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Reference: Date of data extraction: Reviewer: KH

1 PART 1: Study eligibility and characteristics of the study

Exclusion criteria Characteristics of the study Type of

publication

 Not a peer-reviewed original research article, e.g.

commentary, editorial, letter, report, guidelines or conference or meeting proceedings

 Not published in English

-

Study design/

type of study

 Case report

 Conceptual paper

 Other: _____________________

 Observational

 Intervention  Retrospective

 Prospective

 Cross-sectional Data source  Pre-existing material on drug-related morbidity

without evaluation of drug-related morbidity in the current study

 Case records

 Interview

 Reports

 Survey

 Other: __________________________________

Setting  Care unit(s) for patients with specific disease or disease class

 Inpatient setting

 Outpatient setting

 Residential facility

 Community setting

 Academic teaching facility

 Other setting: __________

_______________________

 No setting restrictions

 Africa

 Eastern Mediterranean

 Europe

 North America

 South America

 South-East Asia

 Western Pacific Sampling

frame

Sampling frame represents patients

 with a certain medical condition

 receiving a certain treatment, preventive health intervention or procedure

 Health facility

 Insurance scheme

 Population-based Characteristics

of participating patients

Participants

 with a certain disease, disease class, symptom or other medical condition

 receive a certain treatment, e.g. specific medication, medication group, herbal product, vaccine or medical procedure

 receive a certain preventive health intervention or diagnostic procedure

Sex:

 Male

 Female

 Both

Age group:

 ≤17 years

 18-65 years

 ≥66 years

 No age limitation

Outcome measures and results

Do not represent

 Prevalence/incidence/frequency of drug-related morbidity (or synonymous concepts)

 Preventability of drug-related morbidity Represent exclusively

 potential, not actual, morbidity

 specific medical conditions

 effects of chemical compounds (other than medicines), human transmitters, nutrients, nutritional product, alcohol, tobacco or illicit substances

 pharmacodynamic, pharmacokinetic or pharmacogenetic measures

Prevalence/incidence/frequency of drug-related morbidity (or synonymous concepts)

 Mentioned as an outcome measure

 Not mentioned as an outcome measure, but can be interpreted

Preventability of drug-related morbidity

 Mentioned as an outcome measure

 Not mentioned as an outcome measure, but can be interpreted

 One or more exclusion criteria fulfilled → ARTICLE EXCLUDED

 None of the exclusion criteria fulfilled → ARTICLE INCLUDED → proceed to page 2 H6XSSOHPHQW Literature review data extraction forP $SSHQGL[3DSHU

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Reference: Date of data extraction: Reviewer: KH

2

PART 2: Methods for prevalence and preventability assessment of drug-related morbidity (DRM) Aim of the study

Definition(s) of drug-related morbidity (DRM)

 Adverse drug event (ADE)

 Adverse drug reaction (ADR)

 Drug-related morbidity(DRM)

 Drug-related problem (DRP)

 Medication error (ME)

 Other: ___________________

__________________________

__________________________

 Not defined

 According to reference(s)  Modified from reference(s)  Own definition (no reference) Description (+ relevant references): _______________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

 No definition

Assessment method of prevalence/incidence/frequency/causality of drug-related morbidity (DRM) Measurement:

 Incidence

 Prevalence

 Other frequency measure:

_______________________

_______________________

_______________________

 Not defined

Assessor(s):

 Researcher(s)

 Health professional(s)

 Computer programme

 Other(s)

Describe: ______________

_______________________

_______________________

_______________________

_______________________

 Not defined

Assessment of causality (medication therapy → adverse outcome):

 According to reference(s)  Modified from reference(s)

 Own definition (no reference)

Description (+ relevant references): __________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

 Method not specified (no reference) Additional description, e.g. information on validity or reliability testing:

Assessment method of preventability Reference:

 Bates et al. 1993/1995

 Chan et al. 2001

 Dubois and Brook 1988

 Hallas et al. 1990

 Hartwig et al. 1992

 Hepler and Strand 1990

 Leape at al. 1995

 Schumock and Thornton 1992

 Other reference:

_______________________

_______________________

_______________________

 No reference

Assessor(s):

 Same as above ↑

 Researcher(s)

 Health professional(s)

 Other(s)

Describe: ______________

_______________________

_______________________

_______________________

_______________________

 Not defined

Description of the method:

 According to reference(s)  Modified from the reference(s)

 Own method (no reference)

Description (+ relevant references): __________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

 Method not specified (no reference) Additional description, e.g. information on validity or reliability testing:

Additional notes

(Please continue writing here in case of shortage of space in any parts of the sheet.)

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Reference: Date of data extraction: Reviewer: KH

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Standardising the assessment process

Performing pilot Yes

No Use of operational

manual/guidelines/protocol

Yes No Assessors

Profession Pharmacist(s)

Physician(s) Nurse(s) Not reported Training for/ experienced in assessment Yes

No Number of assessors per case 1

≥2

Not reported Blinding assessors

(if multiple assessors, cat ≥2 from above) Yes No Managing conflicting assessments

(if multiple assessors, cat ≥2 from above) Discussion until consensus

Discussion and reassessment, consensus not required

One assessor interpretation determines assessment

Additional assessor(s) Not reported

Evaluation of assessment method

Reliability of preventability assessments Yes, in same article

Yes, reference to another article No

Sensitivity of preventability assessments Yes, reported in same article Yes, reference to another article No

Specificity of preventability assessments Yes, reported in same article Yes, reference to another article No

eSupplement

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