European Commission plans to tackle counterfeit medicines must not saddle community pharmacists with unnecessary bureaucracy, Pharmacy Voice has warned.
Pharmacy Voice has urged the commission to ensure it does not impose "undue restrictions on the developments of new and innovative services for patients" when it introduces measures to help prevent falsified medicines entering the supply chain.
The commission is consulting on its plans to introduce a system of unique barcodes on medicines packaging that would then be scanned for verification at the point of dispensing.
"The directive has the greatest chance of successful implementation if over-the-counter medicines are not included apart from exceptional cases" Gareth Jones, Pharmacy Voice
But Pharmacy Voice warned any authentication process used in pharmacies would need to be "virtually instantaneous and not impact unduly on pharmacy processes".
Pharmacies had experienced problems scanning barcodes under the electronic prescription service which had "created inconvenience" and "wasted time", it explained.
"If the quality of barcodes used for the authentication check is substandard leading to problems scanning, the serialisation and authentication system will fall into disrepute and potentially disuse," Pharmacy Voice warned.
Concerns have also been raised about how the rules would apply to pharmacies dispensing from bulk packs and over whether dispensing information captured by the system would remain confidential. "All pharmacy owners should expect that information on the volume of their business remains confidential," Pharmacy Voice said in its response to the consultation.
Speaking to C+D, Pharmacy Voice's Gareth Jones said the potential impact of the directive was "huge". "The directive has the greatest chance of successful implementation if all prescription-only medicines require authentication but over-the-counter medicines are not included apart from exceptional cases," he said.
Numark information pharmacist Gary Choo also warned the plans could have an impact on the import and export of UK medicines.
"[The directive] will seek to address and tighten up the sale and distribution of medicines to prevent counterfeit medicines entering the supply chain," he said.
"While this certainly would improve patient safety, it might add restrictions to the import of active pharmaceutical ingredients which might impact on the present medicine shortages."
But Mr Choo added that the new directives might also improve the availability of medicines by leading to an increased scrutiny of exporters.
Pharmacy Voice agreed, saying it welcomed the EU's broader decision to legislate to increase security measures within the medicines supply chain. "On the plus side, the directive could help strengthen and embed community pharmacy's role in patient safety," Mr Jones said.
A spokesperson for the Association of British Wholesalers (ABPI) said the organisation supported the intentions of the European Commission. "Protecting the safety of patients by ensuring medicines are of the highest quality is of paramount importance to the ABPI and we support the intentions of the EU Falsified Medicines Directive," the spokesperson said.
Specific points made in Pharmacy Voice's submission to the European Commission's consultation included:
- All pharmacy owners should expect that information on the volume of their business remains confidential.
- The directive has the greatest chance of successful implementation if all prescription-only medicines require authentication but OTC medicines are not included apart from exceptional cases.
- The authentication requirement must allow for MDS packs to remain available on the market.
- Original pack dispensing is required in the UK to ensure that the anti-counterfeiting system can work here.
- Pharmacists should have the discretion to undertake retrospective authentication or temporarily suspend authentication altogether, in the case of systems failure.
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