The Pharmacy Law and Ethics Resource Centre What's New?

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APPLET is on the move and nine academics from UK Schools of Pharmacy have joined forces to evolve APPLET into an interdependent schools of pharmacy  network with a wider role as the voice of educators in professionalism.  Check out Bulletin 24 for the APPLET Network vision. HOLD THE DATE!  APPLET is offering a CPD event on 31 March 2008 at Aston University.  To help launch the APPLET Network, Keith Ridge, Chief Pharmacist for England is confirmed as our keynote speaker. Registration forms will be accepted early 2008.   April 2007 New law (The NHS (Pharmaceutical Services)(Remuneration for Persons Providing Pharmaceutical Services)(Amendment)(Wales) Regulations 2007) SI No 1112 (W117) makes changes consequent on implementation of the NHS (Wales) 2006 to continue the management of Community Pharmacy Contracts in Wales. May 2007 Information from Pharmaceutical Press regarding new book: Pharmacy Ethics and Decision Making by Joy Wingfield and David Badcott "The scheduled publication date at the moment is the 13th of July. Price yet to be determined." New law (The Health Service Medicines (Information Relating to Sales of Branded Medicines, etc) Regulations 2007) SI No 1320 implements aspects of the five year PPRS (Pharmaceutical Prices Regulation Scheme) agreed in 2005. These regulations require the major pharmaceutical companies to provide DH with quarterly information on their income from the sales, after discount, of each branded medicine sold to the NHS. Information from RPSGB Head of Ethics regarding new Code of Ethics: "The revised Code doesn't come into force until 1 August, so the current Code will still be in effect during this year's summer exams. We are planning to send a separate printed version of the revised code and the supporting standards documents to all registrants in July (we are also looking into how the new code will be distributed to the schools). The Code will also continue to appear in the MEP guide, but as it has changed fundamentally we are sending out a separate printed version to draw attention to it." Attention teachers! Check out the teaching resources page to access the recently updated problem based learning tools, submitted by Dr David Wright from University of East Anglia. August 2007 New law (The Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007) SI No 2154 makes a series of changes, with different start dates, to the CD regulations. From 16th August 2007: Update references to "nursing home" with "care home", "sister" with "senior registered nurse" and descriptions of some other health professional Allows Operating Department practitioners to possess or supply CDs in accordance with a CMP or prescription Authority given to accountable officers to authorise people to witness destruction of CDs From 1st September 2007 In England and Wales, (already implemented in Scotland), removes requirement to retain original of CD scripts in the pharmacy for 2 years but must now be sent to the relevant NHS pricing department From 1st January 2008 Moves midazolam to schedule 3 and allows supply on a PGD From 1st February 2008 Changes headings for the Misuse of Drugs Register to include particulars of person collecting and identity check   You might also find the Pharmaceutical Journal reports useful: http://www.pharmj.com/pdf/_donotindex/pj_20070818_news.pdf http://www.pharmj.com/Editorial/20070818/society/ethics.html#1 http://www.pharmj.com/pdf/_donotindex/pj_20070825_news.pdf and http://www.pharmj.com/Editorial/20070901/society/ethics.html Consultation (MLX 340) proposes to amend the clinical trials regulations 2004 (SI No 1031) to facilitate trials of emergency care medicines for children.Closing date is 7th December 2007 Consultation (MLX 342) proposes to amend section 58 (appropriate practitioners to write scripts) of the Medicines Act to enable UK pharmacists to dispense scripts lawfully prescribed by doctors and dentists in other EEA states and, possibly, Switzerland. Closing date is 12th October 2007 September 2007 New law (The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 SI No 2178 and The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2007 SI No 2179) extends PGDs to independent hospitals, clinics and agencies, and to the private sector in Northern Ireland.It also removes the provision about keeping original scripts for CDs from the substantive regulations.

Archive

2007 January 07   February & March 07   April 07

2006 January 06   April 06  May 06   June 06   August 06   September 06   October 06  November 06  December 06

2005 January 05   February 05  March 05  April 05  May 05  June 05  July 05  August 05   September 05   October 05   November 05 December 05

2004 January 04   February 04   March 04   April 04    May 04   June 04   July 04    August 04   September 04   October 04   November 04   December 04  

2003 April 03   May 03   August 03   September 03   October 03    November 03   December 03  

April 07

• Consultation (MLX 338) on independent prescribing of controlled drugs by nurse and pharmacist independent prescribers. Independent nurse prescribers can currently prescribe 12 forms of controlled drugs within certain conditions. This consultation aims to expand this range and to extend prescribing rights to independent pharmacist prescribers. Consultation closes 15th June 2007.

• Consultation (MLX 336) on proposals to:

  • Expand the range of CDs that can be supplied or administered to under PGDs

  • Expand the use of private sector PGDs to Northern Ireland

  • Correct a technical error in the law on the use of PGDs in the private sector

Consultation closes on the last point on 20 th April 2007 and on the first two points on 15th June 2007.

• New law (The NHS (Charges for Drugs and Appliances) Amendment Regulations 2007 SI No 543 increase the prescription charge (levy) in England to £6.85 in England from 1st April 2007.

• New law (The NHS (Free Prescriptions and Charges for Drugs and Appliances) ( Wales ) Regulations 2007
  SI No 121 (W11) abolishes charges (levies) for NHS prescriptions dispensed in Wales from 2nd April 2007.

February and March 07

• New law (The Approved European Pharmacy Qualifications Order of Council 2007 SI No 564) in anticipation of the repeal of the Pharmacy Act 1954 re-enacts the provisions for reciprocal recognition of pharmacists with European qualifications, updated to include recently acceded Member States.

• A “suite” of new RPSGB Rules come into force from 30th March. These replace the comparable sections of the Society’s Byelaws. The RPSGB (Fitness to Practise and Registration Appeals Committees and their Advisers Rules) Order of Council 2007 SI No 561

• The RPSGB (Fitness to Practise and Disqualification etc, Rules) Order of Council 2007 SI No 442

• The RPSGB (Registration Rules) Order of Council 2007 SI No 441. These Rules should be read in conjunction with the Approved Pharmacy Qualification Order SI 2007 No 564 (above)

• All of the above are made under the powers in the Pharmacists and Pharmacy Technicians Order 2007 SI No 289 (which itself is made under Section 60 of the Health Act 1999). The Order received Royal Assent in February 2007 but the Fitness to Practise and Registration provisions only come into force in March 2007. The provisions regarding technicians are delayed till later in 2007 when Scotland is expected to enact similar legislation for the registration of pharmacy technicians.

• New law (The NHS (Miscellaneous Amendments Concerning Independent Nurse Prescribers, Supplementary Prescribers, Nurse Independent Prescribers and Pharmacist Independent Prescribers) (Wales) Regulations 2007 SI No 205 (W19) brings pharmacist and nurse prescribing into NHS Wales and updates definitions.

• The White Paper on “Trust, Assurance and Safety – The Regulation of Health Professions in the 21st Century” (Cm 7013) is published. Proposals include the establishment of the General Pharmaceutical Council to regulate pharmacy. This will register pharmacist, pharmacy technicians and premises and “be responsible for educational standards”. The White Paper also proposes a “body akin to a Royal College” to undertake leadership and support for clinical excellence within the pharmacy profession.

• See also Pharmaceutical Journal article

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January 07

• SI No. 3373 The National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006
  This instrument tidies up a number of provisions concerning the award of LPS and community pharmacy contracts and brings prescriptions written by pharmacist independent prescribers within the NHS remuneration arrangements.

• SI No. 3332 The Health Service Commissioner for England (Special Health Authorities) (Revocation) Order 2006
  This Order removes the UK Transplant, Retained Organs Commission, National Blood Authority, the Rural Dispensing Committee and Special Health Authorities from the Health Service Commissioner’s jurisdiction (because they have been abolished).

• SI No. 3331 The Misuse of Drugs Act 1971 (Amendment) Order 2006
  This Order reclassifies methylamphetamine, previously a Class B drug, as a Class A drug.

• SI No. 3148 The Controlled Drugs (Supervision of Management and Use) Regulations 2006
  The regulations provide the detailed regime brought into force under the Health Act 2006 (see below).They require certain NHS and independent healthcare bodies (public sector organisations and independent hospitals subject to statutory regulation) to appoint an Accountable Officer and describe the duties and responsibilities of Accountable Officers to improve the management and use of controlled drugs. The regulations also require specified bodies to co-operate with each other, including with regard to the sharing of information, about concerns about the use and management of controlled drugs, and set out arrangements relating to powers of entry and inspection. The Healthcare Commission is the inspection authority for most NHS (hospital trusts and PCTs) and private healthcare organisations. The RPSGB inspectors will be the inspection authority for community pharmacies, as before.
  In extreme cases, sanctions could result in losing authority to continue operating. (see the Explanatory Memo)

• See also explanatory articles in the Pharmaceutical Journal from 9 December 2006, Volume 277
  see page 679: New Arrangements for CD Inspectors to Start Next Year.
  and page 702: RPSGB's chief inspector, Jackie Giltrow, explains the new role of the Society's inspectorate in the monitoring and inspection of Controlled Drugs in community pharmacies.
  (and also see a short briefing by Joy Wingfield)

• SI No. 3125 (C.108) The Health Act 2006 (Commencement No.2) Order 2006
  This Order brings into force those sections of the Health Act 2006 relating to intensified arrangements for monitoring use of controlled drugs (see above). Other sections brought into force include measures relating to applications for inclusion in a pharmaceutical list, powers to enable charges to be levied in relation to such applications, powers to take into account proposals for the sale or supply of over the counter medicines and other healthcare products (that is, in addition to sales or supply of products on prescription), and proposals for the provision of certain types of advice, when determining applications for inclusion in a pharmaceutical list.

• SI No. 3087 The National Health Service (Clinical Negligence Scheme) Amendment (No. 2) Regulations 2006
  This amends the established scheme where NHS trusts and certain other bodies providing NHS services make provision for meeting liabilities to third parties in connection with personal injury arising out of negligence in the carrying out of their functions. It further provides such liabilities to be treated as if they were liabilities of the PCT which has engaged the person. (see the Explanatory Memo)

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December 06

• New law (The Medicines for Human Use (Clinical Trials) Amendment (No 2) Regulations 2006 SI No 2984) brings clinical trials procedures into line with changes required under the Mental capacity Act 2005 (see November below) and amends the Adults with Incapacity (Scotland) Act consequentially.

November 06

• New law (The Medicines (Administration of Radioactive Substances) Amendment Regulations 2006 SI No 2806) allows persons who are operators in nuclear medicine procedures to administer or authorise the administration of radioactive medicinal products, provided they are acting within the IRME regulations: (Ionising Radiation (Medical Exposure) Regulations 2000 SI No 1059, as amended by SIs 2004/1031 and 2006/2523). The original regulations date back to 1978 (SI No 1006, amended by SIs 1995/2147, 2005/2754 and 2006/2407).

• New law (The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 SI No 2807) makes changes consequent upon the radioactive substances amendment above, extends the range of medicines that can be sold, supplied or administered by chiropodists (now called podiatrists) and extends the range of medicines that can be supplied or administered by certificated mountain rescue teams.

• The Mental Capacity Act 2005 will come into force gradually during 2007. New law (The Mental Capacity Act 2005 (Appropriate Body) (England) Regulations 2006 SI No 2810) covering authorisation and regulation of research on people who lack capacity to consent to their participation requires application for approval as an appropriate body from 1st February 2007 and recognition as such by the Secretary of State from April 2007.

• New law (The Mental Capacity Act 2005 (Commencement No 1) Order 2006 SI No 2814 (C95) brings sections 30-41 of the Act (covering research and the appointment of Independent Mental Capacity Advocates) fully into force on 1st April 2007.

• In November 2006, new rules from the MHRA relaxed the licensing rules to allow manufacturers to update labels and leaflets for OTC medicines without having to apply for specific approval. This Pharmaceutical Journal reported it on 11th November 2006, page 568. The PJ article refers to the first recommendations from MHRA's better regulation of over-the-counter medicines initiative (BROMI), published in May 2006.
  

October 06

• New law [The Health Act 2006 (Commencement No. 1 and Transitional Provisions) Order 2006 SI No. 2603 (C88)] implements section 33 of the Act from 1st October 2006. This provides power for amendment of the Medicines Act controls on supervisions and personal control. The nature of the changes will appear in future secondary legislation.

• Consultation (MLX334) is open on the extension of independent prescribing to optometrists (formerly known as ophthalmic opticians). A series of options for prescribing rights are proposed. Consultation closes 27th October 2006.

• Consultation (from MHRA but not numbered) is open on merging the MHRA advisory panels on Borderline Products and Advertising. This is to “promote more efficient use of resources by the membership, reduce duplication … allow external advisers to be used… as the need arises”. Consultation closes on 16th October 2006.

September 06

• New law (The Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006 SI No.1952 and The Medicines (Advisory Board the Registration of Homeopathic Products) Amendment Order 2006 SI No. 2386 bring homeopathic products into a modified safety and efficacy regime to allow them to acquire marketing authorisations as medicines. The remit of the existing advisory board is extended to allow review of homeopathic products with product licences of right (MLR pre 1971) and to scrutinise applications for marketing authorisations for “national homeopathic products”.

• New law (The Misuse of Drugs (Amendment No. 3) Regulations 2006 SI No. 2178) corrects some defects in the Amendment No. 2 Regulations (see June 06 below). Also removes the requirement to keep private scripts for Schedule 2 and 3 CDs (other than for veterinary medicines) on the pharmacy premises (they now have to go to the “relevant NHS agency” as part of the post Shipman requirements – for England this is the pricing bureau, now part of the NHS Business Services Authority). Also delays the implementation of requirement to record details of person collecting the CDs from 1st January 2007 to 1st January 2008 to allow time to redesign the CD register.

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August 06

• New law (The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 SI No. 1928) tightens further the procedures for conducting clinical trials. These regulations amend SI 2004 No. 1031) to implement the latest Good Clinical Practice Directive (2005/28/EC) covering among other things more conditions on design, conduct and reporting of clinical trials, duties of sponsors, inspection and enforcement and a duty to report serious breaches of good clinical practice.

June 06

• New law (The Misuse of Drugs (Amendment No 2) Regulations 2006 SI No 1450) comes into force partly on 7th July and partly on 1st January 2007.

• This implements numerous changes following the Shipman Inquiry, these are detailed and best summarised in the Pharmaceutical Journal article of 1st July 2006 p 25 - 29.

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May 06

• Consultation (MLX333) on proposal to remove requirement to keep originals of prescriptions for Schedule 2 and 3 controlled drugs. The existing requirement to keep originals for other POM scripts for two years will continue. This change is in anticipation of changes to the Misuse of Drugs regulations requiring pharmacists to submit private scripts for Schedule 2 and 3 CDs to the the pricing authorities (not yet in law). Consultation closes on 21st August 2006.

• New law (The NHS (Miscellaneous Amendments Relating to Independent Prescribing) Regulations 2006 SI No 913) came into force on 1st May. This amends three sets of NHS regulations to allow independent nurse and pharmacists to prescribe from the "whole BNF". Nurses have limited prescribing powers for certain CDs in certain situations; pharmacists cannot prescribe any CDs as yet until the Home Office has considered the matter.

• New law (The Medicines (Sale or Supply) (MIscellaneous Amendments) Regulations 2006 SI No 914 came into force on 1st May. This amends four sets of medicines regulations to require entries in the POM register for private prescriptions from "new prescribers", exempts supplies against their prescriptions from the obligations to use CRCs and allows them to prescribe Traditional Herbal Remedies.

• New law (The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 SI No 915 came into force on 1st May. This amends the POM order and the pharmacy and general sale - exemption Orders to change the names of "new pescribers"; they are now to be known as "community practitioner nurse prescriber", "nurse independent prescriber", "pharmacist independent prescriber", supplementary prescriber (no change) or "nurse independent/supplementary prescriber". [So "district/health visitor prescriber", "extended formulary nurse prescriber" and "first level nurse" are dropped]. This order also lists the CDs that can be prescribed by nurse independent prescribers under certain conditions (Schedule3A).

• New law (The Misuse of Drugs (Amendment) regulations 2006 SI No 986) came into force on 1st May. This amends the Misuse of Drugs Regulations to allow "nurse independent prescribers" (formerly extended formulary nurse prescribers") to prescribe certain CDs in certain conditions.

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April 06

• New law (The Medicines (Traditional Herbal Medicinal Products for Human Use) (Consequential Amendment) Regulations 2006 SI 395) brings the 1977 Order on retail sale or supply in line with new legislation.
  

• Please visit our Events 2006 link on the home page for details of forthcoming APPLET events.
  

January 06

• New law (The Misuse of Drugs Act 1971 (Amendment) Order 2005 SI No 3178 and (No 2) Order 2005 SI No 3372) brings ketamine under the control of the Act and regulations.

• New law (The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) (No 2) Regulations 2005 SI No 3324) adds further POM medicines to the list prescribable by extended formulary nurse prescribers and pilocarpine nitrate to the list prescribable by optometrists.
  

December 05

• December The National Prescribing Centre has published its Guide to good practice in the management of controlled drugs in primary care (England). This guide is likely to become the "standard of care" expected in relation to dealings in controlled drugs by all primary health care professionals in England.
  

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November 05

• New law (The Medicines (advertising Amendments) Regulations 2005 SI No 2787) makes amendments to the regulations controlling the advertising of medicines, including the removal of the prohibition on advertising for specific diseases. Any "oldies" who can remember a vague nmemonic about "Cataract, cancer, diabetes, epilepsy, fits, glaucoma, kidney disease, paralysis, TB and VD" can now forget it!
  

• New law (The Misuse of Drugs and the Misuse of Drugs (Supply to Addicts) (Amendment) Regulations 2005
  SI No 2864) amends misuse of drugs legislation to allow:
  

• CD prescriptions to be written in any form, including typing and printing, but the signature must still be handwritten

• The keeping of CD register in computerised form

• legitimate supply of ascorbic acid for "administering or preparing controlled drugs"

• extended formulary nurse prescribers to prescribe certain CDs (subject to expected amendments to the POM Order)

• New RPSGB guidelines have been published in the PJ
  

• Consultation (MLX 331) is taking place on proposals for amendments to the range of medicines which can be sold, supplied or administered by podiatrists (formerly known as chiropodists). Consultation closes 20th January 2006.

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October 05

• New law (The Supply of Relevant Veterinary Medicinal Products Order 2005 SI No 2751) made under the Fair Trading Act 1973 seeks to "remedy or prevent the adverse effects" of the former supply mechanisms for animal medicines. This includes requiring publication of net prices for supply, the prevention of vets from charging a fee for giving a prescription (although they can recover costs in alternative ways) and making it illegal to operate discriminatory pricing between supplies to vets and pharmacists.
  

• New law (The Veterinary Medicines Regulations 2005 SI No 2745) introduces a new regime for animal medicines. These are no longer controlled under the Medicines Act. The former body of law has been revised and re-enacted under the powers in the European Communities Act 1972. The supply categories for animal medicines are now changed: the P category has disappeared and distinctions are made between medicines for food animals and non-food animals.
  A summary of the changes can be found on the RPSGB website
  

• New law ( Medicines (Homoeopathic Medicinal Products for human Use) Amendment regulations 2005 SI No 2753) amends 1994 regulations on homoeopathic medicines by introducing new registration procedures and other amendments to parallel the licensing, marketing and presentation controls on allopathic medicines.
  

• New law (The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 SI No 2750) implements EU Directive 2004/24/EC and adds simplified registration processes for traditional herbal medicines to the licensing and marketing controls for medicines. Exemptions include the ordering or preparation of traditional herbal medicinal products by doctors, dentists or supplementary prescribers.
  

• New law (The Medicines (Advisory Bodies) (Terms of Office of Members) Regulations 2005 SI No 2788) establishes the new Commission for Human Medicines (replaces CSM) and their subcommittees (now known as Expert Advisory Groups)
  

• New law (The Herbal Medicines Advisory Committee Order 2005 SI No 2791) sets up the Herbal Medicines Advisory Committee to advise on any issue relating to the safety, quality and efficacy of unlicensed herbal or regsiterable herbal medicinal products.
  

• Consultation (MLX 330) is taking place on proposals for amendments to medicines legislation to allow supply and administration of medicines by members of mountain rescue teams. Consultation closes 13th January 2006
  

• The new NHS Redress Bill has been introduced into parliament. It is concerned with overhauling the system of compensation available to patients who claim harm has resulted from the provision of health services in hospital. The Bill provides for the establishment of ascheme to enable settlement of claims without the need to commence court proceedings. Note also explanatory notes at the same site

• The NHS Bill has been introduced into parliament. This is a typical "umbrella" piece of proposed legislation to take powers in a variety of areas. The most important proposals for pharmacy are in parts 3 and 4. Part 3, chapter 1 is concerned with powers to effect the Shipman recommendations, notably the appointment of an accountable officer and a duty to share information within NHS organisations and to create a right of entry to inspect CD arrangements.
  Part 3, chapter 2 proposes changes to the supervision and personal control arrangements in the Medicines Act 1968. In particular, there is a proposal for the designation of a "responsible pharmacist" to secure the safe and effective running of a pharmacy business, which may include the absence of a pharmacist from the premises. This person may not (except as provided in proposed regulations) be "responsible" in respect of more than one pharmacy business at any one time and must comply with a range of conditions to be specified in regulations.
  Part 4, chapter 1 proposes changes to the control of entry requirements in community pharmacy permitting the charging of fees and consideration of OTC medicine supply. Other parts of the Bill implement government policy on smoking bans in public places, prevention and control of health care associated infections and provision of information to NHS Counter Fraud services.
  See also explanatory notes on this weblink.

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September 05

• Consultation (MLX 329) is taking place on aspects of administration of radioactive medicinal products by suitably trained operators. Consultation ends on 11th November.

August 05

• Home Office consultation on changes to misuse of drugs legislation - i.e Misuse of Drugs Regulations 2001- applicable to England, Scotland and Wales (following Shipman report No 4). DHSS(NI) will consider similar changes for NI. A useful Summary of the changes in the PJ. Note there will be yet another consultation to come from MHRA on consequent changes to Medicines Act law.

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July 05

• Consultation (MLX 312) on proposals for a new national rules scheme for licensing homeopathics. This provides for a review of Product Licences of Right and to extend the remit of the advisory board. Consultation closes on 12th September 2005. Rules expected to operate from January 2006.

• New laws (The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 SI No 1507 and SI No 1520) extend supplementary prescriber status to registered optometrists (formerly registered ophthalmic opticians), extend the range of medicines that can be supplied by wholesale to "additional supply optometrists" and extend the range that those optometrists can themselves supply or order. Also add Water For Injection (WFI) to the list of parenteral medicines that can be supplied in an emergency without prescription AND allow WFI in 2ml ampoules to be supplied without prescription as part of "lawful drug treatment services".

• Consultation (MLX 325) on implementation of the directive on traditional herbal medicinal products: Directive 2004/24/EC. This will amend section 12 of the Medicines Act 1968. Annex A includes new requirements for pharmaceutical tests to be documented in the licence application, greter information for patients and requirements for pharmacovigilance. Consultation ends 8th September 2005. Should be in national law by 30th October 2005!

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June 05

• New law from Europe on hazardous waste (The Hazardous Waste (England and Wales) Regulations 2005 SI No 894) is conflicting with current and future practice in pharmacy. (Warning - the explanatory guidance is 43 pages long!) "Interim" guidance is now on the Society's website for community pharmacy and hospital pharmacy. Similar advice is on the PSNC website for community pharmacy and an explanatory article in the PJ could be useful. However, the interpretations may change.

• The "opsi" website for Statutory Instruments now also includes "explanatory notes" for some of them. The ones for medicines regulations seem to be blessedly short - 1 or 2 pages - but that is not always the case (see item on hazardous waste)

• DH letter and consultation on "Safe Management of Controlled Drugs" sets out the likely governance arrangements, including monitoring and inspection and a duty to share inspection information. Consultation closes on 30th September. Consultation on the detailed changes to handling CDs, such as record keeping, is still expected.

• A new Act (The Drugs Act 2005) has been passed which amends the Misuse of Drugs Act 1971, principally to strengthen police powers in relations to drug misuse. An order and regulations (Misuse of Drugs (Designation) (Amendment) Order 2005 SI No 1652 and The Misuse of Drugs (Amendment) (No 2) Regulations 2005 SI No 1653) now make it an offence to have any dealings with "magic mushrooms" (containing psilocin or an ester of psilocin) except where they are growing wild or being picked for destruction. So Glastonbury won't be the same again!

• New law (NHS (Pharmaceutical Services) Amendment No 2 Regulations 2005 SI No 1501) allow pharmacists to dispense scripts written by optometrists, clarify arrangements for control of entry and services in rural areas and enable PCTs to suspend more quickly a contractor under the fitness to practise arrangements. The regulations also clarify that where companies send declarations to the PCT, the relevant "home" PCT is the one in which their registered office is located and it will carry out checks on behalf of all the PCTs for which the company is included in a pharmaceutical list in England.

• New law enacted in January 2005 (The Medicines (Marketing Authorisations and Miscellaneous Amendments ) Regulations 2004 SI No 3224) introduced, among other things, a requirement from July 2005 that patient information be legible, clear and easy to use. Guidance on how this "user testing" should be carried out for patient information leaflets is now available on the MHRA website.

May 05

• Consultation (MLX 323) on European measures to improve the availability of paediatric medicines. This comprises incentives, regulatory measures and support for clinical research to reduce the number of "off-label" uses of medicines by encouraging the production of more appropriately labelled and formulated medicines for children. Consultation closes 17th August 2005.

• New website for UK legislation. The HMSO website for legislation now comes under the Office of Public Sector Information, "opsi". You will be linked to this site when you open the old HMSO links but this may terminate at some time in the future.

• New law (The Medicines (Advisory Bodies) Regulations 2005 No 1094) abolishes the Medicines Commission and the Committee on Safety of Medicines and replaces them with the Commission on Human Medicines (CHM). The regulations also make provision for controls on the constitution and functions of the CHM and any subordinate committees - in particular to promote probity and avoid conflicts of interest. Despite the title, these regulations also make significant changes to the licencing sections in the Act and Subordinate legislation. There are transitional arrangements for implementation by October 2005.

• New law (The NHS (Standing Advisory Committees) Amendments Order 2005 SI No 1100) abolishes the standing advisory committees, known as SMAC, SNAC and SPAC to us oldies!

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April 05

• New law(The NHS (PMS) (Miscellaneous Amendments) Regulations 2005 SI No 893) implements a range of changes notably including the extension of requirements for instalment dispensing on the NHS to diazepam and removing the restrictions preventing supplementary prescribers from prescribing CDs or unlicenced medicines.

• The Mental Capacity Act came into force on 7th April 2005 although most of its provisions will be transitional until late 2007. Formerly the Mental Incapacity Bill, this was the subject of a PJ article and seeks to set down criteria and legal tests "to empower and protect vulnerable people who are not able to make their own decisions". The sponsoring Department's website (Department of Constitutional Affairs www.dca.gov.uk) has some excellent simple guides which make good teaching material if you cover "consent". As does the DH website on the same topic.

• New law (The Medicines (Advisory Bodies) Regulations 2005 SI No 1094) abolish the Medicines Commission and the Committee on safety of Medicines and replace both with the Commission on Human Medicines (CHM). The CHM will have 18 members and a chairman; people who are in the pharmaceutical industry or who are shareholders in drug companies will be ineligible.

• New law (NHS (Pharmacutical Services) Amendment regulations 2005 SI No 1015) contains three corrections to the substantive regulations linked below (and is considerably shorter!)

• New law (The Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 2005 No 768) allow supplementary prescribers to prescribe unlicensed medicines and clarifies the definition of supplementary prescriber to include "a first level nurse, a pharmacist, a registered midwife, a chiropodist or podiatrist (yes, they are exactly the same thing), a physiotherapist and a diagnostic or therapeutic radiographer" All are, of course, subject to some limitations on what and when they can prescribe.

• Three new pieces of law (SI 2005 Nos 0764, 0765, 0766 ) (The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulation 2005, The Medicines for Human Use (Prescribing) Order 2005 and The Medicines (Pharmacy and General Sale - Exemption) Amendment Order 2005) make the following changes as from 7th April: Implementing exemptions to allow a range of supplementary prescribers to prescribe POMs; implementing the use of "advanced electronic signatures" rather than signatures in ink for prescriptions "created in electronic form"; extending range of POMs that can be supplied to or by opthalmic opticians.

• Guidance article from DH on the new contract; this is 105 pages long with six appendices.

• New law (SI 2005 No.641 The NHS (Pharmaceutical Services) Regulations 2005) supporting the new NHS contract in England has been belatedly published.The contents have been widely publicised; be aware the document is 138 pages long! These regulations replace the last consolidated regulations made in 1992 and all the almost annual amendments thereafter. Terms of Service for pharmacists can be found in Schedule 1. Of particular interest may be maintenance of the pharmaceutical list (Reg 4 and 5), types of application (Reg 6,7 and others), exemptions from the "necessary and desirable" test (Reg 12 and 13 and Fitness to Practise (Reg 19 and 21) with amplification in Part 3 concerning inclusion, suspension and removal from pharmaceutical list. Draft guidance on implementing the Fitness to Practise controls - initially only applicable to contractors - can be found on DH website. See also PJ Vol 274 16/04/05 p442.

• Amendment to pharmacists' and pharmacy technicians' Code of Ethics to require co-operation with inquiries into their or another healthcare professional's fitness to practise. Also introduces a requirement that the pharmacists abide fully by any undertaking made to the Statutory Committee.

• Reciprocal registration with Australia and New Zealand will end at noon on Friday 30th June 2006. Reciprocal arrangements with Northern Ireland remain in place.

• New law (WALES only) [The NHS (Pharmaceutical Services) (Amendment) (Wales) Regulations 2005 No 1013 (W.67)] came into force on 1st April 2005. These are the "new NHS contract" rules and Terms of Service that will apply to pharmacy contractors in Wales. They are formulated as amendments to the substantive regulations for England and Wales of 1992 (SI 1992 No 662). The "Welsh contract" is initially very similar to that in England but will change over time.

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March 05

• Note that Stat Comm determinations are now available on the site within RPSGB link and the professional regulation section of the curriculum material.

• New law (SI 2005 No 271) adds schedules 2, 3 and 4 CDs to the treatments that can be prescribed by supplementary prescribers within a clinical management plan.

• Consultation (MLX321) on proposals to introduce independent prescribing by pharmacists. Seven options are possible: no change, prescribing for certain conditions from a limited formulary, for any condition from limited formulary, for specific from a full formulary, for any condition from a full formulary, different approaches dependent on the clinical setting and "a hybrid approach". Consultation closes 25th May 2005.

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February 05

• Consultation (MLX 320) on proposals to extend the scope of independent prescribing by extended formulary nurse prescribers. Five options are possible: no change, prescribing for any medical condition from a limited formulary, prescribing for specific medical conditions from a full formulary, prescribing for any medical condition from a full formulary and advanced practice nurses with a higher level of competencies. The inclusion of CDs is a further option. Consultation closes 23rd May 2003.

• Information about PLEA seminar, May 2005, now available on PLEA pages.

• An afternoon session devoted to confidentiality issues and access to patient records is being planned for BPC at Manchester, Monday 26th September. Check BPC for details as they develop.

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January 05

• Consultation (MLX 318) on proposed Herbal Medicines Advisory Committee. This would be a new committee under section 4 of the Medicines Act and is part of the restructuring process for licencing advisory bodies set out in MLX 300 (February 2004. Consultation closes 22nd April 2005.

• Further MHRA consultation (MLX 316) on changes to the Medicines Commission (provisionally to be called the Committee for the Safety and Efficacy of Medicines) and stricter controls over possible conflicts of interests. (Add to proposals in MLX 300, below). Closes 11th February 2005.

• Phase 2 report from RPSGB on Competencies of Future Pharmacy Workforce. Important implications for undergraduate pharmacy teaching (amongst others).

• Department of Health consultation on Making the best use of the pharmact workforce. Proposes radical changes to the law and interpretation of personal control of pharmacies and supervision of POM and P medicines. Closes 11th March 2005.

• RPSGB changes to Code of Ethics: amendments have been made to part 2B (Professional Competence) to reflect new mandatory requirements for CPD and interim amendments concerning standard 9: Online Pharmacy Services. see also explanatory PJ article. (p 889, 18/25 December 2004)

• Website containing resource for patient group directions (PGDs) launched at end of 2004 available within the website of National Electronic Library for Medicines.

• Book Review Medical Records: Use and Abuse by Heidi Tranberg and Jem Rashbass. Radcliffe Medical Press, 2004. ISBN 1 85775 604 5. Review by Joy Wingfield published in PJ (p885 18/25 December 2004).

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December 04

• Pharmacy Law and Ethics Association (PLEA) Day conference for primary care pharmacists on risk and liability rescheduled to Thursday 14th April 2005.

• Book review Pharmacogenomics: Social, Ethical, and Clinical Dimensions, by M A Rothstein. John Wiley & sons, 2003, ISBN 0471227692. Review by A Hedgecoe, published in the Journal of Medical Ethics (2004;30:e6).

• Book review Pharmaceutical Ethics, by S Salek. John Wiley & sons, 2002, ISBN 0471490571. Review by F Wells, published in the Journal of Medical Ethics (2004;30:e2).

• MHRA consults in two areas: changes to the law in the MLX series and applications to reclassify medicines in the ARM series. Both are on the MHRA website consultations. There are too many ARMs to list individually but the latest consultation ARM 25 on reclassifying chloramphenicol eyedrops 0.5% from POM to P is rather special! Consultation closes 20th January 2005.

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November 04

• The Royal Pharmaceutical Society of Great Britain has published its response to the recommendations of the Shipman Inquiry Fourth Report The Regulation of Controlled Drugs in the Community.

• Consultation (MLX314) on proposals to add Naloxone to the range of prescription only medicines which can be administered parenterally by anyone for the purpose of saving life in an emergency. Also proposed is the removal of Diphenhydramine and Mepyramine. Consultation ends 17th January 05.

• Detailed information on the community pharmacy NHS contract is now available from the PSNC website (ignore the £12 fee for glossy version and go to "service specs" links) and a "PCT" version is on the DH website.

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October 04

• Consultation (MLX313) on allowing "people employed in needle exchange schemes" to supply Water For Injection (WFI) without the need for a prescription or PGD. It is not clear whether this proposal covers community pharmacists as well as personnel at a drug treatment centre, but this is likely. Proposals include a maximum volume for individual ampoules of WFI of 2mls, in packs of no more than 10. Consultation ends 11th January 2005.
  Also article in Pharmaceutical Journal page 634 'Water for injections restrictions to be eased'.

• Reports of PLEA's successful BPC seminar on clinical negligence and pharmacy practice have been added to the PLEA seminar pages, together with links to the presentations on the BPC2004 website (Scroll down to Derby Room).

• A revised version of the Consensus Curriculum map is available on the website. This is the version presented to the RPSGB and subject to Council approval, the Education Committee has resolved to use as a range statement to supplement the Society's indicative syllabus for the pharmacy degree course. A full report is being written and will be disseminated as soon as possible.

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September 04

• Copies of materials used at the 13th International Social Pharmacy Conference Malta, for a workshop on Research Ethics. Now available in the Teaching Resources section of the project website.

• Bulletin 12 of the project has a useful guide to new information on the RPSGB website.
  

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August 04

• Consultation (MLX 310) on extending the use of "advanced electronic signatures" to all POM scripts (not CDs). Prescribers will still be able to sign by hand but will not be able to print an electronic signature onto a paper script. Consultation ends 29th October 2004. A "advanced electronic signature" is defined in the Electronic Signatures Regulations 2002 SI No. 318 as an electronic signature which is (a) uniquely linked to the signatory,(b) capable of identifying the signatory,(c) created using means that the signatory can maintain under his sole control, and (d) linked to the data to which it relates in such a manner that any subsequent change of the data is detectable. (Not a lot of people know this...)

• New information about PLEA seminar on clinical negligence at the BPC conference, Manchester, Wednesday 29th September

• Advance information about PLEA/PDA day conference for Primary Care Pharmacists - legal limits and liabilities at Edgbaston, Thursday 4th November 2004.

• Advertising over the counter medicines, written by Professor Joy Wingfield for the Cardiff Centre for Ethics, Law and Society.
  

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July 04

• New Law (SI 2004 N0 1768) changes the NHS complaints procedures to require that, where local resolution is not achieved, complaints should be referred to the Commission for Healthcare Audit and Inspection (CHAI, now known as the Healthcare Commission).

• Useful article from the Pharmacy Magazine (May 2004) on the practical implications of "named-patient" basis prescribing and the use of unlicensed medicines.

• Article on accountability and responsibility for supplying dispensed medicines with examples of application. Pharmaceutical Journal (Vol 273, 3rd July 2004 pp35-37). Also under "professional governance" in teaching resources.

• Approaches to Ethics in Higher Education: Teaching Ethics across the Curriculum. Review by Joy Wingfield of a report prepared for the ETHICS project by Susan Illingworth, published by the Philosophical and Religious Studies Subject Centre, Leeds, March 2004, 95pp.

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June 04

• New Law (NHS Reform (Scotland) Act 2004 asp 7) provides powers to modernise NHS law in Scotland including devolving power to local communities, strengthening public involvement and health improvement. (Anyone in Scotland like to provide comentary on what this really means on the ground?)

• New Law (SI 2004 No 1480) removes long-standing restrictions on the advertising of OTC medicines for a range of "serious" conditions (although some still remain: chronic insomnia, malignant disease, diabetes, HIV, TB and STI - see previous full list in 7th Ed Dale Appelbe p42). Allows future advertising of Zocor Heart Pro (simvastatin).

• A "preview version" has been launched of the National Prescribing Centre guide to good practice in the management of CDs in primary care in England. This is a comprehensive resource; sections are in two parts: clarification of current key legal controls and good practice suggestions - we may expect to see some of the latter become legal requirements after the Shipman Enquiry reports.

• Consultation (MLX 306) (word doc) proposes that optometrists with specific training should be allowed to sell or supply in an emergency, and privately prescribe, a range of POMs to treat infections and allegic conditions. Also proposes to remove the emergency restriction upon sale or supply of P and GSL medicines in the course of a optometrist's professional practice. Closes 27th August 2004.

• Two PJ reports on the PLEA pages about the May PLEA seminar on "A Fair Blame Culture - the legal and ethical consequences of error reporting". Printed copies of powerpoint and handouts are available from Joy Wingfield Special Professor, School of Pharmacy, Nottingham.

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May 04

• Consultation (MLX 305) proposes an expansion of supplementary prescribing powers to chiropodists (podiatrists), physiotherapists, radiographers and optometrists. (all now members regulated by the Health Professions Council). Close 9th August 2004.

• New Law (SI 2004 No 1189) implements extension of independent (extended formulary) nurse prescribing powers to include hydrocortisone, hyoscine and clavulanic acid. Also implements extension for paramedics to administer reteplase and tenecteplase. Also extends supply under PGDs to dietitians, orthotists, occupational therapists and speech therapists.

• New Law (SI 2004 No 1190) adds P and GSL medicines to supply under PGDs by dietitians, occupational therapists, orthotists and speech therapists.

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April 04

• New Law (Welsh SI 2004 No 1021) implements "consequential" amendments following implementation of new GP contract in Wales.

• New Law (Welsh SI 2004 No 1018) extends the ability to arrange repeat dispensing contracts across Wales.

• New Law (SI 2004 No 922) extends the list of PCTs who can arrange for repeat dispensing contracts in their locality. Also makes some "consquential" amendments following the new GP (nGMS) contract.

• Consultation (MLX 304) proposes exemptions to allow the supply of broken pack GSLs by prison staff outside hours of medical/pharmacy staffing. Mainly applies to analgesics and indigestion remidies. Closes 1st July 2004.

• Consultation (MLX 303) proposing further extension to independent (extended formulary) nurse prescribing powers. Mainly covers emergency care, out of hours care and walk-in centres. Wide range of POMs for urgent conditions. Closes 13th July 2004.

• PGDs Useful guide on what they are, when (and when not) to use them, how to prepare them, FAQs and competency framework for health professionals using PGDs.

• New APPLET Email Discussion group launched to replace the web discussion board.

• PLEA seminar, 12th May 2004, London. The legal implications of error reporting. Programme now available. Contact Gordon Appelbe to attend.

• Article by Joy Wingfield, 'How the new NHS code of practice on confidentiality affects all pharmacists', Pharmaceutical Journal (Vol 272, 3 April 2004 pp 416).

• April 2004 checklist of important health circulars and web addresses. Back issues are available from Pharmacy Management

• The Scope of pharmacy ethics - an evaluation of the international research literature, 1990-2002.
  Joy Wingfield, Paul Bissell, Claire Anderson. Social Science & Medicine 58 (2004) 2383-2396.

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March 04

• Consultation (MXL 229) proposes to reform regulation of unlicensed herbal remedies made up for individual patients. Closes 7th June 2004.

• New Law (SI 2004 No 470) removes the restrictions on the sale of methylated spirits in England, Wales and Northern Ireland between 10pm on Saturday evening and 8am on the following Monday morning. Restriction remains in Scotland.

• MHRA consultation (MLX 301) on proposal to add antidotes to chemical warfare agents to the list of medicines that anyone can inject to save life in an emergency.

• Replacement law (SI 2004 No 629) for the NHS "blacklist" and "limited list". These regulations list drugs, medicines, etc that GPs may not prescribe/prescribe within limits on the NHS. The lists will continue to appear in the Drug Tariff.

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February 04

• Consultation (MLX 300) proposes a review of the advisory bodies under the Medicines Act - mainly the Committee on Safety of Medicines and the Medicines Commission. Aims to amalgamate their functions, to retain the Veterinary Products Committee and the British Pharmacopeia Commission and to formalise a range of Therapeutics Advisory Groups. Suggests that members of the pharmaceutical industry will no longer be eligible for the main committees and the introduction of an advisory panel. Closes 17th May 2004.

• Article on Integrating practice and science at East Anglia. Article in the Pharmaceutical Journal (Vol 272, 31 January 2004 pp130)

• New in the NHS section of teaching resources Guide to the NHS for members and officers of health scrutiny committees, November 2003.

• Latest update to the PGD flowchart (version 5) produced by the Pharmacy Community Care Liaison Group.

• New link to DHSSPSNI (Department of Health, Social Security and Public Safety Northern Ireland) has been added to the NHS teachers resource pages. Includes a link to the DHSSPSNI strategy for community pharmacy.

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January 04

• Consultation (MLX298) on the inclusion of unlicensed medicines with a clinical management plan (supplementary prescribers).

• New Law (SI 2004 No 001) permitting the use of "written directions" for extended formulary nurse and supplementary prescribers to authorise administration of P medicines to hospital patients.

• New Law (SI 2004 No 002) formalising the form of "written directions" to be used by extended formulary nurse and supplementary prescribers to authorise POM medicines for hospital patients. Also extends routes of administration available to extended formulary nurse prescribers (eg adding oral erythromycin to external use).

• New Law (amendment directions) from 4th December 2003 in England, to allow repeat dispensing to be provided within LPS schemes (including pilot and new schemes) and for repeat dispensing services to include scripts written by independent nurse prescribers and supplementary prescribers.

• Guidance for brand name prescriptions updated. Article in The Pharmaceutical Journal (Vol 272, 17 January 2004 pp46)

• Consultation on the extension of Patient Group Directions (PGDs) to allied health pofessionals: Dieticians, Occupational Therapists, Prosthetists and Orthotists and Speech and Language Therapists. Legislation expected in April 2004.

• Building a Safer NHS for Patients: Improving Patient Safety January 2004 This is a lengthy report but is a treasure house of practical examples of errors and ways to avoid them. Contains case studies of errors which could be used for workshops or OSCEs and several recommendations for undergraduate education about patient safety.

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December 03

• New Law : Passing of new Health and Social Care Act (England and Wales only) which includes provision for foundation hospitals, changes to governance in health and social care (Commission for Health Care Audit and Inspection CHAI and Commission for Social Care Inspection CSCI) and other minor matters.

• Ban to be lifted on disclosure of manufacturers information. Consultation on Section 118 of the Medicines Act.

• Reporting of adverse reactions extended to medical devices. The Pharmaceutical Journal (Vol 271, 6 December 2003 pp780)

• Patient Safety Four articles in the Pharmaceutical Journal on patient safety.

• Web Links page now has link to RPSGB Library

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November 03

• Methotrexate an article in the Law and Ethics Bulletin by the Professional Standards Directorate on the need for dispensing vigilance.

• Final version of NHS Code of Practice on Confidentiality announced.

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October 03

• New Law (SI 2003 No 1618) Warnings. Reye's Syndrome, under 16, asprin, aloxiprin.

• New Guidance on transitional labelling for asprin 75mg. (See also RPSGB links / Law and Ethics bulletins)

• New Law (SI 2003 No 2317) CRC aspirin, paracetamol, iron, white colouring.

• New Law (SI 2003 No 2429) allowing extended formulary nurse prescribers to prescribe diazepam, lorazepam and midazolam for palliative care and generally prescribe codeine phosphate, dihydrocodeine tartrate and co-phenotrope. Also allows a registered nurse to supply diamorphine under a PGD for cardiac pain in hospital. See also PJ report page 4.
  

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September 03

• Assessment materials from ULSOP and Nottingham .

• New Fact Sheet No 12 Confidentiality issued by RPSGB. Includes some useful scenarios and FAQs.
  

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August 03

• New Law (SI 2003 No 1653) Supply paraphernalia to injecting drug misusers (WFI requires script)

• Teaching resources section redesigned.

• Links to recent articles on the NHS (England, Scotland and Wales).

• New secure password protected area launched. Passwords issued to authorised users.

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May 03

• New Law (SI 2003 No 1084) Pathfinder repeat dispensing sites. Specifies locations and changes to supply arrangements.
  

April 03

• New Law (SI 2003 No 0696) Supplementary prescribing, nurses, pharmacist. PGD outside NHS.

• New Law (SI 2003 No 0697) Allows P and GSL medicines on non-NHS PGD's.

• New Law (SI 2003 No 0698) Amendments to records for supplementary prescriber scripts.

• New Law (SI 2003 No 0699) Allows dispensing of supplementary prescriber scripts.
  

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Last modified: April 2007.