DOMAIN 3: SUPPLY OF MEDICINES AND MEDICAL DEVICES

Behavioural Statements

Competencies

Item No.

Entry Level into Practice

Intermediate Practice

Advanced Practice

Medicine production according to GxP

Materials receiving

3.1.1.1

Apply SOPs and production documentation for receiving materials.

3.1.1.2

Implement and monitor compliance with regard to materials receiving requirements in accordance with SOPs.

3.1.1.3

Interpret guidelines, legislation and policies for receiving material.

3.1.2

Storage of raw materials and finished products

3.1.2.1

Apply SOPs and production documentation for storage requirements

3.1.2.2

Implement and monitor compliance with storage requirements in accordance with SOPs.

3.1.2.3

Interpret guidelines, legislation and policies for storage of raw materials and finished products.

3.1.3

Production

3.1.3.1

Apply SOPs and production documentation according to the manufacturing process

3.1.3.2

Implement and monitor compliance with production requirements in accordance with SOPs.

3.1.3.3

Manage deviations, investigate production failures, develop, review and update guidelines, SOPs and policies relating to the manufacturing process.

3.1.4

Packaging

3.1.4.1

Apply SOPs and production documentation to packaging process.

3.1.4.2

Implement and monitor compliance with packaging requirements in accordance with SOPs.

3.1.4.3

Manage deviations, investigate packaging failures, develop, review and update guidelines, SOPs and policies relating to the packaging process.

3.1.5

Final product release

3.1.5.1

Apply SOPs and review production documentation  final product release.

3.1.5.2

Implement and monitor compliance with the final product release specifications.

3.1.5.3

Review and approve manufacturing records for final product release.

3.1.6

Quality management systems

3.1.6.1

Review and apply SOPs and production documentation in line with quality management systems.

3.1.6.2

Develop and implement quality management systems to ensure product safety, quality and efficacy.

3.1.6.3

Develop and manage quality management policies.

3.1.7

Validation

3.1.7.1

Apply principles of validation.

3.1.7.2

Develop validation protocols and reports.

3.1.7.3

Approve validation protocols and reports.

3.1.8

Regulaory

3.1.8.1

Apply section 15 of Act 101 to compile medicine registration dossiers.

3.1.8.2

Review the dossier for correctness and completeness, and respond to variations from the regulatory authority.

3.1.8.3

Approve the dossier for submission to the regulatory authority.

3.2

Supply chain manage-ment

3.2.1

3.2.1.1

Monitor and report stock requirements and shortages.

3.2.1.2

Implement medicines supply chain protocols to ensure access and availability of safe, effective, quality medicines and medical devices.

3.2.1.3

Develop and review protocols to ensure access and availability of safe, effective, quality medicines and medical devices for various supply and distribution models.

3.2.2

3.2.2.1

Advise consumers/carers of reasons for the delay in supply of medicines and medical devices, and implement the contingency plans to ensure continuity of care.

3.2.2.2

Convey medicine or medical device shortage contingency plan information to the relevant healthcare professionals.

3.2.2.3

Develop, and monitor contingency plans for medicines and medical device shortages.

3.2.3

3.2.3.1

Use the tools to monitor and review stock levels.

3.2.3.2

Assess and determine suitable stock levels and maintenance thereof.

3.2.3.3

Develop and review policies to support the application of the palliative care approach in medicine management.

3.2.4

3.2.4.1

Supply suitable alternative medicines and medical devices in emergency and life-threatening situations.

3.2.4.2

Source and obtain suitable alternative medicines and medical devices in emergency and life-threatening situations.

3.2.4.3

Liaise with prescribers and other stakeholders to identify suitable alternative medicines and medicine devices where supply difficulties are likely to occur.

3.2.5

3.2.5.1

Procure medicines and medical devices in line with approved procurement/supply chain management policies and procedures appropriate to the practice setting.

3.2.5.2

Implement and manage procurement/supply chain management policies and procedures appropriate to the practice setting.

3.2.5.3

Develop and review procurement/supply chain management policies and procedures ensuring no conflict of interest or inappropriate inducements in the sourcing and supply of medicines.

3.2.6

3.2.6.1

Distribute medicines and medical devices in line with approved protocols and policies developed in accordance with GxP.

3.2.6.2

Communicate policies and protocols for medicine and medical device distribution, developed in accordance with GxP, to other members of the healthcare team.

3.2.6.3

Apply GxP principles and relevant legislation in the development of policies and protocols for medicine supply management.

3.2.7

3.2.7.1

Supply unregistered medicines in accordance with relevant legislation.

3.2.7.2

Manage the supply of unregistered medicines in accordance with relevant legislation.

3.2.7.3

Develop systems and protocols for the supply of unregistered medicines in accordance with relevant legislation.

3.2.8

3.2.8.1

Implement an effective stock management and rotation system, including systems for forecasting patient needs and demands and contingency plans for shortages and discontinuations.

3.2.8.2

Work with documented policies and procedures to implement an effective stock management and rotation system, including systems for forecasting patient needs and demands and contingency plans for shortages and discontinuations.

3.2.8.3

Manage sector wide pharmaceutical quantification.

3.3

Formulary develop-ment

3.3.1

3.3.1.1

Contribute to product selection based on systematic evidence-based evaluation criteria, e.g. suitability for intended use, quality and cost of medicines and medical devices, safety profile, reliability of source and bioequivalence.

3.3.1.2

Play an advisory role in product selection based on systematic evidence-based  criteria, e.g. suitability for intended use, quality and cost of medicines and medical devices, safety profile, reliability of source and bioequivalence.

3.3.1.3

Play a leading role in product selection based on systematic, evidencebased evaluation criteria, e.g. suitability for intended use, quality and cost of medicines and medical devices, safety profile, reliability of source and bioequivalence.

3.4

Medicine dispensing

3.4.1

3.4.1.1

Evaluate, interpret and prepare the prescription in line with legislative requirements and inform patients of availability of generic medicines.

3.4.1.2

Manage, organise and prioritise the dispensing of prescriptions according to professional judgment, up-to-date clinical knowledge and in line with legislative requirements.

3.4.1.3

Manage, organise and prioritise the dispensing of prescriptions according to professional judgment, up-to-date clinical knowledge and in line with legislative requirements.

3.4.2

3.4.2.1

Maintain, review and update patient history.

3.4.2.2

Ensure that patient history is recorded and stored appropriately in accordance with applicable legislation.

3.4.2.3

Ensure that patient history is recorded and stored appropriately in accordance with applicable legislation.

3.4.3

3.4.3.1

Perform a therapeutic review of a prescription to ensure pharmaceutical and clinical appropriateness of the treatment.

3.4.3.2

Perform a therapeutic review of more complex prescriptions to ensure pharmaceutical and clinical appropriateness of treatment.

3.4.3.3

Undertake therapeutic review of highly complex prescriptions for patients with multiple coexisting conditions to ensure pharmaceutical and clinical appropriateness of the prescribed treatment for the patient.

3.4.4

3.4.4.1

Apply GPP principles and ensure accurate dispensing in an organised and systematic way, and apply sequential accuracy checks to all phases of dispensing.

3.4.4.2

Apply GPP principles and ensure accurate dispensing in an organised and systematic way, and apply sequential accuracy checks to all phases of dispensing.

3.4.4.3

Put systems in place to ensure that all phases of dispensing as detailed in the GPP are complied with.

3.4.5

3.4.5.1

Prepare extemporaneous preparations according to GxP.

3.4.5.2

Ensure that extemporaneous preparations are prepared in accordance with GxP.

3.4.5.3

Develop SOPs for preparation of

extemporaneous preparations in line with GxP.

3.4.6

3.4.6.1

Perform pharmaceutical calculations accurately.

3.4.6.2

Ensure that pharmaceutical calculations are accurate.

3.4.6.3

Provide reference sources and develop procedures for pharmaceutical calculations.

3.4.7

3.4.7.1

Consult prescribers regarding anomalies or potential problems, e.g. incorrect doses, drug interactions

3.4.7.2

Address prescription anomalies in clinical meetings with healthcare professionals.

3.4.7.3

Advise and guide prescribers on potential problematic treatment regimens.

3.4.8

3.4.8.1

Document and record all interventions.

3.4.8.2

Implement a recordkeeping system and ensure that all interventions are documented.

3.4.8.3

Develop a recordkeeping system and undertake an analysis of all documented interventions to improve patient care.

3.4.9

3.4.9.1

Use dispensing technology in line with practice specific protocols.

3.4.9.2

Implement and monitor the use of dispensing technology developed in line with protocols.

3.4.9.3

Develop protocols to ensure accurate use of all dispensing technologies.

3.5

Medicine     com-pounding

3.5.1

3.5.1.1

Apply pharmaceutical knowledge to the formulation and compounding of medicines.

3.5.1.2

Ensure that pharmaceutical formulation and compounding of medicines are in line with legislation.

3.5.1.3

Source appropriate references for formulation and compounding of medicines in line with GPP and GxP.

3.6

Medicine  recall,  disposal  and destruction

3.6.1

3.6.1.1

Request patients to return any unused, unwanted and/or expired medicines to the pharmacy for safe disposal and implement the protocols for any returned, unused, unwanted, expired and recalled medicines, including the assessment of impact on patient care and required patient follow up.

3.6.1.2

Request patients to return any unused, unwanted and/or expired medicines to the pharmacy for safe disposal and implement the protocols for any returned, unused, unwanted, expired and recalled medicines, including the assessment of impact on patient care and required patient follow up.

3.6.1.3

Develop protocols to ensure the proper management of returned, recalled, expired and unusable products for safe disposal taking into consideration environmental legislations.

3.6.2

3.6.2.1

Quarantine any returned, damaged, expired, recalled or discontinued medicines and implement and monitor the safe destruction and disposal of waste material, pharmaceutical products and cytotoxic products in accordance with relevant legislation.

3.6.2.2

Quarantine any returned, damaged, expired, recalled or discontinued medicines and implement and monitor the safe destruction and disposal of waste material, pharmaceutical products and cytotoxic products in accordance with relevant legislation.

3.6.2.3

Develop a protocol for the safe destruction and disposal of waste material, pharmaceutical products and cytotoxic products in accordance with relevant legislation.

3.6.3

3.6.3.1

Apply the guidelines for recall of medicines

3.6.3.2

Apply the guidelines for recall of medicines.

3.6.3.3

Ensure compliance to the guidelines for recall of medicines.