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Pharmacy Act, 1974 (Act No. 53 of 1974)

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A Pharmacist who offers Immunisation Services in South Africa: Scope of Practice, Competency Standards and the Criteria to Accredit a Generic Short Course for Pharmacists in Immunisation and Injection Technique, and delivering Immunisation Services

Part 3: Criteria to Accredit a Generic Short Course for Pharmacists in Immunisation and Injection Technique, and delivering Immunisation Services

8. Outcomes and associated Assessment Criteria

 

STAGES

TOPICS

SPECIFIC OUTCOMES

ASSESSMENT CRITERIA

Notional Hours

(Interactive Sessions = IS

Practical Sessions = P)

Non-specific

1.1 General immunisation principles
1.1.1 The learner should be able to apply the principles of immunology to vaccination.
1.1.1.1 Explain the concept of vaccine immunology and immunisation.
1.1.1.2 Differentiate between individual and herd immunity.
1.1.1.3 Describe the different types of vaccines.

IS = 2

P = 0

1.1.2 The learner should be able to understand and apply vaccination schedules and strategies for protecting different population groups from vaccine preventable diseases.
1.1.2.1 Interpret and apply South Africa’s public and private sector immunisation schedules.
1.1.2.2 Describe the vaccination strategy for trauma victims.
1.1.2.3 List vaccines that can be given to pregnant woman, when they should be given, and those that cannot be given.
1.1.2.4 Explain the vaccination strategies for vaccinating HIV positive babies, pre-term infants, immunocompromised patients, adolescents, healthcare workers, and the elderly.
1.1.2.5 Describe the vaccination-catchup strategy for babies/children who missed scheduled vaccines.
1.1.2.6 Describe the importance and the use of immunisation data collection.

1.2 Vaccination advocacy, communicationand social mobilisation
1.2.1 The learner should be able to effectively communicate the risks and benefits of vaccination to their clients to build confidence and demand for vaccination, thereby increasing vaccination coverage.
1.2.1.1 Identify and critically reflect on the factors and behaviors associated with vaccine hesitancy.
1.2.1.2 Apply effective communication strategies to address vaccine hesitancy in practice.
1.2.1.3 Actively promote immunisation.
1.2.1.4 Elaborate on how to involve communities and the public in the planning of immunisation activities

IS = 1

P = 0

2. Pre-vaccination
2.1 Preparation of vaccination station
2.1.1 The learner should be able to operate effectively and efficiently within immunisation programmes.
2.1.1.1 Describe the minimum criteria for the vaccination station, equipment, and material according to Good Pharmacy Practice to ensure the facility is appropriate and ready for immunisation.
2.1.1.2 Describe the relevant data management systems for immunisation and demonstrate their use.

IS = 0.5

P = 1

2.2 Cold chain management and storage
2.2.1 The learner should be able to list, describe and demonstrate all key aspects of cold chain management and storage.
2.2.1.1 Explain the requirements for storage and monitoring of vaccines and diluents.
2.2.1.2 Demonstrate how to pack the vaccine refrigerator.
2.2.1.3 Identify alternative cold chain equipment to cater for vaccine storage outside the refrigerator e.g., emergencies, transportation.
2.2.1.4 Demonstrate the packing of vaccines and diluents in cold boxes for transportation, campaign site storage and power failures according to the rules relating to Good Pharmacy Practice and the manufacturer’s specifications.
2.2.1.5 Describe the quality assurance processes, including checking expiry dates, reading and interpreting of Vaccine Vial Monitor (VVM), and using the shake test when appropriate for maintaining vaccine stability.
2.2.1.6 Describe the process of cleaning a vaccine refrigerator.
2.2.1.7 Explain and apply the multidose vial policy.

IS = 2

P = 2

2.3 Patient history taking
2.3.1 The learner should be able to take an appropriate patient history.
2.3.1.1 Identify the correct vaccine recipient.
2.3.1.2 Take an appropriate patient history and identify individuals at risk.
2.3.1.2.1 Identify medicines currently taken.
2.3.1.2.2 Identify current medical conditions.
2.3.1.2.3 Identify all possible and potential vaccine-medicine interactions.
2.3.1.2.4 Identify all possible and potential vaccine-disease interactions.
2.3.1.2.5 Identify any contraindications or special precautions to vaccination.

IS = 1

P = 0

2.4 Pre-vaccination counselling
2.4.1 The learner should be able to perform appropriate pre-vaccination counselling.
2.4.1.1 Apply effective and culturally sensitive communication skills in pre-vaccination counselling of the vaccinee/caregiver.
2.4.1.2 Explain the importance of immunisation, which vaccines are needed, immunisation schedules and dose intervals.
2.4.1.3 Explain the risks and benefits of immunisation, including potential adverse events following immunisation.
2.4.1.4 Describe the process of obtaining and recording informed consent.
2.4.1.5 Respond appropriately to questions and concerns regarding immunisation.
2.4.1.6 Provide accurate and relevant information to the vaccinee/caregiver regarding administration of the vaccine at a specific site.

IS = 1

P = 1

2.5 Infection prevention and control (IPC)
2.5.1 The learner should be able to practice appropriate IPC.
2.5.1.1 Demonstrate the processes involved in IPC necessary for a vaccination station including—
2.5.1.1.1 Use of the appropriate personal protective equipment (PPE).
2.5.1.1.2 Ensure aseptic technique as well as a clean, hygienic, and well-ventilated environment.
2.5.1.1.3 Maintaining physical distancing where appropriate.
2.5.1.1.4 Regular hand washing and/or sanitising.

IS = 1

P = 1

3. Vaccine administration
3.1 Preparing to vaccinate
3.1.1 The learner should be able to safely prepare the different types of vaccines for vaccination.
3.1.1.1 Identify principles which should be adhered to in practice, to prevent any immunisation error related AEFI.
3.1.1.2 Demonstrate the steps involved in the preparation of a vaccine including:
3.1.1.2.1 Identify the correct route of administration and specific injection site for the vaccine according to age, pre-existing condition and current medication taken.
3.1.1.2.2 Position the vaccinee in an enabling and comfortable position.
3.1.1.2.3 Identify/choose/select the appropriate vaccine, needle, and syringe size for the individual and the specific vaccine.
3.1.1.2.4 Check the expiry date of the vaccine and all products used and the lifespan of multidose vials.
3.1.1.2.5 Prepare under aseptic conditions (reconstitute where applicable) the vaccine as per the South African EPI guidelines, GPP and manufacturer’s specifications.
3.1.1.2.6 Draw the accurate dose for administration according to the manufacturer’s specifications.

IS = 1

P = 3

3.2 Administering the vaccine
3.2.1 The learner should be able to safely administer the different types of vaccines.
3.2.1.1 Demonstrate appropriate preparation of the injection site.
3.2.1.2 Demonstrate the ability to safely administer the different types of vaccines, according to the appropriate route of administration, as per EPI guidelines, GPP, and manufacturer’s specifications
3.2.1.3 Demonstrate how to safely discard the needle and the syringe into a sharps container.
3.2.1.4 Record the vaccine specific information in the vaccinee’s immunisation record, whether electronic or paper-based.

IS = 1

P = 4

4. Post-vaccination
4.1 Counselling and observation
4.1.1 The learner should be able to provide suitable post-vaccination counselling and observation.
4.1.1.1 Apply effective and culturally sensitive verbal and written communication in the post-vaccination counselling of the vaccinee/caregiver.
4.1.1.2 Select relevant information to reinforce with the vaccinee/caregiver either verbally or in writing post-vaccination, including potential vaccine responses, what to do if these occur and how to report.
4.1.1.3 Describe the appropriate post-vaccination observation procedures to follow.

IS = 1.5

P = 0

4.2 Anaphylaxis and emergency management
4.2.1 The learner must be able to provide supportive care for the management of anaphylaxis.
4.2.1.1 Describe the signs and symptoms of anaphylaxis.
4.2.1.2 Distinguish between the signs and symptoms of anaphylaxis, general acute stress response, and vasovagal reaction with syncope or fainting, brought on by anxiety or stress, related to immunisation.
4.2.1.3 Demonstrate the safe and timeous administration of emergency medicines.
4.2.1.4 Manage the transfer of the vaccinee to a nearby health care facility for further management or observation.

IS = 3

P = 1

4.3 Adverse events following immunisation (AEFI)
4.3.1 The learner must be able to identify, manage and advise the vaccinee / caregiver regarding AEFI.
4.3.1.1 Differentiate between adverse events resulting from the vaccine or the immunisation process, and coincidental events not due to the vaccine or the immunisation process, but temporally associated with immunisation.
4.3.1.2 Describe potential underlying causes for each type of AEFI and understand the link between the AEFI and its cause.
4.3.1.3 Distinguish between minor and severe (serious and non-serious) AEFI.
4.3.1.4 Identify and describe local and systemic signs and symptoms of AEFI and the appropriate management thereof.

IS = 1

P = 0

4.4 Waste disposal
4.4.1 The learner must be able to discard biohazardous and general waste in a safe and appropriate manner
4.4.1.1 Demonstrate the procedures for disposing of sharps waste.
4.4.1.2 Manage the safe disposal of biohazardous and general waste.

IS = 0.5

P = 0.5

5. Monitoring vaccine safety
5.1 Vaccine pharma-covigilance
5.1.1 The learner should be able to explain and apply the principles of pharma-covigilance specific to vaccines.
5.1.1.1 Identify and describe the correct procedures for the timely reporting of AEFI including using the appropriate tools.

IS = 1

P = 0

6. Data management
6.1 Record keeping and documentation
6.1.1 The learner should be able to record and document the required/pertinent information specified for vaccine administration.
6.1.1.1 Appropriately record and store vaccinee and vaccination details according to GPP.
6.1.1.2 Demonstrate knowledge of the vaccination programme, and the specific data that needs to be recorded and reported to the appropriate authorities.

IS = 1

P = 0.5

7. Stakeholder interactions
7.1 Expanding access to immunisation services
7.1.1 The learner should be able to interact appropriately with relevant stakeholders to expand access to immunisation services.
7.1.1.1 Describe the requirements for establishing a working agreement with relevant stakeholders to render immunisation services in line with written terms and conditions (or service level agreement).

IS = 1

P = 0

 

Abbreviations

AEFI: Adverse events following immunisation

EPI: Expanded Programme on Immunisation

GPP: Good Pharmacy Practice