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Sam

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  1. The new Health and Care Bill gives NHS Digital powers to create a new ‘medicine registry’

    The bill, published earlier this month, will allow NHS Digital to collect a range of information about the use of medicines and their effects in the UK and hold this data in one or more information system(s). The MHRA would be able to then use the information held in an information system to establish and maintain comprehensive UK-wide medicines registries.

    “This would improve post-market surveillance on the use [of] medicines. For example, where a safety issue has led to the introduction of measures to minimise risk to patients, registries would facilitate the early identification and investigation of potential noncompliance so that additional action can be taken by regulators in conjunction with health service providers at a national, local, or individual patient level.”

    The notes added the power is “restricted to purposes relating to the safety, quality and efficacy of human medicines and the improvement of clinical decision-making in relation to human medicines”.

    Anybody who inappropriately shares NHS data collected for the new registry could face a fine and a prison sentence.

    What does this mean for patient safety? What impact will this has on the NHS and for private providers?

    @Helena Gregory. @Kathryn Howard, @Kristen, @Alison Smith, @Phaeds, @CYC, @Dakota, @Steve Turner

     

     

  2. The UK government is seeking views on proposed changes to the Human Medicine Regulations 2012 to help with the safe and efficient distribution of a COVID-19 vaccine and expanded flu vaccine programme in the UK, along with treatments for COVID-19 and any other diseases that become pandemic.

     

    Ministers say there will be no shortcut on safety or effectiveness, and that any vaccine will be approved for the UK only if it meets the highest standards.

    The deputy chief medical officer for England, Prof Jonathan Van-Tam, said: “If we develop effective vaccines, it’s important we make them available to patients as quickly as possible but only once strict safety standards have been met. The proposals consulted on today suggest ways to improve access and ensure as many people are protected from Covid-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine used is both safe and effective.”

    What do you think? Are there patient safety concerns here? We'd love to hear your views. Comment below.

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