Pharmaciae (SAPC) | The sale of HIV screening test kits

The sale of HIV screening test kits – minimum standard approved

Minister of Health Dr Aaron Motsoaledi is punting the message that prevention is key to reach the vision of zero new HIV infections, zero discrimination, zero AIDS-related deaths and zero new vertical transmissions. In his impassioned plea to the public he states It is in our hands to end the scourge of HIV and TB epidemics. The release of HIV screening test kits into the market is hoped to increase the number of people who test, know their status and receive treatment. Council has approved the minimum standard for the sale of HIV screening test kits.

In April 2010, South Africa launched an HIV Counselling and Testing (HCT) campaign that, among other objectives, sought to increase the number of people who test, know their HIV status and receive treatment. This is in line with the goals laid out in the country’s National Strategic Plan (NSP) for HIV, sexually transmitted infections and tuberculosis, which aims to significantly reduce the number of new infections and expand access to appropriate treatment, care and support to people diagnosed with HIV.

The minimum standard for selling HIV screening test kits aims to provide guidance on how the pertinent issues and concerns relating to HIV home testing should be addressed. These issues and concerns are the reliability of the testing instrument, consent and counselling-related concerns.

General considerations

Pharmacist may only sell HIV screening test kits that have been approved by the World Health Organisation (WHO) or such suitable authority.

Pre-test counselling

Buying an HIV home test kit is deemed as giving consent to be tested. Individuals using the tests, however, may not have considered their options and the consequences of the result. Since the person will be performing the test themselves, access to counselling shall be available to:

prepare the person for the result of the test
inform the person that the self-test should not be taken as a conclusive diagnosis
inform the person that the diagnosis of HIV infection is dependent on a confirmatory test.

Knowledge

Pharmacists must ensure they are knowledgeable on all aspects of the HIV screening test kits and have the ability to demonstrate how to use the test kit as and when it is required. They must be able to provide the person with information on:

how to conduct the test
how to correctly interpret the test results
where to access follow-up support services in their surrounding area.

Interested parties are invited to submit, within 90 days of publication of this notice, substantiated comments on or representation regarding the amendments to the existing minimum standards and/or the additional minimum standards. Comments must be addressed to the Registrar, the South African Pharmacy Council, Private Bag 40040, Arcadia, or fax (012)326-1496 or email BN@sapc.za.org.