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Farmacia Hospitalaria

versión On-line ISSN 2171-8695versión impresa ISSN 1130-6343

Farm Hosp. vol.40 no.5 Toledo sep./oct. 2016 



A randomised controlled trial on the efficacy of a multidisciplinary health care team on morbidity and mortality of elderly patients attending the Emergency Department. Study design and preliminary results

Ensayo clínico aleatorizado sobre la eficacia de un equipo multidisciplinar en la morbimortalidad de pacientes ancianos atendidos en un servicio de urgencias. Diseño y resultados preliminares



Rosario Santolaya-Perrín1, Gregorio Jiménez-Díaz2, Nuria Galán-Ramos3, María Teresa Moreno Carvajal4, Juan Manuel Rodríguez-Camacho5, Jesús Francisco Sierra-Sánchez4, Juan Arévalo-Serrano6 and Beatriz Calderón-Hernanz5

1Hospital Pharmacy Department. Hospital Universitario Príncipe de Asturias.
2Emergency Department. Hospital Universitario Príncipe de Asturias.
3Hospital Pharmacy Department. Hospital Manacor.
4Hospital Pharmacy Department. Hospital de Jerez.
5Hospital Pharmacy Department. Hospital Son Llátzer.
6Internal Medicine Department. Hospital Universitario Príncipe de Asturias. Spain.

The study has been promoted by the REDFASTER Group of the Spanish Society of Hospital Pharmacy, and has been funded through grants for research and teaching and care projects for groups provided by the Society in 2013-2014.





Objective: To estimate the prevalence of potentially Inadequate drug prescriptions In elderly patients who attend the Emergency Department.
Design: A multicentre randomized clinical trial. Patients over 65 years of age attending the Emergency Department are randomized to the control arm or the intervention arm. In the intervention arm, the pharmacist will review the chronic medication of patients and identify any potentially inadequate prescriptions, according to the STOPP-START criteria. The cases are discussed with the Emergency Specialist and, if considered adequate, a recommendation to modify the treatment is sent to the Primary Care Physician. The control arm will receive the standard of care, not including a systematic review of the adequacy to the STOPP-START criteria. This article presents preliminary outcomes regarding the prevalence of potentially inadequate prescriptions.
Outcomes: Four hospitals participated in the study, and 665 patients were included (342 in the control arm and 305 in the intervention arm). The mean age in the control arm was 78.2 years vs. 78.99 in the intervention arm. The total number of medications received by patients at the time of inclusion was 3 275. Of these, 9.3% (CI 95%: 8.3-10.4) were considered potentially inadequate prescriptions according to the STOPP criteria. On the other hand, 81.1% (CI 95%: 76.8-85.4) of the patients evaluated presented potentially inadequate prescriptions.
Conclusion: This study has detected a high prevalence of potentially inadequate prescriptions in elderly patients attending the Emergency Department.

Key words: Clinical pharmacist; Emergency Department; Continuity of care; Inadequate prescription; Elderly people.


Objetivo: Estimar la prevalencia de prescripciones potencialmente inapropiadas en pacientes mayores que acuden a urgencias
Diseño: Ensayo clínico multicéntrico aleatorizado. Los pacientes mayores de 65 años que acuden a urgencias son asignados al grupo control o al de intervención. En el grupo de intervención, el farmacéutico revisa la medicación crónica de los pacientes e identifica aquellas prescripciones potencialmente inapropiadas de acuerdo a los criterios STOPP START. Los casos se discuten con el médico de urgencias y, cuando se considera indicado, se envía una recomendación al médico de atención primaria para que modifique el tratamiento. El grupo control recibe los cuidados habituales, que no incluyen una evaluación sistemática de la adecuación a los criterios STOPP START. En este artículo se presentan resultados preliminares respecto a la prevalencia de prescripciones potencialmente inapropiadas.
Resultados: En el estudio han participado cuatro centros y se han incluido 665 pacientes (342 en el grupo control y 305 en el de intervención). La edad media en el grupo control ha sido de 78,2 años frente a 78,99 en el grupo de intervención. El número total de medicamentos que recibían los pacientes en el momento de la inclusión fue de 3.243. De estos, el 9,3% (IC 95%: 8,3-10,4) fueron considerados prescripciones potencialmente inapropiadas de tipo STOPP Por otro lado, el 81,1%. (IC 95%: 76,8-85,4) de los pacientes evaluados presentaron prescripciones potencialmente inapropiadas.
Conclusiones: En el estudio se ha detectado una alta prevalencia de prescripciones potencialmente inapropiadas en pacientes mayores que acuden a urgencias.

Palabras clave: Farmacéutico clínico; Urgencias; Continuidad asistencial; Prescripción inadecuada; Personas mayores.


Contribution of this study to scientific literature

This study was designed in order to assess the efficacy, in terms of morbimortality, of the implementation of multidisciplinary teams in order to reduce the number of inadequate prescriptions in elderly persons. The high prevalence of inadequate prescriptions for these patients is widely known, as well as the clinical and economic problem entailed by this. Therefore, it is interesting to design strategies to reduce them. This study presents a team model which includes Emergency Specialists, Pharmacists, and Primary Care Physicians. This is an innovative strategy, and therefore requires an accurate assessment of its clinical utility.

The first step for developing this project is to determine the prevalence of this problem in the Emergency Departments, which is an aspect dealt with in this article. Besides, the qualitative analysis of these inadequate prescriptions will allow to prioritize targets of action, in order to have an intervention on the most prevalent problems.



Pharmaceutical care in the Emergency Department is a clinical activity that has become increasingly important1,2. Numerous studies have been published, at a national and international level, showing the high prevalence of drug-related problems in patients managed at the Emergency Department, and the ability of the Pharmacist to prevent and correct them, working in collaboration with the multidisciplinary teams.

In this context, one of the better established activities is the review of the chronic treatment that the patient is receiving6-9. Drug-related problems (DRP) are the cause of a major proportion of hospital admissions10,11. Their identification is necessary in order to treat the acute episode presented by the patient. Moreover, obtaining a list of chronic medication is part of the Medication Reconciliation Process, which is necessary in order to adapt the chronic therapy received by the patient to the new clinical situation presented at hospital.

Elderly persons are one of the populations more likely to present problems related with medication at Emergency Departments. This fact has been acknowledged by the American Geriatric Society and The American College of Emergency Physicians, that recommends the inclusion of a Pharmacist in the teams managing these patients12. This population will often present associated comorbidities, and receive many medications. It has been estimated that 6-30% of admissions of elderly persons are due to problems related with medications, and that a major proportion is due to potentially inadequate prescriptions (PIPs)13.

A number of explicit criteria have been developed to identify PIP. Beers Criteria have been the most widely mentioned in international geriatric literature, but their drawback is that they include a high proportion of drugs not marketed in Europe14. The STOPP-START criteria have been introduced more recently, and their clinical development has been conducted by the European Union Geriatric Medicine Society15. This is a tool that identifies potentially inadequate medication (STOPP criteria) as well as potential omissions of medications (START criteria). STOPP-START criteria have been more strongly associated with the development of adverse reactions than Beers criteria16. Therefore, in recent years the STOPP-START criteria have been positioned as the method for PIP detection in our setting.

The primary objective of this article is to determine the prevalence of PIPs, as defined by the STOPP-START criteria, in patients managed at the observation area of the Emergency Department. A multidisciplinary program will be generated in order to promote adherence to these criteria. The impact of this program on the reduction of visits to the Emergency Department and hospitalizations will be the object of a subsequent publication.



The study was a multicenter randomized and controlled clinical trial on >65-year-old patients who attended the Emergency Departments of the centres involved, and were managed at the observation areas. To be included, patients should be receiving at least one drug in the outpatient setting for one chronic condition, defined as any condition lasting over six months. The exclusion criteria were the following:

- Patients managed by the Psychiatry Unit at the Emergency Department.

- Patients in follow-up for palliative care.

- Situations making communication impossible: patients without caregiver and with cognitive deterioration, language difficulties regardless of the assistance of a translator.

- No written source of information available about the chronic treatment of the patient (report by the nursing / retirement home, hospital discharge report from the past year, or Primary Care report), except in those cases in which the treatment received by the patient could be physically confirmed.

- Follow-up of chronic conditions conducted in a prívate medical center.

- Patients who did not sign the Informed Consent Form in order to take part in the study.

Patients were randomly assigned to the control arm and the intervention arm.

The intervention consisted in the implementation of an interprofessional collaboration program between Hospital Pharmacists, Emergency physicians and Primary Care Physicians. The Pharmacist reviewed the treatment previous to the visit of the patient to the Emergency Department, assessing its adequacy to the STOPP-START criteria15. PIPs were identified according to these criteria, and this was communicated to the Emergency Physician involved in the study. If the visit to the Emergency Department was related with the PIP, the emergency physician, could modified the patient's chronic treatment in the Emergency Discharge Report. In case the PIP was not corrected in the Emergency Report, the Primary Care Physician was informed once the patient had been discharged, with a recommendation to re-evaluate the treatment and follow the recommendations. Each participant centre determined its protocol of communication with Primary Care. The protocol was approved by the management of each centre (Table 1).

During this analysis of chronic treatment, any DRPs not included within the STOPP-START criteria, could be detected. DRPs were classified according to the 3rd Granada Consensus17. A plan to resolve these DRPs was also recommended using the same protocol of communication. DRPs were recorded as co-variables.

The control arm received standard medical and pharmaceutical care. A medication list was also obtained, but there was no systematic analysis for detection of PIPs according to the STOPP-START criteria.

The primary end point was the composite of visits to the Emergency Department and all cause hospital admissions 12 months after the intervention. This variable must also be measured at 3 and 6 months. This article presents the outcomes of a secondary variable defined in the project: patients with PIPs.

In order to estimate the sample size, it was assumed that, by eliminating PIPs, there would be an absolute reduction of 18% in the visits to the Emergency Department and urgent hospital admissions, and that 60% of the recommendations made by the pharmacists to the physician would translate into corrections of PIPs. By applying this reduction, it was estimated with a 95% level of confidence, an observational method accuracy of 5%, and an 80% statistical potency, that 555 patients were necessary. Assuming 20% of losses, the estimated sample size in order to conduct the study was of 666 patients.

Patients were randomly assigned to the control arm and the intervention arm. There was complete randomization by hospital and by intervention arm. The coordinating centre generated a table of random numbers for each centre, and was in charge of safe-keeping the randomization list for each centre. Researchers received closed envelopes. Patient selection was consecutive. The researcher opened the randomization envelope only after the patient had signed the Informed Consent Form.

Statistical analysis

The analysis of variables was conducted using the Chi-Square Test for categorical variables, Student's t Test for continuous variables that followed a normal distribution, and Mann-Whitney's U Test for those variables that did not follow the normal distribution. The mean and its typical deviation were estimated, as well as the median and its interquartile range, or the absolute and relative frequencies, as relevant.

For the statistical analysis of data, the SPSS statistical package version 18.0 was used (SPSS Inc, Chicago, IL, USA). P<0,05 values were considered significant.

Once the study has been completed, the primary variable will be analyzed. The Poisson Regression Model will be used. The model will include the influence of other variables: acceptance or not of the intervention, presence of PIPs according to the STOPP-START criteria, Charlson Comorbidity Index, gender, age, patient living or not in a nursing home, number of medications, research centre, method of communication with Primary Care, and presence of DRPs. The analysis will be conducted by Intention to Treat.

For the Mortality variable, a Cox Regression Method will be used, and the influence of other variables will be studied in the same way as in the primary variable.

Ethical aspects

This study was approved by the Ethics and Clinical Research Committee of the Coordinating Centre, and it has received approval by the Spanish Agency of Medicines and Medical Devices.

Patients included in the study received oral and written information, and signed the Informed Consent Form in case they accepted to participate.

Data processing was conducted according to the Organic Law 15/1999, from December, 13th, on Personal Data Protection.



The study is currently conducted in four centres, and the inclusion period has been completed. In total, 666 patients have been included; one of them was excluded before conducting the intervention, because he had already been previously included, Out of the remaining 665 patients, 342 patients were randomly assigned to the control arm, and 323 to the intervention arm. The characteristics of the patients included are detailed in table 2.

For estimating the prevalence of PIPs, only those patients in the intervention arm have been considered, according to what was defined in the protocol.

In total, this group presented 3243 drug prescriptions; out of these, 303 (9.3%; CI 95%: 8.3-10.4) were STOPP-type PIPs. 278 medications that patients were not receiving and should be initiated according to START criteria were identified, which represents an 8.6% (CI 95%: 7.6-9.5) of all the prescriptions analyzed.

Regarding the number of patients who presented PIPs, 262 of the 323 patients assigned to the intervention arm presented some type of PIP, which represents a prevalence of 81.1%. (CI 95%: 76.8-85.4). The majority of PIPs were of the STOPP type.

The description of the most frequent types of PIPs is detailed in tables 3 and 4. The majority of STOPP-type PIPs consisted in the inadequate use of benzodiazepines, followed by the use of antiaggregant drugs. The molecules more frequently involved in STOPP-type PIPs are described in table 5. Regarding START-type PIPs, the most frequent was lack of compliance with anti pneumococcal vaccination.




Patients over the age of 65 years are pluripathological patients who often transit across health care levels. Therefore, different strategies are being developed with the aim to facilitate an adequate continuity of care18. Our program of collaboration between Emergency Specialists, Pharmacists, and Primary Care Physicians, for the management of medication in elderly patients, is an interesting initiative, because these patients will visit frequently the Emergency Units. The outcomes of this study will allow to assess if these teams are able to improve the morbimortality of patients through a reduction in PIPs.

Pharmaceutical care in Emergency Departments is becoming an increasingly established practice, but there are few studies to measure its impact on clinical variables, and few studies focus on interventions over chronic treatments targeted at Primary Care Physicians. Okere and col19 conducted a study with similar characteristics, and were not able to demonstrate a reduction in visits to the Hospital Emergency Departments, though there was a reduction in urgent patient care. This study was conducted in another healthcare system, and therefore its outcomes might not be comparable. Moreover, Gorgas and col20 evaluated the efficacy of an inter-level Pharmaceutical Care Program, with participation by Hospital, Primary Care and Community Pharmacists. Patients who were admitted to hospital were selected. These authors did not find any significant differences in re-admissions. As far as we know, no study has been published involving the coordination of the Hospital Pharmacist, the Emergency Physician and the Primary Care Physician. Outcomes will allow to assess the interest of developing this type of programs over other pharmaceutical care initiatives which have already demonstrated its utility.

So far, the period of inclusion in the study has been completed, which allows to evaluate the prevalence of PIPs in those patients included. The result achieved was 81.1% of patients, which is superior to that mentioned by other authors that have studied patients with a similar complexity index, and have found frequencies between 35.9% and 61.3%21-23. However, it is lower than the one mentioned by Delgado and col24, who analyzed drug-related problems and PIPs in elderly patients, and found that 29% of the prescriptions analyzed were PIPs according to the STOPP criteria analyzed, vs. the 9.3% found in our study. A possible explanation could be that their study included patients with higher complexity, with many of them living in nursing homes.

Regarding the qualitative analysis of PIPs, the majority are of the same type. Thus, 36.6% consist in the excessive use of benzodiazepines, and 7.9% consist in high doses of acetylsalicylic acid. Other authors have found similar data regarding inadequate use of benzodiazepines22. This is interesting, because the risk of falls and hospital admissions in elderly patients who use benzodiazepines has been well documented25,26; therefore, based on these data, the design of educational strategies targeted to prescribing physicians and patients in order to reduce their use could become a priority.

Regarding START criteria, the higher number of PIPs is due to the lack of anti pneumococcal vaccination according to the local protocol; but this could be due to the recent launch of the conjugated vaccine at the time of patient inclusion, and a reduction over time is expected. Another finding was the high frequency of the lack of use of statins in patients with vascular disease, as well as of ACE inhibitors in patients with heart failure. These results are similar to those reported by other authors22,23.

Our study presents limitations. This is a study which requires a great level of coordination with Primary Care, and this can vary in the different participating centres. In order to minimize its influence, the centres involved were required to send to the coordinating centre a protocol for communication with Primary Care approved in the centre. Randomization was stratified by centre; and the method of communication and level of acceptance of the interventions conducted will be entered into the statistical analysis.

Finally, it is worth mentioning that the study of these differences in communication between levels of care could be of great interest. In some centres, communication has been based in the use of computer tools. The development of these tools is necessary, but it does not assure that the physician responsible of the next level of care reads the recommendation. Some centres add an extra communication by e-mail, as a form of alert, to these computer media. Finally, one centre has incorporated the profile of Health Centre Manager, instead of using direct communication between professionals. The analysis of the differences in outcomes between centres can be useful in order to decide which Continuity of Care Procedure presents a higher utility. The ideal coordination model has not been determined, and the outcomes of this study can provide data to define it.


Relación de investigadores participantes

- Rosario Santolaya Perrín. Servicio de Farmacia. Hospital Universitario Príncipe de Asturias.

- Gregorio Jiménez Díaz. Servicio de Urgencias. Hospital Universitario Príncipe de Asturias.

- Erza Honan Roiz Andino. Servicio de Urgencias. Hospital Universitario Príncipe de Asturias.

- Juan Arévalo Serrano. Servicio de Medicina Interna. Hospital Universitario Príncipe de Asturias.

- Ana Ginés Palomares. Servicio de Farmacia. Hospital Universitario Príncipe de Asturias.

- Isabel Sánchez Navarro. Servicio de Farmacia. Hospital Universitario Príncipe de Asturias.

- Silvia García Ramos. Servicio de Farmacia. Hospital Universitario Príncipe de Asturias.

- Nuria Galán Ramos. Servicio de Farmacia. Hospital de Manacor.

- Pere Serra Simó. Servicio de Urgencias. Hospital de Manacor

- Juan Manuel Rodríguez. Servicio de Farmacia. Hospital San Llatzer.

- Albert Armengol Alert. Servicio de Farmacia. Hospital San Llatzer.

- Beatriz Calderón Hernanz. Servicio de Farmacia. Hospital Son Llatzer.

- Teresa García Martínez. Servicio de Farmacia. Hospital Son Llatzer.

- Carla Liñana Granell. Servicio de Farmacia. Hospital Son Llatzer

- Carmen López Doldan. Servicio de Farmacia. Hospital Son Llatzer.

- Jesús Francisco Sierra Sánchez. Servicio de Farmacia. Hospital de Jerez.

- Ma Teresa Moreno Carvajal. Servicio de Farmacia. Hospital de Jerez.

- José Carlos García Ortiz. Servicio de Urgencias. Hospital de Jerez.


Conflicto de interés

Los autores declaran no tener ningún conflicto de interés.



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Correo electrónico:
(Rosarlo Santolaya Perrín).

Recibido el 30 de enero de 2016;
aceptado el 12 de abril de 2016.

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