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Can You Blindly Trust Decisions Made By Stringent Drug Regulatory Agencies?
Clinical Therapeutics Methods: We conducted a retrospective study using the GP computer database (Hatfield, UK) on all 9,400 patients to assess the quality of anticoagulation in patients with a recorded diagnosis of AF. Results: Of the 180 patients with a diagnosis of AF, 107 (59.4%) were treated with warfarin, 19 (10.6%) with a novel oral anticoagulant (NOAC), 31 (17.2%) with aspirin or clopidogrel, and 23 (12.8%) received neither. 37 patients (34.6%) who were taking warfarin had a time in the therapeutic range (TTR) of less than 65%. 45 (27.6%) of the 163 patients who had a CHA2DS2VASc score of two or more were not prescribed a vitamin K antagonist (VKA) or a NOAC. None had a HAS-BLED greater than the CHA2DS2VASc score. Conclusion: Our study demonstrates that one in four patients with non-valvular AF at risk of a stroke are not being adequately treated with an oral anticoagulant in primary care. The majority were treated with warfarin, a third of which had a low TTR. A high proportion of patients are prescribed antiplatelet therapy instead. This is despite overwhelming evidence that VKAs and NOACs and not aspirin or clopidogrel improve outcome in patients with non-valvular atrial fibrillation. We suggest that review of GP practice databases should be considered to identify patients with non-valvular AF at risk of a disabling or fatal event and measures taken to initiate anticoagulant therapy.
P2.10 Can You Blindly Trust Decisions Made By Stringent Drug Regulatory Agencies? S.R. Ahmad Rutgers School of Public Health, NJ; and Georgetown University School of Medicine, Washington, DC Background: There is a general belief that when the United States Food and Drug Administration approves a drug for marketing it is safe and effective for the proposed indication. It is also understood that all regulatory decisions are based on sound scientific evidence. Objective: The objective of this talk is (a) to describe the FDA criteria to approve new drugs and (b) to describe the role played by different stakeholders that can precipitate regulatory action. Description: Different regulatory agencies may take different actions based on the same body of evidence, and these decisions can change over time as more data are accumulated. Regulations in some countries allow regulatory agencies to take temporary action to suspend a drug from the market until more convincing data are available. Scientific data should serve as the basis upon which any regulatory decisions are made. In situations where insufficient data are available, additional research should be done. In this talk, a brief overview of the criteria used by the FDA to approve drugs will be presented, which requires adequate and well-controlled investigations to determine efficacy. The role played by pressure from the Congress, media, litigation, and consumer advocacy or patient support groups in stimulating regulatory action will also be described with examples.
P2.11 Use of Health Technology Assessment Agencies' Reports As Evidence For Making Decisions On Drug Reimbursement In Decentralized Decision-Making Environment M. Mahmic-Kaknjo1; and A. Marusic2 Cantonal Hospital Zenica, Zenica, Bosnia and Herzegovina; and 2 University of Split School of Medicine, Split, Croatia
1
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Background: Bosnia and Herzegovina has a decentralized decision-making system in drug reimbursement with payers with different purchasing power. Cochrane systematic reviews (CSRs) represent unbiased evidence, highest in the hierarchy. We tested HTA agency reports as an additional tool for decision making on drug reimbursement for drugs that are on the core national reimbursement list of Federation of Bosnia and Herzegovina (FBL) but not on the 18th World Health Organization Essential Medicines List (WHO EML) and not having good evidence in CSRs. Materials and Methods: We searched the website of Centre for Reviews and Dissemination (CRD), University of York (National Health Service-NHS, National Institute for Health), for published HTA reports, international national propriety names on medicines that were on FBL but not on EML, and not having good evidence in CSRs. Results: Out of 124 medicines on FBLs but not on EML, 73 medicines (22%) had no quality evidence in CSRs to decide on their reimbursement for various reasons. We found either full HTA reports or bibliographic records for 21 (29%) medicines. Evidence was favorable (“same” or “effective”) for 11 (15%) drugs. There were 13 (18%) medicines that were labeled as an “option in specific clinical situations,” “specialist only prescribing,” or the ones with “restricted use.” For 5 (7%) medicines, HTA reports were classified as “not enough evidence,” “limited,” or “inconclusive evidence”. A very unfavorable evidence regarding reimbursement, such as “not approved,” “cannot be endorsed,” and “not superior but expensive” was found for 3 (4%) medicines. Conclusions: HTA reports can provide additional evidence when deciding on drug reimbursement in a decentralized environment and can supplement WHO EML and CSRs in a making national reimbursement medicine lists.
P2.12 Sodium Selenate Restores Potassium Currents of Diabetic Cardiomyopathy: Rat Model Study S.B. Yanardag; M. Ayaz; and A. Duman Selcuk University, Konya, Turkey Introduction: It is known that cardiomyopathy is one of the leading reasons of morbidity and mortality in diabetic patients. The aim of this study is to reveal the effects of sodium selenate treatment on the potassium channel currents in diabetes caused electrical remodeling in rats. Material and Methods: Myopathy and diabetes were induced by single injection of STZ (50 mg/kg ip). Rats were randomized into three groups (Control: N= 8, Diabetic: N= 12, Sodium selenate [5μ mole/kg/day] treated diabetic: N= 12). Myocytes were freshly isolated by using the Langendorff method. Action potentials were recorded by current clamp mode of patch clamp technique; the potassium currents were recorded by voltage clamp mode. The measurements were done five weeks after STZ injection. Oneway ANOVA and t tests were used. ps the one of the important causal for diabetes induced changes. Our study shows that the decrease of the transient outward current is the main reason for the prolongation of action potentials. Being a part of an antioxidative system, selenium affects the potassium channels via balancing the oxidative stress within the cell. This topic needs further investigation.
Volume 38 Number 10S
P2.10 Can You Blindly Trust Decisions Made By Stringent Drug Regulatory Agencies? S.R. Ahmad Rutgers School of Public Health, NJ; and Georgetown University School of Medicine, Washington, DC Background: There is a general belief that when the United States Food and Drug Administration approves a drug for marketing it is safe and effective for the proposed indication. It is also understood that all regulatory decisions are based on sound scientific evidence. Objective: The objective of this talk is (a) to describe the FDA criteria to approve new drugs and (b) to describe the role played by different stakeholders that can precipitate regulatory action. Description: Different regulatory agencies may take different actions based on the same body of evidence, and these decisions can change over time as more data are accumulated. Regulations in some countries allow regulatory agencies to take temporary action to suspend a drug from the market until more convincing data are available. Scientific data should serve as the basis upon which any regulatory decisions are made. In situations where insufficient data are available, additional research should be done. In this talk, a brief overview of the criteria used by the FDA to approve drugs will be presented, which requires adequate and well-controlled investigations to determine efficacy. The role played by pressure from the Congress, media, litigation, and consumer advocacy or patient support groups in stimulating regulatory action will also be described with examples.
P2.11 Use of Health Technology Assessment Agencies' Reports As Evidence For Making Decisions On Drug Reimbursement In Decentralized Decision-Making Environment M. Mahmic-Kaknjo1; and A. Marusic2 Cantonal Hospital Zenica, Zenica, Bosnia and Herzegovina; and 2 University of Split School of Medicine, Split, Croatia
1
e30
Background: Bosnia and Herzegovina has a decentralized decision-making system in drug reimbursement with payers with different purchasing power. Cochrane systematic reviews (CSRs) represent unbiased evidence, highest in the hierarchy. We tested HTA agency reports as an additional tool for decision making on drug reimbursement for drugs that are on the core national reimbursement list of Federation of Bosnia and Herzegovina (FBL) but not on the 18th World Health Organization Essential Medicines List (WHO EML) and not having good evidence in CSRs. Materials and Methods: We searched the website of Centre for Reviews and Dissemination (CRD), University of York (National Health Service-NHS, National Institute for Health), for published HTA reports, international national propriety names on medicines that were on FBL but not on EML, and not having good evidence in CSRs. Results: Out of 124 medicines on FBLs but not on EML, 73 medicines (22%) had no quality evidence in CSRs to decide on their reimbursement for various reasons. We found either full HTA reports or bibliographic records for 21 (29%) medicines. Evidence was favorable (“same” or “effective”) for 11 (15%) drugs. There were 13 (18%) medicines that were labeled as an “option in specific clinical situations,” “specialist only prescribing,” or the ones with “restricted use.” For 5 (7%) medicines, HTA reports were classified as “not enough evidence,” “limited,” or “inconclusive evidence”. A very unfavorable evidence regarding reimbursement, such as “not approved,” “cannot be endorsed,” and “not superior but expensive” was found for 3 (4%) medicines. Conclusions: HTA reports can provide additional evidence when deciding on drug reimbursement in a decentralized environment and can supplement WHO EML and CSRs in a making national reimbursement medicine lists.
P2.12 Sodium Selenate Restores Potassium Currents of Diabetic Cardiomyopathy: Rat Model Study S.B. Yanardag; M. Ayaz; and A. Duman Selcuk University, Konya, Turkey Introduction: It is known that cardiomyopathy is one of the leading reasons of morbidity and mortality in diabetic patients. The aim of this study is to reveal the effects of sodium selenate treatment on the potassium channel currents in diabetes caused electrical remodeling in rats. Material and Methods: Myopathy and diabetes were induced by single injection of STZ (50 mg/kg ip). Rats were randomized into three groups (Control: N= 8, Diabetic: N= 12, Sodium selenate [5μ mole/kg/day] treated diabetic: N= 12). Myocytes were freshly isolated by using the Langendorff method. Action potentials were recorded by current clamp mode of patch clamp technique; the potassium currents were recorded by voltage clamp mode. The measurements were done five weeks after STZ injection. Oneway ANOVA and t tests were used. ps the one of the important causal for diabetes induced changes. Our study shows that the decrease of the transient outward current is the main reason for the prolongation of action potentials. Being a part of an antioxidative system, selenium affects the potassium channels via balancing the oxidative stress within the cell. This topic needs further investigation.
Volume 38 Number 10S