Anticoagulation

PATIENT EXPERIENCE IN ANTICOAGULATION AND IMPLICATIONS OF NPSA (2007) RECOMMENDATIONS

1. Introduction

1.1 Anticoagulation

An anticoagulant is the term given to a group of medicines that reduce the ability of the blood to form harmful clots in the body by a process referred to commonly as blood thinning. The commonly used parenteral antithrombotic is Heparin. Low molecular weight heparin (LMWHS) is predominately used due to its ease of use and doesn't have many side effects (British Committee for Standards in Haematology; BSCH). They are also called vitamin k antagonists (VKA) of which the most commonly used anticoagulant is warfarin (Barnes G and Froehlich J 2008).

Anticoagulants are supplied to individuals as part of their treatment upon diagnosis of one or more of the following cardiovascular conditions. The most common are Atrial fibrillation (AF), stroke, Deep vein thrombosis (DVT) and Pulmonary embolism (PE).

1.2 Cardiovascular conditions

Atrial fibrillation (AF) is a common arrhythmia that is associated with substantial morbidity and mortality, particularly due to stroke and thromboembolism (Lip G and Lim H 2007a). AF causes atypical heart rhythm giving a fast and irregular heart beat. This affects the contraction of the atria resulting in small amount of blood being pumped from the heart. Blood in the atria can become static and can cause blood clots in the heart. The risk of AF is significantly increased with age and heart disease; 50,000 AF cases are diagnosed each year in the UK (Patient UK 2009). The small clot forming in the heart can travel and get stuck in smaller blood vessels in the brain thus causing a stroke. Approximately 21,000 AF related strokes occur each year in England and Wales (Elliott et al 1999). A combination of anti-arrhythmic and anticoagulant medication can be used for patients to return the heart rhythm back to normal and to reduce the ability of the blood to clot. A meta-analysis study of antithrombotic therapy showed that for patients with AF, warfarin can reduce stroke by approximately 60% (Hart et al 2007).

Lip et al (2007b) assessed patients with chronic AF based on their knowledge of vitamin K antagonists (VKA) in relation to monitoring, dose adjustments and lifestyle restrictions. The study was conducted using 100 patients from several European countries. Overall patient knowledge was found to be poor especially in older patients. Patients generally felt anticoagulation therapy to be a burden on their lifestyle and were unaware of the risks of uncontrolled anticoagulation. Many patients' INRs were continuously out of range and they frequently missed INR monitoring appointments. The study concluded that it was important for healthcare professionals to educate patients and reinforce the need to achieve optimal VKA therapy. A limitation of this study was that the information was generalized when different recruiting methods were used in each country. The bias was that the interview technique involved two methods, telephone and in-person and was carried out by professional interviewers and not by physicians in the absence of medical records. The sample was based on adults ≤60 years of age with only AF patients and patients using VKA were selected for this study to avoid assessing under-treatment. The sample size was small in relation to the number of countries involved thus giving an indication of the problem and therefore cannot be generalised to populations as a whole.

Deep vein thrombosis is defined as a venous thromboembolism (VTE) consisting of a blood clot occurring in a deep vein of the calf or thigh muscle. 1 in 2,000 of the general population is diagnosed with a VTE annually (MeReC Bulletin 2002 Volume 13 No 4). Fragments of the thrombus can break up and travel up the body. This can block the arteries of the lungs where it is then identified as a Pulmonary Embolism (PE). Further complications of thrombi can lead to Post-thrombotic Syndrome and leg ulcer development. DVT and PE are currently the leading causes of preventable in-hospital mortality (Thomas 2006).

(The Pharmaceutical Journal 1999)

1.3 Warfarin

The use of this anticoagulant medication has increased over the years where warfarin is the most commonly used oral anticoagulant in the UK (Hanley J P 2004). Warfarin is available orally and has a long half-life of 36-42 hours. Warfarin is available in 0.5mg (white), 1mg (brown), 3mg (blue) and 5mg (pink) tablets. Contraindications to Warfarin include haemorrhagic stroke, peptic ulcer, pregnancy, and uncontrolled hypertension. Warfarin is made of a racemic mixture of R and S enantiomers of which the S isomer is the most potent. (Patient UK 2009).

1.4 Mechanism

Vitamin K is naturally produced in the body by bacteria in the intestines which the body utilises in bone formation and blood clotting. Vitamin K is involved in the production of clotting factors used in a blood clot. Normal liver sequence involves vitamin K being converted to vitamin K epoxide, which is then ultimately reduced back by epoxide reductase enzyme. This process is linked to the carboxylation of glutamic acid residues leading to activation of the coagulation factors II, VII, IX, X and proteins C and S. The proteins help to break up clots and a deficiency can increase the probability of thrombosis.

The enzyme P450 metabolises warfarin in the liver. Warfarin is an antagonist of vitamin K therefore inhibiting the reductase enzyme and preventing the production of vitamin K clotting factors by inhibiting the carboxylation step in the vitamin K cycle. Warfarin decreases the clotting time by increasing the prothrombin time thus thinning the blood (Bartle et al 2005).

Mechanism of action of vitamin k antagonists (Becquemont 2008)

VKOR - Vitamin K Epoxide Reductase

1.5 Dose

Warfarin dose varies greatly with each individual circumstance, whereby the dose is dependent on age, diet, drug interaction and existence of co-morbidities. British National Formulary (BNF) states that for rapid anticoagulation an initial adult dose of 10mg warfarin is recommended. Further doses should be given according to the patient's International Normalised Ratio (INR). The INR measures the extrinsic pathway of coagulation and is used to determine the clotting tendency of blood. If rapid anticoagulation is not required patients should be started on a lower loading dose for 3-4 weeks. A daily maintenance dose of 3-9mg warfarin is recommended to be taken at the same time each day which is dependent on patients indication (Joint Formulary Committee 2007).

1.6 Monitoring

Monitoring of Warfarin is of paramount importance in ensuring effective anticoagulation treatment and avoiding haemorrhage and blood clots. Warfarin is monitored by assessing the prothrombin time which is translated into the broadly recognised, International Normalised Ratio (INR).

INR=<FENCE><FR><NU>patient&apos;s prothrombin:time</NU><DE>mean normal time</DE></FR></FENCE><SUP>ISI</SUP>

ISI = international sensitivity ratio (Fitzmaurice et al 2002)

An individual not on any anticoagulation therapy would have an INR of around 1.0. The most common target INR range is around 2 to 3 but varies depending on the condition diagnosed where the dose given is dependent on blood clotting test results. Importance is placed on following the recommended target range for each condition (see 3) as a rise in INR value increases the risk of bleeding, and a fall in the value can increase the prospect of clot formation. Initial treatment would include regular blood tests to ensure patients are within the desired target range required. Recommendations include blood tests to be done daily or on alternate days until target is achieved on two consecutive occasions. Then depending on INR stability it should be done 2-3 times weekly and then every 8-12 weeks for prolonged anticoagulation treatment (Guidelines on oral anticoagulation 1998).

INDICATION

TARGET

DURATION

AF (all causes)

2.5

Lifelong

Cardioversion

2.5

3 weeks before, 4 weeks after, assuming return to Sinus Rhythm

Mural thrombus

2.5

3 months

Cardiomyopathy

2.5

Lifelong

Heart Valves: Mechanical Tissue

3.5

2.5

Lifelong

Ask cardiology

Antiphospholipid syndrome

2.5

Review after 2 years

Post op calf DVT, no other risk factors

2.5

6 weeks

Calf DVT, no other risk factors

2.5

3 months

Proximal DVT / PE

2.5

6 months

Recurrent thrombosis off warfarin

2.5

Consider lifelong warfarin for recurrent thromboses or life threatening initial event

Recurrent thrombosis on warfarin

3.5

As above

1.7 Anticoagulation yellow booklet

A yellow anticoagulation booklet called ‘Anticoagulation therapy record' has been devised for the benefit of the patient as well as clinical professionals. The booklet serves as a valuable tool and contains important information on the individual patient's dosage regime. Advice on what the patient should and should not do during treatment, contact information and records can be kept of previous blood test results. Guidelines state to have at least six months record of blood test in the booklet. Information on warfarin interactions is not mentioned in the booklet therefore patients should be given this information by healthcare professional in primary and secondary care. A community pharmacist would be in a great position to give advice and support to patients about their treatment.

1.8 Risk of Bleeding

A major complication of Warfarin is the increased risk of bleeding therefore each individual patient needs to be assessed to see if benefits outweigh the risk of anticoagulant treatment. Risk of bleeding is increased in the elderly, liver disease, uncontrolled hypertension, excess alcohol consumption and especially when INR > 4. The risk of bleeding can be reduced by staying within the therapeutic INR range for each condition as recommended in the guidelines. Minor bleeds are common whilst receiving Warfarin treatment such as nose bleeds and bruising. Major bleeds can be caused by a high INR level and lead to problems such as haematuria, haemoptysis, gastrointestinal bleeds and intracranial haemorrhage, which would need urgent medical care. Experimental and observational studies have shown that approximately 15% of patients have at least one minor event annually whereas annual fatal bleeding rate are 0-4.8% and 2.4-8.1% for major bleeds (Fitzmaurice et al 2002).

DiMarco et al (2005) assessed factors that may affect bleeding during anticoagulation treatment in patients with AF. The study used a self designed trial investigating rhythm management. The patients chosen were diagnosed AF and at least one risk factor for stroke and then assigned to either a rate control or rhythm control strategy group. A Cox proportional hazards model was used to determine bleeding variables. The study found an annual incidence of approximately 2 % per year of major bleeding from assessing 4060 patients over an average 3.5 years. Major bleeding was associated with various factors such as increased age, heart failure, renal disease, diabetes, warfarin use and aspirin use. Minor bleeding was common in both groups with 738 patients reporting this in one or more visits. Overall the study concluded that bleeding is an important issue with regards to management of AF patients. Patient knowledge of such risk factors of major and minor bleeding can be improved thus improving warfarin management. There were limitations in the collection of the data with respect to details of anticoagulation management and using stability of INR values as a risk factor. No record was made of any other drugs taken by the patients therefore drug history was not known at time of event. The study can be used to show a link between various factors and bleeding but cannot be conclusively used to base any firm conclusions without further study being carried out in more detail.

1.9 Factors affecting warfarin

A change in dose prescribed can arise from various factors and requires more vigilant monitoring by clinical professionals. These include changes in the patient's diet, illness, medication and alcohol consumption, consequently increasing the need for further INR blood tests. Concordance can also be a factor in dose adjustments. Vitamin K is known to decrease the effects of warfarin. A healthy and balanced diet is recommended but with special emphasis made not to make sudden changes to diet. An increase in foods high in vitamin K for example broccoli, brussels sprouts, green leafy vegetables and liver can decrease INR due to the high level of vitamin K content in these foods. Patients on warfarin are also advised to limit or avoid cranberry juice because it can interact with warfarin. Alcohol consumption should be moderate and patients should avoid binge drinking as it can cause patients INR to become unstable thus increasing the risk of bleeding. Prolonged fever and vomiting can enhance the effect warfarin has on the body and immediate referral is needed (Nottinghamshire Hospitals).

Warfarin is metabolised by the liver resulting in a lot of medication interactions. Drugs that affect the liver enzyme system can inhibit or induce Warfarin metabolism therefore due care and advice should be given to patients on such drugs. Prescription medication, over the counter (OTC) medication, vitamins and herbal medications may affect Warfarin and INR levels.

Medicine Type

Examples

Prescription

Antibiotics, anti-inflammatory, heart medicines, ulcer and reflux medicines

Over-the-counter

analgesics, aspirin, ibuprofen, cough and cold remedies

Vitamins

vitamin C, vitamin E, vitamin K

Herbal/Natural

Ginseng, garlic, ginger, ginkgo, St John's Wort

Ramsay et al (2005) looked at the rise in the popularity of complimentary and alternative medicines (CAM) and investigated the nature and incidence associated with CAM usage with patients about to start or currently initiated on warfarin treatment. Patients were recruited from an outpatient anticoagulation clinic and patients were seen by the pharmacist. A retrospective analysis of 631 patient care plans during 2003 assessing CAM usage. Patients taking some form of CAM accounted for 170 (26.9%) of patients, with 58% of CAM users taking something that could interact with warfarin. The study found that the most common form of CAM taken by patients was cod-liver oil capsules and garlic capsules that could interact with warfarin. Overall the study concluded that most patients were taking CAM before commencing warfarin treatment and many of these CAM had the potential to interact with warfarin. The study indicated that a full drug history from the patient before starting treatment could be done to avoid such interactions and patients should be advised of the potential risk of CAM with warfarin. This study underline the wide range of interactions warfarin has with other medications and patients may not know of the medications that could interact with warfarin. Patients should be told about these at the start of treatment and information should be reinforced during treatment on an on-going basis to avoid harmful consequences from interacting medications. Patients were seen by a pharmacist at an outpatient clinic at a local teaching hospital suggesting that community pharmacists could be involved in educating patients about warfarin. The study stated that all healthcare professionals in both primary and secondary care involved with patients taking warfarin have a responsibility to be vigilant with issues in relation to CAM use. This can be extended further to all factors that could influence anticoagulant effect of warfarin e.g. diet. This study limitation was that many of the reported interaction between warfarin and CAM were based on theoretical or case reports. In some cases no conclusive association could be found between warfarin taken and taking CAM at the same time. This study is based on a local population in the U.K and further research is required to include data on ethnic backgrounds and the significance of health beliefs and types of CAM taken.

1.10 Pregnant women

Oral anticoagulants are teratogenic and should not be taken by women who are pregnant as it can affect the development of the baby especially during the first and third trimesters. Warfarin can cause embryopathy by affecting the organogenesis phases, which occurs between weeks 6 and 12 post formation. Other complications of foetal abnormalities and foetal bleeding can arise and women are advised of alternative means of treatment. No harmful link has been found between breastfeeding and anticoagulation treatment. Women are also advised to expect heavier periods when taking Warfarin. (Hall et al, 1980; Iturbe-Alessio et al, 1986; Wong et al, 1993).

1.11 Genetic polymorphism

Warfarin is a racemic mixture of R and S enantiomers. The S enantiomer is the more active compared to the R enantiomer. The S enantiomer is metabolised by the enzyme Cytochrome P450, subfamily IIC, polypeptide 9 (CYP2C9) in the liver (Ozgon et al 2008). Studies have shown that polymorphism in the gene coding for the enzyme CYP2C9 can significantly affect the warfarin dose requirements for individual patients. Early studies found two main low-active alleles CYP2C9*2 and CYP2C9*3 which decreased the hepatic clearance of S warfarin. Therefore a lower warfarin dose was needed for carriers of these alleles. It was also found that polymorphisms of the gene coding for warfarin's drug target, vitamin K epoxide reductase complex subunit (VKORC1) could affect pharmacodynamic drug response resulting in a lower warfarin dose required for patients (Wadelius et al 2007). Various studies have been conducted investigating the prevalence of the different alleles in different ethnic groups. Studies have shown that different ethnic groups have different levels of the two variant alleles for CYP2C9. Frequency of CYP2C9 alleles is higher in Caucasian and Hispanics compared to the Asian population but is lower in the African population (Yuan et al 2005). It was also found that within the African populations there are differences in the distribution of CYP2C9 alleles (Wilson et al 2003). These studies have identified that different levels of the CYP2C9 alleles can affect a patient's warfarin dose due to inter-individual and inter-ethnic differences. Warfarin dose may need to be adjusted to achieve a more appropriate dose for each patient and avoid major complications of over-anticoagulation i.e. haemorrhage.

1.12 Self testing

There are two main methods for patients to manage their treatment at home and they are Patient self-testing (PST) and Patient self-management (PSM). Patient self testing is where instructions are given to the patient by the GP on appropriate dose and any INR values measured by the patient are shown to the GP. For PSM patients measure their INR and patients can then adjust their dose after interpreting the results. Guidelines have stated that patients commencing ‘self-management must be trained by a competent healthcare professional and must remain in contact with a named clinician.' (Fitzmaurice et al 2001). PST in anticoagulation management is still a relatively new concept in the UK and little data is available to support its use in the UK. The basic principles of PSM are not new with self-management being used for diabetic patients who are trained to manage their own dose and diet. PSM is used in Germany with over 100,000 patients on long term anticoagulation therapy managing their treatment (Ansell et al 2005). The number of patients taking warfarin is increasing by approximately 15 % per year due to new indications for long term anticoagulation and people live longer. Self management is being seen as an effective way of managing increasing number of anticoagulaed patients thus helping to reduce the burden on the health service. Patient demand to take control of their treatment is also a factor contributing to the rise in popularity of patient self testing. Portable prothrombin time coagulometers are available which have been approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). One of the most popular brands available is the CoaguChek (Roche Diagnostics) and other portable device monitors available include INRatio (Hemosense), Protime (ITC) and SmartCheck (Unipath Limited) (Centre for Evidence-based Purchasing 2008).

Hamad M.A.S and Van Eekelen E (2008) investigated how patient self-testing can improve patients quality of life by controlling anticoagulation medication. The self-managed group of patients used the CoaguChek device and showed that the level of patients staying within target INR range (2.5-4.5 was target INR range) is significantly higher (mean=79.2 ± 11%) compared to the conventional group (53.9 ± 14%; p = 0.01). After a year follow-up period, the number of days that patients INR was outside the range was measured which showed it was lower for the self-managed group (22.2 ±10, p˂0.001) compared to the conventional group (28.6 ± 14). The study concluded that with training patients can self manage their treatment as compared to conventional methods resulting in a greater INR control. The study does concentrate on a small sample of patients which is not representative of the population as a whole. Patients need to be considered who may not have the self confidence to effectively undertake self management. Overall the study showed improved quality of life for this group after a year follow-up (P=0.001) in comparison to conventional management.

1.13 National Patient Safety Agency (NPSA)

NPSA is an ‘arm's length body' of the Department of Health which aims to ‘lead and contribute to improved, safe patientcare by informing, supporting and influencing organisations and people working in the health sector' (NPSA website). Anticoagulants were identified by the NPSA as a class of medication which frequently causes preventable harm and admission to hospital. On March 2007 the NPSA produced a patient safety alert in collaboration with British Society for Haematology (BSH). The patient safety alert advised steps for healthcare organisations when managing risks when prescribing, dispensing and administering anticoagulants. Information resources on anticoagulation management were made available to community pharmacists, GPs, social care providers and dentists. Important guidelines and guidance was produced over a range of actions that can be taken to promote safe practice in anticoagulation management. A key aspect identified by the NPSA was the importance of the role of community pharmacists in anticoagulation management. Guidance specified for community pharmacists was to ensure patients have been given verbal and written information on anticoagulation management which includes patient receiving and understanding the Yellow Book. Community pharmacists also must ensure that patient's INRs are being monitored regularly by asking for the patient INR record before dispensing. Checks should be carried out for medications that interact and if they have been dispensed whilst patients are on anticoagulation medication, then procedures should be in place for additional INR blood test to be done. Steps should be taken to ensure that dose is expressed in mg and not in number of tablets. Another aspect where community pharmacy can promote safe practice by ensuring that all staff involved in patient anticoagulation management (such as dispensers/technicians and counter assistants) all have appropriate training in order to manage patient's anticoagulation therapy. The NPSA have produced two e-learning modules giving information on starting and maintaining patients on anticoagulation therapy for healthcare staff. Community pharmacists as ongoing practice should also review and update clinical procedures when necessary. As part of this ongoing process, community pharmacists should take part in an annual audit of anticoagulation services to help improve anticoagulation therapy for patients.

In May 2009 the NPSA with the help of the Freedom of Information (FOI) team conducted research based on ‘local or national data regarding warfarin incidents: admissions, deaths and litigation' (NHS NPSA 2009). Using the National Reporting and Learning System (NRLS) it was reported that 4 incidents leading to death and 12 incidents leading to severe harm relating to warfarin were found between 1 January 2007 and 31 January 2008. Incidents leading to death were found to be due to inappropriate management of therapy post-discharge from hospital, failure in monitoring, follow-up of medicine use and prescribing errors. Incidents leading to severe harm were found to be due to confusion with alternate day dosing, failure in INR monitoring and errors in dosing and follow-up. These incidents further highlighted the need to improve anticoagulation management by all healthcare professionals involved in patient care. Community pharmacists are vital in improving patient care in anticoagulation therapy and implementing guidelines produced by the NPSA.

1.14 New developments

Presntly new drugs such as dabigatran and rivaroxaban have been developed and are in the process of clinical trials. These drugs especially dabigatran are being developed as a suitable alternative to warfarin. Recent non-inferiority study was completed comparing warfarin and dabigatran. The study found that dabigatran that can ‘safely and effectively reduce risk of stroke and in AF while minimising risk of major bleeding, without restrictions around lifelong blood tests and monitoring.'the study found dabigatran to be non-inferior to warfarin of the primary endpoint for dabigatran doses of 110mg and 150mg (P=0.003 and P<0.001 respectively for each dose). (Clinical Pharmacist 2009).

1.15 Purpose of the study

Studies have shown the high level of risk associated with warfarin and the importance of monitoring warfarin. Risk associated with warfarin and other medication, changes in diet and bleeding complications in relation to unstable INRs. Studies have also shown the need for better patient care and educating patients of the potential risks associated with warfarin, which consequently led to the NPSA producing guidelines on anticoagulation management for healthcare professionals. The purpose of this present study was to evaluate the need for the anticoagulation booklet and whether patients used and understood this booklet. The study also aimed to evaluate patient views and perceptions of community pharmacist. How, as a healthcare professional in the community, the pharmacist was involved in patient anticoagulation management. From the literature research done very little, if any, could be found on patient views regarding the booklet. Studies showed the role of the pharmacist in patient anticoagulation management based in a hospital anticoagulation clinic. Little research was available on patient views on the value of the community pharmacists in their treatment. This study will focus on patient views and opinions of the level of healthcare available from their community pharmacist compared to simple dispensing. It will help to identify if community pharmacists are implementing the NPSA guidelines in anticoagulation management of patients. The study will also give an insight into patient's views on how they feel about their treatment at present and what could be done to improve patient care in anticoagulation management.

Youssef (2007) conducted an audit on patients taking warfarin in a community pharmacy setting. The audit involved carrying out MURs and assessing indications for treatment, dosage, timing, compliance, INR monitoring and interactions with food and drugs. The focus of the MURs was to implement the new guidelines produced by the NPSA from assessing patient knowledge treatment and if patients adhere to the information given to them from other healthcare professionals. A fundamental aspect found from the MURs was the significance of the yellow booklet to patients. It showed patients were using the ‘old style' yellow booklet and not the ‘new style' yellow books distributed in April 2007. Comparison of the ‘new' and ‘old' books revealed that important information in the ‘old' book is not available in the ‘new' book thus emphasising the importance of the pharmacist in advising warfarin patients. Patients were not aware of the interaction that foods and supplement can have on their INR and stated that no such information was given to them during their treatment. The community pharmacists undertaking the audit establishes the need to improve their own knowledge on warfarin. The study is relatively recent and was undertaken from a community pharmacist perspective. Overall the MURs showed the lack of knowledge that patients have of their treatment and how the pharmacist can be a point of call in the community by providing advice to patients.

1.16 Clinical studies

Engova et al (2002) used validation tools such as Medication Adherence Report Scale (MARS), Beliefs about Medication Questionnaire (BMQ) and Intrinsic Desire for Information (IDI) to assess the relationship between patient knowledge and control of Warfarin. A high percentage of patients showed good adherence to taking medication (68%) and taking medication at the same time each day. This study showed that a greater physicians influence on patients, and that patients take their medication based on trust they have in the medical profession; this had a greater impact on older patients with poor understanding and least inclination to receiving information (mean age 71, p<0.0001). The study concluded that there was a need for greater involvement of patients in managing their own health through education. Results were based on patient understanding of a questionnaire which may not be an effective means of obtaining the required information on its own, whereas INR stability could be acknowledged as an enhanced adherence measurement. The results highlighted how community pharmacists could communicate with patients more effectively and bridge the gap in patient knowledge with relation to their warfarin treatment.

Khan A and Rutter P.M (2002) conducted a study on the level of anticoagulation services provided by PCTs nationally across the UK. A postal survey was sent out to all primary care trusts in England. After two mailings a total of 133 replies were returned and 124 of these were used for analysis, excluding incomplete replies. Results showed that 37% of PCTs (n=46) offered an anticoagulant service of which 80% were mostly from GP based clinics (n=37). Results showed that quite a substantial number of PCTs did not provide an anticoagulation service (n=74) and of these half (n=37, 47%) were thinking of providing an anticoagulation service in the future in order to meet the increasing number of patients. This study showed that over the years PCTs have expressed concern of the growing workload due to the increased number of anticoagulation patients. Thus PCTs welcomed and encouraged further involvement by community pharmacists in the future (n=22, 59%). This study was dated and the response level achieved was low but it provides an insight into the level of involvement of community pharmacists and of future prospects.

Macgregor et al (1996) evaluated an anticoagulation clinic in primary care managed by a pharmacist. Patients were followed up at six months and one year achieving INR targets within range of 84% and 90% respectively. A comparison was made between INR values measured for patients at hospital with ones measured in surgeries, showing a considerable improvement (P˂0.001). The study also evaluated the advantages and convenience of setting a clinic in surgeries especially for the elderly with respect to cost (48% less cost for patients), travel times (64% less travelling) and waiting times (˂10 minutes) when compared to hospital clinics. This study failed to address the issue of quality control and the comparisons between costs for both clinics are inadequate. This study has not clarify the settings or the population of patients being studied. It emphasized that more clinics should be accessible to patients and not just centralized in one institution. It also showed how pharmacists can be invaluable in anticoagulant patient management especially with regards to patient safety.

Hu et al (2006) investigated factors impacting on patient knowledge of warfarin therapy after mechanical heart valve replacement. This study took into account in-hospital teaching practices, socio-economic status (SES) and demographic variables with respect to successful anticoagulation treatment. Initial assessment was taken via a validated questionnaire on warfarin, side effects and vitamin K food sources. A telephone survey was carried out 3 to 6 months later among 100 patients and subsequently knowledge scores were compared using the student t-test or one-way analysis of variance (ANOVA). Overall results showed that 61% of patients scored less than 80% thus showing a lack of knowledge about warfarin. Participants showed a better level of understanding and knowledge about warfarin in lower age groups. Similar results could be seen with patients who have a higher level of education and socio-economic status. An interesting aspect found from the study was the improvement in patient knowledge after receiving post-discharge community counselling. This study concluded that improved compliance and control are related to improved patient knowledge. Therefore better access to information in the community via counsellors and/or pharmacists could help reinforce the education received in hospital. Limitations of this study included how well the participants could recall the level and type of education received when conducting a telephone survey 3 to 6 months post discharge. The study does not include any information of INR levels and could not make any correlation to any other factors such as knowledge scores even though previous studies have included such data. With respect to the actual goal of the study does achieve its aims and does shows the importance of community education post discharge especially regards to demographic and SES status. There is a lack of information provided by the study relating to the type and duration of community counselling received by participant or any knowledge of the level of education received in hospital for comparison.

Bajorek et al (2005) organised a study to investigate how to optimise the use of antithrombotic in elderly patients by developing and evaluating a pharmacist led multidisciplinary intervention in a hospital setting. Elderly patient's antithrombotic therapy requirements were based on a stroke risk vs. contraindications criteria and patients were recruited over a six month period. The study found that after the intervention from the pharmacist changes had to be made to optimise antithrombotic therapy. There were 35.8 % of patients requiring changes on existing therapy of whom 76.9 % required upgrade to more effective treatment options. The remaining 23.1 % of patients needed a downgrade to a less effective but maybe a safer option. This study highlighted the effectiveness of having a pharmacist-led intervention which can optimise antithrombotic therapy in elderly patients, thus giving an indication that pharmacist-led community based clinics could be highly effective for optimising antithrombotic use. A study limitation was that no control group was used and therefore results could not be compared to show any differences between a pharmacist and non-pharmacist-led clinic. The criteria included selecting patients at risk that are specific to this study and may not be generalized to the AF patient population. The study was also conducted in Australia which may have different procedures and assessments in hospital which may not relate to the UK.

Couth (2009) conducted a study assessing patient knowledge of warfarin in primary care run clinics. The study evaluated overall patient knowledge, what patients knew about the drug, interactions, risk and identified areas where patient understanding was poor. A questionnaire was given out to patients in a pharmacist run clinic and a nurse-managed surgery. Results from the questionnaires collected were combined together to give a larger cohort and analysed. The study found that overall patients' knowledge was average and that patient appreciation of risks associated with warfarin, as well as which foods and drinks to not take with warfarin, was poor. The study went further showing that as patient age increases the level of knowledge about warfarin is affected and was found to be generally poor overall. Leaflets were to be sent to the clinics and to doctors where a follow-up questionnaire will be carried out in 12 months time. It will assess if there is any improvement in patient knowledge from the leaflet distribution. Overall the study was very vague and no definite information is given, especially about how the patients were recruited. No inclusion or exclusion criteria were taken into account and no information was given on the number of patients that replied to the questionnaire except for percentages. The study also combined the two sets of data from two separate clinics and did not compare the sets of data separated to make any comparison between the two clinics. The study briefly explains the four questions from the questionnaire but no statistical analysis was done on the results. Therefore cannot see if the results are statistically significant or not statistically significant. The results obtained are weak and cannot be used to make any firm conclusions. This study did achieve its aim but further studies need to be done to assess patient knowledge of warfarin. However, the Couth study is the only type of research similar to the aims of this present project and does give an insight into the lack of patient knowledge.

Chan et al (2006) evaluated the difference between a pharmacy-managed anticoagulation clinic compared with a physician-managed anticoagulation clinic in Chinese patients. Patients were recruited from a hospital anticoagulation clinic and on the basis of certain inclusion criteria (which included patients aged over 18 years and patients that required treatment for at least 3 months) in order to include certain patients and excluded patients not fitting the criteria. Patients were randomly separated into pharmacist or physician-managed groups. The study assessed patient INR stability, incidence of major bleeding and the cost per patient per month (cPPPM). Patient completed a questionnaire (PSQ-18) in order to determine patient satisfaction. The study found that patients favoured the pharmacy-managed group (3.8 ± 0.2) and more patients were in the target INR (64%) compared to the physician clinic (59%) (p<0.001). The incidence of major bleeding between the two groups showed no significant difference. The study found cPPPM for the pharmacy-managed group was lower than in the physician-managed group. Overall the study found that a pharmacy-managed anticoagulation clinic was more favoured by patients, with better anticoagulation control and was more cost effective than a physician-managed clinic. One of the study limitations of this study was that the sample size was not large enough to make more detailed conclusions in relation to incidence of complications between the two groups. The administrator of the PSQ-18 was not blinded to the two different groups and therefore could have influenced the questionnaire. The study highlighted how effective pharmacy-managed anticoagulation can be for patients. The study, however, was conducted in China for Chinese patients and therefore the cost analysis made in this study cannot be applied to the UK.

2. AIMS AND OBJECTIVE

2.1 Aim

To evaluate patient appreciation of the need for the anticoagulation booklet and community pharmacist involvement.

2.2 Objectives

1. To assess patient knowledge of the anticoagulation booklet as an effective tool in anticoagulation management.

2. To develop an understanding with respect to the role of the pharmacist in anticoagulation management from a patient perspective.

3. METHOD

3.1 Overview

A patient information pack was sent to patients asking for their participation. The pack was sent directly to 500 patients' home addresses using a patient list provided by anticoagulation clinic at Medway Maritime Hospital (MMH). Patients were recruited using an inclusion and exclusion criteria. Stamped addressed envelopes were provided to patients so they could return questionnaires back to Medway School of Pharmacy which were marked for the attention of the project supervisor. Questionnaires were mailed out a second time if patient did not reply from the first mailing using coding system. Returned completed questionnaires were equally distributed between the students. The data was analysed using SPSS and stored onto memory sticks provided.

3.2Ethical Approval

The project supervisor presented the project to East Kent NHS Ethics Committee for ethical approval. Initial presentation of the study was not approved as contact needed to be made with the MMH Caldicott Guardian regarding issues relating to consent and changes that needed to be made to the Patient Information Leaflet. These issues were dealt with and changes were shown to the Ethics Committee and the study was approved. Once approved, the study was jointly agreed by the Medway School of Pharmacy and Medway Maritime Hospital NHS Trust. Consent was achieved from Medway Maritime Hospital through the hospital Site Specific Research Governance.

3.3 Caldicott Guardian

“A Caldicott Guardian is a senior person responsible for protecting the confidentiality of patient and service-user information and enabling appropriate information-sharing. The Guardian plays a key role in ensuring that the NHS, Councils with Social Services responsibilities and partner organizations satisfy the highest practicable standards for handling patient identifiable information.” Department of Health 2009

The Caldicott Guardian (CG) was a healthcare professional at Medway Maritime Hospital.

3.4 Consent

Consent for accessing patient information from the warfarin clinic was achieved through the Caldicott Guardian at Medway Maritime Hospital. A patient consent form was not sent in the patient information pack. Voluntary completion and returning of the questionnaire by the patient would mean that patients were providing implied consent for the purpose of this study.

Patients were reassured that the purpose of this survey was to improve patient care and that taking part in the survey and completing the questionnaire was entirely voluntary. Patients were advised that their care will not be affected in any way if they decided to not participate in the survey.

3.5 Confidentiality

Patients were assured that all data will be kept confidential and under secure conditions at Medway School of Pharmacy. The information would only be used for the purposes of the project and all responses will be kept confidential. Any direct quotes from patients, if used, would be completely anonymised and non-identifiable. Patients could request a copy of the findings from the study by sending their name and address on a separate sheet of paper with the completed questionnaire.

3.6 Data Storage

The data was stored at Medway School of Pharmacy on a password protected computer. Data would only be accessed by students and project supervisor for this specific project at Medway School of Pharmacy and would not be removed from the premises at any time. A USB memory stick would be provided to each student by the project supervisor to store data from the project and to avoid direct storing of data on personal computers.

3.7 Inclusion Criteria

* ≥ 18 years of age

* Gillick Competence (patients who are able to give consent and information about their own treatment)

* English speaking and reading patients

* Patients collecting own warfarin medication

· Patients who have been clinically diagnosed to need anticoagulation medication

· Patients have been on anticoagulation medication for ≥3 months

3.8 Exclusion Criteria

· ˂18 years of age

* Pregnant women

* Nursing home residents

* Non Gillick competence (patients who are unable to give consent and information about their own treatment)

* Patients not collecting their own medication and where no additional counselling is provided

* Patients that have been on anticoagulation medication for ˂3 months

3.9 Study design

Questionnaires were chosen for this study because of the large sample size chosen for this study and due to time limitations. For this sample size interviews would not have been appropriate whereas questionnaires would be more cost effective and could be used to assess the large sample size. A local anticoagulation clinic was chosen for this study so it would be easier to achieve ethical approval from the local East Kent NHS Ethics Committee. It was also chosen due to its locality and ease of communication between project tutor and Medway Maritime Hospital.

3.10 Patient Information Pack

Patients were provided with the following information sheets and were sent out by the university.

(A) Cover letter: an invitation to the patient about the students and the project. Patients were advised that their participation was voluntary and would not affect their future level of care.

(B) Patient Information Leaflet: gave more in depth information about the purpose of the project thus helping the patient to make an informed decision if they wished to take part. The leaflet explained who was organising the study and how the patient data would be handled and published.

(C) Questionnaire guide: provided an overview about the structure of the questionnaire. It provided information and explained to the patient about confidentiality and provided contact details for patients.

(D) Questionnaire: the questionnaire consisted of open and closed questions. Multiple response questions where patients could select more than one response would also be used. The questionnaire was comprised of three sections; (1) Personal details, (2) Warfarin treatment and management, (3) Community pharmacist involvement.

(E) Pre-paid envelope: provided for patients to return their completed questionnaires.

3.11 Questionnaire design

All the relevant issues were identified in relation to the study objectives of each group member. These were devised into questions and then incorporated into the questionnaire. The questionnaire was designed with patient perceptions in mind. Patients were provided with a questionnaire guide giving clear instructions and contact information for patients. The questionnaire was presented in a larger font size (16) with bold and easy to read writing. Questions were simple, unambiguous and easy to follow, with particular attention to the content validity. The questionnaire gave clear instructions to the patient and if questions were not applicable then instructions were given as to what to do afterwards. Patients were provided with additional space at the end of the questionnaire for further comments. The questionnaire consists of 13 questions which were separated into three simple sections. Patients were advised that the questionnaire will take approximately ten minutes to complete.

3.12 Patient selection and recruitment

Once ethical approval was obtained a patient list of approximately 3000 patients containing details of names and addresses was provided to Medway School of Pharmacy via the project supervisor. This was provided by the warfarin clinic at Medway Maritime Hospital. Patients receiving anticoagulation treatment for less than three months had been removed from the list by the MMH anticoagulation clinic lead pharmacist prior to receipt. The patient list was taken and through random selection 500 patients were selected, taking care to not include patients residing in nursing homes.

3.13 Sample Size

The 500 patient information packs approved by the Ethics Committee was sent out to patients home addresses. The patient information pack included a cover letter, patient information leaflet, questionnaire guide, questionnaire and a pre-paid envelope. For the purpose of this study I am hoping for around 30-40 % feedback. This is to allow for patients who may not reply to the questionnaire and to gain a good level of feedback in order to get enough data to establish an effective conclusion.

3.14 Coding

Every fifth patient from the patient list was taken and numbered from 1 to 500. During the numbering process any nursing home addresses were overlooked moving onto the next name on the list. Five hundred pre-paid envelopes were numbered from 1 to 500. Each numbered, pre-paid envelope was matched with the numbered patient list and filled with a cover letter, patient information leaflet, questionnaire guide and questionnaire. This numbering process was done to keep the patients details anonymous and to help identify which patients needed a second mailing to be sent out that had not returned the questionnaires from the first mailing.

3.15 Setting

A patient information pack will be sent using Royal Mail direct to patients' home address. The questionnaires were returned by stamped, addressed envelopes provided to patients. The returned envelopes were addressed to the project supervisor and returned to Medway School of Pharmacy.

3.16 Mailing

The patient information pack was posted out on two occasions. The two mailings were based on the ethical approval obtained. The first mailing of 500 patients information packs was posted via Medway School of Pharmacy reception. Two weeks was allocated as sufficient time for patients to return the completed questionnaires in the prepaid envelope provided. This applied to both the first and second mailing and was allocated as a realistic time scale available for the purpose of this study. A national postal strikes caused a slight delay in the first mailing of the patient information pack but did not affect the second mailing.

3.17 Communication

The project supervisor contact details would be provided to patients in the patient information pack. Patients were provided an email address and telephone number if they had any queries relating to completion of the questionnaire.

3.18 Questionnaire distribution

Questionnaires were distributed randomly between each of the four group members. The returned questionnaires were separated into ‘yes' and ‘no' categories according to what answer patients gave to the first question in the questionnaire which is based on the inclusion and exclusion criteria. These were then separated into four groups and split evenly in the group. Blank questionnaires were disregarded.

3.19 Statistical methods: SPSS

SPSS is a computer program used for statistical analysis. This program was used to input data and for data analysis. Each question in the questionnaire was defined as separate variables. Both the questions and their corresponding answer was coded using numbers. For multiple response questions each of the available options were coded separately. This process was applied to all the questions in the questionnaire thus forming a database which was entered into SPSS in the ‘variable view' field. All data obtained from the completed questionnaires returned by patients were coded according to this database and entered into SPSS into the ‘data view' field

For example, question one: ‘do you visit the local community pharmacy/chemist yourself to collect your warfarin?' which was coded as ‘Warfarincollect'. The answer to this question was coded as yes=1 and no=2.

3.20 Data Analysis

Data was organised into a table using SPSS and then analysed using frequency tables and chi-squared tests. The data was presented for further analysis into charts such as bar graphs and pie charts.

3. Results

Response Rate

After Mailing

Response

Percentages (%)

1

266

53.2

2

84

16.8

Total

350

70

Was warfarin explained to patient when treatment was started * Information re-explained to patients since starting treatment Crosstabulation

Count

Information re-explained to patients since starting treatment

Total

Yes clearly

Yes not clearly

No

Was warfarin explained to patient when treatment was started

Yes clearly

5

1

42

48

Yes not clearly

1

0

10

11

No

0

0

5

5

I can't remember

1

2

2

5

Total

7

3

59

69

Chi-Square Tests

Value

df

Asymp. Sig. (2-sided)

Pearson Chi-Square

18.274a

6

.006

Case Summary

Cases

Valid

Missing

Total

N

Percent

N

Percent

N

Percent

$WarfarinInformationa

68

95.8%

3

4.2%

71

100.0%

$RiskInformationa

57

80.3%

14

19.7%

71

100.0%

$WarfarinInformation Frequencies

Responses

Percent of Cases

N

Percent

$WarfarinInformationa

General Practioner

10

10.1%

14.7%

Hospital doctor

44

44.4%

64.7%

Nurse

12

12.1%

17.6%

Hospital Pharmacist

16

16.2%

23.5%

Community (dispensing) Pharmacist-in shop

2

2.0%

2.9%

Pharmacy technician-at hospital

13

13.1%

19.1%

Can't remember

2

2.0%

2.9%

Total

99

100.0%

145.6%

.

$RiskInformation Frequencies

Responses

Percent of Cases

N

Percent

$RiskInformationa

General Practioner 1

10

12.0%

17.5%

Hospital doctor 1

28

33.7%

49.1%

Nurse 1

11

13.3%

19.3%

Hospital Pharmacist 1

14

16.9%

24.6%

Pharmacy technician-at hospital 1

12

14.5%

21.1%

Other 3

6

7.2%

10.5%

Can't remember 1

2

2.4%

3.5%

Total

83

100.0%

145.6%

Patient Gender * Know target blood test result (INR value) Crosstabulation

Count

Know target blood test result (INR value)

Total

Yes

No

Patient Gender

Male

37

4

41

Female

20

8

28

Total

57

12

69

Chi-Square Tests

Value

df

Asymp. Sig. (2-sided)

Pearson Chi-Square

4.100a

1

.043

Have a yellow book * Does Community pharmacist ask for patient yellow book Crosstabulation

Count

Does Community pharmacist ask for patient yellow book

Total

Yes always

Yes sometimes

No never

Have a yellow book

Yes

5

2

60

67

No

0

0

2

2

Total

5

2

62

69

Chi-Square Tests

Value

df

Asymp. Sig. (2-sided)

Pearson Chi-Square

.233a

2

.890

.

Does Community pharmacist ask about present warfarin dose

Frequency

Percent

Valid Percent

Cumulative Percent

Valid

Yes

4

5.6

6.2

6.2

No

61

85.9

93.8

100.0

Total

65

91.5

100.0

Missing

System

6

8.5

Total

71

100.0

Does Community pharmacist ask for latest blood test (INR value)

Frequency

Percent

Valid Percent

Cumulative Percent

Valid

Yes

6

8.5

9.2

9.2

No

59

83.1

90.8

100.0

Total

65

91.5

100.0

Missing

System

6

8.5

Total

71

100.0

Does Community pharmacist ask about next blood test

Frequency

Percent

Valid Percent

Cumulative Percent

Valid

Yes

7

9.9

10.8

10.8

No

58

81.7

89.2

100.0

Total

65

91.5

100.0

Missing

System

6

8.5

Total

71

100.0

Does Community pharmacist ask if patients have any problems

Frequency

Percent

Valid Percent

Cumulative Percent

Valid

Yes

1

1.4

1.5

1.5

No

67

94.4

98.5

100.0

Total

68

95.8

100.0

Missing

System

3

4.2

Total

71

100.0

How useful is the community pharmacist advice * How often patient ask community pharmacist for information about warfarin Crosstabulation

Count

How often patient ask community pharmacist for information about warfarin

Total

Never

Sometimes

How useful is the community pharmacist advice

Very useful

0

2

2

Sometimes useful

4

3

7

Not useful

2

1

3

Never needed/obtained any

52

4

56

Total

58

10

68

Chi-Square Tests

Value

df

Asymp. Sig. (2-sided)

Pearson Chi-Square

19.406a

3

.000

Patient happy with quality of service from community pharmacist * Patient Gender Crosstabulation

Count

Patient Gender

Total

Male

Female

Patient happy with quality of service from community pharmacist

Yes

32

17

49

Usually

5

5

10

No

2

7

9

Total

39

29

68

Chi-Square Tests

Value

df

Asymp. Sig. (2-sided)

Pearson Chi-Square

6.029a

2

.049

Patient Gender * Does patient feel confident with warfarin treatment Crosstabulation

Count

Does patient feel confident with warfarin treatment

Total

Yes

No

Patient Gender

Male

38

2

40

Female

26

3

29

Total

64

5

69

Chi-Square Tests

Value

df

Asymp. Sig. (2-sided)

Exact Sig. (2-sided)

Exact Sig. (1-sided)

Pearson Chi-Square

.715a

1

.398

Types of comments

Frequency

Treatment concerns

10

Identification issues

2

Community pharmacist views

16

Warfarin medication concerns

5

Patients happy with service

4

Others

1

Discussion

The response rate was very good despite postal strike at the time of mailing and after the second mailing the group collectively achieved 77% response rate. All the questionnaires that were received were randomly divided into four equal groups. My total number of questionnaires that patients had replied to and did meet the inclusion criteria was 71 (%). The total number of patients that returned the questionnaires and from there answers it was found that did not meet the inclusion criteria was 16 (%).

The findings from the study showed that half the sample population of patients that responded to the study questionnaire are taking warfarin due to being diagnosed with Atrial Fibrillation. A small number of patients, approximately 3.7% did not know why they were taking warfarin. This does raise concern as patient should be aware of the basic facts of their treatment and why they are taking their medication.

Patient's knowledge regarding the problems associated with warfarin was assessed by presenting a question that showed a combination of factors that are and are not problems when taking warfarin. Factors in the list that are regarded as not being a problem when taking warfarin include taking medication at the same time each day, minor bleeding/bruising and keeping to a diet that doesn't vary too much. The proportion of patients that selected these risks is 17%, 28% and 7% respectively. A significant number of patients (23%) recognised the use of pain killers as a problem with warfarin. Low number of patients selected problems associated with warfarin such as certain foods containing vitamin K (8%), exercise (4%), over the counter/herbal medicines (10%) and certain foods containing vitamin C (3%). The results showed again the lack of knowledge from patients with more patients selecting options that are not regarded as being a problem with warfarin than selecting options that may cause problems. This could be due to patients not remembering what is important and what is. Patients may have been given the information at the beginning of treatment but have forgotten the relevant information at the time of completing the questionnaire. Patients may also have got confused with the question and tick answered that they assumed were important.

Results showed that the majority of the patient's answered ‘yes' (83%) when asked if they knew their target blood test result (INR). There were a number of patients that selected the option of knowing their INR value but did not answer the second part of this question and provide their INR target value, which was left blank. A chi-squared test was done between patient gender and knowing target blood test result which gave a probability of 0.043. Therefore the results are statistically significant as probability is lower than the 0.05 probability level. Results showed more males patients knew their INR value compared to the female patients. Thus showing that patients lacked the basic knowledge about their treatment and more needs to be done to tackle these aspects. Patients that did say they knew their INR target value but then did not provide it could be due to patients not fully understanding the question.

Patients overall shows a lack of knowledge about the fundamental aspects of their treatment. Answers to questions put to patients about the problems associated with warfarin and about their target INR was poor. More should be done to reiterate and give written information about these topics and others relating to treatment to patients. Especially when some patients don't know what condition they have been diagnosed with and why they are taking warfarin.

Patients were asked if warfarin was explained to them at the start of the treatment of which 70% and 16% responded ‘yes clearly' and ‘yes but not clearly' respectively. When asked if the information was re-explained to them later upon commencing treatment 86% of sample population replied ‘No'. The chi-squared test showed a probability of 0.006 which is lower than the 0.05 probability level therefore can conclude that there is a statistically significant relationship between patients receiving information about warfarin before and during their treatment. The results show that patients on the whole have received information about their treatment at the start which would explain the general knowledge of warfarin shown by patients. This survey does indicate that after the start of treatment, information is not reiterated again to patients and may explain the gaps of knowledge patients are experiencing. This could be due to patients not being able to remember as most of the sample population on warfarin are in the older age category. This shows that more needs to be done to keep warfarin information fresh in patients minds and that patients understand the importance of all the information that they receive and not just remember selective information.

Patients when asked about the source of the warfarin information they received 65% replied they got their information from the hospital doctor. The second most popular answer was the hospital pharmacist of 24%, compared to only 3% of patients obtaining warfarin information from the community pharmacist. The patients were also asked if they received any risk information about warfarin and if so where did they get this information from. The results for this was the same as the warfarin information question where 49% answered the hospital doctor, 25% hospital pharmacist and 0% answered community pharmacist. The response to both these questions illustrate that patients get their information mainly from the hospital doctor. Most if not all patients would be in contact with the hospital doctor at the start of their treatment and then would be referred to a hospital warfarin clinic for long term treatment and regular check-ups. This would explain why considerable number of patients choose hospital pharmacist as a source for warfarin information after the hospital doctor. The results highlight patient's view of secondary care compared to primary care such as GPs and community pharmacist. Patients are given the tools and the information at the start of the treatment but no follow up is done with patients during treatment and indicates that more needs to be done after the initial treatment is started especially in the community for warfarin patients.

The study found nearly all of the sample population had a yellow booklet but when questioned if the community pharmacist asked to see their yellow booklet, 90% of patients answered ‘no never'. A probability of 0.890 was calculated from the Pearson Chi-Squared test. The value is higher than the probability level of 0.05 therefore results are not statistically significant. These results showed that the community pharmacist may not be following the NPSA guidelines been in place since 2007. Pharmacist should ask patients for their yellow booklet in order to check the progress of individual patients and their present INR level.

Further questions were asked about the community pharmacist and if patients were asked questions about other aspects of their treatment. Questions put to the patients about the community pharmacist were does the community pharmacist asked about their present warfarin dose, latest blood test (INR value), about next blood test and does the community pharmacist ask if patients have any problems that they would like to discuss. Almost all patients answered no to each of these questions about the community pharmacist with around 90% or more of patients portraying the same consensus. According to patients community pharmacists do not ask patients any question relating to warfarin and their treatment. According to the NPSA guidelines community pharmacist should be more vigilant with warfarin especially considering the problems and interactions with warfarin and carry out the necessary steps to ensure patient safety.

Patients were asked how often patients asked community pharmacist for information about warfarin. Majority of patients (85%) answered that they never ask the community pharmacist information about warfarin, with very few patients that they ask the community pharmacist sometimes. Patients were also asked how useful they found the community pharmacist advice was and 82% of patients answered never needed or obtained any advice. The Pearson Chi-Squared test calculated a probability of 0.000 which can be taken as less than 0.0005 (SPSS rounds off to three decimal places) and thus lower than the probability level of 0.05 and statistically significant. Patient's opinion of the community pharmacist is not good and patients do not see them as healthcare professionals that can provide advice except a place where they collect their medication. Patients may not ask questions from the pharmacists but pharmacists should play a more proactive role with patients and show patients how valuable they can be in their treatment with their knowledge and expertise. Community pharmacist should ask warfarin patients for their yellow booklet to check patient's treatment progress and ask patients if they have any questions.

The study found that when patients were asked if they were happy with the quality of service from the community pharmacist the majority of patients answered yes (72%) and 15% answered usually. This was broken down into patient gender and found that more male patients (47%) are happy with the service from the community pharmacist compared to females patients (25%). The Pearson Chi-Squared test calculated a probability of 0.049 which is lower the probability level therefore results are statistically significant. A high percentage of patients (more males) indicating that they are happy with the quality of service from the community pharmacist.

An overall final question put to the sample population was do they feel confident with their warfarin treatment with majority of patients answering yes (93%) and some answering no (7%). More male patients (58%) were confident with their treatment than female patients (42%). The Pearson Chi-Squared test calculated a probability of 0.398 therefore relationship between these two variables is not statistically significant as higher than the probability level.

These results do not reflect previous answers given by patients from earlier questions in the questionnaire. This could be due to how patients perceive the community pharmacist and may have based their answers according to this. Patients see the community pharmacist as a place to collect their medication and the community pharmacist as a person who dispenses their medication and nothing more. Therefore patients may assess how quickly or slow they receive their medication as good or bad service. Which if related to this question would mean that patients are happy with the quick dispensing service provided by the pharmacy. This also brings to attention that patients may not like going to the pharmacy and patients wants to get their medication and leave as quickly as possible. This may explain why patients are reluctant to ask the community pharmacist any questions. This further illustrates patient's view in relation to the role of a community pharmacist and how community pharmacist may not be adhering to the NPSA guidelines and should be providing a better support to warfarin patients.

Comments made in the questionnaire by patients were grouped into similar categories and a table was formed showing the number of patients of that belong to each category. The results show that a number of patients expressed their views about the community pharmacist. The general consensus was that most patients took their prescription to the pharmacy which the pharmacist dispensed and patient went away with their medication. Patient's comments showed that the community pharmacist did not give any advice or check their yellow booklet and only gave advice if asked a question by the patient. A patient commented ‘I don't have any conversation with my pharmacist' and another patient expressed their view of the pharmacist as ‘he or she just hands out pills'. A positive comment from a patient stated that warfarin is supplied and the pharmacist does ask to see their yellow booklet which the patient commented ‘quite happy with this present arrangement'.

A number of patients made comments regarding their treatment with many patients showing concern about their treatment. Patients did use the opportunity of the questionnaire to pose their own questions relating to their treatment. Most of the comments made by patients showed concern about how long term treatment of warfarin may affect them, and asking ‘are there any detrimental effects of warfarin'. A patient was quoted saying ‘don't know if clot will go or how will I know if it goes' whilst another patient stated that ‘I feel weird sometimes, hot, sweaty and slightly out of breath now and again'.

Other concerns made by the patients related to side effects of warfarin. Patients were asking for more information about what foods and other medication they can take whilst taking warfarin. Some patients commented that all they have been told is to avoid grapefruit and cranberry juice. A patient was quoted saying, ‘not told what to avoid other than grapefruit and cranberry would like a diet sheet if possible.'

A couple of patients suggested that the yellow book was bulky and wanted to have a plastic card or a bracelet so that patients can be identified as warfarin patients if for example there was an accident.

Previous studies have shown the importance of the pharmacist involvement in the primary and secondary care. The studies found that patients preferred a pharmacist led clinic and showed improvements in patient knowledge and patient care. Previous studies have evaluates the effectiveness of the pharmacist but have not shown any research into patients views of community pharmacist. This study aimed to evaluate how patient viewed the community pharmacist and how patients used the community pharmacist in their treatment. The results show that the level of knowledge from knowing patients INR value, risks associated with warfarin and general aspects about their treatment is poor. The survey also shows that most do not go to the pharmacist for advice with more seeking the advice of the hospital doctor. Thus showing that patients won't go see the community pharmacist even if patients do not know much about their condition and may have questions about their treatment. This show that patients do not view the community pharmacist as a healthcare professional where they can advice about their treatment but see them as someone whose just dispenses their medication. Therefore more needs to be done to improve patient knowledge and community pharmacist are placed in the heart of the community and can help achieve this. This study shows that community pharmacist may not be actively following the NPSA guidelines because if the guidelines are followed then more patients would come to see the community pharmacist. Patients may not ask question maybe because they don't think community pharmacist will help but community pharmacist can follow the guidelines and ask questions themselves.

A limitation to the study was that the questionnaire did not go into detail and question the patients about the yellow booklet. The questionnaire was tailored for the group and to not make the questionnaire long the numbers of questions was limited. Therefore couldn't effectively evaluate the need for the anticoagulation yellow booklet from a patient's perspectives and therefore further research is required to assess this issue. This presents with another limitation in that due to time and the need for ethical approval it wasn't viable to do four separate questionnaires for each individual in the group. Thus if more time is permitted for future study the questionnaire would be designed and tailored to the specific objectives of this project. Another limitation was that it cannot be assured that the questionnaire was filled out by patients and not by carers or patient's family which could have affected the answers given.

Conclusion

The study aims were achieved and data of patient's views were collected and analysed via a questionnaire. The study found that patient lack basic knowledge about their treatment. Overall the study found that patient's views of the community pharmacist is not good and patients do not go to the community pharmacist for advice. Despite this the study did show that the majority of patients are happy with the community pharmacist service and feel confident about their treatment. One of the study aims was to assess the need for an anticoagulation booklet which the study was unable to assess effectively due to the design of the questionnaire. If the study was done again then more detailed analysis would be done to meet these study aims and a better cohort of questions would be used. If study permits then face to face interviews with patients could be carried out to get more detailed answers.

REFERENCES

1. Barnes G.D and Froehlich J.B (2008) Anticoagulation: where we are and where we need to go. Journal of Thrombosis and Thrombolysis.

2. Anticoagulation Europe UK (2008). What are anticoagulation?, [Online] Kent. Available from http://www.anticoagulationeurope.org/anticoagulants.html [Accessed 8 December 2008]

3. Lip G.Y.H and Lim H.S (2007a) Atrial fibrillation and stroke prevention. Lancet Neural., 6: 981-993

4. Patient UK (2009) Atrial Fibrillation, [Online]. Available from http://www.patient.co.uk/showdoc/23068682.html [Accessed 6 December 2008]

5. Elliott R. A et al. (1999) Appropriateness of antithrombotic prescribing for elderly in patients with atrial fibrillation. Pharmceutical Journal., 263(7063): 408

6. Hart R. et al. (2007) Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial Fibrillation. Annals of Internal Medicines., 146 (12): 857-867

7. Lip G.Y.H et al. (2007b) Oral anticoagulation in atrial fibrillation: A pan-European patient survey. European Journal of Internal Medicine., 18: 202-208

8. National Prescribing Centre, MeReC Bulletins. Available from http://www.npc.co.uk/merec_index.html (Accessed: 12 January 2009),

9. Thomas M (2006) Venous thromboembolism-manifestations and diagnosis. Hospital Pharmacist., 13: 199-204.

10. The Pharmaceutical Journal (1999) Pharmacy anticoagulation clinics could help save 5,000 lives, says NPA. Available from http://www.pharmj.com/Editorial/19990918/news/anticoagulation.html (Accessed: 8 December 2008).

11. Hanley J P (2004) Warfarin reversal. Journal of Clinical Pathology., 57(11): 1132–1139

12. Bartle B et al (2005) Clinical guide-Oral Vitamin K Anatagonists. The Thrombosis Interest Group of Canada, 1-5

13. Becquemont L (2008) Evidence for a pharmacogenetic adapted dose of oral anticoagulant in routine medical practice. European Journal of Clinical Pharmacology., 64:953-960.

14. Joint Formulary Committee (2007). British National Formulary. 54th edition. London: British Medical Association and Royal Pharmaceutical Society of Great Britain, 2.8.2: 125-126

15. Fitzmaurice et al (2002) ABC of antithrombotic therapy: Bleeding risks of antithrombotic therapy. British Medical Journal., 325: 828-831

16. Guidelines on oral anticoagulation; third edition. British Journal of Haematology (1998) 101: 374-387

17. Baglin et al (2005) Guidelines on oral anticoagulation (warfarin): third edition – 2005 update. British Journal of Haematology., 132: 277-285

18. Nottinghamshire Hospitals (2006) Anticoagulation Therapy Advice and Information. Nottingham: Nottinghamshire Hospitals.

19. WA Medication Safety Group (2007) Living with Warfarin: information for patients. Available from http://www.health.wa.gov.au/docreg/Education/Population/Health_Problems/HP8948_warfarin_B.pdf (Accessed: 30 January 2008).

20. Ramsay N.A. et al (2005) Complimentary and alternative medicine use among patients starting warfarin. British Journal of Haematology., 130:777-780.

21. Hall J. Paul R. and Wilson K. (1980) Maternal and fetal sequelae of anticoagulation during pregnancy. American Heart Journal., 68: 122-140.

22. Iturbe-Alessio I. del Carmen Fonseca M. Mutchinik O. Santos M. Zajarias A. and Salazaar E. (1986) Risks of anticoagulant therapy in pregnant women with artificial heart values. New England Journal of Medicine., 315: 1390-1393.

23. Wong V. Cheng C. and Chan K. (1993) Fetal and neonatal outcome of exposure to anticoagulants during pregnancy. American Journal of Medical Genetics., 45: 17-21.

24. Ozgon G.O et al (2008) VKORC1 and CYP2C9 polymorphisms are associated with warfarin dose requirements in Turkish patients. Eur J Clin Pharmacol., 64:889-894.

25. Hsiang-Yu Y et al (2005) A novel fuctional VKORC1 promoter polymorphism is associated with inter-individual and inter-ethnic differences in warfarin sensitivity. Human Molecular Genetics., 14: 1745-1751.

26. Fitzmaurice D.A Machin S.J. (2001) Recommendations for patients undertaking self management of oral anticoagulation. British Medical Journal., 323: 985-989.

27. Ansell J, Jacobson A, Levy J, et al. (2005) Guidelines for implementation of patient self-testing and patient self-management of oral anticoagulation. International consensus guidelines prepared by International Self-Monitoring Association for Oral Anticoagulation. Int J Cardiol., 99:37–45.

28. Centre for Evidence-based Purchasing (2008). Point of care coagulometers for monitoring oral anticoagulation. NHS Purchasing and Supply Agency., CEP 07026.

29. Hamad M.A.S. Van Eekelen E. (2008) Self-management program improves anticoagulation control and quality of life: a prospective randomized study. European Journal of Cardio-thoracic Surgery., 35: 265—269.

30. National Patient Safety Agency (2008). Actions that can make anticoagulant therapy safer: Alert and other information. [Online]. Available from http://www.nrls.npsa.nhs.uk/resources/?entryid45=59814 [Accessed 9 July 2009].

31. Clinical Pharmacist (2009) Dabigatran could replace warfarin for patients with AF. 1:378.

32. Youssef S (2008) Patients taking warfarin: problems revealed by medicines use reviews. The Pharmaceutical Journal., 280: 662-667.

33. Engova D. Duggan C. and MacCallum P. (2002) Patients understanding and perceptions of treatment as determinants of adherence to Warfarin treatment. The International Journal of Pharmacy Practice., 10(suppl): R69

34. Khan A. and Rutter P. M. (2002) The provision of anticoagulation services by primary care groups and trusts: has community pharmacy a role to play? The International Journal of Pharmacy Practice., 10(suppl): R50

35. Macgregor S. Hamley J. Dunbar J. Dodd T and Cromarty J. (1996) Evaluation of a primary care anticoagulant clinic managed by a pharmacist. British Medical Journal., 312: 560.

36. Hu A et al (2006) Factors influencing patient knowledge of warfarin therapy after mechanical heart valve replacement. Journal of Cardiovascular Nursing., 21:169-175.

37. Bajorek B.V et al (2005) Optimizing the use of antithrombotic therapy for atrial fibrillation in older people: A pharmacist-led multidisciplinary intervention. American Geriatrics Society., 53:1912-1920.

38. Chan F.W.H et al (2006) Management of Chinese patients on warfarin therapy in two models of anticoagulation service-a prospective randomized trial. British Journal of Clinical Pharmacology., 62: 601-609.

39. NICE clinical guideline 36, Atrial Fibrillation: the management of atrial fibrillation, 1.4.2.2

40. Tweddell S. J. Wright D. J. Acomb C. and Taylor P. (2003) Enhancing the pharmaceutical care of patients with atrial fibrillation. The International Journal Pharmacy Practice., 11: R76


Please be aware that the free essay that you were just reading was not written by us. This essay, and all of the others available to view on the website, were provided to us by students in exchange for services that we offer. This relationship helps our students to get an even better deal while also contributing to the biggest free essay resource in the UK!