About the EKHUFT Formulary
The formulary is a guide to the status of drugs agreed by the EKHUFT Drugs and Therapeutics Committee (DTC). In particular it details medications without a license that have been approved for use in secondary care. It also has details of the local and national NHS status of most licensed medications although this is now covered better in the joint formulary. For current drug tariff cost information the East Kent Prescribing Group Formulary or BNF are sources. During 2020/21 the hospital formulary will complete its full integration into the joint East Kent formulary and this version of formulary will be finally withdrawn. This version of the formulary is maintained by Medicines Information Tel 01233 616001 (Internal extension 7236001), email prescribingsupport(at)nhs.net
This formulary aims to inform our patients and staff as to the medications and their indications that are routinely available for NHS initiation by Trust clinicians. The default position is that where a patient contact has occurred it is the Trust clinician who is responsible for initiation and for ascertaining the NHS availabibility of a medication in an indication. The formulary considers the status of most of the medications or preparations licensed (i.e. have marketing authorisation) for human use in the UK. It also includes some medications that for various reasons are without a license but where there is evidence for effectiveness. These unlicensed preparations will be detailed if their status has been evaluated favourably by the Trust. In some cases it indicates that a medicine is not available for routine NHS use in Trust patients.
Any drug marketed since December 2005, if found in the formulary, has been approved in an indication specific manner, and the Trust is only likely to be funded for use in the approved indication(s). In particular you need to be aware that the NHS is unlikely to commission treatment of high cost drugs out of licence or outside the criteria of a NICE technical appraisal (NICE TA) without a formal policy. Kent and Medway policies since 2013 are at this link. Applications to add a drug to formulary have to be initiated by a Trust clinician. It is only rarely that a drug will be added without a detailed case being made by the clinician. The most notable exception being the case of NICE TAs which are funded with highest possible priority by the relevant commissioner and where the Trust and relevant commissioner does not need to therefore undertake a detailed appraisal of the drug's place in treatment. From October 2017 drug use by the English NHS will increasingly be guided by the recommendations of the English Regional Medicines Optimisation Committees (RMOCs) and from 2019 NICE will evaluate all new licensed medicinal products.
Modified release/patch formulations require separate addition to formulary, and this will not happen automatically if they were more expensive than the standard generic product. Do remember that different manufacturer's modified release/patch formulations may not be therapeutically equivalent and with drugs with a low therapeutic index the Trust supports MHRA guidance to prescribe by brand name.
Information is available on how to obtain new and exceptional drugs.
Please follow this link for the library of Medicines Safety Bulletins issued by the Trust. Bulletins before 2014 are at this link. Neither are accessible outside the Trust.
Why isn't every drug available?
In most cases this is because the drug is not necessary for the delivery of routine funded NHS care. In some cases, indicated say by a black traffic light sign in formulary an overt decision has been made not to fund the medicine for NHS patients, but all new medicines to market for an indication also need an overt decision to use them. A clinician can often only use a medicine for a particular indication on the NHS. It is possible that a commissioner of NHS services has not commissioned the medicine in a particular indication from the Trust but commissioned it from an other provider. In such a case the medication may be available to an NHS patient but only if the medication is supplied via that provider. The NHS has mechanisms for allowing exceptional availability of a drug because of individual patient circumstances. For medications within tariff this is usually handled by a medicines optimisation decision process. With high cost medicines not commissioned (see link for manual of commissioned high cost drugs), a prospective individual funding request (IFR) for the therapy will have to be made (clinicians see this link for more details of the IFR process). Before an NHS patient is told to obtain a drug privately the prescribing clinician should check that a patient would not qualify by this mechanism, which requires approvial of both the Trust and the patient's NHS commissioner. It is up to the prescribing clinician to make themselves aware of the availability of a drug before offering it as a treatment option. If a clinician assumes a drug is available but it is not, where the formulary status is clear, they are responsible for their oversight. One of the reasons for formularies such as this is to make this task easier. Some drugs may not be available because no local clinician has realised that a case could be made for routine availability to local NHS patients. Clinicians have been informed of the importance of identifying such drugs prospectively, but many of the public as well as clinicians fail to realise that NHS prioritisation is done on an annual basis. This means that any in year re-prioritisation which is necessary if a drug requires extra funding, can only be considered if other services that are intended to be delivered are de-prioritised. Accordingly some drugs may not be available because they are not funded and others because they are still being considered for funding. Patients can only expect rapid access to drugs more expensive than those on formulary if a prior explicate commissioner decision has been made to fund the drug for the patient's indication. Local clinicians may not be aware of all decisions made in the health economy (although they should check the formulary/policy statements of the patient's NHS commissioner as the information is likely to be in the public domain shortly after being made). Many medications are not available because they are poor choices. Many fail to appreciate that because an individual patient responds to a drug not funded by the NHS, this is not a reason (by itself) for the drug to be funded on the NHS. Most funding for Trust patients is through a tariff (determined on average patient costs) and for most drugs the drug component of treatment costs is determined by therapy and prices for that therapy as of 3 years before. Any new more expensive therapy not funded by other means will therefore have to be paid for by either other parts of the treatment regime for a condition being made more cost efficient or savings being transfered from elsewhere. This does not mean new drugs can not be made reasonably quickly available if they are more expensive, but they are only likely to be made available for subgroups of patients that will really benefit. The NHS still has to determine in a prospective manner who is likely to benefit. The decision making process considers the needs of the whole relevant commissioned population, not just an individual patient or even just subgroups where clinical benefit is demonstrated. Further this formulary is very much a live document and a new safety recommendation may change formulary status. We have found that our formulary is able to be more up to date on such issues than the BNF web version.
How can a patient access drugs not on formulary?
If a drug is not on formulary for use either in an outpatient or inpatient the intending initiating clinician is expected to make an application to the Trust. This has to be approved prospectively. The issue may be trivial if it transpires that the drug is recognised for GP repeat prescribing on the patients local primary care formulary, as the clinician can ask the GP if they would consider prescribing. Legally GPs are not restricted in what they can prescribe but they are unlikely to wish to prescribe drugs they are unfamiliar with and in whom the prescription is not seen by them to be in the patients interest. Drugs that require specialist knowledge to use safely such as unlicensed medications are unlikely to be in the patients interest for a GP to prescribe. Some such drugs however are determined to be safe for GPs to prescribe as long as treatment is consistent with a shared care or other agreement between primary and secondary care. Such arrangements can be more convenient for the patient. Patients can access any drug licensed for use in the UK via a private prescription if the prescribing private clinician thinks the drug will benefit the patient. This clinician can only very rarely be the patients NHS clinician via a special and exceptional authorisation process. The general rule is that NHS clinicians can not write a private script during an NHS consultation. Extremely rarely, an NHS patient can pay for the cost of a private drug alone but this transaction must be as far as possible separated from NHS care; with only safety issues, not convenience, dictating if mixed NHS and private access to care is appropriate. The Trust has a policy consistent with National guidance on the issue. Private patients can still access routinely funded NHS care without disadvantage.
Why do links not work ?
Internally within our Trust, and NHS net links should work. However our formulary does link to documents and web pages not in the public domain or that need subscribing to by members of the public. For example while NHS employees can access the (British National Formulary) links within the Trust without a login demand, many others can not do so without paying a subscription. If you think a link is faulty please notify Trust Medicines Information as web pages often shift.
Does the formulary have limitations ?
Yes. For example a drug on formulary may actually be unavailable due to supply chain issues. We have an internal Trust webpage that Trust staff only can access on the latest supply issues. We are also aware of drugs on our commissioners latest lists of NHS approved therapy that have not been available for several years. Such issues are dealt with in terms of patients already on NHS therapy having priority access to a substitute if it is more expensive. In such a case the formulary may not be able to be altered until it is determined that the substitute can be funded within NHS prioritisation. We can only include information known to us and of course may make mistakes or cause ambiguity. Another cause of ambiguity is where one manufacturers product is maintained in formulary while we are actually initiating initiating new patients on another product or the products have slightly different indications. If you become aware of a potential error please contact Trust Medicines Information. Formulary may not include drugs made available to patients as a result of an individual funding request; which is the way the NHS deals with rarity and exceptional health circumstances. Most unlicensed drugs are used so rarely and on an individual basis that they will not be included in formulary. While the formulary should reflect national commissioning decisions made in England and local ones made on behalf of East Kent Clinical Commissioning Groups it may not be relevant to other NHS patients or private patients. Lastly while we try to keep this formulary up to date for hospital only medicines the health economy prioritises keeping the primary care formulary (joint formulary) up to date for medicines used across the interface.
Are there other relevant formularies to my care ?
Yes. The East Kent Clinical Commissioning Groups have agreed a joint care formulary with primary care which for several reasons, includes more drugs than our formulary. We mutually keep these formularies in alignment and indeed are working with NHS partners to remove this formulary which will be done as soon as all the relevant pages in the joint formulary are completed. Speciality networks may exist that allow Trust clinicians to prescribe drugs recommended in coordination with Tertiary Care and NHS England such as those for Hepatitis C. Sometimes you will find our formulary refers to these formularies. Other formularies include:
In Kent and Medway a policy recommendation may exist with regard to a treatment and individual CCGs may adopt these and document this adoption on their websites. Policy recommendations can be accessed at http://www.nelcsu.nhs.uk/health-policy-resource-library/
What do symbols used in the formulary mean ?.
The link adjacent to this symbol takes you NHS accepted evidence, often a NICE Clinical Guideline or other document in the NHS evidence database run by NICE
Note on NHS status such as allowed indication
Note on why not available on NHS routinely. This is usually where a negative funding decision has been made
The drug is restricted to initiation by a group of prescribers expected to know both the properties of the drug and its NHS indications. Prescribers should be careful about delegation of prescribing of such drugs as they have a GMC responsibility to ascertain the competence to prescribe of those they delegate such prescribing to.
Reminder that drug is unlicensed (ie has no manufacturing authorisation in UK or the indication for which it is present in formulary is out of license ("off-label")). See Trust Unlicensed Medications Policy
Warning or Safety note
or Indicates that the drug or drug class is exempt from tariff by NHS England (ie A high cost medicine not reimbursed through national prices set in the National Tariff for England and subject to separate arrangements)
NHS England Cancer Drug Fund
Reminder that medicine is subject to MHRA intensified reporting which means yellow cards reports should be generated for all suspected side-effects, even if well known risk. The list of medicines currently monitored is pan-European and at https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring
Information on Loading Dose
Reasons for using this treatment
Reasons for not using this treatment. We will also use this symbol when evidence for out of license/unlcensed use is known but such use has not been approved
Note on MHRA warnings (no longer used)
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