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Committees

Revised: 27 March 2016

Medicines Adverse Reactions Committee - Committee Process

Composition and membership

The Medicines Adverse Reactions Committee (MARC) comprises up to 13 members who are appointed for a term of three years (renewable for a further three years).

The Chair and other members of the Committee are drawn from experts in various fields of clinical medicine, pharmacy, nursing, pharmacovigilance, epidemiology and biostatistics.

The MARC also holds a position for a layperson (non-healthcare professional) to represent consumer interests.

Members have an expert knowledge of medicines or consumer interests, and an interest in adverse reactions to medicines and medicines regulation.

The composition of the MARC is as follows:

Medsafe may obtain further expert advice from other specialists where such expertise is not available within the Committee.

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Current members

Chair

Associate Professor David Reith (MB BS, MMedSc, PhD, DCH, DipRACOG, FRACP)
Associate Professor Reith is Chair of the MARC and is Head of the Section of Paediatrics and Child Health at the University of Otago. Associate Professor Reith’s clinical and research experience includes drug metabolism, pharmacokinetics, clinical trials, and the epidemiology of poisoning. Associate Professor Reith provides expertise in the field of paediatrics and clinical pharmacology.

Members

Dr Linda Bryant (MClinPharm, PGDipHospPharmAdmin (SHPA), PhD, PGCert (Prescribing), FNZHPA, FNZCP, FPSNZ, MCAPA, NZRegPharm)
Dr Bryant is a Clinical Advisory and Prescribing Pharmacist for Well Health Trust Primary Health Organisation, working at Newtown Union Health Service. She is also a Senior Lecturer for Postgraduate Clinical Pharmacy at the University of Otago. Dr Bryant has a hospital pharmacy background and has worked with primary health organisations for the last 20 years as a pharmacist facilitator/clinical advisory pharmacist. Her research interests include the optimisation of prescribing to reduce drug related morbidity and mortality and she has recently completed a postgraduate certificate in pharmacist prescribing. Dr Bryant provides expertise in the field of clinical pharmacy (primary care).

Dr Nyree Cole (MB BS, MRCP, FRCPath)
Dr Cole is a paediatric haematologist at Starship Children's Health. Her clinical practice covers all aspects of malignant and non-malignant haematology as well as stem cell transplantation. She mentors and supervises haematologists in training and has research interests in children's oncology. Dr Cole is also a member of the Pharmacology and Therapeutics Advisory Committee's Haematology Subcommittee at PHARMAC and the Joint Specialist Advisory Committee in Haematology at the Royal Australian College of Physicians. Dr Cole provides expertise in the field of paediatric haematology.

Dr Kyle Eggleton (BHB, MBChB, DipObstMedGyn, DipPaeds, DIH, PGDipPH, MMedSci, FRNZCGP)
Dr Eggleton is a Kaupapa Maori Medical Officer at Ki A Ora Ngātiwai in Northland. He is also a Senior Lecturer at the Department of General Practice and Primary Health Care of the University of Auckland. Dr Eggleton has worked as a general practitioner in Whangarei, Ruakaka and Rawene and was Clinical Director of Primary Healthcare in Northland. Dr Eggleton provides expertise in the field of rural general practice

Professor Chris Frampton (BSc, PhD)
Professor Frampton is a biostatistician at the Department of Psychological Medicine and Department of Medicine of the University of Otago. He is involved in departmental teaching and the design and analysis of research studies. Professor Frampton has particular research interests in the modelling and prediction of long-term outcome data and developing structural equation models for defining personality constructs. Professor Frampton provides expertise in the field of biostatistics.

Dr Sisira Jayathissa (MBBS, MD, MMedSc (Clin Epi), FRCP (Lon, Edin), FRACP, FAFPHM, FNZCPHM, MBS, Dip OHP (Otago), Dip HSM (Massey), MBS (Health administration))
Dr Jayathissa is Clinical Director of Medicine and Community Health at the Hutt Valley District Health Board and Clinical Senior Lecturer in medicine at the University of Otago. He has a strong interest in population health including the quality, safety and better use of medicines. Dr Jayathissa has been a member of PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) for 11 years and is currently the Chair of PTAC. His research interests include health service research focussing on quality and safety, safe use of medicines and medicine utilisation. Dr Jayathissa provides expertise in the fields of geriatrics, internal medicine and clinical epidemiology.

Dr Peter Jones (MBChB, BMed Sci, PhD, FRCP, FRACP, DipAcadPrac)
Dr Jones is Clinical Chief Advisor at the Ministry of Health and an Honorary Associate Professor of Medicine at the University of Auckland. Dr Jones is a rheumatologist with over 20 years of experience and is still currently practising. Dr Jones also has extensive experience of new drug development in clinical studies of pain, inflammation and rheumatic diseases. He was a member of PHARMAC’s Pharmacology and Therapeutics Advisory Committee from 2003 to 2010. Dr Jones provides expertise in the fields of rheumatology and clinical academia.

Associate Professor David Menkes (MD, PhD, FRANZCP)
Associate Professor Menkes is an academic psychiatrist at the University of Auckland's Waikato Clinical Campus. He is a member of the Pharmacology and Therapeutics Advisory Committee’s Mental Health Subcommittee at PHARMAC and is active in the International Society of Drug Bulletins (ISDB). Associate Professor Menkes provides expertise in the fields of psychiatry and pharmacology.

Mrs Isabel Raiman (MSc (Clinical Studies), BSc (Hons) Professional Practice (Nursing))
Mrs Raiman is a nurse practitioner in diabetes and related conditions and is currently Team Leader of the Diabetes Service in the Bay of Plenty District Health Board. She is also an Honorary Lecturer at the University of Auckland. Prior to this Mrs Raiman worked as a diabetes specialist nurse in a number of hospitals in the United Kingdom and has also worked as a rheumatology nurse consultant. Mrs Raiman provides expertise in the field of nursing.

Mrs Catherine Ryan (LLB)
Mrs Ryan has extensive experience in law relating to health, research ethics and clinical ethics. She is a member of the Health Research Council Ethics Committee and a member of the Ethical Issues Review Committee at the Counties Manukau District Health Board. She has also been a member of the Auckland Medico-Legal Society in the past. Mrs Ryan provides expertise in consumer issues.

Ms Jo Tatler (MSc (ClinPharm), BPharm (Hons))
Ms Tatler is Intensive Care Unit Clinical Pharmacist at the Taranaki District Health Board. Prior to this she worked as a clinical pharmacist at a number of hospitals throughout New Zealand and the United Kingdom. Ms Tatler was also an Associate Editor for the New Zealand Formulary and has past experience as a clinical facilitator for a PHO and as a community pharmacist. Ms Tatler provides expertise in the field of hospital clinical pharmacy.

Dr Michael Tatley (MBChB, BBusSci(Hon), FFCH(SA), FAFPHM, FNZCPHM)
Dr Tatley is Director of the New Zealand Pharmacovigilance Centre (NZPhvC) at the University of Otago. The NZPhvC provides pharmacovigilance services on contract to Medsafe. His experience is in the area of drug safety surveillance and the evaluation of adverse events attributed to medicines. He has a particular interest in vaccine adverse events and vaccinology.

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Meetings

The Medicines Adverse Reactions Committee (MARC) meets in Wellington four times per year (normally on the second Thursday of March, June, September, and December). Meetings usually commence at 9:00 am and finish by 5:00 pm. However, these times are flexible depending on the length of the agenda. The meetings are held in Wellington with lunch and morning/afternoon tea provided.

An agenda and accompanying meeting dossier is sent to members at least one week before each meeting to allow members time to prepare for the meeting. However, information on urgent medicine safety issues may be emailed to members up to two days prior to the meeting.

On rare occasions, an ad hoc meeting or teleconference may be convened to consider an urgent medicine safety issue.

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Responsibilities of the MARC

The Medicines Adverse Reactions Committee (MARC) provides expert advice on medical and scientific evaluations of medicines safety issues, referred to the Committee by Medsafe. Based on these evaluations, the MARC may recommend strategies to improve the risk-benefit profiles of medicines.

MARC members are expected to carefully read the information provided before the meeting, giving consideration to the clinical significance of each item and options for action. At the meeting, MARC members are expected to provide Medsafe with their expert opinion on the issues discussed. Members then recommend what, if any, further action should be taken by Medsafe.

Following each meeting, MARC members review the minutes to confirm that they accurately reflect the discussion and recommendations made during the meeting.

Any media or other queries directed to MARC members are usually referred to the Chair or Medsafe.

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Role of Medsafe in relation to MARC

The Secretariat for the Medicines Adverse Reactions Committee (MARC) is provided by Medsafe.

The Secretariat prepares the agenda and dossier for each meeting, which includes writing reports and risk-benefit reviews.

After each meeting, the Secretariat prepares the minutes and implements the recommendations of the Committee in a timely manner. Where necessary, the Secretariat seeks approval from the Minister of Health, Director-General of Health, or relevant delegates with regard to the recommendations of the Committee.

The Secretariat also ensures that members are reimbursed for their time and travel.

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Travel, expenses and fees

Committee members usually make their own travel arrangements through the Ministry's approved travel agents, paid for by the Ministry of Health.

In addition, members are entitled to meeting preparation and attendance fees and may be entitled to claim for other expenses incurred.

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Conflicts of interest

A conflict of interest arises when a Committee member is involved in matters that could potentially affect their ability to be (or be perceived as being) neutral or impartial.

Committee members, or prospective members, must disclose whether they have any financial, professional, or personal interests that might create a conflict of interest. These may include:

In appointing Committee members with knowledge and expertise in specialised areas, the potential for conflicts of interest may be unavoidable. It would be impractical to exclude members from offering advice where they simply have an interest per se. However, to protect the decision-making integrity of the bodies concerned (and public confidence in them), systems are in place to ensure potential conflicts of interest are identified and managed.

Members are required to complete a conflict of interest declaration form before each meeting to disclose any conflicts arising at that particular meeting. It is the Chair's responsibility to decide whether a member's interest constitutes a material (significant) direct or indirect interest, and, if so, how this conflict should be managed.

Conflicts relevant to any agenda item are included in the minutes of each meeting.

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