Introduction: During the last years of the 20th century, the functions and processes linked to medication logistics were perfected and strengthened, however, policies aimed at the rational use of medications and actions to implement all the measures were implemented much more slowly. processes aimed at patients, which are developed in pharmaceutical services. An objective always present in all these practices is to achieve the role of the pharmacist in health services, with emphasis on its importance in helping to satisfy the social need for effective and safe health care. 

Objective: Detail the action of the pharmacist and primary health care in pharmaceutical services in Cuba and the need for a paradigm shift. 

Methods: A descriptive study of bibliographic searches was carried out, for which primary and secondary sources of information in the medical newspaper library and various information centers were used, in indexed journals on the topic of pharmaceutical services. The sample was defined by scientific articles, degree theses and manuals in databases such as Google Scholar, Medline and Scielo related to Pharmaceutical Care topics; OPS, Pharmaceutical Services, in Spanish and English. 

Conclusions: pharmaceutical services must transform ways of working based on the guidance of the WHO/PAHO, improving themselves professionally to achieve the objectives set in relation to the integration of the pharmaceutical professional into the work of the health team in Primary Health Care (PHC). 

During the last years of the 20th century, the functions and processes linked to medication logistics were refined and strengthened, however, policies aimed at the rational use of medications and actions to implement all the directed processes were implemented much more slowly. to patients, which are developed in pharmaceutical services.[1]. The American College of Clinical Pharmacy (ACCP) defined it as "a health sciences discipline in which pharmacists provide care to patients that optimizes drug therapy and promotes health, well-being, and the prevention of disease."[2]. After a few years of implementation, a critical reflection about clinical pharmacy led some pharmacists to conclude that there were no achievements with respect to the proposal of giving emphasis to the patient, given fundamentally because the majority of pharmaceutical practice was aimed at support the health team, focusing particularly on the medication and with hardly any interaction with the patient.[3].  In this context, Hepler and Strand proposed a novel philosophy of pharmaceutical practice, defined as Pharmaceutical Care (PA), which already implied a process where the pharmacist cooperates with the patient and other health professionals, assuming their responsibility, in achieving quality pharmacotherapy.[3]. 

All these practices at an international level did not encompass the full extension and development expected; when the main causes of their poor generalization are analyzed, many more external elements are found than the pharmacists' own technical-professional capacity, among which These include the insufficient availability of pharmaceutical professionals, isolation or lack of integration of pharmaceutical services (PS) into local health systems, inadequate structure of pharmacies, lack of pharmacist time due to the multiplicity of routine tasks they assume, many of which could be assumed by technicians, the need for systems, computer tools, sources of information and documentation, lack of support from governments and national authorities to implement FA policies, among others.[3]. 

An objective always present in all these practices is to achieve the role of the pharmacist in health services, with emphasis on its importance to contribute to satisfying the social need for effective, safe and economical health care, also highlighting the importance of the "teamwork method", something vital to obtain optimal performance of resources, both human and financial, to meet healthcare needs [4].

In 2006, an article titled "The Pharmacist and Public Health" 4 was published, in which an attempt was made to reflect on a group of factors that undermined the aspiration that the pharmacist could occupy his space as a true professional. in the Cuban health system. After 10 years, the reality that is observed is not far from what was seen back then, especially at the level of Primary Health Care (PHC), where their fundamental task should be to be part of the health team, directing their activity to guarantee proper use of medications by patients, participating in health education and prevention campaigns, aimed at promoting improved health and greater well-being of citizens, something still far away for today's pharmaceutical professional. In this article, it was pointed out that community pharmacists are in an optimal situation to carry out health prevention and promotion activities, since they have the possibility of communication and access to the public that is sometimes more difficult for other health professionals. Therefore, from the pharmacy users can be educated in order to reduce risk factors and modify their behaviors in a way that is favorable to health.[4].

None of these internationally developed models that were previously described have been implemented in Cuba in a generalized manner, with only a few isolated attempts with very good results; An example of this was the development of clinical pharmacy at the Amalia Simoni Hospital in Camagüey and in the provinces of Santiago de Cuba and Villa Clara [5,6]. led in these last two provinces by the Pharmacy Departments of the respective Universities.

It was also commented as a weakness in the work of the pharmacist in community pharmacies, that he was limited only to working with the medication, with little appreciation of his potential as a health promoter in the community. The development achieved by Pharmacoepidemiology and the creation of the Main Municipal Pharmacies, both very weakened in recent years, were given as positive examples; as well as the teaching figures of the Master's Degrees in Clinical Pharmacy and Pharmacoepidemiology as strengths for the development of pharmacists in Cuba, who continue to graduate professionals but are not capable "per se" of guaranteeing the training of all the professionals in charge of developing these models of pharmaceutical performance in Cuba.[4]. Finally, it is proposed that although a group of actions carried out were evident so that the primary care pharmacist had a place in improving the health of the population, it was still very far from providing the expected contribution of this professional [4]. something which currently remains with the same problems described at that time. Due to the above, the need arises to investigate the topic, so the objective is defined to detail the action of the pharmacist and primary health care in pharmaceutical services in Cuba and the need for a paradigm shift.

A descriptive study of bibliographic searches was carried out, for which primary and secondary sources of information were used in the medical newspaper library and various information centers, in indexed journals on the topic of pharmaceutical services; as well as an exhaustive and continuous database search that included 73 articles from WHO/PAHO sites and drug regulatory agencies, among others. The universe was composed of articles in bibliographic databases such as Google Scholar, Medline and those provided by the Virtual Health Library by the Telematic Health Network in Cuba INFOMED; among them CUMED, LILACS, SCIELO, BIREME. The sample was defined by scientific articles in databases such as Pubmed, Medline, Scielo and others that were related to Pharmaceutical Care topics; OPS, Pharmaceutical Services. The articles had to be in Spanish and English. Of the 3 5 articles, 32 were eliminated from the final review due to non-compliance with the criteria established prior to the investigation. Finally, for this work the remaining 3 articles were analyzed.

Development

The pharmacist and Primary Health Care (PHC)

In 2007, when Dr. Margaret Chan assumed the General Directorate of the World Health Organization (WHO), she made the commitment to work on the development of PHC,7 by recognizing that the Member States, through their bodies, Regulators perceive the need to have more equitable, integrative and fair health systems, with a more comprehensive perspective on the effectiveness of the entire health system. Resolution WHA_62R_12.8 reinforces the commitment to continue working to strengthen health systems based on PHC and gives a specific mandate to WHO to support countries in this challenge. 7 Since that moment, PAHO/WHO has been working to reposition the renewed PHC strategy as an instrument for achieving Universal Health Coverage (UHC) where access to safe and effective medical products and technologies are part of one of the three fundamental dogmas. for CSU.[7]. Since the creation of the WHO, medicines have been considered priority inputs to achieve the right to the highest level of health.[7]. 

In 1977, the concept of "Essential Medicines" (EM) was launched and from the World Conference on Primary Health Care, they were considered one of the eight elements necessary to achieve the goal of health for all. Since then, the MEs have constituted one of the pillars of the formulation and implementation of national pharmaceutical policies, with a focus on public health and law.[7]. In 2008, the Pan American Health Organization (PAHO) began to promote an initiative to strengthen FS based on its development as an essential component within PHC, an activity promoted as part of the strengthening of health systems in the Americas.[7].

Despite the efforts and resources invested, access and rational use of medicines constitute a great challenge in most countries in the region. Among the main drawbacks we can mention the multiple problems that arise in management. of supplies, as well as inappropriate use of medications by both patients and users, as well as prescribers and dispensers.[7]. 

For these reasons, it is necessary to change the focus of drug policies and strategies, tending to develop "pharmaceutical policies" that until now only have the drug product strategy as their central axis. Therefore, the new vision of pharmaceutical services is to prioritize the individual, family and community (IFC), satisfying their health needs, seeking to guarantee comprehensive, integrated and continuous care of the population, having medicine as one of the elements essential, contributing to their equitable access and rational use.[7]. 

In 2009, a workshop sponsored by PAHO was held on the model of "Pharmaceutical Services based on Primary Health Care." The fundamental objective of which was to define the guidelines for the development of regional guidelines for the development of pharmaceutical services as an integral part of health services based on PHC. 19 professionals from different countries participated, including doctors, pharmacists and nurses, belonging to the Ministries of Health, Social Security, Academia, NGOs and PAHO. Professionals from the Dominican Republic, Nicaragua, Brazil, Colombia, Costa Rica, and experts from the WHO/PAHO with extensive experience in the pharmaceutical area were represented in this workshop.[7]. 

As a result of the workshop, the Vision of what we want to achieve in the region in relation to pharmaceutical services was defined, and it was written as follows: "pharmaceutical services, with social relevance, integrated into the health system based on PHC , that respond to the needs of the individual, the family and the community, with well-defined roles and functions that promote healthy lifestyles, access and rational use of medicines, contributing to their right to enjoy the highest possible level of health. health".[7].

As part of this initiative, the document "Guide for the development of pharmaceutical services based on PHC" was prepared, which was discussed at several expert meetings and submitted to public consultation. Likewise, the International Federation of Pharmacists (FIP) and the World Health Organization (WHO) updated Good Pharmacy Practices in 2011, which constitute quality standards for pharmaceutical services.[7].

These documents were the subject of discussion at meetings held in Costa Rica and Uruguay, organized jointly by PAHO, the Pharmaceutical Forum of the Americas (FFA) and the International Federation of Pharmacists (FIP), an experience that was later replicated in Argentina in 2012.[7]. 

As a result of all this, a PAHO/WHO position document was published in 2013 in relation to Pharmaceutical Services based on PHC, which defines pharmaceutical services as the "Set of actions in the health care system." health that seek to guarantee comprehensive, integrated and continuous care for the health needs and problems of the population, both individually and collectively, having medicine as one of the essential elements and contributing to its equitable access and rational use. These actions developed by the pharmacist, or under his coordination, incorporated into a health team and with community participation, have as their objective the obtaining of concrete health results with a view to improving the quality of life of the population". The categories, domains or groups of functions required for pharmaceutical practice are also defined, organized into four large groups:[8].

those linked to public policies, the organization, management of pharmaceutical systems and services.[8].

• those linked to the medication.
• those directly linked to the patient, family and community.
• those linked to research and knowledge management.
• those linked to professional performance. 

An interesting aspect discussed in this document is the reorganization of pharmaceutical services from a new perspective using process management.[8].

It is important to note that the "delivery of pharmaceutical services" is defined as a key process, because it is the one that implies the direct relationship with the user/patient. This process includes health promotion activities, dispensing, pharmacotherapeutic support, pharmacovigilance and support for responsible self-medication, processes that today in community pharmacies are not part of the priority tasks of professionals and technicians, fundamentally dedicated to trying to guarantee the presence of medications and their attention from a technical point of view.[8].

Subsequently, the strategic processes are defined that correspond to those that provide the organization's guidelines (policies and planning), as well as those that are not directly related to the patient, but contribute to their care. The activities of these processes are planning, implementation, management and evaluation of pharmaceutical services; the development and implementation of a quality management system for pharmaceutical services; participation in the selection of medications and in the evaluation of health technologies; providing information about medications; participation in the design, monitoring and evaluation of clinical trials; promoting permanent education of human resources and responding to situations of prevention and mitigation of disasters and health emergencies[8]. , practically none of these so-called strategic tasks do pharmacy professionals in Cuba currently actively participate in. It is very interesting to see how the activities that today are the center of the work of Cuban pharmacists, such as the management of the supply of medicines and other health technologies, the formulation and preparation of extemporaneous master preparations of medicines; the repackaging of medicine and other essential supplies, as well as the management of human and financial resources aspects; They are considered by the experts who prepare this document as support processes, which could perfectly be carried out by technical training personnel.[8].

Another aspect that is considered of great importance and designated as a critical success factor for the change of pharmaceutical services based on primary health care is the development of human resources competencies to be able to face the challenge of training part of the APS [8].  teams, something in which much remains to be done in the Cuban reality.

Another of the key work points to face the new realities, and which is considered of vital importance, is the updating of Pharmaceutical Regulation, for which it is essential that the essential regulatory functions can be carried out:[8].

• legal/regulatory framework.
• good practice standards.
• surveillance mechanisms.
• supervision and other mechanisms for compliance with the regulatory framework.[8].

Cuba has a strong and well-established regulatory system, which is governed by the work of the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), as a Reference Regulatory Agency in the region, recognized both nationally and internationally, which has a very important weight in the Regulation of the areas of Industrial manufacturing, Distribution and Export and Import, but not for the activity of community and hospital pharmacy whose regulatory framework is fundamentally at the expense of the Directorate of Medicines and Health Technology of the Ministry of Public Health (MINSAP), does not present the same level of updating and development as that of CECMED.[8].

In this sense, in the month of March 2016, Resolution 88/2016 was approved by the MINSAP, which approves the General Regulation of Community Pharmacies [9]. which provides a legal framework for the functions that the pharmacist must perform, where each one is well classified. One of them, great emphasis is placed on dispensing, dispensary preparation, pharmaceutical care and pharmacovigilance; But this Regulation, in its article 7, assigns the pharmacist a group of economic-administrative activities that in practice result in technical tasks being displaced to the background. Another aspect that draws attention is that at no time is reference made to the PAHO/WHO call on the role of this professional in the actions of the PHC.[9]. 

Another point addressed in the PAHO/WHO document is ethics in pharmaceutical services, dividing it into three large groups: the medicalization of society, the inappropriate use of health technologies and the processes of capital accumulation in this sector [8].  In Cuba, work has been carried out in recent years on the development of a group of strategies aimed at minimizing the impact of the medicalization of society and achieving a more rational use of medicines, with the development since 1996 of Pharmacoepidemiology, However, there are still control aspects that must continue to be delved into to avoid the diversion of medicines and their illegal sale, phenomena that, despite the measures that have been taken at all levels, continue to weigh on the ethics of the professionals and technicians of the sector.[8].The WHO medicines strategy for the period 2008-2013 incorporates the orientation towards PHC, highlighting as a priority the use of scientific and operational evidence to support the renewal of PHC and increase national programs through identification and promotion of best practices. Selection for quality assurance and rational use of medicines for PHC, something in which Cuba had already shown results since the 1990s with the Pharmacoepidemiology strategy, a specialty that needs to rescue its achievements from previous decades, if it really is you want to obtain results in this aspect.[8]. 

Pharmaceutical services in Cuba

In a society like Cuba's, where there is no private pharmacy, there should be no pressure for the pharmaceutical professional regarding commercial profit, typical in any capitalist society, for which he would be in a position to dedicate all his efforts to the tasks of a true professional trained to improve the health of the population, a function that he has been performing without all his scientific potential being fully exploited.[4]. 

Every day the need to use this professional force, as an integral part of the multifactoriality of health, is becoming more evident, to contribute directly not only to the scientific and rational use of medicines in close collaboration with the rest of the health team, but also to to work as part of that team in achieving comprehensive health.[4]. 

It is the opinion of the authors of this article that among the factors that today constitute weaknesses that must be worked on to achieve the integration of the pharmaceutical professional into the PHC working group, are the following:[4]. 

• Insufficient knowledge of the concept of a Pharmaceutical Service as part of the renewed PHC on the part of health professionals
• The guidelines of health policies in the pharmaceutical area are mainly directed at the product
• The insufficient preparation and demotivation of human resources in the SFs to be able to face the paradigm change
• The predominant culture of patients who only believe doctors and hospitals and who in many cases see pharmacies as drug dispensing centers.
• The lack of acceptance by the medical and nursing staff of the pharmacist as a member of the health team. 4

Need for a new paradigm

Society's growing expectations regarding health and health care translate into demands for services that are more focused on the group made up of the individual, family and community (IFC), a higher level of health care at the community level. and more effective participation in decisions [10]. Therefore, changes in Pharmacological Services cannot be less than such expectations.

The demographic transition brings with it an increase in life expectancy and non-communicable diseases [11]. along with the challenge of guaranteeing access to health care and the necessary therapeutic resources, including medicines. Therefore, it is necessary to adapt health systems and FS to recognize and different forms of communication, as well as action [12]. and new technologies that turn the act of prevention, diagnosis and treatment of diseases into a art. [13].

As part of the SF paradigm shift, the following is required: [8,13].

• Full integration of the pharmacist into the PHC work group
• Move from Pharmaceutical Care focused on the disease, towards Pharmaceutical Care focused on health, including promotion and prevention.
• Transition from a Pharmaceutical Service focused on the medication, towards a Pharmaceutical Service focused on the individual, the family and the community
• Achieve teamwork with the rest of the PHC professionals.
• Update standards, guides and processes so that they are in line with the new paradigm.
• Achieve adequate training of human resources and their sustainability.
• Design professional training policies fundamentally service-oriented.

PAHO states that the mission of the pharmaceutical profession is "to contribute to the improvement of health and help patients with health problems to make the best use of medications. This mission has six components:[8].

• always be available to patients.
• identify, manage or detect health problems.
• promote health.
• ensure the effectiveness of medications.
• prevent damage caused by medications.
• make responsible use of limited healthcare resources.[8].

Mission that with the new paradigm, must fundamentally focus on improving the patient's health and that of the six components, the Cuban pharmacist will have to work hard on all of them and emphasize the necessary change of mentality that allows him to understand that his Their function is not to be behind a counter "selling" a health product, but beyond this, their reason for being is to be part of a team, whose fundamental objective is to fight so that health levels in Cuba are increasingly better.[8].

Pharmaceutical services must transform ways of working based on the guidance of the WHO/PAHO and adjusting to the standards established in the country, improving themselves professionally to achieve the objectives set in relation to the integration of the pharmaceutical professional into the work of the health team in the APS achieving a higher level of health care at the community level and more effective participation in decisions where changes in services cannot be less than such expectations so that Health levels in Cuba are increasingly better in response to the needs of society.