenting the interventions should be patient centered and should be supportive of the health care of the patient. It should be done according to Good Pharmacy Practice Guidelines (
The clinical pharmacist makes regular interventions and can record it in the patients’ medical record. This should serve to supplement verbal communication as part of the health care team. Written communication is a permanent record in a legal document and where possible should not replace verbal communication. Verbal communication also serves to strengthen interdisciplinary relationships and should be promoted where possible.
When an entry is made into the medical record, the pharmacist should include the following information:
The pharmacist should identify themselves and their discipline, with their degree and Council registration number, designation and contact details
The instructions should be clearly written based on evidence based medicine with set pharmaceutical goals
Date and time
The inscription should follow a logical sequence e.g. the SOAP method (subjective patient details, objective clinical findings, assessment of the clinical problem and the proposed plan with the pharmacy goals
The following should also be taken into consideration:
The clinical pharmacist should note recommendations to allow room for discussion within the health care team.
Recognized medical abbreviations should be used
The medication related action plan should be noted with clear goals
Any relevant discussions that have taken place surrounding the issue should be noted
All interventions should be signed and dated
A guideline for activities that can be documented by the clinical pharmacist is provided in
Guidelines for the documentation of clinical activities.
Clinical Activity | Activity Description | Data Collection |
---|---|---|
Patient information and medical history | This includes all the administrative and general information that can be obtained by an interview with the patient or from medical records in the instance of neonates or sedated/disorientated patients. |
|
Current drug therapy and adverse drug event management | All the medication that is being given to the patient will be indicated. This will include the date on which the medication was started as well as all the dosages administered. This allows the pharmacist to have an overview of all the medication given to the patient and if the dosages were given according to the prescription. |
|
Laboratory and Microbiological Assessments | This will include parameters like urea, creatinine and other electrolytes, blood elements, liver and kidney function tests, microbiology tests, and other tests as needed per patient case |
|
Therapeutic Drug Monitoring | This involves individualization of dosage by maintaining plasma or blood drug concentrations within a target range (therapeutic range, therapeutic window). There are two major sources of variability between individual patients when discussing drug response. These variations are included in the relationship between: Dose and plasma concentration (pharmacokinetic variability), and Drug concentration at the receptor and the response (pharmacodynamic variability). |
Sampling time in relation to the dose The dosage history (i.e., whether the result represents steady state) The patient's response The desired clinical targets |
Drug therapy assessment | The interventions should be classified according to the categories of drug-related problems as mentioned in the document |
|
Participation in multi-disciplinary team ward rounds or discussions and meetings | Attending and active participation in ward rounds and meetings |
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Information on patient care or medicine use to other members of the multi-disciplinary team | Communication with other health care professionals or fellow pharmacists on patient-related issues or medicine use in patient care |
|
Health care related key performance indicators are quantifiable measures of quality that can be used to track essential processes and specific outcomes. The measurement of processes by measurement of outcomes achieved by health care professionals’ activities, can be seen as the quality assessment of the professional’s practice. They can also assist to ensure accountability to protect patient safety as well as to inform other role-players in decision-making (
Pharmaceutical care related outcome measures to measure outcomes in specific disease-related programs where in-depth documentation with a data range were identified. However, when following the concept of pharmaceutical care as defined by Hepler and Strand, outcome-indicators were rather difficult to implement. Some of the pharmaceutical care indicators proposed is depicted in
Pharmaceutical care key performance indicators.
Indicator | Discussion | Outcome |
---|---|---|
Performance/Medicine substitution | Measures how often pharmacists substitute medicine in accordance with doctors to prevent drug interactions | Show the impact and success of pharmaceutical care |
Hospital admission, frequency, and duration (after pharmacy interventions) | Possible in disease-specific pharmaceutical care programs with good documentation. Measurements could be taken before and after the pharmacy-led intervention. | Show an increase/reduction of hospital stay after pharmacist-led intervention |
Number of pharmacy-led interventions | Relatively easy to measure. However, there is large room for interpretation. |
Show the number of times a pharmacist intervenes in drug therapy |
Number of drug-related problems / medication errors | Classical indicator with regard to pharmaceutical care; however, the possibility of measurement depends on the vigilance systems in different settings. | Show possible reduction of drug-related problems/ medication errors in a disease-specific pharmaceutical care. Can be performed with a rather small group of people. |
Patient satisfaction | Regularly evaluated together with pharmaceutical care programs. | Difficulty in interpretation of this indicator, because often not subjective. |
Regular customers |
Considered as very subjective; therefore, it is difficult to measure and compare it between practitioners and settings. | Show the relationship of pharmacist with patients, customers, or prescribers. |
Process indicators (on key elements of pharmaceutical care, e.g., counselling, documentation) | Proposed indicators are questions on the process: “Is electronic documentation available?” “Is clinical pharmacy implemented?” “Are there indications having intensive programs?” | Questions answered easily, and can show the level of presence of pharmaceutical care. |
Health status indicators, e.g., morbidity rates | Easily measurable and standard indicators in many health systems. |
May show improvement over period of time. |
Adapted from
Adoption of practice guidelines may strengthen clinical pharmacy practice in South Africa, and ultimately improve the quality of care for patients. Since clinical pharmacy as a specialization cannot be registered at the pharmacist regulatory body in South Africa yet, official clinical pharmacists have not been appointed in the allocated posts. The goal of the practice guidelines is to ensure that clinical pharmacists possess the core competencies necessary to contribute to a quality standard of clinical pharmacy and therefor optimize medication use in South Africa.
Clinical pharmacist individuals, postgraduate training programs at universities, private health care institutions as well as the NDoH need to commit to achieve and maintain these competencies and practice guidelines to ensure benefit to patients. The scope of practice of clinical pharmacists has been published by the regulatory body, however, private hospital groups has developed job descriptions for clinical pharmacists with key performance indicators. A need for a standardized standard of practice is evident.
All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
The authors would like to acknowledge all the members of The South African Society of Clinical Pharmacy (SASOCP) who participated in the research.