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Objective: To agree on a proposal for pharmaceutical interventions and establish their classification taxonomy according to the CMO-Pharmaceutical Care Model (Capacity-Motivation- Opportunity). Method: A study conducted between March and May, 2016. Two phases of development were defined. A literature review was initially conducted. Then, the DELPHI-Rand-UCLA methodology was used in order to reach a consensus about those interventions selected, and to define the taxonomy. Fifteen (15) experts, specialists in Pharmaceutical Care for HIV+ patients, were selected. This selection was explicitly conducted, following a protocol in order to avoid any bias. An initial proposal was developed according to the interventions extracted from Phase 1. These were tentatively classified according to the CMO Model, in a category based on their design and utility. Three issues were raised from the initial question: Do you agree with the proposed classification? If not, there was an option to re-categorize. Additionally, they were asked about the importance, priority and impact to achieve pharmacotherapeutic objectives that they would assign to it. Interventions were classified according to the degree of agreement. Once a consensus was reached, the final taxonomy was established. Results: Eighteen (18) articles were finally considered. The initial proposal included 20 pharmaceutical interventions with the following classification: seven in Capacity, eight in Motivation, and five in Opportunity. Those interventions considered to have greater importance and priority were: Review and Validation, Safety, and Adherence. The interventions with the greatest impact were: Review and Validation, Coordination, Adherence, and Motivation. On the other hand, the lowest scores for importance were for: Planning and Social Coordination; and in terms of impact: Social Coordination. Conclusions: The taxonomy reached by consensus will allow to classify pharmaceutical interventions with the new model, and therefore to conduct an improved research and patient care.
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Farm Hosp. 2016;40(6):544-568
Abstract
Objective: To agree on a proposal for pharmaceutical inter-
ventions and establish their classification taxonomy according
to the CMO-Pharmaceutical Care Model (Capacity-Motiva-
tion-Opportunity).
Method: A study conducted between March and May, 2016.
Two phases of development were defined. A literature review
was initially conducted. Then, the DELPHI-Rand-UCLA metho-
dology was used in order to reach a consensus about those
interventions selected, and to define the taxonomy. Fifteen
(15) experts, specialists in Pharmaceutical Care for HIV+ pa-
tients, were selected. This selection was explicitly conducted,
following a protocol in order to avoid any bias.
An initial proposal was developed according to the interven-
tions extracted from Phase 1. These were tentatively classified
according to the CMO Model, in a category based on their de-
sign and utility. Three issues were raised from the initial ques-
tion: Do you agree with the proposed classification? If not,
there was an option to re-categorize. Additionally, they were
asked about the importance, priority and impact to achieve
pharmacotherapeutic objectives that they would assign to it.
Interventions were classified according to the degree of agree-
ment. Once a consensus was reached, the final taxonomy was
established.
Results: Eighteen (18) articles were finally considered. The ini-
tial proposal included 20 pharmaceutical interventions with
the following classification: seven in Capacity, eight in Motiva-
tion, and five in Opportunity.
Resumen
Objetivo: Consensuar una propuesta de intervenciones farma-
céuticas y llevar a cabo su taxonomía de clasificación según el
modelo de Atención Farmacéutica-CMO (Capacidad-Motiva-
ción-Oportunidad).
Método: Estudio realizado entre marzo-mayo de 2016. Se de-
finieron dos fases de desarrollo. Inicialmente, se realizó una
revisión bibliográfica. A continuación, para consensuar las
intervenciones seleccionadas y definir la taxonomía se utilizó
metodología DELPHI-Rand-UCLA. Se seleccionaron 15 exper-
tos, especialistas en Atención Farmacéutica al paciente VIH+.
La selección se realizó explícitamente, siguiendo un protocolo
para evitar sesgos.
Se elaboró, inicialmente, una propuesta a partir de las inter-
venciones extraídas de la fase-1. Se clasificaron tentativamente
según el Modelo-CMO en una categoría según su diseño y
utilidad. Se plantearon tres preguntas a partir de la cuestión
inicial: ¿Está de acuerdo con la clasificación propuesta? En caso
negativo, se daba opción de recategorizar. Adicionalmente, se
planteó qué importancia, prioridad e impacto en la consecu-
ción de objetivos farmacoterapéuticos le daría.
Las intervenciones se clasificaron en función del grado de acuer-
do. Una vez consensuadas, se realizó la taxonomía definitiva.
Resultados: Se consideraron finalmente 18 artículos. La pro-
puesta inicial incluyó 20 intervenciones farmacéuticas clasifica-
das siete en Capacidad, ocho en Motivación y cinco en Opor-
tunidad.
ORIGINALES
Development of a taxonomy for pharmaceutical interventions in
HIV+ patients based on the CMO model
Desarrollo de una taxonomía de las intervenciones farmacéuticas en pacientes
VIH+ basados en el modelo CMO
Ramón Morillo Verdugo1, Andrea Lisbeth Villarreal Arévalo2,
María Álvarez de Sotomayor2 and María de las Aguas Robustillo Cortes1
1Unidad de Gestión Clínica de Farmacia. Hospital Universitario de Valme. AGS Sevilla-Sur. 2Facultad de Farmacia. Universidad
de Sevilla. Spain.
Artículo bilingüe inglés/castellano
* Autor para correspondencia.
Correo electrónico: ralejandro.morillo.sspa@juntadeandalucia.es (Ramón Morillo Verdugo).
Recibido el 24 de junio de 2016; aceptado el 14 de septiembre de 2016.
DOI: 10.7399/fh.2016.40.6.10567
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Development of a taxonomy for pharmaceutical interventions… Farm Hosp. 2016;40(6):544-568 - 545
Contribution to scientific literature
There is a need to reorientate the Pharmaceutical
Care model for HIV+ patients in our country; for this
aim, this article presents a new model of work based on
three basic cornerstones: patient stratification based on
their needs, motivation, and the opportunity to conduct
pharmacotherapeutical follow-up in any setting where
the patient is managed. After identifying the best phar-
maceutical interventions published over recent years,
the panel of experts involved has reached a consensus
regarding the taxonomy, which would include the inter-
ventions according to the model cornerstones.
During the next years, once this model is widespread,
the taxonomy designed and agreed upon will allow, on
one hand, to standardize the interventions to be con-
ducted in this type of patients, and on the other hand,
also to conduct comparisons based on the different stu-
dies designed to this aim in different patient care set-
tings and with different populations.
Introduction
In recent years, there has been a major transforma-
tion in terms of HIV infection: it was a lethal disease, but
now it is considered a chronic condition. Due to improve-
ments in therapeutic arsenal and patient care, currently
patients have a better survival and quality of life. Regar-
ding this higher life expectancy, and as a consequence
of ageing itself as well as of the pro-inflammatory factor
caused by HIV in the body, it is increasingly frequent in
this older population to present multiple conditions and
require more medication, which in some cases can even
become polymedication; this is forcing to a reconside-
ration of patient care models1. On the other hand, the
profile of the naïve patient who initiates treatment has
also been changing in recent years: typically these are
young patients, with a higher education level than pre-
vious patients, and a higher and better management of
new technologies2,3.
HIV has been, and still is, a “core” condition for Hos-
pital Pharmacy in Spain, regarding Pharmaceutical Care
(PhC) development. Since the first drugs dispensed in
Hospital Pharmacy Units arrived, HIV+ patient care has
represented a major challenge. The publication at the
start of the century of the first “Pharmaceutical Care Mo-
del for HIV patients” had a great impact on our profes-
sion4: on one hand, in order to set the basis of work for
the first decade of the century, and on the other hand,
because that model of work for HIV has been used as
a reference for other conditions, which have mirrored
what was done by specialists who conducted the phar-
macotherapeutical follow-up for this type of patients.
There have been many national and international ori-
ginal articles published since then, including systematic
reviews and meta-analyses, demonstrating the useful-
ness of the Hospital Pharmacist work for HIV+ patient
follow-up within a multidisciplinary team, improving the
health outcomes of these patients5,6. That model was
created by analyzing the challenge represented by the
first direct and periodical contact with patients in Phar-
macy Units, the desirable integration with the multidis-
ciplinary team, and the control of treatment efficacy; in
fact, the essential objective was to achieve an adequate
clinical control through the use of medications. This ob-
jective had to be achieved on the basis of three essential
cornerstones: information for patients, encouragement
of treatment adherence, and patient care integration.
Over a decade after that publication, with a comple-
tely different health environment, a different regulatory
setting for each autonomous community, and a patient
profile absolutely different to the one we faced at that
time, the PhC team for HIV+ patients of the Spanish
Society of Hospital Pharmacy (SEFH) decided to analyze
what was happening in terms of the structure of proces-
ses and outcomes of pharmacotherapeutical follow-up
for HIV patients. The outcomes of that “Origen” Pro-
ject, reached after the involvement of 86 hospitals, were
very revealing at showing that the traditional model had
Those interventions considered to have greater importance and
priority were: Review and Validation, Safety, and Adherence. The
interventions with the greatest impact were: Review and Valida-
tion, Coordination, Adherence, and Motivation. On the other
hand, the lowest scores for importance were for: Planning and
Social Coordination; and in terms of impact: Social Coordination.
Conclusions: The taxonomy reached by consensus will allow to
classify pharmaceutical interventions with the new model, and
therefore to conduct an improved research and patient care.
KEYWORDS
Pharmaceutical care; HIV; Stratification; Motivation; M-Health.
Farm Hosp. 2016;40(6):544-568
Las intervenciones consideradas de mayor importancia y prio-
ridad fueron: revisión y validación, seguridad y adherencia. Las
de mayor impacto fueron: revisión y validación, coordinación,
adherencia y motivación. Por contra, las de menor puntuación
en importancia fueron: planificación y coordinación social y, en
impacto, coordinación social.
Conclusiones: La taxonomía consensuada permitirá clasificar
las intervenciones farmacéuticas realizadas con el nuevo mode-
lo y, así, profundizar en la investigación y la mejora asistencial.
PALABRAS CLAVE
Atención farmacéutica; VIH, Estratificación; Motivación;
M-Salud.
Farm Hosp. 2016;40(6):544-568
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546 - Farm Hosp. 2016;40(6):544-568 Ramón Morillo Verdugo et al.
touched its ceiling and a new model should be reconsi-
dered7.
The drive and constant search for the best way to care
for this type of patients has resulted in a reconsideration
of the traditional model, that has been called “CMO”
because that was exactly the acronym for the three es-
sential characteristics in the classical model: Costs (the
main objective in the primary model), Medication (antire-
troviral) as the pivotal axis of our action, and the Organi-
zation (episodic in patient care) as the link with patients.
In order not to lose this connection with the past which
has somehow provided a fantastic professional growth,
with a clear impact on patient improvement, it has been
considered to use the same acronym, but with a radically
different foundation. Thus, we have Capacity (our care
orientation towards those patients who most require it,
in order to give them higher dedication and priority), Mo-
tivation (understood as the ability by patients to link their
short-term with their long-term objectives, and including
here a reinforcement of treatment adherence, and the
identification, prevention and management of drug ad-
verse effects), and Opportunity, defined as being close
to patients whenever they need it, and not exclusively
during their periodical visits to the specialized care units.
As an innovative and emerging PhC concept, there
is no study that classifies the best pharmaceutical inter-
ventions that have been historically published and con-
ducted based on this model, as well as their importance,
feasibility and prioritization.
The main objective of this study is to reach a consen-
sus about a proposal for pharmaceutical interventions,
and to establish their Classification Taxonomy based on
the CMO Model.
Method
A study conducted from March to May, 2016. Two
development phases were defined in order to reach its
objectives.
Initially, a bibliographic review was conducted on the
literature existing in PUBMED. For this aim, a list of words
was used, based on two key domains: “pharmaceutical
care” and “HIV”. The search was built using the conjunc-
tion “AND” and the disjunctive “OR” as logical opera-
tors, and including [(“pharmaceutical care” AND “HIV”
AND “Adherence” OR “patient compliance”) (“phar-
maceutical care” AND “HIV” AND “Chronic diseases”)
(“pharmaceutical care” AND “HIV” AND “motivation”)].
As search limitations, the study included exclusively
articles from clinical trials or research projects in Engli-
sh or Spanish from 2001 until today, which met the
following criteria: studies where pharmaceutical inter-
ventions were established for the improvement of any
health outcomes in HIV patients, or studies comparing
the utility and outcomes of different pharmaceutical in-
terventions in HIV patients.
Additionally, all those manuscripts where interven-
tions had not been conducted partially or totally by a
Pharmacist specialized in HIV were also excluded.
After identifying those articles adequate for inclusion,
the following information was extracted separately:
study design, number of patients included, interventions
(type and description), the study objective, its duration,
outcomes, and conclusions by the author.
As a complement for this search, the review included
any pharmaceutical interventions from the Model for
Selection and PhC for HIV and/or HCV Patients by the
SEFH8.
In the second phase, the DELPHI-Rand UCLA9 Metho-
dology was used in order to reach a consensus about the
interventions selected and establish the taxonomy. This
method, based on the synthesis of scientific evidence and
the collective judgment by a panel of experts, was used in
order to reach a consensus about pharmaceutical interven-
tions in HIV+ patients, with the aim to standardize those
actions with higher benefit for patients and their environ-
ment. For the objectives of this study, said methodology
consisted in the selection of a group of experts who were
asked their opinion about matters regarding future events
in the HIV area, and the pharmaceutical interventions for
the improvement in health outcomes. The general method
consisted of several rounds, where the questionnaire was
sent to a group of experts who answered the questions
anonymously. Then these survey results were tabulated
and sent back to the group. Subsequently, experts were
asked to answer the questionnaire again, with the objecti-
ve of reaching a consensus, but with maximum autonomy
for participants. This iterative process continued until there
was a convergence of opinion about the topic, or until no
significant change in answers occurred. Said methodology
was strictly followed in order to conduct our study.
A panel of 15 Hospital Pharmacy national experts was
selected; they should be involved and specialized in PhC
for HIV+ patients. A 20% loss rate was estimated and
accepted during the process.
Expert selection was conducted explicitly and fo-
llowing a previously established protocol, in order to
prevent any potential bias. The essential selection crite-
ria were, on one hand, objective: gender (at least a 50%
split between women and men), geographical diversity
(no more than 2 experts per autonomous community),
and real time availability after being aware of the work
methodology. On the other hand, subjective criteria
were also used: an acknowledged leadership, a wide
knowledge and interest in the topic, scientific attitude
and ability (at least one publication during the last year
about the topic of the study or their involvement in a
research project), ability to work within a team, lack of
rigid visions, and an intense level of motivation.
The research team prepared a draft questionnaire ba-
sed on the interventions extracted during the bibliogra-
phic review process. These interventions were tentatively
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Development of a taxonomy for pharmaceutical interventions… Farm Hosp. 2016;40(6):544-568 - 547
classified according to the CMO Model. Each interven-
tion was placed on a relevant category, based on its
design and utility; each intervention was described and
exemplified in order to be easily understood by experts.
Three questions were asked on the basis of the ini-
tial one; these were the same for each intervention, and
required a yes / no answer. The initial question was: Do
you agree with the proposed classification? If the answer
was negative, the respondent was given the option to
recategorize the intervention in another setting of ac-
tion within the model. Additionally, experts were asked
which importance and priority they would assign to this
intervention in order to conduct an adequate therapeu-
tic follow-up; a 1 to 10 scale was used, with 1 as the
lowest and 10 as the highest scores. Finally, based on
the previous experience of the reviewer, they were asked
about the impact of this intervention on the achieve-
ment of pharmacotherapeutical objectives by patients
(with 1 as the lowest and 10 as the highest scores).
Lastly, a section was also included for respondents
to suggest or put forward any other initiative that they
considered of interest for this category, and that had
not been included in the questionnaire presented. These
questionnaires were e-mailed to the panel of experts, af-
ter their acceptance to participate. Once the first round
of the Delphi Questionnaire had been answered by the
panel of experts, their answers were analyzed through
descriptive statistics. The interventions were classified
in terms of the level of agreement according to the fo-
llowing definitions: adequate (median 7-10), dubious
(median 4-6 or any median with disagreement), inade-
quate (median 1-3). Once consensus was reached, the
final taxonomy was established. The number of rounds
depended on when the agreement was reached.
The study was approved by the South Seville Research
Ethics Committee.
Results
In total, 283 articles were obtained from the biblio-
graphic review. Out of these, 230 articles were exclu-
ded because the inclusion and exclusion criteria had not
been met. The reasons for exclusion were: Pharmacoki-
netics and Pharmacodynamics studies (21), interventions
not conducted by a Hospital Pharmacist (19), pharma-
coeconomic analysis studies (18), studies where it was
not specified who conducted the intervention (16),
studies about opportunistic diseases (13), prevention
(12), studies on prophylaxis (9), studies conducted on
the community pharmacy (8), Pharmacovigilance (4),
psychosocial problems (3), Pharmacogenomics (1) and
other non-relevant interventions (47) (Figure 1).
There was a pre-selection of 53 articles which were
considered to be within eligibility criteria. From these,
once evaluated by the research team, 13 were excluded
because the intervention had not been conducted by
Pharmacists, or their role was not clear, 10 due to lack
of definition and specificity of the intervention, 7 where
the intervention outcomes showed no utility, and 5 due
to other causes. Finally, 18 articles in total were included,
which met eligibility criteria and were adequate for the
research. Their characteristics are detailed in table 1.
Figure 1. Bibliography re-
view and inclusion of stu-
dies.
Included Elegibility Screening Identication
Search in PUBMED
“Pharmaceutical Care”
AND “HIV” AND
“Adherence” n=207
Search in PUBMED
“Pharmaceutical Care”
AND “HIV” AND
“Chronic diseases”
n=60
Search in PUBMED
“Pharmaceutical Care”
AND “HIV” AND
“Motivation”
n=16
Excluded n=230
* Editorial: 53
* Not specied who conducts
the intervention: 16
* Study not conducted by the
Pharmacist: 19
* Pharmacoeconomic: 18
* Pharmacokinetics and
Pharmacodynamics: 21
* Pharmacovigilance: 4
* Prophylaxis: 9
* Opportunistic diseases: 13
* Pharmacogenomics: 1
* Pharmaceutical industry: 6
* Prevention: 12
* Studies conducted in the
Community Pharmacy: 8
* Phychosocial problems: 3
* Other interventions: 27
* Repeated: 20
Studies included n=18
Total studies identied n=283
Articles assessed for elegibility
n=53
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548 - Farm Hosp. 2016;40(6):544-568 Ramón Morillo Verdugo et al.
Table 1. Bibliographic Review – Pharmaceutical Interventions in HIV+ Patients
Title Authors, year Type of
study
No. Of
participants Interventions Objective Time Conclusions
Impact of a
pharmaceutical
care program on
clinical evolution
and antiretroviral
treatment
adherence:
a 5-year study.
Hernández
Arroyo MJ;
et al. 20135
Retrospective 528 patients
Clinical record assessment at
the start of PhC. To examine
potential lab test alterations
and potential ART
interactions. Information
on HIV and its treatment.
Personalized dosing
schedule.
To determine the impact
of the implementation
of a PhC program in
the improvement of
ART adherence and
immunovirological
response of patients.
60
months
Outcomes suggest that
the development and
maintenance of a PhC
program can increase ART
adherence, and maintain an
undetectable viral load and
an adequate CD4+ count.
Concurrent use
of comedications
reduces adherence
to antiretroviral
therapy among HIV-
infected patients.
Cantudo
Cuenca, MR,
et al. 201413
Observational
prospective
594 patients
Keeping records of
medication dispensing and
adherence. Calculating the
therapeutic index of ART
complexity. Determining the
risk of DRPs based on the
Predictive Index.
To determine
the influence of
comorbidities and
concomitant drugs on
antiretroviral treatment
adherence among HIV-
infected patients.
12
months
The increase in
polymedicated HIV patients
increases the risk of lack of
adherence. Besides, the use
of intravenous drugs and a
high value in the “Predictor”
Index were associated with
lower adherence.
Improving
adherence to
antiretroviral
treatment in
Uganda with a low-
resource facility-
based intervention.
Obua C,
et al. 201417
Intervention
and Cohort
Study
1481 patients
720 pre-treated
761 Naïve
Developing a fast-
appointment system and
providing the medication
required for longer periods,
particularly for patients with
controlled disease.
To assess the effects
of the interventions
implemented upon
the improvement of
overall patient care and
adherence to ART.
17
months
Patient adherence was
improved with the simple
interventions implemented,
without an increase of the
resources or costs required.
An interdisciplinary
HIV-adherence
program combining
motivational
interviewing
and electronic
antiretroviral drug
monitoring.
Krummenacher I,
et al. 201118 Retrospective 104 patients
MEMS Adherence
Monitoring System, semi-
structured interviews, and
individual motivation based
on cognitive, emotional,
behavioural and social
problems.
To analyze the impact
of developing a
multidisciplinary
program for improving
adherence.
44
months
High rates of program
retention and persistence,
and an increase in patients
with undetectable viral load
was detected.
Evaluating the Effects
of an Interdisciplinary
Practice Model
with Pharmacist
Collaboration on
HIV Patient Co-
Morbidities.
Cope R, et al.
201519
Cohorts,
retrospective
96 patients
A set of interventions
focused on follow-up
of clinical parameters:
glycosylated haemoglobin,
LDL, and hypertension
Control of diabetes,
hypertension and
hyperlipidemia in HIV
patients.
18
months
Pharmacist involvement in
HIV patient care seems to
lead to a more adequate
management of chronic
comorbidities which is cost-
effective.
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Table 1 (cont.). Bibliographic Review – Pharmaceutical Interventions in HIV+ Patients
Title Authors, year Type of
study
No. Of
participants Interventions Objective Time Conclusions
Integration among
hospital pharmacists
and infectious
diseases physicians
in the outpatient
management of HIV
infection.
Appolloni L, et
al. 201420
Observational
prospective 659 patients
Analysis through a survey of
self-reported adherence, the
use of concomitant drugs
or diet supplements, and
the development of adverse
effects.
To assess the
improvement in patient
adherence, and to
watch and point
out immediately any
side effects after the
implementation of
a program based on
Pharmacist integration.
3 months
A multidisciplinary approach
among pharmacists and
physicians can improve
adherence and follow-up
of side effects, optimizing
the management of HIV+
patients.
Randomized
controlled trial to
evaluate the impact
of pharmaceutical
care on therapeutic
success in HIV-
infected patients in
Southern Brazil.
Silveira MP, et al.
201421
Non-blind,
randomized
and
controlled
clinical trial.
332 patients
Counselling about
prescription and at the time
of dispensing. Review of
prescription, scheduling
the next appointment.
Information about the side
effects of their medications.
PhC could improve
the overall adherence,
particularly in those
patients with low
adherence or detectable
viral load.
12
months
PhC is not associated with
an increase in self-reported
adherence or the number of
patients with undetectable
viral load. It might be
interesting and effective in
sub-groups of patients with
low adherence.
Predictors of non-
adherence to clinical
follow-up among
patients participating
in a randomized trial
of pharmaceutical
care intervention in
HIV-positive adults in
Southern Brazil.
Silveira MP, et al.
201422 Clinical trial 332 patients
Counselling about
prescription and at the time
of dispensing. Review of
prescription, scheduling
the next appointment.
Information about the side
effects of their medications.
To examine the non-
adherence rate during
clinical follow-up, and
the potential predictors
for lack of adherence
among patients
included in the clinical
trial.
12
months
Young male patients
can benefit more of
the implementation of
Pharmaceutical Care
Programs that encourage
self-care.
The clinical utility
of HIV outpatient
pharmacist
prescreening to
reduce medication
error and assess
adherence.
Seden K, et al.
201323
Observation
for the
prospective
study
200 patients
Consultation with the
Pharmacy Unit including a
complete review of patient
medication, including
OTC and healthcare store
products and medicinal
plants, evaluation of
interactions and of
treatment adherence.
Evaluation of the complexity
perceived by patients.
To evaluate if the
interventions conducted
by a Pharmacist,
including complete
medication review,
interactions and
adherence, have a
beneficial impact on
HIV+ patient care.
22
months
Patients with two or
more concomitant drugs
will benefit more of
the implementation of
interventions.
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550 - Farm Hosp. 2016;40(6):544-568 Ramón Morillo Verdugo et al.
Table 1 (cont.). Bibliographic Review – Pharmaceutical Interventions in HIV+ Patients
Title Authors, year Type of
study
No. Of
participants Interventions Objective Time Conclusions
Feasibility and
reliability of
interactive voice
response assessment
of HIV medication
adherence: research
and clinical
implications.
Hettema JE,
et al. 201224 Prospective 63 patients
Participants should
communicate their daily
adherence during 2 weeks
in the voice system. The
feasibility of the system
was analyzed and,
retrospectively, compared
with the self-reported
adherence data obtained
during previous follow-up.
A pilot study intended
to assess the feasibility
and reliability of an
Interactive Voice
Response System (IVR)
for assessing treatment
adherence.
1 month
The feasibility of these new
promising systems should be
improved. Besides, further
studies should be conducted
with another comparator
for adherence measurement
which is more adequate and
representative.
Development and
validation of a
predictive model for
the identification
of HIV-infected
patients with Drug
Related Problems: E.
PREDICTOR
Morillo Verdugo
R, et al. 201225
Prospective,
multicenter,
open.
733 patients
Periodic
pharmacotherapeutical
follow-up in the PhC
consultations at the
Pharmacy Units in the
hospitals included.
To develop and validate
a predictive model for
detecting drug related
problems (DRPs) in HIV
patients on antiretroviral
treatment.
4 months
The model developed
and validated allows the
detection of those patients
on antiretroviral treatment
at higher risk of developing
a DRP.
Impact of HIV-
specialized
pharmacies on
adherence and
persistence with
antiretroviral therapy.
Murphy P, et al.
201226
Retrospective,
comparative
study of
healthcare
intervention
7064 patients
Review of medication,
evaluation of adherence,
ease in drug access and
improvement in their
availability.
To assess and compare
the adherence and
persistence with ART by
patients who use HIV-
specialized pharmacies
vs. traditional
pharmacies.
12
months
HIV-specialized community
pharmacies can be effective
means to help patients
achieve a better adherence
and persistence with ART.
Pharmacists’
strategies for
promoting
medication
adherence among
patients with HIV.
Kibicho J, et al.
201127
Qualitative,
multicenter,
descriptive.
19
Pharmacists
Semi-structured interview to
participants.
To document the
experience of
pharmacists and provide
a perspective about
adherence barriers
for HIV patients and
describe the strategies
to improve it.
2 months
Further research is required
on the efficacy and cost-
efficacy of interventions
by Pharmacists in clinical
practice, with the aim
to reach a consensus on
reimbursement policies.
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Table 1 (cont.). Bibliographic Review – Pharmaceutical Interventions in HIV+ Patients
Title Authors, year Type of
study
No. Of
participants Interventions Objective Time Conclusions
Using different
calculations of
pharmacy refill
adherence to predict
virological failure
among HIV-infected
patients.
Boer IM, et al.
201028 ______ 201 patients
The adherence calculation
was analyzed through data
provided by the pharmacies
where patients collected
their medication. Assessing
the surplus medication and
the interruptions to the
treatment prescribed.
To analyze the feasibility
of data collection in
pharmacies. To analyze
the impact of surplus
medication and time of
treatment prescribed on
adherence calculation.
12
months
It is important for those
studies using this method
of adherence measurement
to consider the surplus
medication.
Improving adherence
and clinical
outcomes through
an HIV pharmacist’s
interventions.
Ma A,
201029
Retrospective 75 patients
Optimizing the new
antiretroviral regimens
in order to improve
immunological response
and reduce adverse effects
to the minimum, as well
as improving adherence by
reducing the number of pills
and/or the dosing frequency.
To research the clinical
outcomes of a clinical
pharmacist in the
Kaiser Permanente
Program, based on the
experience with drugs,
in order to provide
recommendations for
change in antiretroviral
regimen.
24
months
Clinical pharmacists can play
a major role in optimizing
adherence and improving the
clinical outcomes of patients.
Assessment of a
Pharmaceutical Care
Program to improve
adherence to
antiretroviral therapy
Codina C,
et al.
200428
Multicenter,
observational,
prospective.
541 patients
Previous basal visit and 4
visits every three months.
Adherence estimation is
based on pill count. An
adherence 95% was
considered adequate (at two
timepoints).
To determine the impact
of a Pharmaceutical
Care Program on
the improvement of
adherence to ART
treatment and the viro-
immunological status of
the patient.
12
months
Confirmation of the
need to incorporate
pharmacotherapeutical
follow-up programs
for patients on active
antiretroviral treatment, in
order to optimize benefits.
Pharmaceutical care
for HIV patients on
directly observed
therapy.
Foisy MM,
201430
Prospective
healthcare
intervention
study
57 patients
DRP identification and
management, counselling
to physicians in terms of
selection of initial therapies
and rescue regimens for
patients with therapeutic
failure, advice on medication
for patients, clinical
interview with patients,
direct observation of
treatment follow-up and lab
parameters and adherence.
To describe the
development and
provision of a
pharmaceutical care
program for patients
with directly observed
therapy (DOT), as well
as detection of drug-
related problems (DRPs)
and their respective
outcomes.
14
months
In PhC for HIV patients with
DOT, the Pharmacist offered
a significant contribution to
the initial selection, follow-
up and DRP management
during antiretroviral
treatment. Besides, they can
help in the promotion of
patient adherence, and in
the improvement in health
outcomes.
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Table 1 (cont.). Bibliographic Review – Pharmaceutical Interventions in HIV+ Patients
Title Authors, year Type of
study
No. Of
participants Interventions Objective Time Conclusions
Pharmaceutical
services in an HIV
clinic.
Geletko SM,
200231
Prospective
healthcare
intervention
study
70 patients
Interventions for
pharmacotherapy
optimization, adverse
effect identification and
management, information
and advice about treatment,
recommendations on clinical
parameter monitoring,
identification of interactions,
and management of
referrals to another hospital
unit.
Quantitative assessment
of the interventions
conducted by
pharmacists in HIV+
patients.
48
months
The interventions by
pharmacists in HIV+ patients
improve adherence and
guarantee clinical benefits in
terms of health.
Therefore, the initial proposal was formed by twenty
pharmaceutical interventions extracted from the articles
selected and preliminarily classified by the research team,
according to the essential cornerstones of the CMO mo-
del. Seven interventions were assigned to Capacity, ei-
ght to Motivation and five to Opportunity. Besides, each
intervention was described and exemplified to facilitate
their understanding by experts.
Finally, 13 experts participated in the Delphi round.
Figure 2 shows the level of acceptance by the experts
of the interventions proposed. From the total, 15 inter-
ventions were accepted by 13 experts (100%), 4 inter-
ventions by 12 (92%). 1 intervention by 11 (85%) and
1 intervention by 10 (77%) of the survey participants.
Consensus was reached in one single round.
The interventions acknowledged with the higher im-
portance and priority were, with a score of 10, Review
and Validation, Safety and Adherence. The interventions
with the highest impact, equally assigned a score of 10,
were Review and Validation, Coordination, Adherence
and Motivation. On the contrary, those with the lowest
score in the Importance section were Planning and Social
Coordination; and in the Impact section, Social Coordi-
nation, with a score of 7 (Figure 3).
Table 2 shows the final taxonomy developed.
Discussion
This study presents, for the first time, a taxonomy for
pharmaceutical interventions based on an innovative
Pharmaceutical Care model.
The definition and development of PhC for HIV+ pa-
tients have been adapting to the changes at care and
pharmacotherapeutical level; currently it has become a
key element in the activity of the majority of hospitals in
our country10. Though the current level of PhC in Spain is
acceptable, according to the different studies published,
it is still far from reaching the levels of quality and, most
of all, homogeneity, which would be desirable11.
For this reason, it will be very helpful in the future
to reorientate the work model based on the three cor-
nerstones proposed, as well as being able to reconcile
and reach a consensus regarding the main interventions
that must be conducted, and prioritize the most relevant
ones depending on the type of patient managed. This
will also allow to maximize patient health outcomes, and
the pharmaceutical contribution for achieving pharma-
cotherapeutical objectives in this type of patients.
Needless to say, new methods for the development
of this new model will be required. The recent “Model
for Patient Selection and Stratification”, created by the
Work Group on PhC for HIV patients from the SEFH, is
particularly important8. With a pyramidal approach, this
work tool allows us to stratify patients into three levels:
basal, medium and primary, in an increasing order of
PhC needs due to the risk of not achieving pharmaco-
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therapeutical objectives. This is precisely another of the
great changes in the model: talking about pharmaco-
therapeutical objectives, instead of the traditional term
Drug-Related Problems (DRPs), or the prioritization of
pharmacoeconomic costs. The model includes different
variables, not only associated with drug therapy (total,
not only antiretroviral), but also demographical, social,
and in terms of cognitive and functional status and use
of healthcare resources. The interventions identified in
the Capacity section are precisely based on the use of this
tool and this approach of review, validation and planning
of pharmacotherapeutical objectives in patients, which
should be collated in order to confirm their compliance
or not at each point where PhC is conducted. Given that
the traditional interventions have received the highest
priority in terms of importance, i.e. review of antiretro-
viral treatment, safety and adherence, the basis of the
traditional model is already well established; but it is ne-
cessary to provide a different approach to the follow-up
perspective, in order to review and validate the complete
drug therapy permanently, particularly in polymedicated
patients, following current recommendations12.
Secondly, the Motivation cornerstone forces us to
take a qualitative jump in our relationship with patients.
To this aim, the essential tool will be communication,
and most of all, the interview. However, an advance is
necessary, because from the traditional clinical interview,
widely used in the search for DRPs, we must move on to
a motivational interview approach. This should include
two essential aspects in order to coordinate the interven-
tions proposed, regarding safety, commitment, and the
traditional assessment of treatment adherence. These
aspects are: the ability to generate “internal discrepan-
cies” in our patients, and the ability to “face resistan-
ces” regarding the basal situation and the one expected
to be achieved with this type of patients through PhC.
Particularly in polymedicated HIV+ patients, where there
is a low adherence to concomitant medication, and an-
tiretroviral treatment can have some impact13, this new
approach will be very helpful for polypharmacy mana-
Figure 2. Level of interven-
tion acceptance in each ca-
tegory proposed.
Participants
Sub-category Code
Yes
No
Figure 3. Median scores
obtained for each inter-
vention proposed.
Median
Importance and priority
assigned to this intervention
Impact this intervention
would have
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554 - Farm Hosp. 2016;40(6):544-568 Ramón Morillo Verdugo et al.
gement. However, the low availability of tools to assess
patient motivation is very striking; the “Patient Activa-
tion Measure” questionnaire, not specific for the HIV
population, is one of the few tools that can be used for
this aim14. However, specific tools should be developed
in this setting for the HIV+ population.
Equally, the traditional concept of adherence assess-
ment should be expanded in order to include the new
primary and secondary adherence approach. Now, pri-
mary adherence is the one that occurs since treatment
prescription and until the first 14 days after prescription;
and secondary adherence, the one which we have tradi-
tionally assessed, is the one analyzed since patients have
the treatment in their hands. The study by Gómez E et al
has already pointed out that there could be up to a 33%
lack of primary adherence in HIV+ patients15.
Table 2. Final Taxonomy of Pharmaceutical Interventions in HIV+ patients according to the CMO model.
Category Code Name Sub-category
CAPACITY
1.1 Review and validation. Review and validation of the antiretroviral treatment.
1.2 Concomitant review and
validation.
Review of concomitant medication (self-medication, alternative
medicine, etc.) and monitoring of all potential interactions, offering
the clinician a therapeutic alternative for concomitant medication
whenever possible.
1.3 Review of objectives
To establish a circuit for managing and addressing those objectives not
achieved with medication.
Interactions
Adverse reactions
Medication errors
Adherence
Others
1.4 Coordination Unification of criteria among the different healthcare professionals and
levels of care.
1.5 Referral Considering the potential referral to other professionals.
1.6 Planning Planning the next visit to the Outpatient Unit in coordination with their
Infectious Disease Specialist or with the Patient Appointment Unit.
1.7 Reconciliation Reconciliation of pharmacological treatment at admissions /
discharges.
MOTIVATION
2.1 Safety Treatment safety follow-up.
2.2 Special follow-up Special follow-up for high risk medications.
2.3 Adherence Adherence follow-up, and establishing the most effective strategy in
order to improve it, both for ART and for concomitant medication.
2.4 Motivation Motivating patients and keeping them informed.
2.5 Co-responsibility Encouraging co-responsibility for treatment outcomes (preventing
virological failure at 48 weeks).
2.6 Commitment
Understanding the level of knowledge by the patient of the treatment
prescribed, in order to solve any subsequent doubts about their
disease, treatment, infection ways, etc.
2.7 Information Information about the importance of adherence and current and/or
potential interactions with other medications.
2.8 Encouragement Encouraging a healthy lifestyle. (Advice.)
OPPORTUNITY
3.1 Fast Communication Developing fast ways of communication with patients and their family
and caregivers.
3.2 Transversal follow-up Special follow-up of patients in their contact with the health system
(Primary Care, ER, hospitalization, and community pharmacy).
3.3 Transversal training Developing specific training tools or actions to reinforce critical aspects
associated with treatment / disease.
3.4 Social Coordination Coordination with social services or with the hospital Psychology and
Psychiatry Units.
3.5 Active Coordination Coordination with patient associations.
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Finally, the concept of Opportunity forces us to think
that we are no longer working for hospitals, but from
hospitals. Or to put it differently: that PhC is no longer
face-to-face, and that for this we will need Information
and Communication Technologies (ICTs) and Informa-
tion and Knowledge Technologies (IKTs), in order to face
patient needs; and this will also appear outside our con-
sultations. There are a high number of experiences de-
monstrating the contribution of value from these tools
for the patients in the overall population, also the elder-
ly, and particularly those with multiple conditions and
polymedication. These experiences range from the most
simple, with SMS sent to mobile phones or Apps for
gamification, to more complex experiences such as the
“expert HIV patient 2.0”, with initial results in terms of
satisfaction by users incorporated to this learning model,
based on patients sharing their experiences16.
The present study presents some limitations; firstly,
the sensitivity of outcomes to the potential ambiguity
of questions. For this aim, the terms Importance, Priority
and Impact were clearly defined, so that all experts could
classify their interventions and standardize their answers
as much as possible. Equally, in order to determine the
level of experience of the panel members, there was a
clear determination of the minimum characteristics re-
quired in terms of professional orientation, publications,
and participation in national work groups. Finally, the
fact of using a qualitative analysis method could lead
to an excessive trust evaluation in the judgment by the
experts, tending to be less accurate than other quanti-
tative methods.
Once the taxonomy has been obtained, the priority
will be to conduct prospective studies demonstrating its
utility at the time of conducting an optimal follow-up for
this type of patients, and how to incorporate it to the
comprehensive and multidisciplinary care for this type of
patients. At the same time, future studies will allow to
understand which interventions are most frequent, and
the health outcomes obtained by a systematic use of
these interventions. Also, if necessary, these will allow
to adapt the interventions to future changes in patient
care. It is also a priority to conduct the validation and
adaptation of the taxonomy in other type of conditions.
For all this, a new line of research is suggested: the
incorporation in patient care of the taxonomy for phar-
maceutical interventions in HIV patients according to the
CMO model, and the assessment of their importance,
relevance and feasibility in HIV+ patient follow-up in real
clinical practice. At the same time, with the differences
required for other conditions, the utility of this work me-
thodology in other Pharmacy areas should be assessed.
Summing up, the taxonomy agreed upon by consen-
sus and presented here will allow to classify the phar-
maceutical interventions conducted with the new PhC
model in HIV+ patients and, thus, to improve research
and patient care for this type of patients.
Acknowledgements
This study would not have been possible without the
generous collaboration of all the Pharmacy Specialists
who were part of the expert panel for the development
of the Delphi methodology. We would like to thank each
one for their effort. Herminia Navarro Aznárez. Hospital
Pharmacist. Pharmacy Unit - Hospital Universitario Mi-
guel Servet, Zaragoza (Aragon). Aitziber Illaro Uranga.
Hospital Pharmacist. Pharmacy Unit - Hospital Univer-
sitario Marqués de Valdecilla, Santander (Cantabria).
Purificación Cid Silva. Hospital Pharmacist. Pharmacy
Unit - CHUAC - Xerencia Xestión Integrada, A Coruña
(Galicia). Emilio Molina Cuadrado. Hospital Pharmacist.
Pharmacy Unit - Hospital Torrecárdenas, Almeria (Anda-
lusia). José Manuel Martínez Sesmero. Hospital Pharma-
cist. Pharmacy Unit - Complejo Hospitalario de Toledo,
(Castille-La Mancha). Javier Sánchez-Rubio Ferrández.
Hospital Pharmacist. Pharmacy Unit - Hospital Univer-
sitario de Getafe (Madrid). Sergio Fernández Espinola.
Hospital Pharmacist. Pharmacy Unit - Hospital de An-
tequera, Málaga (Andalusia). Raúl Ferrando Piqueres.
Hospital Pharmacist. Pharmacy Unit - Hospital General
de Castellón (Valencia). Luis Carlos Fernández Lisón.
Hospital Pharmacist. Head of Pharmacy Unit - Complejo
Hospitalario de Cáceres (Extremadura). Mª Paz Valverde
Merino. Hospital Pharmacist. Pharmacy Unit - Hospital
Universitario de Salamanca (Castille and León). Mª José
Huertas Fernández. Hospital Pharmacist. Pharmacy Unit
- Hospital Universitario Puerta del Mar, Cádiz (Andalu-
sia). Alicia Lázaro López. Hospital Pharmacist. Pharmacy
Unit - Hospital Universitario de Guadalajara (Castille-La
Mancha). Gador Callejón Callejón. Hospital Pharmacist.
Pharmacy Unit - Hospital Universitario La Candelaria, Te-
nerife (Canary Islands).
Funding
This document has not received any funding for its
design and development.
Conflict of Interests
None
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Contribucion a la literatura científica
Una vez identificado la necesidad de reorientar el
modelo de Atención Farmacéutica al paciente VIH+ en
nuestro país, el presente artículo presenta un nuevo mo-
delo de trabajo basado en tres pilares básicos como son
la estratificación de pacientes en base a sus necesidades,
la motivación y la oportunidad de llevar a cabo el se-
guimiento farmacoterapéutico independientemente del
lugar donde se encuentre el paciente. Una vez identifica-
das las mejores intervenciones farmacéuticas publicadas
a lo largo de los últimos años, el panel de expertos que
ha participado en el mismo ha consensuado la taxono-
mía en las que se incluirían las intervenciones según los
pilares del modelo.
En los próximos años, una vez que el modelo se ex-
tienda, la taxonomía diseñada y consensuada permitirá,
por una parte, homogeneizar las intervenciones a llevar
a cabo en este tipo de pacientes. Por otra parte, también
realizar comparaciones en base a los diferentes estudios
que se diseñaran al efecto en diferentes entornos asis-
tenciales y sobre diferentes poblaciones.
Introducción
En los últimos años la infección por VIH ha sufrido una
importante transformación, pasando de ser una enfer-
medad letal a considerarse una patología crónica. Fruto
de las mejoras en el arsenal terapéutico y en la asistencia
sanitaria, actualmente los pacientes tienen una supervi-
vencia y calidad de vida mayor. En relación a esa mayor
expectativa de vida y consecuencia, tanto del propio en-
vejecimiento como del factor proinflamatorio que ejerce
el VIH en el organismo, en la población de edad más
avanzada cada vez es más frecuente la aparición de plu-
ripatologías y comedicación, que en algunos casos llega
a ser polimedicación, lo que está obligando a replantear
los modelos de asistencia sanitaria1. Por otra parte, el
perfil del paciente naive que se incorpora a tratamiento
en los últimos años también ha ido cambiado. Siendo,
habitualmente, paciente jóvenes, con un nivel educacio-
nal mas alto de lo que tradicionalmente se había tenido
y un mayor y mejor manejo de las nuevas tecnologías2,3.
Para la Farmacia Hospitalaria en España el VIH ha sido
y es, actualmente, una patología “troncal” en cuanto al
desarrollo de la Atención Farmacéutica (AF). Ya desde
la llegada de los primeros fármacos de dispensación en
los Servicios de Farmacia de los hospitales, la atención
a estos pacientes supuso un gran reto. La publicación,
a principios de siglo, del primer “Modelo de Atención
Farmacéutica a pacientes con VIH” tuvo una importan-
te repercusión en nuestra profesión4. Por una parte, por
poner las bases de trabajo para la primera década del
siglo y, por otra, porque ese modelo de trabajo en VIH
ha servido de referencia para otras patologías, que han
tenido como espejo lo llevado a cabo por los especialis-
tas que realizaban el seguimiento farmacoterapéutico a
este tipo pacientes.
Son muchos ya los trabajos originales publicados desde
entonces, nacionales e internacionales, incluidos revisio-
nes sistemáticas y metanálisis, que demuestran la utilidad
de la labor del farmacéutico de hospital en el seguimien-
to del paciente VIH+, dentro del equipo multidisciplinar,
mejorando los resultados en salud de estos pacientes5,6.
Aquel modelo nació del análisis del reto que suponía por
primera vez el contacto directo y periódico con pacientes
en consultas de farmacia, la deseada integración con el
equipo multidisciplinar y el control de la eficiencia de los
tratamientos, de hecho, el objetivo fundamental era lo-
grar un adecuado control clínico a través del uso de los
medicamentos. Ese objetivo debía alcanzarse en base a
tres pilares fundamentales: la información a los pacientes,
el estímulo de la adherencia y la integración asistencial.
Más de una década después de aquella publicación,
con un entorno sanitario totalmente diferente, un mar-
co normativo diverso según las diferentes comunidades
autónomas y un perfil de paciente absolutamente dife-
rente al que nos enfrentábamos en aquel momento, el
grupo de trabajo de AF al paciente VIH+ de la Socie-
dad Española de Farmacia Hospitalaria (SEFH), decidió
analizar qué estaba pasando en relación a la estructura
procesos y resultados del seguimiento farmacoterapéu-
tico al paciente VIH. Los resultados de aquel proyecto,
llamado “Origen”, obtenidos tras la participación de 86
hospitales fueron muy reveladores respecto a que el mo-
delo tradicional había tocado techo y la necesidad de
replantear un nuevo modelo7.
El empuje y la búsqueda constante de la mejor for-
ma de atender a este tipo de pacientes ha tenido como
consecuencia un replanteamiento del modelo clásico, al
que se ha bautizado como modelo “CMO”, porque pre-
cisamente esas fueron las siglas de las tres características
fundamentales del modelo clásico: los costes (objetivo
principal del modelo primario), el medicamento (antirre-
troviral) como eje pivotal de nuestra actuación y la orga-
nización (episódica en la asistencia) como enlace con el
paciente. Para no perder el vínculo con el pasado, que,
a pesar de todo, ha proporcionado un fantástico creci-
miento profesional, con una repercusión clara en la me-
jora a los pacientes, se ha considerado el utilizar las mis-
mas siglas pero con unos pilares radicalmente diferentes.
Así surge la Capacidad (nuestra orientación asistencial
hacia aquellos pacientes que más lo necesitan para dar-
les una mayor dedicación y prioridad), la Motivación (en-
tendida como la capacidad que tienen los pacientes de
ligar sus objetivos a corto con sus objetivos a largo plazo.
Incluyendo aquí, el refuerzo de la adherencia y la iden-
tificación, prevención y manejo de los efectos adversos
a los fármacos) y la Oportunidad, definida como estar
cerca de los pacientes cuando los pacientes lo necesitan
y no exclusivamente el tiempo que pasan por consultas
de atención especializada de forma periódica.
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558 - Farm Hosp. 2016;40(6):544-568 Ramón Morillo Verdugo et al.
Como concepto de AF innovadora e incipiente no
existe ningún estudio que clasifique las mejores inter-
venciones farmacéuticas que históricamente se han
publicado y llevado a cabo, en base a este modelo, así
como su importancia, factibilidad y priorización.
El objetivo principal de este estudio es consensuar
una propuesta de intervenciones farmacéuticas y llevar
a cabo su taxonomía de clasificación en base al modelo
CMO.
Método
Estudio realizado entre marzo y mayo de 2016. Para
llevar a cabo los objetivos del mismo se definieron dos
fases de desarrollo.
En primer lugar, se realizó una revisión bibliográfica
de la literatura existente en PUBMED. Para ello, se uti-
lizó una lista de palabras creadas a partir de dos domi-
nios clave: “pharmaceutical care” y “HIV”. La búsque-
da se construyó utilizando a la conjugación “AND” y el
disyuntivo “OR” como operadores lógicos e incluyendo
[(“pharmaceutical care” AND “HIV” AND “Adherence”
OR “patient compliance”) (“pharmaceutical care” AND
“HIV” AND “Chronic diseases”) (“pharmaceutical care”
AND “HIV” AND “motivation”)].
Como limitaciones de la búsqueda se incluyeron ex-
clusivamente artículos de ensayos clínicos o proyectos de
investigación en inglés o español desde el año 2001 has-
ta la actualidad que cumplieran los siguientes criterios:
estudios donde se establecían intervenciones farmacéu-
ticas para la mejora de cualquier resultado en salud al
paciente VIH, estudios donde se definieron intervencio-
nes farmacéuticas para la mejora de los resultados en
salud de pacientes VIH, o estudios donde se compararan
la utilidad y resultados de diferentes intervenciones far-
macéuticas en pacientes VIH.
Adicionalmente, se excluyeron todos aquellos ma-
nuscritos donde las intervenciones no fueron llevadas a
cabo por un farmacéutico especialista en VIH de forma
parcial o totalmente.
Tras la identificación de los artículos susceptibles de
ser incluidos, se extrajo, por separado, la siguiente infor-
mación: diseño del estudio, número de pacientes par-
ticipantes, intervenciones (tipo de intervenciones, des-
cripción de la misma), el objetivo del estudio, duración,
resultado y conclusiones de autor.
Como complemento a esta búsqueda, se incluyeron
en la revisión las intervenciones farmacéuticas recogidas
en el Modelo de selección y AF al paciente VIH y/o VHC
de la Sociedad Española de Farmacia Hospitalaria8.
En la segunda fase, para consensuar las intervencio-
nes seleccionadas y llevar a cabo la taxonomía se uti-
lizó la metodología DELPHI-Rand UCLA9. Este método
basado en la síntesis de evidencia científica y en el juicio
colectivo de un panel de expertos, se utilizó para esta-
blecer un consenso de las intervenciones farmacéuticas
en pacientes VIH+ con el fin de homogenizar las actua-
ciones que más beneficien al paciente y a su entorno.
Dicha metodología consistió, para los fines de este es-
tudio, en la selección de un grupo de expertos a los que
se les preguntó su opinión sobre cuestiones referidas a
acontecimientos del futuro en el ámbito del VIH y las
intervenciones farmacéuticas para la mejora de los re-
sultados en salud. El método general constaba de va-
rias rondas, en las que se enviaba un cuestionario a un
grupo de expertos que respondían a las preguntas de
forma anónima. Luego se tabulaban los resultados de la
encuesta y se devolvían al grupo. A continuación, se le
pedía al experto que respondiera de nuevo al cuestiona-
rio, con el objeto de tratar de conseguir consenso, pero
con la máxima autonomía por parte de los participantes.
Este proceso iterativo continuaba hasta que hubiera una
convergencia de opinión sobre el tema o hasta que no
se producía ningún cambio sustancial en las respuestas.
Dicha metodología fue seguida estrictamente para llevar
a cabo nuestro estudio.
Se seleccionó un panel de 15 expertos farmacéuticos
hospitalarios a nivel nacional, implicados y especialistas
en AF al paciente VIH+. Se estimó y admitió un porcen-
taje de pérdidas durante el proceso del 20%.
La selección de expertos se realizó de forma explícita
y siguiendo un protocolo previamente establecido con
el fin de limitar posibles sesgos. Los criterios fundamen-
tales de selección fueron, por una parte, criterios objeti-
vos: sexo (al menos un 50% de mujeres/hombres), diver-
sidad geográfica (no más de 2 expertos por comunidad
autónoma) y disponibilidad real de tiempo tras conocer
la metodología de trabajo. Por otra parte, se utilizaron
también criterios subjetivos: liderazgo reconocido, am-
plitud de conocimiento e interés en el tema, actitud y
aptitud científica (al menos una publicación en el últi-
mo año sobre el tema de estudio o la participación en
un proyecto de investigación), capacidad de trabajo en
equipo, ausencia de visiones rígidas y nivel de motiva-
ción intensa.
Se elaboró, por parte del equipo investigador una
propuesta de cuestionario a partir de las intervenciones
extraídas en el proceso de revisión bibliográfica. Estas
intervenciones fueron clasificadas tentativamente según
el Modelo CMO. Cada intervención se ubicó en una ca-
tegoría correspondiente en base a su diseño y utilidad.
Cada intervención se describió y ejemplificó para facilitar
al entendimiento por parte del experto.
Se plantearon tres preguntas a partir de la cuestión
inicial. Estas fueron las mismas para cada intervención y
se respondían afirmativa o negativamente. La pregunta
inicial fue ¿Está de acuerdo con la clasificación propues-
ta? En el caso de responder negativamente, se daba la
opción de recategorizar la intervención propuesta en
otro ámbito de actuación del modelo. Adicionalmente,
se planteaba a los expertos para llevar a cabo un correc-
to seguimiento terapéutico qué importancia y prioridad
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Development of a taxonomy for pharmaceutical interventions… Farm Hosp. 2016;40(6):544-568 - 559
le daría a esa intervención (siendo 1 la más baja y 10 la
más alta). Por último, en base a la experiencia previa del
revisor, qué impacto tendría esta intervención a la hora
de que el paciente cumpliera sus objetivos farmacotera-
péuticos (siendo 1 la más baja y 10 la más alta).
Finalmente, también se incluyó un apartado para su-
gerir o proponer cualquier otra iniciativa que el exper-
to considerara de interés para esta categoría y que no
hubiera quedado recogida en el cuestionario propuesto.
Dicho cuestionario se envió por vía electrónica al panel
de expertos seleccionado, previa aceptación de partici-
par en el mismo. Una vez contestada la primera ronda
del cuestionario Delphi por el panel de expertos se ana-
lizaron las respuestas utilizando estadística descriptiva.
Las intervenciones se clasificaron en función del grado
de acuerdo de las siguientes definiciones: adecuada
(mediana 7-10), dudosa (mediana 4-6 o cualquier me-
diana con desacuerdo), inadecuada (mediana 1-3). Una
vez obtenido el consenso, se procedió a realizar la taxo-
nomía definitiva. El número de rondas propuestas quedó
a expensas de alcanzar el acuerdo.
El estudio fue aprobado por el comité de ética de in-
vestigación Sevilla Sur.
Resultados
De la revisión bibliográfica se obtuvieron un total de
283 artículos. De ellos, 230 artículos fueron excluidos
por no cumplir los criterios de inclusión y exclusión. Las
razones por las que se excluyeron fueron: estudios de
Farmacocinética y Farmacodinámica (21), intervencio-
nes no llevadas a cabo por un Farmacéutico especialista
(19), estudios de análisis Farmacoeconómicos (18), es-
tudios donde no se especificaba quien llevaba a cabo la
intervención (16), estudios sobre enfermedades opor-
tunistas (13), prevención (12), estudios sobre profilaxis
(9), estudios realizados en farmacia comunitaria (8),
Farmacovigilancia (4), problemas psicosociales (3), Far-
macogenómica (1), otras intervenciones no relevantes
(47) (Figura1).
Se realizó una preselección de 53 artículos que se
consideraba dentro de los criterios de elegibilidad. De
ellos, una vez evaluados por el grupo investigador, se
excluyeron 13 debido a que la intervención no era lle-
vada a cabo por farmacéuticos o no estaba claro el rol
que desempeñaban, 10 debido a la falta de definición
y especificación de las intervenciones, 7 en las que los
resultados de las intervenciones no mostraron utilidad y
5 por otras causas. Finalmente, se incluyeron un total de
18 artículos que cumplieron los criterios de elegibilidad
y estuvieron acorde con la investigación. Las característi-
cas de los mismos se detallan en la tabla 1.
De esa manera, la propuesta inicial se compuso por
veinte intervenciones farmacéuticas extraídas de los ar-
tículos seleccionados y clasificados de manera preliminar
por el equipo investigador, según los pilares fundamen-
tales del modelo CMO. Un total de siete intervenciones
se ubicaron en Capacidad, ocho en Motivación y cinco
en Oportunidad. Además cada intervención se describió
y ejemplificó para facilitar al entendimiento del experto.
Finalmente, se recibió la participación de 13 expertos
en la ronda Delphi.
Figura 1. Revisión de la
bibliografía e inclusión de
estudios.
Incluido Elegibilidad Cribado Identicación
Búsqueda en PUBMED
“pharmaceutical care”
AND “HIV” AND
“Adherence” n=207
Búsqueda en PUBMED
“pharmaceutical care”
AND “HIV” AND
“Chronic diseases”
n=60
Búsqueda en PUBMED
“pharmaceutical care”
AND “HIV” AND
“motivation”
n=16
Excluidos n=230
* Editorial: 53
* No especica quien lleva a
cabo la intervención: 16
* Estudio no llevado por el
farmacéutico: 19
* Farmacoeconomía: 18
* Farmacocinética y
Farmacodinámica: 21
* Farmacovigilancia: 4
* Prolaxis: 9
* Enfermedades oportunistas: 13
* Farmacogenómica: 1
* Industria Farmacéutica: 6
* Prevención: 12
* Estudios realizados en
farmacia comunitaria: 8
* Problemas Psicosociales: 3
* Otras intervenciones: 27
* Repetidos: 20
Estudios incluidos n=18
Total de estudios identicados n=283
Artículos evaluados para
elegibilidad n=53
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560 - Farm Hosp. 2016;40(6):544-568 Ramón Morillo Verdugo et al.
Tabla 1. Revisión Bibliográfica- Intervenciones farmacéuticas en pacientes VIH+
Título Autores, año Tipo de
estudio
Nº de
participantes Intervenciones Objetivo Tiempo Conclusiones
Impact of a
pharmaceutical
care program on
clinical evolution
and antiretroviral
treatment
adherence:
a 5-year study.
Hernández
Arroyo MJ;
et al. 20135
Retrospectivo 528 pacientes
Evaluación de la historia
clínica al inicio AF. Examinar
posibles alteraciones
analíticas y las posibles
interacciones del TAR.
Información sobre el VIH y
su tratamiento. Programa de
dosificación personalizada.
Determinar el impacto
de la implementación
de un programa de
AF en la mejora de
la adherencia TAR
y de la respuesta
inmunovirológica de los
pacientes.
60 meses
Los resultados sugieren
que el desarrollo y el
mantenimiento de un
programa de AF pueden
aumentar la adherencia TAR,
mantener una carga viral
indetectable y un recuento
CD4+ adecuado.
Concurrent use
of comedications
reduces adherence
to antiretroviral
therapy among HIV-
infected patients.
Cantudo
Cuenca, MR,
et al. 201413
Observacional
prospectivo
594 pacientes
Llevar registros de
dispensación de medicación
y adherencia. Calcular
el índice terapéutico de
complejidad de TAR.
Determinación de riesgo de
PRM en función del Índice
Predictor.
Determinar la influencia
de las comorbilidades y
fármacos concomitantes
sobre la adherencia
al tratamiento
antirretroviral en
pacientes infectados por
el VIH.
12 meses
El incremento de pacientes
VIH con polifarmacia
aumenta el riesgo de falta
de adherencia.Además, el
uso de drogas intravenosas,
y un valor elevado del índice
Predictor se asociaron con
una menor adherencia.
Improving
adherence to
antiretroviral
treatment in
Uganda with a low-
resource facility-
based intervention.
Obua C,
et al. 201417
Estudio de
Intervención
y cohortes
1481 pacientes
720 pretratados
761 Naive
Desarrollar un sistema
de citas rápidas y facilitar
medicación para periodos
más prolongados
especialmente para
pacientes con control de la
enfermedad.
Evaluar los efectos
de las intervenciones
implantadas en la
mejora de la asistencia
global y la adherencia
al TAR.
17 meses
La adherencia de los
pacientes mejoró con las
sencillas intervenciones
implantadas sin suponer un
incremento de los recursos
necesarios ni de los costes.
An interdisciplinary
HIV-adherence
program combining
motivational
interviewing
and electronic
antiretroviral drug
monitoring.
Krummenacher I,
et al. 201118 Retrospectivo 104 pacientes
Sistema de monitorización
de la adherencia MEMS,
entrevistas semiestructuras
y motivación individual
en función de problemas
cognitivos, emocionales,
conductuales y sociales.
Analizar la repercusión
del desarrollo
de un programa
multidisciplinar de
mejora de la adherencia.
44 meses
Las tasas de retención y
persistencia al programa
fueron elevadas,
detectándose un incremento
de los pacientes con carga
viral indetectable.
Evaluating the
Effects of an
Interdisciplinary
Practice Model
with Pharmacist
Collaboration on
HIV Patient Co-
Morbidities.
Cope R,
et al. 201519
Cohortes
retrospectivo 96 pacientes
Conjunto de intervenciones
centradas en el seguimiento
de parámetros clínicos:
hemoglobina glicosilada,
LDL e hipertensión.
Control de diabetes,
hipertensión e
hiperlipidemia en
pacientes VIH.
18 meses
La participación del
farmacéutico en la atención
en pacientes VIH parece
conducir a una gestión más
adecuada de comorbilidades
crónicas de una manera
rentable.
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Tabla 1 (cont.). Revisión Bibliográfica- Intervenciones farmacéuticas en pacientes VIH+
Título Autores, año Tipo de
estudio
Nº de
participantes Intervenciones Objetivo Tiempo Conclusiones
Integration
among hospital
pharmacists and
infectious diseases
physicians in
the outpatient
management of
HIV infection.
Appolloni L,
et al. 201420
Observacional
prospectivo 659 pacientes
Analizar a través de una
encuesta la adherencia
autoreferida, el uso de
fármacos concomitantes
o suplementos dietéticos
y la aparición de efectos
adversos.
Evaluar la mejora en
la adherencia de los
pacientes y vigilar y
señalar con prontitud
efectos adversos tras
la instauración de
un programa basado
en la integración del
farmacéutico.
3 meses
Un enfoque multidisciplinar
entre los farmacéuticos y
médicos puede mejorar la
adherencia y el seguimiento
de los eventos adversos,
optimizando el manejo de los
pacientes VIH+.
Randomized
controlled trial to
evaluate the impact
of pharmaceutical
care on therapeutic
success in HIV-
infected patients in
Southern Brazil.
Silveira MP,
et al. 201421
Ensayo
no ciego
aleatorizado y
controlado
332 pacientes
Asesoramiento sobre
la prescripción y en
el momento de la
dispensación. Revisión
de la prescripción,
programación de la próxima
cita, Información sobre los
efectos secundarios de sus
medicamentos.
La AF podría mejorar la
adherencia en general,
especialmente en los
pacientes con baja
adherencia o con carga
viral detectable.
12 meses
La AF no se asocia con un
aumento de la adherencia
autoreferida ni del número
de pacientes con carga viral
indetectable.
Quizás pueda ser interesante
y efectiva en subgrupos
de pacientes con baja
adherencia.
Predictors of
non-adherence to
clinical follow-up
among patients
participating in a
randomized trial of
pharmaceutical care
intervention in HIV-
positive adults in
Southern Brazil.
Silveira MP,
et al. 201422
Ensayo
Clínico 332 pacientes
Asesoramiento sobre
la prescripción y en
el momento de la
dispensación. Revisión
de la prescripción,
programación de la próxima
cita, Información sobre los
efectos secundarios de sus
medicamentos.
Examinar la tasa de
no-adherencia durante
el seguimiento clínico
y los posibles factores
predictivos de la falta
de adherencia entre los
pacientes en el ensayo.
12 meses
Los pacientes jóvenes
varones pueden ser los
más beneficiados de la
implantación de programas
de atención farmacéutica que
fomenten el autocuidado.
The clinical utility
of HIV outpatient
pharmacist
prescreening to
reduce medication
error and assess
adherence.
Seden K,
et al. 201323
Observacional
Prospectivo 200 pacientes
Consulta con servicio
de farmacia que incluye
la revisión completa
de la medicación del
paciente incluyendo OTC,
parafarmacia o plantas
medicinales, la evaluación
de interacciones, de la
adherencia a la terapia.
Valoración de la complejidad
percibida por los pacientes.
Evaluar si las
intervenciones
realizadas por un
farmacéutico en las
que se incluye revisión
de la medicación
completa, interacciones
y adherencia, repercute
de manera beneficiosa
en la atención a los
pacientes VIH+.
22 meses
Los pacientes con dos o más
fármacos concomitantes
son los más beneficiados
por la instauración de las
intervenciones.
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Tabla 1 (cont.). Revisión Bibliográfica- Intervenciones farmacéuticas en pacientes VIH+
Título Autores, año Tipo de
estudio
Nº de
participantes Intervenciones Objetivo Tiempo Conclusiones
Feasibility and
reliability of
interactive
voice response
assessment of
HIV medication
adherence: research
and clinical
implications.
Hettema JE,
et al. 201224 Prospectivo 63 pacientes
Los participantes debían
comunicar la adherencia
diaria durante 2 semanas en
el sistema de voz. Se analizó
la viabilidad del sistema y
de manera retrospectiva,
se comparó con los datos
obtenidos de adherencia
autoreferida durante el
seguimiento previo.
Estudio piloto en el que
se pretende evaluar la
viabilidad y fiabilidad de
un sistema de registro
de adherencia por voz
(IVR).
1 mes
Estos nuevos sistemas
prometedores necesitan
mejorar la viabilidad. Además
se deben realizar estudios
con otro comparador de
medida de adherencia más
adecuado y representativo.
Desarrollo y
validación de
un modelo
predictivo para
la identificación
de pacientes
infectados por el
VIH con problemas
relacionados con
los medicamentos.
E. PREDICTOR.
Morillo Verdugo
R, et al. 201225
Prospectivo
multicéntrico
abierto
733 pacientes
Seguimiento
farmacoterapéutico
periódico en las consultas
de AF de los servicios de
farmacia de los hospitales
participantes.
Desarrollar y validar un
modelo de predicción
para la detección de
problemas relacionados
con medicamentos
(PRM) en pacientes
VIH en tratamiento
antirretroviral.
4 meses
El modelo desarrollado
y validado permite la
detección de los pacientes
en tratamiento antirretroviral
que están en un mayor riesgo
de experimentar un PRM.
Impact of HIV-
specialized
pharmacies on
adherence and
persistence with
antiretroviral
therapy.
Murphy P,
et al. 201226
Estudio
retrospectivo,
comparativo
de
intervención
sanitaria
7064 pacientes
Revisión de la medicación, la
evaluación de la adherencia,
facilidad en la adquisición
de fármacos y mejora en
la disponibilidad de los
mismos.
Evaluar y comparar
la adherencia y
persistencia al TAR
de los pacientes que
utilizan las farmacias
especializadas-
VIH frente a las
tradicionales.
12 meses
Las farmacias comunitarias
especializadas en servicios
de VIH pueden ser medios
eficaces para ayudar a los
pacientes a lograr una mayor
adherencia y persistencia al
TAR.
Pharmacists’
strategies for
promoting
medication
adherence among
patients with HIV.
Kibicho J,
et al. 201127
Cualitativo
multicéntrico,
descriptivo.
19
Farmacéuticos
Entrevista semiestructurada
realizada a los participantes.
Documentar la
experiencia de los
farmacéuticos y
proporcionar una
perspectiva sobre las
barreras de adherencia
para los pacientes VIH y
describir las estrategias
para mejorarla.
2 meses
Se necesita más investigación
sobre la eficacia y el
coste efectividad de
las intervenciones de
los farmacéuticos en la
práctica clínica, con el fin
de consensuar políticas de
reembolso.
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Tabla 1 (cont.). Revisión Bibliográfica- Intervenciones farmacéuticas en pacientes VIH+
Título Autores, año Tipo de
estudio
Nº de
participantes Intervenciones Objetivo Tiempo Conclusiones
Using different
calculations of
pharmacy refill
adherence to
predict virological
failure among HIV-
infected patients.
Boer IM,
et al. 201028 ______ 201 pacientes
Se analizó el cálculo de
la adherencia a través de
los datos proporcionados
por las farmacias donde
los pacientes recogían
la medicación. Valorar
la medicación sobrante
y las interrupciones del
tratamiento prescrito.
Analizar la viabilidad de
la recogida de datos en
las farmacias.
Analizar la repercusión
de la medicación
sobrante y el tiempo de
tratamiento prescrito en
el cálculo la adherencia.
12 meses
Es importante que los estudios
que empleen este método
de medida de la adherencia
consideren la medicación
sobrante.
Improving
adherence and
clinical outcomes
through an HIV
pharmacist’s
interventions.
Ma A. 201029 Retrospectivo 75 pacientes
Optimizar los nuevos
regímenes antirretrovirales
para mejorar la respuesta
inmunológica y reducir al
mínimo los efectos adversos
así como la adherencia
disminuyendo la cantidad
de pastillas y o frecuencia
de dosificación.
Investigar los resultados
clínicos de las
intervenciones de un
farmacéutico clínico en
el programa de la Kaiser
Permanente, basado en la
experiencia con fármacos
para proporcionar
recomendaciones para
cambios de régimen
antirretroviral.
24 meses
Los farmacéuticos clínicos
pueden desempeñar un papel
importante en la optimización
de la adherencia y en la mejora
de resultados clínicos de los
pacientes.
Evaluación de
un programa
de atención
farmacéutica
para mejorar
la adherencia
a la terapia
antirretroviral
Codina C,
et al. 200428
Multicéntrico,
observacional,
prospectivo
541 pacientes
Visita previa basal y 4 visitas
trimestrales. La estimación
de la adherencia se basa
en el recuento de pastillas.
Una adherencia ≥ 95% se
consideró adecuada (en dos
puntos de tiempo).
Establecer el impacto
de un programa de
atención farmacéutica
en la mejora de la
adherencia al tratamiento
antirretroviral y en el
estado viroinmunológico
del paciente.
12 meses
Se confirma la necesidad
de incorporar programas
de seguimiento
farmacoterapéutico en
pacientes con tratamiento
antirrretroviral activo para
optimizar los beneficios.
Pharmaceutical care
for HIV patients on
directly observed
therapy.
Foisy MM.
201430
Estudio
prospectivo
de
intervención
sanitaria
57 pacientes
Identificación y gestión
PRM, asesoramiento a los
facultativos en la selección
de terapias iniciales y los
regímenes de rescate para
pacientes con fracaso
terapéutico, consejo sobre
la medicación al paciente,
entrevista clínica con el
paciente, seguimiento del
tratamiento directamente
observado y de parámetros
de laboratorio y adherencia.
Describir el desarrollo
y prestación un
programa de atención
farmacéutica a
los pacientes con
terapia directamente
observada (DOT), así
como la detección de
problemas relacionados
con medicamentos
(PRM) y sus respectivos
resultados.
14 meses
En la AF a pacientes VIH
con DOT, elfarmacéutico
contribuyó significativamente
a la selección inicial, al
seguimiento y la gestión
de los PRM durante el
tratamiento antirretroviral.
Además puede colaborar
en la promoción de la
adherencia de los pacientesy
en la mejora de los resultados
en salud.
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En la figura 2 se observa el grado de aceptación de
las intervenciones propuestas por parte de los expertos.
Del total, 15 intervenciones fueron aceptadas por 13
expertos (100%), 4 intervenciones por 12 (92%), 1 in-
tervención por 11 (85%) y 1 intervención por 10 (77%)
de los encuestados. En una única ronda se alcanzó el
consenso.
Las intervenciones reconocidas como de mayor im-
portancia y prioridad fueron, con una puntuación de
10, la revisión y validación, la seguridad y la adherencia.
Mientras que las de mayor impacto, igualmente valora-
das con un 10, fueron las de revisión y validación, coor-
dinación, adherencia y motivación. Por el contrario, las
de que obtuvieron una menor puntuación en el aparta-
do de importancia fueron las de planificación y coordi-
nación social y en el impacto la de coordinación social,
puntuadas con 7 (Figura 3).
La taxonomía finalmente desarrollada se observa en
la tabla 2.
Discusión
Este estudio, presenta, por primera vez, una taxono-
mía de intervenciones farmacéuticas basadas en un no-
vedoso modelo de AF.
La definición y desarrollo de la AF al paciente VIH+
se ha ido amoldando a los cambios existentes a nivel
asistencial y farmacoterapéutico, llegando a ser a día de
hoy un elemento clave en la actividad de la mayoría de
centros hospitalarios en nuestro país10. Aunque el nivel
actual de la AF en España, según los diferentes estudios
publicados, es aceptable, aun dista de alcanzar los ni-
veles de calidad y, sobre todo de homogeneidad desea-
bles11.
Por ello, la reorientación del modelo de trabajo en
base a los tres grandes pilares propuestos, así como lo-
grar armonizar y consensuar las principales intervencio-
nes a llevar a cabo y priorizar aquellas mas relevantes se-
gún la tipología de paciente atendido, resultará de gran
ayuda en el futuro y permitirá maximizar los resultados
en salud de los pacientes y la aportación farmacéutica en
la consecución de los objetivos farmacoterapéuticos en
este tipo de pacientes.
Ni que decir tiene que este nuevo modelo debe ve-
nir acompañado de nuevas fórmulas para su desarro-
llo. Particularmente importante es el reciente “Modelo
de Selección y Estratificación de pacientes”, creado por
el Grupo de trabajo de AF al paciente VIH de la SEFH8.
Con un enfoque piramidal, esta herramienta de trabajo
nos permite estratificar a los pacientes en tres niveles,
basal, intermedio y principal, en orden creciente de ne-
cesidades de AF por su riesgo de no consecución de ob-
jetivos farmacoterapéuticos. Precisamente este es otro
de los grandes cambios del modelo, hablar de objetivos
farmacoterapéuticos y no de la clásica terminología de
Problemas Relacionados con los Medicamentos (PRM)
Tabla 1 (cont.). Revisión Bibliográfica- Intervenciones farmacéuticas en pacientes VIH+
Título Autores, año Tipo de
estudio
Nº de
participantes Intervenciones Objetivo Tiempo Conclusiones
Pharmaceutical
services in an HIV
clinic.
Geletko
SM.200231
Estudio
prospectivo
de
intervención
sanitaria
70 pacientes
Intervenciones de
optimización de
la farmacoterapia,
identificación y manejo
de efectos adversos,
información y consejo
sobre el tratamiento,
recomendaciones
sobre monitorización
de parámetros clínicos,
identificación de
interacciones y gestión
de derivaciones a otro
servicio.
Evaluación
de forma
cuantitativa
de las
intervenciones
realizadas por
farmacéuticos en
pacientes VIH+.
48 meses
Las intervenciones
de los farmacéuticos
a pacientes VIH+
mejoran la adherencia
y garantiza beneficios
clínicos en salud.
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ni de priorización de los costes farmacoeconómicos. El
modelo incluye diferentes variables, no solo relacionadas
con la farmacoterapia (total, no solo la antirretroviral),
sino también demográficas, sociales y del estado cog-
nitivo y funcional y de utilización de recursos sanitarios.
Las intervenciones identificadas en el apartado de ca-
pacidad están basadas precisamente en el uso de esta
herramienta y con este enfoque de revisión, validación
y planificación de objetivos farmacoterapéuticos en los
pacientes, los cuales deben ser cotejados para compro-
bar su cumplimiento o no en cada momento en que se
realice AF. Dado que las intervenciones que más se han
priorizado en este estudio en importancia son las clá-
sicas, de revisión del tratamiento antirretroviral, seguri-
dad y adherencia, la base del modelo tradicional ya esta
asentada pero es necesario dar un enfoque diferente en
la perspectiva de seguimiento, para revisar y validar la
farmacoterapia completa de forma permanente, espe-
cialmente en los pacientes polimedicados, tal y como
indican las recomendaciones12.
En segundo lugar, el pilar de motivación, nos obli-
ga, igualmente a dar un salto cualitativo en nuestra
relación con los pacientes. Para ello, la comunicación y
fundamentalmente la entrevista es la herramienta fun-
damental. No obstante, es necesario avanzar ya que de
la clásica entrevista clínica, ampliamente utilizadas en la
búsqueda de PRM, debemos pasar a enfocar la entrevis-
ta motivacional. Esta deberá incluir dos puntos funda-
mentales para coordinar las intervenciones propuestas
tanto de seguridad, compromiso y la clásica valoración
de la adherencia. Estos puntos son la capacidad de ge-
nerar “discrepancias internas” en nuestros pacientes y
la de “afrontar las resistencias” respecto a la situación
basal y la que se espera conseguir en este tipo de pacien-
tes a través de la AF. En pacientes VIH+ polimedicados,
particularmente, donde la adherencia a la medicación
concomitante es baja y puede verse influida por el trata-
miento antirretroviral13, este nuevo enfoque nos va a ser
de gran ayuda en el manejo de la polifarmacia. Resulta
muy llamativo, sin embargo, la escasa disponibilidad de
Figura 2. Grado de acep-
tación de las intervencio-
nes en cada categoría pro-
puesta.
Participantes
Código de Subcategoría
Si
No
Figura 3. Mediana de
las puntuaciones obteni-
das para cada interven-
ción propuesta.
Mediana
importancia y prioridad le
daría a esta intervención
impacto tendría esta
intervención
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566 - Farm Hosp. 2016;40(6):544-568 Ramón Morillo Verdugo et al.
Tabla 2. Taxonomía final de las Intervenciones Farmacéuticas en pacientes VIH + según el modelo CMO
Categoría Código Denominación Subcategoría
CAPACIDAD
1.1 Revisión y validación Revisión y validación del tratamiento antirretroviral.
1.2 Revisión y validación
concomitante.
Revisión de la medicación concomitante (automedicación, medicina
alternativa, etc.) y monitorización de todas las posibles interacciones,
ofreciendo al clínico una alternativa terapéutica para la medicación
concomitante, siempre que sea posible.
1.3 Revisión de objetivos
Establecer un circuito para la gestión y abordaje de los objetivos no
cumplidos con la medicación.
Interacciones
Reacciones adversas
Errores de medicación
Adherencia
Otros
1.4 Coordinación Unificación de criterios entre los diferentes profesionales sanitarios y
los niveles asistenciales
1.5 Derivación Valorar la derivación a otros profesionales.
1.6 Planificación
Planificación de la próxima visita a la unidad de pacientes externos en
coordinación con su médico de infecciosas o con el departamento de
citaciones.
1.7 Conciliación Conciliación del tratamiento farmacológico en los ingresos/altas
MOTIVACIÓN
2.1 Seguridad Seguimiento de la seguridad del tratamiento
2.2 Seguimiento Especial Seguimiento especial de los medicamentos de alto riesgo.
2.3 Adherencia Seguimiento de la adherencia y establecer la estrategia más eficaz
para mejorarla, tanto el TAR como la medicación concomitante.
2.4 Motivación Motivar al Paciente y mantenerlo informado
2.5 Corresponsabilidad Fomento de la corresponsabilidad en el resultado del tratamiento
(evitar el fracaso virológico a las 48 semanas).
2.6 Compromiso
Conocer el nivel de conocimiento que el paciente tiene del
tratamiento prescrito, para posteriormente resolver dudas acerca de
su enfermedad, su tratamiento, vías de trasmisión, etc.
2.7 Información Información sobre la importancia de la adherencia y las interacciones
actuales y/o potenciales con otros medicamentos.
2.8 Fomento Fomentar el estilo de vida saludable. (Consejos)
OPORTUNIDAD
3.1 Comunicación Rápida Desarrollar vías rápidas de comunicación con el paciente y su entorno
familiar y cuidadores
3.2 Seguimiento Transversal
Seguimiento especial del paciente en su contacto con el sistema
sanitario (Atención primaria, urgencias, hospitalización y oficina de
farmacia).
3.3 Formación Transversal Desarrollar herramientas o acciones específicas de formación para
reforzar aspectos críticos relacionados con el tratamiento/enfermedad.
3.4 Coordinación Social Coordinación con los servicios sociales o con los servicios psicológicos
y psiquiátricos del centro hospitalario.
3.5 Coordinación activa Coordinación con asociaciones de pacientes.
herramientas para valorar la motivación de los pacientes,
siendo el cuestionario “Patient activation Measure”, que
no es especifico de población VIH una de las pocas he-
rramientas que pueden ser usadas a este respecto14. No
obstante, deberán desarrollarse herramientas específicas
en este ámbito para población VIH+.
Igualmente, el tradicional concepto de valoración de
la adherencia, deberá ampliarse para incluir el nuevo
enfoque de adherencia primaria y secundaria. Siendo,
ahora, la primaria, la que ocurre desde que se prescribe
el tratamiento hasta los primeros 14 días desde la pres-
cripción y la secundaria, la que clásicamente hemos va-
lorado, la que se analiza desde que el paciente tiene en
su poder el tratamiento. El estudio de Gómez E et al. ya
indica que la falta de adherencia primaria podría llegar a
ser de hasta un 33% en los pacientes VIH+15.
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Por último, el concepto de oportunidad, nos obliga
a pensar que ya no trabajamos para los hospitales, sino
desde los hospitales. O lo que es lo mismo, que la AF ya
no es exclusivamente presencial y que para ello necesita-
remos de las tecnologías de aprendizaje y comunicación
(TIC´s) y las tecnologías de aprendizaje y conocimiento
(TAC´s) para hacer frente a las necesidades de los pacien-
tes y que estas se presentan también fuera de nuestras
consultas. Son ya muy numerosas las experiencias que
demuestran la aportación de valor que estas herramien-
tas tienen para los pacientes en población general, tam-
bién de mayor edad y, particularmente, los pluripatoló-
gicos y polimedicados. Desde experiencias mas simples
con envió de SMS a móviles o Apps destinadas a la gami-
ficación a otras experiencias mas complejas como la de
“paciente experto VIH 2.0”, con incipientes resultados
de satisfacción de los usuarios incorporados a este mo-
delo de aprendizaje basado en compartir experiencias
entre pacientes16.
El presente estudio presenta limitaciones. En primer
lugar, la sensibilidad de los resultados a la posible am-
bigüedad de las preguntas. Por ello, se definieron cla-
ramente los términos importancia, prioridad e impacto
para que todos los expertos clasificaran las intervencio-
nes y homogeneizaran sus respuestas al máximo. Igual-
mente, para establecer el grado de experiencia de los
miembros del panel, se determinaron claramente cuales
eran las características mínimas en cuanto a orientación
profesional, publicaciones y participación en grupos de
trabajo nacionales. Por último, al tratarse de un método
de análisis cualitativos se podría esperar una valoración
de la confianza excesiva en el juicio de los expertos, ten-
diendo a ser menos precisos que otros métodos cuanti-
tativos.
Una vez obtenida la taxonomía, es prioritario llevar a
cabo estudios prospectivos que demuestren la utilidad de
la misma a la hora de llevar a cabo un óptimo seguimien-
to a este tipo de pacientes y cómo se incorporan a la asis-
tencia integral y multidisciplinar de este tipo de pacientes.
A su vez, futuros estudios permitirán conocer cuales son
las intervenciones mas frecuentes y los resultados en sa-
lud obtenidos a raíz de llevar a cabo estas intervenciones
de manera sistematizada. Igualmente, en caso necesario,
permitirán adaptar las intervenciones a futuros cambios
asistenciales que se vayan llevando a cabo. Igualmente es
prioritario, llevar a cabo una validación y adaptación de
la taxonomía en otro tipo de patologías.
Por todo ello se propone una nueva línea de investiga-
ción, como es la de incorporar la taxonomía de interven-
ciones farmacéuticas en Pacientes VIH según el modelo
CMO en la asistencia sanitaria y evaluar la importancia,
relevancia y factibilidad de las mismas en el seguimiento
a pacientes VIH+ en la práctica clínica real. Asimismo,
con los matices propios de otras patologías, valorar la
utilidad de esta metodología de trabajo en otras áreas
de la farmacia.
En conclusión, la taxonomía consensuada y presenta-
da, permitirá clasificar las intervenciones farmacéuticas
realizadas con el nuevo modelo de AF a pacientes VIH+
y, de esa manera, profundizar en la investigación y mejo-
ra asistencial a este tipo de pacientes.
Financiación
El presente documento no ha recibido ninguna finan-
ciación para su diseño y desarrollo.
Conflicto de interés
Los autores declaran no tener ningún conflicto de in-
terés relacionado con la publicación de este artículo.
Agradecimientos
Este estudio no habría sido posible sin la colaboración
desinteresada de todos los farmacéuticos especialistas
que formaron parte del panel de expertos para el de-
sarrollo de la metodología Delphi. A cada uno de ellos
queremos agradecerle su esfuerzo: Herminia Navarro
Aznárez (Servicio de Farmacia - Hospital Universitario
Miguel Servet, Zaragoza, Aragón), Aitziber Illaro Uranga
(Servicio de Farmacia - Hospital Universitario Marqués
de Valdecilla, Santander, Cantabria), Purificación Cid
Silva (Servicio de Farmacia CHUAC - Xerencia Xestión
Integrada A Coruña, Galicia), Emilio Molina Cuadrado
(Servicio de Farmacia - Hospital Torrecárdenas, Almería,
Andalucía), José Manuel Martínez Sesmero (F.E.A Far-
macia Hospitalaria. Pharmacy departament - Outpatient
and Ambulatory Care - Complejo Hospitalario de Tole-
do, Castilla-La Mancha), Javier Sánchez-Rubio Ferrández
(Farmacéutico Adjunto- Servicio de Farmacia, Hospital
Universitario de Getafe, Madrid), Sergio Fernández Es-
pinola (FEA Servicio de Farmacia - Hospital de Anteque-
ra, Málaga, Andalucía), Raúl Ferrando Piqueres (Jefe
de Sección Servicio de Farmacia Hospitalaria - Hospital
General de Castellón, Valencia), Luis Carlos Fernández
Lisón (Jefe de sección. Servicio de Farmacia Hospitala-
ria - Complejo Hospitalario de Cáceres, Extremadura),
Mª Paz Valverde Merino (Servicio de Farmacia - Hospi-
tal Universitario de Salamanca, Castilla y León), Mª José
Huertas Fernández (Farmacéutica Unidad de Atención
a Pacientes Externos - Hospital Universitario Puerta del
Mar, Cádiz, Andalucía), Alicia Lázaro López (Servicio de
Farmacia - Hospital Universitario de Guadalajara, Cas-
tilla-La Mancha), Gador Callejón Callejón (Servicio de
Farmacia - Hospital Universitario La Candelaria, Tenerife,
Canarias).
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009_10567_Desarrollo de una taxonomia de las intervenciones.indd 568 2/11/16 3:43
... On the other hand, the new definition of pharmaceutical care (PC) [12] advocates a change of care orientation based on the direct relationship with the patient and the achievement and achievement of objectives in relation to pharmacotherapy, based on multidisciplinary and multidimensional work. This methodology of PC is called CMO, based on the three pillars that comprise it: capacity (stratification), motivation (objectives in relation to pharmacotherapy) and opportunity (new technologies) has already been developed and used in the PLWH, improving health outcomes, patient activation (knowledge, skills, beliefs, and confidence for managing health and health care), and patient experience [13][14][15]. ...
... Interventions. Patients received routinely applied pharmacotherapeutic interventions in ambulatory care patients according to the CMO PC model [15,16]. It consists of an initial stratification of patients at three levels according to the risk stratified PC model in PLWHIV of the Spanish Society of Hospital Pharmacy [16]. ...
... The taxonomy and description of the interventions are detailed in Morillo et al.[15]. ...
Article
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Objective. To determine the effectiveness of a pharmaceutical intervention, based on the CMO methodology (capacity, motivation and opportunity), to decrease the prevalence of the PIMDINAC concept (potentially inappropriate medication+drug interactions+non-adherence to concomitant medication) in people living with HIV infection. Material and methods. Longitudinal prospective multicenter study, conducted between October 2021 and October 2022. Patients living with HIV older than 65 years, on antiretroviral treatment and concomitant drug prescription were included. Demographic, clinical, and pharmacotherapeutic variables were collected. Pharmaceutical care was provided for6 months according to the CMO model in each patient. The main variable was the percentage of patients who simultaneously fulfilled the PIMDINAC concept, comparing the baseline value with the same value at the end of the study. In addition, the percentage of patient’s adherent to concomitant and antiretroviral treatment and the percentage of patients meeting the pharmacotherapeutic targets established for the prescribed medicationat 24 weeks of follow-up were compared. Results. Sixty-eight patients were included. Seventy-two percent were men, with a median age of 68 years. The median number of concomitant drugs was 7. A 60.6% of the patients had polypharmacy. The prevalence of the presence of the PIMDINAC concept decreased significantly (10.3 vs. 0%). In isolation, each of the aspects also decreased significantly (p<0.031). The percentage of patients who met the objectives improved significantly from 48,5 at baseline to 88.2 (p<0.001). Conclusions. The pharmaceutical intervention based onarmaceutical intervention based on the CMO methodology significantly decreased the prevalence of the PIMDINAC concept and increased the number of patients who achieved the objectives, optimising their pharmacotherapy.
... Human immunodeficiency virus (HIV) infection remains one of the biggest global public health issues, 1 with a death toll currently standing at 36.6 million (27.2-47.8 million) worldwide and 1.5 million (1.0-2.0 million) new cases reported in 2020. 1 Although treatment of HIV infection improved greatly after the implementation of antiretroviral therapy (ART) in 1996, 2 patient needs have evolved since then; their quality of life (QoL) and survival have improved, and HIV has become a chronic infection with several associated comorbidities. 3 This high number of comorbidities, most of them related to aging and to the pro-inflammatory action of the virus, 4 has led to a highly medicated elderly population. The increasing use of medication elicits toxicity, lack of adherence, and drug interaction problems. ...
... Most of the interventions that were appropriate and feasible to pursue in the pharmacotherapeutic follow-up were chosen and adapted from the study by Morillo-Verdugo et al 4 (Tables 1 and 3). The other interventions included, detailed in the "Literature Review" section, addressed relevant aspects of health status and patient environment. ...
... investigate the patient's degree of knowledge in digital and electronic abilities to use applications, websites, the patient (depending on their degree of knowledge) about the use of applications and websites for improved understanding of the next visit to the Outpatient Unit in coordination with their assigned gastroenterologist or specialist in infectious diseases or department in charge of appointments level 3 interventions, and level 1 includes level 2 and 3 interventions. b Interventions adapted from Morillo-Verdugo et al.4 ...
Article
Background People living with human immunodeficiency virus (HIV) require specific pharmaceutical care (PC). Although the 2017 Capacity-Motivation-Opportunity (CMO) PC model allows a multidisciplinary approach that focuses on patient needs, it is too complex and presents room for improvement. Objective The aim of this study is to simplify and adapt the previous 2017 PC tool through a multidimensional approach to improve HIV patient care, to prove the validity of the model in real-life patients. Methods The new PC tool was generated by keeping some of the variables of the 2017 document and conducting a literature search. Content validity was determined by a 2-round Delphi methodology with an expert panel of 42 pharmacists. Consensus for the first and second rounds was defined as ≥70% agreement. The tool generated was validated in 407 real-life patients. Results Thirty-seven experts completed the first round of the Delphi survey and 36 the second. No consensus was reached for 3 variables, any of the frequency options and 4 interventions, while the experts agreed not to include 1 intervention in round 1. Consensus to include them was found for all but 1 variable and 1 intervention in round 2. The final tool obtained to select and stratify HIV-positive patients was composed of 9 dimensions divided into 17 variables. The new tool was validated with real-life patients and 3 priority levels were defined. Conclusions and relevance We created a new pyramid of score thresholds to classify patients into priority levels. The new tool simplifies the 2017 model and improves its utility to help HIV-positive patients, owing to its multidimensional approach.
... The sum of the item scores ranges from 11 to 55 which is converted into an overall score between 0 and 10. 24 Patient satisfaction with the PC received, both in the hospital and in the rural pharmacy) was measured using the EVASAF questionnaire, a survey completed by patients about the PC they received in the hospital, or Armando et al questionnaire for PC in rural pharmacy. 25,26 Secondary variables included PC interventions (performed according to the available taxonomy), 27 coordination of care (number of scheduled and unscheduled visits, both in hospital and rural pharmacies, as well as joint visits), clinical variables (compliance with pharmacotherapeutic objectives according to the clinical conditions of each patient), and measurement of individual holistic results (difference in the EQ5D-5L questionnaire score base vs 48 weeks). 28 ...
Article
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Ramón Morillo-Verdugo,1 Rosa Morillo-Lisa,2 Jaime Espolita-Suarez,3 Olga Delgado-Sanchez4 1Pharmacy Hospital Service, Hospital Valme, Área de Gestión Sanitaria Sur de Sevilla, Sociedad Española de Farmacia Hospitalaria, Sevilla, Spain; 2Rural Community Pharmacy, Sociedad Española de Farmacia Rural, Alcalá de Ebro, Zaragoza, Spain; 3Rural Community Pharmacy, Sociedad Española de Farmacia Rural, León, Spain; 4Pharmacy Hospital Service, Hospital Son Spases, Sociedad Española de Farmacia Hospitalaria, Palma de Mallorca, SpainCorrespondence: Ramón Morillo-Verdugo, Hospital de Valme, Avda/Bellavista s/n, Seville, CP: 41014, Spain, Tel +34 955015467, Email ralejandro.morillo.sspa@juntadeandalucia.es
... 8 It consists in an initial stratification of the patients in three levels according to the risk-stratified model for pharmaceutical care in HIV-patients of the Spanish Society of Hospital Pharmacy. 12,13 Each patient received intensive PC corresponding to the predetermined interventions for each level of care. During face-to-face visit to the Hospital Pharmacy Service, a motivational interview was performed for each patient. ...
Article
Full-text available
Background: People living with HIV (PLWH) have significantly enhanced their life expectancy. Consequently, age-associated comorbidities and related health conditions are increasingly found in PLWH complicating their clinical management. Objective: To determine the effect of the capacity-motivation-opportunity (CMO) structured pharmaceutical care intervention for improving clinical health-care results frequently associated to PLWH. Methods: Multicenter, prospective, pre-post intervention study evaluating the CMO pharmacist-led program in adult PLWH was conducted between September 2019 and September 2020 with six months of follow-up. The primary objective of this study was to determine differences in clinical outcomes (total cholesterol, triglycerides, HDL, blood pressure and glycosylated hemoglobin) and variation in the patient's activation measure before and after the intervention. Results: A total of 61 patients were included, 72% were men with a median age of 53 years. After the implementation of the pharmacist-driven program, the percentage of patients with high levels of total cholesterol decreased significantly (18% to 4.9%; p < 0.001). Similarly, the prevalence of patients with high levels of triglycerides, HDL or with hypertension was significantly lower post intervention (13.1% to 6.6%, p < 0.001; 47.5% to 6.6%, p = 0.019 and 24% to 4%, p = 0.009, respectively). The number of patients who achieved the highest activation level increased from 69% to 77.6% (p < 0.001). Conclusion: The CMO program resulted in significantly better health outcomes during the six months following the pharmacist-led intervention as well as improved activation in PLWH.
... 16 Interventions were classified according to the taxonomy for pharmaceutical interventions in HIV+ patients based on the CMO model. 17 ...
Article
Full-text available
Introduction In recent decades, HIV has become a chronic disease with which the HIV specialist pharmacist plays a fundamental role. The traditional pharmaceutical care model followed to date relied excessively on the medication, obviating the uniqueness of each patient. The purpose of this study was to determine the influence and acceptance of a Capacity-Motivation-Opportunity (CMO)-based structured pharmaceutical care (PC) intervention in a multidisciplinary team for improving healthcare results. Methods Prospective single-centre study of a structured health intervention with patients living with HIV who attended hospital between January 2017 and June 2018 for any cause. Pharmacotherapeutic follow-up was applied according to the CMO PC model based on three key elements, namely stratification, motivational interview and new technologies. To assess differences in the variables collected before and after the intervention, Student's t-test or Wilcoxon test, and McNemar’s test were used for quantitative and dichotomous variables, respectively. Results A total of 349 patients were included, 76.1% of which were men. The acceptance of pharmacist intervention by both doctors and patients was high [336 (97.7%) and 321 (93.3%)] and the adherence rate to antiretroviral therapy before intervention was lower than that observed afterwards (85.6%±33.7% vs 96.4%±17.7%; p<0.001). No differences were found between median viral load pre- versus post-intervention [1175 (62.75–26 050) copies/mL vs 274 (76.75–5542) copies/mL], although the undetectability rate was recorded as higher after intervention compared with the previous period [294 (85.5%) vs 274 (79.7%); p<0.001]. Conclusions Our results could help HIV pharmacy clinic specialists to recognise high-risk patients and to develop personalised follow-up care, thereby ensuring good adherence and response to treatments.
... In strategic terms, education must begin at all levels, but especially during degree studies and specialist training. One of the first concepts to be taught would be the approach to classifying the pharmaceutical interventions conducted in each patient, because this would represent a key step in interpreting and explaining them in an unambiguous way 29 . ...
Article
Objective: To propose an updated definition of Pharmaceutical Care based on the Capacity-Motivation-Opportunity (CMO) model and on the key elements and optimal activities for its development that guarantee the highest levels of quality and excellence in this professional activity. Method: The consensus was developed by a working group composed of members of the Spanish Society of Hospital Pharmacy and other pharmacists from different healthcare fields. A literature review of PubMed was conducted of the available scientific evidence on pharmaceutical healthcare models and activities with the greatest impact and ease of implementation. A working definition was developed and the initiatives chosen as key elements were collected and included in each pillar of the proposed model. After creating an initial list of activities and terms, the working group reviewed it and made corrections or proposed new activities. In addition, the definitions of the three key elements of the CMO model were agreed upon: Capacity-Motivation- Opportunity. In order to incorporate all appropriate suggestions and contributions before finalizing the consensus, the final draft was sent to the different scientific, pharmaceutical, and medical societies as well as patient associations with which the Spanish Society of Hospital Pharmacy has a collaboration agreement. Results: The definition of consensual Pharmaceutical Care was "Any professional activity by which the pharmacist is linked to the patient (and/or caregiver) and other healthcare professionals, to attend to the patient according to their needs, setting out strategies to align and achieve the shortand medium-/long-term objectives of pharmacotherapy and incorporating new technologies and the means available to continuously interact with ment was reached on the definitions of the three key elements of the CMO model. Finally, 27 key elements for the development of pharmaceutical activity were identified and included in the three pillars of the model. Conclusions: A new definition of Pharmaceutical Care has been agreed upon that refocuses this professional activity, allowing us to advance within the multidisciplinary working approach toward a longitudinal and multidimensional approach to the patient.
... The taxonomy of the interventions carried out would undoubtedly be one of the first concepts to be taught, being a fundamental element for interpreting and expressing in a univocal way the interventions made to each type of patient. 15 To demonstrate the commitment and self-demand in terms of quality in Spain, the MAPEX project will shortly launch a pioneer worldwide-quality standard, which will certify the activity of pharmacy services and pharmacists following this new way of working with patients. ...
... This system includes a risk-stratified model for pharmaceutical care in HIV-patients of Spanish Society of Hospital Pharmacy, motivational interviews and the use of new technologies. This new model facilitates the optimization of resources and the development of the most appropriate intervention strategies for each of the established levels, identifying those patients who can benefit more from certain interventions of Pharmaceutical Care [22,23]. In this way, pharmacotherapeutic follow-up can be carried out based on the patients' needs and their established pharmacotherapeutic objectives. ...
Article
Full-text available
Objective: The aim of study was to evaluate the influence of pharmacist intervention based on "CMO model", to improve activation in HIV-patients. Methods: Longitudinal, prospective, single-center study. Eligible patients were HIV-infected, taking antiretroviral treatment. The collected data included demographic characteristics, clinical and HIV-related and pharmacotherapeutic variables. The primary outcome was the variation of patient activation measured by Spanish adapted patient activation measure questionnaire. This questionnaire assesses people's knowledge, skills and confidence in managing their own health care. The assessment was performed at the beginning and 6 months after the program start, which consisted of individualized interventions planned in the stratification model, a motivational interview and a specific pharmacotherapeutic follow-up. Results: A total of 140 patients were included. The most common regimens prescribed were based on non-nucleoside plus nucleoside reverse transcriptase inhibitor (44.0%) and more than half of the patients had chronic concomitant medication. The patients who achieved the highest activation level increased from 28.1% to 68.3% (p<0.0005). The relationship between this increase in patient activation and the stratification level that occurs in largest increases in patients with a low need level, where it was observed an improvement in the percentage of patients with high activation from 28.3% to 74.3% (p<0.001) after intervention. The percentage of patients with adequate adherence to concomitant treatment increased by 18.4% (p = 0.035). Baseline PAM values showed high activation for 28.6% (40 patients), intermediate for 43.6% (61) and low for 27.9% (39). Conclusions: CMO model has an important role for patient activation, improving adherence and health outcomes for HIV+ patients.
Article
Background: HIV+ patients have increased their life expectancy with a parallel increase in age-associated comorbidities. Objective: To determine the effectiveness of an intensive pharmaceutical care follow-up program in comparison to a traditional model among HIV-infected patients with moderate/high cardiovascular risk. Method: This was a multicenter, prospective, randomized study of a structured health intervention conducted between January-2014 and June-2015 with 12 months of follow-up at outpatient pharmacy services. The selected patients were randomized to a control group (usual care) or intervention group (intensive pharmaceutical care). The interventional program included follow-up of all medication taken by the patient to detect and work toward the achievement of pharmacotherapeutic objectives related to cardiovascular risk and making recommendations for improving diet, exercising, and smoking cessation. Individual motivational interview and periodic contact by text messages about health promotion were used. The primary end point was the percentage of patients who had reduced the cardiovascular risk index, according to the Framingham-score. Results: A total of 53 patients were included. As regards the main variable, 20.7% of patients reduced their Framingham-score from high/very high to moderate/low cardiovascular risk versus 12.5% in the control group ( P=0.016). In the intervention group, the number of patients with controlled blood pressure increased by 32.1% ( P=0.012); 37.9% of patients overall stopped smoking ( P=0.001), and concomitant medication adherence increased by 39.4% at the 48-week follow-up ( P=0.002). Conclusion and Relevance: Tailored pharmaceutical care based on risk stratification, motivational interviewing, and new technologies might lead to improved health outcomes in HIV+ patients at greater cardiovascular risk.
Article
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Background: The use of highly active antiretroviral therapy has significantly reduced morbidity and mortality, thus increasing life expectancy of human immunodeficiency virus (HIV)-infected individuals, transforming HIV into a chronic disease. Accordingly, there has been an increase in the number of comorbidities concomitantly present in these individuals and also an increased use of comedications, which may negatively impact antiretroviral therapy adherence. These factors can affect adherence to antiretroviral therapy. The role of the HIV clinical pharmacist is essential to achieve therapeutic objectives and enhance adherence. Objective: To determine the influence of the comorbidities and comedications on antiretroviral therapy adherence among HIV-infected patients receiving services from a clinical pharmacist. Methods: We conducted a prospective observational study that included HIV-infected outpatients who attended the pharmaceutical care office of a hospital pharmacy service, which initiated antiretroviral treatment between January 2002, and December 2011. The variables analyzed in the study were demographics (sex and age), HIV transmission mode, and the following variables at the time of comedication collection: hepatitis C virus or hepatitis B virus coinfection, HIV plasma viral load (copies/mL) and CD4+ T-cell count (cells/µL), Centers for Disease Control and Prevention HIV classification, number of hospital admissions and emergency room visits, and antiretroviral therapy-related features (type at baseline, treatment-naïve status, and number of changes since starting antiretroviral therapy). For follow-up at 12 months, antiretroviral therapy adherence was measured through pharmacy dispensing records and the Morisky Medication Adherence Scale (MMAS). Patients were considered adherent if antiretroviral therapy adherence through dispensing records was greater than 90%, and the MMAS score was 4. Other variables were number of comorbidities and number of comedications for other chronic diseases (non-HIV drugs). According to the number of comorbidities, patients were categorized as having multiple chronic conditions (polypathology) if they had 2 or more chronic diseases. Polypharmacy was defined specifically as the use of 5 or more prescription medications in a medication regimen. In addition, a complexity therapeutic index of antiretroviral therapy was calculated for each patient. We determined the risk of drug-related problems using the tool Predictor Index. To identify independent predictors of adherence to antiretroviral therapy, we performed a univariate logistic regression. Afterward, those variables that showed statistical significance in the univariate analysis and those with P less than 0.25 were included in a multivariate model. The sample size was estimated by the Freeman equation. Results: We included 594 patients in the study (80.1% men, median age 47 years). In the univariate analysis, the variables that showed statistically significant relationships with antiretroviral therapy adherence were HIV transmission mode, detectable viral load, CD4+ T-cell count, AIDS-defining condition, hospital admission, antiretroviral therapy-naïve treatment, type of antiretroviral therapy, high risk of drug-related problems, polypathology, and polypharmacy. Multivariate analysis showed that independent predictors of nonadherence to antiretroviral therapy were HIV transmission by intravenous drug use (OR = 0.56, 95% CI = 0.35-0.90), previous treatment with antiretroviral therapy (OR = 0.09, CI = 0.04-0.24), nontreatment changes (OR = 0.12, CI = 0.05-0.31), high risk of drug-related problems (OR = 0.38, CI = 0.23-0.63), and polypharmacy (OR = 0.36, CI = 0.21-0.61). The value of the Hosmer and Lemeshow test confirmed the validity of this model (P = 0.378). Conclusions: Recently, the number of HIV-infected patients with polypharmacy has been higher, increasing the risk of nonadherence. Furthermore, previous treatment with antiretroviral therapy, HIV transmission by intravenous drug use, and high risk of drug-related problems are also associated with lower adherence.
Article
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Objective To assess the effects of facility-based interventions using existing resources to improve overall patient attendance and adherence to antiretroviral therapy (ART) at ART-providing facilities in Uganda. Methods This was an interventional study which tracked attendance and treatment adherence of two distinct cohorts: experienced patients who had been on treatment for at least 12 months prior to the intervention and patients newly initiated on ART before or during the intervention. The interventions included instituting appointment system, fast-tracking, and giving longer prescriptions to experienced stable patients. Mixed-effects models were used to examine intervention effects on the experienced patients, while Cox proportional hazards models were used to determine the intervention effects on time until newly treated patients experienced gaps in medication availability. Results In all, 1481 patients’ files were selected for follow-up from six facilities – 720 into the experienced cohort, and 761 into the newly treated cohort. Among patients in the experienced cohort, the interventions were associated with a significant reduction from 24.4 to 20.3% of missed appointments (adjusted odds ratio (AOR): 0.67; 95% confidence interval (CI): 0.59–0.77); a significant decrease from 20.2 to 18.4% in the medication gaps of three or more days (AOR: 0.69; 95% CI: 0.60–0.79); and a significant increase from 4.3 to 9.3% in the proportion of patients receiving more than 30 days of dispensed medication (AOR: 2.35; 95% CI: 1.91–2.89). Among newly treated patients, the interventions were associated with significant reductions of 44% (adjusted hazard rate (AHR): 0.56, 95% CI: 0.42–0.74) and 38% (AHR: 0.62; 95% CI: 0.45–0.85) in the hazards of experiencing a medication gap of 7 and 14 days or more, respectively. Conclusions Patients’ adherence was improved with low-cost and easily implemented interventions using existing health facilities’ resources. We recommend that such interventions be considered for scale-up at national levels as measures to improve clinic attendance and ART adherence among patients in Uganda and other low-resource settings in sub-Saharan Africa.
Article
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This systematic review assesses the published literature to describe the landscape of mobile health technology (mHealth) for HIV/AIDS and the evidence supporting the use of these tools to address the HIV prevention, care, and treatment cascade. The speed of innovation, broad range of initiatives and tools, and heterogeneity in reporting have made it difficult to uncover and synthesize knowledge on how mHealth tools might be effective in addressing the HIV pandemic. To do address this gap, a team of reviewers collected literature on the use of mobile technology for HIV/AIDS among health, engineering, and social science literature databases and analyzed a final set of 62 articles. Articles were systematically coded, assessed for scientific rigor, and sorted for HIV programmatic relevance. The review revealed evidence that mHealth tools support HIV programmatic priorities, including: linkage to care, retention in care, and adherence to antiretroviral treatment. In terms of technical features, mHealth tools facilitate alerts and reminders, data collection, direct voice communication, educational messaging, information on demand, and more. Studies were mostly descriptive with a growing number of quasi-experimental and experimental designs. There was a lack of evidence around the use of mHealth tools to address the needs of key populations, including pregnant mothers, sex workers, users of injection drugs, and men who have sex with men. The science and practice of mHealth for HIV are evolving rapidly, but still in their early stages. Small-scale efforts, pilot projects, and preliminary descriptive studies are advancing and there is a promising trend toward implementing mHealth innovation that is feasible and acceptable within low-resource settings, positive program outcomes, operational improvements, and rigorous study design
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Objective: To identify and to promote improvements in the quality of the sanitary attention to the HIV+ patients in the Clinical Units of the hospitals in our country, there being included and reinforcing the perspective of Pharmaceutical Care. Methods: To carry out the project, during the period January- June 2012, the following phases were defined. First, a bibliographical review was realized and reading criticizes related to the pathology HIV and quality criteria. Later, a presencial qualitative investigation phase was carried out with the expert participants. The first one was carried out by means of two technologies: the nominal group and a variant of groups of discussion. The application of the technologies was supported by an technical support that allowed the codification and valuation organized. The last phase of the project consisted of a meeting presencial, where there were outlined the aims of the first meeting and put jointly all the work that the subgroups of work had elaborated to agree on the contents. Of the first selection of ideas, the equipment of investigation worked and prioritized those elements that describe and give response to the raised aims. Concretely, the correct definition of the safety and quality indicators in the area of the hospital pharmacist, there being elaborated a card that was describing every aspect to bear in mind for the later measurement of the indicator. Finally, a plan of actions was elaborated to improve the clinical practice synthesized according to his level of priority. Results: Across the methodology of the project, the experts identified the quality criterias in pharmaceutical care procedure. The principal barriers identified were: asistencial pressure, personnel management system's, security and ignorance of the pharmacotherapy, lack of quality culture and difficulties of access to the information. Principals clinical risks identified were: mistakes in the guidelines with the changes of treatments, lack of information of the whole medication of the patient, lack in resources and time adapted to realize the processes, lack of communication between professionals, ignorance of interactions or adverse events. The principal results that were extracted from the analysis of situation were that the priority line of action had to happen for a link between patients, specialists and primary care. It should promote the clinical management of the units of HIV, the access to the information for all the professionals who realize pharmacoterapeutical follow-up to these patients and the major implication on the part of these. Finally, 29 quality indicators were defined in the pharmaceutical care to the HIV+ patient distributed in structure, processes and results and the plan of improvement for the attention and his level of priority considered. Discussion: This document gives response to the increasing demand for homogenizing the clinical practice and establishing common criteria of quality that result a benefit for the sanitary system and, in consequence, for the professionals and the patients.
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A non-blinded randomized controlled trial evaluated efficacy of pharmaceutical care (PC) (Dáder method) on self-reported antiretroviral adherence and undetectable plasma viral load (UPVL), compared with usual care (UC) in HIV-positive patients in Brazil. Most were male (63 %), mean age 40.3 years (SD = 10). After 12 months, 79.8 % of those receiving PC versus 73.8 % in UC were adherent (RR 1.05, 95 % CI 0.95-1.15, P = 0.35), and 50.3 versus 49.8 % (PC vs. UC, respectively) had UPVL (RR 1.08, 95 % CI 0.97-1.20, P = 0.15). Factors associated with self-reported adherence were regular employment, UPVL, no depressive symptoms, and lower pill load in the treatment regimen. Older age, education, CD4 count <200 cells/mm(3), and shorter treatment duration were associated with UPVL. Of 94 reported drug-related problems, 43 % resolved. In subgroup analyses of patients who experienced therapeutic failure and who were non-adherent at the beginning of the trial (N = 50), no differences were found in UPVL (HR 1.35, 95 % CI 0.57-3.19). Only education level (>12 years) was independently predictive of viral suppression (HR 7.47, 95 % CI 1.69-32.91). In conclusion, PC was not associated with increased self-reported adherence to ART or UPVL in patients treated at a health care facility in southern Brazil. The study suggests, however, that PC could be effective for the subgroup of patients with poor adherence.
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Pharmaceutical care (PC) has been shown to improve adherence to therapeutic interventions as well as improve clinical outcomes. We assessed the predictors of non-adherence to clinical follow-up (i.e., not attending three scheduled routine clinical visits over a 1 year period) among patients who participated in a clinical trial of PC intervention on adherence to HIV antiretroviral therapy uptake (the PC-HIV trial). A total of 332 patients participated: median age was 39 years, 63 % were male, 76 % had CD4 count ≥200 cells/mm³, and 52 % had undetectable viral load. About half, 52.7 %, were non-adherent to clinical follow-up. Identified risk factors for non-adherence were male gender, age <40 years, and being in the trial's "control" group (adjusted odds ratio [AOR] 1.67, 95 % CI 1.05-2.66; AOR 2.21, 95 % CI 1.42-3.47; AOR 1.67, 95 % CI 1.07-2.61, respectively). Younger, male patients may benefit from interventions such as PC, which facilitates engagement in care.
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High levels of adherence to antiretroviral therapy (ART) are needed to achieve the desired results. Because pharmaceutical care might contribute to improved adherence to treatment, the aim of this study was to assess the impact of pharmaceutical interventions on ART via a systematic review of randomized clinical trials (RCT). Study selection, data extraction and risk-of-bias assessment were performed independently by two reviewers. A total of 681 studies were located; only four of these met the inclusion criteria and were analysed. The summary measure corresponding to the outcome adherence to treatment was 1·47 (95% confidence interval [CI]: 0·81-2·65), and the measure corresponding to the outcome virologic suppression was 1·95 (95% CI: 0·61-6·25). The results suggest that pharmaceutical interventions might contribute to improved adherence to ART and the achievement of virologic suppression, although the differences between the intervention and control groups were not statistically significant. Pharmaceutical interventions might be more efficacious in populations with low adherence to treatment and greater vulnerability. © 2015 John Wiley & Sons Ltd.
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Objectives: To describe the structure, process and outcomes with which hospital pharmacist performs health care activity, teaching and research about Pharmaceutical Care (PC) in HIV patients in Spain. Methods: Observational, cross-sectional and multicenter study carried out between November 2011-February 2012 in spanish hospitals. The inclusion criteria were: hospitals pharmacy services that dispensed antiretroviral medication to HIV patients. The questionnaire had 41 questions structured in 9 groups: hospital type and person conducting the survey, structure and resources, health care activities, interventions, communication with the rest of the multidisciplinary team, adherence, and quality records, management and pharmacoeconomy and teaching and research. Descriptive analysis was performed. To analyze the existence of statistically significant relationships, we applied fisher test, chi-square or logistic regression. Results: 86 hospitals completed the survey. In 93%, PC consultation was not classified by pathologies. 27.9% provided continuing PC to all patients. Adherence was determined regularly or when pharmacist suspected poor adherence (57.5 %). 20% of hospital s teaching had a program that allowed a high level of training in PC to HIV patient. 52,3% of participating centers had published scientific articles related to HIV. Conclusions: Pharmaceutical care to HIV patients in Spain need to adapt to a new situation. For this, hospital pharmacists have to consider several issues such as chronicity, comorbidity, incorporation of new technologies and the stratification of patients in order to make it more efficient.
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Permanent monitoring of adherence to combination antiretroviral therapy (cART), together with the assessment and management of related adverse events, plays a key role for optimised management of HIV infection. In our HIV outpatient clinic a dedicated pharmacist provides direct drug distribution and accountability, and gives information on administration mode, possible side effects and drug interactions. A survey card regarding cART adherence and adverse drug reactions (ADRs) is administered to all patients. All figures are recorded in an electronic database. In an ad interim analysis 659 consecutive patients' data were evaluated, of whom 74% were fully adherent to cART. A lower adherence rate was found to be correlated with the presence of concurrent medications, and with the increasing number of daily cART tablets/capsules. A significant impact of cART adherence on a favourable course of the main laboratory surrogate markers of HIV disease progression (CD4+ T-lymphocyte count and HIV viral load) was also observed. Darunavir-containing cART was related to a lower incidence of early gastrointestinal and neuropsychiatric disturbances and also a reduced perception of morphological/physical changes. A multidisciplinary approach based on strict interaction between pharmacists and infectious diseases physicians may significantly improve cART adherence and the monitoring of adverse events, making a considerable contribution to the better management of HIV-infected patients.