Revised: 2 October 2019

Committees

Medicines Adverse Reactions Committee - Committee Process

Composition and membership
Current members
Meetings
Responsibilities of the MARC
Role of Medsafe in relation to MARC
Travel, expenses and fees
Conflicts of interest

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:

  • an epidemiologist
  • two general practitioners (one in urban practice, one in rural practice)
  • a clinical pharmacologist
  • two clinical pharmacists (one hospital based, one community based)
  • four specialist clinicians (eg, from fields such as psychiatry, paediatrics, cardiology etc)
  • a nurse
  • a layperson
  • the Director of the New Zealand Pharmacovigilance Centre

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 Christina (Chris) Cameron (MClinPharm, FRACP)
Dr Cameron is a Consultant in General Medicine at Capital and Coast DHB, Consultant in Clinical Pharmacology at Capital and Coast DHB, Senior Lecturer in clinical pharmacology at the Wellington School of Medicine, University of Otago, Chair of the Medicines Review Committee at Capital and Coast DHB, committee member of the Named Patient Prescribing Authority, PHARMAC, committee member of RUPAG and Schedule Rules, PHARMAC, and Secretary for the Australasian Society for Clinical and Experimental Pharmacologists and Toxicologists.  Dr Cameron provides expertise in the fields of general medicine and clinical pharmacology.

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.

Dr Chip Gresham BA(Psy), BSci(Chem), MD, FACEM
Dr Chip Gresham is a consultant emergency medicine physician and medical toxicologist at Middlemore Hospital (MMH) and is the Clinical Director of Medication Safety at MMH/Counties Manukau DHB. He is a consultant medical toxicologist at the National Poisons Centre and has done research in both antivenoms and antidotes and authors several emergency medicine/toxicology textbook chapters. He is an honorary senior lecturer at The University of Auckland. Dr Gresham provides expertise in the fields of emergency medicine and medical toxicology.

Dr Sean Hanna (MBChB, PGDipGP(Dist), PGDipClinEd(Dist), FRNZCGP, FRACGP)                  
Dr Hanna is currently a General Practitioner and primary health organisation (PHO) clinical lead at high needs urban iwi provider, Ora Toa PHO in Porirua, General Practitioner at Evolve Youth One Stop Shop (Wellington), Lead Medical Educator (GPEP1 Wellington)  and GPEP1 Teacher Royal New Zealand College of General Practitioners (RNZCGP), Wellington Medical School Clinical Education Advisor, University of Otago Rural Medical Immersion Programme Clinical Education Advisor. Dr Hanna is currently a member of PHARMAC’s Pharmacology & Therapeutics Advisory Committee (PTAC), Chair of PTAC’s Diabetes, Anti-infective, Immunisation and Mental Health subcommittees, member of MoH Technical Advisory Group Immunisation and member of the Professional Conduct Committee (Medical Council of New Zealand). Dr Hanna provides expertise in urban general practice.

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.

Associate Professor Lianne Parkin (MB ChB, DipObst, DPH, PhD, FAFPHM)     Associate Professor Parkin is an academic public health physician and epidemiologist at the University of Otago. Her research interests include the use of routinely collected electronic health and pharmaceutical dispensing data to study the utilisation and safety of medicines and medical devices, and she is the Lead Investigator of the Pharmacoepidemiology Research Network Core Academic Group. Associate Professor Parkin provides expertise in the field of epidemiology.

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.

Professor Lisa Stamp (MB ChB, PhD, DipMus, FRACP, MACR, MNZRA)
Professor Stamp is a consultant rheumatologist at Christchurch Hospital and an academic rheumatologist at the University of Otago. She is also the Director of the Canterbury Rheumatology and Immunology Research Group and the President of the New Zealand Rheumatology Association. Additionally, Professor Stamp provides a rural clinic in Kaikoura, and is a member of the PHARMAC rheumatology subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC). Her research interests include gout and rheumatoid arthritis, where she has published over 170 papers in these areas. Professor Stamp received the Value of Medicines NZ prize in 2017 for her world leading work in the use of allopurinol. Professor Stamp provides expertise in the field of rheumatology.

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.

Ms Leanne Te Karu Muaūpoko/ Te Āti Haunui-a-Pāpārangi (DipPharm, PGCertHerbalMeds, PGDipClinPharm, MHSc(Hons), PGCert(Prescribing), MMPA, MCAPA, FPSNZ, NZRegPharm)
Ms Te Karu is a Pharmacist Prescriber at Pihanga Health Medical Centre and Papakura Marae Clinic Medical Centre. Ms Te Karu is also the Associate Dean (Māori) at the University of Otago School of Pharmacy, a presenter/contractor to PHARMAC, an advisor to the Health Quality Safety Commission, an honorary lecturer at the University of Auckland School of Pharmacy, and the Director of Tu Kapua Limited. Ms Te Karu is also currently a Doctor of Philosophy candidate at the Department of General Practice, University of Auckland. Ms Te Karu provides expertise in the field of clinical pharmacy (primary care).

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:

  • directorships or other employment
  • interests in business enterprises or professional practices
  • share ownership
  • beneficial interests in trusts
  • existing professional or personal associations with the Crown body concerned
  • professional associations or relationships with other organisations
  • personal associations with other groups or organisations
  • family relationships (including family members with relevant shares/benefits in trusts).

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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