Login Register Cart 0
Generic placeholder image

Current Drug Safety

Editor-in-Chief

ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Extemporaneous Compounding: A Possible Trigger Tool to Detect Potential Health Incidents

Author(s): Marina Massae Toma, Gabriel de Freitas Santana, Tales Rubens de Nadai, Fabiana Rossi Varallo, Jhohann Richard de Lima Benzi and Patrícia de Carvalho Mastroianni*

Volume 17, Issue 3, 2022

Published on: 28 March, 2022

Page: [183 - 192] Pages: 10

DOI: 10.2174/1574886316666211014155946

Price: $65

Abstract

Background: Extemporaneous compounding (EC) involves the preparation of a therapeutic product for specific patient need. However, there is a potential relationship between this procedure and the occurrence of health incidents (HI). The use of trigger tools increases HI identification.

Objective: This study assessed the performance of EC as a trigger to detect potential health incidents arising from this procedure.

Methods: A one-month observational and cross-sectional study was performed in internal medicine ward and intensive care unit of medium-sized hospital. Data collection was carried out in 5 stages: all triggered patients with dysphagia or enteral feeding tube with prescription of EC were included; EC executed in prescribed standardized drugs was observed; the procedure was compared with the hospital guide and scientific literature; HI monitoring and their evaluation using WHO and NCC MERP algorithms; a search for pharmaceutical alternatives (PA) that would avoid the observed EC.

Results: 197 patients were recruited. Almost half of them were triggered by EC from 84 standardized drugs. 48 patients met the inclusion criteria. 28 adverse drug reactions, 01 therapeutic ineffectiveness, and 29 medication errors were identified. EC as a trigger tool showed a PPV value of 0.38. Only 24 drugs have PA available in the market, which could avoid one third of all observed EC.

Conclusion: It was possible to detect potentially HI in one of two patients with enteral feeding tubes using EC as a trigger tool. The use of EC as a trigger tool contributes to identifying potential HI arising from drugs, which have not gotten pharmaceutical alternatives to be administered via enteral feeding tube.

Keywords: Patient safety, medication therapy management, pharmacy service, trigger tool, extemporaneous compounding, adverse drug event.

« Previous Next »
Graphical Abstract

[1]
Falconer JR, Steadman KJ. Extemporaneously compounded medicines. Aust Prescr 2017; 40(1): 5-8.
[http://dx.doi.org/10.18773/austprescr.2017.001] [PMID: 28246428]
[2]
AlKhatib HS, Jalouqa S, Maraqa N, Ratka A, Elayeh E, Al Muhaissen S. Prevalence, determinants, and characteristics of extemporaneous compounding in Jordanian pharmacies. BMC Health Serv Res 2019; 19(1): 816.
[http://dx.doi.org/10.1186/s12913-019-4684-y] [PMID: 31703672]
[3]
Glass BD, Haywood A. Stability considerations in liquid dosage forms extemporaneously prepared from commercially available products. J Pharm Pharm Sci 2006; 9(3): 398-426.
[PMID: 17207422]
[4]
Thombre AG, Berchielli A, Rogers JF. Extemporaneously prepared controlled release formulations for accelerating the early phase development of drug candidates. Drug Discov Today 2014; 19(5): 694-700.
[http://dx.doi.org/10.1016/j.drudis.2014.02.001] [PMID: 24560934]
[5]
Benzi JR de L. Mastroianni PDC. Analysis of extemporaneous oral liquid from commercially available drugs in hospital. Braz J Pharm Sci 2016; 52(3): 517-25.
[http://dx.doi.org/10.1590/s1984-82502016000300017]
[6]
Fodil M, Nghiem D, Colas M, et al. Assessment of clinical practices for crushing medication in geriatric units. J Nutr Health Aging 2017; 21(8): 904-8.
[http://dx.doi.org/10.1007/s12603-017-0886-3] [PMID: 28972243]
[7]
Silva MRM, Dysars LP, Santos EP, Ricci Júnior E. Preparation of extemporaneous oral liquid in the hospital pharmacy. Braz J Pharm Sci 2020; 56.
[http://dx.doi.org/10.1590/s2175-97902019000418358]
[8]
Mc Gillicuddy A, Kelly M, Sweeney C, Carmichael A, Crean AM, Sahm LJ. Modification of oral dosage forms for the older adult: An Irish prevalence study. Int J Pharm 2016; 510(1): 386-93.
[http://dx.doi.org/10.1016/j.ijpharm.2016.06.056] [PMID: 27346725]
[9]
Mastroianni PC, Lucchetta RC. Regulamentação sanitária de medicamentos. Rev Cienc Farm Basica Apl 2011; 32(1): 127-32.
[10]
Logrippo S, Ricci G, Sestili M, et al. Oral drug therapy in elderly with dysphagia: between a rock and a hard place! Clin Interv Aging 2017; 12: 241-51.
[http://dx.doi.org/10.2147/CIA.S121905] [PMID: 28203065]
[11]
Vincent C, Taylor-Adams S. The investigation and analysis of clinical incidents. Clinical Risk Management: Enhancing Patient Safety. London: BMJ Publishing 2001; pp. 439-60.
[12]
About Medication Errors [Internet].. National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) 2020. Available from:https://www.nccmerp.org/about-medication-errorsAccessed 12th November, 2020
[13]
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(2): 95-9.
[http://dx.doi.org/10.2165/00002018-200023020-00001] [PMID: 10945372]
[14]
Saiyed MM, Lalwani T, Rana D. Is off-label use a risk factor for adverse drug reactions in pediatric patients? A prospective study in an Indian tertiary care hospital. Int J Risk Saf Med 2015; 27(1): 45-53.
[http://dx.doi.org/10.3233/JRS-150642] [PMID: 25766066]
[15]
Benzi JRL, Mastroianni PC. Adequações posológicas - os riscos de seu uso à segurança do paciente. Rev OFIL•ILAPHAR 2019; 4801
[16]
Cornish P. “Avoid the crush”: hazards of medication administration in patients with dysphagia or a feeding tube. CMAJ 2005; 172(7): 871-2.
[http://dx.doi.org/10.1503/cmaj.050176] [PMID: 15795404]
[17]
Thong MY, Manrique YJ, Steadman KJ. Drug loss while crushing tablets: Comparison of 24 tablet crushing devices. PLoS One. 2018; 13.(3) [https://dx.doi.org/10.1371/journal.pone.0193683]
[18]
Nguyen D, Secretan P-H, Auvity S, et al. Assessment of practices for suspended oral drugs by tablet crushing in pediatric units. Eur J Pharm Biopharm 2020; 157: 175-82.
[http://dx.doi.org/10.1016/j.ejpb.2020.10.013] [PMID: 33222769]
[19]
Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: Complementing spontaneous reporting systems. Drug Saf 2013; 36(2): 75-81.
[http://dx.doi.org/10.1007/s40264-012-0014-6] [PMID: 23329541]
[20]
De Wet C, Bowie P. Screening electronic patient records to detect preventable harm: A trigger tool for primary care. Qual Prim Care 2011; 19(2): 115-25.
[PMID: 21575334]
[21]
Rozich JD, Haraden CR, Resar RK. Adverse drug event trigger tool: A practical methodology for measuring medication related harm. Qual Saf Health Care 2003; 12(3): 194-200.
[http://dx.doi.org/10.1136/qhc.12.3.194] [PMID: 12792009]
[22]
Resar RK, Rozich JD, Simmonds T, Haraden CR. A trigger tool to identify adverse events in the intensive care unit. Jt Comm J Qual Patient Saf 2006; 32(10): 585-90.
[http://dx.doi.org/10.1016/S1553-7250(06)32076-4] [PMID: 17066996]
[23]
Rozenfeld S, Chaves SMC, Reis LG da C. Efeitos adversos a medicamentos em hospital público: Estudo piloto. Rev Saude Publica 2009; 43(5): 887-90.
[http://dx.doi.org/10.1590/S0034-89102009005000051] [PMID: 19738995]
[24]
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies. J Clin Epidemiol 2008; 61(4): 344-9.
[http://dx.doi.org/10.1016/j.jclinepi.2007.11.008] [PMID: 18313558]
[25]
WHO-UMC. The Use of the WHO-UMC system for standardised case causality assessment. The Uppsala Monitoring Centre 2014.https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf
[26]
The National Coordinating Council for Medication Error Reporting and Prevention. Index for categorizing medication errors algorithm. 2001. Available from:https://www.nccmerp.org/sites/default/files/algorColor2001-06-12.pdfAccessed September 15, 2020
[27]
Handler SM, Altman RL, Perera S, et al. A systematic review of the performance characteristics of clinical event monitor signals used to detect adverse drug events in the hospital setting. J Am Med Inform Assoc 2007; 14(4): 451-8.
[http://dx.doi.org/10.1197/jamia.M2369] [PMID: 17460130]
[28]
Agência nacional de vigilância sanitária. ANVISA. Câmara de regulação do mercado de medicamentos - CMED. Secretaria executiva. Preços máximos de medicamentos por princípio ativo. Preço fábrica – PF (Preço para laboratórios e distribuidores), Preço máximo ao consumidor – PMC (Preço para Farmácias e Drogarias). Update 2019; 993phttps://www.gov.br/anvisa/pt-br/assuntos/medicamentos/cmed
[29]
Classen DC, Resar R, Griffin F, et al. ‘Global trigger tool’ shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff (Millwood) 2011; 30(4): 581-9.
[http://dx.doi.org/10.1377/hlthaff.2011.0190] [PMID: 21471476]
[30]
Varallo FR, Dagli-Hernandez C, Pagotto C, de Nadai TR, Herdeiro MT, de Carvalho Mastroianni P. Confounding variables and the performance of triggers in detecting unreported adverse drug reactions. Clin Ther 2017; 39(4): 686-96.
[http://dx.doi.org/10.1016/j.clinthera.2016.11.005] [PMID: 27913030]
[31]
Franklin BD, Birch S, Schachter M, Barber N. Testing a trigger tool as a method of detecting harm from medication errors in a UK hospital: A pilot study. Int J Pharm Pract 2010; 18(5): 305-11.
[http://dx.doi.org/10.1111/j.2042-7174.2010.00058.x] [PMID: 20840687]
[32]
Otero MJ, Toscano Guzmán MD, Galván-Banqueri M, Martinez- Sotelo J, Santos-Rubio MD. Utility of a trigger tool (TRIGGER-CHRON) to detect adverse events associated with high-alert medications in patients with multimorbidity. Eur J Hosp Pharm Sci Pract 2020; ejhpharm-2019-002126.
[http://dx.doi.org/10.1136/ejhpharm-2019-002126] [PMID: 32385069]
[33]
Hu Q, Qin Z, Zhan M, Chen Z, Wu B, Xu T. Validating the Chinese geriatric trigger tool and analyzing adverse drug event associated risk factors in elderly Chinese patients: A retrospective review. 2020; 15.(4)
[http://dx.doi.org/10.1371/journal.pone.0232095]
[34]
Carnevali L, Krug B, Amant F, et al. Performance of the adverse drug event trigger tool and the global trigger tool for identifying adverse drug events: Experience in a Belgian hospital. Ann Pharmacother 2013; 47(11): 1414-9.
[http://dx.doi.org/10.1177/1060028013500939] [PMID: 24285758]
[35]
Rozenfeld S, Giordani F, Coelho S. Eventos adversos a medicamentos em hospital terciário: Estudo piloto com rastreadores. Rev Saude Publica 2013; 47(6): 1102-11.
[http://dx.doi.org/10.1590/S0034-89102013000901102] [PMID: 24626548]
[36]
Nwulu U, Nirantharakumar K, Odesanya R, McDowell SE, Coleman JJ. Improvement in the detection of adverse drug events by the use of electronic health and prescription records: An evaluation of two trigger tools. Eur J Clin Pharmacol 2013; 69(2): 255-9.
[http://dx.doi.org/10.1007/s00228-012-1327-1] [PMID: 22706621]
[37]
Giordani F, Rozenfeld S, de Oliveira DF, et al. Vigilância de eventos adversos a medicamentos em hospitais: Aplicação e desempenho de rastreadores. Rev Bras Epidemiol 2012; 15(3): 455-67.
[http://dx.doi.org/10.1590/S1415-790X2012000300002] [PMID: 23090295]
[38]
Roque KE, Melo ECP. Adaptação dos critérios de avaliação de eventos adversos a medicamentos para uso em um hospital público no Estado do Rio de Janeiro. Rev Bras Epidemiol 2010; 13(4): 607-19.
[http://dx.doi.org/10.1590/S1415-790X2010000400006] [PMID: 21180850]
[39]
Kobayashi Y, Ito S, Itai S, Yamamoto K. Physicochemical properties and bioavailability of carbamazepine polymorphs and dihydrate. Int J Pharm 2000; 193(2): 137-46.
[http://dx.doi.org/10.1016/S0378-5173(99)00315-4] [PMID: 10606776]
[40]
Panagopoulou-Kaplani A, Malamataris S. Preparation and characterisation of a new insoluble polymorphic form of glibenclamide. Int J Pharm 2000; 195(1-2): 239-46.
[http://dx.doi.org/10.1016/S0378-5173(99)00401-9] [PMID: 10675701]
[41]
Mirza S, Miroshnyk I, Rantanen J, et al. Solid-state properties and relationship between anhydrate and monohydrate of baclofen. J Pharm Sci 2007; 96(9): 2399-408.
[http://dx.doi.org/10.1002/jps.20894] [PMID: 17549770]
[42]
Vranić E, Planinšek O, Tivadar A, Hadzović S, Srčič S. Physico- chemical characterisation of different clindamycin phosphate samples. Bosn J Basic Med Sci 2007; 7(2): 180-7.
[http://dx.doi.org/10.17305/bjbms.2007.3078] [PMID: 17489758]
[43]
Boetker JP, Savolainen M, Koradia V, et al. Insights into the early dissolution events of amlodipine using UV imaging and Raman spectroscopy. Mol Pharm 2011; 8(4): 1372-80.
[http://dx.doi.org/10.1021/mp200205z] [PMID: 21634435]
[44]
Reilly AM, Tkatchenko A. Role of dispersion interactions in the polymorphism and entropic stabilization of the aspirin crystal. Phys Rev Lett 2014; 113(5): 055701.
[http://dx.doi.org/10.1103/PhysRevLett.113.055701] [PMID: 25126928]
[45]
Santos OMM, Reis MED, Jacon JT, Lino ME de S, Simões JS, Doriguetto AC. Polymorphism: An evaluation of the potential risk to the quality of drug products from the Farmácia Popular Rede Própria. Braz J Pharm Sci 2014; 50(1): 1-24.
[http://dx.doi.org/10.1590/S1984-82502011000100002]
[46]
da Silva LM, Montanari CM, Santos OMM, Cazedey ECL, Ângelo ML, de Araújo MB. Quality evaluation of the Finasteride polymorphic forms I and II in capsules. J Pharm Biomed Anal 2015; 105: 24-31.
[http://dx.doi.org/10.1016/j.jpba.2014.11.045] [PMID: 25527978]
[47]
Deng J, Staufenbiel S, Bodmeier R. Evaluation of a biphasic in vitro dissolution test for estimating the bioavailability of carbamazepine polymorphic forms. Eur J Pharm Sci 2017; 105: 64-70.
[http://dx.doi.org/10.1016/j.ejps.2017.05.013] [PMID: 28487146]
[48]
Capucho HC, Mastroianni PC, Cuffini S. Farmacovigilância no Brasil: A relação entre polimorfismo de fármacos, efetividade e segurança dos medicamentos. Rev Cienc Farm Basica Apl 2008; 29(3): 277-83.
[49]
Rollins CJ. Drug–nutrient interactions in patients receiving enteral nutrition.New York: Humana Press 2010; pp. 367-410.
[50]
Lau ETL, Steadman KJ, Cichero JAY, Nissen LM. Dosage form modification and oral drug delivery in older people. Adv Drug Deliv Rev 2018; 135: 75-84.
[http://dx.doi.org/10.1016/j.addr.2018.04.012] [PMID: 29660383]
[51]
Schiele JT, Quinzler R, Klimm HD, Pruszydlo MG, Haefeli WE. Difficulties swallowing solid oral dosage forms in a general practice population: Prevalence, causes, and relationship to dosage forms. Eur J Clin Pharmacol 2013; 69(4): 937-48.
[http://dx.doi.org/10.1007/s00228-012-1417-0] [PMID: 23052416]
[52]
Minghetti P, Palmieri I, Selmin F. When authorized medicinal products are not available: Possible alternatives to meet legitimate expectations of patients. J Pharm Health Serv Res 2010; 1(3): 107-12.
[http://dx.doi.org/10.1111/j.1759-8893.2010.00018.x]
[53]
Grissinger M. Preventing errors when drugs are given via enteral feeding tubes. P&T 2013; 38(10): 575-6.
[PMID: 24391375]

Rights & Permissions Print Cite
Article Metrics
32
1
© 2024 Bentham Science Publishers | Privacy Policy