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Original Research Article
Cost-utility analysis of a medication review with follow-up service for older adults with
polypharmacy in community pharmacies in Spain: the conSIGUE Program
Short running title: Cost-utility analysis of a medication review with follow-up service
Francisco Jódar-Sánchez
1,2
, Amaia Malet-Larrea
3
, José J. Martín
4
, Leticia García-Mochón
5
, M. Puerto
López del Amo
4
, Fernando Martínez-Martínez
6
, Miguel A. Gastelurrutia-Garralda
6
, Victoria García-
Cárdenas
7
, Daniel Sabater-Hernández
6,7
, Loreto Sáez-Benito
8
, Shalom I. Benrimoj
7
1
Technological Innovation Group. Virgen del Rocío University Hospital, Seville, Spain
2
Andalusian Public Foundation for Health Research Management in Seville. Seville, Spain
3
University of the Basque Country, Vitoria, Spain
4
Applied Economics Department. University of Granada, Granada, Spain
5
Andalusian School of Public Health, Granada, Spain
6
Pharmaceutical Care Research Group. University of Granada, Granada, Spain
7
Graduate School of Health. University of Technology Sydney, Sydney, Australia
8
Pharmacy Department. San Jorge University, Zaragoza, Spain
Corresponding author
José J. Martín
Facultad de Ciencias Económicas y Empresariales
Campus de Cartuja s/n, 18071,
Granada, Spain
Telephone number: +34 958249996
Fax: +34 958244046
E-mail: jmartin@ugr.es
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Abstract
Background
The concept of Pharmaceutical Care is operationalized through pharmaceutical professional services,
which are patient-oriented to optimize their pharmacotherapy and to improve clinical outcomes.
Objective
The objective of this study was to estimate the incremental cost-effectiveness ratio (ICER) of a
medication review with follow-up (MRF) service for older adults with polypharmacy in Spanish
community pharmacies, against the alternative of having their medication dispensed normally.
Methods
The study was designed as a cluster randomized controlled trial, and was carried out over a time horizon
of six months. The target population was older adults with polypharmacy, defined as individuals taking
five or more medicines per day. The study was conducted in 178 community pharmacies in Spain. Cost-
utility analysis adopted a health service perspective. Costs were in euros at 2014 prices and the
effectiveness of the intervention was estimated as QALYs. In order to analyze the uncertainty of ICER
results, we performed a nonparametric bootstrapping with 5,000 replications.
Results
A total of 1,403 older adults, aged between 65 to 94 years, were enrolled in the study: 688 in the
intervention group (IG) and 715 in the control group (CG). By the end of the follow-up, both groups had
reduced the mean number of prescribed medications they took, although this reduction was greater in the
IG (0.28±1.25 drugs; p<0.001) than in the CG (0.07±0.95 drugs; p=0.063). Older adults in the IG saw
their quality of life improved by 0.0528±0.20 (p<0.001). In contrast, the CG experienced a slight
reduction in their quality of life: 0.0022±0.24 (p=0.815). The mean total cost was €977.57±1.455,88 for
the IG and €1,173.44±3,671.65 for the CG. In order to estimate the ICER, we used the costs adjusted for
baseline medications and QALYs adjusted for baseline utility score, resulting in a mean incremental total
cost of €-250.51±148.61 (95% CI -541.79 to 40.76) and a mean incremental QALY of 0.0156±0.004
(95% CI 0.008 to 0.023). Regarding the results from the cost-utility analysis, the MRF service emerged as
the dominant strategy.
Conclusion
MRF service is an effective intervention for optimizing prescribed medication and improving the quality
of life in older adults with polypharmacy in community pharmacies. The results from the cost-utility
analysis suggest that MRF service is cost effective.
Key points for decision makers
- Polypharmacy is a particular concern in older adult populations, and is associated with negative
health outcomes.
- Medication review with follow-up is a service that attempts to optimize pharmacotherapy, not
just by focusing on the process of the use of medication, but also by improving clinical outcomes
for older adults.
- Medication review with follow-up service is an effective intervention for optimizing prescribed
medication and improving the quality of life of older adults with polypharmacy in community
pharmacies. Compared with usual dispensing, this service is cost effective.
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1 Introduction
In 2013, 18% of the Spanish population was older adults, conventionally defined as aged 65 or over. The
percentage was higher among the female (20%) than the male population (16%) [1]. As a result of
population aging, this percentage will represent 22% of the Spanish population in the next ten years (20%
of males and 24% of females) [2]. Older adults usually present a wider variety of health problems, and
therefore make more intensive use of medication than the rest of the population. This often leads to drug-
related problems (DRPs) [3]
and negative outcomes associated with medication (NOMs) [4].
Polypharmacy is a common phenomenon that increases with age. This increase in medication use is in
turn associated with increased morbidity. Although there are a wide range of definitions and different
situations associated with this phenomenon [5], the most widespread strategy is to target patients with
comorbidities who are using over five drugs or more [6].
Medication is the most widely used healthcare technology for dealing with health problems. In Spain,
public expenditure through official prescriptions in the National Health Service (NHS) amounted to
€9,183 million in 2013 [7]. Although this figure represents a 6% drop from previous years, such a high
level of expenditure requires methods to ensure the rational use of medication, to optimize the results
obtained from their use and to ensure that these medications actually do control health problems. Failures
in effectiveness and safety have a cost for the health of patients and also in terms of hospital admissions
and accident and emergency (A&E) department visits, appointments with general practitioners, and
increased pharmacological treatments.
The concept of pharmaceutical care promotes different pharmaceutical professional services, which are
patient-oriented in an attempt to optimize their pharmacotherapy [8,9]. Medication review with follow-up
(MRF) is a service in which the pharmacist evaluates patients' pharmacotherapies and intervenes in
collaboration with the general practitioner and the patients themselves, in order to ensure that therapeutic
goals are achieved. One of the main points of the MRF service is that it attempts to optimize
pharmacotherapy, not just by focusing on the process of the use of medication, but also by improving
clinical results for the patients. When pharmacists play a proactive role in performing medication reviews
and in the active education of other healthcare professionals, pharmacotherapy for older patients is
improved [10]. However, the evidence of the impact of pharmacists' interventions on health outcomes,
quality of life, or cost-effectiveness of care is mixed [11]. Few studies of pharmaceutical care programs
for older adults have undertaken a rigorous economic evaluation, and a more standardized approach to
data collection is required [12].
Based on this, a national research project, the conSIGUE Program, has been implemented to assess
clinical and economic impact of the MRF service for older adults with polypharmacy in Spanish
community pharmacies.
The objective of this study was to estimate the incremental cost-effectiveness ratio (ICER) of a MRF
service for older adults with polypharmacy in community pharmacies against the alternative of usual
dispensing.
2 Methods
2.1 Study design
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The study was designed as a cluster randomized controlled trial carried out over six months of follow-up.
It was conducted in community pharmacies in Spain from November 2011 to January 2013. The target
population comprised older adults, aged 65 or over, with polypharmacy, defined as individuals taking five
or more medicines per day. These five medicines are only prescription medication and over-the-counter
medicines (officially registered medications).
Sample size was calculated according to the results of a pilot study, conducted in the Spanish province of
Cádiz for one month. Taking into account the change in the number of medicines used that resulted from
the pilot study, 530 patients were required in each group in order to obtain significant results. However,
taking into account the cluster design and the confounding variables, 750 patients were required in each
group.
The pharmacists of the participant provinces were informed about the conSIGUE Program through the
Official College of Pharmacists, and voluntarily signed up to be included in the research study.
Pharmacies were allocated into either the intervention or the control group. Each pharmacy selected ten
patients who met the inclusion criteria: age of 65 or over and taking five or more officially registered
medicines.
Pharmacists allocated into the intervention group received a three-day off-site training course and on-site
visits by a facilitator during the six-month follow-up. The functions of the facilitator were assisting
pharmacists in the provision of the service and ensuring the quality and homogeneity of the interventions.
Pharmacists and patients had follow-up visits every 1.2 months, and pharmacists were not compensated
for providing MRF service in the conSIGUE Program.
The variables recorded to measure the economic and clinical outcomes of the MRF service provided in
community pharmacies to older adults with polypharmacy were: the number of used medicines, number
of uncontrolled health problems, health-related quality of life, number of visits to A&E departments,
number of hospital admissions, and ICER of the MRF service. The secondary objectives were to describe
the prevalence of DRPs and NOMs. Variables were recorded during the visits by the patient to the
pharmacy where they interacted with a pharmacist.
The study was approved by the Ethics Committee of the Virgen de las Nieves Hospital in Granada in
2009. All patients signed an informed consent before their inclusion in the study.
The study was carried out taking into account the recommendations of the proposed guidelines for
economic evaluation of health technologies in Spain [13], which have a high degree of consistency with
CHEERS criteria [14], and using data from the NHS. It estimated all identifiable costs to the NHS and
health outcomes in quality-adjusted life years (QALYs). The alternatives compared were intervention
group (IG), older adults who received MRF service in community pharmacies, and control group (CG),
older adults who received usual dispensing in community pharmacies).
2.2 Medication review with follow-up service
The Dader method for MRF service was developed by the Pharmaceutical Care Research Group at the
University of Granada, Spain [15]. The aim of the MRF service is to detect DRPs and to prevent and
resolve NOMs [16]. In the context of this service it is important to establish the conceptual differences
between the terms medication related problem and NOM [4]. A NOM is the result affecting the health of
the patient, which is or may be associated with the use of medications. Older adults in the IG received the
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MRF service as per the methodology agreed upon by a group of pharmaceutical care experts [3]. Table 1
shows the different phases of the MRF service. All sessions were conducted face to face.
Table 1 Phases of the medication review with follow-up service
Stage*
Timing
Description
First interview
First month
Patients took all the medication they were taking to the pharmacy and the
pharmacist asked them a series of questions to obtain information about their
health problems, clinical information about the control of health problems,
and drugs used by patients at the time of the interview. If patients had in
their possession any medical report, they brought them to the pharmacist.
Situation
assessment
First month
The pharmacist processed the information obtained from patients during the
interviews.
Study phase
First month
The pharmacist searched for information in the knowledge database of the
General Council of Pharmaceutical Associations of Spain (Bot PLUS) [17],
and in other sources of information (clinical practice guides, books, therapy
manuals etc.) to enable them to identify DRPs and NOMs.
Evaluation Phase
First month
The pharmacist identified DRPs and NOMs.
Definition of the
action plan
First month
The pharmacist agreed with patients on certain therapeutic objectives to be
reached regarding their pharmacotherapy, and suggested interventions to
patients and/or general practitioners to prevent, resolve, or improve the
identified DRPs and NOMs.
Intervention
phase
First month
The pharmacist went through with the interventions in the action plan.
Follow-up to
ascertain the level
of acceptance of
the interventions
and evaluate their
results
Second to
sixth month
The pharmacist obtained information about the acceptance or non-
acceptance of the proposed interventions by those affected (general
practitioners and/or patients). After this, the pharmacist obtained clinical
information about patients' health problems, about NOMs, and about the
elements of the process of use of the drugs (DRPs), and repeated the process
described for the MRF service.
Additional
contacts
Second to
sixth month
Additional contacts with the patient outside the scheduled contacts.
*Every interview was carried out face to face.
2.3 Control group
Older adults in the CG received usual dispensing in their community pharmacy.
2.4 Community pharmacies
The study was performed in 178 community pharmacies of four Spanish provinces: 64 in Guipúzcoa (34
in IG vs 30 in CG), 42 in Granada (24 in IG vs 18 in CG), 39 in Santa Cruz de Tenerife (16 in IG vs 23 in
CG) and 33 in Las Palmas de Gran Canaria (14 in IG vs 19 in CG).
