The Role of Pharmacovigilance Center in Sudan in Reporting Adverse Drug Reactions

2012 ◽  
pp. 344-354
Author(s):  
Abdalla Omer Elkhawad
Keyword(s):  
Adverse Drug Reactions ◽  
International Organizations ◽  
Healthcare Professionals ◽  
Drug Reactions ◽  
Different Types ◽  
Large Populations ◽  
Pharmacovigilance Center

Pharmacovigilance is an active discipline, which is the study of structured mechanisms of the safety of medicines being used in clinical situations in large populations. In this chapter, the authors attempt to characterize the different types of Adverse Drug Reactions (ADRs) and related problems and mechanisms by which they cause harm to patients. They investigate the methods of detection of ADRs and various pharmacovigilance methods. The role and contributions of international organizations will be presented. The authors present the importance and need for education of healthcare professionals about pharmacovigilance and the proper reporting of ADRs for the purpose of efficient and safe use of medicines. The establishment of the Sudan pharmacovigilance center and how the system works will be discussed. Sources of data and actions taken since its inception are presented. The authors conclude by highlighting the problems and weaknesses of the system and ways to strengthen it.

Pharmacovigilance and Adverse Drug Reactions (Adrs) Practice of Healthcare Professionals

2021 ◽  
Vol 15 (12) ◽  
pp. 3473-3475
Author(s):  
Elsadig Yousif Mohamed
Keyword(s):  
Adverse Drug Reactions ◽  
Healthcare Professionals ◽  
Good Practice ◽  
Cross Sectional Study ◽  
University Hospital ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Pharmacovigilance Center ◽  
Spss Software ◽  
Pharmacovigilance Practice

Aim: To assess pharmacovigilance and adverse drug reactions practice of healthcare professionals in Ribat University Hospital, Khartoum, Sudan. Methods: This was a cross-sectional study to evaluate pharmacovigilance and ADRs practice among physicians, pharmacist and nurses working in the National Ribat University, Khartoum, Sudan. The sample size was calculated as 100. Data were collected by a pre-tested questionnaire after obtaining ethics approval. Data analysis was performed by SPSS software. Results: The HCPs who acquired good and poor pharmacovigilance practice were 16 (16%) and 84 (84%) respectively. Ninety-eight (98%) of the healthcare professionals have ever experienced ADR in their patients during professional practice. Ninety-four (94%) have ever seen ADR reporting form. Forty (40%) have ever reported ADR to the pharmacovigilance center. Pharmacists, Physicians and nurses with good practice were30.8%, 18.4% and 7.9% respectively. Conclusion: Most healthcare professionals acquire good pharmacovigilance practice. The pharmacist acquires higher level of pharmacovigilance practice followed by physicians and nurses. Healthcare professionals with shorter years of experience have significantly higher pharmacovigilance practice. Keywords: Pharmacovigilance, Adverse Drug Reactions, Healthcare Professionals

Pharmacovigilence practice for safety of medication system in India

2018 ◽  
Vol 7 (2) ◽  
pp. 216-221
Author(s):  
Shobharam Sahu ◽  
◽  
Poonam Rishishwar ◽  
Chhaya Rathod ◽  
◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
India Institute ◽  
Family Welfare ◽  
New Delhi ◽  
Drug Reactions ◽  
Medical Sciences ◽  
Ministry Of Health ◽  
Regulatory Authorities ◽  
Pharmacovigilance Center ◽  
Uppsala Monitoring

Pharmacovigilance is very essential tool to ensure the safety of drug. It provides safety to patients in case of medication. Activity of pharmacovigilance is coordinates by National pharmacovigilance center in collaboration with international regulatory authorities (WHO, The Uppsala Monitoring center). Under the aegis of Ministry of Health & Family Welfare, Government of India, the Central Drugs Standard Control Organisation (CDSCO), New Delhi, has initiated a nation-wide pharmacovigilance programme, with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordinating Centre (NCC) for monitoring Adverse Drug Reactions (ADR)

scholarly journals Drug-Drug-Dietary interactions in pharmacotherapy of GIT medication: A review

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 2903-2909
Author(s):  
Akula sowjanya ◽  
Abhisek Pal
Keyword(s):  
Drug Therapy ◽  
Drug Interactions ◽  
Food Consumption ◽  
Adverse Drug Reactions ◽  
Drug Effect ◽  
Google Scholar ◽  
Drug Reactions ◽  
Common Drug ◽  
Different Types ◽  
Dietary Interactions

Successful drug therapy depends on the interaction between drug-drug and drug-diet. Drug interactions are a vital reason for causing adverse drug reactions and modify one drug effect by another drug and these kinds of interactions can increase or decrease the effectiveness of the drug. Polypharmacy could be a major risk for Drug-Drug and Drug-food interactions. Food Consumption can alter the effect of drugs by interfering either with their pharmacokinetics or pharmacodynamics processes. Anti-ulcer drugs are used to treat different types of ulcer and that may interact with another drug showing undesirable effects. GIT medications interfere with another type of medication either with at the pharmacokinetic and pharmacodynamic level. The main objective of this article is to review data regarding common Drug-drug & Drug-food interactions related to GIT medications. Data was collected from Google Scholar, PubMed, and Scopus databases, and they were reviewed for publication on drug-drug & drug-food interactions related to GIT medications. This data is very helpful for pharmacists while reviewing and analyzing prescribed medication, especially in geriatrics prescriptions.

scholarly journals OVERVIEW ON ASSOCIATION OF DIFFERENT TYPES OF LEUKEMIAS WITH RADIATION EXPOSURE

2015 ◽  
Vol 37 (2) ◽  
pp. 89-93 ◽  
Author(s):  
D F Gluzman ◽  
L M Sklyarenko ◽  
M Zavelevich ◽  
S V Koval ◽  
T Ivanivskaya ◽  
...  
Keyword(s):  
Radiation Exposure ◽  
Hematological Malignancies ◽  
Causative Factor ◽  
World Health ◽  
Lymphoid Tissues ◽  
Different Types ◽  
Large Populations ◽  
Precise Diagnosis ◽  
Health Organization

Exposure to ionizing radiation is associated with increasing risk of various types of hematological malignancies. The results of major studies on association of leukemias and radiation exposure of large populations in Japan and in Ukraine are analyzed. The patterns of different types of leukemia in 295 Chernobyl clean-up workers diagnosed according to the criteria of up-to-date World Health Organization classification within 10–25 years following Chernobyl catastrophe are summarized. In fact, a broad spectrum of radiation-related hematological malignancies has been revealed both in Life Span Study in Japan and in study of Chernobyl clean-up workers in Ukraine. The importance of the precise diagnosis of tumors of hematopoietic and lymphoid tissues according to up-to-date classifications for elucidating the role of radiation as a causative factor of leukemias is emphasized. Such studies are of high importance since according to the recent findings, radiation-associated excess risks of several types of leukemias seem to persist throughout the follow-up period up to 55 years after the radiation exposure.

scholarly journals Common Causes and Characteristics of Adverse Drug Reactions in Older Adults: A Retrospective Study

2020 ◽  
Author(s):  
Seong-Dae Woo ◽  
Jiwon Yoon ◽  
Go-Eun Doo ◽  
Youjin Park ◽  
Youngsoo Lee ◽  
...  
Keyword(s):  
Older Adults ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Younger Patients ◽  
Iodinated Contrast ◽  
Common Causes ◽  
Aging Populations ◽  
Pharmacovigilance Center ◽  
Inflammatory Drugs ◽  
Rate Ratios

Abstract Background: Aging populations are often accompanied by comorbidity and polypharmacy, leading to increases in adverse drug reactions (ADRs). We sought to evaluate the causes and characteristics of ADRs in older Korean adults (≥65 years) in comparison to younger individuals (<65 years). Methods: Of 37,523 cases reported at a Korean pharmacovigilance center from 2011 to 2018, we reviewed 18,842 ADRs of certain or probable causality on the basis of WHO-UMC criteria. We estimated the number of ADRs per 1,000 patients exposed to the major culprit drugs, and incidence rate ratios were obtained to assess high- and low-risk medications in older adults. Results: In total, 4,152 (22.0%) ADRs were reported for 3,437 older adults (mean age, 74.6 years and 57.3% female). Tramadol (rate ratio, 1.32; 95% confidence interval [CI], 1.21-1.44; P <0.001) and fentanyl (1.49, 1.16-1.92, P =0.002) posed higher risks of ADRs in the older adults, whereas nonsteroidal anti-inflammatory drugs (NSAIDs) (0.35, 0.30-0.40, P <0.001) and iodinated contrast media (ICM) (0.82, 0.76-0.89, P <0.001) posed lower risks. Ratios of serious ADRs to NSAIDs (odds ratio, 2.16; 95% CI, 1.48-3.15; P <0.001) and ICM (2.09, 1.36-3.21, P= 0.001) were higher in the older adults than in the younger patients. Analgesics primarily elicited cutaneous ADRs in the younger patients and gastrointestinal reactions in the older adults. ICM more commonly led to anaphylaxis in the older adults than the younger patients (3.0% vs. 1.6%, P =0.019). Conclusion: For early detection of ADRs in older adults, better understanding of differences in the causes and characteristics thereof in comparison to the general population is needed.

Knowledge about adverse drug reactions reporting among healthcare professionals in Nepal

2013 ◽  
Vol 25 (1) ◽  
pp. 1-16 ◽  
Author(s):  
Santosh KC ◽  
Pramote Tragulpiankit ◽  
I. Ralph Edwards ◽  
Sarun Gorsanan
Keyword(s):  
Adverse Drug Reactions ◽  
Healthcare Professionals ◽  
Drug Reactions

scholarly journals Adverse Drug Reactions Among Patients Enrolled in an Outpatient Parenteral Antimicrobial Therapy (OPAT) Program 2015–2016 at UNC Medical Center

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S341-S341
Author(s):  
Vahini Chundi ◽  
Anh Eichholz ◽  
Onyeka Nwankwo ◽  
Alan Kinlaw ◽  
Wesley Kufel ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Medical Center ◽  
Critical Role ◽  
Drug Reactions ◽  
Health Records ◽  
Outpatient Parenteral Antimicrobial Therapy ◽  
Initial Cohort ◽  
Recorded Data ◽  
Antimicrobial Regimen

Abstract Background The UNC Medical Center OPAT program was started in 2015 to provide multidisciplinary monitoring and management of patients discharged on parenteral antimicrobials. We examined characteristics of incident adverse drug reactions (ADRs) observed in our initial cohort of OPAT patients. Methods We abstracted electronic health records for the first 250 patients enrolled in the OPAT program. 223 patients with sufficient recorded data for entire OPAT course were included in the analysis. ADRs meeting criteria as detailed in Table 1 were collected and further stratified by antimicrobial regimen. Results 57 patients (26%) experienced at least one ADR during OPAT therapy. The frequency of specific ADRs associated with OPAT therapies are provided in Figure 1. Β-lactam regimens were most frequently associated with liver dysfunction, while combinations of β-lactams and vancomycin were associated with kidney dysfunction. Median days on OPAT regimen was 19 days (IQR: 10–29) for patients who experienced an ADR compared with 39 (IQR: 30–44) for patients who did not experience an ADR. Conclusion ADRs were most commonly observed within the first three weeks of therapy, particularly for patients receiving vancomycin and a β-lactam antimicrobial in combination. These results underscore the critical role of a multidisciplinary team in providing laboratory monitoring and response to abnormal results for OPAT patients. In addition, closer monitoring within the first three weeks of therapy may provide opportunities for regimen changes or dose adjustment to avoid toxicities. Disclosures All authors: No reported disclosures.

scholarly journals Processes and determinants of integration of eGFR in physicians’ drug prescriptions: a qualitative study of semi-structured interviews

2019 ◽  
Vol 20 ◽  
Author(s):  
Louis Lefèvre ◽  
Maud Jourdain ◽  
Jean-Pascal Fournier
Keyword(s):  
Qualitative Study ◽  
Adverse Drug Reactions ◽  
Healthcare Professionals ◽  
Drug Prescriptions ◽  
Theory Approach ◽  
Snowball Sampling ◽  
Drug Reactions ◽  
Structured Interviews ◽  
Training Professional ◽  
Grounded Theory Approach

Abstract Aim: Our objective was to explore the processes and determinants leading physicians to integrate estimated glomerular filtration rate (eGFR) in their drug prescriptions Background: Access to patients’ eGFR would allow primary care pharmacists to optimise their role in the procedure of safe prescribing. Some rare physicians actively integrate eGFR in their prescriptions, in a sporadically and uncoordinated manner. Methods: Qualitative study using semi-directed interviews conducted among 12 French physicians who integrated eGFR in their drug prescriptions, (February 2016–April 2017). These voluntary participants were recruited through different means: Twitter®, forums, direct contact and snowball sampling. Data analysis was based on the grounded theory approach, underpinned by a comprehensive perspective of interactionist orientation. Findings: Residency and training, professional experience – including experiences of adverse drug reactions – and the membership in various communities of professionals were key drivers for the integration of eGFR in prescriptions. The theoretical aim was above all safe prescribing in order to reduce adverse drug reactions, with the control by a dispensing pharmacist and/or other healthcare professionals. Nevertheless, none of the physicians had received any feedback from any healthcare professionals. Despite their disappointment, the physicians remained convinced of the interest of integrating eGFR in their prescriptions and would continue to do so. Characteristics associated with integration of eGFR in drug prescriptions belong partly to Roger’s theory of innovations. If a widespread diffusion of this habit takes place, it will be necessary to evaluate its adoption by both physicians and pharmacists.

The role of pharmacogenomics in adverse drug reactions

2019 ◽  
Vol 12 (5) ◽  
pp. 407-442 ◽  
Author(s):  
Ramón Cacabelos ◽  
Natalia Cacabelos ◽  
Juan C. Carril
Keyword(s):  
Adverse Drug Reactions ◽  
Drug Reactions

Incidence of Roentgen Contrast Medium Reactions after Intravenous Injection in Pre-Registration Trials and Post-Marketing Surveillances

1993 ◽  
Vol 34 (3) ◽  
pp. 210-213 ◽  
Author(s):  
E. Andrew ◽  
T. Haider
Keyword(s):  
Relative Risk ◽  
Adverse Drug Reactions ◽  
Odds Ratio ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Feasible Method ◽  
Ionic Contrast ◽  
Different Types ◽  
Post Marketing ◽  
The Absolute

The relative risk of adverse drug reactions of ionic versus non-ionic contrast media injected i.v. were compared for different types of trials using odds-ratio. The absolute and relative risk found in large post-marketing trials were compared with that found in the iohexol pre-registration trials. The absolute risks were 2 to 10 times higher in the pre-registration trials compared to the post-marketing surveillances. The relative risk for all adverse drug reactions was 3 to 6 times higher for ionic vs. non-ionic media and independent of pre- or post-registration studies. The odds-ratio seems to be a feasible method of comparing the relative risk of adverse reactions in various trials.

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