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Adverse experiences during treatment with zimeldine on special licence in Sweden.

https://arctichealth.org/en/permalink/ahliterature46553
Source
Int Clin Psychopharmacol. 1994;9(1):55-61
Publication Type
Article
Date
1994
Author
B O Bengtsson
B E Wiholm
M. Myrhed
J. Wålinder
Author Affiliation
Department of Psychiatry, Faculty of Health Sciences, University Hospital, Linköping, Sweden.
Source
Int Clin Psychopharmacol. 1994;9(1):55-61
Date
1994
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Aged, 80 and over
Depressive Disorder - drug therapy - psychology
Drug Approval - legislation & jurisprudence
Drug Hypersensitivity - etiology
Female
Follow-Up Studies
Humans
Male
Middle Aged
Neurologic Examination - drug effects
Zimeldine - adverse effects - therapeutic use
Abstract
Adverse experiences during licensed treatment with the antidepressant serotonin (5-HT) reuptake inhibitor zimeldine in Sweden are presented. Data were obtained from a written inquiry of 694 patients and 67 reports to the Medical Products Agency. The spectrum of adverse symptoms was in agreement with those reported in previous studies on zimeldine. The most frequent adverse experiences were headache, nausea, myalgia, signs of liver function disturbance, arthralgia, neurological symptoms, fever and insomnia. No new case of the Guillain-Barré syndrome was found. The estimated frequency of the zimeldine-induced hypersensitivity syndrome (HSS), comprising fever, myalgia and/or arthralgia and signs of liver function disturbance, ranged from 1.4% to 13% in the inquiry and from 0.63% to 3.4% in the report part of the study. Adverse experiences usually had a considerably higher incidence during the first 6 weeks of zimeldine treatment than thereafter. This is in agreement with the clinical experience that most of the adverse reactions occur early during zimeldine treatment. However, a number of adverse experiences did occur with a later onset. This may justify a prolongation of the compulsory 4 weeks' testing of liver function that is required during licensed treatment. There were significantly fewer patients who developed fever among the patients who had experienced previous zimeldine treatment than among those who had not. Otherwise there was no statistically significant difference in frequency of adverse symptoms between these two groups. Consequently zimeldine treatment per se does not seem to predispose to development of an HSS or other types of adverse reactions during subsequent therapy.
PubMed ID
8195584 View in PubMed
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Antiprogestin drugs: ethical, legal and medical issues.

https://arctichealth.org/en/permalink/ahliterature65004
Source
Law Med Health Care. 1992;20(3):149-53
Publication Type
Article
Date
1992
Author
R J Cook
D A Grimes
Source
Law Med Health Care. 1992;20(3):149-53
Date
1992
Language
English
Publication Type
Article
Keywords
Abortifacient Agents, Steroidal
Behavioral Research
Drug Approval - legislation & jurisprudence
Ethical Analysis
Ethics
Female
Humans
Internationality
Personal Autonomy
Pregnant Women
Progesterone - antagonists & inhibitors
Risk assessment
Social Control, Formal
Social Responsibility
United States
Vulnerable Populations
Abstract
RU 486 allows women the choice of a medical rather than a surgical abortion, and, for most women, the choice is one of procedure, not of whether to have an abortion. Issues surrounding RU 486 were explored in an American Society of Law and Medicine conference in December 1991 entitled "Antiprogestin Drugs: Ethical, Legal and Medical Issues." An introduction to 14 conference papers provides an overview of the proceedings. Baulieu, the father of RU 486, described updated developments in its use and the medically supervised method of abortion. Bygdeman and Swahn presented their work in Sweden on combining RU 486 with a prostaglandin to make abortion more effective. They suggested that the drug may be an attractive postovulation contraceptive. Greenslad et al. discussed service delivery aspects of the use of RU 486. Holt considered the implications of use of the drug in low-resource settings. A survey of obstetricians and gynecologists, presented by Heilig, indicates that 22% more physicians would perform a medical abortion. Patient perspectives were addressed by David, who stated that measuring acceptability of an abortion technique is difficult; women have historically used whatever method is available. A collaborative research project in India and Cuba on why women chose certain methods was reported by Winikoff et al. (90% of women would choose medical abortion if faced with the choice again). Berer analyzed French data on women's perspectives on medical vs. surgical abortion. The question of adolescent use of the drug was considered by Senderowitz, who lamented the lack of data on the subject and described what is known about adolescent pregnancy. Macklin proposed a framework for ethical analysis and used facts to address ethical questions. Weinstein provided another ethical framework, to analyze whether pharmacists have a right to refuse to provide abortifacient drugs. Buc approached the subject from a legal point of view and concluded that, whereas legal problems are minimal, political problem are of first concern. Boland described differences in introduction of the drug in France and Britain and the US. The theory of "use it or lose it" in patent legislation is applied differently in the US, France, and the UK. Hayhurst, in a complementary legal analysis, noted that Canadian importation would open access to affluent US women. Pine reported on the legal case Benten vs. Kessler, which did not result in successful importation of the drug for personal use, but resulted in some supportive language from the courts. By refusing to apply to the FDA for marketing approval, RU 486's manufacturer may be setting itself up for a boycott. Approaching the problem from these various perspectives addressed the challenge between medical advances and politics and highlighted the need to balance the benefits to women with perceived threats to values.
PubMed ID
1434754 View in PubMed
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Assessing prescription medications for priority regulatory review.

https://arctichealth.org/en/permalink/ahliterature174776
Source
Regul Toxicol Pharmacol. 2005 Jun;42(1):70-6
Publication Type
Article
Date
Jun-2005
Author
Nigel S B Rawson
Author Affiliation
Center for Health Care Policy and Evaluation, Eden Prairie, MN, USA. nigel.s.rawson@gsk.com
Source
Regul Toxicol Pharmacol. 2005 Jun;42(1):70-6
Date
Jun-2005
Language
English
Publication Type
Article
Keywords
Canada
Drug Approval - legislation & jurisprudence - methods
Drug Evaluation - legislation & jurisprudence - methods - standards
Drug Prescriptions - standards
Humans
Pharmaceutical Preparations - classification - standards
Time Factors
United States
Abstract
Poor concordance exists between medications that receive a priority review in Canada and those given an expeditious review in the United States. The objectives of this study were to obtain an evaluation of the clinical significance of new drugs approved in both countries from expert clinical pharmacologists, and to examine the concordance of their aggregate assessment with whether or not the product received an expeditious review in either country. Five experts assessed 146 new medications approved in both Canada and the United States between 1996 and early 2002. Overall, the concordance between the experts' assessments was poor and there was large variation in products considered to be of sufficient importance for priority status. Nevertheless, the experts' evaluations suggested that several priority-reviewed products did not warrant such a review. Regulatory agencies select new medications of potential clinical significance to receive shorter review times to minimize the delay in access to them, but, in Canada, only a low proportion of priority-status products had review times within Health Canada's performance target. The large variation in the assessment of clinical significance suggests that a more appropriate strategy in Canada is to devote sufficient resources to reviewing all medications in a timely manner.
PubMed ID
15896445 View in PubMed
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Balancing early access with uncertainties in evidence for drugs authorized by prospective case series - systematic review of reimbursement decisions.

https://arctichealth.org/en/permalink/ahliterature301360
Source
Br J Clin Pharmacol. 2018 06; 84(6):1146-1155
Publication Type
Journal Article
Research Support, Non-U.S. Gov't
Systematic Review
Date
06-2018
Author
Susanna M Wallerstedt
Martin Henriksson
Author Affiliation
Department of Pharmacology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Source
Br J Clin Pharmacol. 2018 06; 84(6):1146-1155
Date
06-2018
Language
English
Publication Type
Journal Article
Research Support, Non-U.S. Gov't
Systematic Review
Keywords
Adolescent
Adult
Aged
Aged, 80 and over
Cost-Benefit Analysis
Decision Support Techniques
Drug Approval - legislation & jurisprudence - methods
Drug Costs - legislation & jurisprudence
Endpoint Determination
Evidence-Based Medicine - legislation & jurisprudence - methods
Female
Health Policy
Humans
Insurance, Health, Reimbursement - economics - legislation & jurisprudence
Male
Middle Aged
Models, Economic
Policy Making
Prospective Studies
Research Design - legislation & jurisprudence
Sweden
Treatment Outcome
Uncertainty
United Kingdom
Value-Based Health Insurance - economics
Young Adult
Abstract
To review clinical and cost-effectiveness evidence underlying reimbursement decisions relating to drugs whose authorization mainly is based on evidence from prospective case series.
A systematic review of all new drugs evaluated in 2011-2016 within a health care profession-driven resource prioritization process, with a market approval based on prospective case series, and a reimbursement decision by the Swedish Dental and Pharmaceutical Benefits Agency (TLV). Public assessment reports from the European Medicines Agency, published pivotal studies, and TLV, Scottish Medicines Consortium and National Institute of Health and Care Excellence decisions and guidance documents were reviewed.
Six drug cases were assessed (brentuximab vedotin, bosutinib, ponatinib, idelalisib, vismodegib, ceritinib). The validity of the pivotal studies was hampered by the use of surrogate primary outcomes and the absence of recruitment information. To quantify drug treatment effect sizes, the reimbursement agencies primarily used data from another source in indirect comparisons. TLV granted reimbursement in five cases, compared with five in five cases for Scottish Medicines Consortium and four in five cases for National Institute of Health and Care Excellence. Decision modifiers, contributing to granted reimbursement despite hugely uncertain cost-effectiveness ratios, were, for example, small population size, occasionally linked to budget impact, severity of disease, end of life and improved life expectancy.
For drugs whose authorization is based on prospective case series, most applications for reimbursement within public health care are granted. The underlying evidence has limitations over and above the design per se, and decision modifiers are frequently referred to in the value-based pricing decision making.
PubMed ID
29381234 View in PubMed
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Canadian developments. Buprenorphine now approved for the treatment of opiate addiction.

https://arctichealth.org/en/permalink/ahliterature171456
Source
HIV AIDS Policy Law Rev. 2005 Aug;10(2):20, 22
Publication Type
Article
Date
Aug-2005
Source
Can J Neurol Sci. 2007 Mar;34 Suppl 1:S3-10
Publication Type
Article
Date
Mar-2007
Author
L. Kelly
M. Lazzaro
C. Petersen
Author Affiliation
CNSD, BCANS, Therapeutic Products Directorate, Tunney's Pasture, Ottawa, ON, Canada.
Source
Can J Neurol Sci. 2007 Mar;34 Suppl 1:S3-10
Date
Mar-2007
Language
English
Publication Type
Article
Keywords
Canada
Clinical Trials as Topic - legislation & jurisprudence - standards
Dementia - drug therapy
Drug Approval - legislation & jurisprudence - organization & administration
Drug Evaluation - legislation & jurisprudence - trends
Drug Industry - economics - legislation & jurisprudence - trends
Drug-Related Side Effects and Adverse Reactions
Humans
Meta-Analysis as Topic
Risk assessment
Abstract
The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what "authorization to market a drug in Canada" means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to the drug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues.
PubMed ID
17469674 View in PubMed
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The Canadian perspective: trends in drug and medical device class actions in Canada.

https://arctichealth.org/en/permalink/ahliterature167389
Source
Food Drug Law J. 2006;61(3):569-76
Publication Type
Article
Date
2006

Canadian regulatory requirements for recombinant fish vaccines.

https://arctichealth.org/en/permalink/ahliterature209977
Source
Dev Biol Stand. 1997;90:347-53
Publication Type
Article
Date
1997
Author
M S Sethi
G A Gifford
B S Samagh
Author Affiliation
Veterinary Biologic and Biotechnology Section, Animal and Plant Health Directorate, Agriculture and Agri-Food Canada, Nepean, Canada.
Source
Dev Biol Stand. 1997;90:347-53
Date
1997
Language
English
Publication Type
Article
Keywords
Animals
Biological Products - standards
Biotechnology - legislation & jurisprudence - standards
Canada
Drug Approval - legislation & jurisprudence
Fish Diseases - immunology - prevention & control
Fishes - immunology
Humans
Legislation, Veterinary
Licensure
Quality Control
Vaccines, Synthetic - standards
Veterinary Drugs - standards
Abstract
In Canada, veterinary biological products derived by using conventional and new techniques of biotechnology are licensed and regulated under the Health of Animals Act and Regulations. Biological products include vaccines, bacterins, bacterin-toxoids and diagnostic kits which are used for the prevention, treatment or diagnosis of infectious diseases in all species of animals, including fish. Veterinary biologicals are licensed on the basis of fulfillment of four criteria: purity, potency, safety and efficacy. A risk-based approach is used to evaluate the safety of the product in target species, as well as non-target species, humans and the environment. On the basis of biological characteristics, biotechnology derived veterinary biologicals have been divided into two broad categories, high and low risk products. The paper describes the regulatory framework for the licensing of veterinary biologicals in Canada, with emphasis on the regulatory considerations for recombinant fish vaccines. Stages of movement of the product from research in a contained laboratory facility to a fully licensed product for free sale are discussed. The requirements for field testing and environmental assessment involved in these stages are highlighted. Manufacturers and researchers who intend to commercialize experimental vaccines are encouraged to consult with the Veterinary Biologics and Biotechnology Section early in the product development process so that the research data and quality assurance documentation are consistent with regulatory requirements.
PubMed ID
9270863 View in PubMed
Less detail

[Change of law concerning drug trials is needed: Sweden should allow testing in unconscious patients].

https://arctichealth.org/en/permalink/ahliterature145850
Source
Lakartidningen. 2009 Nov 25-Dec 1;106(48):3217-8
Publication Type
Article

44 records – page 1 of 5.