Ann Winkle MPS
Ann Winkle MPS is a Professional Practice Pharmacist and writer.
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[post_content] => Several women’s health medicines will be on the Pharmaceutical Benefits Scheme (PBS) after new PBAC recommendations.
The listings are in addition to the government’s $573 million women’s health funding announcement last month.
Australian Pharmacist takes a look at these new additions and the impact cheaper medicines will have on women across the nation.
Funding for first ever progesterone-only contraceptive pill
From 1 May, Slinda (drospirenone) – a first-of-its-kind progesterone-only oral contraceptive pill OCP – will be available under the PBS.
Around 80,000 women are paying privately for Slinda, which costs around $80 for 3 months’ supply.
Under the PBS, the medicine will only set women back $31.60 ($7.70 for concession card holders) for 4 months’ supply.
The move will widen birth control options for Australian women, particularly those who can have difficulty with oestrogen-based OCPs
Dr Terri Foran, Sexual Health Physician said Slinda is particularly suitable for women who:
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[post_content] => PSA Lifetime Fellow Dr John McEwen’s evolution from pharmacy apprentice to international authority on pharmacovigilance reflects a career devoted to improving medicine safety.
Why did you decide to pursue pharmacy?
I finished secondary school aged 15 with little idea of a future career. I followed my father into pharmacy but was sensibly apprenticed to another pharmacist.
Tell us about your early career starting with your apprenticeship at the Victorian College of Pharmacy
I spent nearly half of each week at the College of Pharmacy and the remainder in the pharmacy, both in central Melbourne. At the time, that pharmacy sold cigarettes, Agarol (then containing oxyphenisatin) and was dispensing thalidomide. My almost daily task was to make one-gallon quantities of double- strength aspirin, phenacetin and caffeine mixture using a large mortar and pestle.
The College had excellent lecturers who motivated me to further study, leading to a Master of Science in neurophysiology, a period as a lecturer
in physiology and ultimately completing the MBBS.
How did your dual background in pharmacy and medicine shape your work in adverse drug reactions?
I was a resident at Royal Melbourne Hospital when the Department of Health advertised for the Medical Officer, Adverse Drug Reactions. My application was accepted!
I became Secretary to the Adverse Drug Reactions Advisory Committee (ADRAC) where I was encouraged to find and publish medicine/reaction associations of likely clinical importance.1
Then, in 1979, I attended the WHO Programme for International Drug Monitoring. That led to global pharmacovigilance roles including as Chairperson, Advisory Group to the Uppsala Monitoring Centre (UMC) (1985 –1987) and a member of the Executive Committee of the International Society of Pharmacovigilance (ISOP) 2006–2009.
What drove you to maintain your work with the TGA?
I enjoy exploring data relating to medicine efficacy and safety. In early retirement, I was contracted to write A History of Therapeutic Goods Regulation in Australia, published in 2007. It was a fascinating task, with many hours spent at the National Archives. That led to continuing part-time work for TGA, generally undertaking high-level reviews.
How did your senior roles at the TGA enable you to influence Australian medicine safety regulations?
In mid-1989, I developed the basic criteria for ‘less hazardous’ goods being entered in the ARTG, something not initially intended by the Commonwealth. As a consequence, the 1989 Therapeutic Goods legislation included provision for Listed Medicines, giving these Australian products a unique status in the domestic and export markets.
I contributed to the adoption in Australia of initial guidance for product sponsors concerning adverse reactions, including the Australian Pharmacovigilance Guideline (2002), provision for requiring Periodic Safety Update Reports (PSURs) and the Conjoint ADRAC-Medicines Australia guidelines for company-sponsored post-marketing surveillance (PMS) studies.).
What stands out as one of your proudest achievements or most meaningful contributions?
I arranged for the UMC Pharmacovigilance Training Course to be presented at TGA in 2002 and 2004. These were the first occasions the 2-week intensive course had been held outside Uppsala in Sweden. Many TGA colleagues generously contributed, giving Australia a very high status in global pharmacovigilance.
What advice would you give to pharmacists just starting their careers, especially those interested in pharmacovigilance or policy development?
Maintain the curiosity and analytical skills developed during undergraduate study as pharmacy offers many and varied opportunities, including in pharmacovigilance and policy development. Keep up to date throughout your career, as it will span many important developments and changes.
Reference
- Mackay K. Showing the blue card: reporting adverse reactions. Australian Prescriber 2005;28(6):140–2.
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[post_content] => The Therapeutic Goods Administration (TGA) issued an alert over the use of broad-spectrum antibiotics commonly used to treat infections such as urinary tract, respiratory and gastrointestinal infections.
What class of antibiotics prompted the alert?
Antimicrobials from the broad-spectrum fluoroquinolone class of antibiotics, including ciprofloxacin, norfloxacin and moxifloxacin. This includes all oral and injectable forms of fluoroquinolones.
What are the documented adverse effects?
Central nervous system (CNS) and psychiatric events. Although rare, the complications are serious – and are potentially disabling and irreversible.
Adverse events include:
For example, the boxed warning for ciprofloxacin will now state:
Serious disabling and potentially irreversible adverse reactions
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system (see section 4.4 Effects on the CNS), musculoskeletal system (see section 4.4 Tendonitis and tendon rupture) and psychiatric effects (see section 4.4 Psychiatric reactions).
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[post_content] => The Therapeutic Goods Administration (TGA) issued a caution over the use of sodium valproate in men who are planning a family.
Up to 1 in 10 babies (10%) exposed to sodium valproate during pregnancy may be born with birth defects.
One mother in the United Kingdom had two children born with fetal valproate spectrum disorder (FVSD) after using sodium valproate since the age of 16 following an epilepsy diagnosis.
Now, the anticonvulsant—used to manage seizures, mood disorders in bipolar patients, and as migraine prophylaxis—has been linked to an increased risk of neurodevelopmental disorders in children whose fathers used the medicine three months before conception.
These findings are based on a retrospective European observational study comparing the effects of the use of sodium valproate with those of lamotrigine or levetiracetam.
The neurodevelopmental disorders identified include autism spectrum disorder, intellectual disability, communication disorders and ADHD and movement disorders.
However, as of yet there have been no adverse events in relation to paternal exposure reported to the TGA.
What’s changing?
Women are already advised against using sodium valproate in pregnancy, which can cause FVSD. Now men are urged to consider alternative treatment options if planning to father a child or before discontinuing contraception.
New boxed warnings will also be introduced for Epilim. The Product Information (PI) and Consumer Medicine Information (CMI) will feature added warnings about paternal exposure.
Sponsors of generic sodium valproate products must update their safety information to match that of Epilim.
What should pharmacists do?
When dispensing sodium valproate to men, pharmacists should inform them about the risks of using this medicine if planning a family. The use of contraception should be encouraged in both the male patient and their female partner.
Pharmacists should also advise men to contact their GP if their partner is pregnant and they have taken sodium valproate within the 3 months before conception.
Male patients who are taking sodium valproate should not donate sperm for more than 3 months after ceasing treatment.
Pharmacists should recommend that men who have been taking sodium valproate long term have an annual review with the specialist to assess whether it remains the most appropriate treatment – particularly if they are planning on parenthood.
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[post_content] => The theme for 2025 Thank Your Pharmacist Day is ‘Pharmacists stepping up’, acknowledging the increasing role of pharmacists in supporting patient care and strengthening Australia’s healthcare system.
Thank Your Pharmacist Day will take place tomorrow (13 March 2025), with PSA calling on Australians to show their appreciation for pharmacists and the care they provide.
PSA National President Associate Professor Fei Sim FPS said the theme reflects the dedication of pharmacists as they take on expanded roles and responsibilities in response to community needs.
‘Every day, pharmacists across Australia are stepping up to meet growing healthcare demands across a diverse range of practice areas. Thank Your Pharmacist Day is an opportunity to recognise their contributions and the vital role they play in ensuring the health and wellbeing of Australians,’ A/Prof Sim said.
‘As the peak body representing all pharmacists across all areas of practice, PSA is committed to supporting pharmacists as they take on new opportunities through education, training, and advocacy. As our profession continues to evolve, pharmacists remain at the forefront of accessible healthcare.’
PSA is also inviting elected officials around the country to connect with local pharmacists in the lead-up to Thank Your Pharmacist Day, to witness first-hand how pharmacists are stepping up to meet patient needs in their communities.
‘With the federal election approaching, this is an important moment for decision-makers to see the critical role pharmacists play and to understand how supporting pharmacists means better healthcare access and medicine safety for all Australians,’ A/Prof Sim said.
Pharmacists, healthcare professionals, and the public are encouraged to take part by sharing their stories and messages of thanks using #ThankYourPharmacist.
To find out more about Thank your Pharmacist Day, including media and advocacy kits, visit psa.org.au/thankyourpharmacist/
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[post_content] => Several women’s health medicines will be on the Pharmaceutical Benefits Scheme (PBS) after new PBAC recommendations.
The listings are in addition to the government’s $573 million women’s health funding announcement last month.
Australian Pharmacist takes a look at these new additions and the impact cheaper medicines will have on women across the nation.
Funding for first ever progesterone-only contraceptive pill
From 1 May, Slinda (drospirenone) – a first-of-its-kind progesterone-only oral contraceptive pill OCP – will be available under the PBS.
Around 80,000 women are paying privately for Slinda, which costs around $80 for 3 months’ supply.
Under the PBS, the medicine will only set women back $31.60 ($7.70 for concession card holders) for 4 months’ supply.
The move will widen birth control options for Australian women, particularly those who can have difficulty with oestrogen-based OCPs
Dr Terri Foran, Sexual Health Physician said Slinda is particularly suitable for women who:
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[post_content] => PSA Lifetime Fellow Dr John McEwen’s evolution from pharmacy apprentice to international authority on pharmacovigilance reflects a career devoted to improving medicine safety.
Why did you decide to pursue pharmacy?
I finished secondary school aged 15 with little idea of a future career. I followed my father into pharmacy but was sensibly apprenticed to another pharmacist.
Tell us about your early career starting with your apprenticeship at the Victorian College of Pharmacy
I spent nearly half of each week at the College of Pharmacy and the remainder in the pharmacy, both in central Melbourne. At the time, that pharmacy sold cigarettes, Agarol (then containing oxyphenisatin) and was dispensing thalidomide. My almost daily task was to make one-gallon quantities of double- strength aspirin, phenacetin and caffeine mixture using a large mortar and pestle.
The College had excellent lecturers who motivated me to further study, leading to a Master of Science in neurophysiology, a period as a lecturer
in physiology and ultimately completing the MBBS.
How did your dual background in pharmacy and medicine shape your work in adverse drug reactions?
I was a resident at Royal Melbourne Hospital when the Department of Health advertised for the Medical Officer, Adverse Drug Reactions. My application was accepted!
I became Secretary to the Adverse Drug Reactions Advisory Committee (ADRAC) where I was encouraged to find and publish medicine/reaction associations of likely clinical importance.1
Then, in 1979, I attended the WHO Programme for International Drug Monitoring. That led to global pharmacovigilance roles including as Chairperson, Advisory Group to the Uppsala Monitoring Centre (UMC) (1985 –1987) and a member of the Executive Committee of the International Society of Pharmacovigilance (ISOP) 2006–2009.
What drove you to maintain your work with the TGA?
I enjoy exploring data relating to medicine efficacy and safety. In early retirement, I was contracted to write A History of Therapeutic Goods Regulation in Australia, published in 2007. It was a fascinating task, with many hours spent at the National Archives. That led to continuing part-time work for TGA, generally undertaking high-level reviews.
How did your senior roles at the TGA enable you to influence Australian medicine safety regulations?
In mid-1989, I developed the basic criteria for ‘less hazardous’ goods being entered in the ARTG, something not initially intended by the Commonwealth. As a consequence, the 1989 Therapeutic Goods legislation included provision for Listed Medicines, giving these Australian products a unique status in the domestic and export markets.
I contributed to the adoption in Australia of initial guidance for product sponsors concerning adverse reactions, including the Australian Pharmacovigilance Guideline (2002), provision for requiring Periodic Safety Update Reports (PSURs) and the Conjoint ADRAC-Medicines Australia guidelines for company-sponsored post-marketing surveillance (PMS) studies.).
What stands out as one of your proudest achievements or most meaningful contributions?
I arranged for the UMC Pharmacovigilance Training Course to be presented at TGA in 2002 and 2004. These were the first occasions the 2-week intensive course had been held outside Uppsala in Sweden. Many TGA colleagues generously contributed, giving Australia a very high status in global pharmacovigilance.
What advice would you give to pharmacists just starting their careers, especially those interested in pharmacovigilance or policy development?
Maintain the curiosity and analytical skills developed during undergraduate study as pharmacy offers many and varied opportunities, including in pharmacovigilance and policy development. Keep up to date throughout your career, as it will span many important developments and changes.
Reference
- Mackay K. Showing the blue card: reporting adverse reactions. Australian Prescriber 2005;28(6):140–2.
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[post_content] => The Therapeutic Goods Administration (TGA) issued an alert over the use of broad-spectrum antibiotics commonly used to treat infections such as urinary tract, respiratory and gastrointestinal infections.
What class of antibiotics prompted the alert?
Antimicrobials from the broad-spectrum fluoroquinolone class of antibiotics, including ciprofloxacin, norfloxacin and moxifloxacin. This includes all oral and injectable forms of fluoroquinolones.
What are the documented adverse effects?
Central nervous system (CNS) and psychiatric events. Although rare, the complications are serious – and are potentially disabling and irreversible.
Adverse events include:
For example, the boxed warning for ciprofloxacin will now state:
Serious disabling and potentially irreversible adverse reactions
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system (see section 4.4 Effects on the CNS), musculoskeletal system (see section 4.4 Tendonitis and tendon rupture) and psychiatric effects (see section 4.4 Psychiatric reactions).
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[post_content] => The Therapeutic Goods Administration (TGA) issued a caution over the use of sodium valproate in men who are planning a family.
Up to 1 in 10 babies (10%) exposed to sodium valproate during pregnancy may be born with birth defects.
One mother in the United Kingdom had two children born with fetal valproate spectrum disorder (FVSD) after using sodium valproate since the age of 16 following an epilepsy diagnosis.
Now, the anticonvulsant—used to manage seizures, mood disorders in bipolar patients, and as migraine prophylaxis—has been linked to an increased risk of neurodevelopmental disorders in children whose fathers used the medicine three months before conception.
These findings are based on a retrospective European observational study comparing the effects of the use of sodium valproate with those of lamotrigine or levetiracetam.
The neurodevelopmental disorders identified include autism spectrum disorder, intellectual disability, communication disorders and ADHD and movement disorders.
However, as of yet there have been no adverse events in relation to paternal exposure reported to the TGA.
What’s changing?
Women are already advised against using sodium valproate in pregnancy, which can cause FVSD. Now men are urged to consider alternative treatment options if planning to father a child or before discontinuing contraception.
New boxed warnings will also be introduced for Epilim. The Product Information (PI) and Consumer Medicine Information (CMI) will feature added warnings about paternal exposure.
Sponsors of generic sodium valproate products must update their safety information to match that of Epilim.
What should pharmacists do?
When dispensing sodium valproate to men, pharmacists should inform them about the risks of using this medicine if planning a family. The use of contraception should be encouraged in both the male patient and their female partner.
Pharmacists should also advise men to contact their GP if their partner is pregnant and they have taken sodium valproate within the 3 months before conception.
Male patients who are taking sodium valproate should not donate sperm for more than 3 months after ceasing treatment.
Pharmacists should recommend that men who have been taking sodium valproate long term have an annual review with the specialist to assess whether it remains the most appropriate treatment – particularly if they are planning on parenthood.
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[post_content] => The theme for 2025 Thank Your Pharmacist Day is ‘Pharmacists stepping up’, acknowledging the increasing role of pharmacists in supporting patient care and strengthening Australia’s healthcare system.
Thank Your Pharmacist Day will take place tomorrow (13 March 2025), with PSA calling on Australians to show their appreciation for pharmacists and the care they provide.
PSA National President Associate Professor Fei Sim FPS said the theme reflects the dedication of pharmacists as they take on expanded roles and responsibilities in response to community needs.
‘Every day, pharmacists across Australia are stepping up to meet growing healthcare demands across a diverse range of practice areas. Thank Your Pharmacist Day is an opportunity to recognise their contributions and the vital role they play in ensuring the health and wellbeing of Australians,’ A/Prof Sim said.
‘As the peak body representing all pharmacists across all areas of practice, PSA is committed to supporting pharmacists as they take on new opportunities through education, training, and advocacy. As our profession continues to evolve, pharmacists remain at the forefront of accessible healthcare.’
PSA is also inviting elected officials around the country to connect with local pharmacists in the lead-up to Thank Your Pharmacist Day, to witness first-hand how pharmacists are stepping up to meet patient needs in their communities.
‘With the federal election approaching, this is an important moment for decision-makers to see the critical role pharmacists play and to understand how supporting pharmacists means better healthcare access and medicine safety for all Australians,’ A/Prof Sim said.
Pharmacists, healthcare professionals, and the public are encouraged to take part by sharing their stories and messages of thanks using #ThankYourPharmacist.
To find out more about Thank your Pharmacist Day, including media and advocacy kits, visit psa.org.au/thankyourpharmacist/
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[post_content] => Several women’s health medicines will be on the Pharmaceutical Benefits Scheme (PBS) after new PBAC recommendations.
The listings are in addition to the government’s $573 million women’s health funding announcement last month.
Australian Pharmacist takes a look at these new additions and the impact cheaper medicines will have on women across the nation.
Funding for first ever progesterone-only contraceptive pill
From 1 May, Slinda (drospirenone) – a first-of-its-kind progesterone-only oral contraceptive pill OCP – will be available under the PBS.
Around 80,000 women are paying privately for Slinda, which costs around $80 for 3 months’ supply.
Under the PBS, the medicine will only set women back $31.60 ($7.70 for concession card holders) for 4 months’ supply.
The move will widen birth control options for Australian women, particularly those who can have difficulty with oestrogen-based OCPs
Dr Terri Foran, Sexual Health Physician said Slinda is particularly suitable for women who:
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[post_content] => PSA Lifetime Fellow Dr John McEwen’s evolution from pharmacy apprentice to international authority on pharmacovigilance reflects a career devoted to improving medicine safety.
Why did you decide to pursue pharmacy?
I finished secondary school aged 15 with little idea of a future career. I followed my father into pharmacy but was sensibly apprenticed to another pharmacist.
Tell us about your early career starting with your apprenticeship at the Victorian College of Pharmacy
I spent nearly half of each week at the College of Pharmacy and the remainder in the pharmacy, both in central Melbourne. At the time, that pharmacy sold cigarettes, Agarol (then containing oxyphenisatin) and was dispensing thalidomide. My almost daily task was to make one-gallon quantities of double- strength aspirin, phenacetin and caffeine mixture using a large mortar and pestle.
The College had excellent lecturers who motivated me to further study, leading to a Master of Science in neurophysiology, a period as a lecturer
in physiology and ultimately completing the MBBS.
How did your dual background in pharmacy and medicine shape your work in adverse drug reactions?
I was a resident at Royal Melbourne Hospital when the Department of Health advertised for the Medical Officer, Adverse Drug Reactions. My application was accepted!
I became Secretary to the Adverse Drug Reactions Advisory Committee (ADRAC) where I was encouraged to find and publish medicine/reaction associations of likely clinical importance.1
Then, in 1979, I attended the WHO Programme for International Drug Monitoring. That led to global pharmacovigilance roles including as Chairperson, Advisory Group to the Uppsala Monitoring Centre (UMC) (1985 –1987) and a member of the Executive Committee of the International Society of Pharmacovigilance (ISOP) 2006–2009.
What drove you to maintain your work with the TGA?
I enjoy exploring data relating to medicine efficacy and safety. In early retirement, I was contracted to write A History of Therapeutic Goods Regulation in Australia, published in 2007. It was a fascinating task, with many hours spent at the National Archives. That led to continuing part-time work for TGA, generally undertaking high-level reviews.
How did your senior roles at the TGA enable you to influence Australian medicine safety regulations?
In mid-1989, I developed the basic criteria for ‘less hazardous’ goods being entered in the ARTG, something not initially intended by the Commonwealth. As a consequence, the 1989 Therapeutic Goods legislation included provision for Listed Medicines, giving these Australian products a unique status in the domestic and export markets.
I contributed to the adoption in Australia of initial guidance for product sponsors concerning adverse reactions, including the Australian Pharmacovigilance Guideline (2002), provision for requiring Periodic Safety Update Reports (PSURs) and the Conjoint ADRAC-Medicines Australia guidelines for company-sponsored post-marketing surveillance (PMS) studies.).
What stands out as one of your proudest achievements or most meaningful contributions?
I arranged for the UMC Pharmacovigilance Training Course to be presented at TGA in 2002 and 2004. These were the first occasions the 2-week intensive course had been held outside Uppsala in Sweden. Many TGA colleagues generously contributed, giving Australia a very high status in global pharmacovigilance.
What advice would you give to pharmacists just starting their careers, especially those interested in pharmacovigilance or policy development?
Maintain the curiosity and analytical skills developed during undergraduate study as pharmacy offers many and varied opportunities, including in pharmacovigilance and policy development. Keep up to date throughout your career, as it will span many important developments and changes.
Reference
- Mackay K. Showing the blue card: reporting adverse reactions. Australian Prescriber 2005;28(6):140–2.
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[post_content] => The Therapeutic Goods Administration (TGA) issued an alert over the use of broad-spectrum antibiotics commonly used to treat infections such as urinary tract, respiratory and gastrointestinal infections.
What class of antibiotics prompted the alert?
Antimicrobials from the broad-spectrum fluoroquinolone class of antibiotics, including ciprofloxacin, norfloxacin and moxifloxacin. This includes all oral and injectable forms of fluoroquinolones.
What are the documented adverse effects?
Central nervous system (CNS) and psychiatric events. Although rare, the complications are serious – and are potentially disabling and irreversible.
Adverse events include:
For example, the boxed warning for ciprofloxacin will now state:
Serious disabling and potentially irreversible adverse reactions
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system (see section 4.4 Effects on the CNS), musculoskeletal system (see section 4.4 Tendonitis and tendon rupture) and psychiatric effects (see section 4.4 Psychiatric reactions).
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[post_content] => The Therapeutic Goods Administration (TGA) issued a caution over the use of sodium valproate in men who are planning a family.
Up to 1 in 10 babies (10%) exposed to sodium valproate during pregnancy may be born with birth defects.
One mother in the United Kingdom had two children born with fetal valproate spectrum disorder (FVSD) after using sodium valproate since the age of 16 following an epilepsy diagnosis.
Now, the anticonvulsant—used to manage seizures, mood disorders in bipolar patients, and as migraine prophylaxis—has been linked to an increased risk of neurodevelopmental disorders in children whose fathers used the medicine three months before conception.
These findings are based on a retrospective European observational study comparing the effects of the use of sodium valproate with those of lamotrigine or levetiracetam.
The neurodevelopmental disorders identified include autism spectrum disorder, intellectual disability, communication disorders and ADHD and movement disorders.
However, as of yet there have been no adverse events in relation to paternal exposure reported to the TGA.
What’s changing?
Women are already advised against using sodium valproate in pregnancy, which can cause FVSD. Now men are urged to consider alternative treatment options if planning to father a child or before discontinuing contraception.
New boxed warnings will also be introduced for Epilim. The Product Information (PI) and Consumer Medicine Information (CMI) will feature added warnings about paternal exposure.
Sponsors of generic sodium valproate products must update their safety information to match that of Epilim.
What should pharmacists do?
When dispensing sodium valproate to men, pharmacists should inform them about the risks of using this medicine if planning a family. The use of contraception should be encouraged in both the male patient and their female partner.
Pharmacists should also advise men to contact their GP if their partner is pregnant and they have taken sodium valproate within the 3 months before conception.
Male patients who are taking sodium valproate should not donate sperm for more than 3 months after ceasing treatment.
Pharmacists should recommend that men who have been taking sodium valproate long term have an annual review with the specialist to assess whether it remains the most appropriate treatment – particularly if they are planning on parenthood.
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[post_content] => The theme for 2025 Thank Your Pharmacist Day is ‘Pharmacists stepping up’, acknowledging the increasing role of pharmacists in supporting patient care and strengthening Australia’s healthcare system.
Thank Your Pharmacist Day will take place tomorrow (13 March 2025), with PSA calling on Australians to show their appreciation for pharmacists and the care they provide.
PSA National President Associate Professor Fei Sim FPS said the theme reflects the dedication of pharmacists as they take on expanded roles and responsibilities in response to community needs.
‘Every day, pharmacists across Australia are stepping up to meet growing healthcare demands across a diverse range of practice areas. Thank Your Pharmacist Day is an opportunity to recognise their contributions and the vital role they play in ensuring the health and wellbeing of Australians,’ A/Prof Sim said.
‘As the peak body representing all pharmacists across all areas of practice, PSA is committed to supporting pharmacists as they take on new opportunities through education, training, and advocacy. As our profession continues to evolve, pharmacists remain at the forefront of accessible healthcare.’
PSA is also inviting elected officials around the country to connect with local pharmacists in the lead-up to Thank Your Pharmacist Day, to witness first-hand how pharmacists are stepping up to meet patient needs in their communities.
‘With the federal election approaching, this is an important moment for decision-makers to see the critical role pharmacists play and to understand how supporting pharmacists means better healthcare access and medicine safety for all Australians,’ A/Prof Sim said.
Pharmacists, healthcare professionals, and the public are encouraged to take part by sharing their stories and messages of thanks using #ThankYourPharmacist.
To find out more about Thank your Pharmacist Day, including media and advocacy kits, visit psa.org.au/thankyourpharmacist/
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[post_content] => Several women’s health medicines will be on the Pharmaceutical Benefits Scheme (PBS) after new PBAC recommendations.
The listings are in addition to the government’s $573 million women’s health funding announcement last month.
Australian Pharmacist takes a look at these new additions and the impact cheaper medicines will have on women across the nation.
Funding for first ever progesterone-only contraceptive pill
From 1 May, Slinda (drospirenone) – a first-of-its-kind progesterone-only oral contraceptive pill OCP – will be available under the PBS.
Around 80,000 women are paying privately for Slinda, which costs around $80 for 3 months’ supply.
Under the PBS, the medicine will only set women back $31.60 ($7.70 for concession card holders) for 4 months’ supply.
The move will widen birth control options for Australian women, particularly those who can have difficulty with oestrogen-based OCPs
Dr Terri Foran, Sexual Health Physician said Slinda is particularly suitable for women who:
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[post_content] => PSA Lifetime Fellow Dr John McEwen’s evolution from pharmacy apprentice to international authority on pharmacovigilance reflects a career devoted to improving medicine safety.
Why did you decide to pursue pharmacy?
I finished secondary school aged 15 with little idea of a future career. I followed my father into pharmacy but was sensibly apprenticed to another pharmacist.
Tell us about your early career starting with your apprenticeship at the Victorian College of Pharmacy
I spent nearly half of each week at the College of Pharmacy and the remainder in the pharmacy, both in central Melbourne. At the time, that pharmacy sold cigarettes, Agarol (then containing oxyphenisatin) and was dispensing thalidomide. My almost daily task was to make one-gallon quantities of double- strength aspirin, phenacetin and caffeine mixture using a large mortar and pestle.
The College had excellent lecturers who motivated me to further study, leading to a Master of Science in neurophysiology, a period as a lecturer
in physiology and ultimately completing the MBBS.
How did your dual background in pharmacy and medicine shape your work in adverse drug reactions?
I was a resident at Royal Melbourne Hospital when the Department of Health advertised for the Medical Officer, Adverse Drug Reactions. My application was accepted!
I became Secretary to the Adverse Drug Reactions Advisory Committee (ADRAC) where I was encouraged to find and publish medicine/reaction associations of likely clinical importance.1
Then, in 1979, I attended the WHO Programme for International Drug Monitoring. That led to global pharmacovigilance roles including as Chairperson, Advisory Group to the Uppsala Monitoring Centre (UMC) (1985 –1987) and a member of the Executive Committee of the International Society of Pharmacovigilance (ISOP) 2006–2009.
What drove you to maintain your work with the TGA?
I enjoy exploring data relating to medicine efficacy and safety. In early retirement, I was contracted to write A History of Therapeutic Goods Regulation in Australia, published in 2007. It was a fascinating task, with many hours spent at the National Archives. That led to continuing part-time work for TGA, generally undertaking high-level reviews.
How did your senior roles at the TGA enable you to influence Australian medicine safety regulations?
In mid-1989, I developed the basic criteria for ‘less hazardous’ goods being entered in the ARTG, something not initially intended by the Commonwealth. As a consequence, the 1989 Therapeutic Goods legislation included provision for Listed Medicines, giving these Australian products a unique status in the domestic and export markets.
I contributed to the adoption in Australia of initial guidance for product sponsors concerning adverse reactions, including the Australian Pharmacovigilance Guideline (2002), provision for requiring Periodic Safety Update Reports (PSURs) and the Conjoint ADRAC-Medicines Australia guidelines for company-sponsored post-marketing surveillance (PMS) studies.).
What stands out as one of your proudest achievements or most meaningful contributions?
I arranged for the UMC Pharmacovigilance Training Course to be presented at TGA in 2002 and 2004. These were the first occasions the 2-week intensive course had been held outside Uppsala in Sweden. Many TGA colleagues generously contributed, giving Australia a very high status in global pharmacovigilance.
What advice would you give to pharmacists just starting their careers, especially those interested in pharmacovigilance or policy development?
Maintain the curiosity and analytical skills developed during undergraduate study as pharmacy offers many and varied opportunities, including in pharmacovigilance and policy development. Keep up to date throughout your career, as it will span many important developments and changes.
Reference
- Mackay K. Showing the blue card: reporting adverse reactions. Australian Prescriber 2005;28(6):140–2.
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[post_content] => The Therapeutic Goods Administration (TGA) issued an alert over the use of broad-spectrum antibiotics commonly used to treat infections such as urinary tract, respiratory and gastrointestinal infections.
What class of antibiotics prompted the alert?
Antimicrobials from the broad-spectrum fluoroquinolone class of antibiotics, including ciprofloxacin, norfloxacin and moxifloxacin. This includes all oral and injectable forms of fluoroquinolones.
What are the documented adverse effects?
Central nervous system (CNS) and psychiatric events. Although rare, the complications are serious – and are potentially disabling and irreversible.
Adverse events include:
For example, the boxed warning for ciprofloxacin will now state:
Serious disabling and potentially irreversible adverse reactions
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system (see section 4.4 Effects on the CNS), musculoskeletal system (see section 4.4 Tendonitis and tendon rupture) and psychiatric effects (see section 4.4 Psychiatric reactions).
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[post_content] => The Therapeutic Goods Administration (TGA) issued a caution over the use of sodium valproate in men who are planning a family.
Up to 1 in 10 babies (10%) exposed to sodium valproate during pregnancy may be born with birth defects.
One mother in the United Kingdom had two children born with fetal valproate spectrum disorder (FVSD) after using sodium valproate since the age of 16 following an epilepsy diagnosis.
Now, the anticonvulsant—used to manage seizures, mood disorders in bipolar patients, and as migraine prophylaxis—has been linked to an increased risk of neurodevelopmental disorders in children whose fathers used the medicine three months before conception.
These findings are based on a retrospective European observational study comparing the effects of the use of sodium valproate with those of lamotrigine or levetiracetam.
The neurodevelopmental disorders identified include autism spectrum disorder, intellectual disability, communication disorders and ADHD and movement disorders.
However, as of yet there have been no adverse events in relation to paternal exposure reported to the TGA.
What’s changing?
Women are already advised against using sodium valproate in pregnancy, which can cause FVSD. Now men are urged to consider alternative treatment options if planning to father a child or before discontinuing contraception.
New boxed warnings will also be introduced for Epilim. The Product Information (PI) and Consumer Medicine Information (CMI) will feature added warnings about paternal exposure.
Sponsors of generic sodium valproate products must update their safety information to match that of Epilim.
What should pharmacists do?
When dispensing sodium valproate to men, pharmacists should inform them about the risks of using this medicine if planning a family. The use of contraception should be encouraged in both the male patient and their female partner.
Pharmacists should also advise men to contact their GP if their partner is pregnant and they have taken sodium valproate within the 3 months before conception.
Male patients who are taking sodium valproate should not donate sperm for more than 3 months after ceasing treatment.
Pharmacists should recommend that men who have been taking sodium valproate long term have an annual review with the specialist to assess whether it remains the most appropriate treatment – particularly if they are planning on parenthood.
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[post_content] => The theme for 2025 Thank Your Pharmacist Day is ‘Pharmacists stepping up’, acknowledging the increasing role of pharmacists in supporting patient care and strengthening Australia’s healthcare system.
Thank Your Pharmacist Day will take place tomorrow (13 March 2025), with PSA calling on Australians to show their appreciation for pharmacists and the care they provide.
PSA National President Associate Professor Fei Sim FPS said the theme reflects the dedication of pharmacists as they take on expanded roles and responsibilities in response to community needs.
‘Every day, pharmacists across Australia are stepping up to meet growing healthcare demands across a diverse range of practice areas. Thank Your Pharmacist Day is an opportunity to recognise their contributions and the vital role they play in ensuring the health and wellbeing of Australians,’ A/Prof Sim said.
‘As the peak body representing all pharmacists across all areas of practice, PSA is committed to supporting pharmacists as they take on new opportunities through education, training, and advocacy. As our profession continues to evolve, pharmacists remain at the forefront of accessible healthcare.’
PSA is also inviting elected officials around the country to connect with local pharmacists in the lead-up to Thank Your Pharmacist Day, to witness first-hand how pharmacists are stepping up to meet patient needs in their communities.
‘With the federal election approaching, this is an important moment for decision-makers to see the critical role pharmacists play and to understand how supporting pharmacists means better healthcare access and medicine safety for all Australians,’ A/Prof Sim said.
Pharmacists, healthcare professionals, and the public are encouraged to take part by sharing their stories and messages of thanks using #ThankYourPharmacist.
To find out more about Thank your Pharmacist Day, including media and advocacy kits, visit psa.org.au/thankyourpharmacist/
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Australian Pharmacist is the official journal for Pharmaceutical Society of Australia Ltd.
