Module 6

04/10/2024

HCP survey of document usage

Storage, preparation or administration

Preparation of clinical practice guidelines

Therapeutic decision

Dosing Information

Safety Management

Informing patients

All Participants

SmPC

56%

78%

68%

60%

40%

45%

Package Leaflet

11%

34%

24%

37%

10%

51%

Public Assessment Report

30%

19%

34%

11%

25%

14%

Summary of Public Assessment Report

25%

15%

25%

9%

19%

16%

Educational Material

32%

33%

59%

21%

27%

34%

DHPC

45%

41%

59%

26%

30%

26%

Medicines Compendia

52%

66%

52%

45%

32%

32%

Medicines formulary

46%

64%

46%

35%

29%

25%

Clinical practice guidelines

74%

57%

48%

26%

48%

31%

Medical Journal

69%

48%

52%

26%

52%

26%

Source: Presentation from HCP Working Party, March 2016 Responses from >500 HCP participants via organisations in contact with EMA

Red = responses >55%

The Organisation for Professionals in Regulatory Affairs

19

Does the SmPC meet the needs of healthcare professionals?

Quality and reliability of information in the SmPCs ( Int J Environ Res Public Health. 2022 Feb; 19(4):2185 ) • Primary Resource for Prescribers: The SmPC is considered the essential document for healthcare professionals when prescribing medications and research shows it is referred to the most often. • Need for Improvement: While the SmPC serves as a crucial reference, there are areas where enhancements can be made, particularly regarding readability and understandability. • Focus of Research: Previous research has predominantly concentrated on the accuracy and completeness of SmPCs, often overlooking the importance of how easily the information can be read and understood by healthcare professionals. • EU Guidance: European Union guidelines emphasize the necessity for SmPCs to be clear and precise, yet there are no specific standards for readability akin to those established for patient leaflets.

The Organisation for Professionals in Regulatory Affairs

20

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