Skip to main content

Pharmacoepidemiology

  • Reference work entry

Abstract

In the last decades we have witnessed a tremendous progress in the medical sciences that has led to the development of a great number of new powerful pharmaceuticals. These new medicines enable us to provide much better medical care, but occasionally they will cause harm and give rise to serious adverse reactions that were unexpected from preclinical studies or premarketing clinical trials. Against this background, pharmacoepidemiology has developed as a scientific discipline at the interface between clinical pharmacology and clinical epidemiology (cf. chapter Clinical Epidemiology and Evidence-Based Health Care of this handbook). Pharmacoepidemiology can be defined as the application of epidemiological knowledge, methods, and reasoning to the study of the effects and uses of drugs in human populations (Porta et al. 1997). The application of epidemiological methods – i.e., the use of non-experimental observational techniques – the epidemiological perspective with an emphasis on investigations in large unselected populations and long-term studies, the public health approach, and the philosophy of epidemiology are all extended to the scope of clinical pharmacology, i.e., the study of the effects of pharmaceuticals in humans.

This is a preview of subscription content, log in via an institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   999.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD   1,399.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

References

  • Abascal VM, Larson MG, Evans JC, Blohm AT, Poli K, Levy D (1998) Calcium antagonists and mortality risk in men and women with hypertension in the Framingham Heart Study. Arch Intern Med 158:1882–1886

    CAS  PubMed  Google Scholar 

  • Abenhaim L, Moride Y, Brenot F, Rich S, Benichou J, Kurz X, Higenbottam T, Oakley C, Wouters E, Aubier M, Simonneau G, Begaud B (1996) Appetite-suppressant drugs and the risk of primary pulmonary hypertension. International Primary Pulmonary Hypertension Study Group. N Engl J Med 335:609–616

    CAS  PubMed  Google Scholar 

  • Adams RJ, Fuhlbrigge AL, Finkelstein JA, Weiss ST (2002) Intranasal steroids and the risk of emergency department visits for asthma. J Allergy Clin Immunol 109:636–642

    CAS  PubMed  Google Scholar 

  • Almenoff JS, Pattishall EN, Gibbs TG, DuMouchel W, Evans SJ, Yuen N (2007) Novel statistical tools for monitoring the safety of marketed drugs. Clin Pharmacol Ther 82:157–166

    CAS  PubMed  Google Scholar 

  • Amann U, Schmedt N, Garbe E (2012) Prescribing of potentially inappropriate medications for the elderly: an analysis based on the PRISCUS list. Dtsch Arztebl Int 109:69–75

    PubMed Central  PubMed  Google Scholar 

  • Andersohn F, Schade R, Suissa S, Garbe E (2009) Long-term use of antidepressants for depressive disorders and the risk of diabetes mellitus. Am J Psychiatry 166:591–598

    PubMed  Google Scholar 

  • Anonymous (1986) 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. JAMA 256:1749–1757

    Google Scholar 

  • Anonymous (1995a) Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case-control study. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Lancet 346:1575–1582

    Google Scholar 

  • Anonymous (1995b) Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Lancet 346:1582–1588

    Google Scholar 

  • Azoulay L, Schneider-Lindner V, Dell’Aniello S, Filion KB, Suissa S (2010) Thiazolidinediones and the risk of incident strokes in patients with type 2 diabetes: a nested case-control study. Pharmacoepidemiol Drug Saf 19:343–350

    CAS  PubMed  Google Scholar 

  • Barbone F, McMahon AD, Davey PG, Morris AD, Reid IC, McDevitt DG, MacDonald TM (1998) Association of road-traffic accidents with benzodiazepine use. Lancet 352:1331–1336

    CAS  PubMed  Google Scholar 

  • Bate A, Lindquist M, Edwards IR, Olsson S, Orre R, Lansner A, De Freitas RM (1998) A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 54:315–321

    CAS  PubMed  Google Scholar 

  • Bate A, Lindquist M, Edwards IR (2008) The application of knowledge discovery in databases to post-marketing drug safety: example of the WHO database. Fundam Clin Pharmacol 22:127–140

    CAS  PubMed  Google Scholar 

  • Begaud B, Martin K, Haramburu F, Moore N (2002) Rates of spontaneous reporting of adverse drug reactions in France. JAMA 288:1588

    PubMed  Google Scholar 

  • Behr S, Andersohn F, Garbe E (2010) Risk of intracerebral hemorrhage associated with phenprocoumon exposure: a nested case-control study in a large population-based German database. Pharmacoepidemiol Drug Saf 19:722–730

    PubMed  Google Scholar 

  • Behr S, Schill W, Pigeot I (2012) Does additional confounder information alter the estimated risk of bleeding associated with phenprocoumon use-results of a two-phase study. Pharmacoepidemiol Drug Saf 21:535–545

    CAS  PubMed  Google Scholar 

  • Beiderbeck-Noll AB, Sturkenboom MC, van der Linden PD, Herings RM, Hofman A, Coebergh JW, Leufkens HG, Stricker BH (2003) Verapamil is associated with an increased risk of cancer in the elderly: the Rotterdam study. Eur J Cancer 39:98–105

    CAS  PubMed  Google Scholar 

  • Benichou C (1994) Imputability of unexpected or toxic drug reactions. The official French method of causality assessment. In: Benichou C (ed) Adverse drug reactions. A practical guide to diagnosis and management. Wiley, Chichester, pp 271–275

    Google Scholar 

  • Blais L, Ernst P, Boivin JF, Suissa S (1998a) Inhaled corticosteroids and the prevention of readmission to hospital for asthma. Am J Respir Crit Care Med 158:126–132

    CAS  PubMed  Google Scholar 

  • Blais L, Suissa S, Boivin JF, Ernst P (1998b) First treatment with inhaled corticosteroids and the prevention of admissions to hospital for asthma. Thorax 53:1025–1029

    CAS  PubMed Central  PubMed  Google Scholar 

  • Bloemenkamp KW, Rosendaal FR, Helmerhorst FM, Buller HR, Vandenbroucke JP (1995) Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen. Lancet 346:1593–1596

    CAS  PubMed  Google Scholar 

  • Bodmer M, Becker C, Meier C, Jick SS, Meier CR (2012) Use of antidiabetic agents and the risk of pancreatic cancer: a case-control analysis. Am J Gastroenterol 107:620–626

    CAS  PubMed  Google Scholar 

  • Brauchli YB, Jick SS, Meier CR (2011) Statin use and risk of first-time psoriasis diagnosis. J Am Acad Dermatol 65:77–83

    PubMed  Google Scholar 

  • Brookhart MA, Wang PS, Solomon DH, Schneeweiss S (2006a) Instrumental variable analysis of secondary pharmacoepidemiologic data. Epidemiology 17:373–374

    PubMed  Google Scholar 

  • Brookhart MA, Wang PS, Solomon DH, Schneeweiss S (2006b) Evaluating short-term drug effects using a physician-specific prescribing preference as an instrumental variable. Epidemiology 17:268–275

    PubMed Central  PubMed  Google Scholar 

  • Brookhart MA, Rassen JA, Schneeweiss S (2010) Instrumental variable methods in comparative safety and effectiveness research. Pharmacoepidemiol Drug Saf 19:537–554

    PubMed Central  PubMed  Google Scholar 

  • Carson JL, Strom BL, Soper KA, West SL, Morse ML (1987) The association of nonsteroidal anti-inflammatory drugs with upper gastrointestinal tract bleeding. Arch Intern Med 147:85–88

    CAS  PubMed  Google Scholar 

  • Chen H, Zhang SM, Hernan MA, Schwarzschild MA, Willett WC, Colditz GA, Speizer FE, Ascherio A (2003) Nonsteroidal anti-inflammatory drugs and the risk of Parkinson disease. Arch Neurol 60:1059–1064

    PubMed  Google Scholar 

  • Clinical Practice Research Datalink (2012) Welcome to CPRD – Clinical Practice Research Datalink. http://www.cprd.com. Accessed 9 Feb 2012

  • Colditz GA, Hankinson SE, Hunter DJ, Willett WC, Manson JE, Stampfer MJ, Hennekens C, Rosner B, Speizer FE (1995) The use of estrogens and progestins and the risk of breast cancer in postmenopausal women. N Engl J Med 332:1589–1593

    CAS  PubMed  Google Scholar 

  • Confavreux C, Suissa S, Saddier P, Bourdes V, Vukusic S (2001) Vaccinations and the risk of relapse in multiple sclerosis. Vaccines in Multiple Sclerosis Study Group. N Engl J Med 344:319–326

    CAS  PubMed  Google Scholar 

  • Corrao G, Zambon A, Faini S, Bagnardi V, Leoni O, Suissa S (2005) Short-acting inhaled beta-2-agonists increased the mortality from chronic obstructive pulmonary disease in observational designs. J Clin Epidemiol 58:92–97

    PubMed  Google Scholar 

  • de la Porte M, Reith D, Tilyard M (2002) Impact of safety alerts upon prescribing of cisapride to children in New Zealand. N Z Med J 115:U24

    PubMed  Google Scholar 

  • Dietlein G, Schroder-Bernhardi D (2002) Use of the mediplus patient database in healthcare research. Int J Clin Pharmacol Ther 40:130–133

    CAS  PubMed  Google Scholar 

  • Dietlein G, Schroder-Bernhardi D (2003) Doctors’ prescription behaviour regarding dosage recommendations for preparations of kava extracts. Pharmacoepidemiol Drug Saf 12:417–421

    CAS  PubMed  Google Scholar 

  • Donahue JG, Weiss ST, Livingston JM, Goetsch MA, Greineder DK, Platt R (1997) Inhaled steroids and the risk of hospitalization for asthma. JAMA 277:887–891

    CAS  PubMed  Google Scholar 

  • Donnan PT, Wang J (2001) The case-crossover and case-time-control designs in pharmacoepidemiology. Pharmacoepidemiol Drug Saf 10:259–262

    CAS  PubMed  Google Scholar 

  • Downey W, Beck P, McNutt M, Stang M, Osei W, Nichol J (2003) Health databases in Saskatchewan. In: Strom BL (ed) Pharmacoepidemiology. Wiley, Chichester, pp 325–345

    Google Scholar 

  • DuMouchel W (1999) Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat 53:177–202

    Google Scholar 

  • Ekedahl A, Mansson N (2004) Unclaimed prescriptions after automated prescription transmittals to pharmacies. Pharm World Sci 26:26–31

    PubMed  Google Scholar 

  • Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH (1999) Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 48:623–627

    CAS  PubMed Central  PubMed  Google Scholar 

  • Esposito D, Schone E, Williams T, Liu S, Cybulski K, Stapulonis R, Clusen N (2008) Prevalence of unclaimed prescriptions at military pharmacies. J Manag Care Pharm 14:541–552

    PubMed  Google Scholar 

  • Essebag V, Genest J Jr, Suissa S, Pilote L (2003) The nested case-control study in cardiology. Am Heart J 146:581–590

    PubMed  Google Scholar 

  • Etienney I, Beaugerie L, Viboud C, Flahault A (2003) Non-steroidal anti-inflammatory drugs as a risk factor for acute diarrhoea: a case crossover study. Gut 52:260–263

    CAS  PubMed Central  PubMed  Google Scholar 

  • Evans SJ, Waller PC, Davis S (2001) Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 10:483–486

    CAS  PubMed  Google Scholar 

  • Fagot JP, Mockenhaupt M, Bouwes-Bavinck JN, Naldi L, Viboud C, Roujeau JC (2001) Nevirapine and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis. AIDS 15:1843–1848

    CAS  PubMed  Google Scholar 

  • Faich GA (1986) Adverse-drug-reaction monitoring. N Engl J Med 314:1589–1592

    CAS  PubMed  Google Scholar 

  • Fairfield KM, Hunter DJ, Fuchs CS, Colditz GA, Hankinson SE (2002) Aspirin, other NSAIDs, and ovarian cancer risk (United States). Cancer Causes Control 13:535–542

    PubMed  Google Scholar 

  • Farrington CP (1995) Relative incidence estimation from case series for vaccine safety evaluation. Biometrics 51:228–235

    CAS  PubMed  Google Scholar 

  • Farrington P, Pugh S, Colville A, Flower A, Nash J, Morgan-Capner P, Rush M, Miller E (1995) A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 345:567–569

    CAS  PubMed  Google Scholar 

  • Feenstra J, Heerdink ER, Grobbee DE, Stricker BH (2002) Association of nonsteroidal anti-inflammatory drugs with first occurrence of heart failure and with relapsing heart failure: the Rotterdam study. Arch Intern Med 162:265–270

    CAS  PubMed  Google Scholar 

  • Felson DT, Sloutskis D, Anderson JJ, Anthony JM, Kiel DP (1991) Thiazide diuretics and the risk of hip fracture. Results from the Framingham Study. JAMA 265:370–373

    CAS  PubMed  Google Scholar 

  • Friedman DE, Habel LA, Boles M, McFarland BH (2000) Kaiser Permanente Medical Care Program: Division of Research, Northern California, and Center for Health Research, Northwest Division. In: Strom BL (ed) Pharmacoepidemiology. Wiley, Chichester, pp 263–283

    Google Scholar 

  • Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ (1999) The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 281:1728–1734

    CAS  PubMed  Google Scholar 

  • Funkhouser EM, Sharp GB (1995) Aspirin and reduced risk of esophageal carcinoma. Cancer 76:1116–1119

    CAS  PubMed  Google Scholar 

  • Furu K (2008) Establishment of the nationwide Norwegian Prescription Database (NorPD) – new opportunities for research in pharmacoepidemiology in Norway. Norsk Epidemiologi 18: 129–136

    Google Scholar 

  • Furu K, Wettermark B, Andersen M, Martikainen JE, Almarsdottir AB, Sorensen HT (2010) The Nordic countries as a cohort for pharmacoepidemiological research. Basic Clin Pharmacol Toxicol 106:86–94

    CAS  PubMed  Google Scholar 

  • Garbe E, LeLorier J, Boivin JF, Suissa S (1997) Inhaled and nasal glucocorticoids and the risks of ocular hypertension or open-angle glaucoma. JAMA 277:722–727

    CAS  PubMed  Google Scholar 

  • Garbe E, Boivin JF, LeLorier J, Suissa S (1998a) Selection of controls in database case-control studies: glucocorticoids and the risk of glaucoma. J Clin Epidemiol 51:129–135

    CAS  PubMed  Google Scholar 

  • Garbe E, Suissa S, LeLorier J (1998b) Association of inhaled corticosteroid use with cataract extraction in elderly patients. JAMA 280:539–543

    CAS  PubMed  Google Scholar 

  • Garbe E, Suling M, Kloss S, Lindemann C, Schmid U (2011) Linkage of mother-baby pairs in the German Pharmacoepidemiological Research Database. Pharmacoepidemiol Drug Saf 20:258–264

    PubMed  Google Scholar 

  • Garcia Rodriguez LA, Perez GS (1998) Use of the UK General Practice Research Database for pharmacoepidemiology. Br J Clin Pharmacol 45:419–425

    CAS  PubMed Central  PubMed  Google Scholar 

  • Giovannucci E, Rimm EB, Stampfer MJ, Colditz GA, Ascherio A, Willett WC (1994) Aspirin use and the risk for colorectal cancer and adenoma in male health professionals. Ann Intern Med 121:241–246

    CAS  PubMed  Google Scholar 

  • Glessner MR, Heller DA (2002) Changes in related drug class utilization after market withdrawal of cisapride. Am J Manag Care 8:243–250

    PubMed  Google Scholar 

  • GPRD (2012) The Gold Standard of Healthcare Data. http://www.gprd.com/gprd/goldstandard.asp. Accessed 9 Feb 2012

  • Greenland S (1996) Confounding and exposure trends in case-crossover and case-time-control design. Epidemiology 7:231–239

    CAS  PubMed  Google Scholar 

  • Griffin JP (1986) Survey of the spontaneous adverse drug reaction reporting schemes in fifteen countries. Br J Clin Pharmacol 22:83S–100S

    PubMed Central  PubMed  Google Scholar 

  • Grodstein F, Stampfer MJ, Manson JE, Colditz GA, Willett WC, Rosner B, Speizer FE, Hennekens CH (1996) Postmenopausal estrogen and progestin use and the risk of cardiovascular disease. N Engl J Med 335:453–461

    CAS  PubMed  Google Scholar 

  • Grodstein F, Martinez ME, Platz EA, Giovannucci E, Colditz GA, Kautzky M, Fuchs C, Stampfer MJ (1998) Postmenopausal hormone use and risk for colorectal cancer and adenoma. Ann Intern Med 128:705–712

    CAS  PubMed  Google Scholar 

  • Group Health (2012) About us. http://www.ghc.org/about_gh/index.jhtml. Accessed 8 Feb 2012

  • Haramburu F, Tubert-Bitter P, Begaud B (1992) Trends in spontaneous reporting. Post Mark Surveill 6:129–134

    Google Scholar 

  • Haramburu F, Begaud B, Moride Y (1997) Temporal trends in spontaneous reporting of unlabelled adverse drug reactions. Br J Clin Pharmacol 44:299–301

    CAS  PubMed Central  PubMed  Google Scholar 

  • Hartnell NR, Wilson JP (2004) Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacotherapy 24:743–749

    PubMed  Google Scholar 

  • Hee KJ, Grodstein F (2003) Regular use of nonsteroidal anti-inflammatory drugs and cognitive function in aging women. Neurology 60:1591–1597

    Google Scholar 

  • Hennessy S, Strom BL (2000) Nonsedating antihistamines should be preferred over sedating antihistamines in patients who drive. Ann Intern Med 132:405–407

    CAS  PubMed  Google Scholar 

  • Hernan MA, Robins JM (2006) Instruments for causal inference: an epidemiologist’s dream? Epidemiology 17:360–372

    PubMed  Google Scholar 

  • Hernan MA, Hohol MJ, Olek MJ, Spiegelman D, Ascherio A (2000) Oral contraceptives and the incidence of multiple sclerosis. Neurology 55:848–854

    CAS  PubMed  Google Scholar 

  • Hernandez-Avila M, Liang MH, Willett WC, Stampfer MJ, Colditz GA, Rosner B, Chang RW, Hennekens CH, Speizer FE (1990) Exogenous sex hormones and the risk of rheumatoid arthritis. Arthritis Rheum 33:947–953

    CAS  PubMed  Google Scholar 

  • Hernandez-Diaz S, Hernan MA, Meyer K, Werler MM, Mitchell AA (2003) Case-crossover and case-time-control designs in birth defects epidemiology. Am J Epidemiol 158:385–391

    PubMed  Google Scholar 

  • Horwitz RI, Feinstein AR (1981) Improved observational method for studying therapeutic efficacy. Suggestive evidence that lidocaine prophylaxis prevents death in acute myocardial infarction. JAMA 246:2455–2459

    CAS  PubMed  Google Scholar 

  • Hubbard RB, Smith CJ, Smeeth L, Harrison TW, Tattersfield AE (2002) Inhaled corticosteroids and hip fracture: a population-based case-control study. Am J Respir Crit Care Med 166:1563–1566

    PubMed  Google Scholar 

  • Hubbard R, Farrington P, Smith C, Smeeth L, Tattersfield A (2003) Exposure to tricyclic and selective serotonin reuptake inhibitor antidepressants and the risk of hip fracture. Am J Epidemiol 158:77–84

    PubMed  Google Scholar 

  • IPCI (2012a) Interdisciplinary Processing of Clinical Information (IPCI) – information. http://www.ipci.nl/Framework/Frames.php?language=UK&subsite=Publications. Accessed 13 Feb 2012

  • IPCI (2012b) Interdisciplinary Processing of Clinical Information. http://www.ipci.nl. Accessed 13 Feb 2012

  • Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C (1995) Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet 346:1589–1593

    CAS  PubMed  Google Scholar 

  • Jobski K, Behr S, Garbe E (2011) Drug interactions with phenprocoumon and the risk of serious haemorrhage: a nested case-control study in a large population-based German database. Eur J Clin Pharmacol 67:941–951

    PubMed  Google Scholar 

  • Kaiser Permanente (2012a) Who we are. http://www.kaiserpermanentejobs.org/northern-california.aspx. Accessed 8 Feb 2012

  • Kaiser Permanente (2012b) Press releases: Northwest. http://xnet.kp.org/newscenter/pressreleases/nw/2011/062711gateway.html. Accessed 8 Feb 2012

  • Kaufman DW, Kelly JP, Jurgelon JM, Anderson T, Issaragrisil S, Wiholm BE, Young NS, Leaverton P, Levy M, Shapiro S (1996) Drugs in the aetiology of agranulocytosis and aplastic anaemia. Eur J Haematol Suppl 60:23–30

    CAS  PubMed  Google Scholar 

  • KELA – The Social Insurance Institution of Finland (2012) Statistics on reimbursements for medical expenses. http://www.kela.fi/in/internet/english.nsf/NET/151008123439AS?OpenDocument. Accessed 14 Feb 2012

  • Kelly JP, Rosenberg L, Kaufman DW, Shapiro S (1990) Reliability of personal interview data in a hospital-based case-control study. Am J Epidemiol 131:79–90

    CAS  PubMed  Google Scholar 

  • Kennedy J, Tuleu I, Mackay K (2008) Unfilled prescriptions of medicare beneficiaries: prevalence, reasons, and types of medicines prescribed. J Manag Care Pharm 14:553–560

    PubMed  Google Scholar 

  • Ki M, Park T, Yi SG, Oh JK, Choi B (2003) Risk analysis of aseptic meningitis after measles-mumps-rubella vaccination in Korean children by using a case-crossover design. Am J Epidemiol 157:158–165

    PubMed  Google Scholar 

  • Kiel DP, Felson DT, Anderson JJ, Wilson PW, Moskowitz MA (1987) Hip fracture and the use of estrogens in postmenopausal women. The Framingham Study. N Engl J Med 317:1169–1174

    CAS  PubMed  Google Scholar 

  • Kirking DM, Lee JA, Ellis JJ, Briesacher B, McKercher PL (2006) Patient-reported underuse of prescription medications: a comparison of nine surveys. Med Care Res Rev 63:427–446

    PubMed  Google Scholar 

  • Kjaer D, Horvath-Puho E, Christensen J, Vestergaard M, Czeizel AE, Sorensen HT, Olsen J (2007) Use of phenytoin, phenobarbital, or diazepam during pregnancy and risk of congenital abnormalities: a case-time-control study. Pharmacoepidemiol Drug Saf 16:181–188

    CAS  PubMed  Google Scholar 

  • Kromann-Andersen H, Pedersen A (1988) Reported adverse reactions to and consumption of nonsteroidal anti-inflammatory drugs in Denmark over a 17-year period. Dan Med Bull 35:187–192

    CAS  PubMed  Google Scholar 

  • Lando JF, Heck KE, Brett KM (1999) Hormone replacement therapy and breast cancer risk in a nationally representative cohort. Am J Prev Med 17:176–180

    CAS  PubMed  Google Scholar 

  • Lee D, Bergman U (2000) Studies of drug utilization. In: Strom BL (ed) Pharmacoepidemiology. Wiley, Chichester, pp 463–481

    Google Scholar 

  • Lenz W (1987) The Thalidomide hypothesis: how it was found and tested. In: Kewitz H, Roots I, Voigt K (eds) Epidemiological concepts in clinical pharmacology. Springer, Heidelberg, pp 3–10

    Google Scholar 

  • Leone R, Venegoni M, Motola D, Moretti U, Piazzetta V, Cocci A, Resi D, Mozzo F, Velo G, Burzilleri L, Montanaro N, Conforti A (2003) Adverse drug reactions related to the use of fluoroquinolone antimicrobials: an analysis of spontaneous reports and fluoroquinolone consumption data from three italian regions. Drug Saf 26:109–120

    CAS  PubMed  Google Scholar 

  • Levesque LE, Hanley JA, Kezouh A, Suissa S (2010) Problem of immortal time bias in cohort studies: example using statins for preventing progression of diabetes. BMJ 340:b5087

    PubMed  Google Scholar 

  • Lewis MA, Heinemann LA, MacRae KD, Bruppacher R, Spitzer WO (1996) The increased risk of venous thromboembolism and the use of third generation progestagens: role of bias in observational research. The Transnational Research Group on Oral Contraceptives and the Health of Young Women. Contraception 54:5–13

    CAS  PubMed  Google Scholar 

  • Lindquist M, Edwards IR (1993) Adverse drug reaction reporting in Europe: some problems of comparisons. Int J Risk Saf Med 4:35–46

    CAS  PubMed  Google Scholar 

  • MacDonald TM, Morant SV, Goldstein JL, Burke TA, Pettitt D (2003) Channelling bias and the incidence of gastrointestinal haemorrhage in users of meloxicam, coxibs, and older, non-specific non-steroidal anti-inflammatory drugs. Gut 52:1265–1270

    CAS  PubMed Central  PubMed  Google Scholar 

  • Martens EP, Pestman WR, de Boer A, Belitser SV, Klungel OH (2006) Instrumental variables: application and limitations. Epidemiology 17:260–267

    PubMed  Google Scholar 

  • McLeod PJ, Huang AR, Tamblyn RM, Gayton DC (1997) Defining inappropriate practices in prescribing for elderly people: a national consensus panel. CMAJ 156:385–391

    CAS  PubMed Central  PubMed  Google Scholar 

  • Meier C, Brauchli YB, Jick SS, Kraenzlin ME, Meier CR (2010) Use of depot medroxyprogesterone acetate and fracture risk. J Clin Endocrinol Metab 95:4909–4916

    CAS  PubMed  Google Scholar 

  • MHRA Centre NorthWest (2009) Yellow Card. http://www.yccnorthwest.nhs.uk/reporting.aspx. Accessed 10 May 2012

  • Miettinen OS (1983) The need for randomization in the study of intended effects. Stat Med 2: 267–271

    CAS  PubMed  Google Scholar 

  • Mojtabai R, Zivin JG (2003) Effectiveness and cost-effectiveness of four treatment modalities for substance disorders: a propensity score analysis. Health Serv Res 38:233–259

    PubMed Central  PubMed  Google Scholar 

  • Moore N, Hall G, Sturkenboom M, Mann R, Lagnaoui R, Begaud B (2003) Biases affecting the proportional reporting ratio (PPR) in spontaneous reports pharmacovigilance databases: the example of sertindole. Pharmacoepidemiol Drug Saf 12:271–281

    PubMed  Google Scholar 

  • Moride Y, Abenhaim L (1994) Evidence of the depletion of susceptibles effect in non-experimental pharmacoepidemiologic research. J Clin Epidemiol 47:731–737

    CAS  PubMed  Google Scholar 

  • Neutel CI, Perry S, Maxwell C (2002) Medication use and risk of falls. Pharmacoepidemiol Drug Saf 11:97–104

    PubMed  Google Scholar 

  • Nicholas JM, Grieve AP, Gulliford MC (2012) Within-person study designs had lower precision and greater susceptibility to bias because of trends in exposure than cohort and nested case-control designs. J Clin Epidemiol 65:384–393

    PubMed  Google Scholar 

  • Opatrny L, Delaney JA, Suissa S (2008) Gastro-intestinal haemorrhage risks of selective serotonin receptor antagonist therapy: a new look. Br J Clin Pharmacol 66:76–81

    CAS  PubMed Central  PubMed  Google Scholar 

  • Park-Wyllie LY, Mamdani MM, Li P, Gill SS, Laupacis A, Juurlink DN (2009) Cholinesterase inhibitors and hospitalization for bradycardia: a population-based study. PLoS Med 6:e1000157

    PubMed Central  PubMed  Google Scholar 

  • Pedianet Project (2012) Pedianet database, general design. http://www.pedianet.it/en/pedianet-database/general-design/;213. Accessed 13 Feb 2012

  • Perez E, Schroder-Bernhardi D, Dietlein G (2002) Treatment behavior of doctors regarding Helicobacter pylori infections. Int J Clin Pharmacol Ther 40:126–129

    CAS  PubMed  Google Scholar 

  • Perkins SM, Tu W, Underhill MG, Zhou XH, Murray MD (2000) The use of propensity scores in pharmacoepidemiologic research. Pharmacoepidemiol Drug Saf 9:93–101

    CAS  PubMed  Google Scholar 

  • PHARMO Institute for Drug Outcomes Research (2012) Company history. http://www.pharmo.nl/common/page/history. Accessed 13 Feb 2012

  • Pierfitte C, Begaud B, Lagnaoui R, Moore ND (1999) Is reporting rate a good predictor of risks associated with drugs? Br J Clin Pharmacol 47:329–331

    CAS  PubMed Central  PubMed  Google Scholar 

  • Pierfitte C, Royer RJ, Moore N, Begaud B (2000) The link between sunshine and phototoxicity of sparfloxacin. Br J Clin Pharmacol 49:609–612

    CAS  PubMed Central  PubMed  Google Scholar 

  • Pigeot I, Ahrens W (2008) Establishment of a pharmacoepidemiological database in Germany: methodological potential, scientific value and practical limitations. Pharmacoepidemiol Drug Saf 17:215–223

    PubMed  Google Scholar 

  • Porta M, Hartzema AG, Tilson HH (1997) The contribution of epidemiology to the study of drug effects. In: Hartzema AG, Porta M, Tilson HH (eds) Pharmacoepidemiology. The fundamentals. Harvey Whitney, Cincinnati, pp 1–28

    Google Scholar 

  • QResearch (2012a) QRESEARCH specialises in research & analyses using primary care electronic health data. http://www.qresearch.org. Accessed 12 March 2012

  • QResearch (2012b) What is QRESEARCH? http://www.qresearch.org/SitePages/What%20Is%20QResearch.aspx. Accessed 13 Feb 2012

  • Raiford DS, Perez GS, Garcia Rodriguez LA (1996) Positive predictive value of ICD-9 codes in the identification of cases of complicated peptic ulcer disease in the Saskatchewan hospital automated database. Epidemiology 7:101–104

    CAS  PubMed  Google Scholar 

  • RAMQ (2010) Historical background; yesterday and today. http://www.ramq.gouv.qc.ca/en/regie/historique/hier_auj.shtml. Accessed 8 Feb 2012

  • Rassen JA, Brookhart MA, Glynn RJ, Mittleman MA, Schneeweiss S (2009a) Instrumental variables I: instrumental variables exploit natural variation in nonexperimental data to estimate causal relationships. J Clin Epidemiol 62:1226–1232

    PubMed Central  PubMed  Google Scholar 

  • Rassen JA, Brookhart MA, Glynn RJ, Mittleman MA, Schneeweiss S (2009b) Instrumental variables II: instrumental variable application-in 25 variations, the physician prescribing preference generally was strong and reduced covariate imbalance. J Clin Epidemiol 62:1233–1241

    PubMed Central  PubMed  Google Scholar 

  • Rassen JA, Glynn RJ, Brookhart MA, Schneeweiss S (2011) Covariate selection in high-dimensional propensity score analyses of treatment effects in small samples. Am J Epidemiol 173:1404–1413

    PubMed Central  PubMed  Google Scholar 

  • Rawlins MD, Breckenridge AM, Wood SM (1989) National adverse drug reaction reporting – a silver jubilee. Advers Drug React Bull 138:516–519

    Google Scholar 

  • Ray WA (2003) Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol 158:915–920

    PubMed  Google Scholar 

  • Ray WA, Griffin MR (1989) Use of Medicaid data for pharmacoepidemiology. Am J Epidemiol 129:837–849

    CAS  PubMed  Google Scholar 

  • Ray WA, Griffin MR, Downey W, Melton LJ III (1989) Long-term use of thiazide diuretics and risk of hip fracture. Lancet 1:687–690

    CAS  PubMed  Google Scholar 

  • Risselada R, Straatman H, van Kooten F, Dippel DW, van der Lugt A, Niessen WJ, Firouzian A, Herings RM, Sturkenboom MC (2011) Platelet aggregation inhibitors, vitamin K antagonists and risk of subarachnoid hemorrhage. J Thromb Haemost 9:517–523

    CAS  PubMed  Google Scholar 

  • Rothman KJ, Lanes S, Sacks ST (2004) The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf 13:519–523

    PubMed  Google Scholar 

  • Samet JM (2003) Measuring the effectiveness of inhaled corticosteroids for COPD is not easy! Am J Respir Crit Care Med 168:1–2

    PubMed  Google Scholar 

  • Saskatchewan Ministry of Health (2010) Health services databases: information document. http://www.health.gov.sk.ca/health-databases-info-doc. Accessed 24 March 2012

  • Saunders KW, Davis RL, Stergachis A (2000) Group Health Cooperative of Puget Sound. In: Strom BL (ed) Pharmacoepidemiology. Wiley, Chichester, pp 247–262

    Google Scholar 

  • Schade R, Andersohn F, Suissa S, Haverkamp W, Garbe E (2007) Dopamine agonists and the risk of cardiac-valve regurgitation. N Engl J Med 356:29–38

    CAS  PubMed  Google Scholar 

  • Schneeweiss S (2006) Sensitivity analysis and external adjustment for unmeasured confounders in epidemiologic database studies of therapeutics. Pharmacoepidemiol Drug Saf 15:291–303

    PubMed  Google Scholar 

  • Schneeweiss S, Avorn J (2005) A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol 58:323–337

    PubMed  Google Scholar 

  • Schneeweiss S, Rassen J (2011) Re: confounding adjustment via a semi-automated high-dimensional propensity score algorithm: an application to electronic medical records. Pharmacoepidemiol Drug Saf 20:1110–1111

    PubMed  Google Scholar 

  • Schneeweiss S, Setoguchi S, Brookhart A, Dormuth C, Wang PS (2007) Risk of death associated with the use of conventional versus atypical antipsychotic drugs among elderly patients. CMAJ 176:627–632

    PubMed Central  PubMed  Google Scholar 

  • Schneeweiss S, Seeger JD, Landon J, Walker AM (2008) Aprotinin during coronary-artery bypass grafting and risk of death. N Engl J Med 358:771–783

    CAS  PubMed  Google Scholar 

  • Schneeweiss S, Rassen JA, Glynn RJ, Avorn J, Mogun H, Brookhart MA (2009) High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology 20:512–522

    PubMed Central  PubMed  Google Scholar 

  • Schneider MF, Gange SJ, Margolick JB, Detels R, Chmiel JS, Rinaldo C, Armenian HK (2005) Application of case-crossover and case-time-control study designs in analyses of time-varying predictors of T-cell homeostasis failure. Ann Epidemiol 15:137–144

    PubMed  Google Scholar 

  • Schoofs MW, van der Klift M, Hofman A, de Laet CE, Herings RM, Stijnen T, Pols HA, Stricker BH (2003) Thiazide diuretics and the risk for hip fracture. Ann Intern Med 139:476–482

    PubMed  Google Scholar 

  • Schroder D, Weiser M, Klein P (2003) Efficacy of a homeopathic Crataegus preparation compared with usual therapy for mild (NYHA II) cardiac insufficiency: results of an observational cohort study. Eur J Heart Fail 5:319–326

    CAS  PubMed  Google Scholar 

  • Schroder-Bernhardi D, Dietlein G (2002) Lipid-lowering therapy: do hospitals influence the prescribing behavior of general practitioners? Int J Clin Pharmacol Ther 40:317–321

    CAS  PubMed  Google Scholar 

  • Seeger JD, Walker AM, Williams PL, Saperia GM, Sacks FM (2003) A propensity score-matched cohort study of the effect of statins, mainly fluvastatin, on the occurrence of acute myocardial infarction. Am J Cardiol 92:1447–1451

    CAS  PubMed  Google Scholar 

  • Serradell J, Bjornson DC, Hartzema AG (1991) Drug utilization studies: sources and methods. In: Hartzema AG, Porta MS, Tilson HH (eds) Pharmacoepidemiology: an introduction. Harvey Whitney, Cincinnati, pp 101–119

    Google Scholar 

  • Shapiro S (1989) The role of automated record linkage in the postmarketing surveillance of drug safety: a critique. Clin Pharmacol Ther 46:371–386

    CAS  PubMed  Google Scholar 

  • Sin DD, Man SF (2002) Low-dose inhaled corticosteroid therapy and risk of emergency department visits for asthma. Arch Intern Med 162:1591–1595

    CAS  PubMed  Google Scholar 

  • Sin DD, Tu JV (2001a) Inhaled corticosteroid therapy reduces the risk of rehospitalization and all-cause mortality in elderly asthmatics. Eur Respir J 17:380–385

    CAS  PubMed  Google Scholar 

  • Sin DD, Tu JV (2001b) Inhaled corticosteroids and the risk of mortality and readmission in elderly patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 164:580–584

    CAS  PubMed  Google Scholar 

  • Slone D, Shapiro S, Miettinen OS, Finkle WD, Stolley PD (1979) Drug evaluation after marketing. Ann Intern Med 90:257–261

    CAS  PubMed  Google Scholar 

  • Spitzer WO, Suissa S, Ernst P, Horwitz RI, Habbick B, Cockcroft D, Boivin JF, McNutt M, Buist AS, Rebuck AS (1992) The use of beta-agonists and the risk of death and near death from asthma. N Engl J Med 326:501–506

    CAS  PubMed  Google Scholar 

  • Spitzer WO, Lewis MA, Heinemann LA, Thorogood M, MacRae KD (1996) Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women. BMJ 312:83–88

    CAS  PubMed Central  PubMed  Google Scholar 

  • State of New Jersey (2012) Department of Human Services, Division of Medical Assistance and Human Services: monthly enrollment reports NJ FamilyCare/Medicaid enrollment statistics; January 2012. http://www.nj.gov/humanservices/dmahs/news/reports/enrollment_2012_01.pdf. Accessed 13 Feb 2012

  • Stricker BH, Tijssen JG (1992) Serum sickness-like reactions to cefaclor. J Clin Epidemiol 45:1177–1184

    CAS  PubMed  Google Scholar 

  • Strom BL, Carson JL (1990) Use of automated databases for pharmacoepidemiology research. Epidemiol Rev 12:87–107

    CAS  PubMed  Google Scholar 

  • Strom BL, Miettinen OS, Melmon KL (1983) Postmarketing studies of drug efficacy: when must they be randomized? Clin Pharmacol Ther 34:1–7

    CAS  PubMed  Google Scholar 

  • Strom BL, Miettinen OS, Melmon KL (1984) Post-marketing studies of drug efficacy: how? Am J Med 77:703–708

    CAS  PubMed  Google Scholar 

  • Strom BL, Carson JL, Halpern AC, Schinnar R, Snyder ES, Stolley PD, Shaw M, Tilson HH, Joseph M, Dai WS (1991) Using a claims database to investigate drug-induced Stevens-Johnson syndrome. Stat Med 10:565–576

    CAS  PubMed  Google Scholar 

  • Strom BL, Kimmel SE, Hennessy S (2012) Pharmacoepidemiology. Wiley, Chichester

    Google Scholar 

  • Sturkenboom M (2007) Other databases in Europe for the analytic evaluation of drug effects. In: Mann RD, Andrews EB (eds) Pharmacovigilance. Wiley, Chichester/Hoboken, pp 362–372

    Google Scholar 

  • Sturkenboom MC, Middelbeek A, de Jong-van den Berg LT, van den Berg PB, Stricker BH, Wesseling H (1995) Vulvo-vaginal candidiasis associated with acitretin. J Clin Epidemiol 48:991–997

    CAS  PubMed  Google Scholar 

  • Suissa S (1995) The case-time-control design. Epidemiology 6:248–253

    CAS  PubMed  Google Scholar 

  • Suissa S (1998) The case-time-control design: further assumptions and conditions [comment]. Epidemiology 9:441–445

    CAS  PubMed  Google Scholar 

  • Suissa S (2000) Novel approaches to pharmacoepidemiology study design and statistical analysis. In: Strom BL (ed) Pharmacoepidemiology. Wiley, Chichester, pp 785–805

    Google Scholar 

  • Suissa S (2003) Effectiveness of inhaled corticosteroids in COPD: immortal time bias in observational studies. Am J Respir Crit Care Med 168:49–53

    PubMed  Google Scholar 

  • Suissa S (2004) Inhaled steroids and mortality in COPD: bias from unaccounted immortal time. Eur Respir J 23:391–395

    CAS  PubMed  Google Scholar 

  • Suissa S (2007) Immortal time bias in observational studies of drug effects. Pharmacoepidemiol Drug Saf 16:241–249

    PubMed  Google Scholar 

  • Suissa S (2008) Immortal time bias in pharmaco-epidemiology. Am J Epidemiol 167:492–499

    PubMed  Google Scholar 

  • Suissa S, Garbe E (2007) Primer: administrative health databases in observational studies of drug effects–advantages and disadvantages. Nat Clin Pract Rheumatol 3:725–732

    CAS  PubMed  Google Scholar 

  • Suissa S, Blais L, Spitzer WO, Cusson J, Lewis M, Heinemann L (1997) First-time use of newer oral contraceptives and the risk of venous thromboembolism. Contraception 56:141–146

    CAS  PubMed  Google Scholar 

  • Suissa S, Ernst P, Benayoun B, Baltzan M, Cai B (2000a) Low-dose inhaled corticosteroids and the prevention of death from asthma. N Engl J Med 343:332–336

    CAS  PubMed  Google Scholar 

  • Suissa S, Spitzer WO, Rainville B, Cusson J, Lewis M, Heinemann L (2000b) Recurrent use of newer oral contraceptives and the risk of venous thromboembolism. Hum Reprod 15:817–821

    CAS  PubMed  Google Scholar 

  • Suissa S, Ernst P, Kezouh A (2002) Regular use of inhaled corticosteroids and the long term prevention of hospitalisation for asthma. Thorax 57:880–884

    CAS  PubMed Central  PubMed  Google Scholar 

  • Suissa S, Baltzan M, Kremer R, Ernst P (2004) Inhaled and nasal corticosteroid use and the risk of fracture. Am J Respir Crit Care Med 169:83–88

    PubMed  Google Scholar 

  • Szarfman A, Machado SG, O’Neill RT (2002) Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA’s spontaneous reports database. Drug Saf 25:381–392

    CAS  PubMed  Google Scholar 

  • Tamblyn R, Lavoie G, Petrella L, Monette J (1995) The use of prescription claims databases in pharmacoepidemiological research: the accuracy and comprehensiveness of the prescription claims database in Quebec. J Clin Epidemiol 48:999–1009

    CAS  PubMed  Google Scholar 

  • Tamblyn R, McLeod P, Hanley JA, Girard N, Hurley J (2003) Physician and practice characteristics associated with the early utilization of new prescription drugs. Med Care 41:895–908

    PubMed  Google Scholar 

  • Taylor B, Miller E, Farrington CP, Petropoulos MC, Favot-Mayaud I, Li J, Waight PA (1999) Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Lancet 353:2026–2029

    CAS  PubMed  Google Scholar 

  • Tennessee Government (2012) What’s new with TennCare. http://www.tn.gov/tenncare/. Accessed 8 Feb 2012

  • Tennis P, Bombardier C, Malcolm E, Downey W (1993) Validity of rheumatoid arthritis diagnoses listed in the Saskatchewan Hospital Separations Database. J Clin Epidemiol 46:675–683

    CAS  PubMed  Google Scholar 

  • The Danish Medicines Agency (2010) About the Register of Medicinal Product Statistics. http://laegemiddelstyrelsen.dk/en/topics/statistics,-prices-and-reimbursement/statistics-and-analyses/about-the-register-of-medicinal-product---tatistics-. Accessed 14 Feb 2012

  • The Health Improvement Network (2012) Welcome to The Health Improvement Network website. http://www.thin-uk.com. Accessed 12 March 2012

  • The National Board of Health and Welfare (Socialstyrelsen) (2012a) Statistics on health, use of health services, social conditions and social services. http://192.137.163.40/epcfs/index.asp?kod=engelska. Accessed 13 Feb 2012

  • The National Board of Health and Welfare (Socialstyrelsen) (2012b) The National Patient Register. http://www.socialstyrelsen.se/register/halsodataregister/patientregistret/inenglish. Accessed 14 Feb 2012

  • Tsong Y (1995) Comparing reporting rates of adverse events between drugs with adjustment for year of marketing and secular trends in total reporting. J Biopharm Stat 5:95–114

    CAS  PubMed  Google Scholar 

  • UCL Research Department of Primary Care and Population Health (2011) The THIN Database. http://www.ucl.ac.uk/pcph/research-groups-themes/thin-pub/database. Accessed 10 Feb 2012

  • Uppsala Monitoring Centre (2011) Vigibase – now over 7 million ADR reports. http://www.umc-products.com/DynPage.aspx?id=75618&news=10614. Accessed 10 May 2012

  • US Food and Drug Administration (2010) Adverse Event Reporting System (AERS) statistics. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm. Accessed 15 July 2011

  • van den Brandt PA, Petri H, Dorant E, Goldbohm RA, van de Crommert S (1991) Comparison of questionnaire information and pharmacy data on drug use. Pharm Weekbl Sci 13:91–96

    PubMed  Google Scholar 

  • van der Kroef C (1979) Reactions to triazolam. Lancet 2:526

    PubMed  Google Scholar 

  • van Puijenbroek EP, Bate A, Leufkens HG, Lindquist M, Orre R, Egberts AC (2002) A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 11:3–10

    PubMed  Google Scholar 

  • van Staa TP, Abenhaim L, Leufkens H (1994) A study of the effects of exposure misclassification due to the time-window design in pharmacoepidemiologic studies. J Clin Epidemiol 47:183–189

    PubMed  Google Scholar 

  • Venning GR (1983) Identification of adverse reactions to new drugs. III: alerting processes and early warning systems. Br Med J (Clin Res Ed) 286:458–460

    CAS  Google Scholar 

  • Viscoli CM, Brass LM, Kernan WN, Sarrel PM, Suissa S, Horwitz RI (2001) A clinical trial of estrogen-replacement therapy after ischemic stroke. N Engl J Med 345:1243–1249

    CAS  PubMed  Google Scholar 

  • Vlahovic-Palcevski V, Wettermark B, Bergman U (2002) Quality of non-steroidal anti-inflammatory drug prescribing in Croatia (Rijeka) and Sweden (Stockholm). Eur J Clin Pharmacol 58:209–214

    CAS  PubMed  Google Scholar 

  • Waller P, van Puijenbroek E, Egberts A, Evans S (2004) The reporting odds ratio versus the proportional reporting ratio: “deuce.” Pharmacoepidemiol Drug Saf 13:525–526

    PubMed  Google Scholar 

  • Wang J, Donnan PT (2001) Propensity score methods in drug safety studies: practice, strengths and limitations. Pharmacoepidemiol Drug Saf 10:341–344

    CAS  PubMed  Google Scholar 

  • Wang J, Donnan PT, Steinke D, MacDonald TM (2001) The multiple propensity score for analysis of dose-response relationships in drug safety studies. Pharmacoepidemiol Drug Saf 10:105–111

    CAS  PubMed  Google Scholar 

  • Wang PS, Schneeweiss S, Avorn J, Fischer MA, Mogun H, Solomon DH, Brookhart MA (2005) Risk of death in elderly users of conventional vs. atypical antipsychotic medications. N Engl J Med 353:2335–2341

    CAS  PubMed  Google Scholar 

  • Wang PS, Schneeweiss S, Setoguchi S, Patrick A, Avorn J, Mogun H, Choudhry NK, Brookhart MA (2007) Ventricular arrhythmias and cerebrovascular events in the elderly using conventional and atypical antipsychotic medications. J Clin Psychopharmacol 27:707–710

    PubMed  Google Scholar 

  • Wang S, Linkletter C, Dore D, Mor V, Buka S, Maclure M (2012) Age, antipsychotics, and the risk of ischemic stroke in the Veterans Health Administration. Stroke 43:28–31

    PubMed  Google Scholar 

  • Weatherby LB, Walker AM, Fife D, Vervaet P, Klausner MA (2001) Contraindicated medications dispensed with cisapride: temporal trends in relation to the sending of “Dear Doctor” letters. Pharmacoepidemiol Drug Saf 10:211–218

    CAS  PubMed  Google Scholar 

  • Weber JCP (1984) Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs. In: Rainsford KD, Velo GP (eds) Advances in inflammation research. Raven Press, New York, pp 1–6

    Google Scholar 

  • Weintraub JM, Taylor A, Jacques P, Willett WC, Rosner B, Colditz GA, Chylack LT, Hankinson SE (2002) Postmenopausal hormone use and lens opacities. Ophthalmic Epidemiol 9:179–190

    PubMed  Google Scholar 

  • Weldeselassie YG, Whitaker HJ, Farrington CP (2011) Use of the self-controlled case-series method in vaccine safety studies: review and recommendations for best practice. Epidemiol Infect 139:1805–1817

    CAS  PubMed  Google Scholar 

  • West SL (1997) A comparison of data sources for drug exposure ascertainment in pharmacoepidemiologic studies with emphasis on self-reported information. Pharmacoepidemiol Drug Saf 6:215–218

    CAS  PubMed  Google Scholar 

  • West SL, Strom BL, Freundlich B, Normand E, Koch G, Savitz DA (1994) Completeness of prescription recording in outpatient medical records from a health maintenance organization. J Clin Epidemiol 47:165–171

    CAS  PubMed  Google Scholar 

  • West SL, Savitz DA, Koch G, Strom BL, Guess HA, Hartzema A (1995) Recall accuracy for prescription medications: self-report compared with database information. Am J Epidemiol 142:1103–1112

    CAS  PubMed  Google Scholar 

  • Whitaker HJ, Farrington CP, Spiessens B, Musonda P (2006) Tutorial in biostatistics: the self-controlled case series method. Stat Med 25:1768–1797

    PubMed  Google Scholar 

  • Whitaker HJ, Hocine MN, Farrington CP (2009) The methodology of self-controlled case series studies. Stat Methods Med Res 18:7–26

    PubMed  Google Scholar 

  • Wiholm B, Olsson S, Moore N, Waller P (2000) Spontaneous reporting systems outside the US. In: Strom BL (ed) Pharmacoepidemiology. Wiley, Chichester, pp 175–192

    Google Scholar 

  • World Health Organization (1977) The selection of essential drugs. Report of a WHO expert committee. Ser no 615. World Health Organization, Geneva

    Google Scholar 

  • Worzala K, Hiller R, Sperduto RD, Mutalik K, Murabito JM, Moskowitz M, D’Agostino RB, Wilson PW (2001) Postmenopausal estrogen use, type of menopause, and lens opacities: the Framingham studies. Arch Intern Med 161:1448–1454

    CAS  PubMed  Google Scholar 

  • Wu K, Willett WC, Fuchs CS, Colditz GA, Giovannucci EL (2002) Calcium intake and risk of colon cancer in women and men. J Natl Cancer Inst 94:437–446

    PubMed  Google Scholar 

  • Wysowski DK, Pitts M, Beitz J (2001) An analysis of reports of depression and suicide in patients treated with isotretinoin. J Am Acad Dermatol 45:515–519

    CAS  PubMed  Google Scholar 

  • Young-Xu Y, Chan KA, Liao JK, Ravid S, Blatt CM (2003) Long-term statin use and psychological well-being. J Am Coll Cardiol 42:690–697

    CAS  PubMed Central  PubMed  Google Scholar 

  • Zambon A, Polo FH, Contiero P, Corrao G (2009) Effect of macrolide and fluoroquinolone antibacterials on the risk of ventricular arrhythmia and cardiac arrest: an observational study in Italy using case-control, case-crossover and case-time-control designs. Drug Saf 32:159–167

    CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2014 Springer Science+Business Media New York

About this entry

Cite this entry

Garbe, E., Suissa, S. (2014). Pharmacoepidemiology. In: Ahrens, W., Pigeot, I. (eds) Handbook of Epidemiology. Springer, New York, NY. https://doi.org/10.1007/978-0-387-09834-0_31

Download citation

  • DOI: https://doi.org/10.1007/978-0-387-09834-0_31

  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-0-387-09833-3

  • Online ISBN: 978-0-387-09834-0

  • eBook Packages: MedicineReference Module Medicine

Publish with us

Policies and ethics