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

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STAGES

TOPICS

SPECIFIC OUTCOMES

ASSESSMENT CRITERIA

Notional Hours

(Interactive Sessions = IS

Practical Sessions = P)

Non-specific

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

IS = 2

P = 0

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

1.2 Vaccination advocacy, communicationand social mobilisation
1.2.1The 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.
1.2.1.1Identify and critically reflect on the factors and behaviors associated with vaccine hesitancy.
1.2.1.2Apply effective communication strategies to address vaccine hesitancy in practice.
1.2.1.3Actively promote immunisation.
1.2.1.4Elaborate on how to involve communities and the public in the planning of immunisation activities

IS = 1

P = 0

2.Pre-vaccination
2.1Preparation of vaccination station
2.1.1The learner should be able to operate effectively and efficiently within immunisation programmes.
2.1.1.1Describe 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.
2.1.1.2Describe the relevant data management systems for immunisation and demonstrate their use.

IS = 0.5

P = 1

2.2Cold chain management and storage
2.2.1The 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
2.3.1The learner should be able to take an appropriate patient history.
2.3.1.1Identify the correct vaccine recipient.
2.3.1.2 Take an appropriate patient history and identify individuals at risk.
2.3.1.2.1Identify medicines currently taken.
2.3.1.2.2Identify current medical conditions.
2.3.1.2.3Identify all possible and potential vaccine-medicine interactions.
2.3.1.2.4Identify all possible and potential vaccine-disease interactions.
2.3.1.2.5Identify 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

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

IS = 1

P = 1

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

IS = 1

P = 3

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

IS = 1

P = 4

4.Post-vaccination
4.1Counselling 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

4.2Anaphylaxis 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

4.3Adverse events following immunisation (AEFI)
4.3.1The 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.
4.3.1.4Identify and describe local and systemic signs and symptoms of AEFI and the appropriate management thereof.

IS = 1

P = 0

4.4Waste disposal
4.4.1The 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