The role of the pharmaceutical industry in disseminating pharmacovigilance practice in developing countries

Food and Drug Law Journal

Volumn 63, Issue 3, 2008, Pages

  Shani, Segev ^a,b   Yahalom, Zohar ^c  

^a Neopharm Group

^b BEN GURION UNIVERSITY OF THE NEGEV   (Israel)

^c Yahalom Law Offices   (Israel)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; COST EFFECTIVENESS ANALYSIS; DEVELOPED COUNTRY; DEVELOPING COUNTRY; DRUG EFFICACY; DRUG INDUSTRY; DRUG LABELING; DRUG LEGISLATION; DRUG MARKETING; DRUG MONITORING; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; MEDICAL CARE; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; UNITED KINGDOM; UNITED STATES; WORLD HEALTH ORGANIZATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DEVELOPING COUNTRIES; DRUG APPROVAL; DRUG INDUSTRY; EUROPE; GOVERNMENT REGULATION; HEALTH PRIORITIES; HUMANS; INTERNATIONAL COOPERATION; INTERNATIONALITY; SAFETY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 51149119060     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (40)

1. Jeffrey A Johnson & Lyle J Bootman. Drug Related Morbidity and Mortality: A Cost of Illness Model. 155 ARCH INTERN MED 1949-1956 (1995).
2. Troyen A. Brennan, Lucian L. Leape, Nan M. Laird, Liesi Hebert, A. Russel Localio, Ann G. Lawthers, Peter J. Newhouse, Paul C. Weiler & Howard Hiatt, Incidence of Adverse Events and Negligence in Hospitalized Patients: Rresults of the Harvard Medical Practice Study I., 324 NEW ENG J MED 370-376 (1991);
3. Troyen A Brennan, Lucian L. Leape, Nan M. Laird, Ann G. Lawthers, A. Russel Localio, Liesi Hebert, Peter J. Newhouse, Paul C. Weiler & Howard Hiatt. The nature of Adverse Events in Hospitalized Patients: Results of the Harvard Medical Practice Study II., 324 NEW ENG J MED 377-384 (1991);
4. Jason Lazarou, Bruce H. Pomeranz, Paul N. Corey, Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta Analysis of Prospective Studies, 279 J AM MED ASSOC 1200-1205 (1998).
5. Laurie B. Burke, Dianne L. Kennedy, James R. Hunter. Spontaneous Reporting in the United States, in Abraham G. Hartzema, Miquel Porta & Hugh H. Tilson (Editors), Pharmacoepidemiology - An Introduction, Harvey-Whitney Books, 213-234, Cincinnati, OH, (1998).
6. Milestones in U.S. Food and Drug Law History (Aug. 2005), available at: www.fda.gov/opa-com/backgrounders/miles.html.
7. General Accounting Office (GAO), Improvement Needed in FDA's Postmarket DecisionMaking and Oversight Process, GAO-06-402, (Mar.2006).
8. Directive 2001/20/EC of the European Parliament and of the Council, of 4 Apr. 2001, on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, available at: http://eudravigilance.emea.europa.eu/human/docs/Directives/ Dir2001-20_en.pdf; Regulation (EC) No 726/2004 of the European Parliament and of the Council, available at: http://eurlex.europa.eu/LexUriServ/ LexUriServ.do?uri=OJ:L:2004:136:0001:0033:EN:PDF; Directive 2001/83/EC of the European Parliament and of the Council of 6 Nov. 2001 on the Community Code Relating to Medicinal Products for Human Use as amended, available at: http://www.emea.europa.eu/pdfs/human/pmf/2001-83-EC.pdf.
9. EudraVigilance, available at: http://eudravigilance.emea.europa. eu/human/index.asp.
10. Clinical and pharmacological Evaluation of Drugs (WHA16.36), Handbook of Resolutions and Decisions of the World Health Assembly and Executive Board, WHO, Geneva, Switzerland (1973).
11. International Drug Monitoring: The Role of National Centers (WHO Technical Report Series No. 498). WHO, Geneva, Switzerland (1972).
12. http://www.who-umc.org/DynPage.aspx?id=13140&mn=1514.
13. WHO, The importance of Pharmacovigilance - safety monitoring of medicinal products, WHO, Geneva, Switzerland (2002).
14. International Society of Drug Bulletins EU: Berlin Declaration on Pharmacovigilance, (Jan. 2005), available at: http://www.icf.uab.es/ informacion/boletines/ISDB/Declaration.pdf.
15. http://www.biology-online.org/dictionary/Developing_countries, http://en.wikipedia.org/wiki/Developing_country.
16. Munir Pirmohamed, Kwame N. Atuah, Alex N.O. Dodoo & Peter Winstanley, Pharmacovigilance in Developing Countries, 335, BR J MED 462 (2007).
17. Martin Backstrom, Tom Mjorndal & Rune Dhalqvist, Under-reporting of Serious Adverse Drug Reactions in Sweden, 13 PHARMACOEPIDEIOLOGY & DRUG SAFETY 483-487 (2004);
18. Francoise Haramburu, Estimation of underreporting, 7 POST MARKETING SURVEILLANCE 39-49 (1993);
19. Adolfo Figueiras, Fernando Tato, Jesus Fontaiñas, Bahi Takkouche & Juan Jesus Gestal-Otero, Physicians' Attitudes Towards Voluntary Reporting of Adverse Drug Events, 7 J EVALUATION CLIN PRACTICE 347-354 (2001).
20. Sandeep B. Bavdekar & Sunil Karande, National Pharmacovigilance Program, 43 IND PEDIAT 27-32 (2006).
21. Renu N. Srivastava, National Pharmacovigilance Program - Letter to the Editor, 43 IND PEDIAT 458-459 (2006).
22. Kenneth Hartigan-Go, Developing a Pharmacovigilance System in the Philippines, a Country of Diverse Culture and Strong Traditional Medicine Background, 181-182 TOXICOLOGY 103-107 (2002).
23. Andrej Czarnecki & Agata Maciejczyk, Pharmacovigilance in Poland, 6 PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 277-281 (1997).
24. Shadi Baniasadi, Fanak Fahimi & Gloria Shalviri, Developing an Adverse Drug Reaction Reporting System at a Teaching Hospital, 102 BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY 408-411 (2008).
25. Milena Miljkovic, Serbian Pharmacovigilance System, available at: www.who-umc.org/graphics/10891.pdf.
26. Oleg Stefanov, Maria Sharayeva & Victor Jajtchenja, Development of Pharmacovigilance System in Ukraine: First Results, 13 PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 197-199 (2004).
27. Zoriah Aziz, Tan-Ching Siang & Nurul S. Badarudin, Reporting of Adverse Drug Reactions: Predictors of Under-Reporting in Malaysia, 16 PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 223-228 (2007).
28. Li Qing, Zhang Su-min, Chen Hua-ting, Fang Shi-ping, Yu Xin, Liu Dong, Shi Lü-yuan & Zeng Fan-dian, Awareness and Attitudes of Healthcare Professionals in Wuhan, China to the Reporting of Adverse Drug Reactions, 116 CHINESE MED J 856-861 (2004).
29. Hale Zerrin Toklu & Meral Keyer Uysal, The Knowledge and Attitude of the Turkish Community Pharmacists Toward Pharmacovigilance in the Kadikoy District of Istanbul, PHARM WORLD SCI, early publication online (2008).
30. http://en.wikipedia.org/wiki/Emerging_markets.
31. Johnson & Johnson 2007 Annual Report, available at: http://files.shareholder.com/downloads/JNJ/356774079x0x171267/ 057640F8-B2C0-4B0F-9F54-7A24A553C3CE/2007AR.pdf; Lilly Corporate citizenship report 2006/2007, available at: http://www.lilly.com/about/citizenship/ lilly_summary_22.pdf.
32. Elhadi E. Abbas, Industry-Sponsored Research in Developing Countries, 28 CONTEMPORARY CLINICAL TRIALS 677-683 (2007). Clinical trials are now increasingly outsourced to developing countries like India, available at: http://www.offshoringtimes.com/Pages/ 2006/BPO_news926.html.
33. John C.C. Talbot, Bjorn S. Nilsson, Pharmacovigilance in the Pharmaceutical Industry, 45 BR J CLIN PHARMACOL, 427-431 (1998).
34. Guideline for Good Clinical Practice, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (1996), available at: http://www.ich.org/LOB/media/MEDIA482. pdf.
35. Id. Article 5.1.6.
36. Id. Article 5.1.7.
37. GSK position on Pharmacovigilance (2007), available at: http://www.gsk.com/responsibility/downloads/GSK-Public-Policy-on- Pharmacovigilance.pdf.
38. Ivana Hanzl-Dujmovi'c, Zrinka Suli'c-Milǐsíc, Ivana Starěsiníc- Sernhorst, Issues with Regulatory Pharmacovigilance in East European Countries: The Industry Perspective, 168 Toxicology Letters, 228-235, (2007).
39. See Supra note 33.
40. Roselie A. Bright, Strategy for Surveillance of Adverse Drug Events, 62 FOOD & DRUG LAW J, 605-615 (2007).