(CSPOT28) Limited impact of Direct Healthcare Professional Communications when using optimal outcomes and appropriate study populations: a systematic review.

Background: Direct Healthcare Professional Communications (DHPCs) are an important risk minimisation measure. Their effect has shown to be variable and has been measured using different outcomes. Depending on the content of the message, the optimal outcome to measure a direct effect of the DHPC can differ.

Objectives: This systematic review investigates whether the effects of DHPCs differ according to the use of optimal outcomes for assessing direct effects.

Methods: For this systematic review, EMBASE and MEDLINE were searched for European DHPC effectiveness studies up to performed April 6th 2022, evaluating impact of DHPCs issued from 2008 onwards. Optimal outcomes were defined as knowledge/awareness for be aware messages, prescribing of medication (including dosage changes) for restriction indication/new contraindication, dosing changes, and drug-drug interaction messages, and monitoring for monitoring advice messages. Self-reported behaviour (prescribing/monitoring) and adverse events/other health outcomes, including hospitalization were not defined as optimal outcomes for any of the DHPC messages. Outcomes were coded 1 when an effect was shown and 0 if not. When multiple outcomes were reported in a study, a composite outcome was created ranging from 0-1. These composite outcomes were classified as high (0.75-1), intermediate (0.74-0.25), or low (0.24-0). Chi-square or Fisher exact tests were conducted to test whether the effect of a DHPC was influenced by the use of optimal outcomes, with a p value < 0.05 considered statistical significant.

Results: From 7,063 publications identified in our literature search, 62 publications evaluating 31 different DHPCs were identified for our review. From the 62 publications, 106 (composite) outcomes were generated, of which 45 were classified as not an optimal outcome. Prescribing was the most measured outcome, for 56 of the 75 times this was an optimal outcome. Overall, 30 of the 106 outcomes (28%) had a high or full impact, i.e., a composite outcome between 0.75 and 1. The use of optimal outcomes did not significantly influenced the impact observed of the DHPC.

Conclusions: Only a minority of the DHPCs issued after 2008 in Europe showed high impact, regardless of the outcome measures studied. Efforts are needed to improve the communication of drug safety issues.