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Content design and validation of a Standard Operating Procedure to provide pharmacotherapy follow-up for the elderly in Cuba

ABSTRACT

Incorporating methodological tools that allow uniform and standardized development from the clinical pharmacy services to the Pharmaceutical Care practice, is nowadays a necessity. Considering the importance of pharmaceutical care provision to elderly patients, this manuscript introduces the design and content validation of a standard operating procedure to provide pharmacotherapy follow-up to the elderly in nursing homes in Cuba. The procedure was designed based on a deep analysis of documents relative to experiences focused on holistic care to elderly patients, criteria for the identification and assessment of potentially inappropriate prescriptions and the relationship between functional geriatric evaluation and the use of drugs. The content validation was conducted by a panel of experts, using the Delphi methodology, through two working sessions. In addition, we used Likert-type scale to evaluate the procedure by experts, in line with the indicators described. In general, the criteria issued by the experts were very appropriate and allowed us to modify, add or keep several elements of the instrument for the final version. The findings demonstrated that the instrument can be used at any level of health care.

Uniterms:
Standardized Operating Procedure/validation; Pharmacotherapy Follow-Up/elderly/Cuba; Pharmaceutical Care/Cuba; Comprehensive Health Carefor/elderly; Delphi methodology

INTRODUCTION

Demographic studies have shown an increase in the elderly population worldwide (Medeiros et al., 2011MEDEIROS, E.F.; MORAES, C.F.; KARNIKOWSKI, M.; NÓBREGA, O.T.; KARNIKOWSKI, M.G.O. Intervenção interdisciplinar enquanto estratégia para o uso racional de medicamentos em idosos. Ciênc. Saúde Coletiva, v.16, n.7, p.3139-49, 2011.). In Cuba, people over six decades of life, account for19,4% of the population (Oficina Nacional de Estadística e Información, 2015OFICINA NACIONAL DE ESTADÍSTICA E INFORMACIÓN. ONEI. República de Cuba: el envejecimiento de la población: Cuba y sus territorios. 2015. Disponible en: <Disponible en: http://www.one.cu >. Access 16 may. 2016.
http://www.one.cu...
; Ministerio de Salud Pública, 2016MINISTERIO DE SALUD PÚBLICA. Cuba. Anuario estadístico de salud 2015. La Habana, 2016. 208p.). Life expectancy reaches 78.45 years (Oficina Nacional de Estadística e Información, 2013OFICINA NACIONAL DE ESTADÍSTICA E INFORMACIÓN. ONEI. La esperanza de vida: 2011-2013: cálculos para Cuba y Provincias por sexo y edades. Disponible en: <Disponible en: http://www.one.cu/publicaciones/cepde/esperanzadevida2011_2013/8_la_esperanza_de_vida_por_sexo_y_edad.pdf >. Access14 Nov. 2013.
http://www.one.cu/publicaciones/cepde/es...
; Ministerio de Salud Pública, 2016MINISTERIO DE SALUD PÚBLICA. Cuba. Anuario estadístico de salud 2015. La Habana, 2016. 208p.) and is predicted that by 2050, Cuba will be among the largest aging countries in the world (Jiménez, 2013JIMÉNEZ, M.M. A la Cuba de 2030. Periódico Juventud Rebelde, Martes 30 de Abril 2013. Disponible en: <Disponible en: http://www.juventudrebelde.cu/cuba/2013-04-29/mirada-a-la-cuba-de-2030 >. Access: 30 abr. 2013
http://www.juventudrebelde.cu/cuba/2013-...
). Consequently, healthcare strategies should be adopted to manage this situation.

The elderly represents the demographic sector needing higher health care services and which consumes a large amount of drugs, generating significant expenses, and sometimes this demographic group makes an excessive use of either effective, dubious zero-efficacy drugs. Because of this, the elderly group is highly exposed to drug-related problems (DRPs), which can interfere with the outcome of the therapy (Reyes, Pérez, Martínez, 2006REYES, A.; PÉREZ, G.; MARTÍNEZ, G. Errores en la medicación del adulto mayor en el área de salud del Policlínico Universitario, Plaza, Ciudad de La Habana. Rev. Cubana Farm., v.40, n.3, p. 1-11, 2006. Disponible en: <Disponible en: http://www.bvs.sld.curevistasfarvol40_3_06far05306.htm.htm >. Access:22 mayo. 2014.
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), and affect the quality of life of patients, causing the so-called negative outcomes associated with the medication (NOM).

Studies conducted in the United States, Canada and several European countries, show that in elderly outpatients, Potentially Inappropriate Medication (PIM) reaches 10% to 79%, increasing hospitalizations and health expenses (Fick et al., 2003FICK, D.M.; COOPER, J.W.; WADE, W.E.; WALLER. J.L.; MACLEAN, J.R.; BEERS, M.H. Updating the Beers criteria for potentially inappropiate medication use in older adults: results of a US consensus panel of experts. Arch. Intern. Med., v.163, n.22, p.2716-24, 2003. ; Gongora et al., 2004GÓNGORA, L.; PUCHE, E.; GARCÍA, J.; LUNA, J.D. Prescripciones inapropiadas en ancianos institucionalizado. Rev. Esp. Geriatr. Gerontol., v.39, p.19-24, 2004.; Fiolová et al., 2005; Barry et al., 2006BARRY, P.J.; O´KEEFE, N.; O´CONNOR, K.A.; O´MANHONY, D. Inappropriate prescribing in the elderly: a comparison of the Beers criteria and the improved prescribing in the elderly tool (IPET) in acutely ill elderly hospitalized patients. J. Clin. Pharm. Ther.v.31, n.6, p.617-26, 2006.; Jano, Aparasu, 2007JANO, E.; APARASU, R. Health care, outcomes associated with Beers ´Criteria: a systematic review. Ann. Pharmacother., v.41, n.3, p.438-48, 2007.; Sotoca et al., 2011SOTOCA, J.M.; ANGLADA, H.; MOLAS, G.; FONTANALS, S.; ROVIRA, M.; SEBASTIÁN, L. Aplicación de los nuevos criterios de prescripción inadecuada STOPP-START a pacientes geriátricos institucionalizados. Farmacéuticos de Atención Primaria v.9, n.1, p.2-7, 2011.; García-Gollarte et al., 2012GARCÍA-GOLLARTE, F.; BALERIOLA-JÚLVEZ, J.; FERRERO-LOPEZ, I.; CRUZ-JENTOFT, A.J. Inappropriate drug prescription at nursing home admission. J. Am. Med. Dir. Assoc., v.13, n.1, Article 83.e9-15, 2012.; Blanco-Reina et al., 2014BLANCO-REINA, E.; ARIZA-ZAFRA, G.; OCAÑA-RIOLA, R.; LEÓN-ORTIZ, M. 2012 American Geriatrics Society Beers criteria: Enhanced applicability for detecting potentially inappropriate medications in European older adults? A comparison with the screening tool of older person's potentially inappropriate prescriptions. J. Am. Geriatr. Soc. , v.62, n.7, p.1217-1223, 2014.; Filomena et al., 2014FILOMENA, J.; GARCÍA, M.; REDONDO, F.J.; FERNÁNDEZ, M.I. Prescripción inadecuada en pacientes polimedicados mayores de 64 años en atención primaria. Atención Primaria, v. 47, n.1, p.38-47, 2014. ). For this reason, it would of great impact to ensure the effectiveness of the drug treatments through the pharmacotherapy follow-up for these patients, which must be provided on a continuous, systematic and documented basis, in collaboration with the patients themselves and the other professionals in the system health, in order to achieve tangible results which may improve the quality of life of patients (Comité de Consenso, 2007COMITÉ DE CONSENSO. GIAF-UGR, GIFAF-USE, GIF-UGR. Tercer consenso de Granada sobre problemas relacionados con medicamentos (PRM) y resultados negativos asociados a la medicación (RNM). Ministerio de Sanidad y Consumo. Ars. Pharm.v.48, n.1, p.5-17, 2007.).

Pharmacotherapy follow-up is a practice in which the pharmacist assumes the responsibility for the patient's drug-related problems aiming at achieving positive clinical outcomes. Several implicit methods have been described, for the development of the Pharmacotherapy follow-up service: Pharmacotherapy Workup (Cipolle, Strand, Morley, 2004CIPOLLE, R.J.; STRAND, L.M.; MORLEY, P.C. Pharmaceutical care practice: the clinicians guideNew York: McGraw Hill, 2004. p.202-276.); IASER Method (Climente, Jiménez., 2005CLIMENTE, M.; JIMÉNEZ, N.V. Manual para la Atención Farmacéutica. 3.ed. Valencia: AFAHPE; Hospital Universitario Dr. Peset, 2005. p.11-20; 48-58; 99-106.); Dáder Method (Silvia- Castro et al., 2003SILVA-CASTRO, M.M.; CALLEJA, M.A.; MACHUCA, M.; FAUS, M.J.; FERNÁNDEZ-LLIMÓS, F. Seguimiento farmacoterapéutico a pacientes hospitalizados: adaptación del Método Dáder. Seguim. Farmacoter.v.1, n. 2, p.73-81, 2003.; Faus, Amariles, Martínez, 2008FAUS, M.; AMARILES, P.; MARTÍNEZ, F. Atención farmacéutica: conceptos, procesos y casos prácticos Madrid: ERGON, 2008. p.87-138.); SOAP Approach (Cornelli et al., 2005CORNELLI, R.; KRADJAN, W.; KODA-KIMBLE, M.A.; YOUNG, L.; GUGLIELMO, B.J.; ALLDREDGE, B. Assessment of therapy and pharmaceutical care. Apud: KODA-KIMBLE, M.A. Applied therapeutics: the clinical use of drugs. 8. ed. Baltimore: Lippincott Williams &Wilkins, 2005. p.1-22.) and the Medication Appropriateness Index (Hanlon et al., 1992HANLON, J.; SCHMADER, K.; SAMSA, G.; WEINBERGER, M.; UTTECH, K.; LEWIS, I.; COHEN, H.J.; FEUSSNER, J.R. A method for assessing drug therapy appropriateness. J. Clin. Epidemiol., v.45, n.10, p.1045-51, 1992.; Gavilán et al., 2012GAVILÁN, E.; VILLAFAINA, A.; ARÁNGUEZ, A.; SÁNCHEZ, G.A.; SULIMAN, S.; JIMÉNEZ, L. Índice de adecuación de los medicamentos. Versión española modificada manual de usuarios. 2012. Disponible en: <Disponible en: http://www.polimedicado.com >. Acceso en: 08 sept. 2012.
http://www.polimedicado.com...
).

All of these methods have been designed and implemented in different health contexts, being incorporated into standard operating procedures. However, in their manufacture, consideration was not given to the peculiarities of the elderly with respect to the treatment of the problems related to the great geriatric syndromes (Baster, 2010BASTER, J.C. Glosario de términos y definiciones: gerontología y geriatría. La Habana, Cuba: Editorial Ciencias Médicas, 2010. p.24-38.), the established criteria that define inappropriate prescriptions in these patients (Fick et al., 2012FICK, D.M.; SEMLA, T.; BEIZER, J.; BRANDT, N.; DOMBROWSKI, R.; FLANAGAN, N. American Geriatrics Society updated Beers criteria for potentially inappropriate medication use in older adults. J. Am. Geriatr. Soc. v.60, n.4, p.616-31, 2012.; American Geriatrics Society, 2015AMERICAN GERIATRICS SOCIETY. American Geriatrics Society 2015 beers criteria update beers criteria for potentially inappropriate medication use in older adults. J. Am. Geriatr. Soc., v.63, n.11, p.2227-46, 2015.; Gallagher et al., 2008GALLAGHER, P.; RYAN, C.; BYRNE, S.; KENNEDY, J.; O'MAHONY, D. STOPP (Screening Tool of Older Person's Prescription) and START (Screening Tool to Alert doctors to Right Treatment): consensus validation. Int. J. Clin. Pharmacol. Ther., v.46, n.2, p.72-83, 2008.; Silveira et al., 2015SILVEIRA, E.; ERRASQUÍN, B.; GARCÍA, M.; VÉLEZ-DÍAZ-PALLARÉS, M.; MONTOYA, I.; SÁNCHEZ-CASTELLANO, C.; CRUZ-JENTOFT, A. Mejorando la prescripción de medicamentos en las personas mayores: una nueva edición de los criterios STOPP-START. Rev. Esp. Geriatr. Gerontol. v.50, n.2, p.89-96, 2015.) and the holistic care (bio-psycho-social perspective),to solve the health problems of this population group (Merino, Miguel, Sanz, 2005MERINO, A.S.; MIGUEL, F.G.; SANZ, R.C. Yomedicalizo, túmedicalizas, él... reflexiones y propuestas. AMF., v.1, n.5, p.269-78, 2005. Apud: GARCÍA, M. La evidencia científica y la intervención farmacológica preventiva en geriatría. Rev. Cubana Med. Gen. Integr., v.28, n.4, p.747-755, 2012. ).

On the one hand, the Medication Appropriateness Index was specifically developed to assess the adequacy of drug therapy in the elderly. Some authors describe it as a method for improving the prescription of specific drugs (Stuijt et al., 2008STUIJT, C.; FRANSSEN, E.; EGBERTS, A.; HUDSON, S. Appropriateness of prescribing among elderly patients in a Dutch residential home: observational study of outcomes after a pharmacist-led medication review. Drugs Aging, v.25, n.11, p.947-54, 2008.).Otherwise, in Cuban health system, the development of Pharmaceutical Care and Pharmacotherapy follow-up is limited. There are some professional factors that influence in this context: insufficiencies in methods and patterns of clinical performance, non-normalization and non-generalization of patient-centered activity within the health context, low availability of standardized operating procedures to provide Pharmaceutical Care services and scarce human and material resources. Therefore, the exercise is developed as the result of the spontaneity of a few professionals (Reyes, 2012REYES, I. Estrategia para implementar el ejercicio de la atención farmacéutica en instituciones hospitalarias de la provincia de Santiago de Cuba. 2012. Trabajo presentado en opción al grado científico de Doctor en Ciencias Farmacéuticas, Universidad de la Habana, Cuba, 2012.; Dupotey, 2013DUPOTEY, N.M. Paradigma de atención farmacéutica con un enfoque holístico. 2013. Trabajo presentado en opción al grado científico de Doctor en Ciencias Farmacéuticas, Universidad de la Habana, Cuba, 2013. ). This transcends the fact that Cuban pharmacists have not been incorporated as members of the interdisciplinary team of geriatric patient care.

Taking into account the increasing population aging in Cuba (Oficina Nacional de Estadística e Información, 2015OFICINA NACIONAL DE ESTADÍSTICA E INFORMACIÓN. ONEI. República de Cuba: el envejecimiento de la población: Cuba y sus territorios. 2015. Disponible en: <Disponible en: http://www.one.cu >. Access 16 may. 2016.
http://www.one.cu...
; Oficina Nacional de Estadística e Información, 2013OFICINA NACIONAL DE ESTADÍSTICA E INFORMACIÓN. ONEI. La esperanza de vida: 2011-2013: cálculos para Cuba y Provincias por sexo y edades. Disponible en: <Disponible en: http://www.one.cu/publicaciones/cepde/esperanzadevida2011_2013/8_la_esperanza_de_vida_por_sexo_y_edad.pdf >. Access14 Nov. 2013.
http://www.one.cu/publicaciones/cepde/es...
) and the prediction of the percentage of fragile and in-need adults in a country (20% of the elderly population) (Fariñas, 2013FARIÑAS, L. Los retos de envejecer. Periódico Granma, Cuba, 14 de Noviembre del 2013. Disponible en: <Disponible en: http://www.granma.cu/granmad/2013/11/14/nacional/artic01.html >. Acceso en: 16 nov. 2013.
http://www.granma.cu/granmad/2013/11/14/...
), nursing homes are an important health care setting, especially for those patients with a high dependence. This group is exposed to the big consumption of drugs, associated to their medical, psychological, social and functional conditions, increasing the risk of medication-related problems, with consequences for the patient's health, the health care institutions and society in general. The great use of drugs in the elderly population and the morbidity and mortality associated with drugs, in the Cuban geriatric population, has been reported in several studies (Peña, Redondo, Groning, 2003PEÑA, M.A.; REDONDO, G.A.; GRONING, E. Consumo de medicamentos en ancianos. Rev. Cubana Med. Gen. Integr., v.19, n.3, 2003. Disponible en: <Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0864-21252003000300007 >. Access: 23 jun 2012.
http://scielo.sld.cu/scielo.php?script=s...
; Reyes, Pérez, Martínez, 2006REYES, A.; PÉREZ, G.; MARTÍNEZ, G. Errores en la medicación del adulto mayor en el área de salud del Policlínico Universitario, Plaza, Ciudad de La Habana. Rev. Cubana Farm., v.40, n.3, p. 1-11, 2006. Disponible en: <Disponible en: http://www.bvs.sld.curevistasfarvol40_3_06far05306.htm.htm >. Access:22 mayo. 2014.
http://www.bvs.sld.curevistasfarvol40_3_...
; Suárez, 2011SUÁREZ, N. Caracterización epidemiológica del consumo de medicamentos por la población adulta de Cuba. 2007- 2010.Trabajo presentado en opción al grado científico de Doctor en Ciencias de la Salud, Escuela Nacional de Salud Pública, Cuba, 2011.). Albeit the development of research in the area of Pharmaceutical Care for the elderly is growing around the world, in Cuba, it is still insufficient.

Moreover, the design and implementation of the first Standard Operating Procedure (SOP) to provide Pharmacotherapy follow service, in Cuba, was developed by Reyes (2012REYES, I. Estrategia para implementar el ejercicio de la atención farmacéutica en instituciones hospitalarias de la provincia de Santiago de Cuba. 2012. Trabajo presentado en opción al grado científico de Doctor en Ciencias Farmacéuticas, Universidad de la Habana, Cuba, 2012.). The instrument was designed and validated for inpatients pharmacotherapy follow-up, and is applicable to any population. But, its methodological structure does not respond to the identification and evaluation of main geriatric syndromes, associated with the use of drugs.

It has been demonstrated that it is necessary to meet the pharmacotherapy needs of the elderly, so as to prevent and resolve drug-related problems, by developing methodological tools, adapted to the bio-psycho-social peculiarities and the medication experiences of this population, which may allow for the provision of pharmacotherapy follow-up service, in a standardized and systematic manner, promoting the incorporation of pharmacists into interdisciplinary groups for geriatric patient care. In this regard, the manuscript presents the design evaluation and the content validity of a standard operating procedure to provide pharmacotherapy follow-up to elderly patients institutionalized in nursing homes, in Cuba.

MATERIAL AND METHODS

This research study applied the Delphi Method (Dalkey, 1967DALKEY, N.C. Delphi. P-.3704 RAND Santa Mónica. California: RAND Corp., 1967. 14p.), to design and validate the contents of a Standard Operating Procedure in order to provide pharmacotherapy follow-up for the elderly, in nursing homes, in accordance with the Good Pharmacy Practice requirements (OPS, OMS, 1993ORGANIZACIÓN PANAMERICANA DE LA SALUD. ORGANIZACIÓN MUNDIAL DE LA SALUD. OPS/OMS. El papel del farmacéutico en el sistema de atención a la salud. Informe de la Reunión de la OMSTokío, Japón, 31 de Agosto de 1993. Disponible en: <Disponible en: http://www.ops.org.bo/textocompleto/ime9848.pdf >. Access: 11 Feb. 2012.
http://www.ops.org.bo/textocompleto/ime9...
) and the process approach specified in ISO9001: 2008 (ISO Standards, 2009).The study was conducted in the period from September 2014 to August2015.

The research design involved 5 phases: (1) the review of the literature and documentary analysis, (2) construction of the initial version of SOP and mailing the first-round assessment questionnaire to the expert committee, of the, (3) evaluation of the initial version of the SOP by the expert committee, (4) assessment of the revised SOP based on findings of round 1 and the expert panel feedback and the analysis of the evaluation criteria, (5) construction of the final SOP.

Construction of standard operating procedure to provide pharmacotherapy follow-up to the elderly in nursing homes

(1) Review of the literature and documentary analysis

The literature review included all relevant references published from 1990 to 2015, describing and analyzing the following terms: Pharmaceutical Care Philosophy, Pharmaceutical Care Methods and Services (Studies conducted by the groups of the University of Florida (United States), University of Minnesota (United States), University of Granada (Spain), University of Valencia (Spain), Pharmacotherapy Follow-Up Procedures and Methodologies, Drug-Related Problems, Medication and the Elderly, Comprehensive Care for the elderly, Potentially Inappropriate Medication used in the Elderly, and in the Elderly living in nursing homes. Doctoral Thesis of Cuban and foreign authors in the area of Pharmaceutical Care were also reviewed.

The search was made using MEDLINE and INFOMED databases (the most important websites of the Cuban Health System), identifying the appropriate references. Each article or bibliographic material was systematically reviewed by the researchers using a table to outline the following information: objective of the study, type of study design, research methodology used, and quality assurance indicators of the provided services.

(2) Construction of the SOP initial version and forwarding to the expert committee

After a documentary analysis of literature, three steps were taken: (1) a brainstorming session among researchers to select the working methods that were more in keeping with the research objectives, (2) the construction of the SOP initial version and (3) forwarding it to the expert committee.

Ethical considerations

At the beginning, potential participants with recognized expertise in pharmaceutical care research, pharmacotherapy follow-up; geriatric pharmacology, and clinical geriatric medicine, were invited by means of an invitation letter (via regular email)to be present and they were asked their consent to participate, through an informed consent form, to complete our survey. The members of the expert committee were selected from various geographic areas of Cuba.

The evaluation procedure was carried out anonymously to avoid the influence of leaders.

Expert Selection

The expert committee was formed taking into account the following inclusion criteria:

  1. 1. Bachelors of Science in Pharmaceutical Sciences or related professions, whether with a PhD. or MSc. and experience in the area of pharmaceutical care, pharmacotherapy follow-up or health care provision for the elderly.

  2. 2. Geriatricians or General Medicine Specialist with a degree in geriatrics regardless of the working place.

  3. 3. 5 years or more of experience in the health care sector or in teaching activity.

  4. 4. Get a competence coefficient between 0.5 and 1 (0.5 ≤ k ≤1).

The estimated sample included 13 specialists. The response rate for the initial invitation to participate as a panelist was 84,6% (11/13).

The competence of the experts was calculated using two methods: (1) Self-assessment of the potential members, in accordance with the methodology proposed by Hurtado (2002HURTADO, S. Criterio de expertos: Su procesamiento a través del método Delphi. 2002. Disponible en: <Disponible en: http://www.ub.edu/histodidactica/index.php?option=com_content&view=article&id=21:criterio-de-expertos-su-procesamiento-a-traves-del-metodo-delphy&catid=11:metodologiay-epistemologia&Itemid=103 >. Access: 11 jun. 2014.
http://www.ub.edu/histodidactica/index.p...
) and (2) Analysis of academic and scientific performance relative to the subject matter dealt with, through the curriculum vitae review, in the last five years. The indicators used for the evaluation are shown in Table I.

TABLE I
Indicators to assess the experts' competence based on the curriculum vitae (last 5 years)

Experts whose competence coefficient through both methods presented the following combinations: High-High; High-Medium; Medium High; Medium-Medium, were finally included.

The Competence Coefficient (K) based on the analysis of each expert's curriculum, was calculated using the following equation:

where: ni: Value corresponding to each indicator i (1 to 6).

The competence coefficient of the expert was rated high, medium or low using the following criteria:

25≤ K ≤30 high competence coefficient

18≤ K ≤24 medium competence coefficient

12≤ K ≤17 low competence coefficient

The expert panel was finally composed of nine specialists, out of which 77.78% scored a high level of competence. All of them completed two rounds of the study.

(3) Evaluation of the first version of the SOP by the expert committee. First round

So as to validate the contents of the procedure (original version), experts reviewed the printed version of the initial draft document, and then completed an assessment questionnaire. The review was conducted using the Delphi method.

The criteria used for the evaluation of the SOP were taken from Moriyama, modified by Reyes in 2013REYES, I.; CRUZATA, Y.; VIDAL, M.; BERMÚDEZ, I.; NAMBATYA, W.; PERRAND, M.; DUTOK, C.M. Evaluación de un procedimiento para brindar seguimiento farmacoterapéutico a pacientes hospitalizados. Rev. Mex. Cienc. Farm., v.44, n.1, p.66-78, 2013. (Reyes et al., 2013REYES, I.; CRUZATA, Y.; VIDAL, M.; BERMÚDEZ, I.; NAMBATYA, W.; PERRAND, M.; DUTOK, C.M. Evaluación de un procedimiento para brindar seguimiento farmacoterapéutico a pacientes hospitalizados. Rev. Mex. Cienc. Farm., v.44, n.1, p.66-78, 2013.) and adapted to the research objectives.

Criteria description:

  • Reasonable and understandable: it makes reference to whether the item described from the technical point of view conceptually matches the subject matter and if understanding is adequate

  • Traceability of the process: the SOP reflects the way in which the activity being developed is recorded and documented.

  • Adequacy of the indicators: if the presence of each one of items included in the instrument, is justified.

  • Sensitive to variations in the phenomenon being measured: if the instrument allows to discriminate each element of the proposed work systematics (for DRP-NOM characterization) and the respective indicators that are declared so as to assess the structure, processes and results of the service.

  • Formal structure: that the SOP fulfills the established structure by the World Health Organization.

  • Simplicity of the process: it makes reference to the simplicity with which each of the operations included in the process.

After reviewing the SOP, experts evaluated each indicator using the following Likert-Type Scale: strongly agreed (5); in agreement (4); neither in agreement nor in disagreement (3); in disagreement (2); and strongly disagreed (1). Each panelist had the opportunity to make suggestions to improve each indicator of the SOP.

After the analysis of the responses of the first round of the study, we examined each recommendation given so as to assess the modification or not of the SOP, and its subsequent evaluation in the second round. The mean rating and the relevant 95% confidence interval (CI) were calculated, for each indicator obtained from the first round of the assessment. For those indicators which CI > 3, the SOP was not modified. When the CI included 3, the SOP criteria was considered for a second round. Criteria whose CI<3, involved the modification of the SOP. All the suggestions given by the experts, were summarized an evaluated for a second round, to reach a consensus among experts.

(4) Assessment of the reviewed SOP (Second-round)

In the 2nd round, the new version of the printed SOP was sent to the experts, with all suggestions in a document attached. Experts' responses were evaluated in accordance with Likert-Type Scale of 5 points, following the values: 5 = in strong agreement; 4 = in agreement; 3 = neither in agreement nor in disagreement; 2 = in disagreement and 1 = in strong disagreement.

The mean rating and the appropriate 95% confidence interval (CI) per suggestions, were calculated. Those suggestions whose CI>3, led to the SOP modification. When the IC≤3,the SOP was not modified.

Statistical analysis of the indicators in each round was developed by applying the Delphi Method Software (Hurtado, 2002HURTADO, S. Criterio de expertos: Su procesamiento a través del método Delphi. 2002. Disponible en: <Disponible en: http://www.ub.edu/histodidactica/index.php?option=com_content&view=article&id=21:criterio-de-expertos-su-procesamiento-a-traves-del-metodo-delphy&catid=11:metodologiay-epistemologia&Itemid=103 >. Access: 11 jun. 2014.
http://www.ub.edu/histodidactica/index.p...
).Each round was conducted in two weeks.

(5) Final design of the SOP

Once the responses and statistical analysis of the second round, were analyzed, the final version of the SOP was drawn up.

FINDINGS

Standard Operating Procedure to provide pharmacotherapy follow-up for the elderly (initial version)

After reviewing the literature and the documentary analysis, the original version of the SOP was designed. The design included the following sections: Cover Page, Objectives, Applicability, Human resources involved, Reference documentation, Responsibilities, Definitions, Sequence of activities, Records, monitoring, Quality assurance of the Pharmacotherapy Follow-up and Annexes. The Objectives, Applicability, Human resources involved, Reference documentation and Responsibilities differ from the other SOP proposals, specifying that the instrument is for the elderly institutionalized in nursing homes.

Section Definitions included core concepts related to the pharmacotherapy follow-up service. Additionally, terms associated with the use of medications in the elderly were incorporated: the cascade prescription, elderly caregiver, individualized dose, duplicity, chronic illness, geriatric interdisciplinary team, geriatric functional assessment scale, polypharmacy in the elderly, appropriate and inappropriate prescriptions and geriatric syndromes.

Section "Sequence of activities" included core elements that characterize the elderly care, such as:

  • Geriatric interdisciplinary team: Collaborative team, in which the main components are physicians, pharmacists and the nursing staff, who work together, cooperating for the achievement of the previously set therapeutic goals, considering the patient a member of the team and the center (together with his/her family) of the team. Each member should be highly familiarized with the tasks and responsibilities of the rest of the members, so that tasks and duties are, to some extent, interchangeable (Beers, Berkow, 2001BEERS, M.H.; BERKOW, R. (Eds.). The manual Merck de geriatría. 2. ed. Madrid: Editorial Elsevier, 2001. (CD-ROM). ). Thus, the inclusion of patients into the pharmacotherapy follow-up service can be promoted by any of its members.

  • Functional geriatric evaluation: Based on the relationship between geriatric syndromes and drug use and the need for a holistic approach to the comprehensive care of the elderly, therefore it is considered a key element for case documentation.

  • Identification and classification of DRPs: Criteria for the DRPs classification are shown in Table II. The list includes various types of DRP: prescription errors, dispensing errors, drug storage errors, administration errors, drug adverse reactions, and others. Each drug-related problem identified, will allow to determine the therapeutic goal and the appropriate pharmacist's interventions to achieve it. The criteria used for identifying prescription errors were based on the potentially inappropriate prescriptions for the elderly (Fick et al., 2012FICK, D.M.; SEMLA, T.; BEIZER, J.; BRANDT, N.; DOMBROWSKI, R.; FLANAGAN, N. American Geriatrics Society updated Beers criteria for potentially inappropriate medication use in older adults. J. Am. Geriatr. Soc. v.60, n.4, p.616-31, 2012.; Gallagher et al., 2008GALLAGHER, P.; RYAN, C.; BYRNE, S.; KENNEDY, J.; O'MAHONY, D. STOPP (Screening Tool of Older Person's Prescription) and START (Screening Tool to Alert doctors to Right Treatment): consensus validation. Int. J. Clin. Pharmacol. Ther., v.46, n.2, p.72-83, 2008.).

TABLE II
Criteria for the classification of DRPs

The systematic identification and classification of NOM, the care plan implementation and the pharmacotherapy follow-up evaluation: The steps to identify and classify NOMs and the assessment of the interventions outcome, are described, modifying Reyes' criteria in 2013REYES, I.; CRUZATA, Y.; VIDAL, M.; BERMÚDEZ, I.; NAMBATYA, W.; PERRAND, M.; DUTOK, C.M. Evaluación de un procedimiento para brindar seguimiento farmacoterapéutico a pacientes hospitalizados. Rev. Mex. Cienc. Farm., v.44, n.1, p.66-78, 2013. (Reyes et al., 2013REYES, I.; CRUZATA, Y.; VIDAL, M.; BERMÚDEZ, I.; NAMBATYA, W.; PERRAND, M.; DUTOK, C.M. Evaluación de un procedimiento para brindar seguimiento farmacoterapéutico a pacientes hospitalizados. Rev. Mex. Cienc. Farm., v.44, n.1, p.66-78, 2013.) (Figures 1 and 2).

FIGURE 1
Systematic detection and classification of NOM. Legend: NOM: Negative Outcomes associated with Medication.

FIGURE 2
Systematic evaluation of the pharmacist's interventions in the pharmacotherapy follow-up.Legend: DRP: Drugs-Related Problem. NOM: Negative Outcomes associated with Medication.

Models conduct the initial interview and to draw up the pharmacotherapeutic profile for the elderly: The models included peculiarities of elderly associated to drug use: diseases with great prevalence in the elderly, major geriatric syndromes and drugs which they usually take. Besides, the pharmacotherapeutic profile was designed so as to achievea better traceability of the evaluation of the DRPs, the NOMs and the pharmacists' interventions, visits and consultations during patient therapy monitoring. In Section Quality Assurance of Pharmacotherapy Follow-up a system of indicators of structure, process and results, was established. They are shown in Table III.

TABLE III
Quality assurance indicators for Pharmacotherapy Follow-up service

Assessment of the proposal of SOP by the expert committee (First Round)

During the assessment of the proposal, all the evaluation criteria of the SOP sections showed CI values> 3, leading to consensus among experts (Table IV). However, experts made some suggestions to improve the document in some of its parts: Cover Page, Sequence of activities, Quality Assurance of Pharmacotherapy Follow-up and Annexes.

TABLE IV
Assessment results by the expert committee (First Round)

Assessment of the SOP proposal by the expert committee (Second Round)

All the suggestions made the experts individually in the 1st round, were evaluated by all in the 2nd round. The results are shown in Table V.

TABLE V
Assessment results by experts in the second round

Out of the 15 criteria to be assessed in the second round, 12 received favorable responses by the experts, finding consensus among them. Therefore, the contents of the SOP were modified, according to the suggestions made in some sections. The three remaining answers were unfavorable since there was not consensus among the experts.

  • Sections Cover Page, Object, Applicability and Human Resources involved were modified, because most of the experts considered that the SOP use is not restricted to nursing homes, and it can be applied at any level of health care. So, the proposal title was "Standard Operating Procedure to provide Pharmacotherapy Follow-up for the Elderly (PNT-SFTAM/ Acronym in Spanish language).

  • Number "01" was included in the SOP code, being represented by the same acronym: as PNT-SFTAM-01.

  • The meaning of the auto shapes used in the Systematics for the detection and classification of NOMs (Figure 1) and in the Systematics for the evaluation of the pharmacist's interventions in the pharmacotherapy follow-up (Figure 2), were specified.

  • Three phases were explained in the Section Sequence of activities (Figure 3), which were described as follows:

FIGURE 3
Sequence of activities for the pharmacotherapy follow-up. Legend: DRPs: Drugs-Related Problems. NOM: Negative Outcomes associates with Medication.

  • Initial assessment of the patient: To determine the patient's drug-related needs in the order of the indication, effectiveness and safety, service offering to the patient, creating of the pharmacoterapeutic profile, documenting the case and identifying drug therapy problems (DRPs) and negative outcomes associated with medication (NOMs).

  • Design and implementation of a therapeutic patient care plan: Establish goals of therapy, select appropriate interventions for: resolution of drug therapy problems, prevention of drug therapy problems and the evaluation of the results of interventions.

  • Monitoring and evaluation of pharmacotherapy follow-up results in the patient: Include analysis of the final follow-up assessment (Assessment of the scope of therapeutic goals for the patient's care plan and the solution or prevention of NOM) Satisfaction of the patient / caregiver is evaluated.

  • The proposed changes relating to the incorporation of other types of DRPs (insufficient information provided by pharmacist about drug use, medication non-adherence and non-availability of drugs), were accepted as shown in Table I. Likely, the other suggestions issued by the experts were modified in the SOP.

Construction of final SOP

The diagram of the final SOP version is shown in Figure 4, according to the results of both rounds.

FIGURE 4
Diagram of the Standard Operating Procedure for pharmacotherapy follow-up in the elderly. Legend: DRPs: Drugs-Related Problems. NOM: Negative Outcomes associates with Medication.

DISCUSSION

Proposed Standard Operating Procedure to provide pharmacotherapy follow-up to the elderly

The conceptual framework of the first SOP version corresponds to the theoretical and methodological elements of an organizational system designed to provide Pharmacotherapy follow-upservice for the elderly in nursing homes. It takes into account some relevant references in this area, conducted by Gutiérrez (2006GUTIÉRREZ, L. Registros e indicadores de calidad asistencial. Desarrollo del documento de consenso sobre atención farmacéutica. 2006. Trabajo presentado en Opción al Título de Doctor en Ciencias, Universidad de Granada, España, 2006.), Reyes et al. (2013REYES, I.; CRUZATA, Y.; VIDAL, M.; BERMÚDEZ, I.; NAMBATYA, W.; PERRAND, M.; DUTOK, C.M. Evaluación de un procedimiento para brindar seguimiento farmacoterapéutico a pacientes hospitalizados. Rev. Mex. Cienc. Farm., v.44, n.1, p.66-78, 2013.), Reyes (2012)REYES, I. Estrategia para implementar el ejercicio de la atención farmacéutica en instituciones hospitalarias de la provincia de Santiago de Cuba. 2012. Trabajo presentado en opción al grado científico de Doctor en Ciencias Farmacéuticas, Universidad de la Habana, Cuba, 2012. and Dupotey (2013DUPOTEY, N.M. Paradigma de atención farmacéutica con un enfoque holístico. 2013. Trabajo presentado en opción al grado científico de Doctor en Ciencias Farmacéuticas, Universidad de la Habana, Cuba, 2013. ). Gutiérrez, made an important contribution to the Health System of Spain, who developed Quality Operating Procedures for the healthcare activities in community pharmacies.

In Cuba, it is worth highlighting the research conducted by Reyes (2012REYES, I. Estrategia para implementar el ejercicio de la atención farmacéutica en instituciones hospitalarias de la provincia de Santiago de Cuba. 2012. Trabajo presentado en opción al grado científico de Doctor en Ciencias Farmacéuticas, Universidad de la Habana, Cuba, 2012.), Reyes et al. (2013)REYES, I.; CRUZATA, Y.; VIDAL, M.; BERMÚDEZ, I.; NAMBATYA, W.; PERRAND, M.; DUTOK, C.M. Evaluación de un procedimiento para brindar seguimiento farmacoterapéutico a pacientes hospitalizados. Rev. Mex. Cienc. Farm., v.44, n.1, p.66-78, 2013. and Reyes et al. (2014)REYES, I.; BERMÚDEZ, I.B.; STORPIRTIS, S.; BARANDA, S.C.; FERNÁNDEZ, E.S. Sistema organizativo para implementar el ejercicio de la Atención Farmacéutica Hospitalaria en Santiago de Cuba. Rev. Cubana Farm. v.48, n.3, p. 432-45, 2014. Disponible en: <Disponible en: http://bvs.sld.cu/revistas/far/vol48_3_14/far10314.htm >. Access: 06 feb. 2015.
http://bvs.sld.cu/revistas/far/vol48_3_1...
who developed a systemic approach to implementing pharmaceutical care services in hospitals. A SOP to provide pharmacotherapy follow-up at this level of health care, was validated. These works present a system of the vital relationships between patient-drug, the pharmacist and the others health team members. The structure, the process and the outcomes are identified as quality components of the system, connected with all clinical services developed by the pharmacist.

Another theoretical reference for this research was developed by Dupotey (2013DUPOTEY, N.M. Paradigma de atención farmacéutica con un enfoque holístico. 2013. Trabajo presentado en opción al grado científico de Doctor en Ciencias Farmacéuticas, Universidad de la Habana, Cuba, 2013. ), who presents a new paradigm for the improvement of pharmaceutical care in Cuba, based on a comprehensive vision and holistic approach to provide Pharmaceutical Care by pharmacists, with the integrated participation of the Cuban Health System managers, health providers, academics, and patients. This paper highlights the evaluation of the bio-psycho-social condition of the patient, to understand its drug-related problems. This is an essential aspect to be considered in the healthcare service provided for the elderly, because drug therapy in geriatrics requires a more humanistic approach than just a clinical perspective, centered in the elderly patient as an individual. (Merino, Miguel, Sanz, 2005MERINO, A.S.; MIGUEL, F.G.; SANZ, R.C. Yomedicalizo, túmedicalizas, él... reflexiones y propuestas. AMF., v.1, n.5, p.269-78, 2005. Apud: GARCÍA, M. La evidencia científica y la intervención farmacológica preventiva en geriatría. Rev. Cubana Med. Gen. Integr., v.28, n.4, p.747-755, 2012. ).

The SOP proposal defends geriatric patient care, not only from the harmonic analysis of their clinical condition and use of drugs based on the inadequacy of medication criteria (Fick et al., 2012FICK, D.M.; SEMLA, T.; BEIZER, J.; BRANDT, N.; DOMBROWSKI, R.; FLANAGAN, N. American Geriatrics Society updated Beers criteria for potentially inappropriate medication use in older adults. J. Am. Geriatr. Soc. v.60, n.4, p.616-31, 2012.; American Geriatrics Society, 2015AMERICAN GERIATRICS SOCIETY. American Geriatrics Society 2015 beers criteria update beers criteria for potentially inappropriate medication use in older adults. J. Am. Geriatr. Soc., v.63, n.11, p.2227-46, 2015.; Gallagher et al., 2008GALLAGHER, P.; RYAN, C.; BYRNE, S.; KENNEDY, J.; O'MAHONY, D. STOPP (Screening Tool of Older Person's Prescription) and START (Screening Tool to Alert doctors to Right Treatment): consensus validation. Int. J. Clin. Pharmacol. Ther., v.46, n.2, p.72-83, 2008.; Silveira et al., 2015SILVEIRA, E.; ERRASQUÍN, B.; GARCÍA, M.; VÉLEZ-DÍAZ-PALLARÉS, M.; MONTOYA, I.; SÁNCHEZ-CASTELLANO, C.; CRUZ-JENTOFT, A. Mejorando la prescripción de medicamentos en las personas mayores: una nueva edición de los criterios STOPP-START. Rev. Esp. Geriatr. Gerontol. v.50, n.2, p.89-96, 2015.; Holt, Schmiedl, Thurmann, 2010HOLT, S.; SCHMIEDL, S.; THURMANN, P.A. Potentially inappropriate medications in the elderly: the PRISCUS list. Dtsch. Arztebl. Int., v.107, n.31-32, p.543-51, 2010.), and its relationship with geriatric syndromes. The SOP reveals the need of incorporating the bio-psychosocial condition of the patient, to obtain the necessary holistic assessment for the elderly, in a greater contribution and relevance of the pharmacist to solve the health problems of this particular population group, which is growing at an accelerated pace. (Oficina Nacional de Estadística e Información, 2013OFICINA NACIONAL DE ESTADÍSTICA E INFORMACIÓN. ONEI. La esperanza de vida: 2011-2013: cálculos para Cuba y Provincias por sexo y edades. Disponible en: <Disponible en: http://www.one.cu/publicaciones/cepde/esperanzadevida2011_2013/8_la_esperanza_de_vida_por_sexo_y_edad.pdf >. Access14 Nov. 2013.
http://www.one.cu/publicaciones/cepde/es...
).

Likewise, a quality assurance system in the SOP, incorporates the structure, process and outcomes indicators, which allow the evaluation of pharmacotherapy follow-up service for the elderly. This contributes to the continuous improvement of the provided service, responding to the World Health Organization (WHO)'s statements that mentions: ... health systems should support and enhance the implementation and practice of pharmaceutical care by measuring, evaluating and improving pharmacy practice activities, using the conceptual framework of continuous quality improvement. (Widenmayer, Summers, Mackie, 2006WIDENMAYER, K.; SUMMERS, R.S.; MACKIE, C.A. Desarrollo de la práctica de farmacia centrada en la atención del paciente. Organización Mundial de la Salud y Federación Internacional Farmacéutica. MANUAL. Ginebra: OMS, 2006. Disponible en: <Disponible en: http://www.fip.org/files/fip/publications/DevelopingPharmacyPractice/DevelopingPharmacyPracticeES.pdf >. Access: 13 mayo 2014.
http://www.fip.org/files/fip/publication...
).

The designed indicators in the SOP, responding to the Donadebian quality approach (Donadebian, 1988). These indicators consider the three phases of the Sequence of activities: Initial assessment of the patient; Design and implementation of a therapeutic patient care plan and evaluation of results in the patient.

Regarding the structure indicators, there are no differences when comparing it with the one proposed by Reyes et al. (2013REYES, I.; CRUZATA, Y.; VIDAL, M.; BERMÚDEZ, I.; NAMBATYA, W.; PERRAND, M.; DUTOK, C.M. Evaluación de un procedimiento para brindar seguimiento farmacoterapéutico a pacientes hospitalizados. Rev. Mex. Cienc. Farm., v.44, n.1, p.66-78, 2013.). However, the process indicators incorporate others which are not addressed by this author, which are identified as I5, I7, I8, I9, I10 and I11. These are oriented to determine the DRPs per validated medication order, specifically those related to the prescription, dispensing, administration, storage and ADR and thus, to design activities in order to improve the staff training and process control. The NOM is the clinical consequence of the DRP, and the pharmacist's responsibility is to prevent and to resolve them. One NOM may be associated with multiple DRPs. From this point of view, the evaluation of NOM was excluded of the process indicators proposed by Reyes and incorporated as outcome indicators.

The impacts of the pharmacist´s interventions to resolve NOM (I13) and to prevent NOM (I14) were included. Both indicators express the pharmacist's role in the improvement of the pharmacotherapy and if this professional is able to gain benefits with the patient's care plan implemented. There are so many examples of these indicators, whose usefulness in evaluating the impact and adequacy of the pharmacists' interventions, pharmacotherapy results and/or clinical, pharmaco economic, humanistic outcomes, have been reported by several authors, with remarkable results in the patient´s quality of life. (Climente, Jiménez, 2005CLIMENTE, M.; JIMÉNEZ, N.V. Manual para la Atención Farmacéutica. 3.ed. Valencia: AFAHPE; Hospital Universitario Dr. Peset, 2005. p.11-20; 48-58; 99-106.).

Assessment of the SOP proposal by the experts committee (First Round)

The confidence interval values obtainedin the criteria assessment for the SOP proposal revealed a high degree of agreement among experts, which demonstrates the validity of the contents of the proposed instrument to provide pharmacotherapy follow-up for the elderly.

SOP assessment reviewed by the expert committee (Second Round)

The mean and CI values of the suggestions under evaluation by the experts, likely showed a high degree of agreement among experts. It was possible to re-design the SOP initial version and to achieve a content validity of the final reviewed instrument, to provide pharmacotherapy follow-up for the elderly.

Through the SOP analyses, no restrictions to nursing homes were introduced and the possibility of applicability at any level of health care for the elderly was recommended. The inclusion of code (01) for identifying the document, which will make possible the differentiation from other versions, which may appear with respect to the values of the of quality assurance indicators.

To respond the experts' criterion regarding the definition of stages in section "Sequence of activities", Cipolle, Strand and Morley (2004CIPOLLE, R.J.; STRAND, L.M.; MORLEY, P.C. Pharmaceutical care practice: the clinicians guideNew York: McGraw Hill, 2004. p.202-276.) and Dupotey (2013DUPOTEY, N.M. Paradigma de atención farmacéutica con un enfoque holístico. 2013. Trabajo presentado en opción al grado científico de Doctor en Ciencias Farmacéuticas, Universidad de la Habana, Cuba, 2013. ) criteria, were used.

Limitations to this study

Despite ensuring the anonymity of the experts who made up the panel, so as to avoid the effect of leaders, there may be the case that experts exchanged their views with each other, which can lead to information bias.

CONCLUSIONS

The Standard Operating Procedures to provide pharmacotherapy follow-up for the elderly was designed from a detailed documentary analysis that took into account: the need for holistic care to elderly patients, the criteria of inappropriate medication for this population and the relationship between functional geriatric evaluation and the use of drugs.

Two working sessions were established to achieve the procedure content validation, which was reviewed by an expert committee using the Delphi methodology. High degree of agreement among evaluators, was achieved, which allowed to improve the initial version of the instrument and to construct the final procedure.

The validated SOP is a tool that can be used by pharmacists for Pharmacotherapy follow-up forthe elderly at any level of healthcare.

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Publication Dates

  • Publication in this collection
    2017

History

  • Received
    27 Oct 2015
  • Accepted
    19 Dec 2016
Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Av. Prof. Lineu Prestes, n. 580, 05508-000 S. Paulo/SP Brasil, Tel.: (55 11) 3091-3824 - São Paulo - SP - Brazil
E-mail: bjps@usp.br