TY - JOUR

T1 - Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality?

T2 - A retrospective analysis of DHPCs sent out between 2007 and 2018

AU - Højer, Maja-Marie Grønfeldt

AU - De Bruin, Marie Louise

AU - Boskovic, Arnela

AU - Hallgreen, Christine Erikstrup

N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2020

Y1 - 2020

N2 - OBJECTIVE: To assess whether direct to healthcare professional communications (DHPCs) are of sufficient quality to be applicable in clinical practice and study how the quality differs according to safety concerns and type of monitoring.DESIGN: Retrospective cohort study.SETTING: DHPCs containing monitoring instructions were identified among all DHPC issued in Denmark between 2007 and 2018.INTERVENTION: Quality of information of monitoring instructions was assessed according to the Systematic Information for Monitoring (SIM) score. Associations between different characteristics of instructions and the SIM score were compared with analysis of variance and the post hoc test Tukey's honestly significant difference if significant.RESULTS: In total, 297 DHPCs were issued, of which 97 contained 134 monitoring instructions. For 95% of these DHPCs the European Medicines Agency was involved. The average SIM score was 2.6±1.6 (ranging 0-6) and only 47% were considered of sufficient quality (SIM score ≥3). In addition, even fewer (11%) instructions were considered a 'adequate instruction' which also reported about facts and risks. Differences between quality of information according to type of monitoring were observed, specifically between clinical monitoring (average SIM score 1.9) and biomarker monitoring (physical average SIM score 2.9, p=0.029 and laboratory average SIM score 3.4, p<0.0001).CONCLUSIONS: Monitoring instructions were found not to be of sufficient quality to be applicable in clinical practice according to the SIM score. Our study concludes the need for further research and regulatory steps to ensure improve quality of information in safety communications.

AB - OBJECTIVE: To assess whether direct to healthcare professional communications (DHPCs) are of sufficient quality to be applicable in clinical practice and study how the quality differs according to safety concerns and type of monitoring.DESIGN: Retrospective cohort study.SETTING: DHPCs containing monitoring instructions were identified among all DHPC issued in Denmark between 2007 and 2018.INTERVENTION: Quality of information of monitoring instructions was assessed according to the Systematic Information for Monitoring (SIM) score. Associations between different characteristics of instructions and the SIM score were compared with analysis of variance and the post hoc test Tukey's honestly significant difference if significant.RESULTS: In total, 297 DHPCs were issued, of which 97 contained 134 monitoring instructions. For 95% of these DHPCs the European Medicines Agency was involved. The average SIM score was 2.6±1.6 (ranging 0-6) and only 47% were considered of sufficient quality (SIM score ≥3). In addition, even fewer (11%) instructions were considered a 'adequate instruction' which also reported about facts and risks. Differences between quality of information according to type of monitoring were observed, specifically between clinical monitoring (average SIM score 1.9) and biomarker monitoring (physical average SIM score 2.9, p=0.029 and laboratory average SIM score 3.4, p<0.0001).CONCLUSIONS: Monitoring instructions were found not to be of sufficient quality to be applicable in clinical practice according to the SIM score. Our study concludes the need for further research and regulatory steps to ensure improve quality of information in safety communications.

U2 - 10.1136/bmjopen-2019-036498

DO - 10.1136/bmjopen-2019-036498

M3 - Journal article

C2 - 32398337

VL - 10

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 5

M1 - e036498

ER -