New Zealand Pharmacovigilance Guidance you need to know

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New Zealand Pharmacovigilance Complete Guidance

Q: What is Regulatory Authority for New Zealand?

A: Med safe is the Regulatory Authority for New Zealand

Q: What is Pharmacovigilance legislation for New Zealand?

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Q: What is Medsafe?

A: Medsafe is the regulatory unit of the Ministry of Health that has been delegated authority by the Director-General to receive these reports.

Q: Who is responsible for collecting the post-market reports of suspected adverse reactions to medicines in New Zealand Regulatory Agency?

A: This activity is contracted by the Ministry of Health to the Centre for Adverse Reactions Monitoring (CARM). Medsafe and CARM work together to identify safety concerns from these reports.

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Q: Who will take the actions after evaluation of reports?

A: After evaluation of the information on a safety issue, Medsafe will make a decision on the most appropriate regulatory action to take.

Q: What actions may Med safe take?

  • A: Actions include
    • No action to be taken at the present time.
    • Continued monitoring of the situation.
    • A request for additional information or studies from the sponsor to gain further evidence on the issue
    • An instruction to sponsors to communicate to health care professionals (Ex: a Dear Health Care Professional letter.
    • A change to the product information (data sheet).
    • Suspension of the distribution of the medicine while investigations are ongoing.
    • Advice to the Minister of Health to revoke consent for the medicine to be distributed.

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Q: What is responsibility of medicines sponsor if Regulatory Authority enquires about any safety information?

A: Sponsors will be informed in writing if such a review is to be conducted and will be requested to provide evidence to support the efficacy or safety of their product(s). Sponsors have 60 days to respond before any action may be taken. An extension of this time period may be allowed if sponsors can provide adequate justification.

Q: What is MARC?

A: Medicines Adverse Reactions Committee (MARC) is a technical advisory committee established under section 8 of Medicine Act 1981 to advise the Minister of Health on the safety of approved medicines. The MARC provides expert advice on medicine safety issues referred by Med safe. Based on review of these safety issues, the MARC may make recommendations to manage any risk of harm associated with the medicine and improve the risk-benefit profiles of medicines.

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Q: What is MARC Structure?

A: The Chair and other members of the MARC are experts in various fields of clinical medicine, clinical pharmacology, pharmacy, pharmacovigilance, epidemiology, nursing and other medical specialties such as cardiology, biostatistics, and medicines regulation. The MARC also holds a position for a lay person (non-health care professional) to represent consumer interests.

Q: What is tenure of MARC team?

A: Members are appointed for a three-year term, which may be renewed once for a further three years.

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Q: How frequent MARC team meeting happens?

A: The MARC meets four times a year. Secretarial support is provided by Medsafe. Minutes of the meetings and reports presented to the MARC are also published on the Medsafe website.

Q: What is CARM?

A: The Centre for Adverse Reactions Monitoring (CARM).

Q: What causality assessment criteria been used by CARM for assessment of cases?

A: CARM uses the World Health Organization (WHO) causality assessment criteria for this evaluation.

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Q: Is any party reviews the adverse reactions reported in New Zealand?

A: Yes. CARM provides the MARC with a quarterly review of adverse reactions reported in New Zealand. CARM also collaborates with the WHO International Drug Monitoring Programme based in Uppsala, Sweden.

Q: is it possible that, CARM can be contacted?

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Q: What is Sponsors’ obligations and responsibilities?

A: As per 41 section of Medicines Act 1981, sponsors have a statutory obligation to report any substantial untoward effects of their medicines, including safety concerns, to the Director-General of Health. Sponsors should continuously monitor the safety of their medicines and inform Medsafe of any changes to the safety profile that might have an impact on the balance of benefits and risks of harm.

Q: Is it necessary for MAH to establish a contact person for their reporting system of adverse events?

A: Medsafe strongly recommends that sponsors nominate a contact person for dealing with pharmacovigilance matters and reporting to Medsafe.

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Q: Where the Pharmacovigilance person (contact person) of MAH should be located?

A: This contact person should preferably be located in New Zealand or at least be contactable during normal New Zealand business hours. The pharmacovigilance contact person should have access to the expertise of a medically qualified person when necessary

Q: Is there any excuse on stay of contact person?

A: Yes. If the contact person is located overseas, it is expected that the contact person will keep the New Zealand sponsor informed of pharmacovigilance and quality issues.

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Q: Is it required for MAH to send the details of contact person to Medsafe?

A: Yes. Details of the nominated contact person, including name, role, telephone number and email address should be sent to Medsafe at: medsafeadrquery@health.govt.nz

Q: How to deal with spontaneous reports in New Zealand?

A: All spontaneous reports notified by health care professionals or consumers to the sponsor are considered to be suspected adverse reactions, unless the reporter specifically states that the events are unrelated or that a causal relationship can be excluded

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Q: Do sponsors need to report all spontaneous reports of suspected serious adverse reactions to CARM even if they disagree with the reporter(s) assessment of causality?

A: Sponsors must report all spontaneous reports of suspected serious adverse reactions to CARM even if they disagree with the reporter(s) assessment of causality.

Q: How MAH deal with Non-serious cases?

A: Sponsors are not required to report non-serious adverse reactions. However, sponsors should be able to provide these reports on request from Medsafe and include these in Periodic Benefit Review Evaluation Reports (PBRERs). 

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Q: What should be reported as per New Zealand Guidelines of pharmacovigilance?

  • A: The following must be reported.
    • All reports of serious expected and/or serious unexpected adverse reactions associated with approved medicines.
    • All serious reports of adverse reactions associated with reports from solicited sources

Q: Is there scenarios, MAH should not report the adverse experiences?

  • A: Sponsor must not report
    • cases occurring outside New Zealand unless the sponsor is aware that the medicine was dispensed or purchased in New Zealand
    • clinical trial cases for unapproved medicines
    • blinded clinical trial cases for approved medicines when the identity of the suspected medicine or the patient has not been identified.
    • Non-serious reports.
    • Solicited reports not considered to have a causal relationship.
    • Reports that direct supply of a medicine to a patient has been terminated, or is no longer required by the patient, unless the termination of supply is associated with a serious adverse event.

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Q: How MAH deal with an important medical event in New Zealand?

A: Medsafe recommends that sponsors follow the European guidance document. Inclusion/exclusion criteria for the “Important Medical Events” list

Q: What are spontaneous Adverse reaction report sources?

  • A: A spontaneous report is an unsolicited communication that describes one or more suspected adverse reactions. Spontaneous reports may come from sources such as
    • a health care professional
    • a consumer
    • a medicines regulator
    • an international body
    • a sponsor
    • an organisation (eg, the New Zealand Poisons Centre or a district health board)
    • the judicial system (eg, Coroner, Police, legal processes)

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Q: What are Solicited report sources?

A: Adverse event reports that are actively sought from studies or organised data collection systems are solicited reports. Examples of solicited sources include patient support and disease management programmes and surveys of patients or health care providers.

Q: Is it required to report solicited reports?

A:  Valid reports of serious adverse reactions, where a positive causal association to a suspected medicine has been assessed, should be reported to CARM.

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Q: What are invalid cases and how MAH deal with these?

A: The lack of any of these four minimum criteria invalidates the case and it should not be reported to CARM. However, invalid cases should still be recorded in the sponsor’s pharmacovigilance system for use in product safety evaluation activities.

Q: How MAH deal with follow –up of cases?

A: The information in suspected adverse reaction reports may be incomplete on first receipt. Incomplete reports should be followed up as necessary. Follow-up of incomplete reports is particularly important for prospective reports of exposure during pregnancy, death or new safety concerns.

If incomplete information is received directly from a consumer, sponsors should make attempts to contact the consumer directly or obtain consent to contact a nominated health care professional for further information.

If permission is denied, it is recommended that this is recorded in the sponsor’s own pharmacovigilance database. It can also be recorded in the report, but it is not mandatory to do so.

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Q: Can MAH downgrade the case seriousness while reporting?

A: A valid case reported by a primary source should not be downgraded to a non-serious adverse event if a secondary source involved in the care of the primary source disagrees with the primary source’s suspicion. The opinions of both the primary source, and the secondary source (or source of follow-up information) should be recorded in the adverse reaction report.

Q: Can MAH disagree with the causality statement of consumer in a report?

A: Where the sponsor disagrees with the reasonable possibility of a causal relationship between the suspected medicine and the adverse reaction reported by a consumer, the ICSR must still be reported. The opinions of both the consumer and the sponsor should be recorded in the adverse reaction report, including the criteria on which the sponsor has made their assessment.

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Q: What is AEFI?

A: Adverse Event Following Immunisation (AEFI).

Q: Is it required to assess the causality of any adverse event occurred with immunization?

A: No. It is not necessary to assess the causality in this case. The WHO defines an Adverse Event Following Immunisation (AEFI) as any untoward medical occurrence which follows immunisation and which does not necessarily have a causal relationship with the usage of the vaccine.

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Q: AEFI must be treated as serious?

A: Yes. AEFIs judged to be serious should be reported to CARM within the standard timeframe for reporting serious adverse reactions to medicines.

Q: Misuse and abuse cases need to be reported as ICSRs?

A: If serious adverse reactions are associated with valid ICSRs of misuse or abuse, they should be forwarded to CARM.

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Q: If misuse and abuse scenarios not associated with Serious adverse reactions. Then also MAH need to report as ICSRs?

A: No. Not required. Reports of intentional misuse or abuse where no suspected adverse reactions are associated do not need to be forwarded to either CARM or Medsafe. Sponsors should routinely follow up on these reports and include them in their ongoing review and analysis (PBRER).

Q: Is MAH need to report Off-label use reports as ICSRs?

A: Off-label use itself does not have to be reported to CARM but reports of off-label use associated with a suspected reportable adverse reaction(s) should be forwarded to CARM.

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Q: What are Cannabis products?

A: Medicinal cannabis products are medicines that consist of dried cannabis or are products that contain ingredients that are extracted from the cannabis plant.

Q: Is pharmacovigilance to be in place for MAH who are dealing with medicinal cannabis products?

A: Yes. It is mandatory to place Pharmacovigilance system.

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Q: Is it required to submit the suspected adverse reactions to medicinal cannabis products?

A: Yes. All reports of suspected adverse reactions to medicinal cannabis products should be reported to CARM within 15 calendar days.

Q: How MAH deal with post-Authorization studies?

A: Sponsors should report to CARM within 15 calendar days all valid ICSRs of serious adverse reactions which are suspected by the principal investigator to be related to an approved medicine used in studies for which they are responsible for sponsoring.

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Q: How MAH need to deal with Special scenarios such as Medication error, Overdose and Occupational exposure?

A: Sponsors receiving reports of medication error associated with a suspected serious adverse reaction should forward these to CARM provided they are valid unsolicited reports.

Reports of overdose or occupational exposure with associated adverse outcomes should be reported to CARM provided they are valid serious reports. Reports not associated adverse outcome should not be reported as adverse reactions to CARM. Those should be considered in PBRERs

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Q: Is it mandatory for MAH to submit the reports of their products after suspension or removal from the market?

A: All valid serious ICSRs identified by the sponsor after suspension, revocation or withdrawal of a medicine should be reported to CARM. Sponsors should continue to report valid ICSRs for a period up to the date of expiry of the last batch that was distributed before the distribution ceased.

Q: How MAH need to deal with Media reports?

A: Reports of suspected adverse reactions originating from a non-medical source, such as the lay media, should be considered to be a spontaneous report.

Sponsors should regularly screen internet or digital media under their management or responsibility, for potential reports of suspected adverse reactions. This includes digital media that is owned, paid for and/or controlled by the sponsor. Sponsors may also consider utilising their websites to facilitate the collection of reports of suspected adverse reactions.

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Q:  How MAH deal with scientific and medical literature?

A: Sponsors should frequently review the scientific and medical literature and assess reports of suspected adverse reactions occurring in New Zealand.

It is recommended that reviews should be conducted not less than every three months. Reviews should only commence from the time that the medicine is placed on the market and not from the time of submission of the new medicine application, or from the grant of consent to distribute a new medicine.

Sponsors should only report to CARM cases occurring in New Zealand for a medicine they distribute. If the brand of medicine is not known, sponsors should only report if their medicine was in use in New Zealand at the time of the publication. This helps to reduce duplicate reporting.

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Q: How MAH need to deal with quality defect or falsified medicine?

A: When such a report is received by the sponsor, it must be reported directly to Medsafe as soon as possible. This is generally within 72 hours of receipt of the information by the sponsor. These should not be reported to CARM. Medsafe’s preference is for reporting by email, with as much information provided as possible.

Q: How to report to CARM ?

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Q: How to report to MedSafe?

  • A: Medsafe’s preference is for reporting by email, with as much information provided as possible

Q: Where the reports received by CARM archived at agency?

A: Sponsors can access information on suspected adverse reaction reports in New Zealand through the Suspected Medicine Adverse Reaction Search (SMARS) database on Medsafe’s website. SMARS contains anonymised information from reports of suspected adverse reactions to medicines that were reported to CARM. SMARS includes reports received from sponsors and considered by CARM to be causally related to the medicine.

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Q: What is SMARS?

A: SMARS is Suspected Medicine Adverse Reaction Search. Sponsors can access information on suspected adverse reaction reports in New Zealand through this database. The SMARS database is updated once a month.

SMARS includes reports received from sponsors and considered by CARM to be causally related to the medicine.

  • SMARS does not include
    • any report where it is considered that the patient may be identifiable (eg, due to the rareness of the reaction)
    • reports from the last three months.

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Q: Is it required for MAH to report the cases which were identified from CARM?

A: Case reports identified using SMARS should not be re-reported to CARM. However, if upon further analysis of these reports the sponsor identifies a significant safety issue, this should be communicated to Medsafe.

Q:  What is signal management guidance followed in New Zealand?

A: Medsafe recommends that sponsors follow the guidance in the European Medicines Agency document (Module IX of GVP guidelines).

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Q: What are steps involved in Signal Management process?

A: Signal Management process includes

  1. signal detection
  2. validation and confirmation
  3. analysis and prioritisation,
  4. signal assessment
  5. recommending action
  6. Communication and reviewing the result of any action taken.

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Q: How Med safe communicates the potential signals about the products?

A: Medsafe has a system to ensure that concerns with particular medicines are able to be communicated to users and prescribers shortly after they have been identified. Safety concerns for which Medsafe is actively seeking further reports display this symbol M

Q: What is Timeframe for reporting significant safety issues?

A: Sponsors must report any identified significant safety issue to Medsafe as soon as possible. This is generally within 72 hours of awareness of the issue by the sponsor. Significant safety issues should be reported to Medsafe by email. medsafeadrquery@health.govt.nz

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Q: What guidelines to be followed for Aggregate reports in New Zealand?

A: Medsafe recommends that sponsors follow the guidance in relation to PBRERs found in the ICH guideline E2C (R2)

Q: How MAH deal with submission of PBRERs?

A: PBRERs are required to be routinely submitted for the following types of scenarios:

  1. vaccines that are included in the routine National Immunisation Schedule
  2. biological medicines (excluding vaccines)
  3. biosimilars
  4. medicines where a specific requirement for the submission of PBRERs has been imposed as a condition of approval.

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Q: What time frame of PBRER to be followed in New Zealand?

A: PBRERs should be submitted in line with the European Union reporting timetable.

Q: In what scenarios, PBRER is not necessary?

A: Medsafe will advise sponsors when routine submission is no longer necessary. Retrospective submission of PBRERS is not required.  For vaccines that are funded only for a small group of patients and are not on the routine National Immunisation Schedule, there is no need to submit PBRERs routinely.

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Q: What Risk Management plan rules to be followed for MAH of New Zealand?

A: European format described in the guideline to be followed. It is acceptable for sponsors to submit RMPs outside of these circumstances for all their medicines if they wish to do so.

Q: How to submit PBRER or RMP?

A: PBRERs or RMPs should be emailed to Medsafe

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Q: What are dear doctor letters?

A: Information that impacts a change in the severity or incidence of adverse reactions in the general population or a specific section of the population may necessitate a letter to health care professionals and relevant organisations in order to advise them of the overall impact on safety.

Dear Health Care Professional (DHCP) letters should follow the template provided in the EMA’s Safety Communication guideline.

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