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ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems.

https://arctichealth.org/en/permalink/ahliterature269612
Source
Drug Saf. 2015 Apr;38(4):337-47
Publication Type
Article
Date
Apr-2015
Author
Linda Härmark
Florence van Hunsel
Birgitta Grundmark
Source
Drug Saf. 2015 Apr;38(4):337-47
Date
Apr-2015
Language
English
Publication Type
Article
Keywords
Consumer Participation
Drug-Related Side Effects and Adverse Reactions - epidemiology
Humans
Netherlands
Pharmacovigilance
Product Surveillance, Postmarketing - methods
Sweden
Abstract
Consumer reporting of adverse drug reactions (ADRs) has existed in several countries for decades, but throughout Europe the role of consumers as a source of information on ADRs has not been fully accepted until recently. In Europe, The Netherlands and Sweden were among the first countries to implement consumer reporting well before it was mandated by law throughout the EU. Consumer reporting is an integral part of the spontaneous reporting systems in both The Netherlands and Sweden, with yearly numbers of reports constantly increasing. Consumer reporting forms and handling procedures are essentially the same as for healthcare professional reporting; the message in the reports, not the type of messenger, is what is of importance. Studies have established the significant contribution of consumer reporting to ADR signal detection. Combining all reports regardless of reporter type is recommended since it yields the largest critical mass of reports for signal detection. Examples of signals where consumer reports have been of crucial importance for signal detection are electric shock-like sensations associated with the use of duloxetine, and persistent sexual dysfunction after discontinuation of selective serotonin reuptake inhibitors. An example of consumer reporting significantly strengthening a detected signal is Pandemrix(®) (influenza H1N1 vaccine)-induced narcolepsy. Raising public awareness of ADR reporting is important, but time- and resource-consuming. The minimum effort taken should be to passively inform consumers, e.g. via stakeholders' homepages and via drug product information leaflets. Another possibility of reaching out to this target group could be through co-operation with other (non-government) organizations. Information from consumer reports may give a new perspective on ADRs via the consumers' unfiltered experiences. Consumers' views may change the way the benefit-harm balance of drugs is perceived and assessed today, and, being the ultimate users of drugs, consumers could have a relevant influence in the regulatory decision-making processes for drugs. All stakeholders in pharmacovigilance should embrace this new valuable source of information.
PubMed ID
25627832 View in PubMed
Less detail

An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.

https://arctichealth.org/en/permalink/ahliterature280933
Source
Dan Med J. 2017 Jan;64(1)
Publication Type
Article
Date
Jan-2017
Author
Siri Vinther
Pia Klarskov
Hanne Borgeskov
Perle Darsø
Anette Kvindebjerg Christophersen
Bille Borck
Catrine Christensen
Melissa Voigt Hansen
Natalie Monica Løvland Halladin
Mikkel Bring Christensen
Kirstine Moll Harboe
Marie Lund
Espen Jimenez-Solem
Source
Dan Med J. 2017 Jan;64(1)
Date
Jan-2017
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Adverse Drug Reaction Reporting Systems - statistics & numerical data
Aged
Aged, 80 and over
Anticoagulants - adverse effects
Central Nervous System Stimulants - adverse effects
Child
Child, Preschool
Denmark
Dermatology - statistics & numerical data
Factor Xa Inhibitors - adverse effects
Female
Hospital Departments - statistics & numerical data
Hospitals - statistics & numerical data
Humans
Infant
Infant, Newborn
Internal Medicine - statistics & numerical data
Lisdexamfetamine Dimesylate - adverse effects
Male
Middle Aged
Ophthalmology - statistics & numerical data
Otolaryngology - statistics & numerical data
Product Surveillance, Postmarketing - methods
Psychiatric Department, Hospital - statistics & numerical data
Retrospective Studies
Rivaroxaban - adverse effects
Warfarin - adverse effects
Young Adult
Abstract
Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014.
All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively.
A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome.
The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad.
none.
not relevant. .
PubMed ID
28007050 View in PubMed
Less detail

An overview of Canadian and U.S. approaches to drug regulation and responses to postmarket adverse drug reactions.

https://arctichealth.org/en/permalink/ahliterature114900
Source
J Diabetes Sci Technol. 2013;7(2):313-20
Publication Type
Article
Date
2013
Author
Richard Y Cheung
Sarah H Goodwin
Author Affiliation
Fasken Martineau DuMoulin LLP, 333 Bay St., Suite 2400, Toronto, Ontario, Canada M5H 2T6. rcheung@fasken.com
Source
J Diabetes Sci Technol. 2013;7(2):313-20
Date
2013
Language
English
Publication Type
Article
Keywords
Canada
Diabetes Mellitus, Type 2 - drug therapy
Drug and Narcotic Control - legislation & jurisprudence - methods - organization & administration - trends
Humans
Hypoglycemic agents - therapeutic use
Patient Safety - legislation & jurisprudence
Product Surveillance, Postmarketing - methods - trends
Thiazolidinediones - therapeutic use
United States
United States Food and Drug Administration - legislation & jurisprudence - organization & administration
Abstract
Over the years, drug products, including those indicated for diabetes, have been withdrawn from the marketplace because of quality concerns and/or severe adverse drug reactions. While the drug regulatory process is designed to detect, among other things, adverse drug reactions before a drug receives marketing authorization, for various reasons, premarket detection of all potential adverse reactions associated with a drug may not be possible. As such, regulatory authorities must also react to and manage adverse reactions identified at the postmarket stage. In this article, we provide a general overview of drug regulation in Canada and the United States and consider an example of a drug indicated for the treatment of diabetes and how newly identified potential safety concerns were managed in the postmarket environment.
Notes
Cites: N Engl J Med. 2007 Jun 14;356(24):2457-7117517853
Cites: J Am Board Fam Pract. 2001 Sep-Oct;14(5):362-711572541
PubMed ID
23566987 View in PubMed
Less detail

[A pop-up menu linked to a computerized drug prescribing system. Prescribing pattern's feedback via a simple and quick method].

https://arctichealth.org/en/permalink/ahliterature191941
Source
Lakartidningen. 2001 Dec 12;98(50):5772-6
Publication Type
Article
Date
Dec-12-2001
Author
I. Ovhed
J. Berglund
S. Oistämö
K. Lenhoff
H. Odeberg
Author Affiliation
Lyckeby vårdcentral. ovhed_i@blekingefou.pp.se
Source
Lakartidningen. 2001 Dec 12;98(50):5772-6
Date
Dec-12-2001
Language
Swedish
Publication Type
Article
Keywords
Attitude of Health Personnel
Clinical Pharmacy Information Systems
Community Health Centers - statistics & numerical data
Decision Making, Computer-Assisted
Drug Prescriptions - standards
Family Practice - statistics & numerical data
Feedback
Humans
Patient satisfaction
Product Surveillance, Postmarketing - methods
Questionnaires
Software
Sweden
Abstract
It takes time for a GP to acquire sufficient experience of a new drug to be able to prescribe competently. This article describes a project studying the use of computerized records to afford a group of GP's swift feedback on recently introduced drugs of special interest. In the south-east of Sweden a network of primary health care centers has been created in two neighboring counties. The pharmacies of the region are also taking part. When new drugs of particular interest are introduced, each participating GP will automatically see a pop-up menu, asking questions pertaining to each computer-assisted prescription. In the pharmacies, patients are given a questionnaire regarding their expectations with respect to the drug. In this way it will be possible to provide the individual GP swift feedback from a large number of colleagues and patients concerning the drug's effectiveness in clinical practice. We have now been studying the COX-2 inhibitors rofecoxib (Vioxx) and celecoxib (Celebrex). Results show that a pop-up menu used in this way provides the general practitioner quick feed-back on prescribing behavior as well as drug effectiveness in clinical practice.
PubMed ID
11789101 View in PubMed
Less detail

Approval times and the safety of new pharmaceuticals.

https://arctichealth.org/en/permalink/ahliterature178187
Source
Eur J Health Econ. 2004 Dec;5(4):345-50
Publication Type
Article
Date
Dec-2004
Author
Niklas Rudholm
Author Affiliation
Department of Economics, Umeå University, Sweden. niklas.rudholm@econ.umu.se
Source
Eur J Health Econ. 2004 Dec;5(4):345-50
Date
Dec-2004
Language
English
Publication Type
Article
Keywords
Drug Approval - statistics & numerical data
Drug Industry - standards
Drug Monitoring - methods - standards
Humans
Models, Statistical
Pharmaceutical Preparations
Product Surveillance, Postmarketing - methods - standards
Safety
Sweden
Time Factors
Abstract
This study examined the relationship between the approval times for new pharmaceuticals and the number of adverse drug reactions reported to the Swedish Medical Products Agency. Yearly time-series data concerning the number of adverse drug reactions, as well as data concerning prices and quantities sold for 25 pharmaceutical substances during the period 1972-1996 were used. The results show that shorter approval times are associated with more adverse drug reactions, but also that the effects are quite small.
PubMed ID
15452739 View in PubMed
Less detail

Assessing the risk of drug-induced neurologic disorders: statins and neuropathy.

https://arctichealth.org/en/permalink/ahliterature190203
Source
Neurology. 2002 May 14;58(9):1321-2
Publication Type
Article
Date
May-14-2002

Association between nonnaproxen NSAIDs, COX-2 inhibitors and hospitalization for acute myocardial infarction among the elderly: a retrospective cohort study.

https://arctichealth.org/en/permalink/ahliterature166723
Source
Pharmacoepidemiol Drug Saf. 2007 May;16(5):493-503
Publication Type
Article
Date
May-2007
Author
Elham Rahme
Douglas J Watson
Sheldon X Kong
Youssef Toubouti
Jacques LeLorier
Author Affiliation
Department of Medicine McGill University, and Research Institute, McGill University Health Center, Montreal, Canada. elham.rahme@mcgill.ca
Source
Pharmacoepidemiol Drug Saf. 2007 May;16(5):493-503
Date
May-2007
Language
English
Publication Type
Article
Keywords
Age Factors
Aged
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal - adverse effects - therapeutic use
Cohort Studies
Cyclooxygenase 2 Inhibitors - adverse effects - therapeutic use
Diclofenac - adverse effects - therapeutic use
Drug Prescriptions - statistics & numerical data
Drug Utilization - statistics & numerical data
Female
Hospitalization - statistics & numerical data
Humans
Ibuprofen - adverse effects - therapeutic use
Lactones - adverse effects - therapeutic use
Male
Myocardial Infarction - chemically induced - epidemiology
Product Surveillance, Postmarketing - methods - statistics & numerical data
Proportional Hazards Models
Pyrazoles - adverse effects - therapeutic use
Quebec - epidemiology
Retrospective Studies
Sex Factors
Sulfonamides - adverse effects - therapeutic use
Sulfones - adverse effects - therapeutic use
Abstract
To evaluate the association between rofecoxib, celecoxib, diclofenac, and ibuprofen and the risk of hospitalization for acute myocardial infarction (AMI) in an elderly population.
We conducted a retrospective cohort study, using data from the government of Quebec health insurance agency databases, among patients 65-80 years of age who filled a prescription for any of the study drugs during 1999-2002. Cox regression models with time-dependent exposure were used to compare the incidence rates of hospitalization for AMI adjusting for patients' baseline characteristics. Analyses stratified by dose and number of supplied days were also conducted.
At the index date, a total of 91 062 patients were taking rofecoxib, 127 928 celecoxib, 49 193 diclofenac, and 15 601 ibuprofen. The adjusted hazard ratio (HR) (95%CI) of hospitalization for AMI were: celecoxib versus rofecoxib: 0.90 (0.79, 1.01); ibuprofen versus rofecoxib: 0.95 (0.65, 1.37); diclofenac versus rofecoxib: 1.01 (0.84, 1.22). In secondary analyses based on intended duration of use, neither COX-2 selective inhibitor was associated with a higher risk than ibuprofen or diclofenac. The unadjusted risk of AMI for all NSAIDs increased with dose. In the direct two way adjusted comparison of each NSAID stratified by dose, the only statistically significant difference was with rofecoxib >25 mg/day versus celecoxib >200 mg/day.
In this study there was no difference between AMI occurrence in elderly patients taking rofecoxib or celecoxib at recommended doses for chronic indications versus those taking ibuprofen/diclofenac. However, the risk of AMI was higher among patients using higher doses of rofecoxib (>25 mg/day) compared to patients using higher doses of celecoxib (>200 mg/day).
PubMed ID
17086567 View in PubMed
Less detail

A biologic pharmacosurveillance program for rheumatoid arthritis: a single-center experience.

https://arctichealth.org/en/permalink/ahliterature116627
Source
Clin Rheumatol. 2013 Jun;32(6):875-7
Publication Type
Article
Date
Jun-2013
Author
Anthony S Russell
Catherine Mallon
Barbara Conner-Spady
Walter Maksymowych
Author Affiliation
University of Alberta, Edmonton, Alberta T6G2S2, Canada. as.russell@ualberta.ca
Source
Clin Rheumatol. 2013 Jun;32(6):875-7
Date
Jun-2013
Language
English
Publication Type
Article
Keywords
Adrenal Cortex Hormones - administration & dosage
Alberta
Antirheumatic Agents - therapeutic use
Arthritis, Rheumatoid - therapy
Databases, Factual
Female
Humans
Isoxazoles - administration & dosage
Male
Methotrexate - administration & dosage
Middle Aged
Product Surveillance, Postmarketing - methods
Registries
Remission Induction
Severity of Illness Index
Abstract
We have reviewed the experience in a single center of a biologic register for rheumatoid arthritis patients. Over the past decade, the entry demographics show that we are treating patients at an earlier stage and with slightly less severe disease. Our outcomes measured by the percentage in DAS28 remission are comparable with national databases. We were surprised by the small number who were switched from their first biologic to a second (27 %), but this might reflect the lack of a firm "treat to target" approach. Our use of concomitant methotrexate/leflunomide is less than we would have liked and thought, but our use of concomitant corticosteroids is much less than normally seen. A single-center registry can provide useful monitoring and quality assurance data and stimulate change.
PubMed ID
23377198 View in PubMed
Less detail

Clinical safety surveillance study of the safety and efficacy of long-term home treatment with ReFacto utilizing a computer-aided diary: a Nordic multicentre study.

https://arctichealth.org/en/permalink/ahliterature92302
Source
Haemophilia. 2009 Jan;15(1):175-83
Publication Type
Article
Date
Jan-2009
Author
Petrini P.
Rylander C.
Author Affiliation
Department of Pediatrics, Coagulation Unit, Karolinska University Hospital, Stockholm, Sweden. pia.petrini@karolinska.se
Source
Haemophilia. 2009 Jan;15(1):175-83
Date
Jan-2009
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Child
Child, Preschool
Drug Administration Schedule
Factor VIII - adverse effects - therapeutic use
Hemophilia A - complications - drug therapy
Hemorrhage - etiology - prevention & control
Home Care Services, Hospital-Based
Humans
Infant
Male
Medical Records Systems, Computerized
Middle Aged
Product Surveillance, Postmarketing - methods
Recombinant Proteins - adverse effects - therapeutic use
Self Administration
Treatment Outcome
Young Adult
Abstract
A Nordic multicentre, open-label, non-interventional postmarketing surveillance study was carried out during a period of 24 months evaluating safety and efficacy of ReFacto as prophylactic or on-demand replacement therapy in patients with haemophilia A treated by self-medication. Fifty-seven patients were enrolled and studied for safety; efficacy was evaluated in 39 patients who received ReFacto for 24 months and recorded sufficient diary data on a hand-held computer. The compliance of using the device was good in small children, variable in adults and poor in teenagers. The fact that the overall compliance was low constituted a limitation of the number of patients with reliable diary data. Overall safety was rated as excellent or good by the clinicians for all patients at all visits and overall efficacy at 24 months evaluated to be excellent (74%) or good (26%). It was noticed that >/=50% of patients/parents reported no absences from school or work owing to bleeding episodes during the study period. Among patients on regular prophylaxis, 6 of the 30 patients (20%) receiving ReFacto experienced no bleeding episodes. A median of four bleeding episodes occurred during the 24-month study period, and 93% of the episodes were resolved with
PubMed ID
18752534 View in PubMed
Less detail

21 records – page 1 of 3.