MEDICINES WITH SUPPLY PROBLEMS

The Department of Health is committed to ensuring that all essential medicines are available, at the appropriate level of care, to all patients in need. From time to time there are interruptions in the availability of medicines at the facility level. The medicine supply chain is long and complex, with interruptions at any point in the supply chain affecting medicine availability at the facility. These interruptions may relate to, inter alia, the shortage of the active ingredients, regulatory issues affecting formulation, logistical challenges, inadequate volumes produced relative to the ordered quantity and inadequate quantities being ordered. A number of interventions have been implemented to address potential risks in the supply chain. However, these interventions may not always avert a shortage or stock out. The list below identifies those medicines where the interventions implemented may not have been able to avert a shortage and reflects those medicines which manufacturers have been unable to supply. The list is updated on a monthly basis by the Affordable Medicines Directorate Improved Medicine Availability Team (IMAT). If you are aware of items that are in short supply but which are not on the list, please notify the Department using the following e-mail address: stockalert@health.gov.za.

Acronyms and explanations

API – Active Pharmaceutical Ingredient

• The manufacturer of the API has closed down.
• The API manufacturer is experiencing a global shortage of raw materials (intermediates and/or key starting materials).
• The API quality is lower than the acceptable standard (batch/batches of API failed the quality control tests).

Discontinuation – The medicine will no longer be manufactured

• The manufacturer has ceased production of the medicine.

Forecast – The prediction/estimation of the volumes

• Unexpected high usage/uptake of the medicine by the demander.
• Low usage/uptake of the medicine by the demander resulting in short-dated stock and stock expiry.

Supplier capacity

• The contracted supplier does not have the capacity to meet the demand.

GMP – Good Manufacturing Practices

• The manufacturing plant is deemed non-compliant or no longer meets the GMP standards as required by SAHPRA (South African Health Regulatory Authority).

Regulatory – Concerns the control around the production, distribution, and use of the medicine

• The submission of amendments to the dossier that requires approval from SAHPRA, including a change/addition of an API source and/or manufacturing site.
• The importation of a registered medicine in terms of Section 36 of the Medicines and Related Substances Act.
• The application of a Section 21 authorisation, in terms of the Medicines and Related Substances Act, for the acquisition of unregistered medicines for human use in South Africa that is of vital importance for public health.
• Manufactured products requiring additional quality checks by SAHPRA.
• The transfer of ownership of dossiers which results in a change of marketing authorisation.
• Delays in the issuing of the permits for imported medicines.
• Country-specific legislation changes that can impact on the supply of the medicines, e.g. legislation to reduce pollution in countries of manufacture negatively impacting production and supply.

Short term supply constraint

• The release of the medicine from the local/international supplier has been delayed due to operational challenges e.g. machine breakdown, labour unrest, theft, post importation testing, etc.
• Sourcing of products from alternative local suppliers with registered products using quotations.