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.
