Adverse Drug Reactions in Clinical Practice - Journal of ...

358
is mandatory in promoting patients’ safety. Health
professionals who care for patients’ drug therapy are taught
to consider as well the benefit as the risk when making
therapeutic choices. The training regarding adverse events
is often limited, considering the reality that expected (due to
pharmacologic action) or unexpected (due to idiosyncratic
reactions) adverse drug reactions, if not recognised, can
increase the risk of harm. Several aspects should be taken
into consideration in order to recognize and properly manage
adverse drug reactions. The first is that careful observation
and high clinical suspicion are of crucial importance in
order to identify a drug related problem, including adverse
drug reactions. The second is that, even though a drug has
been on the market for several years, is widely used and
with known side effects profile, unusual adverse reactions
may still be identified. Taking into account all these aspects
will lead to better adverse drug reaction management and
increased patients’ safety.
Conflicts of interest
None to declare.
Acknowledgements
The documentation for this study was supported by
a research grant financed by the Romanian Ministry of
Education and Research – PNII Partnership in Prioritary
Issues 12-102 / 2008
References
1. Pirmohamed M, James S, Meakin S, et al. Adverse drug reaction
as cause of admission to hospital: prospective analysis of 18 820
patients. BMJ 2004; 329: 15-19.
2. Lazarou J, Pomeranz B, Corey PN. Incidence of adverse drug
reactions in hospitalized patients. A meta-analysis of prospective
studies. JAMA 1998; 279: 1200-1205.
3. Dormann H, Muth-Selbach U, Krebs S, et al. Incidence and costs
of adverse drug reactions during hospitalization: computerized
monitoring versus stimulated spontaneous reporting. Drug Saf 2000;
22: 161-168.
4. Rodriguez-Monguio R, Otero MJ, Rovira J. Assessing the economic
impact of adverse drug effects. Pharmacoeconomics 2003; 21: 623-
650.
5. Dormann H, Criegee-Rieck M, Neubert A, et al. Lack of awareness of
community-acquired adverse drug reactions upon hospital admission.
Drug Saf 2003; 26: 353-362.
6. The use of the WHO–UMC system for standardised case causality
assessment. Accessed at http://www.who-umc.org/graphics/4409.
pdf on February, 28th, 2009.
7. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the
probability of adverse drug reactions. Clin Pharmacol Ther 1981;
30: 239–245.
8. Lindquist M. The need for definitions in pharmacovigilance. Drug
Saf 2007; 30: 825-830.
Farcas et al
9. Edwards IR, Aronson JK. Adverse drug reactions: definitions,
diagnosis, and management. Lancet 2000; 356:1255–1259.
10. Clinical safety data management: definitions and standards for
expedited reporting. London: European Agency for the Evaluation
of Medicinal Products, Human Medicines Evaluation Unit; 1995.
Accessed at www.emea.eu.int/pdfs/human/ich/037795en.pdf.
11. WHO safety of medicines. A guide to detecting and reporting adverse
drug reactions. Why health professionals need to take action. Geneva:
World Health Organization; 2002. WHO/EDM/QSM/2002.2.
12. Atuah KN, Hughes D, Pirmohamed M. Clinical pharmacology: special
safety considerations in drug development and pharmacovigilance.
Drug Saf 2004; 27: 535-554.
13. Meyboom RH, Lindquist M, Egberts AC. An ABC of drug-related
problems. Drug Saf 2000; 22: 415-423.
14. Mann RD, Andrews EB. Pharmacovigilance. 2nd Edn, Chichester,
UK: John Wiley & Sons, Ltd, 2007.
15. Talbot J, Waller P. Stephens: Detection of New Adverse Drug
Reactions. 5th Edn, Chichester, UK: John Wiley & Sons, 2004.
16. Rehan HS, Chopra D, Kakkar AK. Physician’s guide to
pharmacovigilance: terminology and causality assessment. Eur J
Intern Med 2009; 20: 3-8.
17. Jaquenoud Sirot E, Van der Velden JW, Rentsch K, Eap CB, Baumann
P. Therapeutic drug monitoring and pharmacogenetic tests as tools
in pharmacovigilance. Drug Saf 2006; 29: 735-768.
18. Meyboom RH, Lindquist M, Flygare AK, Biriell C, Edwards IR.
The value of reporting therapeutic ineffectiveness as an adverse drug
reaction. Drug Saf 2000; 23: 95-99.
19. Irey NS. Diagnostic problems in drug-induced diseases. Ann Clin
Lab Sci. 1976; 6: 272-277.
20. Tisdale JE, Miller DA. Drug-Induced Diseases. Prevention,
Detection and Management. Bethesda, Maryland: American Society
of Health-System Pharmacists Press, 2005.
21. Atkin PA, Veitch PC, Veitch EM, Ogle SJ. The epidemiology of
serious adverse drug reactions among the elderly. Drugs Aging 1999;
14: 141-152.
22. Passarelli MC, Jacob-Filho W, Figueras A. Adverse drug reactions
in an elderly hospitalised population: inappropriate prescription is
a leading cause. Drugs Aging 2005; 22: 767-777.
23. Köhler GI, Bode-Böger SM, Busse R, Hoopmann M, Welte T, Böger
RH. Drug-drug interactions in medical patients: effects of in-hospital
treatment and relation to multiple drug use. Int J Clin Pharmacol Ther
2000; 38: 504-513.
24. Laroche ML, Charmes JP, Nouaille Y, Fourrier A, Merle L. Impact
of hospitalisation in an acute medical geriatric unit on potentially
inappropriate medication use. Drugs Aging 2006; 23: 49-59.
25. Jonville-Bera AP, Bera F, Autret-Leca E. Are incorrectly used drugs
more frequently involved in adverse drug reactions? A prospective
study. Eur J Clin Pharmacol 2005; 61: 231–236.
26. Rieger K, Scholer A, Arnet I, et al. High prevalence of unknown
co-medication in hospitalised patients. Eur J Clin Pharmacol 2004;
60: 363–368.
27. Brewer T, Colditz GA. Postmarketing surveillance and adverse drug
reactions. current perspectives and future needs. JAMA 1999; 281:
824-829.
28. Nebeker JR, Barach P, Samore MH. Clarifying adverse drug events:
a clinician’s guide to terminology, documentation, and reporting. Ann
Intern Med 2004; 140: 795-801.