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cpd module






This module is suitable for use by pharmacists as part of their continuing professional development cycle. Complete the record form on page viii for inclusion in your CPD portfolio. Previous modules in the Pharmacy Magazine CPD Programme are available to download at


Welcome to the one hundred and seventy ninth module in the Pharmacy Magazine Continuing Professional Development Programme, which looks at high-risk drugs and MURs. It is valid until August 2013. Continuing professional development (CPD) is now a mandatory requirement for pharmacists. Journal-based educational programmes (unscheduled learning) are an important means of keeping up-to-date with clinical and professional developments and form a significant element of your CPD. Completion of this module will contribute to the nine pieces of CPD that must be recorded a year. Before reading the module, assess your learning needs by answering the questions below. After reading the module, complete the record form on page viii for inclusion in your CPD portfolio. You can also test your knowledge by answering the multiple choice questions. A £3.75 marking charge applies to each module.

Self-assess your learning needs:

· Which high-risk drugs have been identified by NPSA and MHRA drug safety alerts? · Are you familiar with the Beers criteria on inappropriate medication use in older patients? · Which drugs are most commonly associated with preventable hospital admissions?

This module supports the following CPD competences: C1c, C1d, C1k and C4g. More details on pvii







Contributing author: Samixa Shah, MRPharmS, PgDipClinPharm, clinical pharmacist consultant


Pharmacists have a duty to make sure that the right drug is taken at the right dose by the right patient at the right time, every time. Any drug could potentially be categorised as high risk if it falls outside these criteria. In this module we will consider some examples of how pharmacists can help minimise adverse events related to high-risk drugs by improving patient understanding. It is not intended to be an exhaustive list but will highlight how to approach this subject with patients when undertaking a medicines use review (MUR). The National Prescribing Centre's Idealised Medicines Pathway1 identifies patient understanding and concordance/compliance as the key areas where a patient influences his/her own use of medicines. It is especially important to focus on these areas when counselling a patient on high-risk drugs or when conducting a MUR involving medication of this type. The NICE guideline on medicines adherence2 states that healthcare professionals have a duty to help patients make informed decisions about treatment and use appropriately prescribed medicines to best effect.


What are high-risk drugs?

Drugs can be considered `high-risk' for a number of reasons (see Table 2). A recent systematic review3 found that four drug groups accounted for over half (51 per cent) of preventable drugrelated hospital admissions: Antiplatelets (16 per cent) Diuretics (16 per cent) NSAIDs (11 per cent) Anticoagulants (eight per cent). Results for more drug groups are shown in Figure 1 (page iv). These preventable admissions

G O A L : To update pharmacists on how they can contribute to improved patient safety in

relation to high-risk medicines.


After completing this module, you should be able to: · Explain the definition of a high-risk drug · List four ways in which high-risk medicines pose a risk to patient safety · Identify three ways in which you can reduce the potential risks from high-risk medicines.


Table 1: Aims of a MUR service and potential impact on minimising complications due to high-risk drugs

The aim of MURs is to improve patient knowledge, concordance and use of medicines by: Establishing the patient's actual use, understanding and experience of taking his/her medicines Relevance to high-risk drugs

Checks if actual use matches prescribed dose/frequency. Clarify any "when required" wording; ensure that the method of use is acceptable to the patient to increase likelihood of concordance Helps to minimise the risk of incorrect use leading to over/under-dosing Avoids the patient stopping important treatment due to sideeffects that can be managed. Look for alternative drugs if the treatment is unsuitable Identifies wasted medicines that aren't taken because of unacceptability to patient and poor compliance

Identifying, discussing and resolving poor or ineffective use of medicines Identifying side-effects and drug interactions that may affect patient compliance Improving the clinical and cost-effectiveness of prescribed medicines and reducing medicines wastage

were then further categorised by the underlying problem leading to hospitalisation (see Table 3). Let's now consider some of the implications of problems associated with adverse drug reactions/over-treatment and under-treatment, and patient adherence problems associated with these drug groups, as well as with oral anticoagulants, methotrexate and lithium. Some of the main points you can discuss with patients when reviewing these drugs are highlighted.

Adverse drug reactions/over-treatment

Antiplatelet agents such as clopidogrel or aspirin (when used at an antiplatelet dose) may cause haemorrhage. Early signs that the antiplatelet effect is too strong can include bruising and/ or bleeding. Of particular concern are gastrointestinal bleeding (e.g. perforation of a gastric ulcer) and cerebral haemorrhage. A proton pump inhibitor (PPI) such as omeprazole or an H2 antagonist (e.g. ranitidine) can reduce the risk of GI bleeding. Diuretics can lead to dehydration if there is insufficient fluid replacement. Patients should be reminded of the need to maintain adequate fluid intake as long as there are no reasons for intake to be limited. Renal failure can result from reduced renal perfusion as a result of dehydration. Falls are also a risk from excessive diuretic therapy as postural hypotension may occur from dehydration. Diuretic use may also cause electrolyte imbalances, depending on the drug being used, which can cause complications in conditions such as heart failure. Make sure patients are aware of the regular tests that need to be undertaken to ensure diuretics are not putting them at risk from other complications. (Problems with patient adherence with diuretics are discussed later.) NSAIDs are associated with quite a few significant ADRs, so you may need to advise changing to a lower-risk NSAID or another treatment altogether. Remember to include ibuprofen bought OTC when considering NSAIDs during a MUR. Gastrointestinal bleeding linked to NSAID use can be very serious,

MUR service specification (Pharmaceutical Services Negotiating Committee, 2004)

Table 2: Classifying high-risk drugs

Identified as high-risk by: National Patient Safety Agency (NPSA) Drug Alerts4 Examples of high-risk drugs Insulin, lithium, warfarin, methotrexate, liquid medicines, injectable medicines: all may be subject to patient dosing errors and inadequate monitoring leading to toxicity NSAIDs: risk of gastrointestinal bleeding or worsening of asthma Methotrexate: ensure patients have regular blood, liver and renal tests, and understand to report signs and symptoms suggestive of infection Tacrolimus: ensure correct formulation and brand is prescribed Ciclosporin: prescribe and dispense by brand name Digoxin: potential toxicity if patient has decreased renal clearance Hypnotics, sedative antihistamines, anticholinergics: can all cause confusion, drowsiness, increased risk of falls Tricyclic antidepressants: increased risk of falls, confusion, drowsiness; risk of cardiac toxicity Benzodiazepines: risk of falls and fractures, drowsiness and confusion Theophylline, lithium, digoxin, antiepileptics: side-effects and/or toxicity can occur at levels close to therapeutic concentrations Antiepileptics, oral contraceptives, NSAIDs NSAIDs and peptic ulceration: gastrointestinal bleeding Methotrexate, alendronic acid: risk of overdose if patient takes drug daily as opposed to weekly Warfarin, methotrexate, lithium: need to be sure that the patient is taking the drug according to the most recent dosage instructions to avoid over-/under-dosing

Commission on Human Medicines5 (formerly Committee on the Safety of Medicines) advice and warnings ­ detailed in the BNF and Drug Safety Updates6

Beers criteria for potentially inappropriate medication use in older patients7

Narrow therapeutic range

Risk of interactions with other drugs Drugs that can interact with disease Drugs with weekly (or non-daily) dosing

Drugs requiring regular patient testing and/or dose changes






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Patients may also have a complex drug regimen that is difficult to remember, so an assessment should be undertaken to determine whether they would find a medicines reminder device (e.g. a drug chart or monitored dosage system) useful.

Patient adherence problems

Diuretics, particularly stronger ones used in heart failure (e.g. furosemide), can cause a marked increase in urine output, which may be seen by the patient as inconvenient. For example, activities like shopping can become a worry if the patient cannot be certain of finding a convenient public toilet, so he/she may choose to modify usage by only taking the prescribed dose occasionally. If a patient has been prescribed a twice-daily diuretic dose, is the second dose being taken around midday/early afternoon or at night? The latter could lead to disturbed sleep patterns that the patient finds unsuitable. There are also issues for patients who suffer from urinary incontinence/urgency as a diuretic will worsen these symptoms. Any discussion should acknowledge the importance to the patient of any side-effects they experience but, at the same time, it is vital to communicate the importance of taking the drug properly. It may be that during the review you can check whether the patient feels that symptoms, such as leg swelling or breathless-

MURs should be targeted at high-risk drugs

so it is important to ensure that the patient has been co-prescribed a PPI or an H2 antagonist in order to reduce the risk of a bleed. It is also important to check whether a patient is taking aspirin since this will increase the risk of a GI bleed. Appropriate recommendations should be made to the GP The lowest effective dose of . NSAID should be prescribed for the shortest period to control symptoms. NSAIDs can be implicated in renal dysfunction as they can lead to decreased blood flow to the kidneys. Any patients with a history of renal disease should use NSAIDs with caution. Heart failure symptoms can be exacerbated by NSAIDs, so these drugs should be used with caution in patients with, or at risk of, heart failure. They can also cause a worsening of asthma. Their use should be closely monitored

in asthmatic patients to avoid respiratory symptoms. In all cases with NSAIDs, it is worth considering whether an alternative analgesic with a better safety profile (e.g. paracetamol) would be more suitable. Non-pharmacological therapies, such as exercise and physiotherapy, can also be suggested in order to avoid excessive use of NSAIDs for pain control.

Table 3: Underlying problems behind preventable drug-related admissions

Underlying problem Main associated drug group(s) Antiplatelets (e.g. clopidogrel, aspirin) Diuretics (e.g. furosemide, bumetanide) NSAIDs (e.g. diclofenac, ibuprofen, naproxen) Antiepileptics Diuretics, drugs used in diabetes, antiepileptics


Antiepileptics have complex drug-drug interactions, so any patient taking more than one antiepileptic or taking antiepileptics with other drugs should understand that any changes in their symptoms (e.g. an increase in the number or change in pattern of seizures) may be a result of the blood level of the drug being too low due to an interaction. From the patient's point of view, it may be useful to suggest keeping an epilepsy diary so they can monitor how well their seizures are being controlled.

Adverse drug reactions/ over-treatment

Under-treatment Patient adherence problems

Reflection exercise 1

Identify a 30-minute prescribing period and consider what you have dispensed during that time. · How many of the drugs dispensed would you consider high-risk? · How many of your regular patients did you attempt to engage in a MUR to check their understanding of these drugs?









ness, are under control. If symptoms are uncontrolled, this is a good opportunity to reinforce that correct drug use could improve the situation.

Insulin and metformin

Drugs used in diabetes, such as insulin and metformin, may not be used as intended by the prescriber for a number of reasons. This puts the patient at risk from poor blood glucose control, which increases the risk of both shortterm diabetic complications such as urinary tract infections, fungal infections and foot ulcers, and longer-term complications (e.g. vascular damage, renal damage and retinopathy). Insulin is required to be injected which, in itself, may be a barrier to some patients who are not comfortable doing this. Check what training on injection technique the patient has had. If lack of awareness is the cause of poor adherence, use the MUR as an opportunity to contact a nurse at the patient's diabetes clinic. A better understanding of the correct injection procedure will mean the patient is more likely to correctly administer the insulin. Is the injection device suitable for their personal circumstances? A patient with diabetes may have poor eyesight due to diabetic retinopathy or poor manual dexterity due to

Figure 1: Drug groups most commonly associated with preventable hospital admissions

neuropathy. If the injection device is not easy to use, a change of device would be an important recommendation to come out of the MUR. The dose of insulin is very important. Overdosing with insulin can cause hypoglycaemia or even diabetic coma. Ensure the patient knows the signs of a `hypo' and has a way of correcting it. It is also important to check that the dosage is written correctly (not using `as

directed' or the abbreviation `iu') to minimise dosing errors. Linked to insulin use, ensure that patients have a good understanding of blood glucose monitoring (i.e. routine monitoring and how to change their monitoring regimen if they are feeling ill) and that their blood glucose monitor is easy to use. Are the results displayed large enough for the patient to read? Finally, check the patient has a sharps bin and understands the importance of safely disposing sharps and using a new hypodermic needle each time. Metformin can be associated with gastrointestinal disturbances, such as nausea, abdominal pain, diarrhoea (usually transient), particularly with higher doses. If these sideeffects are causing the patient to miss out doses, ensure that the drug is taken with or just after food. If this doesn't improve tolerability, suggest the patient contacts his/her prescriber for alternative treatment options.


Antiepileptics are associated with a wide range of side-effects that can mean patients find it difficult to adhere to the prescribed regimen. Common side-effects across the drug group include drowsiness, dizziness and nausea.

Pharmacists should reinforce correct injection technique for insulin users






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If a patient feels he/she no longer needs treatment after a long period without seizures, refer back to the doctor for a review to see if this would be suitable. If a woman of child-bearing age is taking antiepileptic drugs, make sure that she is taking an adequate dose of contraceptive. Some contraceptives interact with antiepileptic drugs and do not provide sufficient cover as a result. This is particularly important since some antiepileptic drugs are teratogenic and can cause developmental defects in a foetus (e.g. carbamazepine, lamotrigine, phenytoin and sodium valproate can cause neural tube defects).

Other high-risk drugs

Warfarin Warfarin is the most commonly prescribed oral anticoagulant in the community. Its use requires regular monitoring of the patient's INR to ensure that the level of anticoagulation is appropriate for the patient's condition. An over-anticoagulated patient is at risk of haemorrhage, so patients need to know to report uncontrolled bruising or bleeding, details of which are in the yellow anticoagulation therapy information booklet that patients receive. If a patient is under-anticoagulated, there is an increased risk of clotting occurring, which could lead to, among other things, myocardial infarction, stroke and pulmonary oedema. It is important to ensure that the patient's INR is being monitored regularly before dispensing a repeat prescription. The MUR is a good opportunity to educate a patient to always show his/her INR record (yellow record book, printed sheet or other format) to any healthcare professional involved in his/her care, as this will minimise the risk of errors around dose prescribing or administration. MURs are also an ideal opportunity to check that patients know the colour of the different strengths of warfarin tablets and what they need to take to achieve their daily recommended dose. This is a useful way of avoiding dosing errors. During a MUR, stress the importance of a regular, balanced diet, ensuring that vitamin K

Anticoagulants are high-risk ­ check that a warfarin patient's INR is being monitored regularly

intake is relatively constant so as to avoid changes in antagonism of warfarin by the vitamin. If the patient is uncertain about vitamin K-containing foods, provide information about these and check that the patient has a reference source with the relevant details. Warfarin can also interact with cranberry juice, St. John's wort and a number of drugs ­ make sure the patient is aware of these interactions. Again, with women of child-bearing age, there is a risk of foetal abnormality since warfarin is teratogenic. Check that contraception has been discussed and understood. Methotrexate Methotrexate is most commonly prescribed in rheumatoid arthritis because of its immunosuppressive action. However, because of this,

Reflection exercise 2

If a patient requiring regular monitoring has lost or not been given a patient information and monitoring booklet (warfarin, methotrexate, lithium), have you got any spare copies? Do you know how to order them?

patients should know to watch out for signs and symptoms of infection (such as sore throat) or blood disturbance. Ensure the patient knows to report these symptoms and seek medical advice urgently. Regular blood cell, liver and kidney function tests are important to make sure that the methotrexate level is not causing toxicity. In patients who suffer from gastrointestinal or mucosal side-effects as a result of taking methotrexate, check whether they have been prescribed folic acid 5mg weekly (on a different day to the methotrexate dose) to counteract these symptoms. A dose specifying `as directed' is not a suitable instruction as this can leave the patient open to making a mistake. Always stress the fact that methotrexate is usually given as a weekly dose. Patients should receive tablets of the same strength (total dose in either 2.5mg or 10mg tablets) to avoid confusion over which strength of tablet to take and reduce the risk of overdose. Methotrexate interacts with aspirin and NSAIDs, which may be used in patients with









rheumatoid arthritis to control symptoms. Methotrexate levels should be monitored very carefully if this is the case. Aspirin and ibuprofen should not normally be bought over-the-counter by or for patients on methotrexate therapy. An MUR is a good opportunity to ensure that patients have understood pre-treatment information, as well as the importance of taking their methotrexate blood monitoring and dosage record booklet with them whenever they see a healthcare professional. Lithium Lithium salts are used: In the prophylaxis and treatment of mania In the prophylaxis of bipolar disorder As concomitant therapy with antidepressant medication in patients who have had an incomplete response to treatment for acute depression in bipolar disorder In the prophylaxis of recurrent depression. Some patients taking lithium have been harmed because they have not had their dosage

Reflection exercise 3

Think about how you communicate risks about sideeffects to patients on a daily basis. · How can you discuss high-risk drugs in a MUR setting without causing alarm to the patient? · How can you gauge a patient's understanding of the concept of risk?

record booklet and alert card. It is also important to reassure a patient that the full prophylactic effect of lithium may not occur for six to 12 months after initiation.

Communicating with patients about high-risk drugs

It may be the case that the patient has his/her first in-depth discussion about side-effects or complications associated with high-risk drugs during a MUR. Remember to communicate any risks in a responsible way so that patients are not scared or discouraged from benefiting from the treatment that has been prescribed. It is essential to reinforce why the drug has been prescribed so that the patient appreciates the importance of taking it. An important contributing factor to perceptions about the safety of medicines is the way stories are reported in the media. Be prepared to answer patients' concerns about medicines that have featured on TV/the internet and in the press. Ensure that a pharmaceutical care plan is written in language that is easy for the patient to understand and contains enough information to remind him/her of all the points you have covered. A MUR on high-risk drugs could generate a lot of detailed and important information that could easily be forgotten or confused. A clear plan outlining your recommendations will enable the patient to act on agreed next steps and get the full benefit of having undergone a MUR with you. It is vital patients understand that some drugs should not be stopped suddenly (e.g. antiepileptic drugs: may lead to rebound seizures; abrupt withdrawal of beta-blockers can cause a worsening of cardiovascular symptoms).

adjusted based on recommended regular blood tests. If patients are not informed of the known side-effects or symptoms of toxicity (e.g. blurred vision or muscular weakness), they cannot manage their lithium therapy safely. Regular blood tests are therefore very important. Clinically significant alterations in lithium blood levels can occur with commonly prescribed and OTC medicines. Lithium blood levels are dependent on kidney function and the drug has the potential to interfere with renal and thyroid functions. A MUR is therefore an ideal opportunity to ensure that the patient is having all the blood tests required at the recommended intervals and has a lithium information booklet,

Communicating with GPs

It is important that doctors understand why pharmacists carry out MURs. Many in general practice do not know what MURs are or how they differ from clinical medication reviews. Consider using your MUR service as a way of improving links with local GP surgeries. By ensuring that GPs know the significance of the MUR forms that are sent to them, you can help

Effective MURs are about good communication ­ with both patients and doctors






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to ensure that recommendations about high-risk drugs are acted upon appropriately. By the very nature of these drugs, there is the potential that changing the way that a patient takes the medication will lead to undesirable consequences if there is no monitoring e.g. a patient taking levothyroxine and calcium at the same time of day may not absorb the full dose of levothyroxine. Advising the patient to leave a gap of four hours between taking the two drugs will improve the absorption of levothyroxine. However this may lead to the level becoming too high, possibly causing side-effects such as diarrhoea, vomiting, arrhythmias, palpitations and bradycardia. It is therefore useful to communicate with the doctor before a change in dosing time, as it may be necessary to make arrangements for patient monitoring during dose readjustment. When filling in the MUR form, make sure that the pharmaceutical care plan is clear and concise so that the doctor and any other healthcare professionals involved understand the key points you are making.

CPD competences

This module supports the following community pharmacy competences:

Competences C1c Reviewing medication with patients to identify difficulties and potential risks (e.g. concordance issues, adverse effects, changing medication needs) Monitoring indicators of disease progress, drug efficacy or drug toxicity Where this module supports competence development Different ways of identifying high-risk drugs are covered in the module, which also highlights issues around patients' use and experience of common drugs of this type. Reflection exercise 1 asks pharmacists to identify high-risk drugs they regularly dispense This module outlines how to respond appropriately to patients in a MUR with regard to side-effects of drugs, disease symptoms and perceived efficacy of treatment. Reflection exercise 2 focuses on pharmacists having monitoring and treatment information booklets available so that patients can get a replacement if necessary. This ensures that patients have information on potentially dangerous adverse drug reactions (ADRs) and side-effects The importance of a pharmaceutical care plan in a MUR, to both the patient and GP is highlighted , This module examines the place of MURs in the patient journey and encourages pharmacists to work closely with doctors so that MURs have the best possible impact on patients, as well as professional relationships



Documenting pharmaceutical care plans Working across professional boundaries


Practical points for MURs

Consider targeting specific high-risk drugs or drug groups. This will allow you to develop expertise in certain areas. You can link an alert on the PMR to specific drugs or flag prescriptions during the dispensing process where a patient is being dispensed a particular high-risk drug Use your pharmacy support team to the maximum advantage Make sure that local GPs and practice/district nurses know about the service so they can encourage patients to have a MUR. You may wish to inform the local healthcare team about specific drugs or conditions you are targeting and supply them with information leaflets to give to patients

Have leaflets available so that if patients are not interested initially when you approach them, they can read about the service and decide whether to return for a MUR at a later date.

Learning opportunities

Regularly reviewing patients' medicines use ensures that pharmacists update their clinical

knowledge and offers many opportunities for CPD. The skills and competences that pharmacists gain from conducting MURs, especially involving high-risk medicines, could eventually help pave the way for becoming much more involved in the management of patients with long-term conditions and offer additional service development opportunities.


1. An Introduction to Medicines Management. National Prescribing Centre, 2007 2. Medicines adherence: NICE guideline: 3. Howard RL et al. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol 2006; 63:2:136-147 4. National Patient Safety Agency Alerts: available from 5. Commission on Human Medicines: CommissiononHumanMedicines/index.htm 6. Drug Safety Alerts: 7. Fick DM et al. Updating the Beers Criteria for potentially inappropriate medication use in older adults. Arch Intern Med


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1. When offering a MUR, which statement is FALSE?

a. You need to get a patient's consent before carrying out a MUR b. Family or carers can be present with the patient's consent c. A prescription intervention MUR can include high-risk drugs d. It is necessary to have a copy of a patient's full clinical test results




6. Which of the following is TRUE concerning a patient taking methotrexate?

a. Patients taking methotrexate for RA should always take high-strength NSAIDs to ensure that their symptoms are fully controlled b. Taking NSAIDs with methotrexate will lower the plasma levels of methotrexate c. When taking NSAIDs with methotrexate, the methotrexate dose should be carefully monitored d. Ibuprofen would be a good OTC treatment for a patient complaining of a sore throat while taking methotrexate

Activity/development completed (Act)

Date: What did I learn that was new? (Evaluate)

Time taken to complete activity:

2. A patient taking warfarin should be advised to avoid which fruit juice?

a. Cranberry b. Grapefruit c. Blood orange d. Apple

How have I put this into practice? (Provide examples of how learning has been applied ­ what did you do differently as a result?) (Evaluate)

3. How often should patients stable on lithium therapy have their blood levels monitored?

a. 12 months b. Three months c. Six months d. One month

7. What percentage of preventable drug-related hospital admissions are due to antiplatelets, diuretics, NSAIDs or anticoagulants?

a. 50 per cent b. 10 per cent c. 30 per cent d. 70 per cent

4. Which drug does NOT require regular patient testing and/or dose changes?

a. Methotrexate b. Warfarin c. Theophylline d. Lithium

Do I need to learn anything else in this area? (Reflect)

8. What type of problems can normally be associated with antiplatelet medicines?

a. Under-treatment b. Patient adherence problems c. Over-treatment and ADRs d. Forgetting to take the medicines

5. Which statement is TRUE? Lithium is used in the prophylaxis and treatment of:

a. Bipolar disorder b. Mania c. Recurrent depression d. None of the above

If as a result of completing your evaluation you have identified another new learning objective, start a new cycle ­ this will enable you to start at Reflect and then go on to Plan, Act and Evaluate. This form can be photocopied to avoid having to cut this page out of the module.


MODULE 179 ANSWER SHEET ENTER YOUR ANSWERS HERE Please mark your answers on the sheet below by placing a cross in the box next to the correct answer. Only mark one

box for each question. Once you have completed the answer sheet in ink, return it to the address below together with your payment of £3.75. Clear photocopies are acceptable. You may need to consult other information sources to answer the questions.


a. b. c. d.


a. b. c. d.


a. b. c. d.


a. b. c. d.


a. b. c. d.


a. b. c. d.


a. b. c. d.


a. b. c. d.

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