12PHARMACY
FORENSIC PHARMACY: ANALYSIS OF COMPLAINTS ABOUT THE PHARMACEUTICAL PROVISION FOR PRIVILEGED CATEGORIES OF PATIENTS IN UKRAINE (EXPERIMENTAL RESEARCH)
Andriy Gudzenko, Kharkiv medical academy of postgraduate education, PhD in pharmacy, ORCID ID: https://orcid.org/0000-0002-9040-007X,
Valentyn Shapovalov, Kharkiv medical academy of postgraduate education, doctor of pharmacy, professor, Advocates company "Apotheosis", corresponding author, ORCID ID: https://orcid.org/0000-0002-9329-0195,
Valeriy Shapovalov, Lviv medical institute, doctor of pharmacy, professor, ORCID ID: https://orcid.org/0000-0002-6696-6380,
Viktoriya Shapovalova, Kharkiv medical academy of postgraduate education, doctor of pharmacy, professor, ORCID ID: https://orcid.org/0000-0003-4770-7292.
DOI: https://doi.org/10.31435/rsglobal_sr/30042021/7517
ARTICLE INFO ABSTRACT
Received 19 January 2021 The article presents the results of the research from position of forensic
Accepted 15 March 2021 pharmacy concerning analysis of complaints about the pharmaceutical
Published 30 April 2021 provision for privileged categories of patients in Ukraine. Analyzed world
- experience of the reimbursement system (reference pricing) in pharmaceutical
KEYWORDS provision for privileged categories of citizens comparing to existing system in
Ukraine. Studied complaints of privileged contingents of patients concerning forensic pharmacy, pharmaceutical supply in various health care facilities. Based on results created
pharmaceutical provision, a matrix of complaints of privileged contingents of patients regarding
privileged patients, unsatisfactory pharmaceutical provision. Based on the matrix of complaints,
pharmaceutical law. three regional lists of drugs were developed with the further development of
organizational and legal measures to increase the level of pharmaceutical provision of privileged contingents of patients.
Citation: Andriy Gudzenko, Valentyn Shapovalov, Valeriy Shapovalov, Viktoriya Shapovalova. (2021) Forensic Pharmacy: Analysis of Complaints About the Pharmaceutical Provision for Privileged Categories of Patients in Ukraine (Experimental Research). Science Review. 2(37). doi: 10.31435/rsglobal_sr/30042021/7517
Copyright: © 2021 Andriy Gudzenko, Valentyn Shapovalov, Valeriy Shapovalov, Viktoriya Shapovalova. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
Introduction. Benefits in Ukraine are provided on a categorical basis, according to the citizen's belonging to a certain privileged category depending on the social status or professional activity defined by law. Privileges are established for various purposes, as a reward to the state, to ensure an increased level of their social guarantees or as social support to ensure an adequate standard of living [1, 2].
In Ukraine, the main method of the state pharmaceutical privileged categories of patients remains public procurement for budget funds. In addition, at various times, a system of "preferential prescriptions", pilot projects to reimburse the cost of drugs, health insurance funds were introduced into practice. The ideas of insurance medicine have been actively discussed for a long time, but without any real steps for its implementation [3, 4].
Disadvantages of the state system of pharmaceutical provision of privileged contingents of patients in Ukraine include overstated costs for the purchase of drugs due to corruption schemes, lack
of market pricing, a huge number of formal requirements for tender documents, lack of long-term procurement planning by the state for manufacturing companies [5, 6].
That is why the search for alternative methods of pharmaceutical provision for privileged categories of patients at the expense of the state remains relevant.
The world experience of the reimbursement system (reference pricing) is the most cost-effective and optimal, as it implements the principle of targeted subsidies. Reference pricing in the world is primarily aimed at establishing the level of reimbursement at the expense of the state, and retail prices are influenced by market mechanisms and the laws of free competition. This mechanism is used by the vast majority of countries and in practice has reduced health care costs by up to 50% [7, 8, 9].
For the first time in Ukraine, preferential pharmaceutical provision with elements of reimbursement of certain categories of patients with certain diseases was launched in 1998. Unfortunately, this area is developing less actively. Sufficient funds are not allocated for the pharmaceutical provision of beneficiaries with medicines. On the example of preferential pharmaceutical supply of medicines to people affected by the Chernobyl disaster, we can see how the financial support of the state went to a separate fund, which is replenished by direct mandatory payments from the population [10, 11].
In 2012, Ukraine launched the first pilot project to reimburse the cost of drugs for the treatment of people with hypertension. Despite some positive results at the initial stage of the project, such as lower antihypertensive drugs and positive indicators of real reimbursement to patients, today most pharmaceutical companies treat it with irritation rather than interest in participating.
The main feature of the pharmaceutical supply of different contingents of patients is the social orientation. Therefore, it is necessary to actively develop the social potential of health care facilities (hospitals, clinics, pharmacies). The activities of the health care facilities include the implementation of costs, which are the basis for the formation of pricing policy for drugs. In market conditions, the main condition for effective pharmaceutical provision of privileged categories of patients is transparency, completeness, reliability, honesty and efficiency of information about the costs that form the cost of drugs [12, 13, 14].
Purpose of the research was to analyze the complaints of privileged contingents of patients for pharmaceutical supply in health care facilities (hospitals, clinics, pharmacies) from the position of forensic pharmacy and pharmaceutical law.
Materials and Methods. The current research was carried out using the system approach during 2017-2020. The materials were questionnaires of employees of health departments among a number of regional state administrations, 58 health care institutions, 18 communal and private pharmacies that provide pharmaceutical benefits to privileged categories of patients.
The information base of the study consisted of scientific works of foreign and domestic scientists on issues related to the organization of pharmaceutical business, management, forensic pharmacy, pharmaceutical supply, pricing policy for drugs [15, 16, 17].
Modern research methods were used: normative and legal, documentary, retrospective, bibliographic, systemic, forensic-pharmaceutical, sociological (questionnaire survey), comparative, marketing, graphic, mathematical analysis. Mathematical processing and statistical evaluation of data was performed using Microsoft Excel.
The study of the article is a fragment of research work of the Kharkiv Medical Academy of Postgraduate Education on "Improving the organizational and legal procedure for providing patients with drugs from the standpoint of forensic pharmacy, organization and management of pharmacy" (state registration number 0116U003137, deadline 2016-2020) and "Pharmaceutical and medical law: integrated approaches to the drug circulation system from the standpoint of forensic pharmacy and organization of pharmaceutical business" (state registration number D/21U000031, deadline 2021-2026).
Research results. Five thousand fifty complaints from privileged categories of patients about unsatisfactory pharmaceutical supply were processed according to a specially developed questionnaire [18].
Found that 61% of complaints of privileged patients (women accounted for 38%; men - 62%) were related to late or incomplete provision of prescription drugs. Violation of the rights of privileged categories of patients to receive drugs on discounted and free prescriptions of doctors was recorded in 58% of complaints.
At the preparatory stage of the study, a superficial analysis of the study materials was performed in order to eliminate improperly completed questionnaires and calculate the minimum number of them to obtain representative data of the study results according to the formula:
N
n =-
1 + 0.015 • N
where n - is the number of questionnaires;
N - is the total number of respondents.
In the course of the study, a matrix of complaints based on patient reports of unsatisfactory pharmaceutical supply of drugs of different clinical and pharmacological, classification and legal and nomenclature and legal groups was constructed (Fig. 1).
Based on the matrix of complaints, appropriate lists of drugs were developed with the further development of organizational and legal measures to increase the level of pharmaceutical provision of privileged contingents of patients.
Revealed that the reference pricing mechanism in the world is primarily aimed at establishing the level of reimbursement at the expense of the state, and retail prices are influenced by market mechanisms and the laws of free competition. This mechanism is used by the vast majority of EU countries and in practice has reduced health care costs by up to 50% depending on the state [19, 20, 21].
Place of residence, place of work (city, region)
Departure to the health care facility Preparing an answer
Health care facilities (pharmacies, drugstores)
o
Pharmacist, factors of unsatisfactory pharmaceutical provision (absence, 110 preferential release, low-qualily, etc.)
Ô
Classification and legal group
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Diseases, drug benefits, etc.
Levels of interaction in
the system of legal relations "doctor-patient-pharmacist"
<
List of bodies involved in resolving of the complaint
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Nomenclature and legal group
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o
Adoption of organizational and legal
measures
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Fig. 1. Matrix of complaints ofprivileged contingents ofpatients regarding unsatisfactory pharmaceutical provision (source: own development) Discussion. In accordance to the ATC classification, the clinical and pharmacological distribution of drugs by five clinical and pharmacological groups, which appeared in the complaints of privileged contingents of patients [22]:
A - Drugs affecting the digestive system and metabolism (9.5%) C - Drugs affecting the cardiovascular system (44.5%) D - Dermatological products (3.2%) M - Medications for musculoskeletal system (1.6%) N - Drugs acting on the nervous system (41.2%)
Thus, the unsatisfactory level of pharmaceutical provision of privileged categories of patients among the drugs of clinical and pharmacological group C "Drugs that affect the cardiovascular
system" (44.5% of complaints); the share of complaints about drugs of group N acting on the nervous system is 41.2%; group A - 9.5%.
Based on the study, three regional lists of drugs for pharmaceutical support of privileged categories of patients were compiled.
List 1 included OTC drugs of the general group on complaints of privileged contingents of patients (Table 1). The biggest number of OTC drugs of the general group belongs to the ATC codes A and N (by 40% respectively).
Table 1. Regional list one. OTC drugs of the general group on complaints of privileged contingents of patients (source: own development)__
No. INN ATC code Clinical and pharmacological group
1 Fish oil oxidation products D08AX Antiseptics and disinfectants
2 Silymarin A05BA03 Hepatoprotective drugs
3 Hyperici herba, Passiflorae herba, Valerianae radix, Crataegi folium cum flore, Lupuli flos, Melissae herba, Sambusi flos, Guaifenesin N05CM Sedatives
4 Sea buckthorn oil A02X Drugs that affect the digestive system and metabolism. Drugs for the treatment of acid-dependent diseases
5 Metamizole sodium, combinations with psycholeptics N02BB72 Analgesics antipyretics
List two included prescription drugs of the general group on the complaints of privileged contingents of patients (Table 2).
Table 2. Regional list two. Prescription drugs of the general group on complaints of privileged contingents of patients (source: own development)_
No. INN ATC code Clinical and pharmacological group
1 Deproteinized hemoderivative from calf blood A16AX Drugs that affect the digestive system and metabolic processes
2 Chlorpromazine N05AA01 Antipsychotic drugs. Phenothiazine derivatives with aliphatic structure
3 Amlodipine C08CA01 Selective calcium antagonists with a predominant effect on blood vessels. Dihydropyridine derivatives
4 Atenolol C07AB03 Selective P-adrenoceptor blockers
5 Metoprolol C07AB02 Selective P-adrenoceptor blockers
6 Barbiturates in combination N05CB02 Hypnotics and sedatives. Barbiturates in combination
with other drugs with drugs of other groups
7 Essential phospholipids A05BA Hepatotropic drugs
8 Amiodarone C01BD01 Antiarrhythmic drugs, class III
9 Levodopa and decarboxylase inhibitor N04BA02 Antiparkinsonian drugs. Dopaminergic drugs. DOPA and derivatives. Levodopa with decarboxylase inhibitor
10 Nalbuphine N02AF02 Analgesics. Opioids. Morphine derivatives
11 Nimesulide M01AX17 Non-selective nonsteroidal anti-inflammatory drugs
12 Metamizole sodium, Fenpiverinium bromide, Pitofenone hydrochloride A03DA02 Synthetic anticholinergics in combination with analgesics
13 Ethanol D08AX08 Antiseptics and disinfectants
Important to note, that among the prescription drugs of the general group on the complaints of privileged contingents of patients (Table 2) the first three positions on the unsatisfactory level of pharmaceutical supply were drugs with three ATC codes: "N" drugs acting on the nervous system (Aminazine, Valocordine, Levocome, etc.) - 30.8%; "C" drugs that affect the cardiovascular system (Amlodipine, Betaloc, Atenolol etc.) - 30.8%; "A" drugs that affect the digestive system and metabolism (Actovegine, Essentiale forte H, Renalgane) - 23.0%.
As the place of ranking received the most complaints from the privileged contingents of patients regarding the pharmaceutical supply of drugs that affect the cardiovascular system, it was further analyzed, systematized, copied and compiled Regional List three - drugs of the general group affecting the cardiovascular system for complaints of different contingents of patients (Table 3).
Table 3. Regional list three. Drugs of the general group affecting the cardiovascular system on the complaints of privileged contingents of patients (source: own development) _
No. INN ATC code Clinical and pharmacological group Nomenclature and legal group
1 2 3 4 5
1 Amlodipine C08CA01 Selective calcium antagonists with a predominant effect on blood vessels. Dihydropyridine derivatives By the F-1 recipe
2 Atenolol C07AB03 Selective P-adrenoceptor blockers By the F-1 recipe
3 Adenosine C01EB10 Cardiac drugs. Adenosine By the F-1 recipe
4 Enalapril C09AA02 Angiotensin-converting enzyme inhibitors By the F-1 recipe
5 Metoprolol C07AB02 Selective P-adrenoceptor blockers By the F-1 recipe
6 Bisoprolol C07AB07 Selective P-adrenoceptor blockers By the F-1 recipe
7 Lisinopril and amlodipine C09BB03 Combined drugs of ACE inhibitors By the F-1 recipe
8 Enalapril C09AA02 Angiotensin-converting enzyme inhibitors By the F-1 recipe
9 Enalapril C09AA02 Angiotensin-converting enzyme inhibitors By the F-1 recipe
10 Enalapril and diuretics C09BA02 Combined drugs of ACE inhibitors. Captopril and diuretics By the F-1 recipe
11 Calcium gluconate A12AA03 Calcium preparations OTC
12 Captopril and diuretics C09BA01 Combined drugs of ACE inhibitors. Captopril and diuretics By the F-1 recipe
13 Bisoprolol C07AB07 Selective P-adrenoceptor blockers By the F-1 recipe
14 Amiodarone C01BD01 Antiarrhythmic drugs, class III By the F-1 recipe
15 Lacidipine C08CA09 Calcium channel blockers. Selective calcium channel blockers with a predominant effect on blood vessels By the F-1 recipe
16 Lisinopril C09AA03 Angiotensin-converting enzyme inhibitors By the F-1 recipe
17 Lisinopril C09AA03 Angiotensin-converting enzyme inhibitors By the F-1 recipe
18 Betaxolol C07AB05 Selective P-adrenoceptor blockers By the F-1 recipe
19 Losartan C09CA01 Agents acting on the renin-angiotensin system. Simple drugs of angiotensin II receptor antagonists By the F-1 recipe
20 Meldronium C01EB22 Cardiac drugs By the F-1 recipe
21 Nebivolol C07AB12 Selective P-adrenoceptor blockers By the F-1 recipe
22 Trimetazidine C01EB15 Cardiac drugs By the F-1 recipe
23 Propafenone C01BC03 Drugs for the treatment of heart disease. Antiarrhythmic drugs of the IC class By the F-1 recipe
24 Amlodipine C08CA01 Selective calcium antagonists with a predominant effect on blood vessels. Dihydropyridine derivatives By the F-1 recipe
Based on the calculations, it was proved that the most unsatisfactory level of pharmaceutical supply received complaints about drugs Amlodipine, Atenolol, Adenosine, Enalapril, Amiodarone (95.8%).
Conclusions. 1. It is substantiated that the main feature of pharmaceutical provision of privileged contingents of patients is social orientation. It is proved that it is necessary to actively develop the social potential of health care facilities in the format of transparency, completeness, reliability, and efficiency of information about the costs that form the cost of drugs.
2. From the position of forensic pharmacy, five thousand fifty complaints were processed from privileged categories of patients regarding unsatisfactory pharmaceutical supply according to a specially developed questionnaire.
3. In the course of the study, a matrix of complaints based on patient reports of unsatisfactory pharmaceutical supply of drugs of different clinical-pharmacological, classification-legal and nomenclature-legal groups was constructed.
4. On the basis of the matrix of complaints, three regional lists of drugs were developed with the further development of organizational and legal measures to increase the level of pharmaceutical provision of privileged contingents of patients.
5. It is noted that the reference mechanism of drug pricing is aimed at establishing the level of reimbursement at the expense of the state and reducing costs to 50% for pharmaceutical provision of privileged categories of patients.
REFERENCES
1. Anderson P.D., O'Donnell J. The Forensic Pharmacist. Drug Injury: Liability, Analysis, and Prevention. Hardcover. 2017. N 23. Pp. 761-770.
2. ATC-classification. [Electronic resource]. Compendium on-line. Retrieved from http://compendium.com.ua/atc. (application date 05.10.2018).
3. Concerning the importance of forensic and pharmaceutical researches to improve patients' accessibility to medicines / V. Shapovalov, A. Gudzenko, L. Komar, A. Butko, V. Shapovalova, V.Shapovalov. Pharmacia. 2017. Vol. 65. N. 2. P. 23-29.
4. Experience of Great Britain in organization of healthcare system for pharmaceutical provision with medicines for privileged categories of citizens / V.V. Shapovalov (Jr.), V.O. Shapovalova, V.V. Andrieieva, V. V. Shapovalov. Health of society. 2019. Vol. 78, N. 1. P. 36-40. (doi: 10.22141/2306-2436.8. 1.2019.172617).
5. Experience of Poland concerning and organization of healthcare system for the pharmaceutical provision for privileged categories of citizens / V.V. Shapovalov (Jr.), A.O. Gudzenko, V.A. Shapovalova, V.V. Andrieieva, V.V. Shapovalov. Proceeding of articles the international scientific conference «Advance of Science». Czech Republic, Karlovy Vary - Ukraine, Kyiv, 17 May 2019. Czech Republic, Karlovy Vary: Skleneny Mustek - Ukraine, Kyiv: MCNIP, 2019. P. 16-22.
6. Experience of the USA concerning and organization of healthcare system for the pharmaceutical provision for privileged categories of citizens / V.V. Shapovalov (Jr.), A.A. Gudzenko, V.V. Andrieieva, V.A. Shapovalova, V.V. Shapovalov Annals of Mechnikov Institute. 2019. N. 1. P. 81-87. (doi: 10.5281/zenodo.2639521).
7. Freeman J. S. Providing whole-person care: integrating behavioral health into primary care. N.C. Med. J. 2015. Vol. 76, N 1. P. 24-25, 27-28.
8. Forensic and pharmaceutical study of the presence of a causal link between the degree of alcohol abuse and qualification level of the respondents / V. Shapovalov, A. Gudzenko, V. Shapovalova, A. Osyntseva, V. Shapovalov. Pharmacia. 2017. Vol. 66, N. 3. P. 31-39.
9. General characteristic of pharmaceutical provision for privileged categories of citizens in Ukraine / V.V. Shapovalov, O.P. Gudzenko, V.A. Shapovalova, V.V. Andrieieva, V.V. Shapovalov. The 10th International conference "Science and society": Accent Graphics Communications (March 15, 2019). Premier Publishing s.r.o. Hamilton, Canada, 2019. P. 90-96.
10. Gorokhov S.V., Starynchuk S.D. Comparative analysis of medical insurance systems of foreign countries [Electronic resource]. Retrieved from http: //www.apfs. in.ua/v9_2015/8.pdf (application date 04. 02. 2017).
11. Health insurance and mortality in US adults / A. P. Wilper, S. Woolhandler, K. E. Lasser, D. McCormick, D. H. Bor. American Journal of Public Health. 2009. Vol. 99. N. 12. P. 2289-2295.
12. Heilmann P. To have and to hold: personnel shortage in a Finnish healthcare organisation. Scand. J. Public. Health. 2010. Vol. 38. N. 5. P. 518-523.
13. Kuchekar B.S. Forensic Pharmacy. Nirali Prakashan, 2006. 460 p.
14. Mason A., Goddard M., Weatherly H., Chalkley M. Integrating funds for health and social care: an evidence review. Journal of Health Services Research. 2014. P. 20-27.
15. Medicine in the UK: from each - whenever possible, for everyone - on demand. Retrieved from https://www.vz.kiev.ua/medytsyna-velykoyi-brytaniyi-vid-kozhnogo-po-mozhlyvosti-kozhnomu-po-potrebi/ (application date 25.10.2017).
16. Meta D., Shukhov V., Chuchalin A. The British national form (politics, structure, features, example for imitation). [Electronic resource]. Retrieved from http://evbmed.fbm.msu.ru/rwinwww/publica/bnf.html (application date 24.07.2017).
17. Ministry of healthcare of Ukraine official site [Electronic resource]. Retrieved from http://moz.gov.ua/ (application date 07.05.2018).
18. National Health Service. Retrieved from http://www.nhs.uk/pages/home.aspx_(application date 24.07.2017).
19. Organizational and legal evaluation of availability of medicines' circulation for cancer patients / V.V. Shapovalov, S.I. Zbrozhek, V.O. Shapovalova, V.V. Shapovalov. Pharmacia. 2018. Vol. 65, N. 2. P. 17-22.
20. Shapovalova V.A. Link between Forensic Psychiatry and Forensic Pharmacy. Abstracts of the XI World Congress of Psychiatry. London, United Kingdom, 6-11 August 1999. Vol. 2. 300 p.
21. Study of Medication Errors on a Community Hospital Oncology Ward. 2016. [Electronic resource]. PubMed. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2793607/. (application date 07.05.2018).
22. WHO Drug Information. Retrieved from http://www.who.int/medicines/publications/druginformation/en. (application date 07.05.2018).
