News

HDA UK Media And Political Bulletin – 8 March 2017

Media Summary

Safer medical devices: Council adopts new EU rules

European Council, 7 March 2017

The Council has adopted new EU rules to improve the safety of medical devices. The rules encompass certain products which do not have a specifically medical purpose, such as coloured contact lenses. Accessibility and timeliness are key to these rules, as are follow-up guidelines to improve the availability of clinical data on devices. The European Parliament is expected to adopt the two regulations in April, when they will be published in the Official Journal.

Contractors, stop ‘covering your ears’ on hub-and-spoke

Chemist and Druggist, Annabelle Collins, 7 March 2017

At Numark’s conference in Cape Town, Steve Anderson said that contractors can either position themselves against hub-and-spoke, or they can see it as a way to benefit their business. Highlighting how different the current wholesale model is from previous years, Anderson said that wholesalers need to keep up with digital developments. He also stressed that in order to achieve profitable growth, a different type of collaboration is needed across the sector.

Web GPs shut down in CQC swoop

Dispensing Doctor, 8 March 2017

Two online GP and pharmacy providers have shut down following CQC urgent inspections.

The providers are MD Direct and HR Healthcare Ltd. Following an internal review of all 43 online services that are registered, CQC has brought forward a programme of inspections prioritising those it considers as presenting a significant risk to patients.

Parliamentary Coverage

House of Commons, Written Answers, Department of Health

Tuesday 7 March 2017

Kevin Hollinrake (MP):

What steps his Department is taking to regulate the online sale of (a) antibiotics and (b) other medicine.

Nicola Blackwood (MP):

In the United Kingdom, there are legal controls on the retail sale, supply and advertising of medicines which are set out in the Human Medicines Regulations 2012. These apply without distinction to medicines advertised, sold or supplied through the internet.

This means that Prescription Only (POM) and Pharmacy medicines (P) can only be sold or supplied at registered pharmacy premises by, or under the supervision of, a pharmacist. Furthermore, POMs can only be sold or supplied in accordance with a prescription from a doctor, dentist or relevant healthcare professional. POMs cannot be advertised to the general public.

The vast majority of antibiotics are only available as POM for supply only under the supervision of a suitably qualified healthcare professional.

Websites offering to supply POMs without a relevant prescription are in breach of UK legal requirements and the Medicines and Healthcare Products Regulatory Agency will investigate and take appropriate action including criminal investigation and prosecution.

Full Coverage

Safer medical devices: Council adopts new EU rules

European Council, 7 March 2017

On 7 March 2017, the Council adopted new EU rules improving the safety of medical devices for the benefit of patients while preserving a timely access to innovative healthcare solutions.

Medical devices and in vitro diagnostic medical devices help diagnose, prevent and treat or alleviate diseases. They cover a wide range of products, from sticking plasters to hip replacements and hearing aids, and from pregnancy tests to HIV tests.

The new rules keep pace with recent technical developments. Their scope has been extended to cover certain products which do not have a specifically medical purpose, such as coloured contact lenses. The experience of metal-on-metal artificial hips and faulty silicone breast implants also has been taken into account in the preparation of the new rules, in particular by requiring the systematic scrutiny of vital implants by medical experts.

“Medical devices play a crucial role in all our lives. We all regularly use sticking plasters or have dental fillings, and we know people who are still alive thanks to devices that have helped in the diagnosis and treatment of serious diseases. These new rules will do more to help save lives, by having more innovative and safer devices on the market” – Mr Christopher Fearne, Minister for Health of Malta and President of the Council.

The two new EU regulations:

  • provide a stronger mandate to independent notified bodies in their assessment of medical devices before they can be placed on the market, and strengthen the oversight of these bodies by national authorities; the new rules also ensure that notified bodies meet the same high safety standards throughout the EU; these measures will improve the safety of medical devices
  • improve the availability of clinical data on devices and clearly set out manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; this will allow manufacturers to react quickly in the event of concerns being raised and help them improve their devices continuously on the basis of actual data
  • improve the traceability of medical devices throughout the supply chain to the end-user or patient by using a unique identification number; this will allow fast and effective measures to be taken in the event of safety problems
  • set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; this will enable them to make better informed decisions

Next steps

The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.

Web GPs shut down in CQC swoop

Dispensing Doctor, 8 March 2017

Web GPs shut down in CQC swoop.

CQC slams providers where patients self-medicate.

Two online GP and pharmacy providers have shut down following CQC urgent inspections.

The providers are MD Direct (which had traded through the website assetchemist.co.uk and HR Healthcare Ltd (through the website treated.com).

CQC’s inspection of HR Healthcare Ltd was influenced by an investigation by Dr Faye Kirkland for BBC Radio 5 Live Investigates in October 2016, which looked at the online sale of antibiotics from this provider.

Immediately after the inspections, CQC suspended the registration of HR Healthcare Ltd. MD Direct responded to CQC’s concerns by voluntarily cancelling its registration. Both providers have stopped providing services to patients in England (assetchemist.co.uk now uses an alternative online GP provider for its prescription service).

Inspectors found that the two providers demonstrated significant clinical safety and organisational risk to patients, with widespread failings to provide safe care. Among the concerns which were identified:

No (or minimal) identity checks for patients.

No way of identifying whether or not patients lacked capacity to consent or understand their prescribed treatment or medical advice, or if there were any safeguarding concerns (and if they were identified, minimal structures in place to handle them).

No systems or processes to contact the patient’s regular GP, including when medication was prescribed that required monitoring or follow-up

Prescribing practice that did not take account of the patient’s clinical condition or consider differential diagnoses.

Inadequate medical history-taking to inform appropriate prescribing.

No assurances that clinicians had relevant skills or qualifications for the role they were performing.

Following an internal review of all 43 online services that are registered, CQC has brought forward a programme of inspections prioritising those services it considers as potentially presenting a significant risk to patients.

CQC chief inspector of GPs, professor Steve Field said: “We have found websites which in effect allow people to select their own medication, including medicines restricted as prescription only, with little or limited clinical oversight.”

Duncan Rudkin, chief executive of the General Pharmaceutical Council, said: “Where necessary, we are carrying out further inspections of the pharmacies linked to the online primary care services being inspected by the CQC, to assess whether they are meeting our standards and appropriately addressing the issues and risks linked with online prescribing and dispensing.”

HDA UK Media And Political Bulletin – 8 March 2017

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

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