What Regulatory Affairs leaders need to consider in relation to medicine shortages….
If you work with OTC or Prescription Medicines, I’m sure you are aware of the TGA mandatory reporting scheme for medicine shortages in effect from January 2019 https://apps.tga.gov.au/prod/MSI/search.
Whilst the TGA did have some powers to publish notifications of shortages under the voluntary reporting scheme initiated in 2014, the scheme overall was considered to be of limited value to the healthcare community as the information it housed was limited and often not timely.
It is voluntary no more for all prescription medicines and for some OTCs. If in doubt about the legislative basis for this new reporting scheme, it might be wise to take a close look at the two key legal documents and consult your Legal team.
1. The updated Therapeutic Goods Act (2018 Measures No.1) – Section 30 EH, to be precise – which, amongst other things, defines a shortage and specifies the mandatory reporting times for the critical and medium/low impact shortages.
2. The legal instrument Therapeutic Goods (Reportable Medicines) Determination 2018, which specifies the 11 OTC ingredients which qualify under this mandatory scheme.
What does this mean for you, a Regulatory Affairs leader with accountability for reporting medicine shortages? Be prepared. Review your organisation’s readiness and ensure processes enable cross-functional engagement and escalation measures where appropriate.
Above all, no matter how challenging it may be to keep up with supply chain oscillations, be encouraged by the importance of this medicine shortage reporting scheme to patients.
A few more tips for you…
Five questions to consider in developing an efficient approach to reporting medicine shortages
- Am I considering this from the healthcare professional or patient perspective?
- Am I championing the scheme’s importance throughout my organisation?
- Which products are likely to need closer management and the formation of cross-functional rapid response teams?
- Are my team members adequately trained on the new scheme?
- What opportunity is there to optimise my team’s operational efficiency in managing and reporting shortages?
Contact Mary for a complimentary Optimising Team Effectiveness check.