Published: 1 July 2013
1 July 2013
To: Product Sponsors and Healthcare Practitioners
This letter is to advise you of the outcome of the consultation on the proposal to accept bottle presentations of selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs).
As a result of the submissions received, Medsafe has decided to undertake a wider consultation to determine the appropriate packaging for medicines that pose a risk to children if accidentally ingested. Until the outcome of this further consultation has been released there will be no change to the existing requirement that SSRIs and SNRIs are presented in blister strips.
Regulation 37 of the Medicines Regulations 1984 requires tetracyclic, tricyclic and analogous antidepressants to be packaged in safety containers. Safety containers are defined under New Zealand legislation as blister packs. The intent of the legislation is to protect children from accidental ingestion of toxic substances.
Medsafe's interpretation of Regulation 37 has required all antidepressants to be packaged in blister containers, excepting a few medicines for exceptional reasons.
Recently Medsafe was requested by stakeholders to reconsider its position given that modern SSRI and SNRI antidepressants have lower toxicity than tricyclic or tetracyclic compounds. Furthermore, Medsafe was also asked to provide a list of medicines which were traditionally packaged in blisters and for which a bottle presentation would be accepted.
The specific toxicity posed by all medicines, and antidepressants in particular, and the risk of harm to small children is difficult to determine as the relativity of any toxicological studies cannot be quantified. However, as with all medicines, there is a significant risk of harm through accidental overdose and the consequences are most severe for children.
Determining which specific medicines should be in safety containers due to the risk posed to children cannot be undertaken without significant resources. Therefore Medsafe proposed, as part of its consultation, to use an Australian standard (TGO80) as an indication of which medicines need to be in safety containers.
TGO80 requires SSRIs and SNRIs to be in safety containers, but Australian legislation defines safety containers as both non-reclosable (i.e. blister strips) and reclosable (i.e. bottles with lids). To protect children from harm, TGO80 requires that bottles are fitted with a child-resistant closure (CRC) that conforms to an acceptable standard.
Medsafe proposed that adoption of TGO80 would allow consumers and healthcare practitioners the convenience and cost-effectiveness of a bottle while still mitigating the risk of accidental ingestion by children. It would also enable Medsafe to determine which medicines should be in safety containers due to toxicity rather than relying on previously approved presentations.
During its review Medsafe noted that TGO80 also included several other medicines which are not currently supplied to the New Zealand market in safety containers. Australia and New Zealand are moving towards a harmonised medicines market with the proposed establishment of a joint therapeutics agency (ANZTPA) in 2016. It was proposed that harmonisation would be supported by Medsafe adopting TGO80 as best practice for all medicines.
A total of six submissions were received by the deadline of Thursday 28 February 2013. The submitters were New Zealand Self Medication Industry, Medicines New Zealand, Pharmaceutical Society of New Zealand, Health, Quality & Safety Commission New Zealand, a medicines sponsor and a pharmacist.
2 submitters opposed the planned changes,
1 submitter supported the proposed changes,
2 submitters were concerned about adopting TGO80, and
1 submitter requested a wider consultation.
Each theme (in bold) is followed by the comments from submitters that fall within that theme.
TGO80 was developed for the Australian market only:
Several submitters commented that TGO80 was developed specifically for the Australian market and is not applicable to New Zealand. This is because New Zealand is essentially a bulk-pack market for pharmacists to dispense into prescribed quantities.
Adopting TGO80 either means that pharmacists would need to assume responsibility for the safety packaging of medicines or New Zealand would need to move to direct-to-consumer packaging. Currently very few medicines are supplied in child-resistant, direct-to-consumer packaging.
Introduction of bottles with CRC lids is supported for anti-depressants only:
Sponsors of medicines supported the introduction of reclosable safety containers for newer and less toxic non-tricyclic and non-tetracyclic antidepressants such as SSRIs and SNRIs. They commented that the proposal offered advantages such as harmonised labelling with Australia, providing pharmacists with bottle packaging (which are easier for dispensing in medico packs) and providing flexibility for sponsors through a choice of packaging options.
Significant impact on sponsors:
Sponsors also raised concerns about the impact on companies. They commented that there would be a significant cost in reviewing all current products against the guidance and changing to a CRC.
Significant impact on pharmacists:
Pharmacists were concerned about the impact on pharmacists and dispensary technicians. They strongly opposed the proposal as it would mean pharmacists assumed responsibility for mitigating unintentional overdose because manufacturers no longer wish to package SSRIs or SNRIs in non-reclosable safety containers.
Dispensing from bulk packs into safety containers for individual patients imposes additional costs on pharmacists. It was widely felt that the costs for complying with safety practices should be borne by the manufacturers.
One submitter commented that even though SSRIs and SNRIs are considered clinically "safer" in overdose when compared to the likes of tricyclic or tetracyclic antidepressants, these newer classes still carry a risk of toxicity especially to children, when ingested in excessive amounts or when overdosed.
Submitters also commented that the effectiveness of reclosable safety containers has not been quantified. There are anecdotal reports of patients changing the lid to one that is easier to open or leaving lids off. Therefore it is considered that bottle presentations are less secure than non-reclosable safety containers.
Changing the packaging requirements for these medicines to less secure methods will increase the risk of children accidently taking these medicines - contrary to one of the primary intents of Regulation 37 of the Medicines Regulations 1984.
The attractive, bright and colourful appearance of most of the currently available brands of the capsule formulations of SSRIs and SNRIs look very enticing to young children. This contribution to the risk of harm from ingestion also must not be undervalued.
Any changes should take ANZTPA into account:
One submitter expressed concerns that the review made no reference to ANZTPA, and requested that any review of regulatory policy be considered in the wider policy context of ANZTPA.
They requested that alignment with Australia on requirements for packaging for all products should be considered during the transition to ANZTPA so sponsors can make changes to labelling / products in one consolidated action.
Overall the objections were with regard to dispensing practice in New Zealand and the need to consider any changes in light of the transition towards ANZTPA.
None of the submitters commented on the significant risk posed to children through supply of some prescription medicines in general purpose bottles. The proposal would go some way to addressing this issue.
Many of the opposing comments raised issues with New Zealand's medicine market in that many prescription medicines are supplied in large packs which are then dispensed by pharmacists into quantities prescribed for the individual patient.
Pharmacists will be obliged to repackage these medicines into bottles fitted with child-resistant closures, and the additional costs incurred will be passed on to the consumer.
Although there was some support from sponsors for allowing reclosable safety containers for antidepressants, the issues of increased cost and inconvenience to pharmacists and consumers were not addressed.
Sponsors were also concerned that ANZTPA will result in further changes to the labelling and packaging of medicines. They consider all changes should be incorporated into one consolidated action.
Medsafe was disappointed that none of the submitters supported the proposal to require safety packaging for a wider range of medicines. Medsafe is concerned that medicines that pose a risk to children continue to be marketed in general purpose bottles.
The progression of ANZTPA will result in changes to labelling and packaging including the use of reclosable safety containers. Therefore issues with bulk supply and dispensing practice in New Zealand need to be resolved.
Medsafe has therefore decided to conduct a wider consultation to determine the appropriate packaging for medicines that pose a significant risk of harm if accidentally ingested by children. This consultation will seek to identify options to resolve the dispensing issues.
Until this wider consultation has been completed, Medsafe has decided that SSRI and SNRI antidepressants must continue to be packaged in safety containers (defined in New Zealand as blister packs only).
Manager Product Regulation