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Preventability of adverse effects of analgesics: analysis of spontaneous reports

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Objectives

The aims of this study were to determine the patterns of analgesic adverse drug reactions (ADRs) and to assess their preventability and contributing factors.

Methods

This is a retrospective, descriptive study conducted on ADRs of analgesics and other drugs indicated as analgesics, spontaneously reported to the Bordeaux pharmacovigilance center from January 2011 to June 2012.

Results

The 141 cases selected for the analysis included 16 cases of medication errors (11.3 %) and 15 addiction cases (10.6 %). In total, 214 ADRs were registered, for which 173 analgesic medicines were suspected. The most frequent ADRs reported were nervous system disorders (26.6 %), psychiatric disorders (15.0 %), and skin and subcutaneous tissue disorders (12.1 %). Tramadol alone or in combination (17.3 %), followed by morphine (15 %), fentanyl (9.8 %), and paracetamol (8.7 %) were the most frequently involved analgesics. More than half of the cases (54.6 %) were serious and led to hospitalization or prolonged hospitalization. Preventability was determined for 134 cases (95 %): 51.5 % were considered as preventable, 26.1 % not preventable, and 22.4 % not assessable. The main contributing factors for the preventable cases included negligence of recommendations for analgesic use and failure to consider patients’ risk factors when prescribing.

Conclusions

A significant number of analgesic ADRs could be prevented, and being aware of their contributing factors promotes efficient analgesia with minimum risks to the patients.

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References

  1. Boeuf-Cazou O, Lapeyre-Mestre M, Niezborala M, Montastruc JL (2009) Evolution of drug consumption in a sample of French workers since 1986: the ‘drugs and work’ study. Pharmacoepidemiol Drug Saf 18:335–343

    Article  CAS  PubMed  Google Scholar 

  2. Jyrkkä J, Enlund H, Korhonen MJ, Sulkava R, Hartikainen S (2009) Patterns of drug use and factors associated with polypharmacy and excessive polypharmacy in elderly persons: results of the Kuopio 75+ study: a cross-sectional analysis. Drugs Aging 26:493–503

    Article  PubMed  Google Scholar 

  3. Lacroix I, Hurault C, Sarramon MF, Guitard C, Berrebi A, Grau M et al (2009) Prescription of drugs during pregnancy: a study using EFEMERIS, the new French database. Eur J Clin Pharmacol 65:839–846

    Article  CAS  PubMed  Google Scholar 

  4. Collet JP, Bossard N, Floret D, Gillet J, Honegger D, Boissel JP (1991) Drug prescription in young children: results of a survey in France. Epicrèche Research Group. Eur J Clin Pharmacol 41:489–491

    Article  CAS  PubMed  Google Scholar 

  5. Eschalier A, Mick G, Perrot S, Poulain P, Serrie A, Langley P et al (2013) Prévalence et caractéristiques de la douleur et des patients douloureux en France : résultats de l’étude épidémiologique National Health and Wellness Survey réalisée auprès de 15 000 personnes adultes. Douleurs Eval Diagn Traitement 14:4–15

    Article  Google Scholar 

  6. Mick G, Perrot S, Poulain P, Serrie A, Eschalier A, Langley P (2013) Impact sociétal de la douleur en France : résultats de l’enquête épidémiologique National Health and Wellness Survey auprès de plus de 15 000 personnes adultes. Douleurs Eval Diagn Traitement 14:57–66

    Article  Google Scholar 

  7. Casati A, Sedefov R, Pfeiffer-Gerschel T (2012) Misuse of medicines in the European Union: a systematic review of the literature. Eur Addict Res 18:228–245

    Article  PubMed  Google Scholar 

  8. Orriols L, Gaillard J, Lapeyre-Mestre M, Roussin A (2009) Evaluation of abuse and dependence on drugs used for self-medication: a pharmacoepidemiological pilot study based on community pharmacies in France. Drug Saf 32:859–873

    Article  CAS  PubMed  Google Scholar 

  9. Lazarou J, Pomeranz B, Corey P (1998) Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 279:1200–1205

    Article  CAS  PubMed  Google Scholar 

  10. Pouyanne P, Haramburu F, Imbs JL, Bégaud B (2000) Admissions to hospital caused by adverse drug reactions: cross sectional incidence study. BMJ 320:1036

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  11. Bénard-Laribière A, Miremont-Salamé G, Pérault-Pochat MC, Noize P, Haramburu F; EMIR Study Group on behalf of the French network of pharmacovigilance centres (2015) Incidence of hospital admissions due to adverse drug reactions in France: the EMIR study. Fundam Clin Pharmacol 29:106–111

    Article  Google Scholar 

  12. Apretna E, Haramburu F, Taboulet F, Béegaud B (2005) Conséquences médicales et socio-économiques d’effets indésirables médicamenteux. Presse Med 34:271–276

    Article  PubMed  Google Scholar 

  13. Diener HC, Schneider R, Aicher B (2008) Per-capita consumption of analgesics: a nine-country survey over 20 years. J Headache Pain 9:225–231

    Article  PubMed Central  PubMed  Google Scholar 

  14. Queneau P, Bannwarth B, Carpentier F, Guliana JM, Bouget J, Trombert B, Leverve X, Lapostolle F, Borron SW, Adnet F; Association Pédagogique Nationale pour l’Enseignement de la Thérapeutique (APNET) (2007) Emergency department visits caused by adverse drug events: results of a French survey. Drug Saf 30:81–88

    Article  Google Scholar 

  15. European Medicines Agency (2012) Guideline on good pharmacovigilance practices (GVP). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129131.pdf. Accessed 6 Feb 2015

  16. Olivier P, Caron J, Haramburu F, Imbs JL, Jonville-Béra AP, Lagier G (2005) Validation d’une échelle de mesure : exemple de l’échelle française d’évitabilité des effets indésirables médicamenteux. Therapie 60:39–45

    Article  PubMed  Google Scholar 

  17. Lohman D, Schleifer R, Amon JJ (2010) Access to pain treatment as a human right. BMC Med 8:8

    Article  PubMed Central  PubMed  Google Scholar 

  18. Pauly V, Pradel V, Frauger E, Micallef J, Thirion X (2011) Évolution des quantités remboursées d’opioïdes depuis 2004, à partir des données nationales de médicaments remboursés par le Régime général de la sécurité sociale. Therapie 66:369–372

    Article  PubMed  Google Scholar 

  19. Bismuth S, Leng EL, Oustric S, Montastruc JL, Lapeyre-Mestre M (2011) Quel(s) antalgique(s) après le retrait du dextropropoxyphène ? Enquête auprès de médecins généralistes de la région Midi-Pyrénées. Therapie 66:25–28

    Article  PubMed  Google Scholar 

  20. Gaubert S, Vié M, Damase-Michel C, Pathak A, Montastruc JL (2009) Dextropropoxyphene withdrawal from a French university hospital: impact on analgesic drug consumption. Fundam Clin Pharmacol 23:247–252

    Article  CAS  PubMed  Google Scholar 

  21. Abadie D, Durrieu G, Roussin A, Montastruc JL, Français R, des Centres Régionaux de Pharmacovigilance (2013) Effets indésirables « graves » du tramadol : bilan 2010-2011 de pharmacovigilance en France. Therapie 68:77–84

    Article  PubMed  Google Scholar 

  22. Vella-Brincat J, Macleod AD (2007) Adverse effects of opioids on the central nervous systems of palliative care patients. J Pain Palliat Care Pharmacother 21(1):15–25

    Article  PubMed  Google Scholar 

  23. Morss S, Shore A, Hicks R, Morlock L (2007) Medication errors with opioids: results from a national reporting system. J Opioid Manag 3:189–194

    Google Scholar 

  24. Smith HS, Lesar TS (2011) Analgesic prescribing errors and associated medication characteristics. J Pain 12:29–40

    Article  PubMed  Google Scholar 

  25. Agence nationale de sécurité du médicament et des produits de santé (2014) Ventes de médicaments en France: le rapport d’analyse de l’année 2011 – Communiqué. http://www.ansm.sante.fr/S-informer/Points-d-information-Points-d-information/Ventes-de-medicaments-en-France-le-rapport-d-analyse-de-l-annee-2011-Point-d-information. Accessed 6 Feb 2015

  26. Jonville-Béra AP, Saissi H, Bensouda-Grimaldi L, Beau-Salinas F, Cissoko H, Giraudeau B et al (2009) Avoidability of adverse drug reactions spontaneously reported to a French regional drug monitoring centre. Drug Saf 32:429–440

    Article  PubMed  Google Scholar 

  27. Moulis G, Sommet A, Durrieu G, Bagheri H, Lapeyre-Mestre M, Montastruc J-L et al (2012) Trends of reporting of “serious” vs. “non-serious” adverse drug reactions over time: a study in the French PharmacoVigilance Database: short report. Br J Clin Pharmacol 74:201–204

    Article  PubMed Central  PubMed  Google Scholar 

  28. Thiessard F, Roux E, Miremont-Salamé G, Fourrier-Réglat A, Haramburu F, Tubert-Bitter P, Bégaud B (2005) Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986-2001). Drug Saf 28:731–740

    Article  PubMed  Google Scholar 

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Acknowledgments

The authors thank Hélène Géniaux, Anne Bénard-Laribière, Amélie Daveluy, and Hélène Théophile, whose efforts contributed to the research described in the paper. This paper was published under the frame of European Social Fund, Human Resources Development Operational Programme 2007–2013, project no. POSDRU/159/1.5/136893.

Conflict of interest

The authors declare no conflicts of interest.

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Authors and Affiliations

  1. Department of Pharmacology, Physiology and Physiopathology, Faculty of Pharmacy, University of Medicine and Pharmacy “Iuliu Hatieganu”, Cluj-Napoca, 400012, Romania

    Irina Cazacu, Ghada Miremont-Salamé, Cristina Mogosan, Annie Fourrier-Réglat, Felicia Loghin & Françoise Haramburu

  2. Regional Pharmacovigilance Centre, CHU de Bordeaux, F-33000, Bordeaux, Romania

    Ghada Miremont-Salamé, Annie Fourrier-Réglat & Françoise Haramburu

  3. INSERM U657, F-33000, Bordeaux, France

    Ghada Miremont-Salamé & Annie Fourrier-Réglat

  4. University of Bordeaux, F-33000, Bordeaux, France

    Annie Fourrier-Réglat

  5. Department of Toxicology, Faculty of Pharmacy, University of Medicine and Pharmacy “Iuliu Hatieganu”, Cluj-Napoca, 400012, Romania

    Felicia Loghin

Authors
  1. Irina Cazacu
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  2. Ghada Miremont-Salamé
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  3. Cristina Mogosan
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  4. Annie Fourrier-Réglat
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  6. Françoise Haramburu
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Correspondence to Irina Cazacu.

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Cazacu, I., Miremont-Salamé, G., Mogosan, C. et al. Preventability of adverse effects of analgesics: analysis of spontaneous reports. Eur J Clin Pharmacol 71, 625–629 (2015). https://doi.org/10.1007/s00228-015-1829-8

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  • DOI: https://doi.org/10.1007/s00228-015-1829-8

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