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Farmacia Hospitalaria

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

Farm Hosp. vol.41 no.1 Toledo ene./feb. 2017

http://dx.doi.org/10.7399/fh.2017.41.1.10463 

Originals

Pharmacotherapy follow-up of patients under treatment with biologic agents for chronic inflammatory systemic conditions: an agreement among hospital pharmacists for the tandardized collection of a minimum set of data

Miguel Ángel Calleja Hernández1  , Alicia Herrero Ambrosio2  , María Jesús Lamas Díaz3  , Julio Martínez Cutillas4  , José Luis Poveda Andrés5  , Belén Aragón6 

1Hospital Virgen de las Nieves, Granada. España

2Hospital Universitario La Paz, Madrid. España

3Complejo Hospitalario Universitario de Santiago, Santiago de Compostela. España

4Hospital Universitario Vall d´Hebron, Barcelona. España

5Hospital Universitario y Politécnico La Fe, Valencia. España

6Merck Sharp & Dohme. España

Abstract

Background and objective:

The objective of this study was to reach a consensus on the minimum set of data that would allow to optimize the pharmacotherapy follow-up of patients on biologic agents for chronic systemic inflammatory conditions, through structured and standardized collection with an electronic tool in the hospital pharmacy.

Materials and method:

A scientific committee was formed (n = 5 hospital pharmacists). The Delphi Technique was used, 2 rounds of consultation by e-mail for hospital pharmacists. A structured questionnaire was used, based on a bibliographic review and recommendations by the scientific committee; 37 statements were assessed with the Likert 5-point scale (1= “Strongly Disagree”; 5= “Strongly Agree”). Consensus was reached when 75% or more of panel members assigned a score of 1-2 (rejection consensus) or 4-5 (agreement consensus) to the matter reviewed. Descriptive statistical analyses were conducted.

Results:

The study included 21 hospital pharmacists (70 were invited, there was 70% response). Consensus was reached for 100% of statements. The minimum set of data was agreed upon, as well as the recommendations that the pharmacist had to collect and make during visits: to document the health status, health-related quality of life, changes in treatment compliance and in patient autonomy, as well as the conditions to make feasible the systematic collection of the minimum data set.

Conclusions:

There is consensus among hospital pharmacists about a minimum data set to be collected, through an electronic tool, which will order, standardize and structure the pharmacotherapy follow-up of patients with chronic inflammatory conditions on treatment with biologic agents in the Spanish public health system.

KEYWORDS: Pharmacotherapy follow-up; Hospital pharmacy unit; Systemic inflammatory condition; Tumour necrosis factor-alpha; Consensus; Delphi

Contribution to scientific literature

This study used the Delphi Technique in order to reach consensus between Hospital Pharmacists regarding the minimum set of data, collected in a simple, systematic and standardized way, that would allow to optimize the pharmacotherapy follow-up of patients with chronic systemic inflammatory conditions (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease and psoriasis) currently receiving biologic agents in Spain.

Introduction

Pharmacotherapy follow-up is defined as an intervention aimed at preventing, detecting and solving negative outcomes associated with medication (NOMs) as well as drug-related problems (DRPs)1. It requires involvement and commitment by the Pharmacist, in the outpatient and hospital settings, in terms of being responsible for solving any difficulties reported by patients in this sense, and having a continuous, structured and adequate intervention. This is based upon an active collaboration with patients and the rest of healthcare teams, with the objective of achieving benefits not only at clinical and therapeutical levels, but also in terms of health-related quality of life (HRQoL)1.

The DADER method offers simple guidelines to the Pharmacist in order to conduct a structured pharmacotherapy follow-up, as well as to design a plan of action with the patient, in order to promote intervention continuity over time2. This method has been widely used for setting up pharmacotherapy follow-up, particularly in the outpatient setting, and for chronic patient care3,4. Some initiatives with similar objectives have been conducted for various conditions, such as hypertension, diabetes mellitus, rheumatoid arthritis, asthma or depresssion, among others; their purpose is that the Pharmacist can be aware of the essential aspects of health conditions and the medications used for their treatment5,6.

At the same time, there is evidence demonstrating that structuring Pharmacist intervention in chronic patient follow-up is more effective and less costly than the usual non-structured follow-up, even in the setting of geriatric institutions, where one of its benefits is that it leads to a significant reduction in the average number of medicines prescribed to polymedicated elderly patients7.

A systematic collection of data about the medication received by patients seen and followed up at hospital, with a standardization of the different existing pharmacotherapy follow-up methodologies, restructuring the activities included, streamlining the resources available, and prioritizing their basic functions, would lead to a significant improvement in the pharmacotherapy follow-up of patients at hospital8. Additionally, this would be useful in order to promote awareness regarding the clinical role of the Pharmacist in the hospital setting.

Those patients with chronic inflammatory conditions, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease or psoriasis, require thorough attention in terms of the medication received, particularly in the most severe forms of their disease, and when therapeutical regimens become more complex9,10. It is essential to reduce the variability in the use of biologic agents, as well as to watch adherence to biologic treatment, if the objective is to achieve an optimal control of the disease, to recover the functional ability of patients and to improve their HRQoL, while at the same time there is a reduction in the risk-benefit rate of treatment, pharmacological costs are kept low, and equality is ensured in the access to those therapeutic options available11.

The study described here was born out of the need expressed by Hospital Pharmacists about having a minimum set of data, collected in a simple, structured and standardized way, that would allow to optimize the practice of Pharmacists at hospital, as well as the pharmacotherapy follow-up of patients receiving biologic agents for their chronic systemic inflammatory conditions. Given that this standardization requires a wide consensus among the main participants on the adequacy and feasibility of data to be collected, it was suggested to use the Delphi Technique for Consensus, and to explore the opportunity of incorporating said data in an electronic tool specially designed for this aim.

Methods

The Delphi Technique was used in order to determine the degree of agreement existing between Hospital Pharmacists in terms of the minimum set of information to be considered in the pharmacotherapy follow-up of patients receiving biologic agents for chronic inflammatory systemic conditions; and a series of steps were followed, as shown in Figure 1.

Figure 1 Project Outline. 

The Delphi Technique consists in an iterative questioning process used for reaching a common point of view regarding different aspects of the stated problem, in order to define potential lines of action12. The rounds of questions were conducted by e-mail, and were designed to meet four essential requirements inherent to the technique13. Firstly, the rounds of questions allowed a repeated and structured confirmation of the opinions by the panel members. E-mail communication allowed to reach participants in distant geographical areas, to facilitate participation because each respondent could answer the questionnaire at the time of day more convenient for them, to keep confidentiality regarding answers, and to reduce the influence of the most dominant individuals over the rest of the group. Finally, the controlled return of answers in the second round reduced the group effect to the minimum, and allowed the statistical aggregation of groups with similar answers.

The Delphi Technique is widely used in the healthcare setting, particularly in studies aimed at exploring the potential scope of implementing policies14, knowledge15, procedures16 and new health technologies17.

Scientific Committee

A scientific committee was created for the project, formed by five Hospital Pharmacists with experience in the use of biologic agents since their initial introduction in the Spanish Health System. These Pharmacists were expert in the therapeutical management of patients with systemic inflammatory conditions, and were aware of the needs in this group regarding pharmacotherapy follow-up, through the experience transmitted by their team works; they were also promoters of research, education and divulgation in their work centres, and were responsible for decisions around the implementation of new technologies and procedures in their professional settings. One characteristic feature of the scientific committee members was their active participation in academic, political and institutional initiatives in the matter of interest, through scientific societies, and throughout the country.

The scientific committee was in charge of supervising the project development, assessing the adequate use of the information collected in the literature review for preparing the questionnaire to be used in Delphi, defining its characteristics, facilitating the identification of panel members, interpreting its outcomes and encouraging its divulgation.

Literature Review

We reviewed the literature regarding the characteristics of pharmacotherapeutic follow-up in patients treated with biological agents as well as the tools designed to systematize and standardize such follow-up. We found 7 publications from which information could be extracted on: the elements that should constitute a tool for pharmacotherapeutic follow-up, main characteristics of a guide for data collection and storage in pharmacotherapeutic follow-up, main opportunities for optimization of follow-up Pharmacotherapeutic and consensuses in the management of inflammatory systemic diseases for its pharmacotherapeutic follow-up. We also identified 7 publications on Health Related Quality of Life, preferences for treatment and satisfaction with the treatment of patients with inflammatory diseases. Finally, the technical files of the biological agents were reviewed with indication in the treatment of the diseases of interest.

Contents of the Delphi Consultation:

Questionnaires

Based on the findings of the literature review and the recommendations by the scientific committee, a preliminary version of the first questionnaire to be used in the Delphi Consultation was generated.

This version was assessed by a team of five independent Hospital Pharmacists, selected by the scientific committee, and who would not take part in the subsequent consultation, in order to determine the adequacy of the questions included for the project objective, the clarity of their wording, and the convenience of the scoring scale used. After this test, the first questionnaire included 37 statements classified into two information blocks. The first block referred to the pharmacotherapy follow-up of patients, divided into first visit to the Hospital Pharmacist (14 statements) or subsequent visits (17 statements), and the data to be used to measure the outcomes of pharmacotherapy follow-up (6 statements); the second block explored the scope and utility of an electronic tool implemented to structure the activity by Hospital Pharmacists for patients on biologic treatment for their inflammatory systemic conditions (11 statements). All the questions were written as positive statements, and panel members were asked to assign a score to their level of agreement with them, using a 5-point Likert Scale (1=Strongly disagree; 5=Strongly agree).

The second round questionnaire included all those questions for which there was no consensus in the first round. The second questionnaire was personalized for each participant; thus, the score assigned by each participant in the first round was stated for each question, as well as the score by the majority of the other participants. Panel members were asked to consider the likelihood of changing their previous score in order to get closer to the position by the majority, or to suggest any changes that they considered relevant for said question.

Selection of panel members for the Delphi Consultation

Given that the validity of Delphi findings depends mostly of the experience of the persons answering the questions18, the scientific committee of the study recommended a group of Hospital Pharmacists based on selection criteria similar to those described for the scientific committee. Special attention was paid to their affiliation to hospitals of reference in the treatment of moderate and severe systemic inflammatory conditions, with a wide use of biologic agents, and working in Pharmacy Units that were active in the pharmacotherapy follow-up of these patients.

Sample size

Regarding the number of panel members who should participate in a Delphi Consultation, there is little coincidence among authors about the minimum number of participants19,20. Taking as reference other consensus conducted21,22, it was considered that a minimum number of 20 panel members would be enough for this study, taking into account that they had a thorough knowledge of daily practice.

Invitation and participation of panel members

The scientific committee members presented a list of persons adequate for being members of the Delphi Expert Panel, and these were contacted and invited to take part in the consultation, after being explained the background and purposes of the study. Once they accepted participating, the first questionnaire of the consultation was sent to them, and they were given two weeks to answer. If there was no response after the third weekly reminder, it was considered that the panel members had turned down their participation. The same procedure was followed in the subsequent round. The first round of consultation was conducted from October, 13th to October, 27th, 2014; and the second round was conducted from November, 17th to November, 30 th, 2014. Questionnaires for both rounds were sent and collected as e-mail attachments. The panel members remained anonymous from one another during the entire consultation process.

Definition of Consensus

It was considered that consensus had been reached when 75% of participants or more gave a 1-2 score, called rejection consensus, or 4-5, called agreement consensus. When 75% of participants or more gave a score of 3, it was considered that the statement was in indeterminacy. If the participants were distributed among the three answer categories, without reaching 75% in any of them, it was considered that consensus had not been reached for said question.

Data Analysis

After reviewing that all data had been adequately collected in the questionnaires, the scores given by panel members were included in a Microsoft Excel 2007 data-base. The frequency and rates of answers were calculated, and the scores given by the set of panel members to each question were described.

Results

Twenty-one (21) Hospital Pharmacists participated, out of the 30 initially invited (response rate: 70%), from hospitals in eleven autonomous communities. Between the first and the second consultation rounds, consensus was reached in 100% of the questions stated. It was necessary to clarify two statements, in order to reach an agreement on them in the second round. Tables Table 1 to Table 3 show the questions presented, as well as the proportion of panel members with scores between 4 and 5 (partially / strongly agree) at the end of the Delphi Consultation.

Minimum set of data to be collected during the first visit to the Hospital Pharmacist

According to the consensus by panel members, at least the birth date and gender of the patient should be collected during the first visit (sociodemographical variables), as well as a series of anthropometric, clinical and treatment data (Table 1), including weight and height, level of autonomy, date of diagnosis of the basal condition, and referral unit; if it is the first time the patient receives treatment with biologic agents (naïve patient), their current treatment and previous treatments for the condition of interest, both with biologic agents and with other molecules. According to the perception by panel members, enough details should be collected to allow evaluating the therapeutical regimen prescribed (molecule, dates of initiation and ending, dosing regimen and way of administration, reason for discontinuation).

Table 1 Minimum set of recommendations to be made at the first visit 

There was agreement about using the EQ-5D questionnaire and AVS to measure the patient-reported perception of their overall health status, as well as using specific questionnaires by condition, such as Psolife (HRQoL Questionnaire for Patients with Psoriasis), IBDQ (Inflammatory Bowel Disease Questionnaire), AsQol (Ankylosing Spondylitis Quality of Life) or Qol-RA (Quality of Life Measure for Rheumatoid Arthritis).

There was consensus about a minimal set of recommendations that Hospital Pharmacists should make during this visit, including an explanation of the indication and the expected time of response with the biologic drug, guidelines for prevention and action against potential adverse effects associated with the current biologic treatment; main contraindications and precautions that should be taken into account when using it, and practical information about medication storage and administration, as well as reminders for subsequent appointment dates (Table 1).

Minimum set of data to be collected in subsequent visits to the Hospital Pharmacist

There was agreement that, in subsequent visits and taking the previous visit as reference, patient weight and level of autonomy should be documented, in order to detect any significant changes that required a review of the therapeutic indication; also any modifications prescribed for the treatment with biologic agents and other drugs received by the patient. The adequate compliance of the treatment prescribed should also be verified, by counting the doses since the previous visit; it should be assessed if any adverse effects caused by the biologic agent had appeared since the last visit. The majority of panel members coincided that HRQoL should be measured with the generic EQ-5D questionnaire and its AVS, as well as with specific questionnaires for each condition in subsequent visits, with the purpose of recording their evolution over time; at the same time, it was considered adequate to complete the Morisky-Green Questionnaire to monitor treatment compliance (Table 2).

Table 2 Minimum set of data to be collected in subsequent visits 

There was coincidence that, in the second visit, there should be a verification of the precautions required for using biologic agents, while a percentage of participants (4.8%) alerted about the importance of collecting a balanced amount of data, as well as ensuring their record. There has been unanimous agreement about the need to document any interventions by the Pharmacist in all visits.

Frequency of visits

According to the suggestions by panel members in the first round, the frequency of visits should depend on whether patients are on treatments with long duration, without changes and controlled disease, or they are naïve patients, or in the initial stage of a new treatment, or with recent changes in treatment. There was consensus, in the second round, that one visit every six months would be adequate for the first scenario and every three months in the latter scenarios (95.2%).

When writing about this aspect, it was clarified that the recommendation about the frequency of patient appointments should be for guidance only, and that professional judgment should prevail over this recommendation.

Measures to assess the outcomes of structuring pharmacotherapy follow-up

The adequate treatment follow-up, measured with the Morisky-Green over time, as well as the number of interventions by the Hospital Pharmacist in each visit, either requesting treatment review by the treating physician, providing specific information, or making specific recommendations for an adequate use of biologic agents to the patient, were unanimously acknowledged as feasible measures to demonstrate the optimization of pharmacotherapy follow-up at hospital (Table 3). Consensus was also reached about the importance of documenting the evolution of the autonomy level of the patient, particularly when it can be associated with the use of biologic agents, as well as the scores obtained with EQ-5D and its AVS, and in the specific HRQoL questionnaires, as indicators of a better structured pharmacotherapy follow-up.

Table 3 Measures to assess the outcomes of structuring the pharmacotherapy follow-up 

Feasibility of collecting the minimum set of data in daily practice at the Hospital Pharmacy

In the first round, only 57.1% of participants agreed partially / strongly with the feasibility of collecting the set of data recommended in daily practice at the Hospital Pharmacy. Various participants highlighted the importance of having an electronic tool integrated into the computer program of the hospital; and that only those changes occurred since the previous visit should be documented in follow-up visits. Including these considerations, 95% of panel members agreed partially or strongly in the second round with the feasibility of the suggested data set collection.

Objectives to be met with the definition of a minimum set of data to be collected at the Hospital Pharmacy

One hundred per cent (100%) of participants agreed partially / strongly that the objective of defining a minimum set of data, integrated in an electronic tool into the hospital computer platform, should be the standardization of treatment follow-up for patients with a chronic systemic inflammatory disease on biologic treatment. Reaching an objective of this nature should contribute to the optimization of the healthcare quality provided to this group of patients.

Utility of an electronic tool for pharmacotherapy follow-up

In total, ten questions referred to the utility of an electronic tool that collected this minimum set of data for pharmacotherapy follow-up. One hundred per cent (100%) of participants stated that this would solve unmet needs in Hospital Pharmacy, such as pharmacotherapy follow-up standardization; it would facilitate decision making by the Hospital Pharmacist; it would structure the collection of relevant information consistently and independently from user or patient; it would be useful for an early detection of DRPs and a more effective prevention of the development of NOMs, and it would lead to the creation of a prospective registry of the use of biologic agents in specific conditions, allowing the documentation of any changes, incidences or events associated with treatment, the condition or the patient.

Patient-perceived outcomes of the structured pharmacotherapy follow-up

The majority of participants agreed partially / strongly that a structured and systematic pharmacotherapy follow-up would contribute to improve the adherence of patients to treatment, as well as the perception of their overall health status. This type of interventions would ensure a more personalized follow-up for each patient.

Discussion

The outcome of this project is the consensus of Hospital Pharmacists regarding a minimum set of data that will allow to order, standardize and structure the pharmacotherapy follow-up of patients on treatment with biologic agents for systemic inflammatory conditions in the Spanish Public Health System. There is agreement about the adequacy of this collection to cover a need still unmet in Hospital Pharmacy practice, and about its feasibility and potential contribution to an optimization of Pharmacy Care for this group of patients. The simplicity of the data set recommended will ensure that these can be easily collected by the different Hospital Pharmacy Units, making it possible to transfer, compare and analyze the results obtained.

Different studies have applied the Delphi Technique in order to define the characteristics of various models for pharmacotherapeutical action targeted to preventing drug-related errors in populations that are particularly vulnerable. This is the case of a 50-expert panel that determined by consensus the set of aspects that should be considered at the time of validating a paediatric medical prescription23. The outcome was a pharmacotherapeutical action model with a series of items grouped into three levels of complexity: basic, intermediate and advanced. The items included in the basic level of the model included sociodemographical variables, such as name, age and gender; anthropometric variables, such as weight and body surface, and other variables associated with the appropriateness of prescription, such as the adequacy of the way of administration, the doses prescribed, and the confirmation of drug interactions, among others. In another publication, a group of 19 experts reached a consensus about the aspects associated with the safety of prescription forms, which should be assessed in order to reduce the incidence of drug-related errors in newborns and paediatric patients24. The methodology used and the results obtained in these studies are very similar to the ones in this study.

There is evidence about the multiple clinical9 and therapeutical8 benefits in patient-perceived health results25; as well as economic benefits7, derived from an adequate pharmacotherapy follow-up.

In this sense, it has been demonstrated that the proactive action by the Hospital Pharmacist will not only contribute to an effective identification and prevention of drug-related problems, both during hospital admission and at discharge and during the subsequent follow-up, but also that their intervention will allow to reduce the time of hospital stay, rehospitalizations, and the development of secondary conditions26,27.

On the other hand, it is necessary to demonstrate the value added to the healthcare provided by structuring and standardizing patient-follow-up.

The experts understood that the demonstration of the variations in patient attitude towards treatment, which appeared in the answers to the Morisky-Green Questionnaire, as well as the record of the number and nature of the interventions by the Hospital Pharmacist in order to guide, structure or correct treatments with biologic agents, must be used as measures of their intervention outcomes.

Along this line, a group of 26 panel members agreed recently on a set of eight indicators for Hospital Pharmacist action; these included the design of plans for pharmacotherapy follow-up, the provision of education on the condition and the medication, and the promotion of a proactive attitude towards patient treatment follow-up28.

The inclusion of questionnaires, both generic and specific, to measure HRQoL as part of the minimum set of data to be considered for the pharmacotherapy follow-up of patients with inflammatory systemic conditions on treatment with biologic agents, represents a differentiating feature in this consensus. It seems essential to document any changes occurring in this health outcome as an indicator of the adequacy of treatment and pharmacotherapy intervention, given the important compromise of HRQoL in this group of patients, and the significant improvement experienced with the use of biologic treatments29.

An effective pharmacotherapy follow-up will contribute to an improvement in HRQoL, as well as in other patient-perceived results such as treatment compliance and satisfaction, and also in healthcare costs30.

However, the outcomes of this study should be interpreted in the context of its limitations. The Delphi Technique allows to estimate what seems to be more acceptable, acknowledged and feasible, according to the shared opinion by the group of panel members, However, and given that these are agreements regarding healthcare, these outcomes obtained today should be reviewed and updated according to daily practice findings and the dynamic nature of health and its variations over time.

Finally, according to panel members, the inclusion of the minimum set of data in an electronic tool integrated into the hospital computer systems would facilitate their structured collection, as well as their standardization and continuous record over time.

As a conclusion, a minimum set of data has been defined by consensus, which should be collected for a structured and standardized pharmacotherapy follow-up of patients with systemic inflammatory conditions on treatment with biologic agents. This guarantees to facilitate decision making, to structure the collection of relevant data in a consistent manner, to contribute to an early detection of DRPs and a more effective prevention of NOM development, and to allow the creation of a prospective registry of the use of biologic agents for these conditions.

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Financiación Este proyecto ha sido financiado por Merck Sharp & Dohme (MSD)

Received: February 20, 2016; Accepted: October 11, 2016

* Autor para correspondencia. Correo electrónico: mangel.calleja.sspa@juntadeandalucia.es (Miguel Ángel Calleja Hernández).

Conflict of interests

Belén Aragón works in MSD; her coauthors received fees for their participation in the project and preparation of the manuscript. However, the authors declare that both the project outcomes and everything described in the manuscript is the result of their free expression, preparation and interpretation of findings.

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