A world-first pilot has linked Australian pharmacies with national surveillance networks such as the AIR, finding fewer adverse events
Pharmacy and medical researchers have collaborated with industry partners to pilot an active vaccine safety surveillance program for patients immunised in pharmacies.
Such a system will be pivotal in ensuring the safe deployment and continued uptake of the COVID-19 vaccine, say the researchers.
The pilot was led by the University of Western Australia, in partnership with SmartVax, MedAdvisor and the Queensland University of Technology, with support through a $40,000 grant from the Pharmaceutical Society of Western Australia via the JM O’Hara Research Fund.
Promising study results
Researchers conducted a prospective cohort study of individuals aged 10 years and up receiving influenza immunisations from 22 pharmacies and 90 non-pharmacy sites between March and October 2020, in Australia.
Their results have been shared on medRxiv, although readers should note that as a preprint, the paper is yet to be peer reviewed.
The study included nearly 7,000 participants across WA pharmacies and used SMS and smartphone technology to monitor the effects of influenza vaccines administered by pharmacists.
During the study period, immunisations recorded in the MedAdvisor PlusOne system at each pharmacy were automatically sent to SmartVax. SmartVax was then used to actively monitor and record adverse events following immunisation.
Over 94,400 immunisation encounters recorded in the non-pharmacy sites were automatically extracted by SmartVax program each day.
SmartVax sent a series of automated SMS text messages to all participants three to five days after immunisation, to enquire if any adverse events had been experienced. The primary outcome of interest was any adverse event following immunisation.
Secondary outcomes included adverse events resulting in medical attendance, and adverse event profile as reported in the survey (fever, pain, swelling, tired, irritable, sleep, rash, headache, vomiting, diarrhoea, and other).
Of 101,440 complete influenza immunisation encounters, a total 5,100 (72.9%) pharmacy participants and 72,398 (76.7%) non-pharmacy participants responded to the first SMS, providing 77,498 immunisation encounters for analysis. About 96% did so within 24 hours.
There were significantly fewer adverse events overall reported from participants immunised in pharmacies compared to those immunised in non-pharmacy sites, including general practice and other clinics. After adjusting for age, gender and vaccine brand, this difference was still significant although small.
Overall, 4.8% (n=247) pharmacy participants reported an adverse event, compared with 6.0% (n=4,356) non-pharmacy participants (adjusted odds ratio: 0.87; 95% confidence interval: 0.76 to 0.99; p=0.039).
Similar proportions of adverse events following immunisation were reported in pharmacy (5.8%; n=31) and non-pharmacy participants (6.0%; n=1617) aged over 65 years (adjusted odds ratio: 0.94, 95% confidence interval: 0.65 to 1.35; p=0.725).
The authors noted that participants immunised in pharmacies were significantly younger than those in non-pharmacy sites and it was possible that more complex or sicker participants visited non-pharmacy immunisers.
“However, there was no difference in overall adverse events observed in our subanalysis of the over-65 years age group, whom we might expect to have more comorbidities or be sicker,” they said.
Project lead Dr Sandra Salter from the UWA School of Allied Health/Pharmacy added: “In both cases, patients received the flu jab, and there were similar response rates to surveillance messages, reaction types, and all reactions were reported using the same platform.
While the reasons for this difference are yet to be teased out, we can be confident that pharmacists are safe immunisers.
A scalable solution
Dr Salter said when combined with the MedAdvisor PlusOne platform, a program available in approximately 65% of Australia’s pharmacies to record patient immunisations, it provided a robust, automated, user-friendly system to rapidly track vaccine safety.
“The development of this program is very exciting because for the first time we have a system that collects and links pharmacy vaccination data with established infrastructure including the Australian Immunisation Register, AusVaxSafety and the TGA,” she said.
“This infrastructure connects patients, pharmacies, GPs, the Health Department and government authorities together so we can rapidly keep across vaccine use and detect safety signals early.”
Until now there was no structured surveillance system in pharmacy and no mechanism to identify reactions once patients left the pharmacy, said the researchers.
Based on the study results, they believe active vaccine safety surveillance is now instantly scalable to thousands of pharmacies in Australia and can monitor patients previously out of reach.
“The beauty of this system is that it’s scalable, meaning we could soon be monitoring adverse events following immunisation from thousands of pharmacies in real-time,” Dr Salter said.
“Our high levels of patient engagement show the value the public place on this direct communication and support from their trusted pharmacy. And, the system can monitor reactions to any vaccine, aiding public safety and confidence in vaccinations.”
Founder of SmartVax and GP Dr Alan Leeb, who contributed to the paper, said active adverse event surveillance following immunisation played an important role in monitoring and ensuring vaccine safety.
“It has been exciting to partner with the pharmacy sector and MedAdvisor in providing this service to our patients, the Australian public, further enhancing confidence in the safety of our National Immunisation Program,” Dr Leeb said.
Robert Read, CEO of MedAdvisor, said monitoring of vaccine safety has never been so important.
“We are proud to offer a solution for pharmacies that is effective, automated and scalable,” said Mr Read.