DHSC to exercise powers to control cost of specials
Posted: Thursday, May 31st, 2018
In the last week, The Times has published a series of stories about the high prices charged for specials and the cost to the NHS. The Department of Health and Social Care has announced in answer to a parliamentary question that, pursuant to its powers under the Health Service Medical Supplies (Costs) Act 2017, it is "now finalising Regulations, expected to be laid and to come into force later in summer 2018, which include requirements in relation to special medicinal products which will ensure that the Government obtains information from all manufacturers and importers."
GDPR in force today
Posted: Friday, May 25th, 2018
The Data Protection Act received the Royal Assent yesterday, bringing GDPR into force.
Noel Wardle and David Reissner have written a teaching piece for the Pharmaceutical Journal.
Why GDPR will require pharmacies to have a DPO
Posted: Tuesday, May 22nd, 2018
The Data Protection Act 2018 which will bring GDPR into force in the UK on 25 May 2018 requires public authorities to appoint a Data Protection Officer (DPO). This is a responsible role and can be burdensome for small businesses because DPOs are expected to be independent of the management of the business (although businesses can share a DPO). The Act defines all providers of NHS services as public authorities.
Pharmacy organisations and other bodies representing healthcare professionals sought an amendment to the Act, so as to take healthcare providers out of the definition of “public authority”. However, the government rejected the amendment. Chemist & Druggist has just published https://www.chemistanddruggist.co.uk/opinion/GDPR-requirements-make-no-sense-for-pharmacy an article by David Reissner, criticising the government’s reasons for rejecting the amendment.
New pharmacy inspection regime proposed
Posted: Friday, May 18th, 2018
- Changes to the types of inspections - moving to a new model that includes three types of inspection: routine inspections, intelligence-led inspections and themed inspections. This appears to be about responding to information held and "intelligence" received.
- Moving to unannounced inspections as a general rule.
- Changing inspection outcomes - there would be two possible outcomes for an inspection overall (‘standards met’ or ‘standards not all met’), and four possible findings at the principle (sic) level (‘standards not all met’, ‘standards met’, ‘good practice’ and ‘excellent practice’).
- Requiring all standards to be met to receive an overall ‘standards met’ outcome - if any standard was found not to be met, this would result in a ‘standards not all met’ outcome overall.
- Publishing inspection reports, and improvement action plans where relevant, on a new website.
Successful annual seminar and AGM
Posted: Friday, May 18th, 2018
We enjoyed a successful AGM on 16 May 2018, and had a record turnout for presentations testing the new defence to dispensing error prosecutions under section 64 of the Medicines Act 1968; a comparision of fitness to practise procedures in common law jurisdictions; ethical issues when pharmacists collaborate with GPs; and how the issue of dishonesty is dealt with in Fitness to Practise cases, especially since the Supreme Court decision in Ivey v Genting  UKSC 67.
At the AGM, we updated our constitution so as to open membership to all pharmacy professionals, to ensure that pharmacy technicians could become members.
In his Chair's report, David Reissner said he aimed to use Twitter more, to promote PLEA. In fact the conference has generated a lot of traffic on Twitter. Please contribute @PLEA_UK
New premises standards regulations
Posted: Saturday, April 28th, 2018
The Privy Council has made an Order, bringing The Pharmacy (Premises Standards, Information Obligations, etc.) Order 2016 into force on 24 May 2018.
The Premises Standards Order:
- gives the GPhC power to enforce premises standards through improvement notices rather than prosecution
- gives the GPhC power to produce premises standards which will extend not only to registered premises but also to "associated" premises, and will take into account the "working environment"
- gives the GPhC power to refer premises standards cases to the Fitness to Practise Committee
- gives the Fitness to Practise Committee power to disqualify pharmacy owners and to remove premises from the register
- gives the Fitness to Practise Committee power to impose an interim suspension pending a full hearing
- gives the GPhC power to publish inspection reports
NHS market entry review
Posted: Sunday, April 15th, 2018
The Department of Health and Social Care has published a review of the operation in England of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.
The review concludes that the regulations have "largely achieved" the original policy objectives of encouraging the supply of services without excessive provision in areas already meeting demand. However, the review recommends undertaking a consultation on possible amendments to address certain unintended consequences of the Regulations.
The issues that may give rise to future amendment to the Regulations include:
- GPs directing prescriptions to distance selling pharmacies in which they have a commercial interest
- streamlining the application process for "minor" relocations
- relaxing restrictions on dispensing doctors so as to enable them to dispense from addtional premises if they amalgamate with a non-dispensing practice
- Allowing 100-hour pharmacies to reduce their hours if this is necessary in order to remain financially viable
Dispensing error defence in force
Posted: Sunday, April 15th, 2018
Following an order of the Privy Council, The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 comes into force on 16 April 2018. The Order provides a defence to prosecutions under section 64 of the Medicines Act 1968 because the wrong prescription medicine has been supplied and a patient is harmed.
The defence does not apply to over-the-counter medicines, and a defendant will only be acquitted by proving that certain conditions are met. Typically, these will be that the pharmacist did not know that the wrong medicine was being supplied, and that when the error was discovered, the patient was promptly notified.
Find out more at PLEA's annual seminar on 16 May 2018.
Annual Seminar - Booking now open!
Posted: Wednesday, March 21st, 2018
PLEA Annual Seminar and AGM
“What's new in 2018?”
Wednesday 16th May 2018 10.00 - 3.30
At the offices of Charles Russell Speechlys LLP, 5 Fleet Place, London EC4M 7RD
This year's seminar will look at recent changes in the law affecting pharmacists and pharmacy practice, as well as exploring how fitness to practise is dealt with in other jurisdictions such as Australia, Canada and a US State.
The programme will include
- You, the jury: a mock trial involving new defences to prosecutions for dispensing errors under section 64 of the Medicines Act and how the defences might work (or not) in real life
- Fitness to Practise - a comparison of processes in different common law jurisdictions
- Dishonesty - how it arises and is dealt with in Fitness to Practise cases
- Ethical issues when pharmacists collaborate with GPs
To register to attend please register via the events page. This event is free for PLEA members, £50 for non-members.
The Annual General Meeting of PLEA will also be held at this meeting. Lunch and refreshments will be provided.
Thanks are due to Charles Russell Speechlys for the facilities to hold this meeting of PLEA
These news items are not exhaustive but are selected according to their relevance to pharmacy practice, NHS community pharmacy contracts and the regulation of the pharmacy profession. If you wish to add any items that you think we have missed, contact our news editor.