Where is the best place for verification and decommissioning to be performed in your hospital pharmacy?

 
Each hospital pharmacy has the flexibility to select the most suitable location(s) to incorporate the Falsified Medicines Directive (FMD) verification and decommissioning steps into its own standard working practices. It is therefore critical to evaluate where, within your healthcare institution, these steps are best placed to occur. This preparation will enable you to comply with the FMD, whilst maintaining the quality of service you provide, with minimal negative impact on your valuable resources.

Various important factors need to be considered to enable a more informed decision to be reached. Experience gained through research projects with various hospital pharmacies shows that, for practical reasons, the FMD processes should - ideally - be carried out at goods-in and/or after picking.

    
medAspis has created a series of questions which will assist you in considering the best place to integrate the FMD processes within your existing working practices.

Additional handling time

For manual, not robotic, verification or decommissioning, you may need to handle every individual pack of medicine, find the 2D code and scan it. Based on our research projects with various hospital pharmacies, we have found that the average manual handling time is 2.1 seconds per pack. This time will vary, based on the position of the codes in respect to their tertiary package, packaging type (plastic, cardboard), which may facilitate or slow down the overall logistics process. For example, when packs are scanned at goods-in, in some cases, the packs need to be returned to their original outer carton or pallet for storage. This increases the handling time and we have estimated it to take an average of 3.4 seconds per pack.

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Aggregated Codes

If, at any time in the future, packs are received with an aggregated code on the outer sealed carton or the pallet, the amount of work required by the pharmacy to verify the enclosed packs would be significantly reduced.

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Only qualified pharmacy personnel can verify and decommission 2D codes

The decommissioning of the 2D codes and the visual check of the tamper-evident seal can only be carried out by a person authorised and entitled to dispense medicines to the public (which we understand to be pharmacists and pharmacy assistants).

Scanning at goods-in would require assigning highly skilled and qualified personnel at that location. However, if the decommissioning of the 2D codes is performed later in the workflow, for example in the dispensary, this process is easier to integrate into standard working practices.

If medicines are received by goods-in at various times throughout the day, consideration needs to be given to how qualified pharmacy personnel can be made available.

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Return to the supplier

Reversing the decommission state of a pack to active can only be performed within 10 days from the date the 2D code was decommissioned, with some additional conditions being met, including: it not having expired; not been registered in the repositories system as recalled, withdrawn, intended for destruction or stolen; or not been supplied to the public.

If a pack is to be returned to the supplier, this 10-day period must not have elapsed. Therefore, decommissioning as close to the patient as possible (in other words, as late as possible in the dispensing process) enables the pharmacy to achieve maximum flexibility in economic terms by avoiding the need to destroy packs marked for return but decommissioned more than 10-days earlier.

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Third party hospitals

The legislation states that the decommissioning of a pack of medicines is to be performed by the healthcare institution caring for the patient. Thus, a hospital pharmacy is not allowed to decommission medicines intended for hospitals which do not belong to the same legal entity (ie chain, trust or group). Other situations may require a hospital pharmacy to decommission the 2D code on behalf of third parties and these include, supplying medicines to universities, schools, care homes, hospices, etc. Since it is not necessarily known at goods-in which individual packs are intended for internal consumption and which will be supplied to other institutions, decommissioning at this point would not be the optimal choice.

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Timeliness of the scan

The status of a pack can be updated at any time (recalls, reported stolen, etc.), therefore, the later in the workflow the decommissioning step occurs, the more up-to-date this information will be at the time of dispense.

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On-site preparation and manufacturing

If prescription medicines are prepared or manufactured on-site, some ingredients will need to be decommissioned at the first use or verified before every subsequent use (e.g. if an aliquot is taken).

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Narcotics

With the need for narcotics to be stored and processed separately from other medicines, the decommissioning of narcotics must also take place in a separate place.

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Logistical advantages

The 2D codes allow batch numbers and expiry dates to be captured at a pack level. Once scanned, all packs can be monitored and flagged throughout their lifecycle; for example, for an imminent expiry date or a product- or batch-level recall. Hand-held scanners allow for serialised 2D code packs to be counted easily for inventory purposes. The greater the mobility, the greater the flexibility concerning how frequent and where packs are scanned.

medAspis will be happy to support you in your decision to find the right place to perform the verification and decommissioning scans within your hospital pharmacy. Please use the contact form below to send us your assessment of the relevance of the above factors to your existing working practices and we will contact you immediately with our expert feedback.

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