Starting or Strengthening a Drug Bulletin - A Practical Manual
(2005; 165 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentHow the manual was produced
View the documentAbout ISDB
View the documentExecutive summary
Open this folder and view contents1. Introduction
Open this folder and view contents2. Rational use of medicines
Open this folder and view contents3. What are drug bulletins?
Open this folder and view contents4. Defining aims, target and type of bulletin
Open this folder and view contents5. Planning resources
Open this folder and view contents6. Planning bulletin production: schedules and timing
Open this folder and view contents7. The editorial process
Close this folder8. Reviewing a new drug: is it a therapeutic advance?
View the document8.1 Introduction
View the document8.2 When is a new treatment a therapeutic advance?
Open this folder and view contents8.3 Collecting evidence about the drug
Open this folder and view contents8.4 Evaluation in terms of efficacy, harm and convenience
Open this folder and view contents8.5 Judging the overall value of the drug
Open this folder and view contents8.6 Cost
View the document8.7 What patients need to know
View the document8.8 References
Open this folder and view contentsAnnexe to Chapter 8: Evaluating harm
Open this folder and view contents9. Design and production
Open this folder and view contents10. Dissemination
Open this folder and view contents11. Organizational and legal issues
Open this folder and view contents12. Evaluating quality and usefulness
Open this folder and view contents13. Partnership and collaboration
Open this folder and view contents14. Keeping records and creating a memory
Open this folder and view contentsAppendix: Electronic sources of information

8.8 References

1. Prescrire editorial group. A review of new drugs in 2004. Prescrire International 2005;14:68-78. First published in French in la revue Prescrire 2005;25:139-48.

2. International Society of Drug Bulletins. ISDB Declaration on Therapeutic Advance in the Use of Medicines (in English, French, German, Italian, Portuguese, Russian, Spanish) 2001. Available at:

3. Kusuri-no-Check. Available at:

4. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine - selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326:1171-3.

5. Montori VM, Permanyer-Miralda G, Ferreira-González I, et al. Validity of composite end points in clinical trials BMJ 2005;330:594-6.

6. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trails: is blinding necessary? Controlled Clinical Trials 1996;17:1-12.

7. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. Journal of the American Medical Association 1996;276:637-9.

8. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of reporting of meta-analyses. Lancet 1999;354:1896-900.

9. Cooper NJ, Sutton AJ, Abrams KR, Wailoo A, Turner D, Nicholson KG. Effectiveness of neuraminidase inhibitors in treatment and prevention of influenza A and B: systematic review and meta-analyses of randomised controlled trials. BMJ 2003;326:1235-40.

10. Hayashi K and Hama R. Evaluation of oral anti-allergic drugs in Japan. Lancet 1996;347: 77.

11. Bombadier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. New England Journal of Medicine 2000; 343(21):1520-8.

12. Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004;364:2021-9.

13. Kiess W, Raile K, Galler A, Kapellen T. Insulin detemir offers improved glycemic control compared with NPH insulin in people with Type 1 diabetes [letter]. Diabetes Care 2004;27:2567-8.

14. Sackett DL, Oxman AD. HARLOT plc.: an amalgamation of the world's two oldest professions. BMJ 2003;327:1442-5.

15. Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe S, Bor DH. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002;287:2215-20.

16. International Society of Drug Bulletins. ISDB EU: Berlin Declaration on Pharmacovigilance. 2005. (in English, French and German). Available at:

17. Dukes G, Aronson J (eds). Meyler’s side effects of drugs. 14th ed. Amsterdam: Elsevier; 2000.

18. Bertilsson L. Geographical/interracial differences in polymorphic drug oxidation. Current state of knowledge of cytochromes P450 (CYP) 2D6 and 2C19. Clinical Pharmacokinetics 1995;29:192-209.


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