scholarly journals Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
M. Süsskind ◽  
P. A. Thürmann ◽  
C. Lüke ◽  
E. Jeschke ◽  
M. Tabali ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Community Hospital ◽  
Safety Data ◽  
Uppsala Monitoring Centre ◽  
Anthroposophic Medicine ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Medical Wards ◽  
Design And Methods ◽  
Uppsala Monitoring

Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use.Objectives. We aimed to assess adverse drug reactions (ADRs) caused by anthroposophical medicines (AMEDs) in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code), causality (according to the Uppsala Monitoring Centre WHO criteria), and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6%) experienced 211 ADRs (CTCAE grade 2/3n=191, 90.5%, CTCAE grade 4/5n=20, 9.5%) of which 57 ADRs (27.0%) were serious. The median age of patients with ADRs (62.1% females) was 72.0 (IQR: 61.0; 80.0). Six patients (0.2%) experienced six ADRs (2.8% of ADRs) caused by eight suspected AMEDs, all of which were mild reactions (grade 2).Conclusion. Our data show that ADRs caused by AMEDs occur rarely and are limited to mild symptoms.

scholarly journals Pharmacovigilance programme of India: revival of the renaissance

2018 ◽  
Vol 7 (11) ◽  
pp. 2281
Author(s):  
Jyoti B. Gadhade ◽  
Rajesh S. Hiray ◽  
Rekha Y. Aherkar ◽  
Kalpana U. Shah
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Drug Reaction Reporting ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Family Welfare ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
The World ◽  
Health Organization

Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.

scholarly journals Incident adverse drug reactions in geriatric inpatients: a multicentred observational study

2017 ◽  
Vol 9 (1) ◽  
pp. 13-23 ◽  
Author(s):  
Amanda Lavan ◽  
Joseph Eustace ◽  
Darren Dahly ◽  
Evelyn Flanagan ◽  
Paul Gallagher ◽  
...  
Keyword(s):  
Observational Study ◽  
Adverse Drug Reactions ◽  
Feasibility Study ◽  
Median Number ◽  
Economic Consequences ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
P Value ◽  
Drug Reactions ◽  
Monitoring Centre

Background: Adverse drug reactions (ADRs) are common in older adults and frequently have serious clinical and economic consequences. This study was conducted as a feasibility study for a randomized control trial (RCT) that will investigate the efficacy of a software engine to optimize medications and reduce incident (in-hospital) ADRs. This study’s objectives were to (i) establish current incident ADR rates across the six sites participating in the forthcoming RCT and (ii) assess whether incident ADRs are predictable. Methods: This was a multicentre, prospective observational study involving six European hospitals. Adults aged ⩾ 65 years, hospitalized with an acute illness and on pharmacological treatment for three or more conditions were eligible for inclusion. Adverse events (AEs) were captured using a trigger list of 12 common ADRs. An AE was deemed an ADR when its association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre causality assessment. The proportion of patients experiencing at least one, probable/certain, incident ADR within 14 days of enrolment/discharge was recorded. Results: A total of 644 patients were recruited, evenly split by sex and overwhelmingly of White ethnicity. Over 80% of admissions were medical. The median number of chronic conditions was five (interquartile range 4–6), with eight or more conditions present in approximately 10%. The mean number of prescribed medications was 9.9 (standard deviation 3.8), which correlated strongly with the number of conditions ( r = 0.54, p < 0.0001). A total of 732 AEs were recorded in 382 patients, of which 363 were incident. The majority of events were classified as probably or possibly drug related, with heterogeneity across sites (χ2 = 88.567, df = 20, p value < 0.001). Out of 644 patients, 139 (21.6%; 95% confidence interval 18.5–25.0%) experienced an ADR. Serum electrolyte abnormalities were the most common ADR. The ADRROP (ADR Risk in Older People) and GerontoNet ADR risk scales correctly predicted ADR occurrence in 61% and 60% of patients, respectively. Conclusion: This feasibility study established the rates of incident ADRs across the six study sites. The ADR predictive power of ADRROP and GerontoNet ADR risk scales were limited in this population.

scholarly journals Assessment of adverse drug reactions of psychopharmacological drugs in patients of psychiatric disorders

2021 ◽  
Vol 2 (2) ◽  
pp. 27-32
Author(s):  
Rani Kumari ◽  
Rachna Gupta ◽  
Manjeet Singh Bhatia ◽  
Suresh Kumar Gupta
Keyword(s):  
Psychiatric Disorders ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Improve Patient Care ◽  
Assessment Method ◽  
Uppsala Monitoring Centre ◽  
Drug Reactions ◽  
Mortality And Morbidity ◽  
Monitoring Centre ◽  
Common Diagnosis

Introduction: Psychopharmacological drugs are used in the treatment of different types of psychotropic disorders. These drugs are associated with a variety of adverse drug reactions (ADRs). The ADRs due to psychopharmacological drugs are a significant cause of mortality and morbidity. Objectives: The current study assessed the adverse drug reactions of psychopharmacological drugs in patients with psychiatric disorders. Methods: This study was a retrospective study. All ADR forms related to psychopharmacological drugs that were reported to the pharmacovigilance center, UCMS, and GTB Hospital,  between December 2019 to February 2020, were assessed to identify the incidence and nature of important ADRs. Causality assessment was done by WHO Uppsala Monitoring Centre Global Introspection Method. A total of 150 ADR forms were analyzed. Results: Females (60.66 %) experienced more ADRs than males (39.33 %). ADRs were most commonly reported in the age group of 18-28 years followed by 29-39 years. Depression was the most common diagnosis in patients with psychiatric disorders. Dizziness was the most common ADR followed by headache and insomnia. Escitalopram (12.21 %) was the most commonly implicated drug causing ADRs followed by clonazepam (9.92 %). As per the WHO causality assessment method, 77 % of ADRs were possible and 23 % were probable. Conclusions: Therefore, early detection and awareness of ADRs are important to enable health professionals to perform alterations in the prescribed drug treatment to prevent or reduce the adverse effects due to psychotropic drugs. This will improve patient care and safety as well as promote rational use of drugs.

scholarly journals Inter-rater and intra-rater agreement in causality assessment of adverse drug reactions: a comparative study of WHO-UMC versus Naranjo scale

2017 ◽  
Vol 5 (10) ◽  
pp. 4389 ◽  
Author(s):  
Sushil Sharma ◽  
Ajay Kumar Gupta ◽  
G. Jyothi Reddy
Keyword(s):  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Assessment System ◽  
Uppsala Monitoring Centre ◽  
Rater Agreement ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Common Category ◽  
Kappa Value ◽  
Mean Time

Background: The causality assessment system proposed by the WHO collaborating centre for international drug monitoring, the Uppsala monitoring centre (WHO-UMC) and the Naranjo probability scale are the generally accepted and most widely used methods for causality assessment. Both these scales are structured, transparent, consistent, and easy to apply with distinct advantages. The PvPI recommends use of WHO-UMC scale while many clinicians prefer Naranjo scale for its simplicity. As both these scales are used very widely in practise, it is important to study the level of agreement among them, to ensure proper interpretation of the causality assessment of the drugs. Objective was to study the inter-rater and intra-rater agreement in causality assessment of adverse drug reactions between WHO-UMC and Naranjo scale.Methods: A total of 200 cases were analyzed by three raters. Each ADR reporting form was analyzed by the raters independently using both the Naranjo scale and the WHO-UMC scale. The inter-rater and Intra-rater agreement of all the three raters was analyzed using kappa statistics.Results: The most common category of causality assessment was ‘possible’ which was around 73%, while the probable, definite and unlikely accounted for 23%, 3% and 1% respectively. The inter-rater agreement for the various categories of causality assessment when using Naranjo scale ranged from “very good to excellent” (Kappa value 0.95) while the same ranged from “good to very good” when the WHO-UMC scale was used (Kappa value 0.89) while the Intra-rater agreement for the three raters ranged from good to very good. The mean time (in minutes) taken for assessing the suspected adverse drug an ADR was 8. 26±2.53 for WHO-UMC scale while it was 14.18±3.44 when Naranjo scale was used.Conclusions: Both the WHO-UMC scale and Naranjo scale are reliable and valid tools for causality assessment but the Inter-rater agreement was slightly better with Naranjo as compared to WHO-UMC scale.

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 ANALYSIS OF ADVERSE DRUG REACTIONS SPONTANEOUSLY REPORTED TO ADVERSE DRUG MONITORING CENTRE OF A TERTIARY CARE HOSPITAL–PROSPECTIVE STUDY

2018 ◽  
Vol 10 (1) ◽  
pp. 23
Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil
Keyword(s):  
Prospective Study ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Organ Systems ◽  
A Prospective Study

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization

scholarly journals Adverse Drug Reactions and Expected Effects to Therapy with Subcutaneous Mistletoe Extracts (Viscum albumL.) in Cancer Patients

2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
Megan L. Steele ◽  
Jan Axtner ◽  
Antje Happe ◽  
Matthias Kröz ◽  
Harald Matthes ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cancer Patients ◽  
Adverse Drug Reactions ◽  
Anthroposophic Medicine ◽  
Tumour Stage ◽  
Drug Reactions ◽  
Potential Risk Factors ◽  
Mistletoe Extracts ◽  
Local Reactions ◽  
Mistletoe Therapy

Background.In Europe, mistletoe extracts are widely used as a complementary cancer therapy. We assessed the safety of subcutaneous mistletoe as a conjunctive therapy in cancer patients within an anthroposophic medicine setting in Germany.Methods.A multicentre, observational study was performed within the Network Oncology. Suspected mistletoe adverse drug reactions (ADRs) were described by frequency, causality, severity, and seriousness. Potential risk factors, dose relationships and drug-drug interactions were investigated.Results.Of 1923 cancer patients treated with subcutaneous mistletoe extracts, 283 patients (14.7%) reported 427 expected effects (local reactions <5 cm and increased body temperature <38°C). ADRs were documented in 162 (8.4%) patients who reported a total of 264 events. ADRs were mild (50.8%), moderate (45.1%), or severe (4.2%). All were nonserious. Logistic regression analysis revealed that expected effects were more common in females, while immunoreactivity decreased with increasing age and tumour stage. No risk factors were identified for ADRs. ADR frequency increased as mistletoe dose increased, while fewer ADRs occurred during mistletoe therapy received concurrent with conventional therapies.Conclusion.The results of this study indicate that mistletoe therapy is safe. ADRs were mostly mild to moderate in intensity and appear to be dose-related and explained by the immune-stimulating, pharmacological activity of mistletoe.

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