Physician-pharmacist agreement about off-label use of medications in private clinical settings in Baghdad, Iraq

Abstract

Objective: 1) To evaluate the relationship between physician-pharmacist agreement about the off-label drug use and 2) and to identify the most common off-label medication category/indications and prescriber clinical disciplines in private settings in Baghdad area, Iraq

Methods: This study evaluated 980 off-label use requests in the private clinical settings within Baghdad area, Iraq from October 2013 to September 2015. The efficacy, safety, and convenience of each drug request and its alternative options were evaluated according to the patient health and demographic characteristics and standard guidelines.

Results: Of the 980 physician off-label requests, only 22.7% were approved by the pharmacists. Rheumatology and Nephrology accounted for the highest ratio of off-label use requests for adults (30.3% and 26.3%). The pharmacist rejection ratio of off-label use was comparable between the two groups (p>0.05). Most of the issued requests were attributed either to unapproved indication or to combination of more than one drug (38% and 35.3%). A low acceptance rate was reported in the requests issued for treatment in different clinical lines to the authorized one (11.9%). The lowest rate of acceptance was reported in the requests that had very low evidence level (9.1%). The mostly prescribed medications were musculoskeletal agents (28.9%). Finally, 78.2% of the requests came from clinical branches for adults. Although the agreement rate for requests in adults was higher than that in pediatrics, the two rates were not significantly different.

Conclusion: Community pharmacists should effectively take responsibility for assessing off-label drug requests in Iraqi private settings. The quality of evidence does not represent the major factor influencing the approval rate of off-label drug use. The availability of safer and/or affordable alternatives and prescribing for a different patient age category highly impacted the pharmacists’ approval rate.

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References

1. Kwon JH, Kim MJ, Bruera S, Park M, Bruera E, Hui D. Off-label medication use in the inpatient palliative care unit. J Pain Symptom Manage. 2017;54(1):46-54. doi: 10.1016/j.jpainsymman.2017.03.014

2. Wittich CM, Burkle CM, Lanier WL. Ten common questions (and their answers) about off-label drug use. Mayo Clin Proc. 2012;87(10):982-990. doi: 10.1016/j.mayocp.2012.04.017

3. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166(9):1021-1026. doi: 10.1001/archinte.166.9.1021

4. Patil AE, Shetty YC, Gajbhiye SV, Salgaonkar SV. Drug utilization and off-label use of medications in anesthesia in surgical wards of a teaching hospital. Indian J Anaesth. 2015;59(11):721-727. doi: 10.4103/0019-5049.170032

5. Sivadas A, Aneesh SA, Koshy EM, Roshni PR, Sasidharan P. Development and implementation of pediatric formulary and drug therapy guide in a tertiary care hospital in India. Int J Pharm Pharm Sci. 2014;6(6):450-451.

6. Gota V, Divatia JV. Off-label use of drugs: An evil or a necessity? Indian J Anaesth. 2015;59(12):767-768. doi: 10.4103/0019-5049.171555

7. Gota V, Patial P. Off-label use of anticancer drugs in India: To be or not to be!. J Cancer Res Ther. 2011;7(1):35-39. doi: 10.4103/0973-1482.80455

8. Wang B, Kesselheim AS. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review. BMJ. 2015;351:h4679. doi: 10.1136/bmj.h4679

9. Eguale T, Buckeridge DL, Winslade NE, Benedetti A, Hanley JA, Tamblyn R. Drug, patient, and physician characteristics associated with off-label prescribing in primary care. Arch Intern Med. 2012;172(10):781-8. doi: 10.1001/archinternmed.2012.340

10. Ruíz-Antorán B, Piñeiro R, Avendaño C, Román E, Cilleruelo ML, Gutiérrez-Junquera C, Centeno G, Cilleruelo MJ. Drug utilization and off-label drug use in Spanish pediatric gastroenterology outpatients. J Pediatr Gastroenterol Nutr. 2013;56(2):173-177. doi: 10.1097/MPG.0b013e3182566d92

11. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schünemann HJ; GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924-926. doi: 10.1136/bmj.39489.470347.AD

12. Garcia-Sabina A, Rabunal Rey R, Martinez-Pacheco R. Review of use of drugs for conditions not included in product characteristics. Farm Hosp. 2011;35(5):264-277. doi: 10.1016/j.farma.2010.06.011

13. Lozano Ortiz R. Drug use in off-label dosage regimes. Farm Hosp. 2015;39(2):122-126. doi: 10.7399/fh.2015.39.2.8471

14. Ma J, Lee KV, Stafford RS. Depression treatment during outpatient visits by U.S. children and adolescents. J Adolesc Health. 2005;37(6):434-442. doi: 10.1016/j.jadohealth.2005.07.012

15. Kennedy A, Littenberg B. A modified outpatient prescription form to reduce prescription errors. Jt Comm J Qual Saf. 2004;30(9):480-487.

16. Kharadi D, Patel K, Rana D, Patel V. Off-label drug use in psychiatry outpatient department: A prospective study at a tertiary care teaching hospital. J Basic Clin Pharm. 2015;6(2):45-49. doi: 10.4103/0976-0105.152090

17. Sachs GS, Nierenberg AA, Calabrese JR, Marangell LB, Wisniewski SR, Gyulai L, Friedman ES, Bowden CL, Fossey MD, Ostacher MJ, Ketter TA, Patel J, Hauser P, Rapport D, Martinez JM, Allen MH, Miklowitz DJ, Otto MW, Dennehy EB, Thase ME. Effectiveness of adjunctive antidepressant treatment for bipolar depression. N Engl J Med. 2007;356(17):1711-1722. doi: 10.1056/NEJMoa064135

18. Conti RM, Bernstein AC, Villaflor VM, Schilsky RL, Rosenthal MB, Bach PB. Prevalence of off-label use and spending in 2010 among patent-protected chemotherapies in a population-based cohort of medical oncologists. J Clin Oncol. 2013;31(9):1134-1139. doi: 10.1200/JCO.2012.42.7252

19. Bazzano AT, Mangione-Smith R, Schonlau M, Suttorp MJ, Brook RH. Off-label prescribing to children in the United States outpatient setting. Acad Pediatr. 2009;9(2):81-88. doi: 10.1016/j.acap.2008.11.010

20. Pérez-Moreno MA, Villalba-Moreno AM, Santos-Ramos B, Marín-Gil R, Varela-Aguilar JM, Torelló-Iserte J, Núñez-Vázquez R, Jiménez-Jiménez J, Bautista-Paloma FJ. Off-label approval of drug use in a tertiary hospital. Rev Calid Asist. 2013;28(1):12-18. doi: 10.1016/j.cali.2012.05.005

21. Morales-Carpi C, Estan L, Rubio E, Lurbe E, Morales-Olivas FJ. Drug utilization and off-label drug use among Spanish emergency room pediatric patients. Eur J Clin Pharmacol. 2010;66(3):315-320. doi: 10.1007/s00228-009-0747-z

22. Porta A, Esposito S, Menson E, Spyridis N, Tsolia M, Sharland M, Principi N. Off-label antibiotic use in children in three European countries. Eur J Clin Pharmacol. 2010;66(9):919-927. doi: 10.1007/s00228-010-0842-1

23. Fukada C, Kohler JC, Boon H, Austin Z, Krahn M. Prescribing gabapentin off label: Perspectives from psychiatry, pain and neurology specialists. Can Pharm J (Ott). 2012;145(6):280-284. doi: 10.3821/145.6.cpj280
Published
2017-09-03
How to Cite
HUSSAIN, Saad A. et al. Physician-pharmacist agreement about off-label use of medications in private clinical settings in Baghdad, Iraq. Pharmacy Practice, [S.l.], v. 15, n. 3, p. 979, sep. 2017. ISSN 1886-3655. Available at: <https://www.pharmacypractice.org/journal/index.php/pp/article/view/979>. Date accessed: 17 oct. 2017.
Section
Original Research

Keywords

Off-Label Use; Interprofessional Relations; Physicians; Pharmacists; Practice Patterns, Physicians'; Attitude of Health Personnel; Prospective Studies; Iraq