Changing Prescribing in the Light of Tolerability Concerns

Vries, Corinne S de; Duggan, Catherine; Tromp, Tfj; Berg, Lolkje Theodora Wilhelmina de Jong-van den

doi:10.2165/00002018-199921030-00001

Cited by 5 publications

(4 citation statements)

References 47 publications

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“…This has had considerable effect on increased prescribing of drugs. 24 Such public health programs, however, need not focus only on patients but could be used for the benefit of the general public as well. Such awareness building and educational initiatives should also include children and elderly populations and could be greatly facilitated through partnerships with the media, educational institutions, and governmental and NGOs.…”

Section: Pharmacovigilance and Drug Safety Monitoringmentioning

confidence: 99%

Pharmacovigilance in India and its Impact in Patient Management

Singh¹,

Sharma²,

Kumar³

et al. 2017

AMEI's Current Trends in Diagnosis &Amp; Treatment

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Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly the long-term and short-term adverse effects of drugs or treatment. The World Health Organization (WHO) established pharmacovigilance Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. India joined the WHO adverse drug reaction (ADR) monitoring program based in Uppsala, Sweden, in 1998. The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, under the aegis of the Ministry of Health and Family Welfare, Government of India, in collaboration with Indian Pharmacopoeia Commission, Ghaziabad, is a National Coordinating Centre (NCC). Adverse drug reaction monitoring centers (AMCs) under the Pharmacovigilance Programme of India (PvPI) play a vital role in the collection and follow-up of ADR reports from the patients, as drug trials in animals and humans (Phase I–III) do not predict accurately the adverse drug events. Patients with chronic kidney disease (CKD)/liver disease are at risk of enhanced drug-related events. These patients should be closely monitored for any adverse events and it should be reported. Thus, inculcating the habit of ADR reporting will help in generating data specific to Indian population and will contribute toward patient safety. This will also help in modifying the treatment given to the patients, as early identification of ADRs will help in reducing morbidity and mortality in patients. How to cite this article Sharma G, Kumar R, Singh J, Bhandari V, Singh N. Pharmacovigilance in India and its Impact in Patient Management. Curr Trends Diagn Treat 2017;1(1):27-33.

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Section: Pharmacovigilance and Drug Safety Monitoringmentioning

confidence: 99%

Pharmacovigilance in India and its Impact in Patient Management

Singh¹,

Sharma²,

Kumar³

et al. 2017

AMEI's Current Trends in Diagnosis &Amp; Treatment

View full text Add to dashboard Cite

show abstract

“…This has had considerable effect on increased prescribing. [2223] Such public health programmes, however, need not focus only on patients but could be used for the benefit of the general public as well. Such awareness-building and educational initiatives should also include children and elderly populations and could be greatly facilitated through partnerships with the media, educational institutions, governmental and non-governmental organizations.…”

Section: Pharmacovigilance and International Healthmentioning

confidence: 99%

Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring

G¹,

Anusha²

2010

Journal of Young Pharmacists

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Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors.

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“…Yet it remains unclear if such a systematic approach to ADR clarification and documentation in fact alters future prescribing. Or, if despite clarification, the presence of documentation continues to prompt avoidance of implicated drugs, minimizing patient risk but continuing to result in sub-optimal prescribing [15,16]. Given the extensive time and training required to complete PV reviews, it is critical to understand the impact of these programs on patient outcomes.…”

Section: Introductionmentioning

confidence: 99%

Clarification of adverse drug reactions by a pharmacovigilance team results in increased antibiotic re-prescribing at a freestanding United States children’s hospital

Feldman,

Suppes,

Goldman

2024

PLoS ONE

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Documentation of adverse drug reactions (ADRs) is a key factor in guiding future prescribing. However, incomplete documentation is common and often fails to distinguish implicated drugs as true allergies. This in turn leads to unnecessary avoidance of implicated drug classes and may result in sub-optimal prescribing. Pharmacovigilance (PV) programs utilize a systematic approach to clarify ADR documentation and are known to improve patient safety. Yet it remains unclear if PV alters prescribing. Or, if the existence of the ADR documentation itself continues to prompt avoidance of implicated drugs. To address this, our work presents a retrospective cohort study assessing if clarification of antibiotic ADRs by a hospital-wide PV team was associated with future, safe, re-prescribing at a freestanding pediatric hospital in the midwestern United States. First, we compared the likelihood of future prescribing in an antibiotic class with an active ADR, as compared to alternative drug classes, between PV-clarified and non-clarified patients. Second, we assessed differences in adverse event rates 30-days after future prescribing based on PV clarification status. For robustness, analyses were performed on patients with ADRs in four antibiotic classes: penicillin-based beta-lactams (n = 45,642), sulfonamides/trimethoprim (n = 5,329), macrolides (n = 3,959), and glycopeptides (n = 622). Results illustrate that clarification of an ADR by PV was associated with an increased odds of future prescribing in the same drug class (Odds Ratio [95%-CI]): penicillin-based beta-lactams (1.59 [1.36–1.89]), sulfonamides/trimethoprim (2.29 [0.89–4.91]), macrolides (0.77 [0.33–1.61]), and glycopeptide (1.85 [1.12–3.20]). Notably, patients clarified by PV experienced no increase in the rate of adverse events within 30-days following the prescribing of antibiotics in the same class as an active ADR. Overall, this study provides strong evidence that PV reviews safely increase the rate of re-prescribing antibiotics even in the presence of an existing implicated drug ADR.

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Changing Prescribing in the Light of Tolerability Concerns

Cited by 5 publications

References 47 publications

Pharmacovigilance in India and its Impact in Patient Management

Pharmacovigilance in India and its Impact in Patient Management

Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring

Clarification of adverse drug reactions by a pharmacovigilance team results in increased antibiotic re-prescribing at a freestanding United States children’s hospital

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