Occupational toxicology and the control of exposure to pharmaceutical agents at work

Occupational Medicine

Volumn 53, Issue 6, 2003, Pages 363-370

  Binks, Stephen P ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Occupational exposure limit; Occupational exposure to pharmaceuticals; Occupational hygiene; Occupational toxicology

Indexed keywords

ACETYLSALICYLIC ACID; PARACETAMOL; PROPRANOLOL;

BIBLIOGRAPHIC DATABASE; CONTROL STRATEGY; DANGEROUS GOODS; DRUG INDUSTRY; DRUG POTENCY; EMPLOYEE; HAZARD ASSESSMENT; HUMAN; INDUSTRIAL HYGIENE; LEADERSHIP; MEDICAL LITERATURE; MEDLINE; METHODOLOGY; OCCUPATIONAL EXPOSURE; OCCUPATIONAL HAZARD; OCCUPATIONAL HEALTH; OCCUPATIONAL SAFETY; OCCUPATIONAL TOXICOLOGY; PREDICTION; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; TOXICITY TESTING; WORKPLACE;

DRUG INDUSTRY; HUMANS; OCCUPATIONAL DISEASES; OCCUPATIONAL EXPOSURE; OCCUPATIONAL HEALTH; PHARMACEUTICAL PREPARATIONS;

EID: 0141611195     PISSN: 09627480     EISSN: None     Source Type: Journal    
DOI: 10.1093/occmed/kqg116     Document Type: Review

References (55)

1. Teichman RF, Fallon F, Brandt-Rauf PW. Health effects on workers in the pharmaceutical industry - a review. J Soc Occup Med 1988;38:55-57.
2. Heron RJL, Pickering FC. Health effects of exposure to active pharmaceutical ingredients (APIs) Occup Med (Lond) 2003;53:357-362.
3. Alsecchi R, Rohrich O, Cainelli T. Contact allergy to cistoran, an intermediate in ranitidine synthesis. Contact Dermatitis 1989;20:396-397.
4. Fawcett IW, Pepys J, Erooga MA. Asthma due to 'glycol compound powder' - an intermediate in production of salbutamol. Clin Allergy 1976;6:405.
5. Galer D. Occupational toxicology in the pharmaceutical industry. In Gad SC, ed. Safety Assessment for Pharmaceuticals. New York: Van Nostrand Reinhold, 1995; 301-324.
6. Sprague G, Sutton T. Occupational toxicology: test methods and approaches for the pharmaceutical industry. Occup Med State of the Art Rev 1997;12:119-129.
7. European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC). Testing for Worker Protection, Technical Report No. 59. Brussels: ECETOC, Belgium, 1994.
8. Health & Safety Executive (HSE). Making Sense of NONS. A Guide to the Notification of New Substances Regulations 1993. London: HSE Books, 1994.
9. Olson MJ, Seaman CW, Guerriero FJ. An integrated approach to hazard evaluation for worker safety assessment of pharmaceuticals and synthetic intermediates. Toxicol Sci 2002-66:328.
10. Richard AM. Commercial toxicology predictive systems: a regulatory perspective. Toxicol Lett 1998;102-103:611-616.
11. Dearden JC, Barrett MD, Benigni R, et al. The development and validation of expert systems for predicting toxicology. Altern Lab Anim 1997;25:223-252.
12. Reifferscheid G, Heil J. Validation of the SOS/umu test using test results of 486 chemicals and comparison with the Ames test and carcinogenicity data. Mutat Res 1996;369:129-145.
13. 50) testing in the up and down procedure (UDP) from cytotoxicity data. Altern Lab Anim 1999;27:957-966.
14. European Community. Test method B.40 Skin corrosivity. Council Directive 2000/33/EC. Adapting to technical progress for the 27th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal 2000;L136.
15. Curren RD, Harbell JW. In vitro alternatives for ocular irritation. Environ Health Perspect 1998;106:485-492.
16. European Community. Test method B.17 Mutagenicity - in vitro mammalian cell gene mutation test. Council Directive 2000/32/EC. Adapting to technical progress for the 26th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal 2000;L136.
17. Gerberick FG, Ryan CA, Kimber I, Dearman RJ, Lea LJ, Basketter DA. Local lymph node assay: validation assessment for regulatory purposes. Am J Contact Dermat 2000;11:3-18.
18. European Community. Test method B.4 Acute toxicity (skin irritation). Council Directive 92/69/EEC. Adapting to technical progress for the 17th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal 1992;L383A.
19. European Community. Test method B.5 Acute toxicity (eye irritation). Council Directive 92/69/EEC. Adapting to technical progress for the 17th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal 1992;L383A.
20. European Community. Test method B.1bis Acute toxicity (oral) - fixed dose method. Council Directive 2000/32/EEC. Adapting to technical progress for the 17th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal 1992;L383A.
21. European Community. Test method B.12 In vivo mammalian erythrocyte micronucleus test. Council Directive 2000/32/EEC. Adapting to technical progress for the 26th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal 2000;L136.
22. European Community. Test method B.7 Repeat dose (28 days) toxicity (oral). Council Directive 96/54/EEC. Adapting to technical progress for the 22nd time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal 1996;L248.
23. HSE. The Chemicals (Hazard Information and Packaging) Regulations. London: HSE Books, 1994.
24. HSE. Guide to the Health and Safety at Work Act 1974, 5th edn. London: HSE Books, 1992.
25. HSE. COSHH: A Brief Guide to the Regulations: What you Need to Know about the Control of Substances Hazardous to Health Regulations 1999 (COSHH). London: HSE Books, 1999.
26. European Community. Council Directive 2001/58/EC. Amending for the second time Directive 91/155/EEC defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 14 of European Parliament and Council Directive 1999/45/EC and relating to dangerous substances in implementation of Article 27 of Council Directive 67/548/EEC (safety data sheets). Official Journal 2001;L212/32.
27. Evans M. Inaccuracies in safety data sheets. Health Directorate PD/7/1, 1999.
28. Klop PW, Williams PL, Burtan RC. Assessment of the accuracy of material safety data sheets. Am Ind Hyg Assoc J 1995;56:178-183.
29. Anonymous. Guidance on the Compilation of Safety Data Sheets. Chemical Industries Association, 1998.
30. HSE. COSHH Essentials: Easy Steps to Control Chemicals. London: HSE Books, 1999.
31. Hayes EP. Hazard communication: challenges in the pharmaceutical industry. In Stave GM, Joines R, eds. Occupational Medicine State of the Art Reviews, Vol. 12, N. 1. Hanley & Belfus, 1997; 95-105.
32. Machin B. Global harmonisation - Agenda 21 Chapter 19. In McLean F, ed. Croner's Hazard Information and Packaging Special Report. Issue 53. London: Croner Publications Ltd, 1999; 1-8.
33. HSE. EH40/2002 Occupational Exposure Limits 2002. London: HSE Books, 2002.
34. McHattie GV, Rackham M, Teasdale EL. The derivation of occupational exposure limits in the pharmaceutical industry. J Soc Occup Med 1988;38:105-108.
35. Sargent EV, Kirk GD. Establishing airborne exposure control limits in the pharmaceutical industry. Am Ind Hyg Assoc J 1988;49:309-313.
36. Agius R. Occupational exposure limits for therapeutic substances. Ann Occup Hyg 1989;33:555-562.
37. Galer DM, Leung HW, Sussman RG, Trzos RJ. Scientific and practical considerations for the development of occupational exposure limits (OELs) for chemical substances. Regul Toxicol Pharmacol 1992;15:291-306.
38. Naumann BD, Sargent EV. Setting occupational exposure limits for pharmaceuticals. In Stave GM, Joines R, eds. Occupational Medicine State of the Art Reviews, Vol. 12, No. 1. Philadelphia: Hanley & Belfus, 1997; 67-80.
39. Association of the British Pharmaceutical Industry (ABPI). Guidance on Setting In-house Occupational Exposure Limits for Therapeutic Substances and their Intermediates. London: ABPI, 1995.
40. Silverman KC, Naumann BD, Holder JH, et al. Establishing data-derived adjustment factors from published pharmaceutical clinical trial data. Hum Ecol Risk Assess 1999;5:1059-1089.
41. Naumann BD, Weideman PA. Scientific basis for uncertainty factors used to establish occupational exposure limits for active pharmaceutical ingredients. Hum Ecol Risk Assess 1995;1:590-613.
42. Sargent EV, Naumann BD, Dolan DG, Faria EC, Schulman L. The importance of human data in the establishment of occupational exposure limits. Ecol Risk Assess 2001;8:805-822.
43. Olson MJ, Binks SP, Newton DL, Clark GC. Establishing guidance for the handling and containment of new chemical entities and chemical intermediates in the pharmaceutical industry. In Stave GM, Joines R, eds. Occupational Medicine State of the Art Reviews, Vol. 12, No. 1. Philadelphia: Hanley & Belfus, 1997; 49-59.
44. Naumann BD, Sargent EV, Starkman BS, Fraser WJ, Becker GT, Kirk GD. Performance-based exposure control limits for pharmaceutically active ingredients. Am Ind Hyg Assoc J 1996;57:33-42.
45. Gardner RJ, Oldershaw PW. Development of pragmatic exposure-control concentrations based upon packaging regulation risk phrases. Ann Occup Hyg 1991;35:51-59.
46. Brooke IM. A UK scheme to help small firms control risks to health from exposure to chemicals: toxicological considerations. Ann Occup Hyg 1998;42:377-390.
47. Guest I. The Chemical Industries Association guidance on allocating occupational exposure bands. Ann Occup Hyg 1998;42:407-411.
48. Guest I, Newton D. Industrial hygiene in the pharmaceutical industry. In Stave GM, Joines R, eds. Occupational Medicine State of the Art Reviews, Vol. 12, No. 1. Philadelphia: Hanley & Belfus, 1997; 81-94.
49. Walker L. Process containment design for development facility - Part 1. Pharm Eng 2002;22:72-76.
50. Chung J, Brookes S, Cooke MF, Hrytsak MD. Potent compound manufacturing in the pharmaceutical pilot plant. Pharm Eng 1998;18:8-22.
51. Burgess GL, Mashingaidze MT. Respirator leakage in the pharmaceutical industry of northwest England. Ann Occup Hyg 1999;43:513-517.
52. Association of the British Pharmaceutical Industry (ABPI). Guidance on the Selection, Use and Mainenance of Respiratory Protective Equipment in the Pharmaceutical Industry. London: ABPI, 1995.
53. Jersey JA, Burback B, Alllen M, et al. Development, validation and application of an assay to measure GI198745X on glass fiber disks to support industrial hygiene studies. Presented at the Annual Meeting of the American Association of Pharmaceutical Scientists, Seattle, 27-31 October, 1996.
54. Sessnick PJM, Boer KA, Schhfals AP, et al. Occupational exposure to antineoplastic agents at several departments in a hospital. Int Arch Occup Environ Health 1992;64:105-112.
55. Neal AD, Wadden RA, Chiou WL. Exposure of hospital workers to airborne antineoplastic agents. Am J Hosp Pharm 1983;40:597-601.