Neurologists’ Knowledge, Practice, and Attitudes towards Pharmacovigilance and Adverse Drug Reactions Reporting Process in Epileptic Patients—Comparative Analysis from Poland and Egypt

Objectives: To compare neurologists’ knowledge, practice, and barriers of pharmacovigilance (PV) process among patients with epilepsy in Poland and Egypt. Methods: It was an international study that used an online questionnaire e-mailed to neurologists registered to practice in Poland and Egypt. Results: Most of the neurologists were familiar with the definition of PV and adverse drug reactions (ADRs), but relatively few neurologists knew where to report ADRs, especially the Egyptian neurologists. Only 31.11% of the neurologists from Egypt and 39.90% neurologists from Poland declared that they had reported ADRs at least once during their professional practice, and few of them declared the regular reporting of such incidents. The main reason for the neurologists not reporting ADRs was the lack of time and a conviction that reporting ADRs would be an additional burden that would generate extra work. Conclusion: The standards of pharmacovigilance process, safety control, and quality are not the same throughout the world. System-regulated PV stabilization in a country translates into the practice of maintaining PV. Monitoring the safety of pharmacotherapy and knowledge of risks associated with ADRs should be included in the academic curricula of physician courses

Assessment of Patients’ Quality of Life during Conservative Treatment after Distal Radius Fracture

Introduction: This study aimed to assess patients’ quality of life after distal radius fracture treatment (at least six months, but no more than ten years, after the treatment) based on the analysis of objective and subjective parameters and the influence of the fractured side on the final results. Materials and Methods: The study sample consisted of 30 women who claimed to be right-handed, divided depending on the side of the fracture (left vs. right limb). Patients were evaluated with a goniometer for active wrist movement, pronation, and supination in the elbow joint. Furthermore, the global grip strength of the upper limb was assessed using a dynamometer (Biometrics Ltd.) device, after which patients were asked to complete a wrist evaluation questionnaire (PRWE) and the Polish version of the SF-36 questionnaire assessing the quality of life. Results: There were statistically significant differences in the active movement of the wrist of the injured limb compared to the non-injured limb. In addition, inferior results were reported for injury of the right limb to those of the left. Conclusions: Injury of the right limb as opposed to injury of the left limb can have a negative impact on the assessment of quality of life in patients with right-limb dominance

The influence of olanzapine and aripiprazole on spatial memory of female rats exposed to stress in the perinatal period

Cognitive functions, such as learning and memory, are instrumental in improving the patient’s quality of life. Commonly used antipsychotic drugs are also useful in depression treatment, and have a positive effect on spatial memory dysfunction caused by schizophrenia. Olanzapine (OLA) and aripiprazole (ARI) are known to have substantially different pharmacokinetics depending on sex, thus their therapeutic efficacy and dose of treatment may be different for males and females. The aim of the study was to assess whether dysfunction of spatial memory (Morris Water Maze - MWM) and locomotor activity (LA) improve in prenatally stressed rats (animal model of schizophrenia (AMS)) by OLA and ARI. OLA (0.5 mg/kg ip) and ARI (1.5 mg/kg ip) were administered to female Wistar rats (non-stressed control group (NSCG) and PSG). Single administration of ARI and OLA in the NSCG yielded no differences in spatial memory compared to the control group (C-NSCG), while OLA improved memory after 7 days of treatment compared to the C-NSCG. In the prenatally stressed group (PSG), an impairment of spatial memory by the drug was observed (vs. C-NSCG) after long-term treatment. Only chronic administration of ARI and OLA (PSG) improved spatial memory in female rats. Conclusion: Stress causes memory dysfunction in female rats. Chronic administration of ARI and OLA reverses this effect which can probably be associated with the mechanism of action of the drugs used (ARI/OLA). ARI acts as an agonist or antagonist mainly on D2 and 5-HT2A receptors, while OLA induces antagonist effects for these receptors

THE PRESCRIPTION TO OVER-THE-COUNTER SWITCHES AND DOUBLE REGISTRATION OF MEDICINES - THE PERSPECTIVE OF PHARMACISTS FROM THE GREATER POLAND.

The prescription to over-the-counter switch is a global occurrence. However, the switch phenomenon might be considered controversial. Nevertheless, the further development of switches seems to be inevitable, thus we collected pharmacists’ opinions about Rx-to-OTC switches including double registration of medicines. The study was conducted in pharmacies from the Greater Poland, using an anonymous questionnaire, which was delivered by direct contact. Finally, answers from 232 pharmacies were included in the study. Moreover, we analyzed data from 5500 Polish pharmacies, concerning the turnover of selected and doubly registered medicines. Rx-to-OTC switches were negatively evaluated by the majority (81.5%) of respondents. “Furaginum” was the most frequently chosen (60.8%) substance, which according to obtained answers should be available only on prescription. Study participants claimed that the most important drawback (chosen by 44.4% participants) of the double registration of medicines is the development of uncontrolled self-medication. Data obtained from a market research company revealed that the Rx-to-OTC switch may lead to the market share growth of OTC class (e.g. “furaginum”), but it is not the rule (e.g. “omeprazole/pantoprazole”). Although Rx-to-OTC switches are considered somewhat controversial, the switch, as well as double registration phenomenon, seems to be a subject of further development. However, in pharmacists opinion substances like “furaginum” should be available as an Rx-only brand instead of double registered medicine. In the case of Rx-to-OTC switches, additional information about possible side effects and/or interactions should be provided to the patients who might inappropriately use medicines

ANALYSIS OF CHRONIC MYELOID LEUKEMIA PHARMACOTHERAPY COSTS IN POLAND

The aim of this study was to analyze pharmacotherapy cost of chronic myeloid leukemia from the society’s, the payer’s (National Health Fund), and the patient’s perspective. The study included 55 patients with a diagnosed and treated chronic myeloid leukemia at the selected hematology clinic in the city of Poznan. Retrospective study involved time horizon of one calendar year – 2013. The data required for economic evaluation were obtained from the patients’ case histories and the Department of Organization and Accounting of the selected health care facilities. The total cost of chronic myeloid leukemia pharmacotherapy for 55 patients from the society’s perspective in 2013 amounted to 1,483,416.88 EUR. Average annual cost of medication per patient in 2013 amounted to 26,971.22 EUR (Median – 32,854.22 EUR). Average cost of chronic myeloid leukemia pharmacotherapy for a patient without transplantation was 32,167.34 EUR (Median – 30,623.00 EUR), and for a patient after transplantation amounted to 413.13 EUR (Median – 378.40 EUR). The cost from the payer’s perspective is 99.93% of total costs from the society’s perspective. The cost from the patient’s perspective represents 0.07% of the total cost of chronic myeloid leukemia pharmacotherapy from the society’s perspective. Costs of chronic myeloid leukemia pharmacotherapy are very high and represent a significant burden to society. The highest costs associated with treatment of chronic myeloid leukemia are incurred by the society, and, subsequently, the public payer (NHF), and the patient

Affordability of medicines in the European Union.

BACKGROUND:Medications and their prices are key issues for healthcare. Although access to medicines at affordable prices had been specified as a key objective of the European Health Policy, it seems that these goals have not been achieved. Therefore, we attempted an evaluation of affordability of selected medicines at full prices. METHODS:The analysis concerned 2012 and was conducted between 2013 and 2015 in all the European Union (EU) countries divided into 3 groups depending on the date of their accession to the EU. Finally, we considered 9 originators used in the treatment of schizophrenia and multiple sclerosis. Information on drug prices were collected from pharmacies. Participation in the study was voluntary and anonymous in order to avoid accusations of advertising. To evaluate affordability, several factors were used (e.g. minimum earnings and Gini coefficient). Due to unavailability in some countries, the exact number of analyzed medicines varies. RESULTS:Drug prices vary significantly between EU Member States. Almost eleven fold difference was observed between Germany (EUR 1451.17) and Croatia (EUR 132.77) in relation to Interferone beta-1a 22 μg. Generally, prices were the highest in Germany. The cheapest drugs were found in various countries but never in the poorest ones like Bulgaria or Romania. Discrepancies in wages were observed too (the smallest minimum wage was EUR 138.00 in Bulgaria and the highest EUR 1801.00 in Luxembourg). Full price of olanzapine 5mg, however, was higher in Bulgaria (EUR 64.53) than, for instance, in Belgium (EUR 37.26). CONCLUSIONS:Analyzed medications are still unaffordable for many citizens of the EU. Besides, access to medicines is also impaired e.g. due to parallel trade. Unaffordability of medications may lead to the patients' non-compliance and therefore to increased direct and indirect costs of treatment. Common European solutions are needed to achieve a real affordability and accessibility of medications

Effect of Different Blood-Pressure-Lowering Regimens on the Blood Pressure Control among Hypertensive Patients Treated in Hospital Conditions

Background. Scientific references lack sufficient amount of data on analyses of the reasons for hospital admissions or assessment of efficacy of arterial hypertension treatment at hospitals. Objectives. The aim of the study was to evaluate the efficacy of antihypertensive drug therapy on the blood pressure control among hospitalized hypertensive patients. Methodology. A cross-sectional retrospective study consisted of 204 patients aged 18–65 years admitted to the hospital due to hypertension between January 2018 and December 2018. The study was based on analysis of electronic records, obtained from the medical database of the selected healthcare facility. Results. As a result of the treatment applied at the hospital, 65.19% of the patients achieved the desired degree of blood pressure normalization (≤130/80 mmHg). Vast majority of the patients during their stay at the ward would receive three or more hypertensive drugs (63.73%). The most frequently prescribed antihypertensive drug combinations included bitherapies such as diuretics + ACEI and ACEI + β-blockers and tritherapy such as diuretics + β-blockers and calcium channel antagonists and diuretics + ACEI and ARBs. The highest blood-pressure lowering effects were observed among patients receiving combination therapy of a ACEI, a diuretic, and a ARBs. Tritherapy induced a significant mean reduction of inpatients`s SBP compared with bitherapy (p=0.0001). Conclusion. During their hospital stay, vast majority of patients (65.19%) achieved normal values of blood pressure, mostly owing to combined treatment with several hypertensive drugs. Efficacy of the most frequently used combinations of hypertensive drugs in normalizing arterial pressure varies

Employment in schizophrenia –students’ point of view

Schizophrenia is a serious mental disorder and has a huge economic burden related to direct and indirect costs. Direct costs include such expenditure as hospitalization. Indirect costs, however, result mostly from the loss of productivity. Although patients are frequently interested in job opportunities, unemployment is widespread among them. Thus, we evaluated opinions of medical universities students’ concerning situation on the labor market among those in the remission stage of schizophrenia. The study was carried out between October 2015 and October 2016 in Poland and other European Union countries using a self designed questionnaire. The study tool consisting of five questions was distributed to students by direct contact and via the Internet. Of a 5200 distributed sheets, we received 1036 questionnaires and 942 were finally analyzed. In the students’ opinion, patients are generally interested in finding a job but they are afraid coming back to work. Although unemployment is common among patients with schizophrenia, the number of patients capable of working is significantly higher than the number of those actually employed. According to results of the study, getting a job might be effectively supported by non-pharmacological interventions. Considering the noticeably higher number of patients capable of working compared to those employed, development of employment possibilities should be a priority for mental health care decision makers. It should lead to reduction of the patients’ concerns related to looking for a job. Moreover, comprehensive treatment could reduce the economic burden of schizophrenia

Access to vaccination in the Greater Poland (Poland)

Immunization is a very effective health intervention. Moreover, the global vaccines market has been growing rapidly and costs of full children immunization are dramatically higher nowadays than 30 years ago. High vaccine prices may limit affordability of vaccination which is why we attempted an evaluation of availability and affordability of 7 and non-reimbursed vaccines mostly used in children in Poland. The study was conducted between October 2016 and October 2017 using a specially designed anonymous questionnaire comprising three closed-ended questions. The study tool was distributed by direct contact or via the Internet. Eventually, answers from 505 pharmacies from the Greater Poland region and 10 primary care clinics were included. 5 out of 7 vaccines were available in all types of facilities. There were some issues, however, with availability of Bexsero® and Nimenrix®. Considering prices, the highest difference (of more than 100%) was found for Infanrix hexa® and the lowest (38.5%), for Infanrix IPV+HIB®. In 88.17% of pharmacies included, patients were informed about a thermo-insulating package. 48.39% of respondents indicated that such package is free of charge, while in other pharmacies an average price for the package was EUR 0.48. Although availability and affordability of medicines are crucial objectives of the public health policy, it seems that access to vaccines in Poland might be an area for improvement. Thus, prices of non-reimbursed vaccines could be regulated in Poland nationwide. Moreover, to provide trustworthy information concerning vaccination, healthcare decision makers should consider social education about immunization as an important issue