Analysis of patient safety in the process of drug prescription in research

e202106086

Authors

  • Miriam Martín Rufo Hospital Universitario Ramón y Cajal. Madrid. España.
  • Noelia Vicente Oliveros Hospital Universitario Ramón y Cajal. Madrid. España.
  • Carmen Palomar Fernández Hospital Universitario Ramón y Cajal. Madrid. España.
  • Cristina Pueyo López Hospital Universitario Ramón y Cajal. Madrid. España.
  • Isabel Muñoz Ojeda Hospital Universitario Ramón y Cajal. Madrid. España.
  • Álvaro Molina Ruano Hospital Universitario Ramón y Cajal. Madrid. España.
  • Ana Álvarez Díaz Hospital Universitario Ramón y Cajal. Madrid. España.

Keywords:

Prescription, Prescribing errors, Investigational drugs, Clinical trials, Risk level, Safety

Abstract

Background: The increasing complexity of clinical trial protocols and the very nature of investigational drugs increase the likelihood of prescribing errors and require comprehensive control and monitoring of treatments. The aim of this study was to measure and analyze the potential risks of prescribing errors in investigational drugs.
Methods: A prospective, descriptive, and observational study was carried out in a third-level hospital in Madrid, for one month in 2017. Manual prescribing errors (EP) in investigational drugs and potential risks of harm to the patient were analyzed. A descriptive statistical analysis was performed, including the absolute and relative frequency for the variables.
Results: A total of 254 medical orders corresponding to 327 lines of treatment and 274 different drugs were reviewed, of which 83% were categorized as “high-risk”. Results showed 217 (85.4%) EP within the identification of the medical order and 1,045 (319,6%) in the treatment. The risk level of harm to the patient was high for all EP in patient identification and moderate for all EP in the clinical trial identification. The lines of treatment showed an especially high-risk potential for EP in dosage (25%) and frequency (41%).
Conclusions: The high rate of EP found, along with the high-risk potential these entail, reflects the need for improving the security process when prescribing investigational drugs in our field.

Downloads

Download data is not yet available.

References

Naka F, Strober B, Shahriari M. Clinical trials: Kids are not just little people. Clin Dermatol. 2017; 35:583-93.

Trends, Charts, and Maps. U. S. National Library of Medicine [Internet]. clinicaltrials.gov 2020 [fecha de acceso 1 abril 2020]. Disponible en: https://clinicaltrials.gov/ct2/resources/trends

Corrigan JM, Kohn LT, Donaldson MS editors. To err is human: building a safer health system. Washington (DC): National Academies Press; 1999.

Boletín Oficial del Estado. Real Decreto Legislativo 1/2015, de 24 de julio, de Ley de garantías y uso racional de los medicamentos y productos sanitarios. BOE, núm. 177, de 25 de julio de 2015.

Tamer H, Shehab N. Using preprinted medication order forms to improve the safety of investigational drug use. Am J Health Syst Pharm. 2006; 63:1022-1028.

Martínez-Nieto C. Medicación utilizada en un ensayo clínico. En: Ensayos Clínicos. Actualización en ética, normativa, metodología y nuevas tecnologías. Madrid: Merck S.A.; 2017: 251-52.

Pasto-Cardona L, Masuet-Aumatell C, Bara-Olivan B et al. Incident study of medication errors in drug use processes: prescription, transcription, validation, preparation, dispensing and administering in the hospital environment. Farm Hosp. 2009; 33(5):257-68.

Brown JN, Britnell SR, Stivers AP, Cruz JL. Medication Safety in Clinical Trials: Role of the Pharmacist in Optimizing Practice, Collaboration, and Education to Reduce Errors. Yale J Biol Med. 2017; 90(1):125–133.

Velez-Diaz-Pallares M, Delgado-Silveira E, Carretero-Accame ME et al. Using Healthcare Failure Mode and Effect Analysis to reduce medication errors in the process of drug prescription, validation and dispensing in hospitalised patients. BMJ QualSaf. 2013; 22(1):42-52.

Kane MP, Fessele K, Gordilis-Perez J et al. Medication safety in cancer clinical trials: an analysis of medication error reports at a comprehensive cancer center. J Clin Oncol. 2007; 25:6547.

Dyer C. Oncologist is found guilty of misconduct after 27 year old patient dies in trial. Br Med J. 2012; 20:e6352.

Velez-Díaz-Pallarés M, Delgado Silveira E et al. Análisis de errores de la prescripción manual comparados con la prescripción electrónica asistida en pacientes traumatológicos. Farm Hosp. 2011; 35(3):135-139.

Otero MJ, Castaño B, Pérez M, Codina C, Tamés MJ, Sánchez T. Actualización de la clasificación de errores de medicación del grupo Ruiz-Jarabo2000. FarmHosp. 2008; 32:38-52.

Vicente O, Perez-Menendez C, Gramage T et al. Potential future risk of errors in medication administration recording. J Eval Clin Pract. 2016; 22(5):745-50.

Vicente O, Perez-Mendez C, Ávarez AM et al. Grading the potencial safety risk of medications used in hospital care. FarmHosp. 2018; 42(2):53-61.

Jin Young M, Yeonhong L, Ji Min H, Mi Hyung L, Jeong Y, Mi Kyung S, Young Ju K, Hye Sun G. Effects of pharmacist interventions on reducing prescribing errors of investigational drugs in oncology clinical trials. J Oncol Pharm Practice 2020; 26(1):29-35.

Gramage Caro T, Bermejo Vicedo T, Benedi González J. Errores de medicación antes y después de la implantación de un sistema de prescripción electrónica asistida. An. Real Acad. Farm. 2013; 79(3):450-464.

Gandhi TK, Weingart SN, Seger AC, Borus J, Burdick E, Poon EG et al. Outpatient prescribing errors and the impact of computerized prescribing. J Gen Intern Med. 2005; 20:837-41.

Ollivier V, Thelcide C, Simon C et al. Standardized order form for investigational drugs: effect on completeness of the prescription. Pharm World Sci. 2004; 26:178-9.

Bates DW, Cullen DJ, Laird N et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA 1995; 274(1):29-34.

Velez-Diaz-Pallares M, Gado-Silveira E, Carretero-Accame ME et al. Using Healthcare Failure Mode and Effect Analysis to reduce medication errors in the process of drug prescription, validation and dispensing in hospitalised patients. BMJ QualSaf 2013; 22(1):42-52.

Fell GL, O’Loughlin AA, Nandivada P et al. Methods to Reduce Medication Errors in a Clinical Trial of an Investigational Parenteral Medication. Contemp Clin Trials Commun. 2016; 4:64-67.

Coleman DA, Yu R. The other randomization - methods for labeling drug kits. Contemp Clin Trials. 2014; 38(2):270-4.

Published

2021-06-22

How to Cite

1.
Martín Rufo M, Vicente Oliveros N, Palomar Fernández C, Pueyo López C, Muñoz Ojeda I, Molina Ruano Álvaro, et al. Analysis of patient safety in the process of drug prescription in research: e202106086. Rev Esp Salud Pública [Internet]. 2021 Jun. 22 [cited 2024 Nov. 24];95:10 páginas. Available from: https://ojs.sanidad.gob.es/index.php/resp/article/view/554

Issue

Section

Originales

Categories