Published: 2 September 2015
Consultations
Outcome of consultation on the proposed New Zealand Medicines and Medical Devices Recall Code
About the consultation
In December 2014 Medsafe published a proposed recall code for medicines and medical devices (the Code) and sought feedback on the proposed Code by 27 February 2015. Medsafe would like to thank those who took the time to prepare a submission and provide helpful comments and suggestions.
Submissions received
Medsafe received 43 submissions in response to the consultation. Overall, the submissions largely supported the Code.
Question 1 asked submitters if they supported the adoption of the proposed Recall code.
Four submitters did not include a response to Question 1.
Eighteen submitters were in favour of adopting the Code.
Eleven submitters would be in favour of adopting the Code if it was changed to include:
- responsibilities of retailers who are not health professionals
- recalls involving controlled drugs
- mandatory adoption of IT systems to support non-manual recall processes
- changing the terminology relating to medical device recalls
- appropriate requirements relating to processes for General Practitioners and for replacement scripts
- the adoption of particular companies' established recalls procedures or codes.
These submitters also either proposed including requirements for compensation of affected parties or proposed restricting compensation to current obligations.
Ten submitters were not in favour of adopting the Code. Reasons provided for not adopting the Code were that it:
- had no provisions for the recompense of pharmacists or GPs for their time and effort in aiding a recall
- used terminology for medical devices that was considered not to be consistent with the European Union or with international usage, or
- was inconsistent, too rigid and slow to be enforced and the recall action process appeared to be an exercise in box-ticking.
Question 2 asked submitters whether they preferred the information in Appendix 6 (Guidance on legal issues) to be incorporated within the Code or be separately published.
Eleven submitters did not include a response to Question 2.
Twenty-two submitters replied that they were in favour of including Appendix 6 in the Code. The reason provided was that it made sense to have all the information in one place.
Seven submitters replied that they were in favour of publishing Appendix 6 separately, stating that this would make updating the information easier without affecting the rest of the Code, and could be extended to cover frequently asked questions (FAQs).
Three submitters suggested including Appendix 6 in the Code and also publishing it on the Medsafe website.
Medsafe will both include Appendix 6 in the Code, and publish it as a separate document on Medsafe’s website.
Consultation feedback
All submissions have been reviewed by Medsafe. The majority of submitters were in favour of adopting the Code. About a quarter of the submitters made comments in relation to compensation, which is outside the scope of this Code. One of the submitters voicing opposition to the Code unless it included compensation for pharmacists also commented that the submitter would support the Code from the perspective of healthcare professional ethical obligations.
Several submitters suggested wording, format and layout changes for improved clarity and noted minor errors for correction. Where appropriate, these have been incorporated into the final document.
The submitters raised the following issues for consideration by Medsafe and amendments have been made to the text of the Code where these were considered to be appropriate.
Use of ‘should’ and ‘must’
One submitter suggested using the Government Rules of Sourcing to clarify how the terms ‘should’ and ‘must’ are used to mean good practice or mandatory compliance.
Response
Medsafe considers that there is merit in this suggestion but believes that in view of its potential to affect established policies, practices and guidelines, it should first be reviewed for applicability at organisation-wide level.
Product withdrawal
One submitter mentioned that there is no provision in the Code for product withdrawal.
Response
Voluntary product withdrawal is not a recall action, and therefore does not fall within the ambit of the Code.
Terminology
Several submitters mentioned that the term “Recall for Product Correction” was misleading when in many cases product was not physically recalled. Submitters also referred to problems with the terminology used to describe recall actions, in particular that the use of Australian terminology for medical device recalls was inconsistent with international usage.
Response
The comments have been noted. Medsafe plans to review terminology at a later date and stakeholders will be invited to contribute when this work commences. This will provide opportunity to also consider alignment with other regulators.
Risk of switching products in a recall situation
A few submitters highlighted the need for more education about the fact that there is always risk in a recall situation when patients are switched between medicines or devices, balanced against the risk of continuing to use defective product when no alternative is available, and the risk when there is no product at all and patients may have to be managed in some other way.
Response
The effect of all recall actions is considered on a case-by-case basis and Medsafe will ensure the appropriate advice is provided if this situation arises. The letter format in Appendix 2A provides for this advice to be included.
Risk classification, classes of recalls, classes of medical devices, levels of recall actions
Several submitters pointed out that the classes of recalls could be confused with the classes of medical devices in WAND.
Response
This has been addressed in the amended Code.
Response time for recall action
One submitter requested inclusion of the Recall Action Classification on letters so that there is some understanding of the urgency of the action.
Response
All recalls should be actioned promptly, and therefore there should be no need for a Recall Action Classification to be included on Recall letters. Consequently, the letter formats in Appendices 2A and 2B have been revised to remove these headings. However, Medsafe plans to review terminology at a future date and this issue will be revisited at that time. Stakeholders will be invited to contribute when this work commences.
Requirement to consult before a recall
One submitter proposed a requirement to consult with professional bodies for pharmacy and medicine before a recall notice is issued to consumers.
Response
Medsafe will make a judgement on a case-by-case basis on whether a particular professional body should be consulted prior to the issuing of a recall action letter.
Diagram – Overview of the Recall Process
Several submitters suggested amendments to the diagram in order to provide greater accuracy and clarity.
Response
Medsafe considered that some suggestions had merit and has made appropriate changes to the diagram.
Responsibilities of sponsors
One submitter suggested that it is the manufacturer and not the sponsor who collects global reports of field event reports, monitors incident rates etc, to determine if and when action is required. Another submitter suggested that where a sponsor does not hold or own stock, recall procedures cannot be audited.
Response
Where the manufacturer is not located in New Zealand, it is the sponsor as the manufacturer’s representative in New Zealand, that must bear these responsibilities for reporting incidents or any issues to Medsafe and to the manufacturer. All sponsors must have appropriate recall procedures in place regardless of whether they hold or own the stock.
Responsibilities of Medsafe
A few submitters commented that one of Medsafe’s responsibilities should include requiring records to be retained for a period of time similar to that required for stakeholders.
Response
Medsafe is a business unit of the Ministry of Health and complies with the Public Records Act 2005 for record keeping purposes.
Recall action records
One submitter mentioned that it was unclear whether recall action records must be held in New Zealand.
Response
Medsafe considers that the sponsor should have ready access to all information including records for products it distributes.
Contact lists
Several submitters proposed that Medsafe maintain a list of contacts that must be used by sponsors for all recalls.
Response
It is the responsibility of sponsors to know how and to whom their products have been distributed, and to have access to current lists of contacts. Sponsors may themselves be able to accurately identify all recipients of products or may choose to use a commercial organisation to distribute the recall letter/s on their behalf. Care should be taken to ensure that if a commercial organisation is used, confirmation is received that their contacts list is complete and holds current contact details for intended recipients.
Retrieval of the affected product
Two submitters commented that the wording of the draft Code could lead to ambiguity in relation to retrieving affected product without the knowledge of management, or recognition of visitor or stock management policies at the organisations (such as District Health Boards) that had been supplied with the product.
Response
Sponsors should work in consultation with their customers to ensure appropriate procedures are followed for the timely return of the affected stock
Retrieval of controlled drugs
One submitter asked what the provisions were in the new Code for a recall of a controlled drug.
Response
The only controlled drugs that would be recalled under the Code would be controlled drugs that were medicines. These would be handled in the same way as other medicines, except that retrieval should be conducted in accordance with the Misuse of Drugs legislation.
Requirement of a new prescription to authorise replacement medicine
One submitter commented that it may be difficult to re-contact a District Health Board (DHB) prescriber to re-authorise a previously generated DHB prescription.
Response
The normal processes in place to follow up issues about a prescribed medicine with a prescriber should be followed.
Use of IT, workflow systems and identifiers
A few submitters proposed the use of software systems such as those provided by GS1 New Zealand or Toniq & Lots, or the use of identifiers such as the Global Trade Item Number (GTIN) or the New Zealand Business Number (NZBN).
Response
Medsafe is unable to endorse or recommend the use of any specific systems. Medsafe is of the view that companies are free to use any technology and systems that will facilitate their ability to handle recalls provided that these are capable of distributing the agreed communications to all intended recipients.
Use of fax and social media
A few submitters commented on the continued use of fax technology and suggested the use of social media to communicate recalls. One submitter proposed that recalls should be published on the OECD GlobalRecalls Portal.
Response
Community pharmacists continue to advise Medsafe that using fax technology is the surest method of ensuring that they are informed of recalls whereas emails may be held up in electronic mailboxes, and this is reflected in the proposed Code. Medsafe includes information about recalls on the Medsafe Online Recalls Database (MORD) which is on Medsafe’s website. The Ministry of Business, Innovation and Employment (MBIE) is developing a national web portal for all consumer level recalls across New Zealand. Medsafe is working with MBIE to ensure that consumer-level recalls of medicines and medical devices are also included in MBIE’s portal. As this work is in development Medsafe is not currently considering forwarding recalls information to the OECD GlobalRecalls Portal.
Provision of Standard Operating Procedure (SOP) for pharmacies to use in the event of recalls
One submitter proposed their SOP for use by pharmacies.
Response
SOPs for use in recalls at pharmacy level form part of the licensing requirements for pharmacies.
Continued supply, sole supply and critical medicines, product replacements
One submitter asked whether the Ministry had policies to ensure that there are at least two different batches of critical and sole supply medicines at all times to reduce impact in the event of a recall and what would happen where a recall affects a medicine for which there is no therapeutic equivalent substitute. Another submitter mentioned that it is important to know if replacement stock is available from pharmacies’ normal source of supply.
Response
The availability and funding of medicines is primarily PHARMAC’s responsibility. If a recall situation occurs that may result in a disruption-of-supply issue, Medsafe works with PHARMAC and suppliers to ensure the best outcome for consumers.
Implementation
The New Zealand Medicines and Medical Devices Recall Code will be effective from 1 December 2015.
Enquiries
Any questions relating to this consultation should be directed via email to: recalls@health.govt.nz
