Mike Smith puts the world to rights...the Falsified Medicines Directive,  access to patients' records and the RPS Faculty

Be prepared is the famous motto of the Scouts, as I remember from my younger days. Pharmacists, too, have to be well prepared to cope with the challenges (many of them unexpected) that spring up as they get on with the job.

One issue that will need some consideration, and certainly some planning and future investment, is the Falsified Medicines Directive, which is being driven by European Union law.

This will require that each pack of prescription medicine bears a unique number to identify it. Community pharmacies will need to be equipped with a scanner and a rapid link to a central database computer where an instant read-out will authenticate the unique identifier or set off an alarm if an inconsistency is detected.

The market authorisation holder, the manufacturer or the parallel trader (if the product is re-packaged), will affix a 2D matrix to each pack, containing the product code, randomised unique serial number, expiry date and batch number. This data will provide reference for the central hub. A falsified medicine, which will inevitably lack the unique serial number, will set the alarm bells ringing.

The deadline for introduction of the systems to support this legislation is 2017, but I understand this may slip to 2018 because of the technical challenges involved. Despite opposition from the UK, it appears certain that the European Commission will not change its mind, so we do need to be prepared for this.

I have been critical of the PMR suppliers in the past, but they have a very clear role to play in the implementation of this change. I hope that they prove themselves equal to the task because many pharmacists will need support.

The problem of counterfeit medicines is very real and recently £8.6 million worth of illegal drugs have been seized by the MHRA. This included drugs for erectile dysfunction, slimming products, sleeping pills, tranquillisers and anti-depressants, and of these 72 per cent arrived from India and 11 per cent from China. The drugs had not been shipped or stored appropriately and had been found in “appalling conditions”. While the new requirements may seem draconian, it seems that they are also very necessary.

Be prepared is the famous motto of the Scouts, as I remember from my younger days. Pharmacists, too, have to be well prepared to cope with the challenges (many of them unexpected), that spring up as they get on with the job

The debate on access to patients’ records continues. In January the government pledged to give priority access to patient records to unlock their tremendous potential in public health improvement and disease prevention.

Despite this there have been concerns raised by some GPs that this could lead to confusion for patients. Advice based on access to partial patient records could be flawed, it is argued, and there are genuine concerns that the records may be accessed by someone other than a pharmacist. It is clear that protocols need to be thought through carefully and safeguards put in place. Watch this space.

I recently attended the second Board meeting of the Faculty of the Royal Pharmaceutical Society and was pleased to see that the tremendous amount of work undertaken by Catherine Duggan and her team is leading more pharmacists to sign up. I do encourage you to investigate the Faculty. It will enable you demonstrate excellence in your practice and may lead to future employment opportunities for individual pharmacists in this very competitive jobs market. It may also be a useful lever when it comes to tendering for commissioned services.

The Faculty is certainly not just for academics and I encourage community pharmacists to look at it with an open mind. It will undoubtedly add quality to your practice and inevitably value to your business.

I cannot close without commenting on the excellent Alliance Healthcare charity day that I attended in Nottingham last month. The event was attended by more than 300 of our staff and we raised more than £40,000 for our partner charity Friends of EORTC on behalf of the European Organisation for Research and Treatment of Cancer (EORTC) Charitable Trust.

I am so proud of what we achieved – perhaps you could take time to read about the EORTC Charitable Trust on our website.

To conclude, I hope you enjoy the summer and manage to take some time out from the hectic world that is pharmacy.

Mike Smith is chairman of Alliance Healthcare, mike.h.smith@alliance-healthcare.co.uk


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