Opening borders. Part One: The White Paper on the Pharmacy Degree: destination or point of departure. Quo vadis, Pharmacy?

1. INTRODUCTION

Community action regarding higher education is vigorously pursuing the aim of promoting transversal cooperation, contributing to the creation of the European Higher Education Area (EHEA). To quote Cervantes: “Viajar y lo que viajar comporta es una de las condiciones necesarias para que los hombres se hagan sabios.” [“To travel, and what travelling involves, is one of the necessary conditions for men to become wise.”] (1). 1 The mission of the university is not only to prepare students for professional life but also to transmit wisdom, experience, and knowledge. Physical mobility prepares students for their professional, social, cultural, and personal lives and implicitly encourages (2) convergence and mutual confidence, the recognition of degrees, and access to joint courses or double-degree arrangements.
In particular, in Europe, the social, economic, and political union has led to what could be called a rediscovery of the idea of a Renaissance university. The aims and objectives that all the different universities of the continent wish to achieve are similar, although not identical, and sharing them does not necessarily entail (3-4) a homogenization and standardization of attitudes, but rather a voluntary and concerted process of convergence.
Following the initiative of Professor Benito del Castillo, the public and private Spanish pharmacy faculties, under the auspices of the National Agency for Quality Assessment and Accreditation (ANECA), embarked on a project to prepare a white paper on the Pharmacy Degree (4), which, with his support and that of Professor Fidel Ortega Ortiz de Apodaca, I had the honour of coordinating. The experience, which had the support, among other institutions, of the General Council of the Official Colleges of Pharmacists (5) and the Spanish Royal National Academy of Pharmacy, was remarkable, and—after overcoming certain difficulties—a unanimous consensus was reached. This prompted me to quote some verses of Juan Ramón Jiménez at the heading of the acknowledgments on the last page of the project: “He llegado a una tierra de llegada” [“I have arrived at a destination”]. However, is it a destination or a departure point, “Where do we come from?” “Where are we going?” A Spanish unreferenced version of this paper was published in these Anales in 2011.

2. CONTEXT: THE EUROPEAN DIRECTIVE

Despite the importance given to cultural identity, culture and education were not considered among the areas of competence of the European community set out in the Treaty of Rome of 1957, nor in the Single European Act of 1986, which tackled areas largely outside the original treaty, such as the environment, research, and social policy (6). Article 57 of the Treaty provided the basis on which some initiatives were adopted regarding the area of training (7) (Art. 64 in the new numbering of the Treaty on the Functioning of the European Union, so-called since 1st December 2009, the date when the Treaty of Lisbon came into force).
Regarding pharmacy studies, Council Directive 85/432/EEC (8), endorsed by Directive 2005/36/EC (9-10) on recognition of professional qualifications, set out the foundations by detailing i) the necessary conditions for the awarding of the diplomas, certificates, or other formal qualifications of pharmacists in areas of knowledge and in the duration of the period of training and ii) the activities that may be exercised by the holders of diplomas, university degrees, or certificates of pharmacy. Council Directive 85/433/EEC (11), amended by 85/584/EEC (12) and by 90/658/EEC (13) concerns the mutual recognition of diplomas, certificates, and other evidence of formal qualifications in pharmacy and includes measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy. Decision 85/434/EEC (14) set up the Advisory Committee on Pharmaceutical Training (which became effective in March 1989).
The training of students is oriented toward producing trained specialists with knowledge and competence in the ethical, healthcare, and scientific treatment of medicinal products. Yet, Directive 85/432/EEC does not prevent the establishment of supplementary conditions of training for activities not included in the “coordinated minimum range of activities (or subjects)” (9-10, 15), thereby respecting the history, tradition, and special characteristics of the national regulations of Member States. The fourteen minimum subjects referred to in the Directive are the following: plant and animal biology, physics, general and inorganic chemistry, organic chemistry, analytical chemistry, pharmaceutical chemistry (including analysis of medicinal products), general and applied biochemistry (medical), anatomy and physiology (medical terminology), microbiology, pharmacology and pharmacotherapy, pharmaceutical technology, toxicology, pharmacognosy, as well as legislation and, where appropriate, professional ethics.

3. LEGAL FRAMEWORK OF THE PHARMACIST IN SPAIN

Law 44/2003 on the Organization of Healthcare Professionals (16) recognizes pharmacy, in Article 2.2 a), as a degree-level healthcare profession, and the activities within its competence are those relating to the production, storage, and dispensing of medicinal products, as well as collaborating in the processes of laboratory testing, pharmacotherapy, and public health surveillance (Art. 6.2 b).
The training of pharmacist graduates enables them (4, 17-21) to practice the profession in community retail pharmacy, in the pharmaceutical industry, in hospital and non-hospital specialties, in clinical laboratory testing, in health management, and in research and educational activities.
The pharmacist is an expert in medicinal products and in public health concerning the fields of chemistry and biology, so that in Spain, pharmacists have been a veritable reservoir to draw on to supply botanists, chemists, biochemists, laboratory analysts, food scientists, soil scientists, parasitologists, microbiologists, etc., as these disciplines have been introduced into Spain, to a considerable extent (19, 22), via the lecture halls of pharmacy faculties.
It is also worth mentioning the extensive participation of pharmacists in the activities of the Consejo Superior de Investigaciones Científicas (CSIC) [Spanish National Research Council], from José María Albareda Herrera (23) in its early days to Manuel Losada Villasante (24) and Cesar Nombela Cano (25) more recently.
Law 29/2006 on the Guarantees and Rational Use of Medicines and Healthcare Products (26) details in its stated purpose that “the work undertaken by pharmacists and other healthcare professionals in the processes of pharmaceutical care has a paramount importance, as it ensures accessibility to the medicinal product as well as offering, in coordination with the appropriate medical staff, healthcare advice, pharmacotherapeutic follow-up, and professional support to the patient.”

4. THE WHITE PAPER ON THE PHARMACY DEGREE

The White Paper (4), endorsed by the universities in which pharmacy courses are taught, is a reflection about the new educational paradigm. Based on a “top-down” design, from society to the academic world, it gathers together analysis of the current situation of pharmacy studies in Europe, the selected model of European studies, the relationship between demand and supply for each Spanish institution, studies about employment and the professional profiles of pharmacists, and has a major impact on the issue of competences, having carried out surveys for this purpose with employers, university students, and teachers. Using all this information, the objectives of the degree, the professional competences required, and the proposed curricula were all set out on the basis of the six broad areas defined in the report by the Advisory Committee on Pharmaceutical Training (27): Chemistry, Physics, and Mathematics; Biology; Pharmaceutical Technology; Basic Medicine and Pharmacology; Social Aspects of Pharmacy; and Law Relating to Pharmacy. This report served as a guide to the Ministry when drawing up Order CIN/2137/2008, of 3rd July (28), which sets out the requirements for the verification of official university degrees to be able to exercise the pharmacy profession.
The Consultative Group on the Role of the Pharmacist of Vancouver under the auspices of the World Health Authority (WHO) identified, in its report of 1997, seven roles for the pharmacist (29): caregiver, providing pharmacy services; decision maker, communicator, leader, manager, lifelong learner, and teacher. The Consultative Group of Vancouver understood (30), prior to the Bologna Declaration (31), that education should have a greater focus on the student, where the student is an active participant in the learning process, highlighting the importance of developing problem-solving and critical thinking skills. These curriculum objectives of 1997 coincide with, but predate, those that later appeared in the “Tuning” of the European Union (32).
The determinants of the new paradigm are (33): learning (rather than teaching), student (rather than teacher), society (rather than university), skills (not only knowledge), and LLL (lifelong learning) (not early scholarship followed by a “desert” of inactivity), which is why the gradual incorporation of new teaching methods is required that focus on the development of competencies: case studies, problem-based learning, problem-solving exercises, collaborative or cooperative learning, project-oriented learning, and learning contracts.
In its Vienna declaration, the International Pharmaceutical Federation (FIP) issued a ‘Statement of Policy on Good Pharmacy Education Practice’ (30), which recommended that undergraduate degree programs should provide pharmacy students with a sound and balanced grounding in the natural, pharmaceutical, and healthcare sciences that provide the essential foundation for primary practice in the multi-professional healthcare environment.
Point 4.4 of the report drawn up by the Advisory Committee on pharmaceutical training of the European Union has already stated (27) that during the training period, pharmacy students must be provided with a sound and balanced grounding in the physical, chemical and biological sciences that represent the basis for their main training in: i) biological systems, the chemistry of drugs and other constituents of medicines, as well as their interactions; ii) the design and manufacture of medicines; iii) the actions and uses of drugs, medicines and other products; and iv) an introduction to the practice of pharmacy in hospital, industrial, academic and community pharmacy settings, including an introduction to the relevant aspects of the social and behavioural sciences.

Educational programs—the 2nd point of the FIP’s Vienna Declaration—should ensure (30) that patient-focused pharmaceutical care is a mandatory part of the curriculum, something that has been strongly advocated by the European Association of Faculties of Pharmacy (EAFP) in its La Laguna (34) and Malta (35) Documents, under the presidency of Professor Benito del Castillo, and the Pharmaceutical Group of the European Union (PGEU) in its Declaration about “The Bologna Process and Pharmacy Training” (36), under the leadership of Pedro Capilla.
The tree of science was an artificial classification, and the contents on each branch are nearly exhausted. Today, the advances are produced at the interfaces between the disciplines. Chemistry and pharmacy had an interface with physics after the Second World War. It was then the era of instrumentation, of the introduction of the powerful and precise physical methods of measurement. In the 1970s, the interface occurred with mathematics, thanks to the dramatic appearance of computers and personal computers. This was the era of chemometrics, of pharmacometrics, and of the application of mathematical and statistical methods to measurement processes. Currently, the interface is with biology, as had been anticipated years before by Arthur Kornberg (37). For this reason, FIP’s Vienna Declaration, in its third major point, strongly advocates (30) the introduction of new subjects such as molecular biology, biotechnology, gene therapy, and developments in information technology in recent years.
The White Paper has carefully considered (4, 38-41) the following: the care interface (i.e., pharmaceutical care; please see the extensive section developed under the heading “Mission of Pharmacy and Pharmacy Practice”); the interface with molecular biology, including pharmaceutical biotechnology, with its descriptors genomics and proteomics, the identification of therapeutic targets, the biotechnological production of drugs, and pharmacogenomics; and, finally, the interface with information technology, scientific methodology, and information technology in pharmacy. It has also backed a revolution in the contents of the large areas described as minor subjects in the Directive, concentrating on descriptors such as phytotherapy, bioinorganic chemistry, chemometrics, clinical trials, diet therapy, nutraceutics, ecotoxicology, pharmacoeconomics, biophysics, chemoinformatics, combinatorial synthesis of drugs, and registration of medical products.

5. ORDER CIN/2137/2008 OF JULY 3RD

Throughout history (22), as Professor Puerto Sarmiento has indicated on a number of occasions, pharmacy studies have undergone numerous modifications, resulting from progress and differentiation in the different branches of science involved in the degree, from the evolution of the profession, and also from the transformations that have affected university institutions (4, 20, 42).
The 1990 guidelines concisely recognize (43): “Moreover, knowledge about public health, health education, and health-related analysis will be provided, as they are necessary subjects for practicing pharmaceutical activities.”
The professional competences specified in full in the Order of 3rd July 2008 (28) are virtually a literal transcription of those referred to in the White Paper (4), pages 194 and 195 (an adaptation of an agreement on “Pharmacy Teaching,” approved by the Board of the Faculty of Pharmacy of Barcelona), among which, in addition to those traditional ones covered in the previously mentioned Community Directive, are the following:
To be able to design, apply, and evaluate reagents, methods, and clinical laboratory testing techniques, knowing the basic aspects of clinical testing, as well as the characteristics and content of diagnostic laboratory reports.
To be able to use clinical design and evaluation for preclinical and clinical trials.
To participate in pharmacosurveillance activities.
To provide therapeutic advice in pharmacotherapy and diet therapy, as well as in the nutritional and food science fields in the establishments where they work.
To carry out clinical and social pharmacy activities, following the cycle of pharmaceutical care.
To intervene in health promotion and disease prevention activities at the individual, family, and community levels, with a holistic and multi-professional vision of the health-disease process.
To develop analytical tests for public health and hygiene, especially those related to food and the environment.
To develop communication and information skills, both oral and written, for treating patients and dealing with users, where their professional activity takes place.
To be able to promote skills in multidisciplinary teamwork and collaboration and in work relationships with other healthcare professionals.
All the above is the result of an unanimous agreement regarding the White Paper and of the consensus between the General Council of the Official Colleges of Pharmacy and the Council of Deans of Pharmacy Faculties in Spain at a meeting on 21st December 2007, after jointly suggesting modifications to the initial draft of the Order, sent by the Ministry of Science and Innovation for their consideration and study. Sixty-four years after the publication of the Law of 7th July 1944 about the Organization of a Faculty of Pharmacy (44), once again justice was done to Pharmacy.

6. THE NEW ROLES

Currently, the pharmacy profession is developing new functions and responsibilities in response to the efficacy, potency, precision, risk, and costs of pharmacotherapy (4, 28, 38, 45-48). Today, the extent of these activities includes participation in the decision-making process regarding treatment. These functions support the rational use of medicines and are directed towards the patient. Some of these activities are undertaken by healthcare professionals other than pharmacists, some are routinely carried out by pharmacists, and an increasing number of pharmacists are engaged in all these activities. More detailed accounts of these aspects can be found in the works cited in this section, and also in the previously mentioned section “Mission of Pharmacy and Pharmacy Practice” of the White Paper on the Pharmacy Degree (4). As indicated earlier, the Order CIN/2137/2008 of July 3rd has been, in this context, a big step forward (28).

7. THE ORIGINS OF PHARMACY IN SPAIN (“WHERE WE CAME FROM”)

Pharmacy was recognized by Philip IV of Spain (1621-1665) as a scientific art equal to Medicine, and the Royal College of Apothecaries of Madrid, dedicated to the nurture and promotion of Pharmacy, Chemistry, Botany and Natural History, was created by Royal Order of Philip V in 1737, giving rise first to the Faculty of Pharmacy of Madrid, and later to the foundation of the Royal National Academy of Pharmacy in 1934 (44, 49). On 6th February 1920, the scientific character with which the Corporation had been founded was again confirmed, and the title of ‘Royal’, which had been lost during the political struggles of the 19th century (50), was restored (by Royal Order of 13th March). His Majesty King Alfonso XII presided at a Session of the Academy in November and presented a large portrait with a dedicatory inscription to the Academy (51).
The Law of July 1944 recognized (44): “The intimate connection between pharmacy and chemistry and the notable expansion of the limits of this science, due to its particular relationship with the field of biology, have led to close links regarding the aims of these two branches of human knowledge, which act as a basis for the current concept of pharmacy.”

8. THE FUTURE OF PHARMACY (“WHERE ARE WE GOING?”)

In a Sunday supplement of the newspaper ABC, Paulo Coelho, the well-known Brazilian writer, commented in a review entitled “De aquí a 50 años” [“In 50 years time”] that only medical, legal, and engineering studies would survive (52), because people were tired of studying subjects that are worthless. Irrespective of whether or not these opinions are correct, medicine can here be understood in its broadest sense as the health sciences—always in demand—so that there is no reason for alarm. Hence, there is no need to refer to the contention that humans are different from animals because of their urge to take medicines, a well-known phrase by an Anglo-Saxon author quoted by Professor Aquiles Arancibia in his admission speech to the Iberoamerican Academy of Pharmacists.
A detailed reading of the scientific article “Value of Pharmaceutical Sciences” by Ronald T. Borchardt (53), based on a report by the American Pharmaceutical Association (now the American Pharmacists Association), will enlighten us. To indicate some items mentioned: “a) What are prodrugs?; b) Physical Pharmacy–Preformulation; c) Drug analysis; d) Dosage form design; e) Manufacturing technology; f) Drug disposition; g) Toxicokinetics; h) Therapeutic evaluation,” as well as “breakthrough technologies a) Combinatorial chemistry; b) In vitro biopharmaceutical techniques; c) Molecular aspects of drug metabolism; d) Analytical technology; e) Biomaterials; f) Gene therapy”
As acknowledged by Professor María Teresa Miras Portugal, stem cells offer some promising opportunities in regenerative medicine, biotechnology, and the pharmaceutical industry. Hence, there is a need for specific training in molecular and cell biology, in stem cell biology and technology, and in tissue engineering and its clinical applications (54).
The following areas of greater demand can be mentioned (57-67): animal models, development of trials, bioassays, bioinformatics, cell biology, cloning, electrophysiology, etc. A quick glimpse of the career possibilities on offer in Industry (4) can be gleaned from the distribution of duties of members affiliated with the Spanish Association of Industrial Pharmacists (AEFI) and also provides further cause for optimism. Those career possibilities include technical director of records, quality control, technical director of production, research, marketing, clinical trials, Pharmacosurveillance, pharmaceutical development, medical department, management, documentation, institutional relations, and business development.
The launching of new scientific journals supported by prestigious publishers, for example, “Recent Patents on Drug Delivery & Formulation” (68), is a clear sign of vitality.

9. THE MIRROR OF DIVERSITY

The legal separation between medicine and pharmacy occurred for the first time (69) in Christian Western Europe in 1240, in the Kingdom of the Two Sicilies.
The science/profession dichotomy has always existed. Rouelle the elder (1703-1770), demonstrator at the Royal Botanical Gardens of Paris (70) and master apothecary, recognized: “Regarding pharmacy, it is difficult to differentiate between Galenic and chemical pharmacy. Without the latter, the former are no more than combinations derived from mixtures, which, far from achieving their proposed aim, are often disastrous ….” (71). In 1800, a conflict—reported in the “Annals de Chimie” [Annals of Chemistry]—took place between an ambitious young chemist, Thenard, and an experienced pharmacist, Delunel, about the training of pharmacists. Thenard was in favor of prior theoretical training in the principles of chemistry, whereas Delunel defended (72-73) the importance of practical learning from the day-to-day operations of the profession. The contribution of medical doctors and pharmacists to the creation of chemistry was studied by Montequi (74). Pharmaceutical knowledge is one of the single key attributes of the pharmacy profession, and if it is not fully utilized, the “status” of the profession could become questioned (75).
Urdang, in his excellent study about the “History of Pharmacy as an academic discipline” (76), acknowledges the common aims of pharmacy and medicine but, at the same time, also gives a warning about the limitations of pharmacy. In a similar vein, Magin Bonet y Bonfill had stated this position much earlier in his admission speech to the Royal Academy of Exact, Physical, and Natural Sciences in 1868, about “De la constitución de individuo o especie en Química” [Regarding the constitution of the individual or the species in Chemistry], in a footnote about Davy.
The “Commission to Implement Change in Pharmaceutical Education” reaffirmed the need (78) for a strongly scientific component in the curriculum, stressing the role of the basic sciences as the foundations of pharmaceutical education and as an essential support of pharmaceutical care. The provision of pharmaceutical care to patients requires an understanding of the chemical entity of the medical products, of the release characteristics of the formulations, of the distribution of the active ingredients in the different compartments, and of the physiological and pharmacological results of their interactions with the biological organism. What makes pharmacists unique among healthcare professionals is their in-depth knowledge of the biological, physical, and chemical interactions and of how these interactions affect the outcomes of the therapy (4, 38, 47-48, 78).
Under the title “Le miroir de la diversité” [The mirror of diversity], the official journal of the French National Academy of Pharmacy, the “Annales Pharmaceutiques Françaises,” describes pharmacy as follows (79):
“A key player in the health sector, pharmacy stands at the crossroads between chemistry, biology, pharmacology, and related sciences. This broad range of competencies covers scientific, legal, regulatory, ethical, and practical aspects. This specialist about drugs and other medical products also understands cosmetology, the environment, nutrition … Such diversity falls within a multidisciplinary, multi-purpose environment.” This is the same multidisciplinary training requested by the General Council of the Official Colleges of Pharmacy in Spain (80) and promoted by the White Paper on the Pharmacy Degree (4), in accordance with that set out in Directive 2005/36/EEC, regarding pharmacy studies (9-10).

10. REFERENCES

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