Starting or Strengthening a Drug Bulletin - A Practical Manual: Annexe to Chapter 8: Evaluating harm: 8.An-4 References

Starting or Strengthening a Drug Bulletin - A Practical Manual
(2005; 165 pages)

Table of Contents

Preface
How the manual was produced
About ISDB
Executive summary
1. Introduction
	1.1 Are you starting or developing a bulletin?
	1.2 Objectives of this manual
	1.3 The need for the manual
	1.4 The importance of feedback
2. Rational use of medicines
	2.1 The relationship between evidence and rational use
	2.2 Other influences on the choice of medicines
	2.3 Sources of information for prescribers
	2.4 The special role of drug bulletins
	2.5 Specific ways in which bulletins can help
	2.6 Bulletins as part of wider initiatives for promoting rational use of medicines
	2.7 Summary
3. What are drug bulletins?
	3.1 Definition
	3.2 The history of drug bulletins
	3.3 What makes an ‘independent’ drug bulletin independent?
	3.4 Types of editorial content
	3.5 Styles of communicating information
	3.6 The institutional base
	3.7 References
4. Defining aims, target and type of bulletin
	4.1 Principles
	4.2 What is already available?
	4.3 Information on drug utilisation helps you choose topics
	4.4 Defining and refining the aims of the bulletin
	4.5 Who are the readers?
	4.6 What type of information is needed?
5. Planning resources
	5.1 The first steps in planning
	5.2 Identify what is already available or accessible
	5.3 Make a realistic assessment of additional needs
	5.4 Human resources: who will do the work?
		5.4.1 The editorial team
		5.4.2 The advisory board
		5.4.3 External reviewers
	5.5 Maintaining the motivation of contributors
	5.6 Material resources - an office, equipment and references
	5.7 Financial resources - the key to sustainability
	5.8 Long-term sustainability
	5.9 Cost-saving strategies
	5.10 Key messages for starting a drug bulletin
	5.11 References
6. Planning bulletin production: schedules and timing
	6.1 Why is planning necessary?
	6.2 Start modestly and grow gradually
	6.3 Develop a framework for producing articles
	6.4 Flexible planning for each issue
	6.5 Allow time for delays in distribution
	6.6 Integrate necessary sidelines into your overall planning
	6.7 A few principles for planning the production of a bulletin
7. The editorial process
	7.1 Outline of the editorial process
	7.2 Editing a drug bulletin
		7.2.1 Editorial independence
		7.2.2 Strong and sustained editorial policy and a committed team
		7.2.3 Selecting topics for articles
		7.2.4 Using and adapting existing material
		7.2.5 Planning a bulletin issue
	7.3 Writing bulletin articles
		7.3.1 Finding and motivating authors
		7.3.2 Rewarding authors
		7.3.3 Writing an article
		7.3.4 Outlining the topic
		7.3.5 Searching for documentation
		7.3.6 The first draft
		7.3.7 Discuss the draft with an editor
	7.4 Reviewing the article
		7.4.1 How many people should review an article?
		7.4.2 Should a bulletin set up a permanent review board?
		7.4.3 Should readers be included in the review board?
		7.4.4 Should patients or lay people be included?
		7.4.5 Should the pharmaceutical industry review drafts?
		7.4.6 Tips for reviewing articles
		7.4.7 Rewarding reviewers
	7.5. Rewriting the article
	7.6 Final checks
	7.7 Follow-up after publication
		7.7.1 Indexing
		7.7.2 Authors’ certificates
		7.7.3 Post-publication correspondence
		7.7.4 Corrections
		7.7.5 Requests for reproduction
		7.7.6 Keeping track of how bulletin articles are quoted and used
	7.8 References
8. Reviewing a new drug: is it a therapeutic advance?
	8.1 Introduction
	8.2 When is a new treatment a therapeutic advance?
	8.3 Collecting evidence about the drug
		8.3.1 Where to find evidence on new drugs?
		8.3.2 What about using unpublished information?
	8.4 Evaluation in terms of efficacy, harm and convenience
		8.4.1 Efficacy
		8.4.2 Adverse effects/harms
		8.4.3 Convenience
	8.5 Judging the overall value of the drug
		8.5.1 Considering the new drug in the local and individual context
		8.5.2 Overall rating scales
	8.6 Cost
		8.6.1 Compare costs in the light of true therapeutic value
		8.6.2 Comparisons should be appropriate and practical
		8.6.3 Bear in mind additional costs for using drugs
	8.7 What patients need to know
	8.8 References
Annexe to Chapter 8: Evaluating harm
	8.An-1 Talk about harm, not risk
	8.An-2 Assessment of causation of a harmful effect
	8.An-3 Assessing coherence with preclinical data
		8.An-3.1 General principles
		8.An-3.2 Chemical structure of new drugs
		8.An-3.3 Considering the profile of adverse effects
		8.An-3.4 Ratio of toxic and efficacy level in the same animal
		8.An-3.5 Extrapolation of animal toxicity (safety) level to humans
	8.An-4 References
9. Design and production
	9.1 Elements of good design
	9.2 Creating the design
	9.3 Using images
	9.4 The production process
	9.5 Developing a house style
	9.6 Ensuring accuracy - proof reading
	9.7 Printing
	9.8 Electronic publishing
	9.9 Further reading
10. Dissemination
	10.1 Why dissemination is important
	10.2 Managing a subscription-based approach
	10.3 Guidelines for effective distribution
	10.4 Communicating your bulletin’s messages more widely
	10.5 Key messages
11. Organizational and legal issues
	11.1 Introduction
	11.2 Why does a drug bulletin need a structure?
	11.3 Different kind of structures
		11.3.1 An association
		11.3.2 A foundation
		11.3.3 Other legal entities
		11.3.4 A bulletin within another organization
	11.4 How to deal with legal action
	11.5 Copyright
		11.5.1 Limits to copyright
		11.5.2 How is copyright created?
		11.5.3 How to use copyrighted material
		11.5.4 Fair use and quotes
	11.6 Further reading
12. Evaluating quality and usefulness
	12.1 Introduction
	12.2 Evaluation brings many benefits
	12.3 Three approaches: audit, feedback and impact assessment
	12.4 Start with your own evaluation of the bulletin
	12.5 Assessing readers' opinions of the bulletin
		12.5.1 Methods of assessing readers’ opinions
		12.5.2 Potential problems
		12.5.3 Selecting the data collection method
		12.5.4 Planning the survey
		12.5.5 How many replies are enough?
		12.5.6 Drafting the questions
	12.6 Evaluating the impact of the bulletin
	12.7 Feedback is achievable and invaluable
	12.8 Simple observations can tell a lot
	12.9 References
13. Partnership and collaboration
	13.1 The importance of supportive partners
	13.2 Possibilities at national, regional and international levels
	13.3 Various forms of collaboration
		13.3.1 Twinning arrangements
		13.3.2 Sharing information and resources
		13.3.3 Using established bulletins’ expertise
		13.3.4 Training sessions and workshops
		13.3.5 Ongoing information exchange between bulletins
		13.3.6 Collaborative research among bulletins
		13.3.7 Information and support for funding applications
	13.4 Identifying partners and networks
	13.5 Clearly define conditions for partnership
14. Keeping records and creating a memory
	14.1 Why keep records?
	14.2 What to keep and record?
	14.3 Creating an organizational memory
	14.4 How to start an archive
	14.5 Further reading
Appendix: Electronic sources of information
	For general access to evidence
	Journal articles
	Systematic reviews
	National disease prevention and control, health promotion etc.
	Health technology assessment
	Clinical guidelines
	Formularies/Essential medicines
	Regulatory authorities
	Adverse effects
	Information about/for patients
	Drug promotion
	Networks and directories
	ISDB member bulletins
	Feedback and evaluation form

8.An-4 References

1. Herxheimer A. Communicating with patients about harms and risks. PloS Medicine 2005; 2(2):e42-43. Available at: http://medicine.plosjournals.org/perlserv/?request=getdocument&doi=10.1371/journal.pmed.0020042

2. Fisher FD. An introduction to epidemiology - a programmed text. New York: Appleton-Century-Crofts; 1975.

3. Rothman KJ, Greenland S. Causation and causal inference. In: Rothman KJ, Greenland S, editors. Modern epidemiolog. 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 1998.

4. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981 Aug;30(2):239-45.

5. Pioglitazone hydrochloride, new drug approval package (NAP). Japan Pharmacists Education Center 1999 (in Japanese). Available at: http://www.jpec.or.jp/

6. GlaxoSmithKline. Study reports of paroxetine for pediatric and adolescent patients. Unipolar major depression: study 329. Available at: http://www.gsk.com/media/paroxetine.htm

7. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines. Safety guidelines. Available at:
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254

8. ICH Safety guideline S1C: Dose selection for carcinogenicity studies of pharmaceuticals. Available at: http://ww.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254

9. Addendum to ICH S1C: (Addition of a limit dose and related notes). Available at:
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254

10. Kusuri-no-Check Editorial Team. Don't take ACTOS!!! Kusuri-no-Check (Check-up your Medicines) 2004;1:36-39 and 43-47. Available at:
http://www.npojip.org/english/check-up1/check-up04.htm

11. Hama R, Sakaguchi K. Gefitinib story. ISDB Newsletter 2003;17(1):6-9. Available at:
http://www.npojip.org/english/The-gefitinib-story.pdf

12. Hama R. Adrenal insufficiency induced by inhaled fluticasone propionate. The Informed Prescriber 2004;19:25-29. This summary will be available at the following site in a few months:
http://www.npojip.org/english/

13. Hama R, Shimazu T. Tacrolimus (Protopic) ointment and cancer risk. The Informed Prescriber 2003;8:86-90. Summary is available at:
http://www.fda.gov/ohrms/dockets/ac/05/slides/20054089OPH2_09_Rokuro%20Hama%20letter.pdf and http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4089OPH2_10_Rokuro%20Hama%20slides_files/frame.htm

14. U.S. Food and Drug Administration Pediatric Advisory Committee 15 February 2005.
http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4089s2.htm

15. CHMP to look at potential cancer risk with pimecrolimus and tacrolimus. SCRIP No.3053, 11 May 2005: 30.