Pub Date : 2020-01-01DOI: 10.35248/2329-6887.20.8.282
Munnuri Sindhu Bharghavi
Pharmacovigilance is defined because the science and activities regarding the detection, assessment, and prevention of adverse drug reactions in humans. Pharmacovigilance has been thought to be a kind of continual monitoring of unwanted effects and other safety-related aspects of medication, which are already placed in markets. The pharmacovigilance has been known to play a vital role in rational use of medicine, by providing information about the adverse effects possessed by the drugs generally population. this review presents briefly about the clinical trails and goal of pharmacovigilance.
{"title":"Mini review on Goals of Pharmacovigilance","authors":"Munnuri Sindhu Bharghavi","doi":"10.35248/2329-6887.20.8.282","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.282","url":null,"abstract":"Pharmacovigilance is defined because the science and activities regarding the detection, assessment, and prevention of adverse drug reactions in humans. Pharmacovigilance has been thought to be a kind of continual monitoring of unwanted effects and other safety-related aspects of medication, which are already placed in markets. The pharmacovigilance has been known to play a vital role in rational use of medicine, by providing information about the adverse effects possessed by the drugs generally population. this review presents briefly about the clinical trails and goal of pharmacovigilance.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76347993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2329-6887.20.8.280
V. Jeevangi, B. S. Kumar, Sodabattula Manjusha
Background: Drug-information service (DIS), is still in a nascent stage, and might be due to late introduction of such tradition in India. It is an undervalued course of department of pharmacy practice that is barely used to their full potential in providing information about drug to the health-care professionals in India. This study has been conducted to expound and explore the information regarding drug needed to enquirer mainly patient specific. The service comprises of collecting, reviewing, evaluating, indexing, and distributing information requested by enquirer. Rational drug use demands access to unbiased drug-information. Aim: To assess and evaluate the DIS provided by department of pharmacy practice based on enquirer’s perspective. Materials and methods: A hospital based prospective study for six months was conducted. Results: A total of 113 queries were received with an average of 18.83 queries per month. Majority of queries were received from interns (39.82%) and general medicine physicians (21.23%). Predominantly asked for the purpose of education or academic 51(37.50%), update of knowledge 31(31.61%) and better patient care 36(26.47%). The feedbacks of the response were rated as ‟good and satisfactory”. Conclusion: The quality of the services provided by the center suggests providing more awareness regarding DIS.
{"title":"Assessment and evaluation of drug information services provided by department of pharmacy practice based on enquirerandrsquo;s perspective at tertiary care hospital, Kalburgi","authors":"V. Jeevangi, B. S. Kumar, Sodabattula Manjusha","doi":"10.35248/2329-6887.20.8.280","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.280","url":null,"abstract":"Background: Drug-information service (DIS), is still in a nascent stage, and might be due to late introduction of such tradition in India. It is an undervalued course of department of pharmacy practice that is barely used to their full potential in providing information about drug to the health-care professionals in India. This study has been conducted to expound and explore the information regarding drug needed to enquirer mainly patient specific. The service comprises of collecting, reviewing, evaluating, indexing, and distributing information requested by enquirer. Rational drug use demands access to unbiased drug-information. Aim: To assess and evaluate the DIS provided by department of pharmacy practice based on enquirer’s perspective. Materials and methods: A hospital based prospective study for six months was conducted. Results: A total of 113 queries were received with an average of 18.83 queries per month. Majority of queries were received from interns (39.82%) and general medicine physicians (21.23%). Predominantly asked for the purpose of education or academic 51(37.50%), update of knowledge 31(31.61%) and better patient care 36(26.47%). The feedbacks of the response were rated as ‟good and satisfactory”. Conclusion: The quality of the services provided by the center suggests providing more awareness regarding DIS.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77881027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2329-6887.20.8.292
Ambati Keerthana
PMS may be a collection of forms and activities utilized to screen the execution of a medical device. These activities are outlined to create data with respect to utilize of the gadget to expediently distinguish gadget plan and/or utilization issues and precisely characterize the real-world device conduct and clinical results. The require for PMS emerges promptly upon commercialization of the device. Ensuring satisfactory restorative input into the hazard administration handle amid item improvement will offer assistance producers characterize conceivable item safety issues.
{"title":"Requirements of Post Market Surveillance","authors":"Ambati Keerthana","doi":"10.35248/2329-6887.20.8.292","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.292","url":null,"abstract":"PMS may be a collection of forms and activities utilized to screen the execution of a medical device. These activities are outlined to create data with respect to utilize of the gadget to expediently distinguish gadget plan and/or utilization issues and precisely characterize the real-world device conduct and clinical results. The require for PMS emerges promptly upon commercialization of the device. Ensuring satisfactory restorative input into the hazard administration handle amid item improvement will offer assistance producers characterize conceivable item safety issues.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83433773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2329-6887.20.8.279
Mohd. Yaqub Khan, Min-Hua Chen
Micro-needle transport approach has been used from past few a long time as a method to break the stratum corneum layer of skin and to perform the effective transport of drug across the skin and it is especially used for delivery of peptides, protein, DNA, oligonucleotides, molecular mass medicine and inactivated viruses across the dermal layer of the skin. In this hypothetical paper, we specifically targeted on how we will develop double-layer microneedle which can deliver drug-mixture therapy efficaciously. Because there are many diseases together with cancer, tuberculosis, diabetes, leprosy, HIV, and AIDS, which may be efficiently handled by way of drug-combination therapy however this remedy is particularly confined to the tablet, capsule or another form of dosage. If we can develop double- layered micro-needles, can an opportunity to treat these illnesses with painless delivery. In the paper, we have tried to deal with type-2 diabetes with double-layered micro needle and that is formulated with the aid of hypothetically designed capsule which has the projection in it and which may be connected with projection of primary micro-needle and can form cone-like cavities and from these cavities we will deliver our drug and materials for the development of secondary layer on a primary layer of micro-needle and this technique can be utilized in different disease remedy and it is going to reduce fee of treatment, increase in patient compliance, site directed drug-delivery, increase in bioavailability of drug in the blood stream and increase in therapeutic index with less side effects.
{"title":"An Idea of Using Drug Combination Therapy through Dissolving Microneedles to Treat Streptozotocin-nicotinamide Induced Diabetic Rats","authors":"Mohd. Yaqub Khan, Min-Hua Chen","doi":"10.35248/2329-6887.20.8.279","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.279","url":null,"abstract":"Micro-needle transport approach has been used from past few a long time as a method to break the stratum corneum layer of skin and to perform the effective transport of drug across the skin and it is especially used for delivery of peptides, protein, DNA, oligonucleotides, molecular mass medicine and inactivated viruses across the dermal layer of the skin. In this hypothetical paper, we specifically targeted on how we will develop double-layer microneedle which can deliver drug-mixture therapy efficaciously. Because there are many diseases together with cancer, tuberculosis, diabetes, leprosy, HIV, and AIDS, which may be efficiently handled by way of drug-combination therapy however this remedy is particularly confined to the tablet, capsule or another form of dosage. If we can develop double- layered micro-needles, can an opportunity to treat these illnesses with painless delivery. In the paper, we have tried to deal with type-2 diabetes with double-layered micro needle and that is formulated with the aid of hypothetically designed capsule which has the projection in it and which may be connected with projection of primary micro-needle and can form cone-like cavities and from these cavities we will deliver our drug and materials for the development of secondary layer on a primary layer of micro-needle and this technique can be utilized in different disease remedy and it is going to reduce fee of treatment, increase in patient compliance, site directed drug-delivery, increase in bioavailability of drug in the blood stream and increase in therapeutic index with less side effects.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79235791","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2329-6887.20.8.284
Ranjit Sonny
Background and objective: Pharmacovigilance in conventional system of medicine is operational for more than sixty years. Homoeopathy, being the second largest way of treatment, is widely practiced all over the world. Hence pharmacovigilance in Homoeopathy is indispensable especially in wake of malpractices like use of drugs violating its principles, increasing incidences of misleading and objectionable advertisements etc. Through this review we shall explore the status of pharmacovigilance in Homoeopathy. Methods: An intense literature search was made on the web pages, databases, journals, bibliographic resources regarding practice of pharmacovigilance in Homoeopathy. Available Publications till May 2020 along with literatures of Homoeopathy were analysed. Results: Data of adverse drug reaction (ADR) arising out of homoeopathic drugs are negligible in the literatures. In India Homoeopathy is patronised by the Government under AYUSH systems. Recently, Ministry of AYUSH, Govt. of India, has taken an initiative of Pharmacovigilance of Ayurveda, Sidha, Unani & Homoeopathy (ASU&H) drugs for reporting and taking measures against ADR of ASU&H drugs and objectionable advertisements in print and electronic media. Some European countries have also started pharmacovigilance of herbal and traditional medicine. Homoeopathy remained careful regarding adverse drug reaction since beginning which is evident from its literatures having full of criticisms to adverse drug events/reactions (ADE/ADR) with examples. Christian Friedrich Samuel Hahnemann (1755-1842), The Father of homoeopathy, devoted his whole life in providing a least harmful, gentle and simple system of therapeutic. Conclusion: Although the data of ADRs in Homoeopathy is negligible but in view of increasing incidence of malpractices and misleading advertisements in Homoeopathy, system of pharmacovigilance with full participation of whole homoeopathic fraternity is the need of the hour for enhancing its validity and market value.
{"title":"Pharmacovigilance and Homoeopathy: A Review","authors":"Ranjit Sonny","doi":"10.35248/2329-6887.20.8.284","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.284","url":null,"abstract":"Background and objective: Pharmacovigilance in conventional system of medicine is operational for more than sixty years. Homoeopathy, being the second largest way of treatment, is widely practiced all over the world. Hence pharmacovigilance in Homoeopathy is indispensable especially in wake of malpractices like use of drugs violating its principles, increasing incidences of misleading and objectionable advertisements etc. Through this review we shall explore the status of pharmacovigilance in Homoeopathy. Methods: An intense literature search was made on the web pages, databases, journals, bibliographic resources regarding practice of pharmacovigilance in Homoeopathy. Available Publications till May 2020 along with literatures of Homoeopathy were analysed. Results: Data of adverse drug reaction (ADR) arising out of homoeopathic drugs are negligible in the literatures. In India Homoeopathy is patronised by the Government under AYUSH systems. Recently, Ministry of AYUSH, Govt. of India, has taken an initiative of Pharmacovigilance of Ayurveda, Sidha, Unani & Homoeopathy (ASU&H) drugs for reporting and taking measures against ADR of ASU&H drugs and objectionable advertisements in print and electronic media. Some European countries have also started pharmacovigilance of herbal and traditional medicine. Homoeopathy remained careful regarding adverse drug reaction since beginning which is evident from its literatures having full of criticisms to adverse drug events/reactions (ADE/ADR) with examples. Christian Friedrich Samuel Hahnemann (1755-1842), The Father of homoeopathy, devoted his whole life in providing a least harmful, gentle and simple system of therapeutic. Conclusion: Although the data of ADRs in Homoeopathy is negligible but in view of increasing incidence of malpractices and misleading advertisements in Homoeopathy, system of pharmacovigilance with full participation of whole homoeopathic fraternity is the need of the hour for enhancing its validity and market value.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88262471","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-07DOI: 10.4172/2329-6887.1000270
Assefa Mb, T. Kassahun
Background: Cardiovascular patients are more often reported with drug-drug interactions as compared to patients with other diseases. The high rate of prescribed drugs in elderly patients increases the likelihood of drug interactions and thus the risk that drugs themselves can be the cause of hospitalization. Purpose: The objective of the research is to assess drug interaction in cardiovascular patients at Yekatit 12 Hospital, Addis Ababa, Ethiopia. Patients and Methods: Retrospective cross-sectional study design was involved to assess drug-drug interaction and associated factors in cardiovascular patients admitted in Yekatit 12 Hospital Medical College. A total of 209 medical charts of cardiovascular patients were included to this study. Drug-drug interaction was checked using standard drug interaction checker software (Micromedex). A test of association was done using Chi-square test. In addition, the significance for the association of variable with the dependent variable was tested at p value less than 0.05. Result: The medical records of 209 cardiovascular patients were included to this study. From these, 55.5% were female whereas, 45% were in the age group of less than 65 years. The mean hospital stay of patients was 11.2 days. Nearly half (44.5%) of the patients had a diagnosis of CHF. A total of 1485 drugs were prescribed during the mean hospital stay of 11.2 days, with a mean of 7.1 medications per patient. Sixty-eight patients (32.5%) had at least one major drug-drug interaction. DDI was found significantly associated with increase in number of drugs (polypharmacy) (p=0.001; chi-square=31.04). In addition patients with prolonged hospital stay were associated with potential drug interactions (p=0.012; chi-square=5.75). Conclusion: The finding of present study reveals that nearly one third of the elderly patients are exposed to at least one major DDI. The most common drug interaction in these cardiovascular patients is between omeprazole and digoxin. Clinical pharmacists must remain vigilant in monitoring potential DDIs and making appropriate dosage or therapy adjustments.
{"title":"Drug Interactions in Cardiovascular Patients in Yekatit 12 Hospital, Addis Ababa, Ethiopia","authors":"Assefa Mb, T. Kassahun","doi":"10.4172/2329-6887.1000270","DOIUrl":"https://doi.org/10.4172/2329-6887.1000270","url":null,"abstract":"Background: Cardiovascular patients are more often reported with drug-drug interactions as compared to patients with other diseases. The high rate of prescribed drugs in elderly patients increases the likelihood of drug interactions and thus the risk that drugs themselves can be the cause of hospitalization. \u0000 \u0000Purpose: The objective of the research is to assess drug interaction in cardiovascular patients at Yekatit 12 Hospital, Addis Ababa, Ethiopia. \u0000 \u0000Patients and Methods: Retrospective cross-sectional study design was involved to assess drug-drug interaction and associated factors in cardiovascular patients admitted in Yekatit 12 Hospital Medical College. A total of 209 medical charts of cardiovascular patients were included to this study. Drug-drug interaction was checked using standard drug interaction checker software (Micromedex). A test of association was done using Chi-square test. In addition, the significance for the association of variable with the dependent variable was tested at p value less than 0.05. \u0000 \u0000Result: The medical records of 209 cardiovascular patients were included to this study. From these, 55.5% were female whereas, 45% were in the age group of less than 65 years. The mean hospital stay of patients was 11.2 days. Nearly half (44.5%) of the patients had a diagnosis of CHF. A total of 1485 drugs were prescribed during the mean hospital stay of 11.2 days, with a mean of 7.1 medications per patient. Sixty-eight patients (32.5%) had at least one major drug-drug interaction. DDI was found significantly associated with increase in number of drugs (polypharmacy) (p=0.001; chi-square=31.04). In addition patients with prolonged hospital stay were associated with potential drug interactions (p=0.012; chi-square=5.75). \u0000 \u0000Conclusion: The finding of present study reveals that nearly one third of the elderly patients are exposed to at least one major DDI. The most common drug interaction in these cardiovascular patients is between omeprazole and digoxin. Clinical pharmacists must remain vigilant in monitoring potential DDIs and making appropriate dosage or therapy adjustments.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91076752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-01DOI: 10.4172/2329-6887.1000274
T. Dawit, R. Mulugeta, T. Melake, B. Iyassu, A. Usman, G. Semere
Many countries have been facing multiple disease burdens which have clinical, economic, and social impact; one of which is adverse drug reactions (ADRs). In the United States, for example, the annual financial burden is estimated to be USD 177.4 billion. It is well-recognized that there is a strong linkage between health and economic growth. In Eritrea,healthcare is provided by the Government of the State of Eritrea (GOE) through public hospitals, which is highly subsidized. The health policy of the GOE is ensuring access to healthcare services to all citizens in an equitable and affordable manner guided by the principle of social justice. Despite the efforts underway in the country, Eritrea is still facing newly emerging public health problems like ADRs, whose clinical, economic and social burden need to be determined. In this nationwide study, 18 hospitals (17 public and one private) were included. During the five-month study period, a total of 5,848 patients admitted to the 18 Eritrean hospitals were screened for ADRs. Of the total patients screened, 922 (15.8%) were identified with at least one suspected adverse drug reaction. The average expenditure per patient was found to be ERN 4,766 (equivalent to USD 318) and the overall ADR related economic burden in the five months period was determined to be ERN 4,394,089 (USD 292,939). From this study it was concluded that, the occurrence of ADR was high which had substantial economic burden for the GOE and the patients.
{"title":"Economic Burden of Adverse Drug Reactions among Hospitalized Patients in Eritrea: A Five-month Prospective Analysis of 5848 Patients","authors":"T. Dawit, R. Mulugeta, T. Melake, B. Iyassu, A. Usman, G. Semere","doi":"10.4172/2329-6887.1000274","DOIUrl":"https://doi.org/10.4172/2329-6887.1000274","url":null,"abstract":"Many countries have been facing multiple disease burdens which have clinical, economic, and social impact; one of which is adverse drug reactions (ADRs). In the United States, for example, the annual financial burden is estimated to be USD 177.4 billion. It is well-recognized that there is a strong linkage between health and economic growth. In Eritrea,healthcare is provided by the Government of the State of Eritrea (GOE) through public hospitals, which is highly subsidized. The health policy of the GOE is ensuring access to healthcare services to all citizens in an equitable and affordable manner guided by the principle of social justice. Despite the efforts underway in the country, Eritrea is still facing newly emerging public health problems like ADRs, whose clinical, economic and social burden need to be determined. In this nationwide study, 18 hospitals (17 public and one private) were included. During the five-month study period, a total of 5,848 patients admitted to the 18 Eritrean hospitals were screened for ADRs. Of the total patients screened, 922 (15.8%) were identified with at least one suspected adverse drug reaction. The average expenditure per patient was found to be ERN 4,766 (equivalent to USD 318) and the overall ADR related economic burden in the five months period was determined to be ERN 4,394,089 (USD 292,939). From this study it was concluded that, the occurrence of ADR was high which had substantial economic burden for the GOE and the patients.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82052728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-01DOI: 10.4172/2329-6887.1000276
Laila Carolina Abu Esba
Objective: Recognizing the limitation of spontaneous adverse drug reaction reporting and the need for better quality of data to monitor the safety of drugs, we explore here the possibilities of complementing the spontaneous ADR reports at an institutional level with data extracted from our electronic health records. Method: Data on adverse drug reactions documented in patient’s electronic health records was extracted from the hospital’s health information system. Results: A significant difference in rate and type of adverse drug reactions was observed in comparison to those reported spontaneously by healthcare providers. Conclusion: implementing a continuous process of complementing hospital based spontaneous adverse drug reaction reporting data with data from patient’s electronic health records can serve as a better tool in improving ADR monitoring.
{"title":"Complementing ADR Data by Utilizing Electronic Health Records:Experience Form a Tertiary Care Hospital in Saudi Arabia","authors":"Laila Carolina Abu Esba","doi":"10.4172/2329-6887.1000276","DOIUrl":"https://doi.org/10.4172/2329-6887.1000276","url":null,"abstract":"Objective: Recognizing the limitation of spontaneous adverse drug reaction reporting and the need for better quality of data to monitor the safety of drugs, we explore here the possibilities of complementing the spontaneous ADR reports at an institutional level with data extracted from our electronic health records. Method: Data on adverse drug reactions documented in patient’s electronic health records was extracted from the hospital’s health information system. Results: A significant difference in rate and type of adverse drug reactions was observed in comparison to those reported spontaneously by healthcare providers. Conclusion: implementing a continuous process of complementing hospital based spontaneous adverse drug reaction reporting data with data from patient’s electronic health records can serve as a better tool in improving ADR monitoring.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77121646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-01DOI: 10.4172/2329-6887.1000275
A. Yoshimi, Y. Yoshijima, Masayuki Miyazaki, H. Kato, Kato Yk, Kiyofumi Yamada, N. Ozaki, R. Kaneko, A. Ishii, A. Mitsuma, M. Sugishita, Y. Ando, Y. Noda
Objective: Oxycodone is widely used in cancer patients with pain, but interindividual differences in both its analgesic efficacy and adverse effects are major clinical disadvantages to therapeutic use. To explore specific polymorphisms affecting drug plasma concentrations, analgesic efficacy, and adverse effects, we performed an association study between genetic polymorphisms affecting pharmacokinetics and pharmacodynamics of oxycodone and response to drug treatment in cancer patients with pain. Methods: Blood samples were collected from 50 patients 12 h after administration of oxycodone. Genetic polymorphisms related to the pharmacokinetics and pharmacodynamics of oxycodone [cytochrome P450 (CYP3A4*1G, CYP3A5*3, and CYP2D6*10), P-glycoprotein (ABCB1), and opioid receptor μ1 (OPRM1)] were genotyped by real-time polymerase chain reaction (PCR) and plasma concentrations of oxycodone and noroxycodone were determined by ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS). Results: Carriers of specific polymorphisms (CYP3A4 *1G/*1G, CYP3A5 *1/*1, CYP2D6 100CC+CT, and ABCB1 2677TA+TT+AA) were associated with increased average total daily dose of oxycodone. CYP3A4 *1G/*1G and CYP3A5 *1/*1 were also associated with increased number of rescues and plasma concentration of oxycodone. Moreover, OPRM1 118AG+GG carriers were related to greater average total daily dose of oxycodone and increased number of rescues. Conclusion: These findings suggest that genetic polymorphisms of genes related to pharmacokinetics and pharmacodynamics of oxycodone have a potential impact on clinical responses to drug in cancer patients with pain.
{"title":"Association Study between Genes Related to Pharmacokinetics andPharmacodynamics of Oxycodone and Response to Drug Treatment: AGenetic Cohort Study","authors":"A. Yoshimi, Y. Yoshijima, Masayuki Miyazaki, H. Kato, Kato Yk, Kiyofumi Yamada, N. Ozaki, R. Kaneko, A. Ishii, A. Mitsuma, M. Sugishita, Y. Ando, Y. Noda","doi":"10.4172/2329-6887.1000275","DOIUrl":"https://doi.org/10.4172/2329-6887.1000275","url":null,"abstract":"Objective: Oxycodone is widely used in cancer patients with pain, but interindividual differences in both its analgesic efficacy and adverse effects are major clinical disadvantages to therapeutic use. To explore specific polymorphisms affecting drug plasma concentrations, analgesic efficacy, and adverse effects, we performed an association study between genetic polymorphisms affecting pharmacokinetics and pharmacodynamics of oxycodone and response to drug treatment in cancer patients with pain. Methods: Blood samples were collected from 50 patients 12 h after administration of oxycodone. Genetic polymorphisms related to the pharmacokinetics and pharmacodynamics of oxycodone [cytochrome P450 (CYP3A4*1G, CYP3A5*3, and CYP2D6*10), P-glycoprotein (ABCB1), and opioid receptor μ1 (OPRM1)] were genotyped by real-time polymerase chain reaction (PCR) and plasma concentrations of oxycodone and noroxycodone were determined by ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS). Results: Carriers of specific polymorphisms (CYP3A4 *1G/*1G, CYP3A5 *1/*1, CYP2D6 100CC+CT, and ABCB1 2677TA+TT+AA) were associated with increased average total daily dose of oxycodone. CYP3A4 *1G/*1G and CYP3A5 *1/*1 were also associated with increased number of rescues and plasma concentration of oxycodone. Moreover, OPRM1 118AG+GG carriers were related to greater average total daily dose of oxycodone and increased number of rescues. Conclusion: These findings suggest that genetic polymorphisms of genes related to pharmacokinetics and pharmacodynamics of oxycodone have a potential impact on clinical responses to drug in cancer patients with pain.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89242342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
N. Araya, D. Yemane, Andegiorgish Ak, I. Bahta, Mulugeta Russom
Background: Taking the overstretched healthcare system, inappropriate prescribing, self-medication seeking behavior, infiltration of substandard and counterfeit medicines in the resource-constrained countries into, having a well-functioning Pharmacovigilance system has paramount importance to ensure patient safety. The aim of this study is therefore to assess the degree and pattern of Pharmacovigilance system diffusion and its barriers in Eritrean healthcare system. Methods: This is an exploratory cross-sectional study among healthcare professionals from representative health facilities in all administrative regions in Eritrea. Participants were selected using systematic random sampling method. Assisted self-administered questionnaire was used for data collection between June 27 and September 8, 2017. Association among demographic variables, knowledge, attitude and practice of Pharmacovigilance were analyzed. Two-tailed p-value <0.05 was considered statistically significant. Results: A total of 390 healthcare professionals from 141 health facilities across the country were enrolled in the study. Of the respondents, 90% know what Pharmacovigilance is about and 89% know how to report adverse drug reactions (ADRs). There was a significant difference in knowledge among the professional categories (p<0.001) and their level of education (p=0.002). As the level of education increases, so does the positive attitude towards reporting ADRs in professional practice (p=0.009). About three-fourth (73%) reported that they transfer Pharmacovigilance knowledge to their colleagues. Physicians and Pharmacists were found to be the main players in diffusing the system. Majority of the respondents (72%) encountered patients with ADRs and 64% of them claimed they have reported ADRs. Inadequate knowledge, unavailability of suitable reporting channels and inadequate motivation were the main barriers for those unable to report adverse drugs reactions. Conclusion: Pharmacovigilance as innovation is highly adopted and diffused in Eritrea with an impressive Knowledge, attitude and practice of healthcare professionals in reporting adverse drug reactions and other related problems. Limited knowledge on how to report ADRs, unavailability of suitable reporting channels and inadequate motivation were, however, the top three ADR reporting barriers identified which could negatively impact the progress of the diffusion process.
{"title":"Diffusion of Pharmacovigilance in the Eritrean Healthcare System: A Cross-sectional Study","authors":"N. Araya, D. Yemane, Andegiorgish Ak, I. Bahta, Mulugeta Russom","doi":"10.35248/2329-6887.","DOIUrl":"https://doi.org/10.35248/2329-6887.","url":null,"abstract":"Background: Taking the overstretched healthcare system, inappropriate prescribing, self-medication seeking behavior, infiltration of substandard and counterfeit medicines in the resource-constrained countries into, having a well-functioning Pharmacovigilance system has paramount importance to ensure patient safety. The aim of this study is therefore to assess the degree and pattern of Pharmacovigilance system diffusion and its barriers in Eritrean healthcare system. Methods: This is an exploratory cross-sectional study among healthcare professionals from representative health facilities in all administrative regions in Eritrea. Participants were selected using systematic random sampling method. Assisted self-administered questionnaire was used for data collection between June 27 and September 8, 2017. Association among demographic variables, knowledge, attitude and practice of Pharmacovigilance were analyzed. Two-tailed p-value <0.05 was considered statistically significant. Results: A total of 390 healthcare professionals from 141 health facilities across the country were enrolled in the study. Of the respondents, 90% know what Pharmacovigilance is about and 89% know how to report adverse drug reactions (ADRs). There was a significant difference in knowledge among the professional categories (p<0.001) and their level of education (p=0.002). As the level of education increases, so does the positive attitude towards reporting ADRs in professional practice (p=0.009). About three-fourth (73%) reported that they transfer Pharmacovigilance knowledge to their colleagues. Physicians and Pharmacists were found to be the main players in diffusing the system. Majority of the respondents (72%) encountered patients with ADRs and 64% of them claimed they have reported ADRs. Inadequate knowledge, unavailability of suitable reporting channels and inadequate motivation were the main barriers for those unable to report adverse drugs reactions. Conclusion: Pharmacovigilance as innovation is highly adopted and diffused in Eritrea with an impressive Knowledge, attitude and practice of healthcare professionals in reporting adverse drug reactions and other related problems. Limited knowledge on how to report ADRs, unavailability of suitable reporting channels and inadequate motivation were, however, the top three ADR reporting barriers identified which could negatively impact the progress of the diffusion process.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81449607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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