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

¹ Unidad de Gestión Clínica de Farmacia. Hospital Universitario de Valme. AGS Sevilla-Sur.
² Facultad de Farmacia. Universidad de Sevilla. Spain.

Correspondence

 

 

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ABSTRACT

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 recategorize. 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.

Key words: Pharmaceutical care; HIV; Stratification; Motivation; M-Health.

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RESUMEN

Objetivo: Consensuar una propuesta de intervenciones farmacéuticas y llevar a cabo su taxonomía de clasificación según el modelo de Atención Farmacéutica-CMO (Capacidad-Motivación-Oportunidad).
Método: Estudio realizado entre marzo-mayo de 2016. Se definieron 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 expertos, 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 intervenciones 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 consecución de objetivos farmacoterapéuticos le daría.
Las intervenciones se clasificaron en función del grado de acuerdo. Una vez consensuadas, se realizó la taxonomía definitiva.
Resultados: Se consideraron finalmente 18 artículos. La propuesta inicial incluyó 20 intervenciones farmacéuticas clasificadas siete en Capacidad, ocho en Motivación y cinco en Oportunidad.
Las intervenciones consideradas de mayor importancia y prioridad 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 modelo y, así, profundizar en la investigación y la mejora asistencial.

Palabras clave: Atención farmacéutica; VIH, Estratificación; Motivación; M-Salud.

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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 pharmaceutical interventions published over recent years, the panel of experts involved has reached a consensus regarding the taxonomy, which would include the interventions 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 conducted in this type of patients, and on the other hand, also to conduct comparisons based on the different studies designed to this aim in different patient care settings and with different populations.

 

Introduction

In recent years, there has been a major transformation in terms of HIV infection: it was a lethal disease, but now it is considered a chronic condition. Due to improvements in therapeutic arsenal and patient care, currently patients have a better survival and quality of life. Regarding 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 reconsideration of patient care models¹. On the other hand, the profile of the naive patient who initiates treatment has also been changing in recent years: typically these are young patients, with a higher education level than previous patients, and a higher and better management of new technologies^2,3.

HIV has been, and still is, a "core" condition for Hospital 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 Model for HIV patients" had a great impact on our profession⁴: 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 pharmacotherapeutical follow-up for this type of patients.

There have been many national and international original articles published since then, including systematic reviews and meta-analyses, demonstrating the usefulness of the Hospital Pharmacist work for HIV+ patient follow-up within a multidisciplinary team, improving the health outcomes of these patients^5,6. That model was created by analyzing the challenge represented by the first direct and periodical contact with patients in Pharmacy Units, the desirable integration with the multidisciplinary 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 objective 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 completely 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 processes and outcomes of pharmacotherapeutical follow-up for HIV patients. The outcomes of that "Origen" Project, reached after the involvement of 86 hospitals, were very revealing at showing that the traditional model had touched its ceiling and a new model should be reconsidered⁷.

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 essential characteristics in the classical model: Costs (the main objective in the primary model), Medication (antiretroviral) as the pivotal axis of our action, and the Organization (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), Motivation (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 adverse 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 interventions that have been historically published and conducted based on this model, as well as their importance, feasibility and prioritization.

The main objective of this study is to reach a consensus 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 conjunction "AND" and the disjunctive "OR" as logical operators, and including [("pharmaceutical care" AND "HIV" AND "Adherence" OR "patient compliance") ("pharmaceutical 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 English or Spanish from 2001 until today, which met the following criteria: studies where pharmaceutical interventions were established for the improvement of any health outcomes in HIV patients, or studies comparing the utility and outcomes of different pharmaceutical interventions in HIV patients.

Additionally, all those manuscripts where interventions 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 Methodology 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 interventions in HIV+ patients, with the aim to standardize those actions with higher benefit for patients and their environment. 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 objective 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 following a previously established protocol, in order to prevent any potential bias. The essential selection criteria 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 based on the interventions extracted during the bibliographic review process. These interventions were tentatively classified according to the CMO Model. Each intervention 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 initial 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 action within the model. Additionally, experts were asked which importance and priority they would assign to this intervention in order to conduct an adequate therapeutic 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 achievement 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, after 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 following definitions: adequate (median 7-10), dubious (median 4-6 or any median with disagreement), inadequate (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 bibliographic review. Out of these, 230 articles were excluded because the inclusion and exclusion criteria had not been met. The reasons for exclusion were: Pharmacokinetics and Pharmacodynamics studies (21), interventions not conducted by a Hospital Pharmacist (19), pharmacoeconomic 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.

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 model. Seven interventions were assigned to Capacity, eight 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 interventions were accepted by 13 experts (100%), 4 interventions 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 importance 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 Coordination, 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+ patients 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 cornerstones 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 pharmacotherapeutical 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 pharmacotherapeutical objectives. This is precisely another of the great changes in the model: talking about pharmacotherapeutical 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 antiretroviral treatment, safety and adherence, the basis of the traditional model is already well established; but it is necessary 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 interventions proposed, regarding safety, commitment, and the traditional assessment of treatment adherence. These aspects are: the ability to generate "internal discrepancies" in our patients, and the ability to "face resistances" 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 antiretroviral treatment can have some impact¹³, this new approach will be very helpful for polypharmacy management. However, the low availability of tools to assess patient motivation is very striking; the "Patient Activation 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 assessment should be expanded in order to include the new primary and secondary adherence approach. Now, primary 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 traditionally 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.

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 Information and Knowledge Technologies (IKTs), in order to face patient needs; and this will also appear outside our consultations. There are a high number of experiences demonstrating the contribution of value from these tools for the patients in the overall population, also the elderly, 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 required 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 quantitative 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 pharmaceutical 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 methodology in other Pharmacy areas should be assessed.

Summing up, the taxonomy agreed upon by consensus and presented here will allow to classify the pharmaceutical 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 Miguel Servet, Zaragoza (Aragon). Aitziber Illaro Uranga. Hospital Pharmacist. Pharmacy Unit - Hospital Universitario 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 (Andalusia). José Manuel Martínez Sesmero. Hospital Pharmacist. Pharmacy Unit - Complejo Hospitalario de Toledo, (Castille-La Mancha). Javier Sánchez-Rubio Ferrández. Hospital Pharmacist. Pharmacy Unit - Hospital Universitario de Getafe (Madrid). Sergio Fernández Espinola. Hospital Pharmacist. Pharmacy Unit - Hospital de Antequera, 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). M^a Paz Valverde Merino. Hospital Pharmacist. Pharmacy Unit - Hospital Universitario de Salamanca (Castille and León). M^a José Huertas Fernández. Hospital Pharmacist. Pharmacy Unit - Hospital Universitario Puerta del Mar, Cádiz (Andalusia). 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, Tenerife (Canary Islands).

 

Funding

This document has not received any funding for its design and development.

 

Conflict of Interests

None

 

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Correspondence:
Correo electrónico: ralejandro.morillo.sspa@juntadeandalucia.es
(Ramón Morillo Verdugo).

Recibido el 24 de junio de 2016;
aceptado el 14 de septiembre de 2016.