Knowledge and attitudes to reporting adverse drug reactions by health professionals: Implications fo

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Knowledge and attitudes to reporting adverse drug
reactions by health professionals Implications
for immunisation programmes?

• Andrew Pulford
• Senior Public Health Research Officer - NHS
  Ayrshire Arran
• William Malcolm
• Pharmaceutical Adviser - Health Protection
  Scotland

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UK Immunisation Programme

• The two public health interventions that have
  had the greatest impact on the worlds health are
  clean water and vaccines
• (World Health Organisation)
• Immunisation programme in UK is constantly
  developing
• Inclusion of new vaccines into the programme in
  an attempt to protect the population against a
  range of infectious diseases and their
  complications

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Adverse drug reactions (ADRs)

• Although the safety of new drugs is tested in
  clinical trials prior to licensing, not all
  adverse reactions will be discovered
• Only with widespread use in the general
  population that any rare side effects or benefits
  can be detected
• Because of these limitations, post-marketing
  surveillance is important in identifying
  potential dangers caused by medicines

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Reporting adverse drug reactions

• Medicines and Healthcare products Regulatory
  Agency (MHRA) has statutory responsibility for
  monitoring the safety of all medicines, including
  vaccines, in the UK
• MHRA operates a spontaneous reporting system
  called the Yellow Card Scheme
• Relies on healthcare professionals, patients and
  general public to report suspected ADRs

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Reporting adverse drug reactions

• Not all reactions need to be reported

• At-risk groups
• children aged under 18
• adults aged 70 years and over
• pregnant women

• Serious Reactions
• reactions that are fatal
• life threatening, disabling or incapacitating
• resulting in or prolonging hospitalisation
• congenital abnormalities
• or otherwise medically significant

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Black Triangle Medicines

• Some medicines are placed under enhanced
  surveillance
• Healthcare professionals are advised to report
  any suspected adverse reactions, regardless of
  individual risk factors or seriousness
• Medicines that are to be monitored intensively
  are assigned an inverted Black Triangle to
  indicate this

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Underreporting of adverse drug reactions

• Universally accepted that ADRs are greatly
  underreported
• Seven deadly sins (Inman 1976)
• Ignorance (unsure how to report)
• Diffidence (may appear foolish)
• Fear (legal liability)
• Lethargy (too busy)
• Guilt (reluctant to admit that may have caused
  harm)
• Ambition (rather collect cases and publish them)
• Complacency (only safe drugs are marketed)

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Expansion of responsibility for reporting

• Yellow Card System initially only allowed doctors
  and dentists to report
• To address underreporting responsibility has been
  widened to include all healthcare professionals
• Coincided with nurses taking a lead role for
  administering vaccines as part of national
  immunisation programmes

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Aim of study

• To evaluate knowledge of and attitudes to
  reporting ADRs among the professional groups most
  likely administer - and therefore most likely to
  see suspected reactions to - vaccines, including
  nursing professionals whose views have not been
  included in previous studies

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Methodology

• Self-completion questionnaire
• Study target population practice nurses, school
  nurses, health visitors, GPs and community
  paediatricians working for NHS AA during
  June-Aug 2007
• All members of identified professional groups
  surveyed with the exception of GPs
• Each practice asked to identify one GP felt was
  most interested in vaccination issues

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Respondent profile
Total number of GPs invited to participate in
the survey
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Awareness of reporting system

• 90 aware of responsibility to report
• 49 felt they had good knowledge of Yellow Card
  system
• 32 had ever received training on reporting ADRs
• Some confusion over functions of Yellow Card
  System
• 46 correctly identified meaning of Black Triangle

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Awareness of reporting system

• 10 hypothetical situations were devised which
  outlined possible adverse reactions to vaccines
• Mean 6 hypothetical ADRs identified correctly
• Higher levels of knowledge appear in relation to
  serious reactions and ADRs that do not require to
  be reported
• Lower levels of knowledge seem to be apparent in
  relation to Black Triangle medicines and
  reactions in under-18s

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Attitudes/barriers to reporting

• Strong agreement
• professional obligation to report ADRs
• aware which ADRs should be reported
• would feel confident in discussing a suspected
  ADR with the prescriber

• Strong disagreement
• too busy to report ADRs
• reporting ADR may breach patient confidentiality
• one suspected ADR cannot contribute to medical
  knowledge
• too complicated
• too time consuming
• Yellow Cards unavailable when needed

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Potential solutions

• Suggestions thought to be most effective
• clearer priorities for reporting
• making reporting a professional responsibility
• training on reporting suspected ADRs
• electronic submission of Yellow Cards with fields
  populated automatically from GP prescribing and
  recording systems
• Divided views
• financial reimbursement for providing the
  service of reporting ADRs

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Conclusions

• Respondents showed positive knowledge and
  attitudes towards reporting ADRs, however, some
  gaps in knowledge were apparent
• Low levels of training reported in our study
  raises concerns
• Gaps in respondents knowledge of the
  requirements for reporting non-serious reactions
  to Black Triangle medicines and among those at a
  greater risk of harm

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Conclusions

• Given the increasing role of nursing staff in
  immunisation programmes it is important that the
  planning of nurses role in such programmes
  addresses not just the physical administration of
  vaccines, but also pharmacovigilance issues

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Knowledge and attitudes to reporting adverse drug
reactions by health professionals Implications
for immunisation programmes?

• Andrew Pulford
• Senior Public Health Research Officer - NHS
  Ayrshire Arran
• William Malcolm
• Pharmaceutical Adviser - Health Protection
  Scotland