1. Major progress on access to medicines and consumer awareness of pharmacist-only meds
24 January 2018
The Australian Self Medication Industry has announced its support for the TGA’s commitment to change restrictions on the advertising of pharmacist-only (Schedule 3 or S3) medicines, and the establishment of a working group that will proactively identify prescription medicines suitable for downscheduling to pharmacist-only and over-the-counter (OTC) access (‘switch’).
ASMI has long advocated a relaxation of advertising restrictions for S3 medicines – “the medicines consumers are not allowed to know about” – and a ‘switch agenda’ that will help enable greater consumer access to medicines by identifying candidate substances for, and facilitating the process of, prescription-only to OTC ‘switch’.
The TGA’s updated AHMAC Scheduling Policy Framework for Medicines and Chemicals states that the default position for advertising S3 (pharmacist-only) medicines will shift so that S3 medicines will be allowed to be advertised unless the Scheduling Delegate determines that there are clear and specific reasons they should not be.
There is no specific transition date set for this change yet, as important details still need to be determined, such as clearly defining the criteria that will be applied for deciding when advertising of a S3 medicine is not appropriate.
A newly-created working group will advise the TGA on these matters and several other topics related to medicine scheduling, including proactively identifying candidates for ‘switch’ and new controls for pharmacist-only medicines, particularly those that have been downscheduled.
“ASMI has already done preliminary work in this area and we anticipate being able to add value to discussions on these factors,” said Regulatory and Legal Director Steve Scarff.
ASMI also anticipates that the downscheduling process will be streamlined to encourage more manufacturers to apply for S4 (prescription-only) medicines to be switched to OTC.
This working group will also include representatives from pharmacy, medicine and state and Federal governments.
“This is very welcome and reflects ASMI’s long-standing position,” Mr Scarff said.
“The ASMI Secretariat will be involved with this group at the initial meeting in February 2018.”
2. Filomena Maiese departs ASMI
30 January 2018
After nearly seven years with the Australian Self Medication Industry (ASMI), Director of Marketing & Business Development Filomena Maiese is departing to take up an exciting new challenge.
Ms Maiese will move to iNova Pharmaceuticals, where she will be Executive Director of Portfolio Strategy and Innovation across all regions. Her last day with ASMI will be 1 February.
“I feel privileged to have worked with an amazing group of experts at ASMI, all of whom are committed to advancing the non-prescription medicines industry,” Ms Maiese said. “They are the unsung heroes behind a lot of positive industry reforms that are currently underway.
“I am sad to leave ASMI, but I am equally excited about my new role.”
Ms Maiese has been instrumental in the successful advancement of key strategic industry initiatives, such as prescription to over-the-counter ‘switch’ and S3 consumer advertising.
Under Ms Maiese’s guidance, ASMI has developed key industry partnerships and driven crucial research initiatives that have been vital to advancing the non-prescriptions medicines sector and providing essential evidence to support key industry asks to regulatory bodies and stakeholders.
Prior to joining ASMI, Ms Maiese headed up Johnson & Johnson Pacific’s ANZ OTC business unit.
Ms Maiese will now focus on driving expansion plans for iNova, developing new product and innovation pipelines across all markets.
Brenda Davy will move from a part-time to full-time role at ASMI, taking on the position of Director of Business Development immediately upon Ms Maiese’s departure.
Ms Davy will continue to lead strategic projects and provide support to the Stakeholder Management Subcommittee in addition to taking up many of Ms Maiese’s ongoing responsibilities, including management of member and industry engagement, ASMI events and services, and the Marketing & Ethics Subcommittee.
“In her almost seven years with ASMI, Filomena made enormous contributions to the association, and I would like thank her on behalf the membership and the ASMI team,” ASMI CEO Deon Schoombie said.
“It was a pleasure working with Filomena, she was a source of energy and enthusiasm. We wish her all the best in the new role.”
3. Pregnant women reminded to check medicines with pharmacist or doctor
3 February, 2018 –
The Australian Self Medication Industry (ASMI) today reminded consumers that over-the-counter ibuprofen medicines, like all other medicines, should only be used during pregnancy under the advice of a healthcare professional.
This follows reports of a study published in the journal Human Reproduction, which examined the relationship between use of ibuprofen in the first trimester of pregnancy interferes with the fertility of female children.
ASMI Regulatory and Legal Director, Steve Scarff, says: “OTC ibuprofen has a well-established safety profile and a long history of safe use in Australia and around the world for acute pain and fever.”
The Therapeutic Goods Administration (TGA) has completed a rigorous review of OTC NSAIDs (a category of medicines including ibuprofen), concluding that: “These drugs provide effective pain relief when used according to the label at recommended doses for short durations,” and that; “The use of OTC NSAIDs is safe when they were used according to the recommended doses for short durations, as instructed on the label.”
Products labels for over-the-counter ibuprofen products have the instruction:
“Do not use if you are pregnant or likely to become pregnant.”
ASMI advises that women who are pregnant or trying to become pregnant should not take ibuprofen except on the advice of a doctor. Additionally, ASMI reminds pregnant women seeking pain relief to use it at the lowest possible dose for the shortest possible time.
ASMI welcomes new research on over-the-counter medicines, however the research team for this study highlight that further studies would be required to determine the possible effect ibuprofen could have on human health during pregnancy.
“While ibuprofen has been used in Australia for many years and does have a well-established safety profile, all medicines have risks,” Mr Scarff said. “These risks need to be carefully weighed against the risks of not treating pain or fever during pregnancy. Consumers are therefore reminded to follow the label instructions and to talk to their healthcare professional about their pain relief options during pregnancy before they use any medicine.”
- Ibuprofen is deleterious for the development of first trimester human fetal ovary ex vivo, Human Reproduction, 31 January 2018
- https://www.tga.gov.au/sites/default/files/medicines-review-nsaid.pdf(at page 65)