Risk minimization practices for pregnancy prevention: Understanding risk, selecting tools

Pharmacoepidemiology and Drug Safety

Volumn 16, Issue 3, 2007, Pages 337-348

  Uhl, Kathleen ^a   Trontell, Anne ^b   Kennedy, Dianne ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b AGENCY FOR HEALTHCARE RESEARCH AND QUALITY   (United States)

Author keywords

Birth defects; Drugs medications; Pregnancy; Pregnancy prevention; Prevention; Risk management; Risk minimization; Teratogens

Indexed keywords

DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ISOTRETINOIN; TERATOGENIC AGENT; TETRACYCLINE; THALIDOMIDE;

BIRTH DEFECT; BIRTH RATE; CONTRACEPTION; DRUG CLASSIFICATION; DRUG INDICATION; DRUG LABELING; DRUG MONITORING; DRUG SAFETY; FETUS OUTCOME; HEALTH CARE ACCESS; HIGH RISK PREGNANCY; HUMAN; MEDICAL DECISION MAKING; NONHUMAN; PATIENT EDUCATION; POSTMARKETING SURVEILLANCE; PREGNANCY TEST; PRENATAL DRUG EXPOSURE; PRIORITY JOURNAL; REMINDER SYSTEM; REPRODUCTIVE TOXICITY; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; RISK REDUCTION; TERATOGENICITY; TOOTH DISCOLORATION;

ABNORMALITIES, DRUG-INDUCED; CONTRACEPTION; DRUG LABELING; FEMALE; HUMANS; INFANT, NEWBORN; PATIENT EDUCATION; PHARMACEUTICAL PREPARATIONS; PHYSICIAN'S PRACTICE PATTERNS; PREGNANCY; PREGNANCY COMPLICATIONS; RISK ASSESSMENT; RISK MANAGEMENT; TERATOGENS;

EID: 33947264253     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1312     Document Type: Review

References (34)

1. March of Dimes Birth. Medical References: Birth Defects. Available at http://www.marchofdimes.com/professionals/681_1206.asp, accessed 27 January 2005.
2. Peller AJ, Westgate MN, Holmes LB. Trends in congenital malformations, 1974-1999: effect of prenatal diagnosis and elective termination. Obstet Gynecol 2004; 104: 957-964.
3. Schardein JL. Chemically Induced Birth Defects (3rd edn). Marcel Dekker: New York, NY, 2000.
4. Koren G, Pastuszak A, Ito S. Drugs in pregnancy. N Engl J Med 1998; 338(16): 1128-1137.
5. Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol 2004; 191: 398-407.
6. Food and Drug Administration Guidance for industry: Premarketing risk assessment. Available at http://www.fda.gov/cder/guidance/6357fnl.htm, accessed 30 January, 2006.
7. Food and Drug Administration Guidance for industry: Development and use of risk minimization action plans. Available at http://www.fda.gov/cder/ guidance/6358fnl.htm, accessed 30 January 2006.
8. Food and Drug Administration Guidance for industry: Good pharmacovigilance practices and pharmacoepidemiologic assessment. Available at http://www.fda.gov/cder/guidance/6359OCC.pdf, accessed 30 January 2006.
9. Brent RL. Addressing environmentally caused human birth defects. Pediatr Rev 2001; 22(5): 153-165.
10. Ventura SJ, Martin JA, Curtin SC, et al. Births; final data for 1999. Natl Vital Stat Rep 2001; 49(1): 1-100.
11. Brent RL, Beckman DA. Angiotensin-converting enzyme inhibitors, an embryopathic class of drugs with unique properties: information for clinical teratology counselors. Teratology 1991; 43: 543-546.
12. Rosenn B, Miodovnik M, Combs CA, et al. Glycemic thresholds for spontaneous abortion and congenital malformations in insulin-dependent diabetes mellitus. Obstet Gynecol 1994; 84(4): 515-520.
13. Fu H, Darroch JE, Haas T, Fu H, et al. Contraceptive failure rates: new estimates from the 1995 National Survey of Family Growth. Fam Plann Perspect t999; 31(2): 56-63.
14. Pettinato A, Emans SJ. New contraceptive methods: update 2003. Curr Opin Pediatr 2003; 15: 362-369.
15. Thalomid® (thalidomide) Capsules, Full Prescribing Information. February 2005.
16. Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cisapride: impact of food and drug administration regulatory action. JAMA 2000; 284(23): 3036-3039.
17. Weatherby LB, Walker AM, Fife D, et al. Contraindicated medications dispensed with cisapride: temporal trends in relation to the sending of 'Dear Doctor' letters. Pharmacoepidemiol Drug Safe 2001; 10(3): 211-218
18. Cuspidi C, Lonati L, Sampieri L, et al. 'To better know hypertension': educational meetings for hypertensive patients. Blood Press 2000; 9(5): 255-259.
19. Rimer B, Levy MH, Keintz MK, et al. Enhancing cancer pain control regimes through patient education. Patient Educ Couns 1987; 10(3): 267-277.
20. Food and Drug Administration, Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC). Overview of Accutane and Pregnancy Exposure Performance of the Current Pregnancy Prevention Program, September 18, 2000, transcripts. Available at http://www.fda.gov/ohrms/dockets/ac/00/ backgrd/3639ble-03.pdf, accessed 17 February 2006.
21. Food and Drug Administration, Drug Safety and Risk Management Advisory Committee (DSaRM) and Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC), February 26, 2004, transcripts. Available at http://www.fda.gov/ohrms/dockets/ac/04/agenda/4017A1-Final.htm, accessed 30 January 2006.
22. Lotronex (alosetron hydrochloride) information. Available at http://www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm, accessed 30 January 2006.
23. Chee CB, James L. The Singapore tuberculosis elimination programme: the first five years. Bull World Health Organ 2003; 81(3): 217-221.
24. Haddad MB, Wilson TW, Ijaz K, et al. Tuberculosis and homelessness in the United States, 1994-2003. JAMA 2005; 293(22): 2762-2766.
25. Tracleer® (bosentan) tablets, Full Prescribing Information. November 2005.
26. FDA Public Health Advisory: Strengthened risk management program for isotretinoin. Available at http://www.fda.gov/cder/drug/advisory/ isotretinoin2005.htm, accessed 27 January 2006.
27. Food and Drug Administration, Psychopharmacologic Drugs Advisory Committee. June 16, 2003, transcripts. Available at http://www.fda.gov/ ohrms/dockets/ac/03/transcripts/3959T1.htm, accessed 30 January 2006.
28. Dear Health Care Provider letter. Important drug warning and new information for Clozaril (clozapine). Novartis Pharmaceuticals Corporation, December 2005. Available at http://www.fda.gov/medwatch/ safety/2006/Clozaril_chart_letter_final 12-2005.pdf, accessed 30 January 2006.
29. Uhl K, Cox E, Rogan R, et al. Thalidomde use in the US: experience with pregnancy testing in the S.T.E.P.S.® programme. Drug Saf 2006; 29(4): 321-329.
30. Kennedy DL, Uhl K, Kweder SL. Pregnancy exposure registries. Drug Saf 2004; 27(4): 215-228.
31. Food and Drug Administration Guidance for industry: Establishing pregnancy exposure registries. Available at http://www.fda.gov/cder/ guidance/3626fnl.pdf, accessed 27 January 2006.
32. Blaiss MS. Asthma disease management: a critical analysis. Ann Allergy Asthma Immunol 2005; 95(5S): S10-S16.
33. Norris SL, Nichols PH, Caspersen CJ, et al. The effectiveness of disease and case management for people with diabetes: a systematic review. Am J Prev Med 2002; 22(4S): 15-38.
34. Badamgarav E, Weingarten SR, Henning JM, et al. Effectiveness of disease management programs in depression: a systematic review. Am J Psychiatry 2003; 160: 2080-2090.