Below is a list of answers to the most frequently asked questions about clinical indications. This version was prepared by Dr Nigel Masters, a General Medical Practitioner on 16 September 2006.
If you have a question that is not adequately answered elsewhere on the site please contact us and we will do our best to answer it.
The essential feature of indication labeling is the direct linking of the named medication with the clinical indication. It is a form of drug knowledge management and the prescriber provides the information link. This connection may be seen both in medical notes and on prescriptions in a wide variety of healthcare settings.
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General practitioners are the main source of repeat medication in the United Kingdom and with the rapid rise of preventative poly-pharmacy it is easy for patients to be bewildered by their list of medications. Although drug inserts and information leaflets are available, they are often not specific and directly related to the clinical indication for which the medicine has been prescribed. Prescriptions with clinical indications are very popular with patients, carers, primary care staff and pharmacists. In addition, such prescriptions are particularly helpful for the elderly and also those patients on numerous drugs such as diabetics. For example In America senior citizens on the Medicare scheme have on average six prescriptions each.
In training practices clinical indications can be helpful to doctors and health students who are learning the wide use of common drugs. In the new GMS2 contract for general practitioners there is a quality marker which states that for repeat medicines an indication for the drug can be identified from the records (minimum standard 80%) and clearly this can be easily demonstrated in this way.
At present there are no quick ways to provide the clinical indications for each repeat script. Thus they are written as free text alongside the drug directions. An attempt is made to limit the clinical indication to three words, e.g. to lower blood pressure. A pilot practice (5,800 patients) took one and half years to enter the free text to each repeat prescription such that it attained 85% coverage. In one week of observation there were 1,200 repeat items with attached clinical indications produced by the practice.
In existing computer systems short codes, or macros, can make the task slightly easier. Hopefully in the future such clinical indications will become a standard feature of computerised prescribing packages thus making the doctor’s task easier. At one practice using Vamp vision the clinical indications have been incorporated in the computerised practice formulary so that it is easy to deliver the clinical indications on prescriptions.
The clinical indications provide clear guidance as to why a drug has been prescribed and therefore enhance patient safety. Certain clinical indications cover sensitive issues and patients should be asked if they are in agreement with placing an item of information on the prescription list, examples include epileptic and cancer patients. Patients who do not wish to have a clinical indication recorded can have the phrase - patient preference no clinical indication - on their repeat prescription.
The use of clinical indications could be mentioned in the practice leaflet, stressing the safety benefits in the repeat prescribing section. Pharmacists will record the clinical indication with the directions and thus packages left visible in shared accommodation could be seen by others, but patients can be advised that they should be more discreet with their medicines. In the future, drug packages could have clinical indications added or missing from the label by ticking a box on the prescription pad, which would inform the pharmacist that the clinical indication should not to be written on the label.
General Practitioners in the United Kingdom issue 1.3 million prescriptions every single day and thus medication errors will occur. Indication labeling can provide simple safety to health staff and patients to reduce the risk of mistakes. Indication labeling ensures the correct drug is issued for the correct condition. Drugs with similar names can be prescribed in error, e.g. carbimazole for thyrotoxicosis and carbamazepine for epilepsy and this is less likely to happen. In addition drugs can have many uses such as atenolol ‘to lower blood pressure’, ‘to prevent palpitations’, ‘to prevent angina’, ‘to prevent heart attacks’, etc, and such clarity helps other health staff to link the correct illness with the use of the drug. Some drugs need a specific phrase to ensure clear understanding thus methotrexate ‘take four tablets ONCE weekly ‘ and the use of standard phrases would enhance safety. The wide range of asthma inhalers can lead to confusion so the addition of a specific colour to the prescription should enhance safety e.g. salbutamol inhaler to relieve asthma symptoms (blue inhaler).
Some drugs need more specific safety labeling. For example the contraceptive pill is linked to the phrase ‘yearly blood pressure check required’. Time limited prescribing can have a stop date placed on the repeat prescription, e.g. warfarin for prescribing for deep vein thrombosis, tamoxifen prescribing for breast cancer. Some drugs require frequent blood checks and this can also be added - ‘regular three monthly blood tests required’. Thus automated updated safety information labelling would be very helpful in the future.
The government is keen to encourage the use of non-medical prescribers such as pharmacists and nurses and, as they have a limited specific indications list, such linking of prescribed item and it’s clinical use would enhance safety. Prescribing errors will be reduced if all those involved in this activity are informed and advised, especially patients, carers, pharmacists and other health staff - we simply cannot rely on the prescriber and the ‘intelligent’ computer to prevent medication errors. For example avoid erythromycin is recorded on all simvastatin scripts as these drugs can interact to cause a serious myopathy.
At present there is no evidence that clinical indications assist with adherence with prescribed drug regimes, although intuitive thinking would suggest that this would be beneficial. Current methods of improving medication adherence are considered costly and relatively ineffectual and further innovation is required.
A small survey at our practice has been carried out on the use of statins, which have been shown in many studies to have poor compliance rates. This survey showed very high compliance rates. In addition the practice also had high levels of clinical indications on the repeat scripts. The project suggests that these two features may be linked but prospective studies with controls should be undertaken to see if this innovation really does improve drug adherence.
In order to make this an efficient service, the clinical indications should be standardised as much as possible. Of course individual clinical indications should continue, but they are less likely to be adapted to computer shorthand techniques. Such lists linked to the repeat prescriptions provide a rudimentary active patient summary list and this can be useful both out-of-hours to emergency health staff and other visiting medical personnel. Staff can easily audit clinical indication by checking the number of repeat drugs leaving the surgery without a stated clinical indication. This can be referred to as a the clinical indication departure audit whereas checks of medication use drug charts at nursing homes provides a clinical indication destination audit.
A survey in 2004 on the www.onmedica.net website of 360 general practitioners showed that 70% were in favour of clinical indications being added automatically to all repeat prescriptions. (Nevertheless the developer of clinical indications believes that prescribers should pick recommended phrases from lists and does not recommend automatic use of standard phrases. In addition the prescriber should remain medicolegally responsible for the addition of the clinical indication phrases.) This website includes numerous comments by general practitioners – look under polls. This future direction will require a small core group with the umbrella title ‘Clinical Indications Development Unit’ (CIDU). This unit will provide a centre to hold the clinical indications dictionary and hopefully work with the British National Formulary to fully realise the concept. Clearly, working with the drug dictionary computer suppliers and other IT infrastructure will be vital. Clinical indication prescribing will be valuable both in hospices and in the prison service, which often act independently of the NHS pharmaceutical service.
The clinical indications may also be translated to other languages to aid understanding of drug use. The clinical indication information will be of great value for future research in drug costs and off label drug use.
Careful wording may enhance drug performance e.g. ’to promote positive mood’ on the drug label and this needs careful evaluation. Another feature that could be developed with indication labeling is the supply of disease information leaflets by the pharmacist with the prescription. For example if allopurinol is given to prevent gout the prescriber could add ‘please supply information leaflet for the prescribed condition (gout) at the pharmacy’. At present only general leaflets about the drug are given to the patient. Indication labelling is a United Kingdom innovation but countries with ageing populations and polypharmacy will also need to copy this lead.
In the future clinical indications linked to prescriptions may be medico-legally essential to justify the inherent risk of the medication. A comparison can be made with the use of x-ray radiography in patient care where it is mandatory to explain the clinical indication to justify exposure to a potentially hazardous procedure. It could be argued that medicines are potentially far more hazardous than X rays tests to individuals. It is probable that clinical indication labeling can help in risk management by providing other key heath workers with information to balance risk and benefit of a prescribed medicine to a given individual. This is particularly helpful to dispensing pharmacists who are at present uncertain about the risk versus the benefit in any given patient.
A Clinical Indications Directory as been developed at a local general practice Which contains commonly used drugs and the linked clinical indications. This directory will require refinement and adaptation over time to enhance the delivery of this useful information. The first version was created in April 2005.
View the sample directory.
The best way to start is for the clinician, usually the general practitioner, to set simple targets by focusing on certain patient groups such as the over 75 years, then over 65 years – such age banding is visible on the repeat prescriptions. This can be very time-consuming as many patients are on a large number of repeat prescriptions, but these will be the most useful in the long-term. The next groups to target are those in the new GMS targets, such as the diabetics and heart disease patients. Some practices have simply adopted the pragmatic approach that any patient on more than four medication items should have clinical indications added to their listing. Hopefully, having been encouraged by the feedback from staff and patients, it will soon start to become an everyday routine!
On 26 October 2004 Clinical Indications won the overall GP Enterprise Award 2005 for innovation in primary care (Risk Management Category). Dr Stephen Ladyman Health Minister and also Dr Roger Neighbour President of the RCGP presented the award at the House of Commons. On the 11 November 2005 Sir Graham Catto President of the General Medical Council presented Clinical Indications with the BUPA Communication Award. In 2005 Clinical Indications was also a finalist in the Medical Futures competition (Patient Safety category) and also the Guidelines in Practice Awards (Medicines Management Category). In 2006 Clinical indications was given a Judges Commendation in the IT/Knowledge Management Category for the South East NHS Innovations Awards. You can find out more at the awards page.
As this is a novel way of prescribing, the widespread use of indication labeling will require an educational program to help prescribers use such information safely and effectively. Initially this could become part of the medical education program, which is involved with prescribing and patient communication for medical undergraduates. However all prescribers will need training to ensure efficient delivery of this significant prescribing development.
Clinical indications have been very grateful for all the encouragement provided by healthcare staff and patients, in particular those involved with Highfield Surgery, Hazlemere, and High Wycombe Buckinghamshire. In addition it is pleased to thank Wycombe Primary Care Trust which hosts clinical indications on the medicines management part of their website. Also clinical indications wishes to thank Mary Newland Art Educationalist NDD MBE for her generous donation for graphic design work.
Clinical indications would like to encourage research in this prescribing development but it does not have access to funds. Dr Masters would be happy to assist any healthcare staff that needs help for research. For example the BUPA Foundation would be keen to support such research to rigorously evaluate the use of this novel communication. Dr Nigel Masters can be contacted at [email protected] In addition The Florence Nightingale Foundation would consider grants to nurses exploring this prescribing system.
Patients have been delighted by this initiative. Feedback at the pilot practice has been very positive. For example ‘It enables me to be in control of my own health’. ‘It puts patients’ minds at rest’ ‘For carers, etc, it would be another check that the right drug was being used for the right complaint’ ‘Some people may not want others to know their health details’. Only two patients have requested changes to their clinical indication wording in three years and only two other patients have asked to have ‘patient preference – no indication’ written on their prescription.
A patient focus group was held on 18 October 2005 to discuss clinical indications. This was an expert cardiac patient group who learnt about clinical indications and the phrases attached to cardiology drugs. The meeting was positively received and the patients hoped this new concept would succeed. In addition certain word changes were requested and will be incorporated in future versions of the formulary.
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This describes good clinical practice in the use of clinical indications and follows the prescription pathway to its final long term destination, often the labelled prescription drug boxes in the patient’s home. Thus the doctor who prescribes and records the use on the clinical record in the hospital, e.g angiogram report with drug listing, needs to ensure that the hospital pharmacy are synchronised in their use of clinical indications. This then flows out to the primary care service. Firstly the practice computer then captures this information and then the local pharmacy computer. Eventually the indication is placed on the MAR (medicine administration records) if the patient is in a home where care staff is involved. Alternatively the clinical information is placed on the drug label on the package within the patient’s home. All these processes are important in the seamless delivery of clinical indications. This activity may be helped by the introduction of the electronic prescription service, which is due to start in the NHS in 2007. Such seamless delivery can be checked by departure and destination clinical indication audits.
The new pharmacy contract 2006 invited pharmacists to interview patients in a confidential setting to explore their medicines usage. Clinical Indications streamlines this process, as the pharmacist and patient already understand the need for the medication. At our practice all chronic disease reviews are delivered yearly based on the patient’s birth month. Thus the pharmacist can then coordinate his MUR prior to the practice review.
Dr Nigel Masters first described clinical indications on repeat prescription in the British Medical Journal in 2003 as an email suggestion to improve medicines management in primary care. At his practice over eighty per cent of his repeat prescriptions contained this information and recommended such action to others. This simple idea was revolutionary for medicines delivery as it was the biggest single change for 50 years! Dr Nigel Masters delivered the first Clinical Indications Directory in 2005 and has been enthusiastically promoting the concept to healthcare colleagues around the world. Dr Nigel Masters has been a full time general medical practitioner in the United Kingdom for 26 years and has already been responsible for other developments such as the easy air nebuliser and written papers on housing design and depressive illness, medication caries and nebulised opiate delivery. Dr Nigel Masters declares no conflicts of interest in the preparation of material for this first dedicated website for best practice with clinical indications.