MedDRA User Group. Paris, April 16, 2015 Victoria Newbould, European Medicines Agency. An agency of the European Union
|
|
- Marjory Arnold
- 6 years ago
- Views:
Transcription
1 MedDRA User Group Paris, April 16, 2015 Victoria Newbould, European Medicines Agency An agency of the European Union
2 HMA meeting 28 November 2013 HMA agreed with the deliverables to be completed over the next 21 months (Jan 2014 Sep 2015) and Member States to provide input via existing development frameworks: Governance structure for the implementation of the pharmacovigilance legislation Project Team 1 * for good practice guide (technical) for reporting errors Project Team 2 # for good practice guide (scientific) for risk minimisation SCOPE (EC s Joint Action) for awareness campaign and communication toolbox MedDRA Points to Consider (PTC) Expert Group on best use of terminologies For all deliverables, collaboration with EC s Patient Safety & Quality of Care Working Group (PSQCWP) is foreseen *Project Team 1: Collection of key information on medicines #Project Team 2: Better analysis and understanding of data and information 1
3 Consultation steps Good practice guide on recording, coding, reporting and assessment of ME: Draft developed and finalised by Project and Maintenance Group 1 Draft consulted with the European Commission s Patient Safety Quality of Care Working Group (PSQCWG) 5 December February 2015 Draft consulted and agreed with PRAC 12 February 2015 Draft consulted with EV-EWG 20 February 2015 Implementation Group consultation and agreement 6 March 2015 ERMS- FG approval 17 March
4 Public consultation Good practice guide on recording, coding, reporting and assessment of Medication Errors : Apr 15: Release for 2 months public consultation Jun 15: Revision in line with comments received Sep 15: Final guidance for publication Comments to:medicationerrors2013@ema.europa.eu 3
5 Reporting of Medication errors: Indicates event did happen; indicates event did not happen; N/A not applicable; EV EudraVigilance 1 The PSUR summary information includes interval and cumulative summary tabulations in line with GVP VII, and on request of the competent authority or the Agency additional listings of cases of medication error of special interest relevant for the benefit-risk evaluation. 2 Not in line with the definition of a patient safety incident which is any unintended or unexpected incident which could have or did lead to harm for one or more patients receiving e.g. NHS England care. Report prevented patient safety incidents (known as near misses ). Therefore a potential error is not an incident because it has not occurred and is not a near miss because it cannot be said that it has been prevented. 3 Only applicable after successful EudraVigilance audit 4
6 Good Practice guidance on ME Bridging gap between pharmacovigilance and patient safety Some examples in guide are more related to patient safety or are for periodic reporting not ICSRs MedDRA not designed for and has not included patient safety/human use factors Commission/omission Omission may lead to harm but can not be ADR because there is no drug Monitoring errors clinical practice or part of the drug usage process? 5
7 Examples in Annex of guide (v 17.1): Reported LLT Term Selected Comment Dose calculation error in an adolescent treated for growth failure results in insulin-like hypoglycaemia Incorrect dose administered; Hypoglycaemia; There is no term for coding dose calculation error but this information should be provided in the case narrative. Patient was prescribed 10 fold higher strength of an oral opioid and went into respiratory failure at home after having taken 3 doses Patient well controlled on antiepileptic medicines failed to get repeat or emergency supply and was hospitalised with partial seizures Drug prescribing error; Respiratory failure; Accidental overdose Drug dose omission; Partial seizures; The PT Prescribed overdose should not be selected; the overdose is not intended and consequence of a medication error. The fact that it is a supply issue cannot be coded and should be recorded in the narrative of the database. 6
8 Proposal for process for using E2B (R3) Once implemented, the ICH E2B (R3) data element G.k.10.r Additional information on drug (coded) should always be populated with the respective code for medication error at drug level (i.e. code 7) if the primary source has indicated that any type of medication error may have occurred The advantage of using the G.k.10.r flag is to identify medication error cases at drug level rather than only at case level If there is no explicit indication of a medication error by the primary source which would clearly transpose into a MedDRA term in the reaction section but there is a hint that there may have occurred an error in the context of the clinical course description, the sender may choose to populate data element G.k.10.r at their discretion to flag a medication error. The case should be followed up to confirm if there was actually a medication error. 7
9 E2B (R3) and Medication errors ICH E2B (R3) - Additional Information on Drug (coded) (G.k.10.r): 7= Medication error More than one code can be selected, for example if a medication error led to unintentional overdose both codes for the medication error (code 7) and for the overdose (code 2) should be selected. In addition to the flag, a MedDRA Lowest Level Term (LLT) should also be provided in data element Reaction(s)/Event(s) (E.i.2.1) selecting the most specific code possible to provide details on the type of medication error at case level, and where this information cannot be coded it should be provided in the narrative (H.1). In addition, data element G.k.11 can be used to provide further information in free text format where it cannot be specified by G.k.10. 8
10 E2B (R3) and Medication errors- senders diagnosis E2B (R2) B.5.3 Sender's diagnosis/syndrome and/or reclassification of reaction/event This section provides the sender with an opportunity to combine signs and symptoms that were reported into a succinct diagnosis and the reasoning would be included in section B.5.4. MedDRA terminology. B.5.4 Sender's comments This section provides information concerning the sender's assessment of the case and can be used to describe disagreement with, and/or alternatives to the diagnoses given by the initial reporter. E2B (R3) H.3.r.1.b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code)this data element provides the sender with an opportunity to combine signs and symptoms that were reported into a succinct diagnosis. Supporting rationale for the term selection is included in Section H.4.A MedDRA LLT code should be used. H.4 Sender's comments This data element captures the sender's assessment of the case and can be used to describe disagreement with, and/or alternatives to the diagnoses given by the reporter(s). Question- MedDRA principles of do not infer/do not add info? 9
11 E2B (R3) and Medication errors Inferred medication errors There may be instances where the initial primary reporter has not specifically stated there was a medication error but it is clear from the information provided that there has been an error. MedDRA coding principles advise that medication errors should not be inferred unless specific information is provided. There may be a conflict between potential liability and the implied pharmacovigilance obligation of the marketing authorisation holder to classify medication errors as such when reporting suspected adverse reactions to national competent authorities or the Agency- a disclaimer is proposed 10
12 Ongoing related discussions on ME ICSR ME flag - use of Additional Information on Drug (G.k.10.r) in connection with Sender s diagnosis and Sender s comments data elements proposal for coding process is under discussion with EV-EWG, PRAC SMART and PMG1; Proposed disclaimer in ICSRs to address the conflict between potential liability and pharmacovigilance obligations of MAHs/NCAs; Methodological guidance on signal detection of ME under development by PRAC SMART; e-rmr pilot with term list Proposed EMA service to make available to NCAs collated reports on ME via EVDAS in line with the revised EV Access Policy; Whether and how to present ME reports on adrreports.eu website; These issues/questions will be informed by the public consultation 11
13 Further guidance? Transcription error (V 18.0) Still questions about misuse vs medication error vs off label 12
14 Titration error (V 17.0) vs Dose calculation error Supposed to take 20 mg and titrate to 40 mg, and finally 80 mg but initiated treatment at 80 mg daily patient had been inadvertently increased dosage from 8 mg/kg/min to 16. The dose was doubled instead of increasing by 2ng/kg/min. Dosage was slowly titrated back down. Dose was increased without reason (context of accusation of 'murder' by nurse) Is there common understanding of titration in all regions? Type of calculation error? Loading dose error a titration error? 13
15 Ongoing related discussions related to MedDRA Call for further examples Guidance for v 18.0 Points to consider Medication error guide Procedure for using E2B (R3) applicable to other scenarios (off label/abuse etc) Paediatric term list initiatives 14
16 15 THANK YOU
SCOPE Work Package 4 ADR Collection. Medication Errors
Medication Errors Contents Acknowledgments 3 1. Introduction 4 1.3 Definitions and abbreviations 5 2. Medication errors 7 2.1 Coding of medication errors 7 2.2 Exemption from liability for HCPs when reporting
More informationDraft EU Guidance on Medication Errors
Draft EU Guidance on Medication Errors Revision after PSQCWG and PRAC consultation PSQCWG meeting Brussels, 11 February 2015 Presented by Dr. Thomas Goedecke Senior Scientific Officer, Regulatory Affairs
More informationOverview of comments received on draft 'Good practice guide on recording, coding, reporting and assessment of medication errors' (EMA/762563/2014)
23 October 2015 EMA/190895/2015 Pharmacovigilance Risk Assessment Committee Overview of comments received on draft 'Good practice guide on recording, coding, reporting and assessment of medication errors'
More informationSafeguarding public health. The New PV Legislation. Perspective from a Member State
Safeguarding public health The New PV Legislation Perspective from a Member State Mick Foy Reinforcing patient safety in Europe, Zagreb June 2011 Content Background The new EU PV Package ADR Definition
More informationGood Pharmacovigilance Practice. Overview of GVP Modules on ADR, PSURs, Signal Management and Additional Monitoring Mick Foy - MHRA
Good Pharmacovigilance Practice Overview of GVP Modules on ADR, PSURs, Signal Management and Additional Monitoring Mick Foy - MHRA Content ADR Reporting Definition & Increased scope Transition arrangements
More informationSafeguarding public health. The New PV Legislation its Impact on PV & MI
Safeguarding public health The New PV Legislation its Impact on PV & MI Sarah Vaughan - MHRA PIPA 2013 Manager s Meeting 13 th February 2013 Content Scope of change Key areas - ADR reporting - DDPS to
More informationImplementation of the new pharmacovigilance legislation: Overall update and activities in 2013
Implementation of the new pharmacovigilance legislation: Overall update and activities in 2013 Workshop for micro, small and medium-sized enterprises (SMEs) European Medicines Agency (EMA), London 26 April
More informationMedDRA Coding and Medication Error Topics. Patrick Revelle (MSSO)
MedDRA Coding and Medication Error Topics Patrick Revelle (MSSO) Topics for Presentation MSSO's MedDRA maintenance role MedDRA's history with medication errors Developmental efforts FAERS and ICSRs MedDRA
More informationImplementing ISO ICSR/ICH E2B(R3): Key changes for pharmacovigilance
Implementing ISO ICSR/ICH E2B(R3): Key changes for pharmacovigilance Training Module PhV-M2a The impact of the new ISO/ICH E2B(R3) ICSR standard on adverse reaction reporting and the new business rules
More informationAdopted by Pharmacovigilance Risk Assessment Committee 20 February Adopted by Pharmacovigilance Inspectors Working Group 21 March 2014
21 March 2014 EMA/INS/PhV/192231/2014 Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal Adopted
More informationThe New EU PV Legislation: View from the European Commission
The New EU PV Legislation: View from the European Commission International seminar 26 May 2011 Lenita LINDSTRÖM Senior Policy Officer Pharmaceuticals Unit/DG SANCO Rationale for the revision Calls for
More informationEV Reporting process for users: Creating and sending ICSRs using EVWEB part II
EV Reporting process for users: Creating and sending ICSRs using EVWEB part II Training Module EV-M3e An agency of the European Union Content Summary Introduction Nullifications and Amendments Creating
More information1. PURPOSE 2. SCOPE 3. RESPONSIBILITIES
1. PURPOSE The purpose of this standard operating procedure (SOP) is to inform all Alexion personnel, and applicable service providers who become aware of a Pharmacovigilance (PV) Event of their responsibility
More informationGuideline on good pharmacovigilance practices (GVP)
1 2 26 July 2012 EMA/118465/2012 3 4 Guideline on good pharmacovigilance practices (GVP) Module XV Safety communication 5 Draft finalised by the Agency in collaboration with Member States and submitted
More informationGuidance notes for patient safety and pharmacovigilance in patient support programmes
Guidance notes for patient safety and pharmacovigilance in patient support programmes Authors: The ABPI Pharmacovigilance Expert Network Version: 2.14 Date: March 2018 Acknowledgements: We thank the many
More informationBETTER REGULATION OF MEDICINES INITIATIVE (BROMI): FIFTH REPORT ON PROGRESS
A2 BETTER REGULATION OF MEDICINES INITIATIVE (BROMI): FIFTH REPORT ON PROGRESS March 2012 A3 BETTER REGULATION OF MEDICINES INITIATIVE (BROMI) FIFTH REPORT ON PROGRESS Chief Executive s foreword In January
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA This document has been prepared to serve as a guideline to those reporting adverse drug reactions.
More informationElectronic submission of information on medicinal products in accordance to Article 57(2) requirements: Maintenance submission
Electronic submission of information on medicinal products in accordance to Article 57(2) requirements: Maintenance submission SME workshop: Focus on quality for medicines containing chemical entities
More informationPharmacovigilance assessor. National Institute of Pharmacy and Nutrition (OGYÉI) (Hungary) Senior hospital Pharmacist
Curriculum vitae PERSONAL INFORMATION Gyorgyi Fodor WORK EXPERIENCE September 2011 Present Pharmacovigilance assessor National Institute of Pharmacy and Nutrition (OGYÉI) (Hungary) Benefit/risk assessment,
More informationFOOD AND DRUGS AUTHORITY GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE
FOOD AND DRUGS AUTHORITY GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE Document No. : FDA/SMC/SMD/GL-QPP/2013/03 Date of First Adoption : 1st February, 2013 Date of Issue : 1 st March, 2013 Version
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL REPORTING ADVERSE DRUG REACTIONS IN SOUTH AFRICA IMPORTANT NOTE This guideline applies only to the reporting of SAEs during clinical trials. An update of the guideline for this
More informationCorporate Induction: Part 2
Corporate Induction: Part 2 Identification of preventable Adverse Drug Reactions from a regulatory perspective March 1 st 2013, EMA Workshop on Medication Errors Presented by Almath Spooner, Pharmacovigilance
More informationICH Topic E 2 D Post Approval Safety Data Management. Step 5 NOTE FOR GUIDANCE ON DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (CPMP/ICH/3945/03)
European Medicines Agency May 2004 CPMP/ICH/3945/03 ICH Topic E 2 D Post Approval Safety Data Management Step 5 NOTE FOR GUIDANCE ON DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (CPMP/ICH/3945/03)
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL REPORTING OF POST-MARKETING ADVERSE DRUG REACTIONS TO HUMAN MEDICINAL PRODUCTS IN SOUTH AFRICA Important Note: Guideline 2.11 Reporting ADRs in South Africa addresses the reporting
More informationINVOLVING PATIENTS IN PHARMACOVIGILANCE EPF TOOLKIT. Susanna Palkonen, EPF Board Member
INVOLVING PATIENTS IN PHARMACOVIGILANCE EPF TOOLKIT Susanna Palkonen, EPF Board Member EPF About us Independent, non-governmental umbrella organisation set up in 2003 VISION: High-quality, patientcentred,
More informationGuideline on good pharmacovigilance practices (GVP)
9 October 2017 2017 EMA/118465/2012 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module XV Safety communication (Rev 1) Date for coming into effect of first version 24 January 2013 Draft
More informationEvaluating adverse events from patient support and market research programs: proposed best practices and regulatory changes
Evaluating adverse events from patient support and market research programs: proposed best practices and regulatory changes 2 nd Adverse Event Reporting and Safety Strategies Summit December 8-9, 2015
More informationPharmacovigilance Office of Product Review
Pharmacovigilance Office of Product Review Dr Jane Cook Office Head Office of Product Review, Monitoring & Compliance Group, TGA 7/10/2011 Overview of talk Overview Post TGA 21 and OPR New Guidelines Key
More informationUse of disease registries for benefitrisk evaluation of medicines: A regulatory perspective. DIA Europe April Basel, Switzerland
Use of disease registries for benefitrisk evaluation of medicines: A regulatory perspective DIA Europe 2018-17-19 April Basel, Switzerland Presented by Xavier Kurz Head of Service Surveillance and Epidemiology
More informationSafe Medicine Administration Policy
Safe Medicine Administration Policy Objectives Students under the direction of Nursing & midwifery staff will be able to : Identify important practice in the new Safe Medicine Administration policy Use
More informationCapturing the value of SCOPE to the EU Flagship Event London, 23 November 2016
Capturing the value of SCOPE to the EU Flagship Event London, 23 November 2016 Helen Lee European Commission, Health and Food Safety Directorate General Outline of the presentation Characterisitics of
More informationImproving the reporting of medication-related safety incidents
Rationale Improving the reporting of medication-related safety incidents Research shows that organisations which regularly report more patient safety incidents usually have a stronger learning culture
More informationSubmission of new substance and IMP data in the extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
EMA Implementation Working Group with EU Pharmaceutical Industry Associations on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 Submission of new substance and
More informationThe Pharmaceutical Risk Assessment Committee (PRAC) of the EMA
The Pharmaceutical Risk Assessment Committee (PRAC) of the EMA Albert van der Zeijden (PRAC member) Expert representing patients perspective Eurordis Summerschool Friday June 5, 2015 Content The history
More informationHow to Report Medication Safety Incidents from a GP Practice on the National Reporting and Learning System (NRLS)
pecialist Pharmacy ervice Medicines Use and afety How to Report Medication afety Incidents from a GP Practice on the National Reporting and Learning ystem (NRL) This document provides a quick explanation
More informationINDEPENDENT NON-MEDICAL PRESCRIBING (NMPs) POLICY. Suffolk GP Federation Board
INDEPENDENT NON-MEDICAL PRESCRIBING (NMPs) POLICY Version: 1.0 Policy owner: Ratified by: Clinical Governance Lead Chief Executive Date approved: 28 th November 2014 Approved by: Suffolk GP Federation
More informationGuideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
1 2 31 January 2017 EMA/430909/2016 3 4 5 Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or Draft Adopted by GCP Inspectors Working Group (GCP IWG) 30 January 2017 Adopted
More informationWhat does governance look like in homecare?
What does governance look like in homecare? Dr David Cousins PhD FRPharmS Head of Pa)ent Safety, Healthcare at Home Ltd This Satellite is sponsored by Healthcare at Home Ltd Definitions Clinical governance
More informationLessons from the EMA Patient Registries Initiative
Lessons from the EMA Patient Registries Initiative STAMP Commission Expert Group 8 th June 2018 Presented by Peter Arlett, with contributions from Patricia McGettigan and Jane Moseley Head of Pharmacovigilance
More information<Insert Picture Here> Some Background and What You Should Know and Do Now to Prepare
1 E2B (R3): Some Background and What You Should Know and Do Now to Prepare The following is intended to outline our general product direction. It is intended for information purposes
More informationSOP Title: Reporting Adverse Events and New Safety Information
Page 1 of 14 General Control of medication use requires collecting field data about adverse events (AEs) resulting from medication therapy. Regulation 7(B)(2) of Pharmacists Regulations (Medical Products)
More informationReport from the CMDh meeting held on November 2013
Report from the meeting held on 18-20 November 2013 Pharmacovigilance Outcomes of informal PSUR work-sharing procedures The has adopted the conclusions of PSUR assessment for alprostadil, ciclosporin,
More informationMEDICINE USE EVALUATION
MEDICINE USE EVALUATION A GUIDE TO IMPLEMENTATION JOHN IRELAND VERSION 1 2013 Posi%ve Impact www.posi%veimpact4health.com Email: ji@icon.co.za Ph: 0823734585 Fax (086) 6483903, Melkbosstrand, South Africa
More informationStandard Operating Procedure
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-07-004 Recording, managing and reporting Adverse Events for Clinical Trials of Investigational Medicinal Products and trials of Advanced
More informationCommission Guidelines for the implementation of the Clinical Trials Regulation NTA Ethics Oslo
Commission Guidelines for the implementation of the Clinical Trials Regulation NTA Ethics 30.1.2017 Oslo 3.2.2017 O. Konttinen 1 Background Based on directive 2001/20/EC of the clinical trials on medicinal
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE SCOPE
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE 1 Guideline title SCOPE Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes 1.1 Short title Medicines
More information...FREEDOM TO EXPLORE YOUR REGULATORY NEEDS
...FREEDOM TO EXPLORE YOUR REGULATORY NEEDS 1 Table of Contents Pg 3 Pg 4 Pg 5 About Ivowen Limited Meet the team Pharmaceutical Regulatory Affairs Services: Human & Veterinary Pg 5 Pg 5 National Procedures
More informationNew European Union Clinical Trial Regulations
New European Union Clinical Trial Regulations Incorporate Monitoring and Safety Reporting Techniques into U.S. and EU Clinical Trial SOPs Anita K. Murthy Deputy Director, Global Regulatory Affairs Bayer
More informationWHO Programme for International Drug Monitoring, Pharmacovigilance Centres & Patient Safety
WHO Programme for International Drug Monitoring, Pharmacovigilance Centres & Patient Safety Birth of WHO Drug Monitoring Programme Thalidomide Phocomelia 2 16th World Health Assembly 1963 Assembly Resolution
More informationMeasures of impact of pharmacovigilance processes (3.3)
Measures of impact of pharmacovigilance processes (3.3) Session 4 - Reports from breakout sessions: gaps and observations Workshop: Measuring the Impact of Pharmacovigilance Activities London, 5-6 December
More informationAPPENDIX 8-2 CHECKLISTS TO ASSIST IN PREVENTING MEDICATION ERRORS
APPENDIX 8-2 CHECKLISTS TO ASSIST IN PREVENTING MEDICATION ERRORS Use the following checklists in the appropriate areas of your office, facility or practice to assist in preventing medications errors:
More informationAdministration of Oral Prescription Medication Procedure Page 1 of 6
Page 1 of 6 RATIONALE: Hamilton-Wentworth District School Board is committed to ensuring the provision of plans, programs, and/or services that will enable students with health or medical needs to attend
More informationCommunity Nurse Prescribing (V100) Portfolio of Evidence
` School of Health and Human Sciences Community Nurse Prescribing (V100) Portfolio of Evidence Start date: September 2016 Student Name: Student Number:. Practice Mentor:.. Personal Tutor:... Submission
More informationDrug Safety Research Unit. DSRU Education & Training
Drug Safety Research Unit DSRU Education & Training Courses and Symposia 2017 Experts in Pharmacovigilance Education www.dsru.org Welcome Welcome to the latest Drug Safety Research Unit (DSRU) Course and
More informationVersion Number: 003. On: September 2017 Review Date: September 2020 Distribution: Essential Reading for: Information for: Page 1 of 13
CONTROLLED DOCUMENT Reporting Research Incidents and Breaches Policy CATEGORY: CLASSIFICATION: PURPOSE Controlled Number: Document Policy Governance To set out the framework and principles for reporting
More informationSELF - ADMINISTRATION OF MEDICINES AND ADMINISTRATION OF MEDICINES SUPPORTED BY FAMILY/INFORMAL CARERS OF PATIENTS IN COMMUNITY NURSING
CLINICAL PROTOCOL SELF - ADMINISTRATION OF MEDICINES AND ADMINISTRATION OF MEDICINES SUPPORTED BY FAMILY/INFORMAL CARERS OF PATIENTS IN COMMUNITY NURSING RATIONALE Medication errors can cause unnecessary
More informationMarie-Claire Rickard, RG and GCP Manager Jimena Lovos, Quality Assurance Manager Elizabeth Clough, R&D Governance Operations Manager
Standard Operating Procedures (SOP) for: Pharmacovigilance processing for the JRMO SOP Number: 26c Version Number: V1 Effective Date: 5/8/16 Review Date: 5/8/17 Author: Reviewer: Reviewer: Authorisation:
More informationSUPPLEMENTARY PRESCRIBING: PHARMACIST PRACTITIONERS
SUPPLEMENTARY PRESCRIBING: PHARMACIST PRACTITIONERS A Guide for Implementation within NHSScotland Scottish Executive Health Department SUPPLEMENTARY PRESCRIBING: PHARMACIST PRACTITIONERS A Guide for Implementation
More informationRequirements for the Mentcare system
Requirements for the Mentcare system 1 Requirements for the Mentcare system A system to support the clinical management of patients suffering from mental illness Requirements for the Mentcare system 2
More informationSHRI GURU RAM RAI INSTITUTE OF TECHNOLOGY AND SCIENCE MEDICATION ERRORS
MEDICATION ERRORS Patients depend on health systems and health professionals to help them stay healthy. As a result, frequently patients receive drug therapy with the belief that these medications will
More informationPHARMACY SERVICES/MEDICATION USE
25.01. 10 Drug Reactions & Administration Errors & Incompatibilities. Drug administration errors, adverse drug reactions and incompatibilities must be immediately reported to the attending physician and
More informationPSUR and PSUR repository. Legal basis. PSUR/PBRER General comments
PSUR and PSUR repository Mag. Dr. Irmgard Resch Dep. Assessment Pharmacovigilance AGES-Gespräche Vienna, 22.9.2015 www.basg.gv.at Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Legal
More informationGuide to Incident Reporting for In-vitro Diagnostic Medical Devices
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices SUR-G0004-4 02 AUGUST 2012 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes
More informationReducing Medication Errors
Reducing Medication Errors 1 st July 2015 Dr David Gerrett Senior Pharmacist April 2015 Patient Safety NHS E Manchester MCC Content 1. The Pharmacovigilance landscape 2. MSOs 3. What we know of error from
More informationAsian Journal of Phytomedicine and Clinical Research Journal home page:
Research Article CODEN: AJPCFF ISSN: 2321 0915 Asian Journal of Phytomedicine and Clinical Research Journal home page: www.ajpcrjournal.com TOWARDS ACTUALIZATION OF PHARMACOVIGILANCE IN ERITREA Mussie
More informationVarious Views on Adverse Events: a collection of definitions.
Various Views on Adverse Events: a collection of definitions. April 20, 2008 Werner CEUSTERS a,1, Maria CAPOLUPO b, Georges DE MOOR c, Jos DEVLIES c a New York State Center of Excellence in Bioinformatics
More informationEnsuring our safeguarding arrangements act to help and protect adults PRACTICE GUIDANCE FOR REPORTING MEDICATION INCIDENTS INTO SAFEGUARDING
Ensuring our safeguarding arrangements act to help and protect adults PRACTICE GUIDANCE FOR REPORTING MEDICATION INCIDENTS INTO SAFEGUARDING Contents Page 1.0 Purpose 2 2.0 Definition of medication error
More informationNurse Orientation. Medication Management
Nurse Orientation Medication Management Objectives Discuss basic principles/rights of medication administration, according to your site policy Describe principles of patient/family education related to
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Safety Reporting in CTIMPs and ATMPs SOP number: TM 003 SOP category: Trial Management Version number: 03 Version date:
More informationBackground and Methodology
Study Sites and Investigators Emergency Department Pharmacists Improve Patient Safety: Results of a Multicenter Study Supported by the ASHP Foundation Jeffrey Rothschild, MD, MPH-Principal Investigator
More informationStudents Controlled drugs means those drugs as defined in Conn. Gen. Stat. Section 21a-240.
Students 5143 ADMINISTRATION OF STUDENT MEDICATIONS IN THE SCHOOLS A. Definitions Administration of medication means any one of the following activities: handling, storing, preparing or pouring of medication;
More information3 HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION
1 PURPOSE The purpose of this procedure is to describe the method by which Adverse Events (AE)/relevant Safety Information and Product Quality Complaints (PQC) will be received, triaged, and documented
More informationClinical Documentation
Approved by: Chief Operating Officer; and Chief Medical Officer Clinical Documentation Corporate Policy & Procedures Manual Number: III-120 Date Approved January 4, 2018 Date Effective February 9, 2018
More informationHigh Level Pharmaceutical Forum
High Level Pharmaceutical Forum 2005-2008 Final Conclusions and Recommendations of the High Level Pharmaceutical Forum On 2 nd October 2008, the High Level Pharmaceutical Forum agreed on the following
More informationThanks to Anne C. Byrne, RN, Medical Monitor at Northwest Georgia Regional Hospital. This presentation was developed from one she designed for that
Thanks to Anne C. Byrne, RN, Medical Monitor at Northwest Georgia Regional Hospital. This presentation was developed from one she designed for that hospital. 1 2 3 Note that an actual variance occurs when
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Risk Assessment SOP-RES-002 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s) Reviewer(s)
More informationPolicy for Supporting Pupils with Medical Conditions
Policy for Supporting Pupils with Medical Conditions Introduction At Hadfield Nursery School, children with medical conditions, in terms of both physical and mental health, will be properly supported in
More informationExpiry Date: January 2009 Template Version: Page 1 of 7
YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Clinical Condition Indication: Inclusion criteria: Exclusion criteria: Cautions/Need for
More informationEuropean network of paediatric research (EnprEMA)
17 February 2012 EMA/77450/2012 Human Medicines Development and Evaluation Recognition criteria for self assessment The European Medicines Agency is tasked with developing a European paediatric network
More informationOverview of e-portfolio Learning Activities for Part III Community Pharmacy Placements
Overview of e-portfolio Learning Activities for Part III Community Pharmacy Placements Placement Module 2 & 3 The following sections must be completed for Placement. Pre-placement Preparation My Glossary
More informationTeleconference Course Materials You may duplicate this for each person attending the conference.
TC001603A Teleconference Course Materials You may duplicate this for each person attending the conference. Show Me Your Safety Data... FDA & EU Pharmacovigilance Inspections by Steve Jolley SJ Pharma Consulting
More informationObservatory 29 th July 2015
National Medication Safety Network Observatory 29 th July 2015 Observatory of recent safe medication practice research, reports, and publications Presented by Varinder Rai varinder.rai@nhs.net Recent regulator
More informationOverview of Draft Pharmacovigilance Protocol
Overview of Draft Pharmacovigilance Protocol Identifying ADRs in Africa Special Challenges Malaria - pan-systemic clinical features Life-threatening condition Real-world trial AS/SP and co-artem safety
More informationConstant Pursuit of Medication Safety. Geraldine Koh Chief Pharmacist
Constant Pursuit of Medication Safety Geraldine Koh Chief Pharmacist 1 Alexandra Hospital 400 beds Multi discipline except Paeds & ObGyn Restructured in Oct 2000 Transformation Creating A Safety Culture
More informationRITAZAREM CRF Completion Guidelines
RITAZAREM CRF Completion Guidelines 10 Sept 2013 Version 1.2 Author: Michelle Lewin RITAZAREM Trial Coordinator Michelle.lewin@addenbrookes.nhs.uk Tel: +44(0) 1223 349350 Fax: +44(0) 1223 586767 Version
More informationObjective Competency Competency Measure To Do List
2016 University of Washington School of Pharmacy Institutional IPPE Checklist Institutional IPPE Team Contact Info: Kelsey Brantner e-mail: ippe@uw.edu phone: 206-543-9427; Jennifer Danielson, PharmD e-mail:
More information1 The EU Harmonised technical ectd guidance version 4.0
Annex 2 to the HMA esubmission Roadmap: Implementation of mandatory ectd format for regulatory submissions (Status: Final version adopted by the esubmission CMB. Dated 26 July 2016) Scope This annex is
More informationNHS Lanarkshire Policy for the Availability of Unlicensed Medicines
NHS Lanarkshire Policy for the Availability of Unlicensed Medicines Prepared by: NHS Lanarkshire Chief Pharmacist Endorsed by: Area Drug & Therapeutic Committee Previous Version/Date: Primary Policy Date:
More informationEuropean Patients Academy (EUPATI) Update
European Patients Academy (EUPATI) Update EMA meeting with patient/consumer organisations 11 Dec 2013 Maria Mavris EURORDIS // EUPATI WP4 Co-Lead For patient-centric medicines R&D and to contribute to
More informationSection 6: Referral record headings
Section 6: Referral record headings Referral record standards: the referral headings are primarily intended for recording the clinical information in referral communication between general practitioners
More informationManaging medicines in care homes
Managing medicines in care homes http://www.nice.org.uk/guidance/sc/sc1.jsp Published: 14 March 2014 Contents What is this guideline about and who is it for?... 5 Purpose of this guideline... 5 Audience
More informationManagement of Reported Medication Errors Policy
Management of Reported Medication Errors Policy Approved By: Policy & Guideline Committee Date of Original 6 October 2008 Approval: Trust Reference: B45/2008 Version: 4 Supersedes: 3 February 2015 Trust
More informationSection 7: Core clinical headings
Section 7: Core clinical headings Core clinical heading standards: the core clinical headings are those that are the priority for inclusion in EHRs, as they are generally items that are the priority for
More informationMaryland Patient Safety Center s Annual MEDSAFE Conference: Taking Charge of Your Medication Safety Challenges November 3, 2011 The Conference Center
Maryland Patient Safety Center s Annual MEDSAFE Conference: Taking Charge of Your Medication Safety Challenges November 3, 2011 The Conference Center at the Maritime Institute Improving Staff Education
More informationReducing Medication Errors: National Update
Reducing Medication Errors: National Update Ahmed Ameer Medication Safety Officer Ahmed.Ameer@NHS.net Safer Medication Practice & Medical Devices Team 27 th January 2015 Agenda 1. Development of the National
More informationMEDICAL CONDITIONS POLICY
MEDICAL CONDITIONS POLICY Purpose Clear procedures are required to support the health, wellbeing and inclusion of all children enrolled at the service. Our service practices support the enrolment of children
More informationEuropean Medicines Agency Inspections ANNEX V TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: PHASE I UNITS
European Medicines Agency Inspections London, 23 July 2008 EMEA/INS/GCP/197215/2005 Procedure no.: INS/GCP/3/V ANNEX V TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: PHASE I UNITS GCP
More informationHAEMOVIGILANCE POLICY
REASON FOR ISSUE: New document describing Haemovigilance System 1. INTRODUCTION NZBS has adopted the Council of Europe definition that states that haemovigilance is: The organised surveillance procedures
More informationAN OVERVIEW OF THE NEWLY REVISED GUIDELINES FOR MEDICATION ADMINISTRATION IN KANSAS SCHOOLS, JUNE 2017
AN OVERVIEW OF THE NEWLY REVISED GUIDELINES FOR MEDICATION ADMINISTRATION IN KANSAS SCHOOLS, JUNE 2017 A COLLABORATIVE EFFORT OF LICENSED PROFESSIONAL REGISTERED NURSES FROM SCHOOL DISTRICTS AND PUBLIC
More informationImplementing Changes in Pharmacovigilance Regulations. Presented by Dr Ennis H Lee, Senior Partner, TranScrip 14 June 2016
s Presented by Dr Ennis H Lee, Senior Partner, TranScrip 14 June 2016 Monitor for changes in regulations Regulatory Authority websites Pharmaceutical industry bodies Pharmaceutical press Use global subsidiaries
More information