On March 20-22, 2013 was held the National Congress “Clinical Pharmacy: 20 years in Ukraine”, keynote of which was the efficient use of medicines, role of clinical pharmacist in the health care system, quality and safety of medicines. In addition, during the forum were discussed many current issues of national and international pharmacy.
To participate in the Congress were invited clinical pharmacists, pharmacists, medical practitioners, scientists, leading specialists of pharmaceutical companies, research institutions, representatives of government agencies and non-governmental organizations, teachers, postgraduate students, students of profession oriented educational institutions of Ukraine, Austria, Belarus, Great Britain, Armenia, Georgia, Ireland, Kazakhstan, Latvia, Moldova, Netherlands, Norway, Russian Federation, the United States, Hungary, Uzbekistan, France, Czech Republic, Switzerland – altogether from twenty near and far abroad countries.
National Congress was inaugurated by rector of the National University of Pharmacy, corresponding member of the National Academy of Sciences of Ukraine, D.Sc. in Pharmacy, D.Sc. in Chemistry, Professor Valentin Petrovich Chernykh. He greeted the participants of the Congress and emphasized that the health of the nation is a question of national importance, and medicines in this context is a national treasure. Valentin Petrovich stopped on an exceptionally important role of pharmacists, including clinical, in the system of adequate health care provision, noting that the quality of pharmaceutical education in our country is not inferior to those in developed countries, but the number of specialists per capita is much lower. As noted V.P. Chernykh, clinical pharmacist is a person who speaks the same language both with doctors, helping them to prescribe optimal pharmacotherapy, and patients, helping them to successfully undergo treatment, and in case of side effects or lack of therapeutic effect to react swiftly. In the opinion of professor, clinical pharmacist is a professional of the highest class in the sphere of rational use of drugs. “There are rare cases when doctors prescribe medicines whose interaction can be dangerous for health, and clinical pharmacist is able to prevent it”.
Roman Bogachov, Deputy Minister of Public Health of Ukraine, reading greetings from the Minister of Public Health of Ukraine Raisa Bohatyriova, said that this event is an excellent opportunity for research scientists, physicians, pharmacists, and other professionals whose work is related to Clinical Pharmacy, to share their experience and knowledge, to tell about the achievements and prospective lines of development, including the terms of cooperation at the international level. The Deputy Minister said that, in his opinion, Clinical pharmacist is an essential element of medicine of the future. “To State Classifier was added a new profession – clinical pharmacist – and were added new positions in medical and pharmaceutical institutions, created normative and procedural framework”.
Aleksandr Krapivnyu, director of the Department of State Regulation of wholesale and retail sale of medicines of the State Service of Ukraine on medicines, in his welcoming speech to the participants of the forum noted that today the flagship of Ukrainian Pharmacy – National University of Pharmacy – gathered those who determine the future of the pharmaceutical industry of Ukraine – the branch without which it is impossible to imagine a health care system. This is because healthcare provision is largely depends on the rational prescription of quality medicines. Provision of high quality, effective and safe medicines is the most important task of the healthcare system. In this context particularly important functions are entrusted to the clinical pharmacist. The speaker focused on the activities of regulatory bodies that continue implementation of the reforms started in 2004, bringing the activities of all parts of the pharmaceutical industry in Ukraine to world standards. So by now have been already implemented GMP (Good Manufacturing Practice) for both domestic and foreign manufacturers; is continuing implementation of GDP (Good Distribution Practice), and on the agenda is implementation of GPP (Good Pharmacy Practice).
With welcome speech appeared Galina Siroshtan, Deputy Chief of the Main Department of Public Health of Kharkiv regional state administration. She noted that only close cooperation between physicians, pharmacists and scientists will be able to positively affect the quality of healthcare.
Particular interest of participants of the Congress aroused the report of Nicholas Kilstra, professional coordinator, senior inspector of inspection on healthcare of the Ministry of Health, Welfare and Sport of the Netherlands, Chairman of the expert committee on quality and safety standards in pharmacy practice and pharmaceutical care, Deputy Chairman of the European Committee on pharmaceutical and medical assistance from the European Directorate for the quality of Medicines and healthcare (Council of Europe), dedicated to the quality of pharmaceutical care in clinical and pharmaceutical practice. “Clinical Pharmacy, according to the definition of the European Association of Clinical Pharmacy (European Society of Clinical Pharmacy), is rational and appropriate use of medicines, and use of health products by society and individual patient. Committee on pharmaceutical supervision is structure that defines the necessary measures to optimize the provision of medical care for the public”. The speaker informed the audience about the joint development of database for quality indicators and indicators of the benefit-risk profile of medicines. This system allows to track the sales of medicines, correctness of treatment regimen for each patient, and how effective was the treatment, and whether the therapeutic goal was achieved. Operation of such database requires enormous work related to the creation of relevant reports and documentation, collection of information on the history of diseases and accepted therapeutic decisions. “This approach is particularly informative in the treatment of chronic illnesses because it allows to display the effectiveness of therapy in time.” In addition, the Chairman of the expert committee focused on the problem of adverse drug interactions. Thus, according to N. Kilstra, about 5% of all hospitalization cases are connected with the manifestation of this interaction and its prevention is a very important task. The speaker focused on the availability and effectiveness of medicines, noting that even medicines with proven efficacy may not provide the intended action related to pharmacogenetic aspects. In this context clinical pharmacist seems to have a particularly important role. N. Kilstra said that the Ministry of Health of the Netherlands pays special attention to the study of pharmacokinetic and pharmacodynamic parameters of medicines, as well as the characteristics of their interaction. “There were taken measures to develop and adopt standard protocols of pharmaceutical care. I hope that in the future will be successful the attempts to create gold standards of pharmaceutical treatment that can be adopted not only in the Netherlands but also in other countries.”
On increasing importance of pharmacists in healthcare system of the USA reported Lawrence Brown, director of research in the field of legislation and o healthcare outcomes at the Department of Clinical Pharmacy, Faculty of Pharmacy, University of Tennessee (Memphis, USA), D.Sc. in Pharmacy, D.Sc. in Philosophy, Professor. “In the U.S.A. Clinical Pharmacy started up more than 40 years ago and today in this specialty are distinguished different specializations. In the last decade in ambulatory practice increases the importance of the role of the pharmacist as a professional who provides disease prevention, including immunization and control of medications that provides pharmaceutical care. The role of the clinical pharmacist in outpatient treatment especially evident in cases of acute respiratory viral infections, since for their treatment a patient often refers directly to pharmacies, not a doctor.”
Importance of presence of a clinical pharmacist in the medical team, which decides on the prescription of treatment, is that such a specialist examines possible drug interactions and selects a combination of drugs that will achieve maximum therapeutic effect with minimal side effects. Thus optimizes the process of healthcare delivery by reducing the probability of selecting of incorrect dosing, interactions between drugs and other drug-related adverse events. The speaker elaborated on the functions of a clinical pharmacist in the context of pharmaceutical care, and announced the creation of the pharmaceutical patient’s profile and other aspects of healthcare reform in the U.S.A.
With the report “Medicines, Pharmacy and Health” appeared Martin Henman, coordinator of the Center for Pharmaceutical Practice of Trinity College Dublin (Ireland), head of the European system of pharmaceutical care, member of the European Clinical Pharmacy Community, Pharmaceutical Community of Ireland, Professor. He noted that the responsibility for the selection of a particular medicine rests both doctors and clinical pharmacists. This approach is quite effective as evidenced by the reduction in the number of medical problems, duration of hospital stay, and reduced mortality from many nosologies. As emphasized M. Henman, for the operation of such a system in Ireland are developed the appropriate regulatory standards and requirements. Problems can arise after accomplishment of treatment in medical institution when it is necessary to continue treatment in outpatient mode, because it may be associated with decreased patient adherence to treatment or symptoms of adverse reactions. “Discontinuation of medicines may be due to inadequate appraisement of treatment results, especially if the therapeutic effect is of delayed manifestation in time, which is often regarded by patient as a lack of such effect. In such case comes at an opportune time educational and awareness-raising work. Pharmacist in this system may provide assistance to patients, screening risks and wellness programs with representatives of various agencies and organizations.” In the end, M. Henman informed that to achieve the maximum foreseeable effect from drug administration it is necessary to develop complex approach to this issue. In this case, the doctor and patient, and pharmacists are equally important.
Norbert Valechka, director of the Austrian professional association of pharmacists, told about the structure of pharmacy in Austria, including the training of pharmacists. Thus, at present, only in 3 universities in Austria there are pharmaceutical faculties, and the number of students who study there is about 4400. The speaker noted that it is not enough to ensure adequate pharmaceutical services in the country. He said that the main task of the Austrian professional association of pharmacists is participation in determination of pharmacists’ salaries and represent their interests at the state level.
In the report of Golovenko Nicholay, head of the Department of Physical and Chemical Pharmacology of A.V.Bogatsky Physico-Chemical Institute of the NAS of Ukraine (Odessa), academician of NAMS of Ukraine, D.Sc. in Biology, professor were raised such important issues as the definition of therapeutic equivalence of generic medicine to reference medicine, which includes an assessment of pharmacodynamic, clinical and bioequivalent indicators and researches in vitro. The speaker outlined to the audience the regulatory requirements regarding bioequivalence study, characterization of the main pharmacokinetic parameters and limits of their variability, examined the reasons for high pharmacokinetic variability of medicines, as well as methods of establishing of bioequivalence of medicines. In addition, the speaker focused on the problems of medicines with low therapeutic index and introduced a variant of study of such a medicine.
On clinical and pharmaceutical aspects of the use of nonsteroid anti-inflammatory drugs (NSAIDs) reported Igor Zupanets, head of the Department of Clinical pharmacology with pharmaceutical care of the NUPh, D.Sc. in Medicine, Professor. The choice of the theme of the report was due to several factors: high prevalence of vectors of human diseases that require prescription of NSAIDs and the development of side effects in many cases the use of drugs in this group. These include effects on platelet aggregation, development of cardiovascular events, liver failure, etc. I. Zupanets focused on the rational drug therapy, noting among other things that for optimal treatment can be very helpful to create a document similar to «Orange Book» (collection published in the U.S., which provides information on all registered drugs, their therapeutic action and, most importantly, about discovered during their application side effects). Using this document, doctor or pharmacist can make the right decision when choosing a regimen. Also I. Zupanets spoke about the difficulties associated with the development and implementation of new medicines into the world market. He also gave a list of medicines that have been refused to register, or that have been withdrawn from the pharmaceutical market in the U.S.A., the E.U. and Ukraine. The speaker emphasized the need in such a specialist as clinical pharmacist in clinical practice and underlined that many deaths associated with administering illiterate, could have been avoided through consultation with a clinical pharmacist and his active involvement to the therapeutic activity in hospitals.
About pharmaceutical developments, the impact of pharmaceutical factors on efficiency, bioavailability and safety of medicines reported Nikolay Lyapunov, senior research assistant in SE “State Expert Centre for Drugs and Medical Products”, D.Sc. in Pharmacy, professor. He noted that it is necessary for pharmaceutical development to investigate the properties of active substances and excipients of the medicine. Functional characteristics and requirements are specific for each medicine. He also emphasized that at the stage of pharmaceutical development it is necessary to conduct screening researches, that include the study of functional characteristics of the medicines and, if necessary – specific actions, bioavailability and safety by varying the significant parameters. The composition of active substances and excipients should be chosen taking into account the results of such research, including biomedical requirements for medicines. In addition, there was stressed the importance of proper selection of carrier-coupled materials. The speaker noted that the clinical pharmacist must understand how the above-mentioned parameters can affect the efficacy and safety of the medicine. “Today the biggest challenge is the presence in the market of medicines developed without modern biomedical requirements and appropriate scientific justification that poses a risk to the health of patients and may lead to ineffective treatment and development of adverse reactions.”
On the national model of clinical pharmacy reported Andrew Zimenkovsky, head of the department of Clinical Pharmacy, Pharmacotherapy and Medical standardization of LvivNationalMedicalUniversity named after Daniel Galician, D.Sc. in Medicine, Professor. In particular, he noted that overseas clinical pharmacy is developing in such key directions: academic, scientific and applied. The last direction is especially important for national health care system, because it permits to defend the role of the clinical pharmacist as an expert in the field of rational pharmacotherapy. Among the mechanisms that may contribute to the development of clinical pharmacy in Ukraine, the speaker highlighted the following: promotion of pharmaceutical care, promotion of civil structures, and creation of specialized association. A. Zimenkovsky stopped on the development of clinical pharmacy in Ukraine, including the role of the clinical pharmacist in the pharmacovigilance and clinical trials.
Elena Matveeva, head of post-marketing surveillance department of SE “StateExpertCenter” of the Ministry of Public Health of Ukraine, C.Sc. in Medicine, reported that one of the main objectives of pharmacovigilance is to evaluate the benefit / risk ratio for the entire life cycle of medicines. The applicant or the regulator may collect information about adverse reactions to drugs in different ways. Thus, routine pharmacovigilance involves the collection of spontaneous reports on adverse reactions, analysis of safety reports, etc.
E. Matveeva noted that if the market launches new medicines, the routine approach is not optimal, since data on the safety of these drugs is not enough. The essential condition, which allows registration and withdrawal from the pharmaceutical market of one or another country, is a risk management plan. The speaker stopped on medical errors and patients’ noncompliance to doctors’ appointments as aspects that lead to increased risk. Among the routine methods of minimizing risks were marked: labeling of medicines, reduction of the number of doses in a single package, provision of detailed information on the medicine in package inserts. O. Matveeva underlined the importance of creation of awareness of the medical staff and patients of possible risks.
In his report, Viktor Chumak, Adviser to the Minister of Public Health, focused on the problem of implementation in Ukraine of GPP (Good Pharmacy Practice). This, as he said, will help to reduce the risks of adverse reactions in case of self-treatment. He also emphasized that health care reform, including the implementation of the requirements of Good Pharmacy Practice should not affect the economic availability of therapy. Adviser to the Minister stressed that the implementation of GPP demands in our country is aimed at the sale of medicines without reducing the benefits of therapy. V. Chumak also noted the important role of the clinical pharmacist in optimization of pharmaceutical treatment.
During the Congress have been conducted research and training activities. Thus, during the scientific workshop “Experimental and clinical research of drugs” ZupanetsI., A.Zimenkovsky, Aleksander Barinov, senior researcher of Neurology and Clinical Neurophysiology Department of the I.M. Sechenov First Moscow State Medical University delivered the reports. At the workshop were discussed such issues as adverse reactions associated with the use of drugs as a tool of applied clinical pharmacy, drug bioequivalence studies in Ukraine from the perspective of EBM and Clinical Pharmacy, interaction of drugs as a risk factor for the development of medical errors, development of the system of quality assurance at clinical research.
In educational seminar “Issues of the training of clinical pharmacist” presented such reports as the introduction of “Protocols of pharmacist” in the curriculum of students enrolled in the specialty “Pharmacy”, introduction of integrated license exam KROK-2 into the curriculum of students in “Clinical Pharmacy”, pre-postgraduate education in “Clinical Pharmacy”. There was also provided information on clinical pharmacy in higher pharmaceutical education in Kazakhstan. In addition, there was presented the first edition of the textbook “Clinical Pharmacy”.
There were conducted training seminars on good clinical and pharmacy practice. Anatoliy Moroz, professor, deputy executive director of State Enterprise “StateExpertCenter” of the Ministry of Public Health of Ukraine reported on legal regulation of clinical trials in Ukraine. There were discussed issues such as the practical aspects of clinical trials in Ukraine, documentary support of clinical research, audit of clinical research and ethical aspects of their conduction. Elena Lischishyna, director of the medical services standardization department of SE “StateExpertCenter” of the Ministry of Public Health of Ukraine reported on the GPP requirements as the basis for development of standards for pharmaceutical services in Ukraine.
The participants shared their experiences in the development and implementation of standards for GPP in the UK, the Republic of Moldova, and Ukraine. Inna Demchenko, first deputy chairman State Medical Service of Ukraine, spoke about the implementation of these standards in the legal framework of Ukraine, and Mikhail Pasechnik, President of Pharmacy Professional Association of Ukraine, focused on their development in our country.
Clinical Pharmacy – integrated science that combines pharmaceutical and clinical aspects of pharmaceutical science, promotes creation of theoretical and methodological basis for the rational use of medicines in clinical practice. Clinical pharmacy may permit to optimize drug treatment, pursuing the main goal – to improve the health of the nation. Conduction of such a Congress at such level in the pharmaceutical capital of Ukraine indicates that the clinical pharmacy in our country is actively developing and that national health care system is on the right track.