Formulary is a continually revised compilation of pharmaceuticals and some important ancillary information that reflects the current clinical judgement of medical staff. The main reason for developing hospital formulary is to set standards for best practice, promoting high quality, evidence based prescribing thus reduces the variation in the level of treatment provided to the patients and controlling drug cost.
Hospital formulary is the vehicle by which the medical, pharmacy and nursing staffs make use of the system; hence it is important that it should be complete, concise, updated and easy to use. The implementation of the formulary will have significant impact on clinical practice of health care professionals.
It helps physicians to know about the available drugs in the hospital pharmacy and also helps in better inventory control. In addition, any matters of interest raised within pharmacy can be fed back directly to the DTC, for example, a sudden increase in the use of a non-formulary item, or the availability of a cheaper generic version of a patented drug. The formulary pharmacist is usually involved at every stage of formulary development, from conception to publication and distribution.
Although the work is usually done in conjunction with a consultant, it is nevertheless arduous and challenging. Updating the formulary not only requires the addition of new drugs, but policies and procedures also require revision. This involves liaising with lead clinicians and section heads. Copies of the relevant sections from the old formulary are sent out systematically to specialist consultants.
They are asked to make any amendments as appropriate. In addition, specialist pharmacists are asked for their input. The process of obtaining comments isa fairly lengthy one and involves a considerable amount of correspondence and waiting for responses. It is important to get as many people as possible involved at this stage, so as to engender a general sense of ownership that will assist later in the implementation of the formulary.
After receiving feedback from the various parties, the formulary pharmacist incorporates the amended sections in the new edition. The layout and design of the formulary is usually left to the pharmacist. Great care is taken to ensure consistency throughout the book and that the format is clear and easy to understand.
A draft copy is printed and proofread by a team of pharmacists. Once a final version has been produced, a suitable printing firm is chosen and the formulary sent for printing. Choice of paper, cover and type of binding is limited by the budget allocated.
Many trusts and specialist teaching hospitals are able to sell their formularies on a large scale, enabling them to produce glossy documents while keeping their costs to a minimum. After publication, it is important to ensure that the message of rational prescribing conveyed by the formulary is consistently understood and applied in day-to-day practice.
Thus the launch of the new edition is publicised in every way possible, ranging from newsletters to seminars. Rational prescribing is also promoted through prescription monitoring as well as direct liaison with consultants. Many hospitals have a policy where pharmacists are authorised to substitute any non-formulary item with an equivalent from the hospital formulary.
In such cases, formulary control is relatively easy. This means that the pharmacy department would have to keep a large variety of non-formulary medicines. To overcome this, such items are obtained on an individual patient basis, sufficient for their stay as inpatients and to take home on being discharged.
This has become much simpler with the introduction of one-stop dispensing. The most challenging aspect of formulary implementation is to get consultants to adhere to prescribing formulary items only.
However, this is a constant struggle because, almost as soon as a particular batch of doctors are trained, it is time for them to move on. Fortunately, the formulary pharmacist is able to enlist the support of ward pharmacists and dispensary staff in promoting formulary use. It is important to remain vigilant at all times. If a team of doctors are allowed to prescribe non-formulary items without check, the problem seems to expand rapidly and it becomes extremely difficult to regain adherence to the formulary.
The performance of a formulary and adherence to it needs to be monitored regularly through an audit of non-formulary items. This can be done in a variety of ways and there are various data analysis programs available to assist the formulary pharmacist. The data can highlight problem areas that can then be tackled individually, either by contacting the relevant consultant or through the DTC.
However, a degree of flexibility is usually required to allow for unusual or urgent cases. The aim of monitoring is to ensure that the DTC is aware of all drugs prescribed within the trust. In order to be able to fulfil their roles, formulary pharmacists have to be multiskilled.
The basic skills required for the role include the following:. Project management skills are required for managing all aspects of formulary production effectively. Excellent organisational skills are also required. It is essential that the formulary pharmacist should be able to communicate successfully with all levels of staff. Good listening skills, a positive attitude and a positive body language are all involved. It also helps if the formulary pharmacist is a competent team player, because there is considerable involvement in subcommittees and working parties in addition to the DTC.
Often, the evidence is not clear-cut and good negotiating skills can prove useful in preventing unnecessary confrontations. It is also a great asset if the formulary pharmacist can persuade consultants that having a formulary is in their interest. In addition to the above, the formulary pharmacist must have a clear understanding of the NHS structure both within the hospital setting and in primary care. It is important to be aware of the lines of accountability and have an idea of how different parts of the NHS are interconnected.
A good grasp of the legal issues surround-ing refusal of treatment to patients in theNHS is useful when making decisions at theDTC meeting. For example, it is not considered appropriate to refuse treatment endorsed by NICE simply on the basis of cost. Although there have been cases where experts in particular fields do not agree with NICE guidance, in the final analysis, evidence-based medicine should prevail.
It is expected that the formulary pharmacist will have some knowledge of the procurement process and the hospital discounting scheme, although this is usually the responsibility of the procurement pharmacist or the pharmacy business manager. In addition, a good clinical knowledge base is required, as well as critical appraisal skills and basic IT skills to search databases and the internet. General medicines information skills such as knowledge of different information sources, and the ability to develop sound search strategies, are also essential for the accomplished formulary pharmacist.
Medicines management is vital for containing the sudden explosion in drug expenditure caused by the advent of new and expensive medicines. Since a rigorous application of the formulary is central to any respectable medicines management system, the future for formulary pharmacists looks bright.
They are likely to become more influential, particularly with the introduction of electronic prescribing and the intranet-based formulary, in addition to the development joint trust and PCT formularies. These changes will facilitate the implementation of a better medicines management system, reduce expenditure and improve the continuity of care to patients. The formulary pharmacist can indeed have a positive impact on the delivery of health care within the NHS.
Nuffield Foundation. Pharmacy: a report to the Nuffield Foundation. London: Nuffield Foundation; Tweedie A. Medicines management and change management — the PSNC pilot trials.
Pharm J ; Haria M, Slater A. London:London Regional Pharmacy Services; Johnson M. Where to start looking for medicines information on the internet. Pharm J ;—9. A comprehensive system for managing medicines in secondary care. Pharm J ;—8. Commercial sites arealso an excellent source of information, butshould be treated with caution. A literature search would not be com-plete without a search of abstract databases. Apart from the pharmaceutical companies,these databases are often the best source foridentifying original clinical trials.
The data-bases most frequently used by the formularypharmacist are Medline contains abstractsfrom over 3, medical journals andPharmline reviews over 90 journals, mainlypharmacy- based. Medline is available freeon the internet through search engines suchas PubMed other versions are also availablebut may require subscription. Sound training and athorough search technique are required touse these databases effectively by means ofmedical subject headings MeSH terms.
The search can often bring to light researchpapers offering an alternative view to thatpresented by a pharmaceutical company,particularly if the research has been con-ducted independently or by a rivalconcern. Evaluating the information collectedThere isno guarantee that the evidence collectedwill be robust or credible.
Hence, it must besubjected to a series of criteria to establish itsusefulness to the decision making process. Each piece of evidence or clinical trial mustbe critically appraised to ascertain whether itcontains any substance, and not just a seriesof unjustifiable statements.
Critical appraisalis an essential skill for the formulary phar-macist. Many books have been written onthe subject, and there are training coursesavailable either as study days or distancelearning via the internet. In general, the for-mulary pharmacist should ask three keyquestions of each paper:6, Are the results of the study valid?
What are the results? Will the results help to improve patientcare? There is an increasing trend to gradeclinical interventions according to thestrength of evidence portrayed in the study.
Such agrading system is particularly useful whenreviewing a drug for which a lot of informa-tion is available. However, when reviewingnewly launched or licensed drugs, there isoften not much data available apart fromthree or four clinical trials sponsored by thepharmaceutical company. In such cases, acritical appraisal of each trial is even moreimportant to ensure that the evidence isbased on sound methodology and reliablestatistical analysis.
A quick calculation showing the numbersneeded to treat NNT , that is, the numberof patients that need to be treated to achieveone positive clinical effect, is a valuablemethod for assessing the clinical benefit ofthe intervention. Writing the reportThe appraised evidencemust now be compiled into a report for sub-mission to the DTC.
The format should besimple and the text easy to read and under-stand, because most DTC members havelimited time to wade through reams of evi-dence that is the job of the formularypharmacist! Usually, the evaluation shouldprovide a brief introduction to the newdrug, within the context of currently avail-able treatments.
The introduction is followedby the proposed indication for the drug andthe appropriate dose. It is important torecognise that some drugs are licensed fortwo or more indications. The local formulary serviceis therefore a crucial part of the medi-cines management process because it canprovide an immediate medicines evalua-tion system close to prescribers. Despite being such a critical service,the induction and training of new staff isoften difficult as the use of reference ortraining documents is limited.
In London, the formulary and medi-cines evaluation FAME group has beenmeeting for over six years under thechairmanship of Allan Karr, and assists inthe development and education of thoseinvolved in this important specialty. Thegroup convenes three times a year atstudy days to debate mutually interestingsubjects, as well as being an opportunityfor participants to network informally.
Recently, support and funding from Lon-don trust pharmacy managers was madeavailable to the FAME group in order todevelop a reference manual that isintended to be a useful resource. TheFAME manual is a major step towardssupporting those individuals who requirea greater insight into this critical pharma-cy service. At present, the publication is inuse by formulary pharmacists working inLondon and will be available to the NHSon a web-site later this year.
Furtherinformation about the FAME group canbe obtained by contactingalison. In order to maintain formularycontrol and limit expenditure, it is usuallynecessary to specify the indication s forwhich the item is requested. The next part of the evaluation normallyforms the bulk of the report.
The information can be presented inthe form of a table showing all the relevantclinical trials and their conclusions, or in theform of a report in which appropriate state-ments are suitably referenced. The cost of thenew drug is also compared with currenttreatments, taking care to compare equiva-lent therapeutic strengths and doses.
This canalso incorporate other factors that are likelyto affect the overall cost of the intervention,for example, reduced nursing time orincreased patient compliance. Costs mayvary considerably between primary and sec-ondary care, and since prescribing insecondary care has a considerable impact onGP prescribing, any cost analysis must reflectthis. The report concludes with the recom-mendations of the formulary pharmacist. Its decision has considerable bearing ondrug expenditure and the DTC takes itsresponsibilities seriously.
To ensure that the DTC is free of bias, itsmembership is taken from the various keyareas within the hospital. Some members arealso recruited from outside the hospital. Thecommittee chairperson is usually a seniorhospital consultant, with the formularypharmacist acting as secretary. A typicalcommittee of about 20 members will com-prise consultants in medicine, surgery,dermatology, rheumatology, microbiologyand paediatrics. Other members include thechief pharmacist, lead nurse practitioners, asenior member of staff from the financedepartment, GPs, and representatives fromthe local primary care trust PCT andneighbouring hospital trusts.
The DTC has a broad range of functionsand responsibilities. The most basic functionof the DTC is to make decisions regardingnew drugs and therapies, based on evidence ofefficacy, safety and cost-effectiveness. In sometrusts, the DTC will assess the clinical effec-tiveness of the drug, but will leave the finaldecision to another tier of decision makers,who will consider whether appropriate fund-ing is available before approving the drug.
The DTC also takes a lead role in imple-menting change regarding clinical practice,for example, switching from intravenous tooral antibiotics after 48 hours, and treatingpotassium chloride as a Controlled Drug toprevent errors in administration.
All proto-cols such as those dealing with unlicensedmedicines, nurse prescribing, and dischargeprescription writing by pharmacists mustbe approved by the DTC before they canbe implemented. In addition, the commit-tee takes a keen interest in prescribingissues in the local PCT.
Representativesfrom both primary and secondary caretrusts meet regularly to discuss areas ofcommon interest. Furthermore, the DTC isresponsible for ensuring that NICE guide-lines are put into practice, and that there is aprocedure in place for monitoring theprogress of each guideline through all stagesof implementation.
DTC decision on formulary admissionOnce the formulary pharmacist has com-piled a report on the requested drug, adecision has to be made by the DTC. Theappraised report is sent out with the agendafor the next DTC meeting, giving commit-tee members time to assimilate theinformation before the meeting. During theDTC meeting, the formulary pharmacistpresents the evidence for or against eachrequested drug. The requesting consultant isalso invited to put his or her case in person. The committee will then debate whether ornot it is appropriate to accept the drug intothe formulary, and under what circum-stances or restrictions, if any.
Implementation of the decisionIf a drugis approved, then it is left to the formularypharmacist to add it to the formulary. Gen-erally, the pharmacist will liaise with thepharmacy business manager to ensure thatall computer systems within the pharmacyare updated and the correct parameters forordering and dispensing the newly approveditem are set. If the formulary is on the hospital intranetthen it can be amended fairly rapidly. All deci-sions are publicised, often through a DTCnewsletter produced by the formulary phar-macist in conjunction with the DTCchairman, or through a pharmacy newsletter.
In addition to new formulary additions, thenewsletter is used to inform trust staff of newprotocols and other medicine related issues. DTC secretaryThe formulary pharmacistis often also the DTC secretary, and thecombination of these two roles makes thepost of formulary pharmacist quite demand-ing and one which carries considerableresponsibility.
It is the duty of the formularypharmacist to liaise closely with the chair-man of the DTC, arrange DTC meetings,produce agendas and minutes, and generallyensure that all committee members are keptabreast of new decisions. DTC meetings areheld on a regular basis, although the fre-quency varies from trust to trust. Between meetings, the formulary phar-macist is responsible for responding to newdrug requests from consultants. Thisincludes the whole process of criticalappraisal from research to report writingoutlined above.
The formulary pharmacist also has a sup-porting role within the pharmacydepartment, providing assistance and back-up to colleagues whenever prescribing issuesarise. In addition, any matters of interestraised within pharmacy can be fed backdirectly to the DTC, for example, a suddenincrease in the use of a non-formulary item,or the availability of a cheaper generic ver-sion of a patented drug.
The formulary pharmacist is usuallyinvolved at every stage of formulary develop-ment, from conception to publication anddistribution. Although the work is usuallydone in conjunction with a consultant, it isnevertheless arduous and challenging. Updating the formulary not only requiresthe addition of new drugs, but policies andprocedures also require revision.
This involvesliaising with lead clinicians and section heads. Copies of the relevant sections from theold formulary are sent out systematically tospecialist consultants.
They are asked to makeany amendments as appropriate. In addition,specialist pharmacists are asked for theirinput. The process of obtaining comments isa fairly lengthy one and involves a consider-able amount of correspondence and waitingfor responses.
It is important to get as manypeople as possible involved at this stage, so asto engender a general sense of ownershipthat will assist later in the implementation ofthe formulary. After receiving feedback from the variousparties, the formulary pharmacist incorporatesthe amended sections in the new edition. Great care istaken to ensure consistency throughout thebook and that the format is clear and easy tounderstand.
A draft copy is printed andproofread by a team of pharmacists. Once afinal version has been produced, a suitableprinting firm is chosen and the formularysent for printing. Choice of paper, cover andtype of binding is limited by the budget allo-cated. Many trusts and specialist teachinghospitals are able to sell their formularies ona large scale, enabling them to produceglossy documents while keeping their coststo a minimum.
After publication, it is important to ensurethat the message of rational prescribing con-veyed by the formulary is consistentlyunderstood and applied in day-to-day prac-tice. Thus the launch of the new edition ispublicised in every way possible, rangingfrom newsletters to seminars.
Rational pre-scribing is also promoted throughprescription monitoring as well as direct liai-son with consultants. Many hospitals have a policy where phar-macists are authorised to substitute anynon-formulary item with an equivalentfrom the hospital formulary.
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