Lack of remuneration, time an issue for reporting


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A study has found community pharmacists have ‘suboptimal’ knowledge on reporting adverse drug reactions, making up only 6% of reports in 2017

Community pharmacists need more training on adverse drug reactions (ADRs) and the reporting process surrounding them, argue researchers from the University of Tasmania’s School of Medicine (Pharmacy).

After surveying 232 community pharmacists from NSW, Queensland, Victoria and Tasmania, the researchers found only 9% correctly identified what the TGA considers to be a serious ADR.

Only 14% correctly identified examples of an adverse event.

While the majority of survey respondents (85%) knew the type of ADRs that the TGA wants health professionals to report, only 3% were able to identify the office responsible for the collection and analysis of ADRs at the TGA.

Just one quarter (25.4%) of respondents correctly identified the common safety issues involving medicines on the market.

Altogether the median knowledge score was five out of 10.

“Knowledge of community pharmacists in reporting ADRs is suboptimal and there are several barriers that need to be overcome to improve the ADR reporting rates,” study author Raymond Li tells AJP.

“This presents an opportunity for ADR reporting to be included in undergraduate pharmacy curriculums.”

More than two-thirds (72%) of respondents believed reporting ADRs should be mandatory.

However only 35% had reported at least one ADR in the previous 12 months, despite 88% having encountered an ADR in a patient and 66% recording ADRs as part of a clinical intervention at least once a month.

According to the latest TGA statistics for 2017, only 6% of ADRs reported to the TGA came from community pharmacists.

More adverse event reports were provided by consumers (7%) and hospitals/hospital pharmacists (10%) in the same year.

Non-reporting pharmacists were more likely to report lack of time as a barrier (p < 0.001).

Just over 40% of respondents agreed they don’t have time to report ADRs as part of their usual professional practice, while 65% agreed remuneration would encourage them to report ADRs.

There was a moderate correlation between not having the time to report ADRs, and being encouraged to report ADRs if reporting was remunerated (P < 0.001).

“This shows that the current lack of remuneration for reporting ADRs in Australia is a substantial barrier,” say the authors of the study published the International Journal of Clinical Pharmacy.

Twenty-two percent said they believed there were no results or actions taken based on the ADRs they did report, signifying they thought reporting was ineffective or a waste of time.

“Under reporting of adverse drug reactions is very high,” says Mr Li.

“We understand community pharmacists are busy healthcare professionals, but one of the key findings from this research is that community pharmacists who have reported ADRs to the TGA did not see ‘lack of time’ as a barrier to reporting.”

According to respondents, the best ways to encourage pharmacists to report include:

  • Having patient information automatically populated from the dispensing software into an ADR report ready for submission (92%)
  • Providing general education on pharmacovigilance (89%)
  • Setting a reminder in the dispensing software (85%)

A worldwide review of 462 medicines removed from the market for safety reasons showed the median time from drug launch to drug withdrawal was 10 years, with delays contributing significantly to increased healthcare costs, say researchers.

The TGA’s Black Triangle Scheme encourages health professionals to report ADRs for certain types of new prescription medicines, or those being used in significantly different ways.

Pharmacists can look out for the black triangle symbol, which will appear on the  Product Information (PI) and Consumer Medicines Information (CMI) of products included in the scheme.

“The Black Triangle does not denote that there are known safety problems, just that the TGA is encouraging adverse event reporting to help us build up the full picture of a medicine’s safety profile,” says the organisation.

Pharmacists and other healthcare professionals can report ADRs here. Adverse events can be reported here.

While health professionals are encouraged to report suspected adverse events directly to the TGA, they can also report to the sponsor or manufacturer.

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