Drug Utilization Research

Methods and Applications

EDITORS

Monique Elseviers

University of Antwerp, Belgium

Björn Wettermark

Karolinska Institutet, Sweden

Anna Birna Almarsdóttir

University of Southern Denmark, Denmark

Morten Andersen

Karolinska Institutet, Sweden

Ria Benko

University of Szeged, Hungary

Marion Bennie

University of Strathclyde, Scotland

Irene Eriksson

Karolinska Institutet, Sweden

Brian Godman

Karolinska Institutet, Sweden

Janet Krska

Universities of Greenwich and Kent, United Kingdom

Elisabetta Poluzzi

University of Bologna, Italy

Katja Taxis

University of Groningen, The Netherlands

Vera Vlahović-Palčevski

University of Rijeka, Croatia

Robert Vander Stichele

Ghent University, Belgium

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Library of Congress Cataloging-in-Publication Data

Names: Elseviers, Monique, editor.
Title: Drug utilization research : methods and applications / editors,
Monique Elseviers [and 12 others].

Description: Chichester, West Sussex : Hoboken, NJ : John Wiley & Sons Inc.,
2016. | Includes bibliographical references and index.

Identifiers: LCCN 2015039626 | ISBN 9781118949788 (cloth)

Classification: LCC RM301.25 | NLM WB 330 | DDC 615.1072/4--dc23 LC record available at
http://lccn.loc.gov/2015039626

A catalogue record for this book is available from the British Library.

Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books.

CONTENTS

List of contributors

Acknowledgements

Advisory board
Reviewers

About the companion website

Part 1: Introduction

Chapter 1: Introduction to drug utilization research
1. Room for improvement in drug utilization
2. The history of drug utilization research
3. Definition and delineation
4. Skills needed to be a drug utilization researcher
5. Areas of inquiry in drug utilization research reflected in this book

Part 2: Methodology

Chapter 2: Study designs in drug utilization research
1. Introduction
2. Quantitative and qualitative research
3. Observational studies: from descriptive to analytical approaches
4. Study designs for descriptive drug utilization studies
5. Study designs for analytical drug utilization studies
6. Experimental and quasiexperimental study designs in drug utilization research
7. Other study designs for drug utilization research
Chapter 3: Primary data collection for drug utilization research
1. Introduction
2. Identifying primary data sources for drug utilization research
3. Collecting valuable primary data in drug utilization research
4. Instruments and forms for primary data collection in drug utilization research
5. Modes of primary data collection for drug utilization research
6. Ethical considerations
7. Conclusion
Chapter 4: Secondary data sources for drug utilization research
1. Introduction
2. Sales data
3. Electronic health records
4. Pharmacy dispensing data
5. Reimbursement data
6. Patient registries
7. Secondary analysis of population health survey data
8. Record linkage in drug utilization research
9. Privacy, confidentiality and security
10. Data quality
Chapter 5: Classification systems for drugs and diseases
1. Introduction
2. ATC
3. Other drug classification systems
4. Other classification systems relevant for drug utilization research
5. Linkage of classification systems
Chapter 6: Measurement units of drug utilization
1. Introduction
2. DDD: definition and general considerations
3. Principles of DDD assignment
4. Alterations and misuse of DDDs
5. Other aggregate measures for prescribing
6. Other drug utilization metrics
7. Use of drugs in animals
8. How to report aggregated drug use
9. DDDs for special population groups
Chapter 7: Individual-level drug utilization analyses
1. Introduction
2. General principles
3. Epidemiological measures
4. Other measures
5. Strengths and limitations of individual-level statistics
Chapter 8: Measurement of drug expenditure
1. Introduction
2. Definitions and perspectives
3. Price-related units of pharmaceutical expenditure
4. Methodological challenges related to pharmaceutical expenditure
Chapter 9: Basic statistical methods in drug utilization research
1. Introduction
2. Why we need statistical methods in drug utilization and health services research
3. Use of population data versus sample data
4. Types of variables
5. Describing data with descriptive statistics
6. Investigating the difference between the means and medians of numerical variables
7. Investigating the difference between proportions of categorical variables
8. Understanding the notion of a risk calculation
9. Describing the relationship between two numerical variables using regression analysis
10. Assessing the combined effect of explanatory variables in multivariate statistical analysis
11. Summarizing the results of different studies in a meta-analysis
12. Conclusion
Chapter 10: Visualization of drug utilization data
1. Introduction
2. Basic (static) graphical display of findings
3. Interactive visualization – including time and geospatial visualization
4. Practical hints and tools
5. Conclusion
Chapter 11: Multilevel analyses in drug utilization research
1. Introduction
2. Multilevel structures
3. Why are MLRA techniques necessary?
4. Basic concepts in MLRA: a didactic example
5. A real empirical example
6. Conclusion
7. Acknowledgements
8. Notes
Chapter 12: Defining and developing quality indicators for drug utilization
1. Introduction
2. Definition of a quality indicator
3. Dimensions and classifications
4. Data sources
5. Drug-oriented prescribing quality indicators
6. Disease-oriented prescribing quality indicators
7. Other types of indicator
8. Development and validation of prescribing quality indicators
9. Conclusion
Chapter 13: Qualitative methods in drug utilization research
1. Reasons for using qualitative methods in drug utilization research
2. The role of qualitative research methods in drug utilization research
3. Research questions within drug utilization research that require qualitative research methods
4. Common qualitative data collection methods that could benefit drug utilization research
5. Sampling strategies in qualitative research
6. Analysis of data gathered in qualitative research
7. Validity concepts in qualitative research
8. Conclusion

Part 3: Applied drug utilization research

Section A: Comparative drug utilization research
Chapter 14: Comparison of drug utilization across different geographical areas
1. Introduction to comparative studies
2. Practical guide to geographical comparisons of drug utilization
3. Regional drug utilization comparisons
4. Cross-national drug utilization comparisons
5. Data collection for CNCs
6. Methodological challenges in CNCs
7. National activities that can facilitate CNCs
8. Conclusion
Chapter 15: Comparison of drug utilization in different health care settings
1. Health care settings
2. The relevance of drug utilization research in the hospital and ambulatory care settings
3. Comparative drug utilization studies provide transparency and input for other areas of research
4. Conclusion
Chapter 16: Time-dependent and seasonal variations in drug utilization
1. Introduction
2. Life cycle of a drug
3. Examples of factors influencing the natural life cycles of drugs
4. Utility of variation in drug utilization over time in the surveillance of health care issues
5. Examples of seasonal drug use variability
6. Conclusion
Chapter 17: Comparative studies of patient and prescriber characteristics
1. Introduction
2. Patient characteristics and drug use
3. Prescriber characteristics and drug use
4. Concordance of patient and prescriber characteristics
5. Conclusion
Chapter 18: Comparative studies of health systems
1. Introduction
2. The role of medicines in health care systems
3. Drug utilization studies and health care systems
4. Comparative drug utilization studies of health care systems
5. Drug utilization studies of self-medication and nonprescription drugs
6. Conclusion
Section B: Drug utilization and health policy
Chapter 19: Drug utilization and health policy
1. Introduction
2. Defining pharmaceutical policy
3. Forming pharmaceutical policy across the globe
4. Legal and institutional framework
5. Influencing pharmaceutical expenditure
6. Conclusion
Chapter 20: Managed introduction of new drugs
1. Introduction
2. New models to improve the rational use of new medicines
3. Conclusion
Chapter 21: Management of drugs in a health care system
1. Introduction
2. Supply-side measures
3. Demand-side measures
4. Policy case histories
5. Conclusion
Chapter 22: The pharmaceutical industry and health policy
1. Introduction
2. Ensuring value for money when financing future health needs
3. Application of drug utilization methods throughout the product life cycle
4. Conclusion
Section C: Drug utilization in specific populations
Chapter 23: Drug utilization in pregnant women
1. Background
2. Sources used in drug utilization studies in pregnancy
3. Methodological considerations in drug utilization studies in pregnancy
4. Conclusion
Chapter 24: Drug utilization in the paediatric population
1. Introduction
2. The need for paediatric drug utilization studies
3. Age categories and sample size issues
4. Data sources
5. Measurement units
6. Off-label use
7. Examples of paediatric drug utilization studies
8. Conclusion
Chapter 25: Drug utilization in older people
1. Introduction
2. Prescribing patterns in older people
3. Assessing prescribing quality
4. Deprescribing
5. Conclusion
Section D: Drug utilization in specific therapeutic areas
Chapter 26: Drug utilization research in the area of antibiotics
1. Introduction
2. Antibiotic use in relation to antibiotic resistance
3. Antibiotic use in ambulatory care
4. Antibiotic use in hospital care
5. Conclusion
Chapter 27: Drug utilization research in the area of cardiovascular medicines
1. Introduction
2. Trends in utilization of cardiovascular drugs
3. Antihypertensive drugs
4. Lipid-lowering therapy
5. Antithrombotic drug therapy: oral anticoagulants
6. Antithrombotic drug therapy: acetylsalicylic acid
7. Patient adherence to cardiovascular drugs
8. Cardiovascular polypharmacy
9. Conclusion
Chapter 28: Drug utilization research in the area of analgesics and psychotropics
1. Introduction
2. Pain medications
3. Psycholeptics: antipsychotics, anxiolytics and hypnotics/sedatives
4. Psychoanaleptics: antidepressants and psychostimulants
5. Conclusion
Chapter 29: Drug utilization research in the area of biologicals
1. Introduction
2. Multiple sclerosis
3. Rheumatoid arthritis
4. Psoriasis
5. Potentials and pitfalls of using registries in drug utilization research
6. Conclusion
Chapter 30: Drug utilization research in the area of cancer drugs
1. Background
2. Drug utilization studies in oncology
3. Methodological aspects
4. Conclusion
Section E: Determinants of drug utilization
Chapter 31: Health system perspectives
1. Introduction
2. Access to medicines
3. Finance and affordability
4. Supply and availability
5. International influences
6. Conclusion
Chapter 32: Prescriber perspectives
1. Introduction
2. Education of prescribers
3. Making prescribing decisions
4. Prescribing processes
5. Influences on prescribers
6. Additional issues in low-income countries
7. Conclusion
Chapter 33: Patient perspectives
1. Introduction
2. Importance of the patient perspective
3. Key issues in medicine use
4. Actual use of medicines
5. Use of information about medicines
6. Determining the patient perspective on medicines
7. Involving patients in drug development and monitoring
8. Conclusion
Section F: Adherence and drug utilization research
Chapter 34: An introduction to adherence research
1. Definition and taxonomy
2. The importance of patient adherence to medications
3. Measurement of adherence
4. Considerations for future research
Chapter 35: Assessment of medication adherence in field research
1. Introduction
2. Assessment of adherence
3. Reporting adherence estimates
4. Measuring adherence using electronic monitoring
5. Measuring adherence using questionnaires
6. Other as measures of adherence in field research
7. Advantages and disadvantages of different adherence assessment tools
8. Conclusion
Chapter 36: Assessment of adherence to drug treatment in database research
1. Introduction
2. Measuring adherence: prescription versus dispensing administrative data
3. Measurement selection
4. Measuring initiation
5. Measuring persistence/discontinuation
6. Measuring compliance (implementation)
7. Limitations of administrative data
8. Conclusion
Chapter 37: Interventions to improve adherence to drug treatment
1. Introduction
2. Determinants of medication adherence
3. Research on medication adherence-enhancing interventions
4. Transfer of intervention programmes in routine care
5. Interdisciplinary approaches
6. Conclusion
Section G: The role of drug utilization within the field of pharmacoepidemiology
Chapter 38: Drug utilization research and risk management
1. Introduction
2. Drug utilization research and risk assessment
3. Drug utilization research and risk minimization
4. Conclusion
5. Disclaimer
Chapter 39: Drug utilization research and pharmacovigilance
1. The new era of pharmacovigilance in Europe
2. Getting the most out of current SRSs
3. Combining drug utilization data with spontaneous reports
4. Conclusion
5. Acknowledgements
Chapter 40: Drug utilization research and the regulator's perspective in pharmacovigilance
1. Introduction
2. Specific objectives of drug utilization studies in pharmacovigilance
3. Experience of drug utilization studies in the EU PAS Register
4. Measurement of the effectiveness of risk minimization
5. Measurement of the public health impact of adverse drug reactions
6. Conclusion
7. Disclaimer
Chapter 41: Drug utilization research and outcomes research
1. Introduction
2. Multiple roles of drug utilization in outcome research
3. Advantages and limitations of different sources of drug utilization data in outcomes research studies
4. Conclusion
5. Acknowledgment
Chapter 42: Drug utilization research and pharmacoeconomics
1. Introduction
2. Challenges in health care decision-making
3. Frameworks of economic evaluation
4. Choice of comparator drug
5. Identifying the incidence/prevalence of disease (morbidity data)
6. Describing current treatment pathways or disease management patterns and contributing to cost-of-illness studies
7. Comparative effectiveness and safety
8. Medication adherence
9. Costs of drugs
10. Budget impact analysis
11. Performance-based risk sharing
12. Developing local formulary/clinical practice guidelines
13. Communicating to prescribers
14. Assessing the impact of health policy initiatives
Section H: Assessment and improvement of the quality of medicine use
Chapter 43: Assessment of quality of prescribing using quality indicators
1. Introduction
2. Conceptual framework
3. Diabetes and cardiovascular risk management
4. Medication safety in the elderly
5. Prescribing quality indicators in practice
6. Conclusion
Chapter 44: Quality indicators for patient care in pharmacy practice
1. Introduction
2. Dimensions of quality in pharmacy practice
3. Pharmacy interventions and intervention studies
4. Review of existing and validated quality indicators
5. Application of quality indicators in pharmacy practice
Chapter 45: Interventions that influence prescribing decisions and drug utilization
1. Introduction
2. Classification of interventions
3. Educational/professional interventions
4. Developing an intervention strategy
5. Conclusion
Chapter 46: Development, delivery and evaluation of implementation programmes
1. Introduction
2. Theoretical models of behavioural and organizational change
3. Theoretical models supporting successful implementation programmes
4. Application of these theoretical models to the three stages of implementation programmes: development, implementation and evaluation
5. Conclusion
Chapter 47: Towards a better understanding of prescribing-enhancement interventions
1. Introduction
2. The indeterminate nature of pharmacotherapeutics
3. Classification of interventions which influence prescribing
4. Definitions, boundary delineations and outcome and context problems
5. Complex interventions
6. Evolution of methods of evaluating complex interventions
7. Conclusion

Part 4: Epilogue

Chapter 48: The many futures of drug utilization research
1. Introduction
2. Drivers of the future
3. Promises for the future
4. Caveats for the future
5. The role of patients
6. Conclusion
7. Acknowledgements

Glossary

Index

EULA

List of Tables

Chapter 1

Table 1.1

Chapter 2

Table 2.1
Table 2.2
Table 2.3
Table 2.4
Table 2.5
Table 2.6
Table 2.7
Table 2.8
Table 2.9

Chapter 3

Table 3.1
Table 3.2
Table 3.3

Chapter 4

Table 4.1
Table 4.2
Table 4.3
Table 4.4
Table 4.5

Chapter 5

Table 5.1
Table 5.2
Table 5.3
Table 5.4
Table 5.5
Table 5.6
Table 5.7

Chapter 6

Table 6.1
Table 6.2

Chapter 8

Table 8.1

Chapter 9

Table 9.1
Table 9.2
Table 9.3
Table 9.4
Table 9.5
Table 9.6

Chapter 10

Table 10.1
Table 10.2
Table 10.3

Chapter 11

Table 11.1

Chapter 12

Table 12.1
Table 12.2
Table 12.3
Table 12.4

Chapter 13

Table 13.1
Table 13.2
Table 13.3

Chapter 15

Table 15.1
Table 15.2
Table 15.3
Table 15.4
Table 15.5
Table 15.6

Chapter 16

Table 16.1

Chapter 17

Table 17.1
Table 17.2
Table 17.3
Table 17.4

Chapter 18

Table 18.1
Table 18.2

Chapter 19

Table 19.1
Table 19.2
Table 19.3
Table 19.4

Chapter 20

Table 20.1
Table 20.2
Table 20.3
Table 20.4
Table 20.5
Table 20.6
Table 20.7

Chapter 21

Table 21.1
Table 21.2
Table 21.3
Table 21.4
Table 21.5

Chapter 22

Table 22.1

Chapter 23

Table 23.1

Chapter 24

Table 24.1
Table 24.2
Table 24.3
Table 24.4
Table 24.5

Chapter 25

Table 25.1
Table 25.2
Table 25.3

Chapter 26

Table 26.1
Table 26.2
Table 26.3

Chapter 27

Table 27.1

Chapter 29

Table 29.1
Table 29.2
Table 29.3
Table 29.4
Table 29.5
Table 29.6
Table 29.7
Table 29.8

Chapter 30

Table 30.1
Table 30.2
Table 30.3
Table 30.4

Chapter 34

Table 34.1

Chapter 35

Table 35.1
Table 35.2
Table 35.3

Chapter 36

Table 36.1
Table 36.2
Table 36.3

Chapter 37

Table 37.1
Table 37.2
Table 37.3

Chapter 39

Table 39.1
Table 39.2
Table 39.3

Chapter 40

Table 40.1
Table 40.2
Table 40.3
Table 40.4
Table 40.5
Table 40.6

Chapter 41

Table 41.1

Chapter 42

Table 42.1

Chapter 43

Table 43.1

Chapter 44

Table 44.1
Table 44.2
Table 44.3

Chapter 45

Table 45.1
Table 45.2