- Olga A. Khroutski and Konstantin S. Khroutski
Institute of Medical Education, Novgorod State University after Yaroslav-the-Wise, Novgorod the Great (Russia)
Contact: A/B 123, PO-25, Novgorod the Great 173025, Russia
Eubios Journal of Asian and International Bioethics 12 (2002), 97-103.
AbstractIn this article authors argue that, at present, the object of the patient who is independently purchasing medicines is missed. However, a serious bioethical problem is that this patient (medicating himself) sacrifices safeguards of professional (physician's) supervision and, thus, risks to take unacceptable drugs and dozes. Hence, modern pharmacist has to face bioethical issues in daily practice and herein he is a genuine 'gatekeeper' for the medical system, informing while serving the consumer. This problem has a special significance in Russia for the reason that there has happened the spontaneous and mass re-classification of the majority of prescription drugs and their transition into the kind of over-the-counter medicines. Tackling this problem authors put forward (concerning rational pharmacotherapy) a novel category of 'pharmaceutical pharmacoethics' and, further on this basis, - a bioethical conception of the 'Doctor of Pharmacotherapy' (DPT) in a drugstore. DPT is a bioethical notion, which is realizable principally on the personal level of pharmacist's operation. The figure of 'Doctor of Pharmacotherapy' is designed to directly serve the interests of human wellbeing: (a) on becoming informed on the rational pharmacotherapy (in his particular condition); (b) in enhancing free access to medical care; (c) in improving the person's entire quality of life. Key words: Pharmacy, bioethics, rational pharmacotherapy, pharmaceutical pharmacoethics
IntroductionThe pharmaceutical profession has undergone radical shifts in ethics in the last few decades due to new technologies in various fields of science. However, the bioethical aspects of pharmaceutical contribution to the solution of the problem of rational pharmacotherapy - a central matter of effective conservative therapy - still is staying beyond the mainstream of bioethical topics and bioethicists' activities. Macer (2000) drew attention to this field focusing, therein, our consideration on the figure of pharmacist who "has to face bioethical issues in daily practice, especially with over-the-counter drugs and remedies in which case the pharmacist should view their role as a kind of gatekeeper for the medical system, informing while serving the customers." He also regards that generally "the area of pharmacy and bioethics has not been explored as much as some," hence; "bioethics challenges us to reexamine our decisions and the relationships we have with others." (Macer, 2000). Indeed, if not the assistance of pharmacist, customer (visitor of a drugstore) who medicates himself, will certainly bypass the safety net performed by licensed health professionals and thus, sacrificing safeguards of direct professional supervision. It loses an opportunity for a correct diagnosis or the identification of a contraindication to the drug. Henceforce, the problem is that all acceptable drugs, being used by a customer medicating himself (person who "medicates himself" (MH) visitor of a drugstore), should be safe, effective, affordable and meet real medical indications. Thereby, pharmacist is an actual "the last barrier" to the adverse and even dangerous effects of medications and, hence, druggist is a genuine "gatekeeper" of man's well being and health (as concerns the rational pharmacotherapy). This judgment deeply accords with our own convictions on the matter. This is a severe problem in contemporary Russia. The evidence is that the large part of medications is available at present in Russia for free purchasing and thus, de facto, it considerably magnifies the range of 'over-the-counter drugs' and extends the seriousness of the problem. Therefore, the notion (and role) of pharmacist-"gatekeeper" takes on a real actuality for our country and calls for a special bioethical exploration. 1. Rational Pharmacotherapy - Due Physician-Pharmacist-Patient Interaction 'Alliance' Normally, rational pharmacotherapy is based on the two chief components: 1) on the doctor's correct diagnosis and the rational individual choice (proper prescription) of the medicine for the patient's treatment; 2) on the procedure of a patient's full informing on the medicine having been prescribed by the doctor. It is essential to emphasize that patient provision with necessary information (on the rational drug taking although having secondary character) is of the equal significance to the meeting of criteria of correct rational pharmacotherapy: efficacy, safety, individual suitability and convenience (comprising the use of combinations), cost efficiency. Only the unity of these two chief conditions (Of the proper individual choice of a medication based on the correct diagnosis by a physician, together with the complete provision of the patient with information on the use of this medication.), guarantees the safe, effective, and cost-efficient use of medications. Therefore, the role of pharmacist (in the rational pharmacotherapy) can hardly be over-estimated. Indeed, the rational pharmacotherapy is scarcely available nowadays without the assistance of pharmacist - to completely elucidate (for the patient) the questions of pharmacodynamics, pharmacokinetics, formulation of the cautions and the conditions of the proper use of the drug having been prescribed by the doctor. Henceforth, rational pharmacotherapy is normally the scene of interaction of three main figures: Physician, Pharmacist, and Patient (P-P-P-interaction). In this, Physician plays the chief role, so far as he determines the nature of a disease (the nosologic diagnosis) and specifies the utmost appropriate medicine for the patient. The pharmacist (druggist) provides the patient with the complete information on the use of the prescribed medication and thus he plays the necessary role of intermediary. Finally, the patient is another main figure of the triple interaction, for he is the direct object of the rational pharmacotherapy on the whole. However, in this threefold interaction the patient evidently has the passive role, in so far as he relies generally on the competence of physician's diagnosis and pharmacist's instructions. The pharmacist normally takes the role of intermediary in this threefold P-P-P-alliance serving the objects of rational pharmacotherapy. Nevertheless, underlining this point once again, the true rational pharmacotherapy is impossible, in principal, without the active participation of pharmacist, who not only prepares and dispenses drugs, but has knowledge concerning their properties and additionally (to physician's orders) provides patient with necessary and complete information on the drug use. World biomedicine constantly strives to enhance effectiveness of the functioning of this triple P-P-P-pattern of rational pharmacotherapy, which is with respect, ultimately, to the well being of Patient. First of all, therein, patient himself (in the civilized world) is ever an object of the enlightenment as concern biomedical problems including rational drug therapy. Modern biomedicine likewise constantly is dedicated to an immediate and long-term change on physician prescribing habits and druggist's communicational and informational abilities that will result in improved effects of rational pharmacotherapy. To exemplify this point, Western 'The Doctor of Pharmacy (Pharm.D.) educational program is demonstratively broad and thus quarantines future graduates with clear understanding the diagnosis and treatment of diseases and the rational selection of drugs, as well as teaches to understand and appreciate the social, emotional, and psychological aspects of diseases and, likewise, to understand pharmacokinetic principles well enough to improve dosage regimens for individual patients; etc. At this point, see, for instance, the web-site on the Program of the Doctor of Pharmacy (Pharm.D.) professional degree at the University of Michigan, College of Pharmacy: (http://www.umich.edu/~pharmacy/degrees/pharmd.html) The similar processes are taking place in the space of post-soviet countries. The Ukrainian Academy of Pharmacy started (since the 1998) the training of clinical pharmacists. Therein, clinical pharmacy is considered as "a clinical science, which serves as the theoretical and practical basis for consulting work of a pharmacist among physicians and population on issues of rational drug therapy." (www.ukrfa.kharkov.ua/) Likewise, in the Russian Federation (since the 1997) the qualification of clinical pharmacologist was introduced. Although a clinical pharmacologist must have the basic qualification of D.M. - Doctor of Medicine, his main objectives are just the same and stressed on the rational and individualized drug choice and use. 2. The Missed Bioethical Object of the Patient Who Has Made a Decision on Self-Treatment It is significant that all the above stated refer to the interactions of the three main figures: Physician, Pharmacist, and Patient. Essentially, Patient acts therein principally within the sphere and under the protection of physician"s competence and pharmacist's assurance of patient's proper use of the medicinal remedy. However, the objective of this exploration is quite different. Authors highlight a novel object for bioethical exploration - of the patient who has made a decision on self-treatment - patient medicating himself. Strictly speaking, in this way, the diseased man stops to be a patient but rather becomes merely the visitor of a drugstore (MH-visitor) - one who is suffering from a diseases or disorder, but who has decided to medicate himself. For Russia of today, this type of MH-visitor of a drugstore is a very common occurrence and the latter, evidently, brings up a problem of critical importance to be tackled and settled. Authors completely agree with the judgement of the editorial staff of the Russian journal "Pharmateca" that: "Self-treatment by means of drugs is one of the key problems of public health care." Moreover, the significance of this factor increases every year (Contemporary problems of self-treatment, 2000). As a matter of fact, to the view of Pharmateca, it has happened in Russia due to the "spontaneous and mass re-classification of the majority of prescription drugs and their transition into the category of over-the-counter medicines." What is the origination of this phenomenon in Russia? What compels contemporary Russian diseased people to avoid the successive visits to the doctor, but, instead, to use the information for self-treatment by drug therapy from his own experience, or to follow the advice of his neighbor, or 'recipes' of mass media? We believe there are two chief reasons for this: 1) MH-visitor to a drugstore in Russia has a real opportunity to purchase the needed medicines for his self-treatment. The latter largely is taking place due to the weakness of contemporary insurance medicine in Russia. That means that the majority of prescriptions (except a few ones of stringent registration: like narcotics, poisonous substances, etc., or the special "privileged" prescriptions for preferential categories of the population) has no obligatory status for Russian pharmacists, for, the majority of prescriptions do not fall under legitimate control or the compensation of their cost is a common practice in the Western health care systems. 2) The low standard of current Russian system of primary free medical service. That is likewise the appraisal of Pharmacon; the similar opinion is expressed by Russian leading physicians. For instance, academician G.B.Fedoseev points that (a) from 30 to 60% of all drugs are used by patients without the reasonable grounds; (b) only 25% of patients strictly follow the orders of the physician; (c) only 30% of ambulatory patients take the recommended drugs regularly (Shetinina, 2000, p.10). Herein, the underlying substantial factors may be: a) the limits of time at physician"s disposal: doctor on duty at an adult polyclinic (Outpatient department in today's Russia) officially has no more than 15 minutes on the reception of a patient; b) not infrequently long queues in adult polyclinics (outpatient departments) that cause unwillingness to repeat the visit to the doctor; c) contemporary Russian physicians, due to the deficit of financing, have not a possibility to undergo regularly the courses of updating and enhancement of their qualification. All the latter seriously influence and not infrequently form Russian patient's unwillingness to successive visits to the doctor. Instead, a contemporary Russian patient increasingly often arrives at the decision to choose by himself the remedy for treating a particular morbid condition. Henceforth, such 'self-prescribing' of drugs by the patient (who has decided to medicate himself, MH-patient) inevitably delays proper diagnosis and treatment of illnesses, or that involves taking inappropriate drugs or dosages. At any rate, the given problem is worthy of serious ethical concern. 3. Rational Pharmacotherapy: P-P-P-pattern and A-(MH)V-pattern. Ethical Notion of the 'Doctor of Pharmacotherapy' in Pharmacy. Naturally, the best possible combination is that of the interaction of the informed physician, informed pharmacist and informed patient. Likewise, it is not worth to explain that the self-prescription always verges on inappropriate and even dangerous self-treatment. However, the chief object of our consideration is the patient (diseased person) who has already made the decision for self-treatment. Doubtlessly, the latter is a special case. The main feature of this patient is that he certainly will not follow the paternalistic directives from pharmacist on the rational choice and use of drugs, in so far as he has already made the decision not to come to see the doctor. At this point, moreover, besides the democratic autonomy of individuals to make choices (while respecting the choices of others), there are specific circumstances in modern Russia (characterized above) that enlarge the number of people, who deliberately choose self-prescription and self-treatment. Thereby, while we have in the normal way the efficient triple Physician-Pharmacist-Patient-pattern (P-P-P-pattern) of hierarchical interaction - of the prescribing function of doctor, instructing and dispensing role of apothecary, and deliberate role of performing by patient, the other category of isolated Apothecary-(MH)Visitor relationship - A-(MH)V-pattern - have the distinct and particular (autonomous) essence. We use here the term "apothecary" instead of "pharmacist" for the reasons: 1) because it is a synonym of "pharmacist"; 2) to underline the specificity of the A-(MH)V-pattern; 3) bearing in mind that the medieval apothecaries, in the history of pharmacology, both prepared and prescribed drugs. Primarily, the patient (visitor) acquires there a novel characteristic: now he will be unreceptive to the directive assessment and paternalistic instructions of an apothecary (druggist) with respect to his choice of the remedy, in so far as he had already made the decision not to accept physician"s (and any other) administering in principle. Therefore, herein, a point of crucial significance emerges: a MH-visitor (who is concerned with self-treatment), to authors" view, will certainly pay attention and follow the druggist"s advice in the sole case if the latter will immediately establish and further maintain a unique and equal relationship with the patient. Therefore, there is needed a new orderliness of apothecary-(MH)visitor relationship (A-(MH)V-pattern) based on the principle of equality: of respecting the autonomy, individuality and dignity of each patient. The pharmacist (apothecary), herein, is rather a consultant and adviser, a well-informed 'neighbor', than a licensed health professional. In other words, pharmacist (in the A-(MH)V-interrelations) rather creates necessary conditions (sphere) for the MH-visitor to arriving independently at the right (safe, effective and cost-efficient) personal decision on the choice of needed medicinal remedy (or, on the contrary, on becoming aware that the necessity exists to consult a doctor). As a corollary, A-(MH)V-pattern is a new pattern in the sphere of rational pharmacotherapy and a new bioethical issue in pharmacy. Unlike a normal triple P-P-P-pattern, the alternative A-(MH)V-pattern consists only of two functional elements (of pharmacist and MH-visitor of a drugstore). There are two main characteristics of this new orderliness of druggist-visitor relationship: 1) there are no hierarchical interrelations, in principal, but precisely the equal form of relationship between druggist and visitor ought to be established; 2) moreover, exactly MH-visitor himself displays the initiating role and acts as a 'doctor'. It is important that the A-(MH)V-pattern of rational pharmacotherapy directly serves the personal interests of a person: (a) on becoming informed on the rational pharmacotherapy (in his particular condition); (b) in enhancing free access to medical care; (c) in improving the person's entire quality of life. There is one more factor: self-treatment reduces the expenditure of the entire health care system. Journal Pharmateca defines three ways to resolve the problem of self-treatment (in Russia): 1) to change nothing (what is absolutely impermissible); 2) to establish a more strict dispensing of drugs; 3) to realize a global revision of the whole inventory of drugs and to considerably extend the list of "over-the-counter" medicines - under the conditions of introducing additional measures to provide safety of the use of drugs, including the enhancement of the consultative role of pharmacists. To the view of Pharmateca, in the conditions of low quality of primary free medical care, the most preferable is considered to be the third way. Our approach comes near the Pharmateca"s third way of a solution of the problem of self-treatment but, at the same time, it has essential distinctive features. The heart of the matter is that we introduce and cultivate the autonomous A-(MH)V-pattern of rational pharmacotherapy, which is also considered to be an effective one, but which is realized, in contradistinction to the other approaches, chiefly on the personal level. Resolutely, it likewise serves the ultimate ends of patient's well being - namely of the safety and efficacy of the rational pharmacotherapy with respect to MH-person - man who medicates himself. We are firmly convinced, pharmacist who conducts the being under consideration A-(MH)V-pattern of rational pharmacotherapy is genuinely (following Macer (2000)'s definition) a "gatekeeper' for the entire medical system. Reasonably, pharmacist (apothecary) plays in this pattern precisely the role of 'Doctor of Pharmacotherapy'. At this point we mean that 'Doctor of Pharmacotherapy' level is basically characterized by the following substantial features: 1) Sufficient competence of a druggist in the questions of diagnosis and treatment of diseases; understanding of pharmacokinetic principles - to improve dosage regiments for individual patients; ability to retrieve and interpret information on drugs from pharmaceutical and biomedical sources and apply the information to specific patient care conditions; ability to develop a patient data base from a patient interview and patient chart - of all - to effectively assist the MH-visitor of a drugstore with his personal (independent) rational selection of a correct medicine; 2) Professional and moral ascending and operation at the novel ethical level of 'Doctor of Pharmacotherapy' - of equal relationship with a MH-visitor. This novel ethical level of druggist-visitor interrelations distinguishably has (a) the equal subject-subject essence, but never - of hierarchical subject-object relationship, like the 'neighbor with neighbor', or 'pharmacist with pharmacist', or 'doctor with doctor' relationship, (b) the latter is realizable exclusively under the conditions of the high professional qualification of a druggist. 3) The other distinction of this being advanced notion of the 'Doctor of Pharmacotherapy' (DPT) is that it the DPT bioethical level is unreachable in principle without the personal inherent intention and willingness of a druggist and his clear vision of the ends of its achievement - to maximally enhance the provision of pharmaceutical care and improve entirely the quality of the patient life. We state in the strongest possible terms that the only way to assist a MH-visitor (medicating himself) to exercise individual proper choice and the further proper usage of the safe, effective, and cost-efficient medicine, can be achieved exclusively within the realm of equal subject-subject relationship of the A-(MH)V-pattern of rational pharmacotherapy, premised on mutual trust and respect, where druggist performs namely the ethical function of 'Doctor of Pharmacotherapy". 4. Activities on the 'Drugstore'-Level and Suggestions to 'Above-Drugstore' Level It is a matter of fact that Russian pharmacists actively respond to the crisis situation (with self-treatment) having occurred. It would be relevant for us to speak of the endeavors, which are being undertaken on the level of drugstore; and, likewise, to express our suggestions for the 'above-drugstore' level, where the management of the whole pharmaceutical branch is performed. We can refer to our own experience - of the drugstore N70, located in Novgorod the Great, Russia. Therein, tackling the problem under consideration (of self-treatment), the governing body and personnel of this drugstore considered it necessary and expedient to put forth efforts (and to actually have performed them) in the following directions: 1) To provide working places with necessary facilities (PC, use of Internet, complete set of updated pharmaceutical and clinical-pharmacological directories, formularies, and State Pharmacopoeia, etc.) to effectively retrieve and to be easy in representing up to date, evidence based, practical information on rational drug therapy; 2) Pursuing the similar ends (of accumulation highly practical information on rational pharmacotherapy), to regularly attend postgraduate scholarships, courses, conferences, etc., and thus to continually improve professional competence and enhance constantly personnel qualification; 3) To regularly request the services of a teacher of clinical pharmacology - to deliver lectures on clinical pharmacology and to consult patients; 4) To engage in scientific explorations aimed at the subjects evolving the pharmacist-patient relationship and the entire optimizing of pharmaceutical care; 5) To maintain a phito-bar at the trade department of the drugstore. Phytotherapy, although economically not profitable, carries a distinctive bioethical component; in so far as adequate phytotherapy administered separately or within a complex course of treatment evidently effects in the lessening in severity of the symptoms of many chronic (and some acute) diseases. The latter reduces, to some extent, the use of chemical medicinal substances. Finally, a separate direction is occupied with our personnel (personal) endeavors to grow up ethically and to achieve the interactive level of the "Doctor of Pharmacotherapy", characterized by mutual trust of pharmacist and visitor of a drugstore, and the respect of their autonomy, individuality and dignity, ultimately aiming at the establishment and maintenance of a unique relationship with each patient. In the other sphere, our suggestions concern the central organs, which administer the entire pharmaceutical trend in the country. At this point, we consider the following directions of activity to be foremost in importance: 1) to form a state (official) long-term policy aimed at the cultivation of the active attitude of Russian persons towards their individual health; 2) to enhance the quality of education and scholarship with respect to rational pharmacotherapy; 3) to reconsider the ethical norms of pharmacist-patient interrelations. Primarily, herein, we stress upon the fact that the existing Ethical Code of the pharmaceutical worker in Russia fully lacks the reference to the interrelations of pharmacist with a MH-visitor of a drugstore. Therefore, the existing Russian Code pays no attention to the actually existing problem of a person in Russia, who has decided to conduct self-treatment. At the same time, there is the section 2 ("Pharmaceutical worker and patient"), which clearly formulates a figure of modern pharmacist to be a competent specialist who is able "to inspire confidence in the medicinal substance". Moreover (paragraph 2.1.), "pharmaceutical worker ought to let the patient to feel that in the person of him (of pharmacist. - Auth.) he meets highly educated, cultured, and competent specialist." (Ethical code, 1999, p.19) Naturally, all that is absolutely necessary for the effective establishment of the normal P-P-P-pattern of rational pharmacotherapy. However, as to a distinguished A-(MH)V-pattern, which establishes rational pharmacotherapy with respect to the patient who medicates himself and stays physician"s supervision, who has arrived at the firm and final decision to medicate himself, then the existing ethical principles of pharmacist-patient relationship scarcely can be evaluated as satisfactory ones. At this point, a revised code of ethics approved in 1996 by the Ontarion College Pharmacists is worthy of meticulous attention. For, "the new code stressed a 'patient-centered care' approach." Noteworthy, its principles were modeled after a code of ethics developed by the American Pharmaceutical Association and endorsed by member organizations (Gosgnach, 1998). Essentially, this revised code includes the novel items, which state that pharmacist: Establishes and maintains a unique relationship with each patient..., Actively promotes the wellbeing of every patient..., Respects the autonomy, individuality and dignity of each patient., Acts with honesty and integrity., Advocates for health promotion at the individual, community and societal levels. Apparently, the 'Ontarion' novel ethical principles approach much more closely to the being advanced bioethical figure of 'Doctor' and, precisely, - of the 'Doctor of Pharmacotherapy' (DPT). At the same time, the evidence is that they serve chiefly the optimal functioning of the same P-P-P-pattern of rational pharmacotherapy. Thereby, they can not meet satisfactorily the new proposed challenge to bioethics - of DPT-pharmacist appearance on the scene of world biomedicine. Henceforth, we need eventually to introduce one more necessarily macro-direction of the problem solution (besides the well-grounded means on the 'drugstore'-level and 'above-drugstore'-level of self-treatment problem tackling) - of the substantial theoretical foundation of the whole enterprise. 5. Medical and Pharmaceutical Pharmacoethics In pursuit of valid theoretical grounds, we primarily lead on the scene the significant term "pharmacoethics", which was originally developed by Western scientists. MacDonald (2001) defines "pharmacoethics" as "the study of the ethical implications of...not just drug therapy...but of the development, promotion, sales, prescription, and use of pharmaceuticals." Now, in our discourse and in the light of the entire stated, we propose to divide the entire sphere pharmacoethics into two distinct categories: medical pharmacoethics (MPE) and pharmaceutical pharmacoethics (PPE). The former (MPE) refers to the scope of medical practice, science, and philosophy. The latter (PPE), on contrary, falls within the sphere of purely pharmaceutical activity. Noteworthy, they both have the identical purposes - to assure the safe, effective, and cost-efficient use of medications by patients. From the other side, they have substantially different means to achieve the goals. Medical pharmacoethics has the main object of the patient who has come to see the doctor and, thus, MPE naturally aims at the perfecting and individualizing of the first basic component of rational pharmacotherapy (process of making an accurate diagnosis and the following adequate treatment of the patient as a person); to recognize that each patient represents a unique problem, to found each patient"s therapy on the individual patient"s needs, and to prescribe the actually necessary medicinal remedy (preferably in the form of monotherapy); also to achieve the availability of medicines for all - fair distribution of drugs; to strictly observe ethical norms during biomedical research involving human subjects; etc. Essentially, MPE acts within the functional domain of P-P-P-pattern of rational pharmacotherapy. Normally, therein, the pharmacist is an obligatory intermediary with "safeguarding function", who instructs a patient while serving and thus necessarily contributes to the whole process of rational pharmacotherapy. At any rate, however, P-P-P-pattern of rational pharmacotherapy is a paternalistic pattern as its essence. It means that the accurate medical diagnosis and the following adequate choice by the doctor of the medicine determine the effect of rational pharmacotherapy on the whole. Of course, patient (in a democratic society) is able to act independently and, therefore, abandon the treatment and change the doctor, but he will never be able (as refers to rational pharmacotherapy) to drop the accurate diagnosis and adequately prescribed treatment in principal. Thereby, the ethical relation of pharmacist to patient, as well as doctor to patient, bears chiefly the deontological character and, hence, prescribes generally a passive role to patient in the pattern of P-P-P-interactions. In turn, pharmaceutical pharmacoethics (PPE) acts under the conditions of A-(MH)V-pattern functioning (within the realm of rational pharmacotherapy) and has its main object of a patient who resolutely has decided to medicate himself. Both pharmacist (druggist, apothecary) and MH-patient (visitor of a drugstore) take on, therein, active positions in the process of rational pharmacotherapy. Hence, druggist, as concerns A-(MH)V-pattern, radically changes his attitude towards a patient, now treating him exclusively in a humanist manner, but never as an object of applied adequate (prescribed by the doctor) rational pharmacotherapy. For, there is no "prescribed by the doctor" pharmacotherapy in principle, in so far as the patient has already made the personal decision to medicate himself. In this A-(MH)V-pattern of relationship, the patient, moreover, initiates the whole process of pharmacotherapy having primarily made the decision on the choice and use of the drug. The interacting pharmacist, who actively assists patient in this process of the proper (safe, effective, and cost-efficient) choice and use of the medicine, involuntarily takes on therein a role of the 'Doctor of Pharmacotherapy' - DPT. The latter concerns as much the dispensing of over-the-counter drugs, as the large amount (for instance, in the case with contemporary Russia) of the medicines, which de facto had become really accessible for the customers (visitors of drugstores). Significantly, the realization of this DPT-pharmacist assistance is possible, as it was already argued above, from substantially novel ethical positions. The point is that on the DPT-level pharmacist and patient (visitor of a drugstore) interact as equal subjects (as 'doctor with doctor', or as 'pharmacist with pharmacist', or as good 'neighbor with neighbor'). That is principally a new ethical level in biomedicine (as concerns rational pharmacotherapy). We know that many of humans" present and future problems of well being turn, as a rule, to be essentially social, political, or economic in nature. In this case, unlike, precisely the personal level of action (as it refers to the rational pharmacotherapy) has been advancing on the front line. It likewise means that 'Doctor of Pharmacotherapy' is the personal and mature level of pharmacist"s activity, chiefly depending on the inherent intention and willingness of a pharmacist to actively develop in qualificatory and ethical directions. In other words, ethically matured "Doctor of Pharmacotherapy" is a specialist who demonstrates professional ability and personal calling (and responsibility) to conduct good (equal, respectful, careful) pharmacist-visitor communication and obtain, in this way, the needed data base on the patient, from the visitor (of a drugstore) interview and visitor chart, which further would allow the DPT-pharmacist to assist the visitor to independently reach the decision in his choosing the right drug or, on the contrary, to realize the necessity to consult a doctor. Consequently, we likewise revise, at this point, the system of getting consent of the person, and argue that the being advanced A-(MH)V-pattern of rational pharmacotherapy is deeply consistent with "good life" (eu-bios) for a patient (in the case of his self-treatment), as far as it optimizes the appropriate selection of the right medicinal remedy and safeguards the patient from adverse and even dangerous taking of inappropriate drugs and dosages. Henceforth, to our view, a pharmacist - "Doctor of Pharmacotherapy" - is a significant pharmaceutical figure of today. Two typical examples: the first, the man suffering simultaneously from erosive gastritis and arthrosis independently decides to medicate his arthrosis by taking acidum acetylsalicylicum (active ulcerogenic substance); the second example, the person who has excruciating headaches takes large doses of the over-the counter analgesics, being fully unaware that there is the need to check his (elevated) blood pressure and consult a doctor on the matter of arterial hypertension. These examples provide direct evidence that without the humanist assistance of 'DPT'-pharmacist each patient (who has started to medicate himself) risks obtaining inappropriate medication and thus taking even dangerous effects. We assume the 'DPT'-pharmacist is ethically matured and highly qualified in clinical pharmacology, and who also understands the diagnosis and treatment of diseases. The other evidence is, in this case, that nobody but the 'DPT'-pharmacist, who communicates with a patient on the ground of mutual trust, solely might create the conditions for a patient to reach the right choice of the medicinal remedy and avoid the adverse and even dangerous effects of inappropriate pharmacotherapy. This is in so far as patients who medicate themselves inevitably sacrifice the opportunity for a correct diagnosis and the identification of contraindications to the drug by a health professional. Factually, therefore, the DPT-pharmacist is genuinely a "gatekeeper" for the entire medical system. It is likewise necessary to state, in completion, that our pharmaceutical "Doctor of Pharmacotherapy" is an autonomous notion and qualification. The latter substantially differs from the above characterized similar qualifications of "Doctor of Pharmacy", "Clinical Pharmacist", "Clinical Pharmacologist". Firstly, "Doctor of Pharmacotherapy" is an ethical notion and qualification, but not the graduated (or post-graduated) qualification level based on the faculty training. In other words, "Doctor of Pharmacotherapy" is the public and expert recognizing of the appreciable merits of a pharmacist in scholarship and practice of rational pharmacotherapy. Further, 'Doctor of Pharmacotherapy' (DPT) is rather an axiological than deontological subject. Indeed, DPT is simultaneously a notion, an ideal, and process. It is an ethical notion, in so far as it is not a subject of a college (university or post-graduate) curriculum and training; for, DPT is an ideal of personality growth for the conscientious pharmacists, who voluntary (inherently) and deliberately express the willingness to reach the PDT-level - of ability to actively serve and promote (in a continuos process of improving his competence and communication skills, and enhancing service and care) the well-being of every patient (especially, of MH-patient), due to high professional qualification and ethical maturity, and also based on the humanist. In other words, DPT-pharmacist, while communicating with a patient on the basis of mutual trust and respect, strives to achieve the best possible outcome for the patient, previously having inquired his specific clinical and life circumstances, and providing him with complete appropriate information on the needed medicines - of all - 1) to prevent the adverse and dangerous effects of self-treatment; 2) to enhance the availability of proper treatment for the diseased man; and, ultimately, 3) to improve the entire quality of the man"s life. It is important to emphasize this in completion, once again, that "Doctor of Pharmacotherapy" is not the trained qualification level, but the one that grows out of pharmacist"s personal inherent endeavors and achievements (in the sphere of rational pharmacotherapy) having been estimated by patients, themselves, and the chiefs from a Board of Pharmacy. At any rate, to our firm conviction, pharmaceutical 'Doctor of Pharmacotherapy' could decisively contribute to the solution of the problem of self-treatment. It is reasonable and relevant, thereby, 1) to raise a question of the possibility and legal capacity of the pharmaceutical 'Doctor of Pharmacotherapy' existence; and, in the case of satisfactory solution of this question, 2) to recognize that the directed selection of the DPT-pharmacists and maximum promote in their endeavors and operations ought to become the prime task for the chiefs of pharmacy. Conclusion Indisputably, the normal and most optimal situation (for rational pharmacotherapy) is the interaction of well-informed physician, pharmacist and patient (P-P-P-pattern, in our context), where physician plays the leading role (for, the accurate diagnosis ever is the very basis of rational pharmacotherapy). However, it is a matter of fact that the problem actually exists (and tends to increase) of inadequate pharmacotherapy with respect to a patient who medicates himself. The fact is also that this problem stays insoluble. Henceforth, appropriate endeavors ought to be undertaken to improve and eventually normalize the situation on the whole, including activity in the pharmaceutical sphere. Essentially, our way to settle this complicated problem (in the sphere of pharmacy) chiefly advances the bioethical approach. Of course, the latter, by no means, should not lower the significance (for the rational pharmacotherapy) of the necessary optimization of education and scholarship in pharmacy and development of the entire use of pharmaceuticals and the provisions of pharmaceutical care - towards the enhancement of the profession of pharmacy. The latter is especially important in the case of normal P-P-P-pattern of rational pharmacotherapy establishment. But the point is that we take under investigation precisely the object of a patient who medicates himself and, in this connection, we evidently deduce, in our conclusion, that the original shifts should be realized exactly on the personal bioethical level of a pharmacist on duty (working druggist) - to ultimately achieve the grade of rational pharmacotherapy for that type of diseased man (MH-patients). That is the chief reason of our creating of the category of 'pharmaceutical pharmacoethics' and the A-(MH)V-pattern of pharmacotherapy, and putting forward the bioethical notion of the 'Doctor of Pharmacotherapy' - a person (pharmacist) who is inherently inclined and independently aims to transcend on the higher professional level of serving the patients by virtue of: a) continuous pursuing and gaining excellent knowledge in pharmaceutical care; and b) acquiring the ability to effectively communicate and assist a patient (chiefly, in his making the personal decision on purchasing the right medicine) on the grounds of mutual trust and respect, and evaluating each visitor of the drugstore as a unique person. Therefore, in our context, 'Doctor of Pharmacotherapy' (in the sphere of pharmacy) is a real novel challenge to current world bioethics.
AcknowledgmentsAuthors wish to express their gratitude to organizers of the First National Congress on Bioethics in Kiev (Ukraine; September 17-20, 2001) and participants of the pharmaceutical section, who has made possible the fruitful discussion on the topic; likewise we deeply appreciate the participation of Prof. Hyakudai Sakamoto and his far-reaching influence on the bioethical issues having been considered during this Congress.
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