Pharmacy Act, 1974 (Act No. 53 of 1974)Board Notice2018 Competency Standards for Pharmacists in South AfricaDomain 2: Safe and Rational Use of Medicines and Medical Devices |
INTRODUCTION
Domain 2 covers the rational use of medicines, a concept adopted by the World Health Organization (WHO), which advocates that patients receive medicines and medical devices that are:
• | appropriate to their clinical needs; |
• | in doses that meet individual requirements; |
• | for an adequate period of time; and |
• | cost-effective for the patient and community. |
Participation of the pharmacist in the promotion of rational use of medicines will contribute to improved access to quality medicines and other pharmaceutical services.
Pharmacists have a professional obligation to the public to ensure an adequate and reliable supply of safe, cost-effective medicines and medical devices of acceptable quality as prescribed in the National Drug Policy (1996). Patients must be educated in respect of the correct use of medical devices that meet all regulatory, safety and performance requirements.
Patients and healthcare workers are encouraged to report all medicine safety related complaints, and pharmacists should monitor, record and process such complaints.
In the domain of safe and rational use of medicines and medical devices, effective verbal and non-verbal methods of communication with patients and other healthcare professionals, are essential competencies. Pharmacists require these competencies to improve patient health outcomes and to build and maintain professional working relationships within a healthcare team. This domain also encompasses activities such as pharmacist initiated therapy (PIT), medicine utilisation reviews and use evaluations, and monitoring of therapeutic outcomes.
The competencies required in the domain for the safe and rational use of medicines and medical devices are:
2.1 | Patient consultation |
2.2 | Patient counselling |
2.3 | Patient medicines review and management |
2.4 | Medicines and medical devices safety |
2.5 | Therapeutic outcome monitoring |
2.6 | Pharmacist initiated therapy (PIT) |
2.7 | Pharmacovigilance |
2.8 | Clinical trials |
DOMAIN 2: SAFE AND RATIONAL USE OF MEDICINES AND MEDICAL DEVICES |
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Behavioural Statements |
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Competencies |
Item No. |
Entry Level into Practice |
Intermediate Practice |
Advanced Practice |
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2.1 |
Patient consultation |
2.1.1 |
2.1.1.1 |
Undertake consultations, in an appropriate setting, with minimal interruption, while maintaining verbal, auditory and personal privacy. |
2.1.1.2 |
Undertake more complex consultations, in an appropriate setting with minimal interruption, while maintaining verbal, auditory and personal privacy. |
2.1.1.3 |
Ensure that appropriate facilities are available to permit patient consultation. |
2.1.2 |
2.1.2.1 |
Use appropriate communication and questioning techniques to gather relevant patient information on allopathic, complementary and alternative medicines and therapy use. |
2.1.2.2 |
Provide accurate and evidence-based information on allopathic, complementary and alternative medicines and therapy use. |
2.1.2.3 |
Provide guidance to pharmacists and pharmacy support personnel on allopathic, complementary and alternative medicines and therapy use, using evidence-based information. |
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2.1.3 |
2.1.3.1 |
Consult with a patient and/or caregiver to determine health needs in a culturally sensitive manner. |
2.1.3.2 |
Implement protocols to ensure that all personnel maintain cultural sensitivity in all patient interactions. |
2.1.3.3 |
Develop and review protocols to ensure that all personnel maintain cultural sensitivity in all patient interactions. |
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2.1.4 |
2.1.4.1 |
Identify the need for further information and/or referral to an appropriate healthcare provider/resource. |
2.1.4.2 |
Implement protocols for referral in consultation with other members of the healthcare team. |
2.1.4.3 |
Develop and review protocols for referral in consultation with other members of the healthcare team. |
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2.1.5 |
2.1.5.1 |
Where appropriate and after obtaining patient consent, use diagnostic aids and/or tests. |
2.1.5.2 |
Implement protocols to ensure appropriate use/application of diagnostic aids and/or tests. |
2.1.5.3 |
Develop and review protocols to ensure appropriate use/application of diagnostic aids and/or tests. |
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2.1.6 |
2.1.6.1 |
Where applicable, examine patient records to obtain patient medication and disease history. |
2.1.6.2 |
Implement care plans based on patient records. |
2.1.6.3 |
Develop and review a care plan based on patient records and monitor patient outcomes. |
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2.1.7 |
2.1.7.1 |
Maintain confidentiality of patient information in line with legislative requirements. |
2.1.7.2 |
Manage the risk assessment plan relating to breach of confidentiality of patient information in line with legislative requirements. |
2.1.7.3 |
Develop and review the risk assessment plan relating to breach of confidentiality of patient information in line with legislative requirements. |
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2.1.8 |
2.1.8.1 |
Keep and maintain appropriate records. |
2.1.8.2 |
Implement procedures and protocols for document management and recordkeeping. |
2.1.8.3 |
Develop and review procedures and protocols for document management and recordkeeping. |
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2.2 |
Patient counselling |
2.2.1 |
2.2.1.1 |
Establish existing understanding and knowledge of health conditions, medicines use for a patient and the need for counselling. |
2.2.1.2 |
Formulate a counselling plan according to the needs of the patient to ensure the safe and effective use of medicines. |
2.2.1.3 |
Ensure that all patients receive appropriate counselling that is in line with facility specific protocols. |
2.2.2 |
2.2.2.1 |
Counsel patients on the safe and rational use of medicines and medical devices (including selection, use, contraindications, storage, and side effects). |
2.2.2.2 |
Implement systems to ensure that patient counselling is performed in accordance with GPP. |
2.2.2.3 |
Develop and manage systems to ensure that patient counselling is performed in accordance with GPP. |
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2.2.3 |
2.2.3.1 |
Listen effectively, using active and reflective listening techniques. |
2.2.3.2 |
Respond appropriately to more challenging or complex scenarios that require attentive listening.. |
2.2.3.3 |
Use advanced listening skills to differentiate or distinguish challenging and complex scenarios.. |
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2.2.4 |
2.2.4.1 |
Use an appropriate counselling plan based on patient needs and ensure the safe and effective use of medicine. |
2.2.4.2 |
Respond appropriately to more challenging or complex scenarios requiring patient counselling. |
2.2.4.3 |
Develop and review counselling plan templates to ensure the safe and effective use of medicine. |
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2.2.5 |
2.2.5.1 |
Maximise opportunities for counselling and the provision of information and advice to patients. |
2.2.5.2 |
Identify opportunities for counselling and the provision of information and advice to patients. |
2.2.5.3 |
Create opportunities for counselling and the provision of information and advice to patients. |
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2.2.6 |
2.2.6.1 |
Communicate in a manner that demonstrates sensitivity to alternative customs and approaches to healthcare. |
2.2.6.2 |
Implement communication techniques/systems that consider alternative customs and approaches to healthcare. |
2.2.6.3 |
Develop communication techniques/systems that consider alternative customs and approaches to healthcare. |
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2.2.7 |
2.2.7.1 |
Use language, including verbal and nonverbal cues, that the patient is likely to understand. |
2.2.7.2 |
Implement and monitor the use of a language policy that includes verbal and nonverbal cues that the patient is likely to understand. |
2.2.7.3 |
Develop a language policy that includes verbal and nonverbal cues that the patient is likely to understand.
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2.2.8 |
2.2.8.1 |
Where appropriate, use instructional aids. |
2.2.8.2 |
Implement the use of instructional aids appropriately. |
2.2.8.3 |
Develop instructional aids that can be used to maximise counselling. |
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2.2.9 |
2.2.9.1 |
Obtain feedback from the patient to confirm their understanding of the information provided during the counselling process. |
2.2.9.2 |
Implement processes and procedures to obtain patient feedback regarding counselling. |
2.2.9.3 |
Develop processes and procedures to obtain patient feedback in counselling. |
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2.3 |
Patient medicine review and management |
2.3.1 |
2.3.1.1 |
Confirm patient adherence to a medicine regimen or treatment plan. |
2.3.1.2 |
Encourage and facilitate patient adherence to a medicine regimen or treatment plan. |
2.3.1.3 |
Identify, prioritise and resolve medicines management problems. |
2.3.2 |
2.3.2.1 |
Assist with medicine utilisation reviews. |
2.3.2.2 |
Perform medicine utilisation reviews, as appropriate, to ensure the rational use of medicine and clinical outcomes. |
2.3.2.3 |
Recognise and manage trends associated with inappropriate medicine prescribing behaviour. |
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2.3.3 |
2.3.3.1 |
Liaise with the prescriber or other healthcare professionals to ensure the optimal use of medicines. |
2.3.3.2 |
Liaise with the prescriber or other healthcare professionals to implement a plan to ensure the optimal use of medicines. |
2.3.3.3 |
Contribute to strategies to optimise patient medication management using clinical tools where appropriate. |
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2.3.4 |
2.3.4.1 |
Use appropriate protocols to ensure cost-effective use of medicines and medical devices. |
2.3.4.2 |
Use appropriate protocols to ensure cost-effective use of medicines and medical devices. |
2.3.4.3 |
Develop protocols to ensure the cost-effective use of medicines and medical devices. |
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2.3.5 |
2.3.5.1 |
Identify patients requiring additional monitoring. |
2.3.5.2 |
Recognise and advise on any additional patient monitoring required. |
2.3.5.3 |
Recognise and advise on any additional patient monitoring required in complex scenarios. |
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2.4 |
Medicine and medical device safety |
2.4.1 |
2.4.1.1 |
Report dispensing errors, side and adverse effects. |
2.4.1.2 |
Implement developed protocols to avoid common dispensing errors such as ‘look-alike’ and ‘sound-alike’ medicines. |
2.4.1.3 |
Develop protocols to avoid common dispensing errors such as ‘look-alike’ and ‘sound-alike’ medicines. |
2.4.2 |
2.4.2.1 |
Keep abreast of emerging medicine safety information. |
2.4.2.2 |
Implement and maintain a ‘near-misses’ and error reporting system. |
2.4.2.3 |
Disseminate information relating to medicine safety and alter practice accordingly. |
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2.4.3 |
2.4.3.1 |
Participate in prevention and resolution of medication errors. |
2.4.3.2 |
Identify, record, act and report medication errors. |
2.4.3.3 |
Review and interpret medication error reports to identify trends and implement appropriate corrective action. |
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2.4.4 |
2.4.4.1 |
Identify medicines, and medical devices with quality issues and report according to applicable policies. |
2.4.4.2 |
Source medicines and medical devices of an acceptable quality and standard, in accordance with relevant SOPs. |
2.4.4.3 |
Develop SOPs to ensure that medicines and medical devices are of an acceptable quality and standard, and are sourced from licensed and approved suppliers. |
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2.4.5 |
2.4.5.1 |
Identify medicines and medical devices that are a high risk in respect of medication errors or that exhibit increased safety risks and take steps to minimise and mitigate the risk. |
2.4.5.2 |
Implement developed systems and protocols to minimise and mitigate medication errors and adverse effects. |
2.4.5.3 |
Develop systems and protocols to minimise and mitigate medication errors and adverse effects. |
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2.4.6 |
2.4.6.1 |
Store medicines and medical devices in a safe, secure, organised and systematic manner. |
2.4.6.2 |
Implement developed systems to ensure safe, secure, organised and systematic storage of medicines and medical devices. |
2.4.6.3 |
Develop systems to ensure safe, secure, organised and systematic storage of medicines and medical devices. |
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2.5 |
Therapeutic outcome monitoring |
2.5.1 |
2.5.1.1 |
Monitor therapeutic outcomes. |
2.5.1.2 |
Monitor and optimise therapeutic outcomes for more complex scenarios. |
2.5.1.3 |
Ensure that protocols are in place to support the optimisation of therapeutic outcomes by pharmacists.
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2.5.2 |
2.5.2.1 |
Consult with other healthcare professionals to optimise therapeutic outcomes. |
2.5.2.2 |
Contribute to the PTC or at formulary design level to optimise therapeutic outcomes. |
2.5.2.3 |
Participate in optimisation of therapeutic outcomes at PTC/formulary design level. |
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2.6 |
Pharmacist initiated therapy (PIT) |
2.6.1 |
2.6.1.1 |
Assess and treat a patient based on objective and subjective signs and symptoms as guided by relevant legislation and within the scope of practice. |
2.6.1.2 |
Ensure all medicine selection and advice provided reflects best evidence and guidance. |
2.6.1.3 |
Ensure that protocols are in place to facilitate supervision of pharmacy support personnel involved in pharmacist initiated therapy (PIT). |
2.6.2 |
2.6.2.1 |
Discuss the use of appropriate medicines and obtain consensus from the patient, taking into account patient preferences, allergies and medical history. |
2.6.2.2 |
Implement the guidelines and policies on the appropriate use of medicines. |
2.6.2.3 |
Develop guidelines and policies for appropriate use of medicines. |
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2.6.3 |
2.6.3.1 |
Document any intervention, including medicine supply, according to current legislative requirements. |
2.6.3.2 |
Implement the developed pharmacist intervention documentation system. |
2.6.3.3 |
Develop a pharmacist intervention documentation system. |
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2.6.4 |
2.6.4.1 |
Refer patients, when required, to an appropriate healthcare provider/resource. |
2.6.4.2 |
Implement the referral system to an appropriate healthcare provider/resource. |
2.6.4.3 |
Develop a patient referral system. |
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2.7 |
Pharmaco- vigilance |
2.7.1 |
2.7.1.1 |
Monitor, receive, record and report quality defects, adverse drug reactions and events. |
2.7.1.2 |
Manage pharmaco-vigilance activities and classify the events accordingly. |
2.7.1.3 |
Design and implement interventions to prevent and minimise adverse drug events. |
2.7.2 |
2.7.2.1 |
Perform post marketing surveillance studies. |
2.7.2.2 |
Compile reports of the post marketing surveillance studies. |
2.7.2.3 |
Review pharmaco- vigilance reports and report to regulatory authority.
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2.8 |
Clinical trials |
2.8.1 |
2.8.1.1 |
Apply master documents (e.g. SOPs) according to GxP. |
2.8.1.2 |
Implement and monitor compliance in line with GxP. |
2.8.1.3 |
Interpret guidelines, legislation and policies in line with GxP. |
2.8.2 |
2.8.2.1 |
Compile master documents. |
2.8.2.2 |
Review master documents. |
2.8.2.3 |
Approve master documents. |