Author
Pharmacoepidemiology, the application of epidemiological methods and data to evaluate the use and effects of therapeutics, finds itself at a crucial moment. For a long time, pharmacoepidemiology studies have served an important role in evaluating the safety of therapeutic agents as used in the population. Now, therapeutic risk management initiatives across the world have started to change the way the benefits and risks of therapeutic agents are evaluated and improved. Risk management addresses: systematic and planned estimation and evaluation of risk, determination of acceptable level of risk, communication of risk, implementation of interventions to minimize risk, and evaluation of the effectiveness of these activities. Most of these activities are not new. What is probably the largest change – and it is an important one – is the systematic, planned and integrated implementation thereof. As therapeutic safety risk management principles are applied, pharmacoepidemiology studies will grow both in number and in relative importance. Professionals working in this area are increasingly expected to provide both the population-based evidence through pharmacoepidemiological studies, as well as the public health perspective to propose, plan and evaluate these activities.
As we enter a period of heightened interest in pharmacoepidemiology, it is a good time to look back at the development of our field. When I was asked by the Esteve Foundation to provide a list of the 20–25 papers that have shaped the discipline of pharmacoepidemiology, I wanted to include a range of examples that have made an impact on the field because of the relevance of the topic, the method employed, the pioneering role, or the controversy they generated. I chose to include not only my personal choice, but also one that could represent, at least in some way, the views of other professionals in the field. The idea was not so much a systematic criteria-driven selection process, but a more personal reflection. I asked a number of colleagues, most of them long-time researchers, and current or past Officers of the International Society for Pharmacoepidemiology, ISPE, to think back about reading studies that impacted our work as pharmacoepidemiologists. Many responded to the call, and their help is much appreciated.
I hope that you enjoy this selection.
Susanne Pérez-Gutthann
Past president, International Society for Pharmacoepidemiology
Senior Director of Epidemiology, Pfizer Worldwide Development, Barcelona, Spain
Full document | ||
Full PDF | Susanne Pérez-Gutthann | [wpdm type=”btn3″] |
Chapters | ||
Acknowledgements | [wpdm id=30 type=”btn”] | |
Introduction | S Pérez-Gutthann | [wpdm id=32 type=”btn”] |
Index | [wpdm id=31 type=”btn”] | |
1. Thalidomide and congenital abnormalities | WG. McBride | [wpdm type=”btn3″] |
2. The design and logic of a monitor of drug use | DJ. Finney | [wpdm type=”btn3″] |
3. Thromboembolic disease and the steroidal content of oral contraceptives: A report to the Committee on Safety of Drugs | WHW. Inman / MP. Vessey / B. Westerholm / A. Engelund | [wpdm type=”btn3″] |
4. Adenocarcinoma of the vagina. Association of maternal stilbestrol therapy with tumor appearance in young women | AL. Herbest / H. Ulfelder / DC. Poskanzer | [wpdm type=”btn3″] |
5. Regular aspirin intake and acute myocardial infarction | Boston Collaborative Drug Surveillance Group | [wpdm type=”btn3″] |
6. Confounding and effect-modification | OS. Miettinen | [wpdm type=”btn3″] |
7. Drug evaluation after marketing | D. Slone / S. Shapiro / OS. Miettinen / WD. Finkle / PD. Stolley | [wpdm type=”btn3″] |
8. The central role of the propensity score in observational studies for causal effects | PR. Rosenbaum / DB. Rubin | [wpdm type=”btn3″] |
9. Postmarketing studies of drug efficacy: How? | BL. Strom / OS. Miettinen / KL. Melmon | [wpdm type=”btn3″] |
10. Risks of agranulocytosis and aplastic anemia. A first report of their relation to drug use with special reference to analgesics | The International Agranulocytosis and Aplastic Anemia Study | [wpdm type=”btn3″] |
11. Psychotropic drug use and the risk of hip fracture | WA. Ray / MR. Griffin / W. Schaffner / DK. Baugh / LJ. Melton | [wpdm type=”btn3″] |
12. Prescribed fenoterol and death from asthma in New Zealand, 1981-83: Case-control study | J. Crane / N. Pearce / A. Flatt / C. Burgess / R. Jackson / T. Kwong / M. Ball / R. Beasley | [wpdm type=”btn3″] |
13. The role of automated record linkage in the postmarketing surveillance of drug safety: A critique | S. Shapiro | [wpdm type=”btn3″] |
14. The future of automated record linkage for postmarketing surveillance: A response to Shapiro | GA. Faich / BV. Stadel | [wpdm type=”btn3″] |
15. The case-crossover design: A method for studying transient effects on the risk of acute events | M. Maclure | [wpdm type=”btn3″] |
16. Nonsteroidal anti-inflammatory drug use and increased risk for peptic ulcer disease in elderly persons | MR. Griffin / JM. Piper / JR. Daugherty / M. Snowden / WA. Ray | [wpdm type=”btn3″] |
17. Validation of information recorded on general practitioner based computerized data resource in the United Kingdom | H. Jick / SS. Jick / LE. Derby | [wpdm type=”btn3″] |
18. The use of beta-agonists and the risk of death and near death from asthma | WO. Spitzer / S. Suissa / P. Ernst / RI. Horwitz / B. Habbick / D. Cockcroft / JF. Boivin / M. McNutt / AS. Buist / AS. Rebuck | [wpdm type=”btn3″] |
19. The increased risk of hospitalizations for acute liver injury in a population with exposure to multiple drugs | S. Pérez Gutthann / LA. García Rodríguez | [wpdm type=”btn3″] |
20. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs | LAG. Rodríguez / H. Jick | [wpdm type=”btn3″] |
21. Risk of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs | MJS. Langman / J. Weil / P. Wainwright / DH. Lawson / MD. Rawlins / RFA. Logan / M. Murphy / MP. Vessey / DG. Colin-Jones | [wpdm type=”btn3″] |
22. The case-time-control design | S. Suissa | [wpdm type=”btn3″] |
23. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components | H. Jick / SS. Jick / V. Gurewich / M. Myers / C. Vasilakis | [wpdm type=”btn3″] |
24. Third generation oral contraceptives and risk of venous thromboembolic disorders: An international case-control study | WO. Spitzer / MA. Lewis / LAJ. Heinemann / M. Thorogood / KD. MacRae | [wpdm type=”btn3″] |
25. Appetite-suppressant drugs and the risk of primary pulmonary hypertension | L. Abenhaim / Y. Moride / F. Brenot / S. Rich / J. Benichou / X. Kurz / T. Higenbottam / C. Oakley / E. Wouters / M. Aubier / G. Simonneau / B. Begaud | [wpdm type=”btn3″] |
26. A population-based study of appetite-suppressant drugs and the risk of cardiac-valve regurgitation | H. Jick / C. Vasilakis / LA. Weinrauch / CR. Meier / SS. Jick / LE. Derby | [wpdm type=”btn3″] |
27. A comparison of the risks of venous thromboembolic disease in association with different combined oral contraceptives | RDT. Farmer / RA. Lawrenson / JC. Todd / TJ. Williams / KD. MacRae / F. Tyrer / GM. Leydon | [wpdm type=”btn3″] |