Drug Utilization Research: Methods and Applications

Towards a better understanding of how medicines are used in society

Drug Utilization Research (DUR) is a discipline which combines aspects of pharmacotherapy, epidemiology, and health services research into an interdisciplinary set of methods for analyzing and assessing the prescribing, dispensing and consumption of medicines. It combines both qualitative and quantitative approaches to facilitate the safe and effective use of pharmaceuticals. Drug Utilization Research: Methods and Applications provides a comprehensive introduction to this discipline, prepared by an international team of authors with broad experience in numerous fields. Now reorganized and updated to reflect the latest research and global challenges, it is an indispensable resource for understanding the use of pharmaceuticals.

Readers of the second edition of Drug Utilization Research will find:

• New chapters on methods, including more hands-on guidance on how to plan and conduct different types of drug utilization
• A section on specific applications in areas such as psychotropics, opioids, cancer drugs, antibacterials, and cardiovascular drugs
• A new section with case studies illustrating applications of DUR in different continents
• Detailed treatment of subjects including DUR and health policy, DUR in specific populations, and many more

Drug Utilization Research is ideal for epidemiologists, pharmacists, physicians, nurses and others interested in drug use and its outcomes.

List of contributors ix

Preface to the second edition xvii

Acknowledgements xix

About the companion website xxiii

Part 1 Introduction to drug utilization research 1

1 Introduction to drug utilization research 3
Björn Wettermark, Monique Elseviers, Tanja Mueller, Anna Birna Almarsdottir, Ria Benkö, Marion Bennie, Irina Iaru, Katarina Gvozdanovic, Mikael Hoffmann, Verica Ivanovska, Seán MacBride-Stewart, Elisabetta Poluzzi, Lisa G. Pont, Hege Salvesen Blix, Gabriel Sanfelix-Gimeno, Gisbert W. Selke, Katja Taxis, Ana Tomas Petrovic, Indre Treciokiene, and Sabine Vogler

Part 2 Methodology of drug utilization research 15

2.1 Research methods in drug utilization research 17
Björn Wettermark, Indre Treciokiene, Sofia Kälvemark Sporrong, and Louise C. Druedahl

2.2 Qualitative methods in drug utilization research 25
Louise C. Druedahl and Sofia Kälvemark Sporrong

2.3 Quantitative studies in drug utilization research 41
Björn Wettermark, Monique Elseviers, and Cristina Mihaela Ghiucic

2.4 Descriptive studies in drug utilization research 51
Cristina Mihaela Ghiciuc, Indre Treciokiene, Björn Wettermark, and Monique Elseviers

2.5 Analytical studies in drug utilization research 63
Per-Jostein Samuelsen, Björn Wettermark, and Monique Elseviers

2.6 Intervention studies in drug utilisation research 73
Tanja Mueller, Giampiero Mazzaglia, and Carlos E. Durán

2.7 Statistics in drug utilization research 82
Monique Elseviers

2.8 Primary drug utilization data 95
Tatiana Chama Borges Luz and Evalill Nilsson

2.9 Secondary drug utilization data 104
Mohammadhossein Hajiebrahimi, Lisa G. Pont, and Kristina Garuoliene

2.10 Classification systems in drug utilization 115
Hege Salvesen Blix, Stuart McTaggart, and Robert Vander Stichele

2.11 Measuring volumes in drug utilization 126
Hege Salvesen Blix and Mikael Hoffmann

2.12 Measuring price and expenditure in drug utilization 137
Sabine Vogler

2.13 Aggregate-level drug utilization analyses 148
Indre Treciokiene and Claudia Garcia Serpa Osorio-de-Castro

2.14 Individual-level drug utilization analyses 158
Lotte Rasmussen, Björn Wettermark, Mikael Hoffmann, and Douglas Steinke

2.15 Multilevel analyses in drug utilization research 169
Juan Merlo and George Leckie

2.16 Visualization of drug utilization data 188
Maria Matuz, Ria Benko, and Mikael Hoffmann

2.17 Artificial intelligence and machine learning in drug utilization research 205
Maurizio Sessa, Saeed Shakibfar, Morten Andersen, and Jing Zhao

2.18 Ethics in drug utilization research 215
Indre Treciokiene, Sofia Kälvemark Sporrong, Björn Wettermark, and Louise C. Druedahl

Part 3 Applied drug utilization research 223

Section 3.1 Drug utilization research and health policy 225

3.1.1 Pharmaceutical policy and drug utilization: Definitions, concepts, and taxonomies 225
Sabine Vogler and Anna Birna Almarsdóttir

3.1.2 Managed introduction of new medicines in healthcare systems 233
Irina Iaru and Sabine Vogler

3.1.3 Promoting appropriate use of medicines in a healthcare system 248
Marion Bennie, Amanj Kurdi, and Yared Santa-Ana-Téllez

Section 3.2 Comparative drug utilization research 258

3.2.1 Introduction to comparative drug utilization research 258
Seán MacBride-Stewart and Ana Tomas Petrovic

3.2.2 Comparison of drug utilization across countries 260
Yared Santa-Ana Tellez and Monique Elseviers

3.2.3 Comparative drug utilization research comparing regions within countries 271
Seán MacBride-Stewart

3.2.4 Comparison of drug utilization across different prescribers and different health care settings 280
Seán MacBride-Stewart, Ksenia Zagorodnikova, and Irene Langner

3.2.5 Comparative drug utilization research comparing different patients 292
Ana Tomas Petrovic and Mia von Euler

Section 3.3 Drug utilization research in specific populations 303

3.3.1 Drug utilization in pregnant women 303
Hedvig Nordeng and Marleen van Gelder

3.3.2 Drug utilization in the paediatric population 314
Antonio Clavenna and Ingvild Odsbu

3.3.3 Drug utilization in older people 321
Petra Denig and Katharina Schmidt-Mende

Section 3.4 Drug utilization research in specific therapeutic areas 331

3.4.1 Introduction to methodological issues in specific therapeutic areas 331

3.4.2 Drug utilization research on cardiovascular medicines 332
Elisabetta Poluzzi, Ana Tomas Petrovic, and Björn Wettermark

3.4.3 Drug utilization research on antibacterials 342
Ria Benko and Samuel Coenen

3.4.4 Drugs utilization research in specific therapeutic areas - opioids 352
Aleksi Hamina, Svetlana Skurtveit, and Mikael Hoffmann

3.4.5 Drug utilization research on selected psychotropics 363
Jonathan Brett and Helga Zoega

3.4.6 Drug utilization research in the area of cancer drugs 373
Tanja Mueller and Mikael Hoffmann

Section 3.5 Adherence and drug utilization research 381

3.5.1 Introduction to medication adherence research 381
Bernard Vrijens

3.5.2 Assessment of medication adherence in field research 387
Monique Elseviers and Bernard Vrijens

3.5.3 Assessment of medication adherence in databases 397
Gabriel Sanfélix Gimeno and Tanja Mueller

3.5.4 Interventions to improve medication adherence 406
Catherine Goetzinger and Marie P. Schneider

3.5.5 Digital tools and medication adherence 419
Alexandra L. Dima, Urska Nabergoj-Makovec, and Job F.M. van Boven

Section 3.6 The role of drug utilization in the broader field of health research 428

3.6.1 Risk management and drug utilization research 428
Giampiero Mazzaglia, Ippazio Cosimo Antonazzo, and Peter Mol

3.6.2 Pharmacovigilance and drug utilization research 437
Katarina Gvozdanovic, Bernard Begauld, and Emanuel Raschi

3.6.3 The role of drug utilization in outcomes research 445
Henrik Toft Sørensen, Gianluca Trifirò, and Evalill Nilsson

3.6.4 Pharmacoeconomics and drug utilization research 456
Cara Usher, Kathleen Bennett, Lorenzo G. Mantovani, and Dyfrig Hughes

3.6.5 The environment and drug utilisation research 464
Marmar Nekoro, Johanna Villén, and Ana Tomas Petrovic

Section 3.7 Assessment and improvement of the quality of medicine use 482

3.7.1 Defining the quality of medicines use 482
Seán MacBride-Stewart

3.7.2 Assessing the quality of medication use 488
Petra Denig, Björn Wettermark, and Wade Thompson

3.7.3 Challenges in the quality of medicine use 498
Katja Taxis and Carl Llor

3.7.4 Development and evaluation of interventions to improve the quality of medicine use 505
Seán MacBride-Stewart and Katja Taxis

3.7.5 Implementation of interventions to enhance quality use of medicines 517
Liset van Dijk and Marcia Vervloet

3.7.6 Patient perspectives 525
Janine Traulsen and Janet Krska

Part 4 Drug utilization research around the world 535

4.1 Introduction to drug utilization research around the world 537
Monique Elseviers

4.2 Drug utilization research in Africa 541
Ilse Truter, Johanita Burger, and Joseph Fadare

4.3 Drug utilization research in the Eastern Mediterranean region 546
Mamoon A. Aldeyab, Zainab Said Al-Hashimy, and Maha Talaat

4.4 Drug utilization research in South-East Asia 551
Anita Kotwani, Nithima Sumpradit, and Aminath Moomina

4.5 Drug utilization research in the Western Pacific Region 557
Lisa G. Pont, Tuan Anh Nguyen, and Elizabeth Roughead

4.6 Drug utilization research in North America 563
Juan M. Hincapie-Castillo, Shawn Bugden, and Ingrid Sketris

4.7 Drug utilization research in South and Central America 569
Claudia Garcia Serpa Osorio-de-Castro, Luciane Cruz Lopes, and Carlos E. Durán

4.8 Drug utilization research in Europe 574
Marion Bennie, Lotte Rasmussen, and Janne Sepp

4.9 The Glasgow Declaration 580
Monique Elseviers, Björn Wettermark, Tanja Mueller, Anna Birna Almarsdottir, Ria Benkö, Marion Bennie, Irina Iaru, Katarina Gvozdanovic, Mikael Hoffmann, Verica Ivanovska, Seán MacBride-Stewart, Elisabetta Poluzzi, Lisa G. Pont, Hege Salvesen Blix, Gabriel Sanfelix-Gimeno, Gisbert W. Selke, Katja Taxis, Ana Tomas Petrovic, Indre Treciokiene, and Sabine Vogler

Index 583

Editors

Monique Elseviers, Björn Wettermark, Tanja Mueller, Ria Benkő, Marion Bennie, Katarina Gvozdanović, Mikael Hoffmann, Irina Iaru, Verica Ivanovska, Seán MacBride-Stewart, Elisabetta Poluzzi, Lisa Pont, Hege Salvesen Blix, Gabriel Sanfélix-Gimeno, Gisbert Selke, Katja Taxis, Ana Tomas Petrović, Indrė Trečiokienė, Sabine Vogler