Medicines legislation to be consolidated
November 22, 2011 by admin
The MHRA is consulting on plans to consolidate and review UK medicines legislation to provide a clear, coherent regulatory framework (see here for the consultation details - the deadline is 17 January 2012).
About 200 statutory instruments and much of the Medicines Act 1968 could be replaced with one set of regulations that will be shorter and simpler - much of the existing law is obsolete - and provide a platform for future changes. Some policy changes are also included, with the proposal to remove the need for pharmacists to attempt to contact the prescriber before making certain changes to prescriptions probably attracting the most comment. The aim is to allow pharmacists to optimise the use of medicines - for example by adjusting an antibiotic schedule. At present, pharmacists can only make these changes if they have tried to contact the prescriber but failed. This suggestion has attracted questions about where the legal responsibility lies, whether there is a conflict of interest for the pharmacist as the seller of drugs, and whether adverse events reporting would be compromised.
Another change will remove statutory warnings and replace them with warnings in the relevant marketing authorisation, a speedier and more flexible system. A different proposal will remove some of the current exemptions from the Act that allow health professionals and other people to sell, supply and/or administer medicines, and extend or introduce others, for example about water for injections. The suggestion that the appropriate professional bodies should hold and maintain the list of medicines that can be accessed by their particular professional group, rather than the lists being specified in statutory instruments, with all that implies, is being considered separately.
Finally, what will happen to Patient Group Directions (PGDs)? Well, their current general structure and requirements will be retained, and only registered health professionals will be able to use them. But it is proposed that NHS bodies should be able to supply medicines not from pharmacies according to the directions of independent nurse, pharmacist and optometrist prescribers, as they can currently for doctors and dentists. Other proposals relate to the way independent hospitals, clinics and agencies are registered with the Care Quality Commission, and removing the distinction as far as PGDs are concerned between NHS-funded dental services and others. Unlicensed medicines will continue to be excluded from the scope of PGDs.
ANP Chair, Barbara Stuttle, said, “The law has certainly become confusing - this is a chance for us all to influence the system we work under - and it could produce something we can all work with!”
DH consults on independent prescribing by podiatrists and physiotherapists
October 20, 2011 by admin
Should independent prescribing be extended to podiatrists and physiotherapists? The Department of Health and MHRA have published two consultations with these proposals, which can be found here. The deadline for responses to both is 8 December 2011.
The physiotherapist consultation proposes that physiotherapists can become independent prescribers and that physiotherapist independent prescribers should be able to mix medicines before administration, and direct others to do so, and to prescribe some specified controlled drugs independently. Those physiotherapists who are currently supplementary prescribers would have to undergo additional training to become independent prescribers. The proposals would need changes to the Misuse of Drugs Regulations 2001, as well as to the Medicines Act 1968. Independent prescribing of unlicensed medicines is not included in either document.
The consultation sets out the list of options, ranging from prescribing for any condition from the complete formulary, to prescribing for specified conditions from a specified formulary. The proposals for podiatrists are similar and both consultations give examples of areas where independent prescribing could be useful.
An analysis of the responses to last year’s engagement exercise (see here) is included in the consultations, and shows a lot of support for the option of prescribing for any condition from the full formulary (option 5). The most limited extension - independent prescribing for specified conditions from a specified formulary - found support with the BMA and the Royal College of Physicians, among others. The more limited versions are likely to require frequent revisions to the lists of conditions and/or formularies, a process that those nurses who were prescribing before the formulary was opened up will remember only too well!
The future of PGDs - have your say
November 10, 2010 by admin
Do Patient Group Directions (PGDs) prevent professionals getting non-medical prescribing qualifications? Are they now being used to manage planned care? Should they be retained and if so what changes could be made? Do they foster innovation and improvements in care? Are they bureaucratic? Are there other groups of health professionals who should be able to use PGDs? The Medicines and Healthcare products Regulatory Agency (MHRA) has launched an informal consultation about the provisions for PGDs in the NHS and private sector and other related matters and would like responses by 19 November. Revised guidance may accompany any new legislation, as the review offers the opportunity to look at this as well, and to clear up any misunderstandings.
Medicines legislation review
October 17, 2010 by admin
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched an informal consultation about future provision for the exemptions to the Medicines Act that allow health professionals, and also others, to sell, supply and administrate medicines. The deadline for responses is 1 November.
The MHRA is considering a major simplification of the current processes, in addition to its specific proposals for each of the current legal provisions. At present, for health professionals, the current mechanism is that changes to specific lists of medicines covered by the exemptions must be made by legislation following consultation. This can be a lengthy process that does not respond quickly to changes in professional practice, which can mean treatment delays for patients. The MHRA is suggesting that instead of the law specifying lists of medicines, and any attached conditions, it would specify the health professionals that are allowed to sell, supply or administer medicines. What they are allowed to sell, supply or administer would be determined by the “relevant statutory regulatory body” - so the current consultative and legislative processes would not be required. The MHRA says this is an idea that needs further discussion and exploration, and is seeking views on it now.
Among the specific proposals is one concerning the administration of a specified list of medicines by anyone - not necessarily a health professional - for the purpose of saving life in an emergency. The MHRA intends to retain the list but is asking for views on possible changes, perhaps including medicines used in cardiac arrest. It is also asking for views on whether there should be a separate provision allowing people who hold the Resuscitation Council’s Advanced Life Support to administer these medicines in emergencies involving cardiac arrest.
Online medicines project suspended
September 20, 2010 by admin
The Medicines and Healthcare products Regulatory Agency (MHRA) has said it has ‘no immediate plans’ to proceed with the project to make medicines’ product information available online. It launched a discussion about whether this would be useful earlier this year (see here). Despite this and other research indicating support for a ‘credible, centralised and easy-to-use database’, the MHRA has called a halt, for now, to the project, citing the economic climate.
MHRA warns against Bonjela for use in under-16s
April 25, 2009 by admin
Bonjela and Bonjela Cool Mint Gel should not be used by people under 16 years of age, according to a new recommendation from the MHRA issued on 21 April. Other Bonjela products are not affected.
The new advice is that “topical oral pain relief products containing salicylate salts should be contraindicated in children and young people under the age of 16 years”. New packaging and patient information is expected to be available in May.
The MHRA says that this is a precautionary measure because of the theoretical risk of Reye’s syndrome, and brings these products into line with others containing oral salicylates. MHRA advice is that those under 16 should not take aspirin unless recommended by a doctor.
By April 2009, the MHRA had received a total of three suspected serious Adverse Drug Reactions (ADR) reports associated with the use of topical oral gels containing choline salicylate in children: Reye’s syndrome was suspected in all three but confirmed in none.
One other product is also affected: Pyralvex is a pharmacy-only product, an oral paint containing salicylic acid for denture and mouth ulcer pain for people over 12 years old; the new advice is it should only be used in those over 16.
The MHRA suggests alternatives to these products. For infant teething pain, it says gentle pressure with something cool may be helpful; a number of products containing a local anaesthetic/mild antiseptic that do not contain a salicylate can be used for teething pain or mouth ulcers; salt water mouthwashes are recommended for pain associated with orthodontic devices; and paracetamol is suggested for discomfort linked with tooth movement.
MHRA warning about cough and cold medicines in under-sixes
April 10, 2009 by admin
The MHRA has said that a number of over-the-counter (OTC) cough and cold medicines should no longer be used in children under the age of six (see here for the detailed advice and the list of products affected). The MHRA says that there is no robust evidence that they work and they can cause side effects, such as allergic reactions, effects on sleep or hallucinations. Parents and carers should follow the Department of Health 2007 “Birth to Five” guidance .
For older children, aged six to 12, these medicines will continue to be available, but only through pharmacies, and with clearer advice on the packaging and from pharmacists. Older children should not be given these medicines as first-line treatments and not for more than five days, and the medicines will have stronger warnings on the packaging and labelling.
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