East & South East England Specialist Pharmacy Services
East of England, London, South Central & South East Coast
Regulatory Changes currently Regulatory Changes currently under consultationunder consultation
Richard BatemanRichard BatemanQuality Assurance Specialist Pharmacist Quality Assurance Specialist Pharmacist
East & South East England Specialist Pharmacy Services
East of England, London, South Central & South East Coast
Scope• Consolidation and review of UK medicines legislation
(MLX 375)• Falsified Medicines Directive (2011/62EU)• MHRA Review of Unlicensed Medicines
• NHSPQAC “Guidance on the licensing requirements of prepacking and overlabelling operations”
East & South East England Specialist Pharmacy Services
East of England, London, South Central & South East Coast
MLX 375• Timescales• Legal Powers• The consolidation – key points• Government and NHS Reform• Consolidation• Patient Group Directions • Optimisation of medicines• Keeping up to date• Summary
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TimescalesTimescales• Consolidation and review of UK medicines legislationConsolidation and review of UK medicines legislation Public consultation MLX 375 responses by 17 January 2012Public consultation MLX 375 responses by 17 January 2012• Spring 2012 consolidated regulations (Human Medicines Spring 2012 consolidated regulations (Human Medicines
Regulations) before ParliamentRegulations) before Parliament• July 2012 come into force July 2012 come into force • Expected shortly related consultation (MLX 374) on Expected shortly related consultation (MLX 374) on
pharmacovigilance requirements European Directive 2010/84/EUpharmacovigilance requirements European Directive 2010/84/EU• Directive implemented July 2012Directive implemented July 2012• European Directive 2011/62/EU on falsified medicines European Directive 2011/62/EU on falsified medicines
implementation by 2 January 2013implementation by 2 January 2013
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Legal Powers• ‘Consolidated regulations will primarily
implement Directive 2001/83/EC• Continue to rely on Medicines Act 1968 for
powers that fall outside of European obligations
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The consolidation – key points from MLX 375
Will replace• About 200 statutory instruments• Much of the Medicines Act 1968Will remove• Much obsolete lawWill result in• Shorter simplified law easier to understand and applyWill reduce• Net burdens for users• Save time and costs• Different interpretations of the law
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Government & NHS Reform• A ‘priority to minimise regulatory burdens in order to
boost enterprise and drive growth’ – ‘One in, One out’
• ‘The consolidation is not part of proposed NHS reforms, but we will aim to ensure that the consolidated regulations reflect any changes to the NHS legislation as necessary’
• To include changes to Patient Group Directions
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Consolidation• To replace all UK legislation relating primarily
to medicinal products for human use (with some exceptions)
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Scope of the consolidation (1)IN – Pharmacy includes:• Medicines Act 1968
– Part III Medicines Act 1968 - dealing in medicinal products, classification)– Large parts repealed– (But Act stays)
• Prescription Only Medicines (human Use) Order 1997 (SI 1997/1830) – (with exceptions Sch. 1 POMs status for medicines supplied without a MA)
• Enforcement functions of the GPhC (sections 108 and 109 Medicines Act 1968 (with exceptions)
• Pharmacy qualifications for QPs in relation to a manufacturers' licence
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Scope of the consolidation (2)OUT (or coming later!)• Section 10 is not consolidated and will be retained in the
Medicines Act 1968 amended to refer to the consolidated regulations– Exception – subsection (7) to be repealed
• Areas of MHRA regulation no covered – medical devices, blood, GLP, veterinary medicinal products
• MHRA fees• Medicines (Administration of Radioactive Substances)
Regulations 1978• Certain Prohibition orders (e.g. Chloroform, Kava-kava)
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Scope of the consolidation (3)• Clinical trials – Ongoing negotiations in Europe– Directive requiring substantial changes to the
regulation of clinical trials– Chancellor to review UK implementation of the
CTD to ‘reduce perceived gold plating and to increase proportionality of the system’
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Scope of the consolidation (4)– Removal of the Section 10(7) Medicines Act 1968 exemption for
pharmacy wholesale dealing• Exemption permits pharmacists to trade in small quantities of medicines
without WDL• Not compatible with EU law• Pharmacists requiring to trade commercially will require WDL• WDL not required if medicines provided to healthcare professionals and
others to pass on to their patients• Pharmacists allowed to supply other pharmacists with small quantities
without WDL on occasional and not for profit basis and to meet individual needs of patients
• Considering placing certain new obligations on wholesale dealers and RPs . ‘If we were to decide’ included in consolidated regulations 2012
– MHRA developing advice for pharmacy on impact of these changes on current practice (see impact assessment) with ‘duty to review clause’.
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Scope of the consolidation (5)• Amendment of section 64 (Protection of purchasers
of medicinal products) of the Medicines Act 1968 to ensure a proportionate regulatory approach to dispensing errors– MHRA do not have the powers under EC Act 1972 – Section 64 to remain in force at present– Improvements made by way of guidance– Intention more proportionate regulatory approach– Way forward to be discussed with interested parties
Autumn 2011
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Also included in consolidating the law (1)
– Sections 9 to 12 (NOT section 10) removed– ‘we think that practitioners will be able to
continue to conduct professional activities …)– Therapeutic rather than commercial context and
not industrially produced• ‘MHRA will issue guidance (Note term ‘prepared’
replaced with ‘manufactured’)
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Also included in consolidating the law (2)• Offence provisions
– Civil sanctions to address breaches of advertising and borderline requirements
– Due diligence defence• Sch.1 Medicines for Human Use (MAs, etc) Regulations 1994
(SI 1994/3144)– Permits supply of unlicensed medicines to a person for administration
during the course of their business to a patient under their care– Clarified (defines authorised healthcare professionals)!
• Removal of the requirement for fluted bottles
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Also included in consolidating the law (3)
• Policy changes (6 sections in MLX)– ‘Legislation currently requires MA holders to
include ‘statutory warnings’ on labelling, in PILs for certain over the counter medicines’• Propose to remove them and replace with product-
specific or class warnings in MA• Exception for paracetamol?
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Also included in consolidating the law (4)
– Extension of existing exemptions• Sale of supply of medicines to organisations concerned
with research - extend to other organisations• Increasing the 2ml ampoule size limit for water for
injection – used by drug treatment services• Removal of restriction on parenteral administration of
adrenaline (1 in 1000)• Additions to medicines that can be administered by
registered ambulance paramedics on their on initiative – addition IV Paracetamol, Ondansetron
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Also included in consolidating the law (6)
• New exemptions– Water for injection• Currently classified as a POM• Obtain without a prescription for other purposes not
parenteral administration
– Administration of Adrenaline and Amiodarone• By holders of Resuscitation Council (UK) Advanced Life
Support certificate in cardiac arrest
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Patient Group Directions (1)• Duplication of effort• Raise awareness of the PGD website hosted by NeLM• Retain general structure and requirements in their current
form• Will make minor changes
– Enabling an NHS body to supply in accordance with written directions by an independence nurse, pharmacist or optometrist independence prescriber
– Reflecting changes in the Care Quality Commission registration process
– New provision• Allowing dental practices dental clinics registered with the CQC to sell,
supply or administer medicines under PGDs
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Optimisation of medicines use• ‘In the exercise of professional skill and judgement they
believe it is appropriate to do so a pharmacist may make changes to a prescription relating to a) name of the product or common name; b) directions for use ; precautions relating to the use of the product.’
• Only if the pharmacist cannot contact the prescriber• Commonly interpreted as optimising the use of the medicine
eg dose, duration • Proposal to remove above (not to interfere with clinical
reason for prescribing)
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Keeping the consolidated regulations up to date
• Amendments to UK’s medicine legislation will continue as will development of EC law
• Proposal to re-make the consolidated regulations every few years
• MHRA to undertake a ‘Regulatory Excellence’ programme– To focus on lifting the burdens on business– Feedback to the ‘Red tape Challenge’– Informal consolidated version of regulations each time
amended on website (not legal)
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Falsified Medicines Directive 2011/62 EU
• Needs to be enacted by 2/1/13• No consultation yet. • Pre consultation questionnaire. Closing date
3/2/12. V short turnaround – may still make comments.
• Looking at potential economice impact assessment
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Falsified Medicines Directive 2011/62 EU
• Amends 2001/83EC• Brokering activities – formal controls• WDL – need for supply to 3rd country• Import notification for centrally authorised
products• WD to verify products received are not
falsified
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Falsified Medicines Directive 2011/62 EU
• Safety features – to be defined• Not all to require – POM?• Tamper evident seal and unique pack identifier – bar
codes, RFID?• APIs – additional controls – audit, GMP, GDP,
registration• If safety features are removed ? Need to replace
with equivalent?
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Review of Unlicensed Medicines• Started 2007 – concept paper, interim report,
consultation• Late 2010 – March 2011 – “update in light of
coalitions regulatory agenda”• March 2011 onwards ????????
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RUM – what was not changed from consultation
• Quality and manufacturing standards applying to Specials
• Strengthen pharmacovigilance• Advertising
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RUM – changes proposed after consultation
• Patient Information – healthcare professionals judgement
• Notification system for both domestic manufacture and imports
• Notification – safety concerns / need• Labelling – English (NB NHSPQAC guidance)• Regulatory Impact?
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NHSPQAC Guidance• “Guidance on the licensing requirements of
prepacking and overlabelling operations”• To be published shortly• Clarification of existing position regarding these
activities within the NHS Trusts• Should be referred to when reviewing an assembly
activity to decide whether the activity requires an MHRA license or can be carried out under S10
