Revista Colombiana de Ciencias Químico-Farmacéuticas

INTRODUCTION

The activities of the pharmacist have introduced a significant change since the 1990s, which has been described by Hepler as a change in the paradigm of the profession. However, it must be clarified that this implies a different conception of the health-disease concept, the drug, and the process itself of pharmaceutical care.

The main activity of the new professional pharmacist was the artisanal manufacture and personalized distribution of the medicine in the seventeenth century. This situation remained until the end of the 19^th century when the industrialization processes reached the field of medicine, and the pharmacist had to leave the apothecary aside to make way for the pharmacy-drugstore. In the middle of the 20^th century, due to a series of political, social, and economic facts, the professional pharmacist faces a different relationship with people who use medicines, which we will call in this document "Pharmaceutical Care Activities (PCA)." The reason for the shift in the relationship was the pharmacist's role: in the pharmaceutical industry to design new pharmaceutical forms, production, quality control of medicines, and in the community pharmacy to the distribution, procurement, and dispensing of medications ^[1-3]. This relationship was born, at least in part, with the aim of controlling and reducing the medicine's toxic effects and improving their effectiveness when their production and availability in the market increased. Although it was initially insisted that this constituted a commitment and a responsibility of the pharmacist with the patient to maximize the chances of therapeutic success with minimal adverse effects; the economic background in this undertaking is perceived as such ^[4,5].

Hepler attributes a change to this new activity in the paradigm of the profession. An affirmation that is necessary to clarify since this concept acquires different meanings, for example, for Plato the paradigm is a case of the model or the rule; for Aristotle, is the argument that is destined to be generalized; for Kuhn, they are the models that establish the form in which the scientific investigation is realized, these models are constituted by laws, theories, application, and tools necessary for their demonstration; for Morín, it is "... a mental and cultural structure which one looks at the reality, and because of being cultural, are unconscious"; and finally, for the Social Sciences, it consists of a "set of opinions and beliefs that make up the general image or concept of the world that a person, time, or culture has, from which a person interprets its nature and everything that exists" (world's view). In any case, every paradigm contains hidden a small nucleus of postulates and principles of knowledge; which rules and controls the entire cognitive field of reference, and constitutes the set of beliefs, imaginaries, discursive practices, concepts, ideas, recognized values, techniques, and truth criteria of a community ^[6-9].

For the development of PCAs, the concepts of 'health' and 'health care' must be taken into account. In one hand, it is necessary to clarify that 'health' is not the antagonist of illness and it is rather constituted of a relational matter that affects the daily life of social groups, and it is part of a process in which subjectivity is constructed collectively. The social response to the disease (care) is also a common and frequent fact that contributes to the formation of an essential structure for the production and reproduction of society ^[10,11]. The disease and the response that it originates are fundamental processes in all social systems and groups that produce representations and practices, and constitute a piece of knowledge that allows them to understand, confront, solve and, in many cases, pretend to eliminate diseases. For that reason in the social medicine field the term, Health-Disease-Care process is used since these events cannot be disconnected ^[12,13]. Concerning the care process for our case, it is composed of drugs and pharmaceutical care (PC). For the first, drugs are considered a chemotherapeutic agent that presents an ontological dichotomy (merchandise and symbol) that is studied from different perspectives: experimental pharmacology, clinical trials, pharmacoepidemiology, and pharmaceutical technology, among others. About PC, it has been established as the paradigm (according to Plato and Aristotle) of PCA. The concept was proposed in 1990 by Hepler ^[4], in the United States from a term used by Mikeal et al. in 1975 as an approximation of the definition analogous to medical care, then it was spread to Europe and Latin America, and since that moment, it has been subject to changes and proposals, mainly methodological ones. Both the health-disease concept and the care activities have undergone transformations throughout the human history depending on the current paradigm.

It is proposed to reflect on the paradigmatic basis, concept, approaches, and methodology of the PCA to contribute to the construction of the knowledge object in a different way that recognizes and stimulates the existence and manifestations of diverse perspectives, to understand and to debate them, for which the following elements are required: 1) To recognize and identify the person as an individual immersed in complex social relationships that make him/her more than the sum of cells, tissues, organs, and systems, 2) To use the term cuidado ("care" in Spanish) that includes many other aspects such as commitment, responsibility, and needs assessments that left out in the term atención (current translation into Spanish of the word "care"), 3) To construct the drug related problems (DRP) from the perspective of social medicine and taking into account the priority of the patient's needs according to the proposal of Maslow, and 4) To propose the use of social epidemiology and other qualitative methodological approaches (participatory action research, for example) for research and professional practice that allow individual and collective interventions from the social paradigm.

METHODOLOGY

Design: a scoping study was carried out using tools of the Reviews of Reviews.

Question for the review: what are the approaches, methodologies, and results obtained in the different systematic reviews and meta-analyses on PCAs?

Inclusion and Exclusion Criteria: papers that had a SR or Meta-Analysis (MA) as a research design, which was already published at the time of the search, and that described or evaluated the PCA in any setting (community, ambulatory or hospital) were included. The papers were classified as SR if it includes at least the following characteristics: a described search strategy, the use of at least two databases, and selection of papers in pairs. Those studies in which the pharmacist's intervention was not sufficiently clear in the full text or that has been carried out by pharmacy students were excluded since it is intended to identify the PCA from a professional performance perspective and not from the academic standpoint.

Information Sources: the MEDLINE, EMBASE, LILACS databases were used. Besides, the papers cited in the articles obtained to detect more relevant articles, and in turn, the references of those articles were reviewed until that strategy was exhausted. It was used the bibliographic material the authors had and was found in publications that are unique to the topic in the following journals: Research in Social and Administrative Pharmacy, Pharm Care Esp, American Journal of Health-System Pharmacy, American Journal of Hospital Pharmacy.

The searching strategy included:

MEDLINE: (Pharmaceutical services [MeSH] OR "Pharmaceutical care" [tw] OR "Drug Therapy Management" [tw]) AND ("Systematic review" [tw] OR "Meta-analysis" [tw]).

EMBASE: 'pharmaceutical services' / exp OR 'pharmaceutical services' OR 'community pharmacy services' / exp OR 'community pharmacy services' OR 'pharmacy service, hospital' / exp OR 'pharmacy service, hospital' AND (systematic review 'AND' systematic review (topic) '/ OR' meta-analysis').

LILACS ("pharmaceuticalcare" OR "atención farmacéutica") OR "pharmaceuticalser-vices" OR "servicios farmacéuticos". Limited to systematic reviews and meta-analyses.

Studies Selection: two reviewers independently pre-selected the references by titles and abstracts, and then, the pre-selected reviews were evaluated with the full text. If the study did not meet all the inclusion criteria or if it had any exclusion criteria; it was classified as an 'excluded study,' justifying the reason for disqualification. Disagreements between the reviewers were solved after discussion with the authors, and in any case, an external evaluator was required.

Data collection: data were extracted from published studies using a pre-piloted Microsoft Excel^® format, initially based on the variables contained in the Data Collection Checklist of the Cochrane Effective Practice and Organization of Care Review Group (EPOC), which was refined, based on the work objectives and the reference framework presented. The extraction of data from each article was carried out by three independent reviewers (including the authors), who resolved their disagreements through the author's participation in the review of reviews.

RESULTS AND DISCUSSION

This section presents a general description of the type of review, the settings of care, and the terminology used in the title to describe care activity. Subsequently, the results of the approach are presented, then the construction of the knowledge object and finally the methodology used.

Scoping studies offers a good alternative since they are used when a literature volume has not yet been extensively reviewed or exhibits a large, complex, or heterogeneous nature that is not amenable to a more accurate systematic review ^[18,19]. Other designs were not adequate to perform our review ^[14-17].

Figure 1 describes the selection process where 86 reviews published between 1998 and 2014 were finally included; of which 73 (84.9%) were SR and 13 (15.1%) were MA. These SR/MA studied all care settings (n = 34, 39.5%), community (n = 19, 22.1%), ambulatory setting (n = 19, 22.1%), and hospitality setting (n= 14, 16.3%). Care setting refers to the place where the practitioners perform their activities. Thus, ambulatory setting is outside of hospitals, hospitality setting is in the hospital and community setting refers to the neighborhood pharmacy. According to the title, 7 reviews were recovered with pharmaceutical care, 4 with pharmacist care, 56 referring to the role of the pharmacist (29 explicitly mentioned the intervention), 8 with clinical pharmacy services, 4 with pharmaceutical/pharmacist/pharmacy service, 3 with medication review, 2 with medication management, 1 with pharmacotherapeutical follow-up, and another with pharmaceutical patient assistance programs.

Figure 1: Scheme of inclusion and exclusion criteria of studies.

Construction of the knowledge object (PCAs)

In the construction of the knowledge object, the following activities, among others, were taken into account:

Recognition of the problem of drug use: 23.3% (20/86) of SR/MA used the term drugs-related problem (DRP). Of these, 60% (12/20) referred to the classification proposed by Strand; the rest did not reference any author. Because there is no unit of judgment regarding the DRPs classification, some of them are mentioned without their being in a particular classification: 23.3% of the reviews identified that the problem of drug use was related to clinical aspects (adherence, interactions, adverse reactions), administrative (errors in dispensing, lack of access), and in some cases economic (therapy cost).

Identification of the causes of the drug problem: 67% (58/86) of the reviews identified the causes, which were related to the patients in a 34.5% (20/58), with prescribers in 55.1% (32/58). Other causes such as the care load, lack of capacity of the institution, informal prescribers, and pharmaceutical promotion represented 10.4% (6/58). In general terms, 25% of the reviews identified a lack of knowledge and skills as a cause of inadequate medicines uses, 15% lack of independent information, 1% non-restrictive availability of medicine, and excessive work of health professionals. Lack of access to medications, inadequate promotion, and profit sales was not identified in the reviews.

It seems that the identification of problem associated with the drug use is the central axis of the pharmacist's care activity, which is done according to the literature consulted through the DRP. However, this term or some of its equivalents (Medication Related Problem, Drug-Related Problem) are far from being universally accepted. Some authors have found up to 14 different classifications, some of which have no definition or have not been validated ^[40-42]. On other cases, it has also been used in the context of pharmacovigilance, not only in its definition but as a system for classifying adverse drug reactions ^[43,44].

The results of this review show that only a deficient number of reviews use the term DRP and in almost all cases they refer to Strand et al. Also, it can be identified in all of them that these DRPs are related to biological aspects (not control of a disease, insufficient or excessive doses, adverse reactions, etc.), administrative aspects (inadequate dispensing, no medication availability, lack of controls, lack of information, etc.), communicative aspects (lack of information, communication, education, etc.), and only in the case of PCNE explicitly recognize economic problems (the medicine is more expensive than necessary) ^[32,42].

Although Hepler [4] firmly insisted that PC constituted a paradigm change where the pharmacist activities were now focused on the patient rather than on the medicine; the definition and classification of DRPs dealt a severe blow to this claim, since its construction is based on the product (interactions, adherence to the medicine, lower doses, adverse reactions, etc.) Despite the individual efforts to show the identification of DRPs from the patient's point of view, the other needs (according to Maslow) that contribute to the current health situation are not discussed or considered ^[45]. DRPs are conceptual and theoretical constructions of pharmacists where patients' participation has not been taken into account, with some exceptions ^[46], and the pharmacists do not consider that most of the identified DRPs are not the responsibility of the patient. An individual identification and intervention are made without taking into account the social, cultural, and economic context in which the patient lives. These findings may mean how deep the positivist paradigm is rooted in the pharmacist's thinking scheme, which partially explains the inconclusive results of the pharmacist interventions.

In almost half of the systematic reviews, the authors conclude that it is not possible to attribute to the pharmaceutical interventions the observed changes in the evaluated variables, almost always due to methodological reasons. By analyzing the results in this way, interventions are being evaluated in terms of HMM (control of biological parameters and in the best cases hospitalizations) and the health system management model (efficiency in the service provision from the optic of the patient and the provider), which is generally related to the increase in expenditure, which puts the financial viability of health systems at risk.

It is evident in this way of constructing the knowledge object that the characteristics of the positivist paradigm which confer the 'objective' character given by the rules of the scientific method, with experimental research, standardized tests, and extensive participation of statistics in an improper process, far from the object-subject relationship of research-care ^[47]. The health concept is interpreted as absence of something (lack of clinical manifestations or symptomatology). Hence, the pharmacist is recognized as an agent that controls the process, verifies the prescriptions, externally and objectively manipulates the health status and needs of the patient. In the relationship with the patient, the profession is practiced from the vertical relationship, causing the patient to act passively, placing his/her trust in the pharmacist's knowledge, discarding his/her knowledge about what happens in his/her body. A change in the paradigm could show that DRPs have unknown social causes: discrimination (gender, class, ethnic), social stigmatization of certain diseases and medicalization, among others. The medications can also be shown as a source of enrichment for particular groups or to be considered in its symbolic dimension ^[35,48].

Some of the explanations for this way of constructing the knowledge object can be found in the United States. First with the reform of the faculties of medicine by the foundations of John D. Rockefeller and Andrew Carnegie in the years before the World War II, and the reformist processes of health systems that began in the 80's and were exported to other countries since the 90's ^[49,50]. These last reforms allowed the financial capital introduction in the health sector and, with this, new social actors, changes in the sector regulation, and new models of insurance that directly impacted the administration and the provision of services. The overwhelming entry of this capital and its logic in the health sector changed the rules of the game at an economic level, introduced changes in individual and collective subjectivities in relation to the health/ illness conception, transformed patients/users into clients/consumers ^[50], and forced the professionals decisions to be subject to those of a system administrators in order to ensure efficiency in the delivery of services (health as a real market), through control of prescriptions and decisions based on EBM ^[51]. The pharmaceutical industry took advantage of the transformation strategy to customers/consumers and promoted silent reforms to reposition itself in the market: it stimulated regulatory changes that allowed to impact the medicines and medical technology approval and commercialization, the creation and redefinition of diseases (mongering disease), the modifications in the clinical protocols that favor the over-diagnosis, and the mechanisms used to promote the demand for procedures and medicines that also justify the high prices that have to be paid for them ^[35,50]. It is in this scenario that the pharmacist assumes a leading role in advocating for the rational use of drugs with an apparently humanitarian objective (reducing adverse reactions, ensuring therapeutic results, improving the quality of life), but with a background eminently economic of a capital accumulation that is in dispute: financial capital vs. industrial capital ^[50].

Methodologies used in the practice of PCAs

Due to in practically none of the reviews describe the methodology used in the original studies, the chosen aspects were analyzed taking into account the people who participated in the care activity (who and to whom the intervention was performed), and the context in which this activity was carried out and the interventions were implemented.

Actors in the practice of PC: the categories of the personnel that was intervened by the pharmacist during the development of the studies were related. In 69.7% (60/86) the patient was the only subject of intervention; whereas, the physician was intervened in the 1.1% (1/86) of the reviews. The staffgrouping refers to the group of physicians and nurses, clarifying that none of the reviews refer to another professional.

Situations in which the pharmacist intervenes: the pharmacist activities can be focused on either the person with an illness or the person as a drug consumer. In 59.3% (51/86) of the reviews focus the problem of the chronic non-communicable diseases. The 4.6% (4/86) was included in the category of "several diseases" since, in the hospital setting, patients are hospitalized for complications of their chronic processes or for acute diagnoses (infections, trauma, cancer), which for their high diversity are very difficult to group. 8.1% (7/86) of the reviews were concerned with the use of medication and the polymedication.

Interventions: according to the classification proposed by Berimoj ^[52], Type 2 interventions (education activities) were the most frequent with 52.3%, followed by Type 10 interventions (drug therapy follow-up or any other type of follow-up) with a 29%. Type 7 and Type 9 interventions (signs and symptoms monitoring, education and surveillance device, respectively) were not performed in any of the studies included in the review.

Outcomes: since there are different ways of classifying the evaluated outcomes in the literature on this topic, for this study we present the two most recognized ways of doing so. According to the proposal of Kozma et al. ^[53], clinical outcomes are the most frequently evaluated with 83.8%, followed by economic ones with 31.3%, and humanistic ones with 27.9%. According to the Benrimoj classification ^[52], Level III outcomes (other indirectly connected variables, pre and post educational tests such as medication use, adherence, etc.) with 37.2%, and Level IV outcomes (other variables not connected with clinical outcomes such as patient satisfaction, physician satisfaction, etc.) with 34.9%, were the most frequently evaluated. In economic outcomes, all studies belonged to Level I and II (minimum cost information, descriptive studies of cost). The percentages add more than 100% because the studies can evaluate more than one level of outcomes.

For the discussion of the methodology used in the development of the PCA, it can be affirmed that all of them have a very similar structure, closely related to the Clinical Method and the Nursing Care Process, which includes the following steps: problem identification, analysis and evaluation (diagnosis), proposal and implementation of solutions, and evaluation of results. The results show a high percentage in which only two actors appear: the pharmacist and the patient. Few studies include physicians or nurses, much less other health professionals, the state, the pharmaceutical industry, insurers, hospitals, employers, among others. Morin insists on using the transdisciplinarity to overcome the splitting of knowledge and thus build a totalizing and interacting reality ^[7]. Although the consulted bibliography emphasizes on the fact that the center of attention is the patient, it could not be observed in any of the recovered studies that the patient was involved as an active or participatory person within the process ^[4,5]. Another aspect related to the actors is the performance of the pharmacist; since for the provision of the PC service requires the development of new knowledge and skills; that by not being described, can lead to different conclusions due to a lack of homogeneity in these competencies and the practice sites of each study ^[22,54].

There is a high interest in the intervention of chronic non-communicable diseases and problems such as polymedication and the adequate use of medications. Interventions are individual and focused on biological aspects. The outcomes assess the results regarding the HMM and the health system management model. Once again a paradigm of positivism at the service of economic interests is exposed, either as financial capital or industrial capital.

The use of classical epidemiology as a research tool leads to an excessive confidence in statistics and can lead to results with negative consequences, such as the stigmatization of people with some characteristic that is far from 'normal.' Mathematics is an exact science, but its application to the social sciences is not, because behind every study there are decisions that are influenced by personal, cultural, political, and economic aspects. Researchers often forget this limitation and interpret the results of a statistical study as if they were the absolute truth. Therefore we make decisions in public health based mainly on these results that sometimes find spurious associations. As a consequence, it is possible for society or decision-makers to conclude that something has to be done to help those who are supposedly affected, stating the beginning of medicalization and iatrogenic ^[55].

The concept of PC was popularized 27 years ago, and it began to develop in the world. It seems to be time to reflect on the importance of these health care activities on public health and the welfare of people. From the analysis made in this discussion, it seems that the pharmacists have dedicated ourselves to reproduce the HMM, because this gives us the tranquility of a "scientific" support that seems indisputable, the labor stability and the social recognition that we have tried to demonstrate since we started to venture into this field of pharmacy. It is clear that epistemological changes are required to help to construct the knowledge object differently with a methodology that allows a realistic approach to the patient and their needs without isolating the social determinants of the health-disease process, and it is also necessary to rethink the ethical basis of the PPR in order to contribute to the understanding, interpretation, and explanation of the raised problems. That way may be the primary cause for many SR/MA fail to show conclusive results.

CONCLUSIONS

A lack of consensus or agreement was identified in the definition of what is and is not PC, although it must be recognized an effort to explain the differences and proposed agreements in the consulted literature. The literature describes the existence of two approaches: technical prescription-focused and humanistic (patient-centered), however, it was only possible to have evidence of the first one. The construction of the knowledge object is based on the positivist paradigm, where DRP is the pharmacist's center of attention, despite there is still no consensus on the different proposals. The used methodology shares elements of the Clinical Method and the Nursing Care Process, and apparently, with values of the principlism ethics. Interventions, outcomes, and results are supported by the HMM and the studies in classical epidemiology that reproduces this way of understanding health-disease-care, where the social, economic, and political aspects related to medicine are invisible.