The Efficacy of Patient and Healthcare Provider Communication Tools as Risk Mitigation Strategies
A peer-led small-group education process has also been demonstrated to be a useful strategy for effecting changes in prescribing in general practice and sustaining changes over time against a background of ongoing monthly meetings on new topics.30
Much more educational
research is necessary to determine ways and means of making larger changes in physician prescribing behaviour.24
Electronic health records and communications have been an inevitable addition to healthcare practice and are vital to the ongoing process and evaluation of risk mitigation. Although clinicians are critical of the quality of e-prescribing alerts, electronic alerts may lead to clinically significant modifications in patient management not readily apparent based on ‘acceptance’ rates.31
A random-sample survey of 300 ambulatory care clinicians (who used a commercial e-prescribing system to alert physicians of allergy risks) showed that physicians thought that e-prescribing improved the quality of care delivered (78%), prevented medical errors (83%), enhanced patient satisfaction (71%) and improved clinician efficiency (75%). Thirty- five per cent of respondents said an electronic alert had caused them to modify a dangerous prescription in the last 30 days.31
Alerts also led
to counselling patients about potential reactions, reviewing information on medical references and changing the way a patient was monitored.31
An additional study showed that strategies that ‘worked’ for improving antibiotic use included computer-based algorithms that prompted professionals to prescribe antibiotics appropriately, the introduction of order entry forms and interactive educational outreach (where counsellors visit professionals to provide one-on-one education).32
Although the studies analysed often combined professional-orientated strategies (e.g. studies aimed at persuading professionals to prescribe antibiotics appropriately), these persuasive strategies were effective and may provide insight for future REMS communications.32
Conclusion
Rational use of drugs and patient safety are often seriously compromised by a lack of precise information, education and
1.
US Food and Drug Association, FDA, September 2009. Available at:
www.fda.gov/downloads/Drugs /GuidanceComplianceRegulatoryInformation/Guidances/ UCM184128.pdf (accessed 21 July 2010).
2. Kramer JM, Pharmacoepidemiol Drug Saf, 2005;14:619–28. 3. McCaughan M, The RPM Report, 2009;4(6):5–12. Available at:
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4. Anonymous, Eye on FDA, August 26, 2009. Available at:
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5. Seligman PJ, Pharmacoepidemiol Drug Saf, 2003;12:291–3. 6.
7. Van Doren S, DIA Global Forum, 2010;2(1):20–3. 8.
Sakai S, Van Doren S, RAPS Journal, submitted.
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Funch D, Norman H, Wong J, et al., Pharmacoepidemiol Drug Saf, 2010;19:448–56.
July 2010).
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12. Mazor KM, Andrade SE, Auger J, et al., Pharmacoepidemiol Drug Saf, 2005;14:869–75.
13. Bullman WR, Division of Dockets Management (HFA-305) Food and Drug Administration, 5 August 2005. Available at:
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14. Lee LY, Kortepeter CM, Willy ME, et al., J Am Pharm Assoc, 2003;48:494–500.
15. Woodcock J, Drug Industry Daily, October 2009;8(192). 16. Weatherby LB, Walker AM, Fife D, et al., Pharmacoepidemiol Drug Saf, 2001;10:211–8.
17. Smalley W, Shatin D, Wysowski DK, et al., JAMA, 2000;284:3036–9.
18. Weatherby LB, Nordstrom BL, Fife D, et al., Clin Pharmacol Ther, 2002;72:735–42.
19. Guo JJ, Curkendall S, Jones JK, et al., Pharmacoepidemiol Drug Saf, 2003;12:295–301.
20. Shatin D, Gardner JS, Stergachis A, et al., Pharmacoepidemiol Drug Saf, 2005;14:149–54.
effective communication at all stages of drug development and use.33 Current methods of drug information communication do not provide those responsible for prescribing and dispensing drugs with the data and information they need to pass on complex and often changing messages to patients and the public.33
should not be the sole primary tools used for risk mitigation in the future. Risk mitigation tools and the actual methods used to evaluate the interventions need to be addressed with new effort and courage. Tools that have been used in the past that do not appear to be effective need to be replaced with more effective strategies. The methods for evaluating new tools need to be sound and validated. As specific risk mitigation tools are found to be effective, best methods for the use of a particular tool should also be considered (particularly related to e-alerts and e-learning).
Evidence provided in this article suggests that the existing communication tools developed over the decades by the FDA and drug industry25
At the very least, future REMS tools should bring additional interactive educational safety updates for clinicians and pharmacists, joint-issuance of letters to pharmacists and physicians, and additional electronic risk communication options in the form of alerts, warnings and requirements as well as e-learning. n
Sally Van Doren is President and Chief Executive Officer of BioSoteria, a drug safety and risk management consultant group and service provider. She is also an Instructor of Drug Safety at the University of California, Berkeley Extension and for the University of California, San Francisco School of Pharmacy. She is an Adjunct Assistant Professor and a Member of the Board of Visitors at the University of Maryland School of Pharmacy and is an active member of the Drug
Information Association and the International Society of Pharmacoepidemiology. Dr Van Doren has 21 years of experience in the biopharmaceutical industry, where she has held leadership positions in drug and biological safety, clinical development and medical information services prior to founding BioSoteria in 2007. Dr Van Doren has been directly involved in safety analyses for numerous products in development and post-marketing and has advised numerous companies in a broad range of product safety and therapeutic risk management issues.
21. Cluxton RJ Jr, Li Z, et al., Pharmacoepidemiol Drug Saf, 2005;14:1–9.
22. Graham DJ, Presentation at the Advisory Committee for the Division of Endocrine and Metabolic Drugs, 26 March 1999, Bethesda, MD.
23. Anonymous, ParagonRx, September 2009. Available at:
www.paragonrx.com/rems-hub/rems-history/ (accessed 21 July 2010).
24. Gray J, Can J Clin Pharmacol, 2006:13(1):e81–4. 25. Werble C, J Am Pharm Assoc (Wash), 1996; NS36(4): 263–9.
27. Sbarbaro JA, Clin Infect Dis, 2001;33(Suppl 3):S240–4. 28. Collins TM, Mott DA, Bigelow WE, et al., Health Serv Res, 1997;32(4):471–89.
29. Davis D, Galbraith R, Chest, 2009;135:42S–48S. 30. Richards D, Toop L, Graham P, Family Practice, 2003;20: 199–206.
31. Weingart SN, Simchowitz B, Shiman L, et al., Arch Intern Med, 2009;169(17):1627–32.
32. Hulscher MEJL, Grol RPTM, van der Meer JWM, Lancet Infect Dis, 2010;10:167–75.
33. Hugman B, Edwards IR, Expert Opin Drug Saf, 2006;5(4): 495–9.
DRUG DEVELOPMENT
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