Occupational Certificate: Health Products Vigilance Officer (HPVO)

Purpose

The purpose of Occupational Certificate: Health Products Vigilance Officer (HPVO) part qualification is to prepare a learner to operate as a Health Product Vigilance Officer.

A Health Products Vigilance Officer (HPVO) conducts vigilance and post-marketing surveillance activities in a health product regulatory environment. They ensure registered and licensed health products are continuously safe to use by monitoring the occurrence of adverse events and assisting with requests for product recall. Health products include medicines, medical devices and in vitro devices (IVDs), veterinary and personal care products. These applications are submitted to the regulatory body electronically in the main.

A qualified learner will be able to

• Conduct / perform vigilance and post marketing surveillance.

Achieving this Health Products Vigilance Officer (HPVO) qualification will provide several benefits to the learner, including:

• Acquiring in-depth knowledge of vigilance and post-marketing surveillance activities with respect to health products.
• Taking a significant step into the health products sector with the prospect of acquiring higher or related qualifications in the field.
• Acquisition of a formal qualification in vigilance and post-marketing surveillance with respect to health products, if learner does not already have a qualification.
• Increasing the opportunity of gaining employment with companies that manage health product applications for registration and licensing. Considering South Africa's huge unemployment rate, a qualification like this has the potential to get learners into meaningful employment.

Typical graduate attributes include proficiency, efficiency, and effectiveness in carrying out the important functions of assisting a Responsible Pharmacist or Authorised Person to complete and submit adverse reaction/event reporting forms and health product recall documents to the regulatory body. The Health Products Vigilance Officer (HPVO) is a person of integrity and high ethical standards as they work within a regulatory framework to ensure the safety of the public from harmful health products.

Rationale

No health product may be sold in South Africa unless it has been registered with an appropriate regulatory body. This qualification covers medicines, medical devices and in vitro devices (IVDs), complementary medicines, personal care products and veterinary products. Currently, the South African Health Products Authority (SAHPRA) registers health products as defined by the Medicines Act 101 of 1965 and its Amendments - whether they are manufactured locally or abroad - to ensure safety, efficacy, and quality

A health product can only be marketed once it is registered by SAHPRA. However, clinical trials which are performed to identify safety issues of a health product before its registration cannot completely identify all the reactions to a health product. This is done by monitoring the use of a product through vigilance and post-marketing surveillance.

This qualification plays a very critical role in monitoring the use of a product through vigilance and post-marketing surveillance. In spite of the critical role of the HPVO, there is no qualification registered on the NQF for this much-needed occupation. This is the first time a qualification for this occupation is being developed. Current training is disparate and carried out by companies that register and market health products. There is a need to standardise such disparate training and set the benchmark for the occupation.

There are no similar Qualification(s) and Part-Qualifications registered on the NQF, and no Skills Programmes approved by the QCTO

As the number of health products grows significantly in view of scientific advancement (the plethora of health products being a case in point), the Health Products Vigilance Officer part qualification becomes critical to both fulfil the needs of the country for safe health products and standardise current but disparate training offered by companies dealing in health products.

Another significant aspect is that the part qualification will contribute to ensuring that health products are safe to use by monitoring their effects. HPRAs will be qualified to apply SAHPRA's criteria for vigilance and surveillance.

The qualification has the potential of creating employment as it is needed in the industry and there is a potential uptake of the qualification by significant number of learners. Increased employment will translate into increased benefits for the economy.

Typical learners will be those currently practising as Health Products Vigilance Officers who have been operating without training on a formal qualification. Other learners could include matriculants or those with a relevant higher education qualification wishing to enter the health product regulatory sector.

In the development of this qualification, the following stakeholders were consulted

• Training providers
• Regulator
• Employers/employer organisations

Recognition of Prior Learning (RPL)

RPL for Access to Training

Learners may use the RPL process to gain access to training opportunities for a programme of learning, part-qualification if they do not meet the formal, minimum entry requirements for admission. RPL assessment provides an alternative access route into a programme of learning, part-qualification. Such an RPL assessment may be developed, moderated and conducted by the accredited Skills Development Provider which offers that specific part qualification. Such an assessment must ensure that the learner is able to display the equivalent level of competencies required for access, based on the NQF level descriptors.

RPL for Access to the External Integrated Summative Assessment (EISA)

For exemption from modules through RPL, learners who have gained the stipulated competencies of the modules of a programme of learning, part-qualification through any means of formal, informal or non-formal learning and/or work experience, may be awarded credits towards relevant modules, and gaps identified for training, which is then concluded.

Entry Requirements

• An NQF Level 4 qualification, with Mathematics and Science.

This qualification is made up of compulsory Knowledge, Practical Skill and Work Experience Modules

Knowledge Modules

• 242213-001-00-KM-01, Overview of Current Health Products Industry/Sector, NQF Level 5, 5 Credits.
• 242213-001-00-KM-02, Anatomy and Physiology, NQF Level 5, 10 Credits.
• 242213-001-00-KM-03, Health Products, NQF Level 5, 8 Credits.
• 242213-001-00-KM-04, Science for the Health Product Regulatory Assistant (HPRA), NQF Level 5, 3 Credits.
• 243302-001-00-KM-07, Vigilance and Post Marketing Surveillance, NQF Level 5, 6 Credits.

Total number of credits for Knowledge Modules: 32

Practical Skill Modules

• 242213-001-00-PM-03, Conduct Oneself Professionally and Ethically, NQF Level 4, 3 Credits.
• 242213-001-00-PM-04, Perform Vigilance and Post Marketing Surveillance, NQF Level 5, 5 Credits.

Total number of credits for Practical Skill Modules: 8

Work Experience Modules

• 242213-001-00-WM-05, Processes to Perform Vigilance and Post Marketing Surveillance, NQF Level 5, 6 Credits.

Total number of credits for Work Experience Modules: 6

1. Conduct / perform vigilance and post marketing surveillance to ensure the safe usage of health products.

Associated Assessment Criteria for Exit Level Outcome 1

ELO 1: Conduct / perform vigilance and post marketing surveillance to ensure the safe usage of health products.

• Explain concepts, definitions and terminology associated with vigilance.
• Complete adverse reaction/event reporting forms in an assistive capacity and submit to the regulatory body through its appropriate submission procedure/mechanism.
• Implement a health product recall assignment in an assistive capacity according to standard operating procedures.
• Prepare a report on vigilance in an assistive capacity as per standard operating procedures.
• Prepare recall letters and media releases in an assistive capacity and sent to the industry, standard operating procedures.

Integrated Assessment

Integrated Formative Assessment

Formative assessments are conducted throughout the training of learners. A range of formal, nonformal, and informal ongoing assessment activities is used to focus on teaching and learning outcomes to improve learner attainment.

Formative assessments are conducted continuously by the facilitator to feed into further learning, to identify strengths and weakness, and to ensure the learner's ability to apply knowledge, skills and workplace experience gained.

Formative Assessments are conducted by the accredited Skills Development Provider (SDP), and a variety of ongoing assessment methods may be used, for example, quizzes, assignments, tests, scenarios, role play, interviews. Continuous feedback must be provided.

Integrated Summative Assessment

Integrated Assessment involves all the different types of assessment tasks required for a particular part- qualification, such as written assessment of theory and practical demonstration of competence. To achieve this, the Internal Assessment Criteria (IAC) for all modules as found in the QCTO curriculum document must be followed.

An accredited SDP should implement a well-designed, formal, relevant, final internal Summative Assessment strategy for all modules to prepare learners for the EISA. These assessments evaluate learning achievements relating to the achievement of each module of the relevant components of the part-qualification.

Internal Summative Assessments are developed, moderated, and conducted by the SDP at the end of each module or after integration of relevant modules, e.g., applied knowledge tests, workplace tasks, practical demonstrations, simulated tasks/demonstrations, projects, case studies, etc