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adherence than the control group (81.6% vs 60.2%(P < 0.0001)). The difference in the EQ-5D scores reachedstatistical significance in the VAS scale (54.6 vs 47.3;P = 0.004). Although the improvement in the mean utilityscale score reached clinical significance, it was not statisti-cally significant (0.51 vs 0.43; P = 0.062). The probabilityof the intervention being cost-effective compared withstandard care was found to be in excess of 90% at a willing-ness-to-pay threshold of £30000 per QALY which, accord-ing to the National Institute for Health and ClinicalExcellence,3 strengthens the case for its acceptance as aneffective use of NHS resources.

This ongoing study indicates that a clinical pharmacy-ledmanagement programme can improve adherence, reduce theneed for hospital care in patients with moderate-to-severeCOPD, and improve aspects of their health-related quality oflife. The intervention, at this 6-month time point, was foundto be cost-effective.

1 Bourbeau J, Julien M, Maltais F et al. Reduction of hos-pital utilization in patients with chronic obstructive pul-monary disease: a disease specific self-managementintervention. Arch Intern Med 2003;163:585–591.

2 Lorig KR, Sobel DS, Stewart AL et al. Evidence suggest-ing that a chronic disease self-management program canimprove health status while reducing hospitalization: arandomized trial. Med Care 1999; 37, 5–14.

3 Guide to the methods of technology appraisal. London:National Institute for Health and Clinical Excellence; 2004.

Practice development and audit

Meeting the need for medication review: involving general practitioners and nurses

D Hansford1, J Krska2,3 and D Gill3

1The Robert Gordon University, Aberdeen, UK, 2Liverpool John Moores University, Liverpool, UK and 3Angus CHP, Tayside, UK. Email: [email protected]

■ Which primary care professionals, other thanpharmacists, provide medication reviews is notknown

■ A training programme aimed at general practition-ers (GPs) and nurses was viewed as worthwhile,increasing reviews, but time and lack of administra-tive support are barriers to their provision

■ More work is required to assess the extent andcontent of reviews provided by GPs and nurses

Estimates suggest that 50% of registered patients in the UKtake repeat prescribed medicines,1 and should have a medica-tion review according to the Quality and Outcomes Framework(QOF).2 Restricting the estimate of need for medication reviewto patients aged 65 years or over taking at least four repeatmedicines still requires 4.5 million reviews annually.3 Medi-cines use reviews (MURs) provided by community pharmacistscould contribute to meeting the need, but the extent to whichpractices include MURs in QOF submissions is not known. In2005, 93.7% of the available points for medication reviewwithin the QOF were attained,2 although community pharma-cists in England and Wales provided only 14591 MURs,4

which suggests that other professionals are providing reviews. A large project in one area of Scotland started in 2002 and,

after piloting,3 offered training in medication review to allgeneral practitioners (GPs), community pharmacists and prac-tice and community nurses to enhance the quality and consist-ency of reviews. Participants’ views on the training and theirperceptions of benefit have been published elsewhere andwere positive. This study aimed to determine views of seniorpractice staff on the impact of the training programme onmedication review provision and barriers to provision.

Separate questionnaires were developed for practice manag-ers, lead GPs and lead community nurses. Face and contentvalidity were confirmed by project steering group members(representing all healthcare professions plus patients). Thequestionnaires comprised both open and closed questions anda checklist of barriers derived from previous training evalua-tion questionnaires. Questionnaires to practice managers alsorequested data on list size, and numbers of patients taking anyrepeat medicine and four or more repeat medicines. Question-naires were sent to each of the three professionals in all 17practices in the area, with prepaid envelopes for return to anindependent researcher. Tayside Ethics Committee advisedapproval was unnecessary. Responses to questionnaires wereanalysed using SPSS (v12).

A total of 32 responses were obtained: nine from practicemanagers (53%), 11 from GPs (65%) and 12 from com-munity nurses (71%). Data from eight managers showed that,overall, 45% of registered patients had at least one repeatmedicine, while 20% had four or more. The numbers of

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medication reviews provided in a typical month were not rou-tinely available, but six managers stated that the number hadincreased since the start of the project, including those pro-vided by community pharmacists. Managers in five practicesstated that medication reviews were done opportunistically,while four targeted specific patients. Six managers, sevennurses and three GPs thought the project was worthwhile,although several GPs and nurses indicated that they had beendoing reviews before it started. Lack of time was cited by allGPs and nurses, and eight managers, as a barrier to providingreviews. Six respondents also cited a lack of administrativesupport.

The proportion of patients taking repeat medicines from theeight responding practices is slightly lower than previous esti-mates suggest, but to reach both of the QOF targets, around20 000 patients in these practices require reviews. Despite thebarriers cited by our respondents, GPs and nurses are rou-tinely providing reviews to meet these targets. There is a lackof literature on reviews by these professionals, and their fre-quency and content is unknown. The extent to which reviewsby community pharmacists can contribute to QOF targets alsorequires investigation.

1 Saving time, helping patients: a good practice guide toquality repeat prescribing. Liverpool: National prescrib-ing centre; 2004.

2 The Information Centre, Prescribing Support Unit.National Quality and Outcomes Framework statistics forEngland 2005/06. [online publication] <http://www.ic.nhs.uk/webfiles/publications/qof/NationalQualityOutcomesFramework280906_WORD.doc> (accessed June 11, 2008).

3 Krska J, Ross SM, Watts M. Medication reviews providedby GPs and nurses: an evaluation of their quality. Int JPharm Pract 2005;13:77–84.

4 Blenkinsopp A, Celino G, Bond CM, Inch J. Medicinesuse reviews: the first year of a new community pharmacyservice. Pharm J 2007;278:218–23.

A survey of the use and misuse of intravenous cannulae in a major tertiary teaching hospital in Scotland

Y Kumarasamy1, N KinKade1, J Kelly1, C McGoldrick2, I Tonna2, RBS Laing2, U Jayaram2 and F Notman1

1Robert Gordon University, Aberdeen, UK and 2Aberdeen Royal Infirmary, Aberdeen, UK. Email: [email protected]

■ This study aimed to determine the level of use,misuse and consequences of intravenous cannulaein patients admitted to the acute medical assess-ment unit in a major tertiary teaching hospital.

■ It was found that almost 91% of patients had a can-nula inserted, and of these 28% were never used.

■ The insertion of cannulae that are not subse-quently used may reflect inappropriate insertion,and places the patients concerned at potentiallyneedless risk of cannula-related complications

It has been reported that up to 80% of hospitalised patientsreceive intravenous (IV) therapy during their hospital admis-sion. An IV cannula is often used for patients who are vomit-ing, ‘nil by mouth’, or have impaired consciousness, as IVadministration is the only route available1,3. It also facilitatesrapid drug absorption, and allows a greater bioavailability fordrugs with limited oral bioavailability. In many UK hospitals,it has become common practice to insert an IV cannula on thepatient’s admission, irrespective of need1,2. Their use canbe associated with complications including phlebitis, extra-vasations, infection and embolism2,3.

The aim of this study was to determine the level of use,misuse and consequences of IV cannulae in patients admittedto the acute medical assessment unit (AMAU) in a major ter-tiary teaching hospital.

A prospective observational study was conducted on the AMAUin Aberdeen Royal Infirmary (ARI) over a 6-week period. Aftercritical appraisal of relevant literature, a data-collection tool wasdeveloped, and data were obtained from patient medical records,nursing notes, drug kardexes and by briefly interviewing thepatients. Data collection took place on weekdays only.

Inclusion criteria were patients admitted to the AMAUbetween 8 am on the day prior to data collection and 8 am on theday of data collection. Exclusion criteria were patients less than18 years of age, barrier-nursed patients, and adults with learningdifficulties or mental illness. The project was reviewed by the eth-ical review panel of The Robert Gordon University, and Gram-pian Research Ethics Committee (GREC). It was also approvedby the NHS Grampian Clinical Effectiveness Department.

Three-hundred and forty-five patient records were reviewed.Of these, 49% (n = 169/345) were male and 51%(n = 176/345) female. The median age was 65 years (inter-quartile range (IQR) = 30) with a range of 18 to 97 years.Ninety-one per cent (n = 313/345) had a cannula inserted, and

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in 27.48% (n = 86/313) the cannula was not used. All positivemicrobiology results in these patients were discussed with aninfectious diseases specialist registrar, and in four patients theinformation available could not exclude cannula-relatedbacteraemia. It was also noted that in 71% of patient recordsthere was no documentation of cannula insertion, and in 57%no documentation of cannula removal.

As almost one-third of the inserted cannulae were subse-quently not used, this could be termed as inappropriate inser-tion, and these patients are placed at potentially needless risksof cannula-related complications. The study also demon-strated the lack of cannula-related documentation in thepatient records in the majority of cases. This may be a causefor concern as documentation can play a key role in ensuringthat IV cannulae are used responsibly.

1 Thomas A, Hayes P, Lockie T, Harrington D. Venflons:why can’t we resist putting them in? (Letter to the editor).J Hosp Infect 2006;63:108–9.

2 Vandenbos F, Basar A, Tempesta S et al. Relevance andcomplications of intravenous infusion at the emergencyunit at Nice University Hospital. J Infect 2003;46:173–6.

3 Josephson DL. Intravenous infusion therapy for nurses:principles and practice, 2nd ed. Clifton Park, NY: Thom-son/Delmar Learning; 2004.

4 Injections Policy Working Group. Policy for the prescribing,preparation and administration of injections and infusions innear patient areas. Aberdeen: NHS Grampian; 2002.

A survey of the use, views about and attitudes towards complementary and alternative medicines (CAMs) in patients with long-term fatigue

Y Kumarasamy1,2, A Mackenzie2, C McGoldrick2, I Tonna2, C Robb1, L Young1, RBS Laing2, F Notman1 and U Jayaram2

1Robert Gordon University, Aberdeen, UK and 2Aberdeen Royal Infirmary, Aberdeen, UK. Email: [email protected]

■ The aim of the study was to determine the extent towhich complementary and alternative medicines

(CAMs) are being used by patients suffering fromlong-term fatigue, and their level of satisfactionwith them

■ It was found that 34% of participants believed thatCAMs were more effective than traditional medi-cine in the treatment of their long-term fatigue

■ Although a small sample size, this study correlateswith previous work in literature and suggests thatin chronic disease states such as chronic fatiguesyndrome, CAMs are useful for symptom controland there is a need to educate healthcare profes-sionals about their usefulness

CFS (chronic fatigue syndrome) is also known as ME (myalgicencephalomyelitis) or fibromyalgia syndrome1. For the pur-pose of this study, long-term fatigue (LTF) was defined as: ‘thepresence of listlessness or tiredness that affects normal dailyroutine and is present for more than 3 months. It should not bedue to any underlying infection, cancer or anaemia’.

This fatigue is not what is experienced by the normalpopulation after over-exertion, but fatigue which is debilitat-ing in nature and unrelieved by rest. There is currently nostandard treatment for the LTF that accompanies CFS1,2.Studies have demonstrated that, due to the failure of orthodoxtreatments and/or lack of support from the healthcare team,many patients opt to try alternative therapies.

The aim of this study was to determine the extent to whichCAMs are being used by patients suffering from LTF, andtheir level of satisfaction with them.

This was a survey conducted over a 6-week period. After crit-ical appraisal of the literature, a data-collection tool wasdeveloped and assessed for its feasibility.3 The data-collectiontool was a structured, anonymous self-completed question-naire available as a paper or electronic version.

Patients who fitted the criteria of LTF as determined bythe doctors running outpatient clinics on the infection ward atAberdeen Royal Infirmary were invited to participate in thestudy. In addition, invitations were sent to CFS supportgroups in Dundee and Edinburgh. The form also had a link toan online version. Exclusion criteria were all patients whohad fatigue due to infections, cancer or anaemia.

The project was reviewed by the ethical review panel ofthe Robert Gordon University, and Grampian Research EthicsCommittee (GREC). It was also approved by the NHS Gram-pian Clinical Effectiveness Department.

There were 41 participants, 68% were female and had an agerange from 25–65 years (mean = 35; standard error = 1.1).

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About 34% of participants believed that CAMs were moreeffective than traditional medicines in alleviation of theirsymptoms, and 60% believed they were what kept them well.It was also found that 73% of participants who reported usingCAMs believed that they had improved their health. Of thosewho reported using chiropracty, 83% said they very satisfiedwith it. Almost 98% believed that CAMs should be availablethrough the NHS, and 46.3% believed that combination ofCAM and orthodox medicine was better than using traditionalmedicine alone.

As many of the patients believe CAM to be a useful adjunctto treatment and feel it is helpful in alleviating their symp-toms, it would be useful to educate healthcare professionalsabout their availability and enable them to reduce use of pre-scription medications for symptomatic relief in LTF patients.

1 Carruthers BM, Van de Sande MI. Myalgic encephalo-myetitis/chronic fatigue syndrome: a clinical case defini-tion and guidelines for medical practitioners an overviewof the canadian consensus document. Vancouver:Carruthers and van de Sande; 2005. [online document]<http://www.mefmaction.net/Portals/0/docs/Canadian_ME_Overview_A4.pdf> (accessed June 10, 2008).

2 Baker R, Shaw EJ. Diagnosis and management of chronicfatigue syndrome or myalgic encephalomyelitis (orencephalopathy): summary of NICE guidance. BMJ2007;335(7617):446–8. [online article] <http://www.bmj.com/cgi/content/full/335/7617/446?hits=10&FIRSTINDEX=0&HITS=10&fulltext=pharmacological+treatments+fatigue&searchid=1&resourcetype=HWCIT> (accessedJune 10, 2008).

3 Edwards P, Roberts I, Clarke M et al. Increasing responserates to postal questionnaires: systematic review. BMJ2002;324(7347):1183. [online article] <http://www.bmj.com/cgi/content/full/324/7347/1183?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=advantages+of+follow+ up+letters+in+surveys&searchid=1&FIRST-INDEX=0&resourcetype=HWCIT> (accessed June 10,2008).

Dispensing incidents in hospital: an exploratory study of labelling mistakes

BP Anto1, D Barlow1, CA Oborne1,2, C Tam1,2, A Gass1,2, A Vlassoff1,2 and C Whittlesea1

1Kings College London, London, UK and 2Guy’s and St Thomas’ NHS Foundation Trust, London, UK. Email: [email protected]

■ This paper describes an exploratory study of theextent of prevented dispensing incidents andpotential causes of labelling mistakes in one trust

■ Inexperience, a lack of knowledge, hurryingthrough task, repetitive nature of task and distrac-tion were some suggested predisposing factorsleading to labelling mistakes

■ Staff training in the use of dispensing computerprograms and self-checking were suggested strat-egies for preventing labelling mistakes

■ Labelling mistakes were prevalent (manual 48%;automated 59%) during dispensing

Information technology (IT) in the medication use processcould potentially reduce human mistakes and lapses, thus elim-inating certain error types.1 In the dispensing process, however,IT has been implicated in dispensing incidents caused byhuman–computer interface problems.2 Labelling mistakes, e.g.wrong patient name, wrong drug name/strength, wrong/incom-plete instructions, represent a significant proportion of dispens-ing incidents.3 No study has investigated how and why theseoccur. This study aims to explore the potential causes of label-ling mistakes in prevented dispensing incidents.

The study was conducted between October and December2007 at a 1200-bed trust with two main pharmacy dispensa-ries (manual and automated). The first phase was key inform-ant interviews (n = 7) conducted with dispensary managersand staff trainers at both dispensaries. The dispensing work-flow at both dispensaries was validated through non-partici-pant observation over a 5-day period. Prevented dispensingincidents were prospectively collected over 4 weeks using avalidated data-collection form.4 Interviews were taperecorded, transcribed and analysed with NVivo7. Transcriptswere coded for concepts and grouped under themes. Theobservation and quantitative data were analysed using SPSS.

Key informants indicated inexperience, lack of knowledge(computer software and medicines), hurrying through tasks,repetitive tasks and distractions as predisposing factors contrib-uting to labelling mistakes. Prevention strategies identifiedincluded: training and encouraging staff to use ‘fast search’codes in drug and instruction selection, and self-checking ateach stage of the process, irrespective of workload. Validateddispensing workflow for both dispensaries involved thesequence: receipt of prescription, validation of patient informa-tion, log of prescription, label generation, drug selection,assembly of drugs, labelling of drug, completion of CD/private

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prescription registers, self-checking/endorsing and final accu-racy check. The total number of incidents recorded in eachdispensary was: manual, 44 of which 21 (48%) were labellingmistakes, and automated, 64 of which 36 (59%) were labellingmistakes. The prevented dispensing incident rates were:353/100 000 (manual), 255/100 000 (automated). The mostcommon labelling mistake was different for each site: manual,wrong direction on labels (25%, n = 16), automated, wrongdrug strength (18%, n = 8).

As in previous studies, errors in selecting items on a com-puter screen and distraction were reported as predisposingfactors to prevented dispensing incidents.2,4 Informants sug-gested use of ‘fast search’ codes potentially reduces labellingmistakes, because it limits computer screen menus andincreases drug/instruction selection accuracy. Staff traininghas previously been recommended as an incident-preventionstrategy.4 The prevalence of label mistakes at both manual(48%) and automated (59%) dispensaries was comparable tothat previously reported (58%).3 A limitation of this studywas the inability to objectively determine the causes of label-ling mistakes. Future work will explore the views of dispens-ing staff involved in prevented dispensing incidents in orderto objectively determine causes of labelling mistakes.

1 Department of Health. Building a safer NHS for patients:improving medication safety. London: The StationeryOffice; 2004.

2 Beso A, Franklin BD, Barber N. The frequency andpotential causes of dispensing errors in a hospital phar-macy. Pharm World Sci 2005;27:182–90.

3 Spencer M, Smith A. A multicentre study of dispensingerrors in British hospitals. Int J Pharm Pract1993;2:142–6.

4 James K, Barlow D, Hiom S, Roberts D, Whittlesea C.A study of unprevented dispensing incidents in WelshNHS hospitals. Int J Pharm Pract 2008;16:175–88.

A retrospective evaluation of the relative incidence of adverse effects of recommended antihypertensive drugs: are there differences within the same therapeutic class?

W Baqir1,2

1Northumbria Healthcare NHS Foundation Trust, North Shields, UK and 2University of Sunderland, Sunderland, UK. Email: [email protected]

■ This study investigated the incidence of adverseevents leading to treatment discontinuation of anti-hypertensive drugs within the same therapeutic class

■ The results demonstrated that discontinuationrates for drugs within the same class varied, andthat this may be related to the relative frequencyof specific adverse effects

■ Practitioners should audit their use of antihyper-tensive drugs to ensure that they use drugs withlower adverse event rates within their population

National guidelines for the management of hypertension werepublished in 2006, recommending angiotensin-converting enzyme(ACE) inhibitors, angiotensin-II receptor antagonists (A-IIAs),calcium channel blockers (CCBs) and thiazide diuretics asfirst-line treatment.1 Of central importance when prescribing anyantihypertensive drug is its tolerability, to ensure that patientsremain using the medication in the long term, without experienc-ing adverse events that may affect compliance. However theguidelines do not specify the drug to be used from within eachtherapeutic class. Many antihypertensive drugs are associatedwith classical side-effects, for example cough with ACE inhibi-tors, and ankle oedema with CCBs. This study investigated therelationship between the prescribing of specific antihypertensivedrugs and the incidence of adverse events leading to treatmentdiscontinuation, in a large suburban general medical practice.

Patients with hypertension were identified from the practiceelectronic clinical records system using clinical codes. Indi-vidual records were then searched to identify those patientswho had been commenced on antihypertensive therapy duringa pre-specified 18-month period, and who had subsequentlyceased treatment with that therapy. Further interrogation ofpatient records was then undertaken to ascertain the reason(s)for the discontinuation of the antihypertensive treatment.

Of 10 297 patients registered at the practice, 1507 (14.6%) hada current diagnosis of hypertension. Over the 18-month period,453 patients were commenced on an antihypertensive drug.CCBs were the most frequently prescribed therapy (43%), fol-lowed by ACE inhibitors (33%), thiazide diuretics (13%) andA-IIAs (10%). CCBs were also the most commonly discontin-ued therapeutic class (29% of patients commenced on that classof therapy) followed by thiazide diuretics (19%), ACE inhibi-tors (17%) and A-IIAs (11%). The most frequent reason citedfor discontinuation of an ACE inhibitor was cough (16.6%),with lisinopril (7 from 65 patients discontinued) appearing to

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be better tolerated than perindopril (17 from 80 patients) withdiscontinuation rates of 10.5% vs 21.3% respectively (absoluterisk reduction (ARR) = 10.8%, number needed to harm(NNH) = 9 (i.e. for every nine patients treated with perindoprilinstead of lisinopril one additional patient will discontinuetreatment due to cough)). Ankle swelling was the most fre-quently recorded reasons for CCB discontinuation. Lerca-nidipine appears to be better tolerated (26 from 127 patientsdiscontinued) than amlodipine (31 from 67 patients), with dis-continuation rates of 21% and 46% respectively (ARR = 25%;NNH = 4). Additional data relating to the incidence and reasonfor discontinuation of antihypertensive therapy will be dis-cussed at the associated oral presentation.

Variation in discontinuation rates between antihypertensive drugswithin the same therapeutic class was observed, and this may berelated to the relative frequency of adverse effects associated witheach drug. Two important factors in the drug treatment of hyper-tension are achieving an acceptable level of blood pressure con-trol and ensuring that the patient is able to continue using the drugover the long term. This study demonstrates that selecting drugswith the lowest incidence of adverse effects from within the sametherapeutic class may result in greater persistence with treatment.

1 NICE Guideline – CG34 Hypertension (2006). London:National Institute for Health and Clinical Excellence; 2006.[website] <http://www.nice.org.uk> (accessed June 10, 2008).

Improving disease-modifying antirheumatic drug (DMARD) monitoring in primary care: a patient safety audit

AM Bourke2 and W Baqir1,2

1Northumbria Healthcare NHS Foundation Trust, North Shields, UK and 2The Village Green Surgery, Wallsend, UK. Email: [email protected]

■ Disease-modifying antirheumatic drugs (DMARDs)are useful agents in managing a number of condi-tions (e.g. inflammatory arthritis) but are associ-ated with serious adverse effects, so monitoringis important

■ DMARD monitoring in primary care is found to besuboptimal, with some patients getting incom-plete or no blood tests

■ Secondary care often fails to notify primary carewhen DMARD monitoring has been done, so it isnot possible to ascertain which patients are get-ting appropriate monitoring

■ Systems (tracking patients on DMARDs) in practiceneed to be implemented to improve monitoring

Disease-modifying anti rheumatic drugs (DMARDs) reduce jointdamage and pain in patients with inflammatory arthritis and areused for a number of other conditions (e.g. psoriasis). However,due to their potential side-effects, regular blood monitoring isnecessary. Many NHS organisations have approved shared careagreements between primary and secondary care so that monitor-ing and prescribing of DMARDs is undertaken in primary care,allowing patients the convenience of monitoring at their practiceand freeing up hospital clinics. This audit was undertaken in ageneral medical practice to ensure there was appropriate monitor-ing in patients being managed by the practice. As far as theauthors are aware, similar work has not been published.

Patients who were prescribed a DMARD (methotrexate, sul-fasalazine, leflunomide, hydroxychloroquine, azathioprine,myocrisin, D-penicillamine, auranofin, ciclosporin, myco-phenolate and anti-TNF-alpha therapies (infliximab, entaner-cept, adalimumab)) were identified by searching thepractice’s electronic clinical system. Data collected included;gender, DMARD, indication for therapy, authority respons-ible for monitoring, date of last blood test, date of nextfollow-up appointment and vaccination status (influenza andpneumococcal). Data were analysed using Microsoft Excel.

Of the 10 500 patients registered at the practice, 61 were pre-scribed a DMARD, of whom four were excluded from thisaudit (stopped drug/death – this could not be linked to lack ofDMARD monitoring). Forty-five patients were on the drugfor rheumatological reasons and 12 for other reasons. Metho-trexate and sulfasalazine were the most commonly prescribeddrugs. Thirteen patients were managed by the practice, 28 wereunder the care of rheumatology departments, 12 under othersecondary care specialties and two patients did not need mon-itoring (on hydroxycholoroquine). Monitoring arrangementsfor two patients were not clear. Of the 13 patients managed inprimary care, only five (38%) were being monitored appro-priately, with the remaining eight having no recent or incom-plete tests. Where patients were being monitored by hospitals,primary care did not receive any information on what moni-toring was being done. Of the 57 patients, only 21 were givena pneumococcal and a current influenza vaccine, 22 patientsreceived influenza only, 13 received neither and one refusedvaccination.

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The number of patients being monitored is small; however,the majority are not getting any or complete tests. Followingon from this audit, the practice has implemented two safetychecks to ensure that monitoring is done: the 13 patientsmonitored by the practice will have to give receptionists thedates of the last and next test when ordering DMARDs, andphlebotomists have been given guidelines on what blood testsneed to be done for the different DMARDs. Hospital datawere not clear and an audit in secondary care would beneeded to assess if monitoring is appropriate.

Reducing cardiovascular risk in diabetic patients through auditing statin and antiplatelet use

W Baqir1,3, B Duncan2, A Husband2 and R Bridgewater3

1Northumbria Healthcare NHS Foundation Trust, North Shields, UK, 2University of Sunderland, Sunderland, UK and 3Village Green Surgery, Wallsend, UK. Email: [email protected]

■ An audit of antiplatelet and statins use in patientswith diabetes at the general practitioner practicewas undertaken in patients aged 40 years andover

■ One in four patients who should be on antiplate-lets and/or a statin were not on the treatment

■ Highlighting these patients through practice auditwill ensure that they are offered antiplatelets andstatins where appropriate

It is estimated that diabetes and its complications areresponsible for 1 in 17 deaths in the UK.1 In particular,cardiovascular complications are a major cause of mortal-ity and morbidity. The National Service Framework forDiabetes insists on early and intensive prophylaxis in allpatients with diabetes, to prevent cardiovascular complica-tions developing.2 There is consensus that these patientsaged over 40 years should be on antiplatelets (aspirin orclopidogrel) and statins. This view is upheld by localguidelines (unpublished), which recommend statins andantiplatelets in all patients with diabetes (type 1 and 2)aged 40 years and over. This audit assessed the use of

antiplatelets and statins in patients with diabetes, at a gen-eral medical practice in North East England.

The practice’s clinical system was used to identify patientswith diabetes mellitus aged 40 years and over. The medicalrecords of these patients were assessed to see if they wereprescribed an antiplatelet and/or any statin. Patients were cat-egorised as needing antiplatelet and statin prophylaxis or justantiplatelet or just statin prophylaxis alone. Patients who hadprevious adverse events and those where these drugs werecontraindicated were excluded. The remaining patients willbe reviewed at their next annual diabetic clinic appointment,where antiplatelet/statin therapy will be discussed andencouraged.

Of the 10 500 patients registered with the practice, 482patients had a diagnosis of diabetes mellitus, of whom 447(92.7%) were aged 40 years or over. There were 120patients not prescribed antiplatelets and 81 patients notprescribed statins, with 47 of these patients not prescribedeither a statin or antiplatelet. Adverse events accountedfor 46 patients (from 120) not being on aspirin and 18patients (from 81) not being on a statin. This left 68patients needing antiplatelets and 50 patients needing stat-ins. Following this audit, the electronic records for allpatients who were suitable for treatment with antiplateletsand/or statins were flagged. These patients will be offeredthese treatments. To date, prophylaxis has already beenstarted in 22 patients (9 started on antiplatelets and 13 onstatins).

Although this project was undertaken in one general practice,it still shows that despite their high cardiovascular risk, one infour patients with diabetes mellitus is not being treated withprophylactic aspirin and/or statin. The authors recommendthat general medical practices and diabetic centres audit theirpatients to ensure that their local guidance on statins/antiplateletsis being implemented.

1 Murray CJL, Lopez AD. The global burden of disease.Geneva: World Health Organisation, Harvard School ofPublic Health; 1996.

2 Department of Health. National Service Framework forDiabetes. [website] <http://www.dh.gov.uk/en/Healthcare/NationalServiceFrameworks/Diabetes/index.htm> (accessed10 June, 2008).

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Development of a novel comparator for monitoring statin prescribing in primary care

H Elliott1, C Tibbitts1, K Wood1 and M DasGupta2

1Aston University, Birmingham, UK and 2Birmingham East and North PCT, Birmingham, UK. Email: [email protected]

■ A novel comparator was developed to directlycompare statins across a group of practices

■ The current prescribing comparator in primarycare for statin prescribing is average daily quantity(ADQ) per specific therapeutic age-related pre-scribing unit (STAR-PU)

■ The ADQs do not accurately reflect potencies ofstatins

■ The novel comparator reflects low-density lipo-protein (LDL)-lowering capacity of the statins andis easy to apply

The current comparator to monitor statin prescribingusing e-PACT (e-prescribing analysis and cost) data inprimary care is ADQ (average daily quantity) perSTAR-PU (specific therapeutic age-related prescribingunit). The ADQ for simvastatin is 30 mg and for atorva-statin 20 mg; until fairly recently these were 15 mg and20 mg respectively.1 These ADQs do not reflect thepotencies of statins, thus the prescribing comparator can-not compare the effectiveness of statin prescribingbetween practices in a primary care trust (PCT). The aimof this study is to develop a novel comparator that takesinto account the relative potency (low-density lipoprotein(LDL) lowering) of statins.

The literature on statins was critically appraised toascertain the relative potencies of the individual statins.Simvastatin 40 mg and atorvastatin 10 mg both reduceLDL cholesterol by 37%;1 these were given an index of 1.All doses of the five statins available in the UK werethen indexed according to their LDL-lowering effect;based on this, a novel prescribing comparator wasdeveloped. The values were calculated by multiplying thenumber of tablets prescribed by the assigned indexvalues, and then dividing the resulting figure by theSTAR-PU. This novel comparator was then applied to a

virtual prescribing scenario and then to e-PACT datawithin BEN (Birmingham East and North) Primary CareTrust (PCT). This was compared to the old and currentprescribing comparator.

The virtual prescribing scenario is two practices, practiceA prescribing 1200 simvastatin 40 mg and practice B pre-scribing 1200 atorvastatin 10 mg. Using the ADQ values,practice A has 1600 ADQs and practice B has 600 ADQs.These are clearly not the same, although the lipid-loweringeffect should be identical. Using the novel comparator,both practices produce identical index units (1200). Themethod was then applied to e-PACT data for the periodOctober to December 2007 to analyse statin prescribingacross all 82 practices within BEN PCT. The results werecompared to those achieved using the ADQ per STAR-PUcomparator. As expected, the novel comparator and thecurrent prescribing comparator showed differences in pre-scribing, as the novel comparator takes into accountpotency. However the new ADQ per STAR-PU valueshave been shown to be an improvement upon the previousvalues. For a given practice in BEN PCT the ADQ perSTAR-PU using the old and new ADQ values, were125.25 and 1395.52 respectively. For the same practice,the BEN Aston per STAR-PU value was 1633.2. Theprevious ADQ per STAR-PU comparator under- orover-estimates prescribing of statins in terms of theirLDL-lowering capabilities. The novel comparator how-ever, accounts for these differences, hence the differingvalues.

Comparators are used to assist the identification of prac-tices that may benefit from targeted prescribing advice ortherapeutic education. The current ADQ per STAR-PUprescribing indicator is a better reflection of the averagemaintenance dose than its predecessor. However, it is stillnot a true reflection of potency. The novel comparatorreflects LDL lowering of statins, and is easy to apply toe-PACT data.

1 The Information Centre. Average daily quantities. Availa-ble from: <http://www.ic.nhs.uk/our-services/improv-ing-patient-care/prescribing-support-unit-psu/measures/adqs> (accessed June 10, 2008).

2 Law MR, Wald NJ and Rudnicka AR. Quantifying effectsof statins on LDL cholesterol, ischaemic heart disease andstroke: systematic review and meta analysis. BMJ2003;326:1423–9.

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C69

An audit to determine to what extent general practitioner surgeries in Hertfordshire adhered to the National Patient Safety Agency guidelines on oral anticoagulant management

O Otesile and EK Rosenbloom

King’s College, London, UK. Email: [email protected]

■ Communication pathways have failed to developto support adherence to the National PatientSafety Agency and British Committee for Stand-ards in Haematology guidelines on oral anticoagu-lant management

■ An audit was conducted to determine to whatextent general practitioners (GPs) adhered to theNational Patient Safety Agency guidelines on oralanticoagulant management

■ GPs were aware of patients’ clinical conditions forwhich warfarin was prescribed, and prescribedwarfarin in milligrams

■ Most patients fail to present their yellow book toGPs to support prescription requests

The National Patient Safety Agency (NPSA) released guide-lines on oral anticoagulants in 2006 to reduce the risk of fatalmedication errors associated with this class of drug.1 Warfarinis the most widely prescribed oral anticoagulant. Guidance hasinformed the development of systems and processes to supporteffective medicines management for people prescribed warfarinin the primary care setting. The aim of this audit was to identifythe extent to which general practitioners (GPs) were adhering tothe NPSA guidelines to inform practice and service develop-ment. This study was restricted to warfarin as it is the most usedoral anticoagulant. Standards used for this audit were based onNPSA and British Committee for Standards in Haematology(BCSH) guidelines on oral anticoagulant management.2

An audit tool was designed and piloted by four GP practiceslocated in neighbouring primary care trusts (PCTs) to Hert-fordshire. In November 2007, following minor modificationsto the audit tool, GPs in Hertfordshire were invited to parti-cipate. Audit standards were set based on the recommendedguidelines by the NPSA. Participation in the audit was volun-tary and surgeries were encouraged to complete it if it wasappropriate for their practice development plan. Standards

focused on clinical conditions, international normalised ratio(INR) values, alternate-day dosing, and inspection of the yel-low patient-held record book.

The audit was completed by 22 GP surgeries (20%) and datawere collected for 111 patients. Of the 16 standards set, GP sur-geries passed two standards: they were able to list all patients’clinical conditions for which warfarin was prescribed, and pre-scribed all warfarin doses in milligrams. However, many sur-geries were unable to provide patient-specific data includingtarget INR values, intended duration of treatment and a recentINR value history. Some patients (n=9, 8%) had alternate-daydosing, and eight patients (7%) had more complex regimes.Fifty per cent of INR values were within 0.5 INR units of target,and 80% of INR values were within 0.75 INR units of target

Of the 38 patients who could be assessed, 30 patients wereconsidered to be controlled on warfarin because their INRvalues were within 1.0 unit of their target INR for the past 2months. Of the 71 patients managed predominantly in thehospital setting but prescribed warfarin by GPs, no evidencecould be provided for 64 (90%) patients to determine if thepatient was established on warfarin. The yellow book was theintended source of INR values for 41 patients (37%).

The main barrier to the implementation of the NPSA guide-lines was found to be a failure in the communication pathwaysbetween anticoagulation clinics, GPs and community pharma-cists. These communication failures resulted in GPs beingunable to verify patients’ INR values, and patients had notbeen educated to present their yellow books to support theirprescription requests. Electronic communication systems andprocesses should be developed to ensure that GPs have accessto patients’ current INR values. A structured medicines usereview could support the medicines-management process;3

GPs and community pharmacists should work together toensure that patients are prescribed warfarin safely. Undertak-ing this audit highlighted system failures that are currentlybeing addressed. The GP contract should be developed tocomplement the community pharmacy contractual frameworkwhich indicates the need to complete a multidisciplinary audit.

1 Patient safety alert 18: actions that can make anticoagu-lant therapy safer. London: National Patient SafetyAgency; 2007. pp1–12.

2 British Committee for Standards in Haematology. Guide-lines on oral anticoagulation: third edition. Br J Haematol1998;101:374–87. <http://www.bcshguidelines.com/pdf/bjh715.pdf> (accessed June 10, 2008).

3 The new contract for community pharmacy. London.Pharmaceutical Services Negotiating Committee; 2004.

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References



C70

An investigation into general practitioner compliance with local guidelines for the management of infection control aiming to reduce the risk of antibiotic resistance, improving quality of life

T Sweeney, IJ Cubbin and A MacAlavey

Liverpool John Moores University, Liverpool, UK. Email: [email protected]

■ This study is an investigation into the adherenceof general practitioners (GPs) with local antibac-terial formulary guidelines

■ The frequency of prescribing co-amoxiclav, clari-thromycin, quinolones and clindamycin was studied

■ Antibacterials are being prescribed more outsideof the recommendations of the guidelines

■ There has been an overall decline in antibacterialsprescribed over the last 3 years

Antibiotics are used to treat many conditions, all of whichundermine health and reduce quality of life. Appropriate useof antibiotics is vital to ensure the best clinical outcome whentreating a patient and to reduce the development of furtherantibiotic resistance. This has led to the introduction of strictclinical guidelines on antibiotic prescribing. Paradoxically thisproduces a tendency to concentrate on which antibiotic to userather than question whether an antimicrobial is useful at all.1

The local antibiotic formulary Management of infectionguidelines for primary care was reviewed in September 2007. Itis an established guide in Western Cheshire PCT (primary caretrust) and mirrors guidelines from Health Protection Agency.2

Local resistance patterns vary with time, consequently for-mulary updating is imperative. A major factor in the successof local antibiotic formularies is the adherence of the generalpractitioners (GPs).3 Monitoring prescribing habits of GPshelps to minimise resistance and give insight into triggers foradherence to local antibacterial guidelines.

The investigation, carried out on a whole population of88433, reviewed prescribing of antibiotics and adherence tothe local formulary for infection control in December 2007.Every prescription issued for antibiotics was logged, andinterrogation of specific agents and classes was carried outfrom the medical records at all 13 surgeries. The month ofDecember has been continuously monitored within this popu-lation since 2005, and a substantial dataset developed.4

A total of 3766 prescriptions were issued for antibacterialsin December 2007 compared to 4429 prescriptions inDecember 2006 and 4676 prescriptions in 2005. Of the 3766antibacterial drugs prescribed, 229 were for co-amoxiclav.compared with 414 (2006) and 456 (2005). Quinolones wereprescribed 104 times compared to 130 (2006) and 159(2005). Clarithromycin was identified as a high-cost mac-rolide in 2006 and was prescribed 119 times, comparingfavourably with the former 142 prescriptions. Of the totalantibacterials prescribed, 28 were for clindamycin. The fre-quency prescribing of these drugs on first presentation hasalso altered over the period, and now stands at 123, 70, 55and 12 times respectively for co-amoxiclav, clarithromycin,quinolones and clindamycin, with the rest being prescribedfollowing a review.

The local formulary indicates these drugs as first line for veryfew conditions. Frequently, these drugs were prescribed out-side of the formulary guidelines. They account for 13% of thetotal antibacterial prescriptions, of which approximately halfwere issued on first presentation. This is being further investi-gated with the GPs to confirm ownership of the formulary,and establish the underlying reasons for these outside pre-scriptions and determine if there are valid clinical reasons forsuch action.

Selection of drugs was often based on a GP’s preferenceand experience of particular patients rather than local guide-lines. Patient expectation is also an issue. Compliance toguidelines was associated with individuals and not practices.The results show prescribing of antimicrobials continues todecline and that constant reinforcement to prescribers andpatients alike is of great importance. The introduction ofscript-switch and the use of positive messages at the point ofprescribing was identified as another positive contribution tothis latest improvement. The weather in December 2007 wasnotably mild compared to previous years, which may havefurther added to the reduction in antibiotics prescribed.

1 Principles for best practice in clinical audit. London:National Institute for Clinical Excellence; 2002.

2 Management of infection guidelines for primary care.Chester: Western Cheshire PCT and Chester PublicHealth Laboratory; 2007.

3 Khan F. Using medicines wisely: the place of the formularyin medicines management. Hosp Pharm 2002;9:159–63.

4 Aspinall, R. An investigation into GP adherence withlocal guidelines for the management of infection within aprimary care trust. Liverpool: John Moores University;2006.

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References



C71

Label design for different-strength morphine sulphate injections to reduce the risk of administration error

YT Liu1, P Tunstell2 and B Forbes1

1King’s College London, London, UK and 2St Thomas’ Hospital, London, UK. Email: [email protected]

■ The objectives of the study were to develop anevaluation tool to audit the labelling of sterileproducts and use this to develop labels for mor-phine sulphate injection, a preparation with dif-ferent concentrations

■ The regulations and guidance of the Medicinesand Healthcare Products Regulatory Agency andNational Patient Safety Agency for labelling ofpharmaceutical products were used to produce anevaluation tool with 10 criteria. This was used toguide label design for morphine sulphate injec-tion, which complied with all the safety criteriaidentified

■ An evaluation of labelling of sterile products pro-duced at Guy’s and St Thomas’ Hospital high-lighted areas for improvement in productlabelling. The design of new labels for morphinesulphate injection was optimised to minimise therisk of drug administration error

Labelling of medicines produced in hospital pharmaciescan contribute to medication errors. Many recommenda-tions and guidelines have been introduced to address thisissue. However, there are few reports on the adherence tothese recommendations within NHS production facilities.The aim of this study was to evaluate the labelling of prod-ucts currently produced within Guy’s and St Thomas’ Hos-pital and to ensure that best practice was considered in thedesign of labels for a new product range of morphine sul-phate syringes in different concentrations – 2.5 mg/ml,10 mg/ml, 30 mg/ml and 50 mg/ml.

Following review of regulations and guidance of the Medi-cines and Healthcare Products Regulatory Agency,1,2 andNational Patient Safety Agency,3 for labelling of pharma-ceutical products, a safety evaluation tool was produced toevaluate label compliance with best practice. The

evaluation tool had 10 criteria which were described underthe headings: (1) text size and space, (2) font type, (3)strength, (4) pharmaceutical form, (5) route of administra-tion, (6) warnings and instructions, (7) critical informa-tion, (8) legal requirements, (9) product validity and (10)legibility and readability. This evaluation tool provided ascore out of 10 for compliance with the criteria, and wasused to guide the design of new labels for morphinesulphate.

The labelling of two sets of sterile products was assessedusing the evaluation tool. Set A labels included sixbatch-produced items, nine dispensed products, eightCIVAS (Centralised Intravenous Additive Service) prod-ucts, and two oncology items. Set B products were 18items produced by aseptic preparation. The mean scorefor the labels of the two sets of products were 6.2 for setA and 6.8 for set B, revealing room for improvement inlabelling practices. The only criterion that was met fullyacross the sample sets was font type (i.e. use of a sansserif font such as Arial); however, there was failure toprovide critical information for every product evaluated.Labels for the new product range of morphine sulphatesyringes were designed to comply fully with the criteriafor evaluation. Features that were introduced includedmaking it easier to differentiate product strength by usingunique features for each strength, the use ofcolour, emphasis on critical information and features toaid readability.

An evaluation tool for assessing the labelling of pharmaceuti-cal products has been developed and resulted in a genericlabel specification that could be applied to all products toreduce the risk of administration error. An audit using thistool identified areas for improvement in current labellingpractices, and the design of new labels for morphine sulphateinjection was optimised.

1 Report of the committee on safety of medicines from theworking group on labelling and packaging of medicines.London: Medicines and Healthcare Products RegulatoryAgency; 2003.

2 MHRA Guidance Note No 25. Best practice on labellingand packaging of medicines. London: Medicines andHealthcare Products Regulatory Agency; 2003.

3 Information for patient safety: a guide to the graphicdesign of medication packaging. London: NationalPatient Safety Agency; 2006.

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C72

Validation of protocols used to clean manufacturing equipment in an NHS manufacturing facility

O El Hannani1, O Rabiu2 and B Forbes1

1King’s College London, London, UK and 2St Thomas Hospital, London, UK. Email: [email protected]

■ The objectives of the study were (i) use arisk-assessment approach to identify the most dif-ficult-to-clean scenario, and (ii) use physical, chem-ical and microbiological methods to evaluate theeffectiveness of cleaning protocols

■ The study was applied to non-sterile manufac-ture products selected with beclometasonedipropionate 0.0025% ointment and clobazam1 mg/ml suspension selected on the basis of theirtoxicity, solubility and difficulty-to-clean aftermanufacture

■ Residual drug levels after cleaning were withinthe acceptable limits. Next product analysis failedto detect drug carry over, and visual inspectionand microbiological evaluation also indicated thatthe cleaning protocols were effective

Cross-contamination is a critical issue in the manufacturingof pharmaceutical products. To prevent cross-contamination,protocols used to clean manufacturing apparatus must be val-idated to ensure that they are effective. A quantitativerisk-assessment approach was used to identify the worst-casescenario out of the 10 creams/ointments and 18 liquid formu-lations manufactured at Guy’s and St Thomas’ Hospital.Beclometasone dipropionate (BDP) 0.0025% ointment andclobazam 1 mg/ml suspension were selected for the study onthe basis of their low lethal dose 50 (LD50), solubility anddifficulty-to-clean after manufacture.

High-pressure liquid chromatography (HPLC) methodswere established for BDP and clobazam and validatedaccording to ICH (International Conference on Harmoni-sation) guidelines. Sampling procedures (swabbing andrinsing) and recovery of drug from samples were verified.Acceptance criteria were established that required that (i)the equipment tested was visually clean, (ii) residual druglevels after cleaning were within the acceptable limits, and(iii) there was no detectable carry-over of the drug to the

next manufactured product.1–3 The limits for residual BDPand clobazam were calculated based on estimates of sur-face area of processing equipment and LD50

1,2. For thestudy, standard batches of each product were manufac-tured, and standard cleaning procedures (soaking, wipingusing hot water, then spray and wipe with industrial meth-ylated spirit) were performed, after which the equipment(mixers and vessels) was sampled or used to make a subse-quent product for next product analysis. Quantitativemicrobiological assays were also used to evaluate thecleaning procedures.

HPLC assays were established with limits of detection (LOD)and quantification (LOQ) for BDP of 0.048 μg/ml and0.145 μg/ml respectively. The recovery of BDP from manu-facturing equipment was 90.6%. The maximum acceptablelimit of residual BDP was calculated to be 12 μg/cm2. LODand LOQ for the HPLC clobazam assay were 12.73 μg/mland 38.57 μg/ml respectively. The recovery of clobazam frommanufacturing equipment was 90.1%. The maximum acceptablelimit of residual clobazam was calculated to be 44 μg/cm2.When the standard cleaning procedure was applied to meetthe visually clean criterion (two cleaning cycles for the oint-ment; one cleaning cycle for the liquid), the levels of BDPand clobazam recovered were below the calculated accept-ance criteria at <0.276 μg/cm2 and <0.011 μg/cm2 respec-tively. No BDP or clobazam was detected in the nextmanufactured product, and the microbial analysis was withinspecification.

The cleaning procedures applied to the manufacturing equip-ment were efficient at removing chemical residues to the pre-determined acceptable limits. The selection of the mostchallenging of the ointment and liquid formulations for thisstudy allowed the worst-case scenario to be evaluated underthe rationale that procedures that are effective for these prod-ucts will also be effective for less-challenging products of thesame formulation type.

1 LeBlanc DA. Establishing scientifically justified accept-ance criteria for cleaning validation of finished drug prod-ucts. Pharm Technol 1998;22:10.

2 Forsyth RJ, Van Nostrand V. Application ofvisible-residue limit for cleaning and validation in phar-maceutical manufacturing facilities. Pharm Technol2005; 29:152–61.

3 LeBlanc DA. Dispelling cleaning validation myths: part II.Pharm Technol Int 2005;17:45–7.

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Documents

Practice Development and Audit