Linking a pharmaceutical claims database with a birth defects registry to investigate birth defect rates of suspected teratogens

Pharmacoepidemiology and Drug Safety

Volumn 19, Issue 11, 2010, Pages 1137-1150

  Colvin, Lyn ^a,b   Slack Smith, Linda ^b   Stanley, Fiona J ^a   Bower, Carol ^a  

^a UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^b UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

Author keywords

Birth defect; Claims data; Data linkage; PBS; Pharmacovigilance; Pregnancy; Validation

Indexed keywords

ATORVASTATIN; AZATHIOPRINE; CARBAMAZEPINE; ENALAPRIL MALEATE; ETHOSUXIMIDE; HYDROCHLOROTHIAZIDE PLUS IRBESARTAN; HYDROCHLOROTHIAZIDE PLUS QUINAPRIL; HYDROXYCHLOROQUINE SULFATE; INDAPAMIDE PLUS PERINDOPRIL; INTERFERON BETA SERINE; IRBESARTAN; ISOTRETINOIN; LAMOTRIGINE; MEDROXYPROGESTERONE ACETATE; NORETHISTERONE; PAROXETINE; PERINDOPRIL; PHENYTOIN; QUINAPRIL; RAMIPRIL; RECOMBINANT FOLLITROPIN; SIMVASTATIN; TERATOGENIC AGENT; VALPROIC ACID;

ADRENAL DISEASE; ARTICLE; AUSTRALIA; BILLING AND CLAIMS; BIRTH DEFECT; CARDIOVASCULAR MALFORMATION; CHROMOSOME ABERRATION; CLEFT LIP; CLEFT PALATE; CONGENITAL HEART MALFORMATION; CONTROLLED STUDY; CYSTIC FIBROSIS; DATA BASE; DIGESTIVE SYSTEM MALFORMATION; DISEASE REGISTRY; DRUG SURVEILLANCE PROGRAM; EAR MALFORMATION; EYE MALFORMATION; FACE MALFORMATION; FEMALE; GENITAL MALFORMATION; HEMOLYTIC ANEMIA; HUMAN; HYPOTHYROIDISM; INFANT; LIMB MALFORMATION; MALABSORPTION; MALE; MUSCULOSKELETAL SYSTEM MALFORMATION; NECK MALFORMATION; NERVOUS SYSTEM MALFORMATION; PRADER WILLI SYNDROME; PREGNANCY; PREGNANT WOMAN; PRESCRIPTION; PRIORITY JOURNAL; PULMONARY VALVE DISEASE; RESPIRATORY TRACT MALFORMATION; SMITH LEMLI OPITZ SYNDROME; SPINA BIFIDA; THYMUS DISEASE; UMBILICAL MALFORMATION; XANTHOGRANULOMA;

ABNORMALITIES, DRUG-INDUCED; ADVERSE DRUG REACTION REPORTING SYSTEMS; DATABASES, FACTUAL; FEMALE; HUMANS; INFANT, NEWBORN; MALE; MEDICAL RECORD LINKAGE; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; PHARMACEUTICAL PREPARATIONS; PREGNANCY; REGISTRIES; WESTERN AUSTRALIA;

EID: 78049313187     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1995     Document Type: Article

References (65)

1. World Health Organisation. The Safety of Medicines in Public Health Programmes: Pharmacovigilance an Essential Tool. WHO: Geneva, 2006.
2. The Erice Manifesto: for global reform of the safety of medicines in patient care. Drug Saf 2007; 30(3): 187-190.
3. Stanley FJ. Fetotoxic chemicals and drugs. Med J Aust 1981; 1(13): 688-693.
4. Goldman AS. Critical periods of prenatal toxicity. Clin Perinatol 1979; 6(2): 203-218.
5. Loebstein R, Lalkin A, Koren G. Pharmacokinetic changes during pregnancy and their clinical relevance. In Maternal Fetal Toxicology: A Clinician's Guide (3rd edn), Koren G (ed.). Marcel Dekker: New York, NY, 2001; 1-22.
6. Moore KL, Persaud TVN. Before We Are Born: Essentials of Embryology and Birth Defects (6th edn), Saunders: Philadelphia, 2003.
7. Buhimschi CS, Weiner CP. Medications in pregnancy and lactation: part 1. Teratology. Obstet Gynecol 2009; 113(1): 166-188, 10.1097/AOG.0b013e31818d6788.
8. Soldin OP, Mattison DR. Sex differences in pharmacokinetics and pharmacodynamics. Clin Pharmacokinet 2009; 48(3): 143-157, 10.2165/00003088-200948030-00001.
9. Webster WS, Freeman JA. Prescription drugs and pregnancy. Expert Opin Pharmacother 2003; 4(6): 949-961, 10.1517/14656566.4.6.949.
10. Koren G, Pastuszak A, Ito S. Drugs in pregnancy. N Engl J Med 1998; 338(16): 1128-1137.
11. Mitchell AA. Systematic identification of drugs that cause birth defects - a new opportunity. N Engl J Med 2003; 349(26): 2556-2559.
12. Mattison D, Zajicek A. Gaps in knowledge in treating pregnant women. Gend Med 2006; 3(3): 169-182. 10.1016/S1550-8579(06)80205-6.
13. Lo WY, Friedman JM. Teratogenicity of recently introduced medications in human pregnancy. Obstet Gynecol 2002; 100(3): 465-473.
14. Shapiro S. The role of automated record linkage in the postmarketing surveillance of drug safety: a critique. Clin Pharmacol Ther 1989; 46(4): 371-386.
15. Edwards IR, Biriell C. WHO Programme - Global Monitoring. In Pharmacovigilance C (2nd edn C), Mann RD, Andrews EB (eds). John Wiley & Sons Ltd.: West Sussex, England, 2007; 151-166.
16. US Department of Health and Human Services. Advancing the health, safety, and well-being of our people. 2010 [cited 10/02/2010]; Available from: .
17. Colvin L, Slack-Smith L, Stanley FJ, Bower C. Pharmacovigilance in pregnancy using population-based linked datasets. Pharmacoepidemiol Drug Saf 2009; 18(3): 211-225, 10.1002/pds.1705.
18. National Centre for Classification in Health. International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM). National Centre for Classification in Health: Sydney, 1999.
19. Bower C, Rudy E, Callaghan A, Quick J, Cosgrove P, Nassar N. Report of the Birth Defects Registry of Western Australia, 1980-2008. Subiaco: King Edward Memorial Hospital, Women and Newborn Health Service; 2009 December. Report No.: 16. Available from: .
20. Bower C, Rudy E, Callaghan A, Quick J, Nassar N. Age at diagnosis of birth defects. Birth Defects Res A Clin Mol Teratol 2010; 88(4): 251-255.
21. British Paediatric Association. Classification of Diseases. Codes designed for use in the classification of paediatric and perinatal disorders (Successor to the Cardiff Diagnostic Classification) A paediatric supplement compatible with WHO International Classification of Diseases, 1977. BPA: London, 1979.
22. Australian Government Department of Health and Ageing. Schedule of Pharmaceutical Benefits. 2008 [cited 23 September 2008]; Available from: .
23. Australian Government Department of Health and Ageing. About the PBS [website] 2010 January 1 [cited 26 March 2010]; Available from: ; .
24. Australian Institute of Health and Welfare. Australia's Health 2006. Canberra: AIHW; 2006. Report No.: AIHW Cat. No. AUS 73. Available from: .
25. Pharmaceutical Benefits Advisory Committee, Drug Utilization Sub-Committee. Australian statistics on medicines 2004-2005. Canberra: Australian Government Department of Health and Ageing; 2007. Available from: .
26. Australian Drug Evaluation Committee. Prescribing Medicines in Pregnancy: An Australian Categorisation of Risk of Drug Use in Pregnancy (4th edn), (e999 [cited 20 October 2009]) Available from:. .
27. Therapeutic Goods Administration. Amendments to the Prescribing Medicines in Pregnancy Booklet. 2006 February [cited 26 March 2008]; Available from: .
28. WA Therapeutic Advisory Group. Annual Report, 2004-2005. WATAG: Perth, WA, 2006.
29. Newcombe HB. Handbook of Record Linkage, Appendix H. OUP: New York, 1988.
30. Knuth DE. The Art of Computer Programming, Vol. 3: Sorting and Searching. Addison-Wesley: Reading, MA, 1973.
31. Holman CD, Bass AJ, Rouse IL, Hobbs MS. Population-based linkage of health records in Western Australia: development of a health services research linked database. Aust NZ J Public Health 1999; 23(5): 453-459.
32. Australian Bureau of Statistics. Australian Historical Population Statistics, 2006. Commonwealth of Australia, Canberra; 2006. Report No.: 3105.0.65.001. Available from: .
33. Bower C, Silva D, Henderson TR, Ryan A, Rudy E. Ascertainment of birth defects: the effect on completeness of adding a new source of data. J Paediatr Child Health 2000; 36(6): 574-576, 10.1111/j. 1440-1754.2000.00575.x.
34. Giles GG. Medical record linkage in Australia: this is as good as it gets. ANZ J Surg 2005; 75(5): 259. 10.1111/j.1445-2197.2005.03412.x.
35. SAS/STAT. Copyright(c) 2002-2003 by Institute SAS Cary, Inc., NC, USA.
36. MIMS Australia Pty Ltd. Monthly Index of Medical Specialties Online. 2009 [cited 11 June 2009]; Available from: .
37. Australian Drug Evaluation Committee. Adverse Drug Reactions Bulletin. Available from: .
38. Adverse Drug Reactions Advisory Committee. Avoiding fetal abnormalities with isotretinoin. Aust Adverse Drug React Bull 2005; 24(1): 3.
39. Adverse Drug Reactions Advisory Committee. Statins contraindicated in pregnancy. Aust Adverse Drug React Bull 2005; 24(1): 4.
40. Adverse Drug Reactions Advisory Committee. Serious reaction reminders: sodium valproate and fetal malformations. Aust Adverse Drug React Bull 2009; 28(2) 2-3.
41. Pharmacy Department Royal Women's Hospital. Drugs and Pregnancy. Melbourne: Royal Women's Hospital, 2006.
42. The Reproductive Toxicology Center. ReproTox. . [Accessed 23/06/2009].Copyright © 1994-2008.
43. Edison RJ, Muenke M. Mechanistic and epidemiologic considerations in the evaluation of adverse birth outcomes following gestational exposure to statins. Am J Med Genet A 2004; 131(3): 287-298, 10.1002/ajmg.a.30386.
44. Cleary BJ, Källén B. Early pregnancy azathioprine use and pregnancy outcomes. Birth Defects Res A Clin Mol Teratol 2009; 85(7): 647-654, 10.1002/bdra.20583.
45. GlaxoSmithKline. Paroxetine HCl - Paxil and generic paroxetine [Dear Healthcare Professional Letter] 2005 [cited 30/11/2009]; Available from: Research Triangle Park: NC, 2005.
46. Diav-Citrin O, Shechtman S, Weinbaum D, et al. Paroxetine and Fluoxetine in Pregnancy: Controlled Study. 33rd Annual Conference of the European Teratology Society; 2005; Haarlem. The Netherlands, Reprod Toxicol; 2005; p. 459.
47. Källén B, Otterblad Olausson P. Antidepressant drugs during pregnancy and infant congenital heart defect. Reprod Toxicol 2006; 21(3): 221-222, 10.1016/j.reprotox.2005.11.006.
48. Therapeutic Goods Administration. Advice for women taking paroxetine intending to become pregnant or in early pregnancy. 2005 [cited 15 November, 2006]; Available from: .
49. Ornoy A. Valproic acid in pregnancy: how much are we endangering the embryo and fetus? Reprod Toxicol 2009; 28(1): 1-10, 10.1016/j.reprotox.2009.02.014.
50. Csizmadi I, Collet J-P, Boivin J-F. Bias and confounding in pharmacoepidemiology. In Pharmacoepidemiology C (4th edn C), Strom BL (ed.). John Wiley & Sons, Ltd: West Sussex, 2005; 791-809.
51. Hansen M, Kurinczuk JJ, Bower C, Webb S. The risk of major birth defects after intracytoplasmic sperm injection and in vitro fertilization. N Engl J Med 2002; 346(10): 725-730.
52. Lau HS, de Boer A, Beuning KS, Porsius A. Validation of pharmacy records in drug exposure assessment. J Clin Epidemiol 1997; 50(5): 619-625, 10.1016/S0895-4356(97)00040-1.
53. van den Brandt PA, Petri H, Dorant E, Goldbohm RA, Van de Crommert S. Comparison of questionnaire information and pharmacy data on drug use. Pharm Weekbl Sci 1991; 13(2): 91-96.
54. Koren G, Pastuszak A, Ito S. Drugs in pregnancy. In Maternal Fetal Toxicology: A Clinician's Guide (3rd edn), Koren G (ed.). Marcel Dekker: New York, NY, 2001; 37-56.
55. Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol 2004; 191(2): 398-407, 10.1016/j.ajog.2004.04.025.
56. Malm H, Martikainen J, Klaukka T, Neuvonen PJ. Prescription of hazardous drugs during pregnancy. Drug Saf 2004; 27(12): 899-908.
57. Olesen C, Sorensen HT, de Jong-van den Berg L, Olsen J, Steffensen FH. Prescribing during pregnancy and lactation with reference to the Swedish classification system. A population-based study among Danish women. The Euromap Group. Acta Obstet Gynecol Scand 1999; 78(8): 686-692, 10.1034/j.1600-0412.1999.780805.x.
58. Colvin L, Payne J, Parsons DE, Kurinczuk JJ, Bower C. Alcohol consumption during pregnancy in non-indigenous West Australian women. Alcohol Clin Exp Res 2007; 31(2): 276-284, 10.1111/j.1530-0277.2006.00303.x.
59. Stanley FJ, Croft ML, Gibbins J, Read AW. A population database for maternal and child health research in Western Australia using record linkage. Paediatr Perinat Epidemiol 1994; 8(4): 433-447, 10.1111/j.1365-3016.1994.tb00482.x.
60. Diav-Citrin O, Shechtman S, Weinbaum D, et al. Paroxetine and fluoxetine in pregnancy: a prospective, multicentre, controlled, observational study. Br J Clin Pharmacol 2008; 66(5): 695-705, 10.1111/j.1365-2125.2008.03261.x.
61. Adverse Drug Reactions Advisory Committee. Australian Adverse Drug Reactions Bulletin 2009 [cited 3 April 2009]; Available from: .
62. Therapeutic Goods Administration. Office of Medicines Safety Monitoring. 2010 [cited 6 April 2010]; Available from: .
63. Davis S, King B, Raine JM. Spontaneous reporting UK. In Pharmacovigilance (2nd edn), Mann RD, Andrews EB (eds). John Wiley & Sons Ltd: West Sussex, England, 2007; 199-215.
64. Moride Y, Haramburu F, Requejo AA, Begaud B. Under-reporting of adverse drug reactions in general practice. Br J Clin Pharmacol 1997; 43(2): 177-181, 10.1046/j.1365-2125.1997.05417.x.
65. Ehrenstein V, Sørensen HT, Bakketeig LS, Pedersen L. Medical databases in studies of drug teratogenicity: methodological issues. Clin Epidemiol 2010; 2.