HOW DO DANISH GPS READ REGULATORY SAFETY ADVISORIES? A RHETORICAL PROTOCOL ANALYSIS.

UNI VE R S I TY O F C O PE NH AGE NFAC UL TY O F H E AL TH AND ME DI C AL S C I E NC E S

INTRODUCTIONTaxonomy of Direct to Healthcare Professional Communication

Guideline on good pharmacovigilance practicesModule XV 2012; Zomerdijk et.al. 2012.

Direct to Healthcare Professional Communication

Additional Risk Management Initiative

Risk Management Plans

AGENDA

o Background and purposeo Research design and methodologyo Findings• Network of medicine risk information• Medicine risk info as ‘tools’ • GPs’ reading strategies• Reasons for disapproval• Relevance of recommendations

o Conclusion and future considerations

BACKGROUND AND PURPOSE

• Methodological gaps in assessing effectiveness of communicative risk minimization measures

• Lack of insights into the situated reception of the communication and its role in the clinical context of drug risk management.

• Risk management requires a more complex governance approach

• Risk communication scholarship emphasizes engagement and in-depth understanding of audiences

IntentionReal-world use

BACKGROUND AND PURPOSEThe need for more contextual understanding

Purpose is

• to get a thorough understanding of the clinical context for receiving the DHPCs

• to develop quality criteria for medicine risk communication to healthcare professionals and provide input to current practice of DHPCs

RESEARCH DESIGNSequence of substudies

Literature review

Qualitativeinterviews with

GPs

Qualitativeprotocol reading

exercises with GPs

Evidence-basedrecommendations

RESEARCH DESIGNMethodology and sample

• ‘Instrumental’ case strategy based on a specific Direct to Healthcare Professional Communication• 2013 DHPC on NOACs (Eliquis® (apixaban), Pradaxa®

(dabigatranetexilat) og Xarelto® (rivaroxaban) • Sampling criteria: GPs are most accessible target group -> more

varied data• Recruitment strategy: Cold calls, network and “snowballing”• 16 active GPs from Greater Copenhagen and Sealand Region (so

far…)• Age: 42 – 75• Years of clinical practice experience: 2 – 42 years• Gender: 50/50

RESEARCH DESIGNComplementary methods

Qualitativeinterviews

Read aloudprotocol

Focus: Medicine risk info generally

Focus: Specific DHPC case text

WHERE DO GPS FIND/GET INFO ON MEDICINE RISKS?

NETWORK OF MEDICINE RISK INFO SOURCESInformational sources as rhetorical network

Pro.medicine Institute for Rational Pharmacotherapy UTH Reg Sjælland Ugeskriftet

KAP-H nyhedsbrev Lægehåndbogen Medicin.dk Interaktionsdatabasen

Guidelines fra selskaber Medibox Dagens medicin PLO nyhedsbreve

Nyt om medicin Månedsskriftet Månedsskriftet for Praktisk lægegerning

NETWORK OF MEDICINE RISK INFO SOURCES

Pro.medicine

Institute for Rational Pharmacotherapy

UTH RegSjælland

Ugeskriftet

KAP-H nyhedsbrev

Lægehåndbogen

NETWORK OF MEDICINE RISK INFO SOURCESForms of interaction

• Push communication is the distribution of messages to intended audiences.

• Pull communication is the acquisition of information by audiences as they search and consult sources

Pro.medicine

Institute for Rational

Pharmacotherapy

UTH RegSjælland

Ugeskriftet

KAP-H nyhedsbrev

Lægehåndbogen

NETWORK OF MEDICINE RISK INFO SOURCESCharacteristics of a node

Institute for Rational Pharmacotherapy

A node is characterized by

• recognizable pattern of communication over time

• expectations of credibility

• expectations of usefulness

Network is hierarchical, dynamic and individual to the GP

NETWORK OF MEDICINE RISK INFO SOURCES

Pro.medicine

Institute for Rational Pharmacotherapy

UTH RegSjælland

Ugeskriftet

KAP-H nyhedsbrev

Lægehåndbogen

NETWORK OF MEDICINE RISK INFO SOURCESHow does the DHPC fit in?

• The GPs recognize DHPCs as a recurrent text in their clinicalpractice.

• They diverge in their estimation of the frequency, media and purpose of DHPCs but they all recognize thatthey continuously receive them.

• They recognize its form, its layout, have ideas about the intentions with the letter and they have specific expectations about itspractical value and credibility.

• DHPCs are valued relatively againstalternative nodes in the network.

DHPC

HOW DO GPS USE INFO ON MEDICINE RISKS?

MEDICINE RISK INFO AS ‘TOOLS’ Cognitive tools in clinical practice

Vygotsky (1978); Norman (1999)

• A cognitive tool has an organizing and controlling function for cognitive tasks and extends thinking beyond existingcapabilities.

• Perceived affordances are the perceived ”action possibilities” or potential of a given tool to solve a task at hand.

HOW DO GPS READ REGULA-TORY SAFETY ADVISORIES?

READING A DHPCReadings strategies

REASONS FOR DISAPPROVAL

RELEVANCE OF RECOMMENDATIONS

PRELIMINARY CONCLUSIONS

• Medicine risk info is received as part of network of sources and assessed as such

• Sources are assessed according to their pattern, credibility and clinical usefulness and applied as ‘cognitive tools’

• Protocol analysis suggests that• DHPC are scanned for items that are useful• reading of a DHPC may reflect perceptions of the existing relations

with the sender• Readers expect the content to be tailored to their clinical work

FUTURE CONSIDERATIONS FOR DHPCS

• Adapt the DHCP format to its network of sources to increase its relative value

• Segment, test and tailor format to target-group to increase content relevance

• Involve additional stakeholders in risk governance (e.g. medical associations)

• Process approach – ongoing and dependent on relations and trust.