RFMO-03 - Rapid fire session from selected oral abstracts

M1-M2

Medication Shelf Life Extension Proposal For The Public Health Institutions In South Africa

  • By: NCAYIYANA, Philisiwe Precious (Akademi Turizm Ve Organizasyon Tic. A.Ş., South Africa)
  • Co-author(s): Ms Philisiwe Precious Ncayiyana (South African Military Health Services, Pretoria, South Africa)
  • Abstract:

    Hypothesis: To have a program to test state drugs for stability in order to extend expiration date by at least12 months, through a government or South African Health Products Regulatory Authority (SAHPRA) initiative.

    Background information:
    Tons of drugs are destroyed each year by States facilities in South Africa, costing the taxpayer millions of dollars. The ethical dilemma is the fact that some drugs when being taken off the shelf are still within their specifications and stability requirements.

    Product expiration date extension happens sometimes in SA but often initiated by a manufacturer. A Shelf Life Extension Program (SLEP) was established in the United States (US) in 1986 (FDA, 2023). This was after the US government realised that in order for the state to successfully stockpile drugs to ensure adequate supplies during a public health emergency for both the Military and its citizens a longer shelf life was required. That’s how SLEP was introduced to help reduce costs associated with replacing expired drugs.

    The FDA through Emergency Use Authorisation has authorised Tamiflu capsules (not the generics) in strategic stockpiles to be used for a maximum of 20 years, provided recommended storage conditions are maintained (FDA, 2023). This means there is adequate room to explore extension for thousands of drugs even in SA.

    Purposea. To minimise costs associated with the disposal of expired drugs
    b. To help extend shelf life of usable drugs

    Method: Literature review and Observational Study through my years of handling drugs, from ordering, dispensing and disposal of drugs. Data was extrapolated from my pharmacy's disposal schedule.

    Results:
    Literature review supports the shelf life extension for about 80% of drugs tested with an average extension period of 66 months from the SLEP. The consensus is on tablets and capsules which are regarded as more stable than liquids. Despite this in SA a lot of drugs still get disposed off due to uncertainty and fear of litigation.

    Conclusion:

    A specialised program to extend the shelf life of tablets, dry powders and powders for injection is recommended. This will help Military deployments and SA government in making sure that there are enough supplies of medication in times for humanitarian crisis. This will also help reduce wastage and unnecessary expenditure due to destroying drugs that may still be safe for human consumption.