Summary

This document discusses clinical pharmacy, including prescription monitoring, medication errors, and adverse drug reaction reporting. It also covers topics such as patient education, and clinical outcomes.

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Clinical Pharmacy-I (PP517) Level 5 PharmD Program Chapter-I Clinical Pharmacy According to the American College of Clinical Pharmacy's (ACCP) Clinical pharmacy is defined as: Clinical pharmacy is that area of pharmacy concerned with the...

Clinical Pharmacy-I (PP517) Level 5 PharmD Program Chapter-I Clinical Pharmacy According to the American College of Clinical Pharmacy's (ACCP) Clinical pharmacy is defined as: Clinical pharmacy is that area of pharmacy concerned with the science and practice of rational medication use. Clinical pharmacy is a health science discipline in which pharmacists provide patient care that optimizes medication therapy and promotes health, wellness, and disease prevention. Clinical duties: 1. Prescription monitoring. 2. Prescribing advice to medical and nursing staff. 3. Medication errors and adverse drug reaction reporting. 4. Medication history-taking and medicines reconciliation. 5. Patient education and counselling. 6. Pharmacokinetics and therapeutic drug level monitoring. 7. Personalised medicine 8. Education and training 9. Medicines formularies 10. Clinical outcomes 11. Professional and clinical audit 1. Prescription monitoring: The prescription is reviewed for medication dosing errors, appropriateness of administration route, drug interactions, prescription ambiguities, inappropriate prescribing and many other potential problems. Patients can be questioned on their medication histories, including allergies and intolerances, efficacy of prescribed treatment, side- effects and adverse drug reactions (ADRs). 20 Clinical Pharmacy-I (PP517) Level 5 PharmD Program The routine presence of medical and nursing staff on the ward allows the pharmacist to communicate easily with other members of the healthcare team who value the prescription-monitoring service that clinical pharmacists provide. 2. Prescribing advice to medical and nursing staff Help with choice of medicine dose Method of administration Side-effects Interactions Monitoring requirements Other aspects of medicines use. 3. Medication errors and adverse drug reaction reporting Adverse events occur in around 10% of all hospital admissions and medication errors account for one quarter of all the incidents that threaten patient safety. Clinical pharmacists have an important role to play in the detection and management of ADRs and, more recently, directly reporting ADRs via the Yellow Card scheme. Yellow Card Scheme Pharmacists along with doctors, other health professionals, can submit reports of suspected ADRs identified in patients with whom they have had contact. The general public have also been able to report directly since 2005. It is not essential to be certain that there is an association between the medicine and the reaction to submit a report, only a suspicion. Information from Yellow Card reports is entered into a database and further information is sought from reporters if required to enable the report to be assessed. 21 Clinical Pharmacy-I (PP517) Level 5 PharmD Program What is collected in Yellow Card Scheme? Nature of the reaction: Some clinical events are commonlycaused by medicines,such as Stevens Johnson syndrome. Timing of the reaction: Some events occur minutes or hours after taking a single dose and are thus likely to be associated, althoughother events can be considerably delayed, even by years. Relationship to dose: If the dose changes, corresponding changes in the severity of the event may indicate an association. Exclusion of other possible causes: Other medicines being taken or symptoms associated with disease states present should be considered as possible causes. 4. Medication history-taking and medicines reconciliation Taking a medication history from patients and prescribing on admission have traditionally been done by junior doctors, but published work suggests that pharmacists are able to take more accurate medication histories than medical staff. It recommended that pharmacists should be involved in medicines reconciliationas soon as possible after hospital admission. Medicines reconciliation was defined as: a) Collecting information on medication history (prior to admission) using the most recent and accurate sources of informationto create a full and current list of medicines. b) Checking or verifying this list against the current prescription chart in the hospital, ensuring any discrepancies are accounted for and acted on appropriately. c) Communicating through appropriate documentation any changes, omissions or discrepancies. Why? The increased risk of morbidity, mortality and economic burden to health services caused by medication errors and noted that errors occur most commonly on transfer between care settings, particularly at the time of admission. 22 Clinical Pharmacy-I (PP517) Level 5 PharmD Program How? Access to patients' summary care record from their general practitioner. The pharmacistcan also question patients on concordance with prescribed treatment. Clinical pharmacists can work alongside medical and nursing staff, to help ensure that full and accurate details of medication are recorded. 5. Patient education and counselling Helping patients to understand their medicines and how to take them is a major feature of clinical pharmacy. Empowering patients to take an active role in managing their own care. Clinical pharmacists can help to improve patients' knowledge of their treatment. They can also improve patient adherence to treatment. Improved adherence should lead to improved outcomes. Patient compliance Patient compliance, defined as adherence to the regimen of treatment recommended by the doctor. Adherence to treatment, particularly for long-term chronic conditions,can be poor and tends to worsen as the number of medicines and complexity of treatment regimens increase. Between a third and half of all medicines prescribed for long-term conditions are not taken as recommended. Increased cost of admissions resulting from patients not taking medicines as recommended. Concordance In recent years, use of the term 'compliance' has been criticised because it implied that patients must simply follow the doctors orders, rather than making properly informed decisions about their healthcare. The term 'concordance' has been proposed as a more appropriate description of the situation. 23 Clinical Pharmacy-I (PP517) Level 5 PharmD Program Concordance is an agreement reached after negotiation between a patient and healthcare professional that respects the beliefs and wishes of the patient in determining whether, when and how medicines are taken. If patients are to make informed choices, then the need for comprehensive patient education becomes more pressing. Concordance with treatment is dependent on a complex interplay of beliefs, trust and understanding with non-adherence falling into two overlapping categories o intentional:the patient decides not to follow the treatment recommendations o unintentional: the patient wants to follow the treatment recommendations, but practical problems prevent the patient from doing so. Why Patient education and counselling? 'nothing about me, without me' There is a greater need for informationand education of patients and/or carers in order for them to be able to make informed decisions about their treatment. How patients take their medicines is a crucial component of whether the desired outcomes will be achieved. Improve patient adherence to treatment and improve the outcomes. Self-administration schemes Schemes which allow patients to self-administer their medicines whilst in hospital (in selected groups or settings). The schemes have several purposes: o a diagnostic role: checking to see if patients can cope with their medicines regimen o an educational role: giving diminishing levels of support prior to discharge, allowing patients to gain skills and confidence with their medicines o An empowering role: allowing patients to provide self-care as they would at home. Schemes may also allow nursing staff to focus on other issues. 24 Clinical Pharmacy-I (PP517) Level 5 PharmD Program However, whilst these schemes may seem attractive, evidence of their benefits is limited and considerable effort may be required to assess patients' suitability. Clinical pharmacists and pharmacy technicians can support nursing staff in establishing and running self-administration schemes. Integrated medicines management 'Integrated medicines management' is a term that has been used to describe bringing together several elements of clinical pharmacy services, delivering additional input at key phases of a patient's stay: admission, inpatient monitoring and counselling and discharge. By focusing additional clinical pharmacy input to selected patients, reduced length of stay and a decreased rate of readmission have been demonstrated, in addition to improved clinical outcomes for patients. 6. Pharmacokinetics and therapeutic drug level monitoring A sound knowledgeof the pharmacokineticprofiles of different drugs enables the pharmacist to assess the dosing requirements for certain drugs in patients in extremes of age and in the presence of impairment of kidney and liver function. Clinically importantdrug interactions and adverse reactions can sometimes be predicted. Dosing calculations of aminoglycoside antibiotics are usually made by employing pharmacokinetic principles. A number of medicines in common use have a narrow therapeutic index; that is, the difference between the lowest effective dose and a potentiallytoxic dose can be quite small. In many cases it is necessary or desirable to undertake therapeutic drug level monitoring (TDM) to ensure that patients can be treated safely. TDM services include the measurement of drug levels in the patient's blood and the application of clinical pharmacokinetics to optimise drug therapy. 25 Clinical Pharmacy-I (PP517) Level 5 PharmD Program There is a wide range of medicines that fall into this category, but T DM services typically include aminoglycoside antibiotics, anticonvulsants, immuno-suppressants, digoxin, lithium and theophylline. Monitoringdrug levels in patients can also provide an important indicator as to whether they are taking their medicine. Clinical pharmacy input into T DM services can range from the provision of simple advice to other clinicians on when to take samples and how to interpret results, to fully fledged services that may include collection and laboratory analysis of the blood sample. 7. Personalised medicine The fact that not all patients respond to the expected benefits of medicines and some have disproportionately adverse effects from them is leading to the development of personalised medicines services. Good clinicians have always tailored treatment to individual patients' needs, but this typically relied on trial and error. Personalised medicine can start from using biomarkers rather than clinical outcomes as surrogate markers of effectiveness. A new specialty of pharmacogenetics that aims to assess phenotypic differences in responding to and handling drugs that may account for a significant proportion of the variation in patient response. Principles in the use of medicines Medicines should be used only when they are necessary. The benefit of administration of medicines should be considered in relation to the risk involved. Examples of benefits vs risk of medicine use Antibacterials: treating infectionvs occurrence of gastrointestinal side-effects Anticancer agents: increased life expectancy vs gastrointestinal side-effects, hair loss. 26 Clinical Pharmacy-I (PP517) Level 5 PharmD Program Barriers to proper use of medicines Patient compliance and adherence with treatment Patient confusion Communication problems Side-effects Dispensing errors Cost of medicines Accessibility and availability. 8. Education and training As hospital clinical pharmacy services expanded, there was a growing recognition of the need for postgraduate training for pharmacists. Many clinical pharmacists contribute to the teaching on postgraduate courses. Clinical pharmacy services also include the regular provision of training and education for other healthcare staff at most hospitals —a service that is valued highly. 9. Medicines formularies Pharmacists play a role in the development of medicines formularies. A formulary is a list of drugs/medicinal products recommended for use and available for use in a given population. A formulary management system is usually needed to initiate, develop, monitor, manage and review a local formulary and any prescribing policies contained within it. e.g: British national formulary (BNF) Pharmacists providing clinical services are responsible for ensuring that prescribers' practices comply with formulary recommendations. Clinical pharmacists' detailed knowledge of medicines and the regular contact they have with doctors, nurses and patients mean that they are ideally placed to influence prescribing. 27 Clinical Pharmacy-I (PP517) Level 5 PharmD Program 10. Clinical outcomes Clinical outcomes are the ultimate validation of the effectiveness and quality of medical care. Standardised mortality rates have become a crude outcome measure but are used to describe a healthcare organisation's overall success. Patient-reported outcome measures (PROMs) have been advocated as a relevant outcome measure to describe patients' satisfaction in their healthcare provider. 11. Professional and clinical audit Clinical audit brings together professionals from all sectors of healthcare to consider: o clinical evidence, o promote education and research, o develop and implement clinical guidelines, o enhance informationmanagement skills, o contributeto better management of resources all with the aim of improving the quality of care of patients. Audit aims to improve patient outcomes by examining how current clinical practice compares to agreed standards of care, implementingany changes necessary and then re-examining practice to ensure that real improvements have been made. Clinical pharmacists can be involved in many different types of audit. These may range from topics including audit of clinical services themselves (for example, clinical pharmacy interventions) or may examine which treatments are used and how they are implemented within the framework of drug use evaluations. Clinical audit is pivotal in patient care. Guidelines A clinical guideline is a series of systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. Guidelines may not indicate which specific drug or product to use in any given circumstance, often recommending a therapeutic class. 28 Clinical Pharmacy-I (PP517) Level 5 PharmD Program Guideline users must be able to form an opinion about how the guideline was developed, and internationalconsensus is available on best practice in guideline development. NICE guidelines (National Institute for Health and Care Excellence). Egyptian Guideline on ADR reporting for Healthcare professionals. Evidence-based pharmacy Evidence of effectiveness of therapy is based on: Systematic literature review Randomised controlled trials Non-randomised experimental studies Observational studies Expert opinion of clinicians Identifying patient needs Liver disease Renal impairment Adverse drug reactions Drug interactions Medication errors Liver disease Liver disease may alter the response to drugs (e.g. due to impaired drug metabolism). Drug prescribing should be kept to a minimum in all patients with severe liver disease and doses need to be reviewed in patients with liver disease. For example, the use of paracetamol in patients with liver disease: dose- related toxicity may occur, large doses should be avoided. Renal impairment The use of drugs in patients with reduced renal function can give rise to problems such as failure to excrete drug or its metabolites. 29 Clinical Pharmacy-I (PP517) Level 5 PharmD Program In patients with renal impairment dose adjustment is recommended. Adverse drug reactions Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of adverse drug reactions (ADRs) are important. Definitions Side-effect: 'Expected, well-known reaction resulting in little or no change in patient management.' The effect has a 'predictable frequency' Adverse drug reactions: 'An unexpected, unintended, undesired or excessive response' to a drug with sequelae. An ADR can lead to (sequelae of ADRs): Drug discontinuation Dose modification Hospital admission Prolonged hospitalisation Requirement of supportive treatment Complication of diagnosis Negative impact on prognosis Temporary/permanent harm, disability or death. Seriousness of Adverse drug reactions Serious adverse event or reaction is any untoward medical occurrence associated with the use of a medical product in a patient that at any dose, the patient outcome is one of the following: — Death — Life-Threatening — Hospitalization (initial or prolonged) — Disability — Congenital Anomaly — Medically important event or reaction Processes of an ADR monitoringprogramme Monitoring Detecting Evaluating 30 Clinical Pharmacy-I (PP517) Level 5 PharmD Program Documentation Reporting to authorities Updates and discussions with healthcare team members. Pharmacist actions in an ADR monitoring programme Analysis of ADR reports Identificationof drugs and patients at high risk Educating prescribers and other health professionals on the implementation and running of an ADR programme Reporting to authorities. Drug interactions Administrationof two or more drugs at the same time may lead to an exertion of their effects independently or may cause an interaction. The interactionmay be potentiationor antagonism of one drug by the other. Occurrence and impact of drug interactions should be evaluated on the basis of clinical significance and potential for hazardous outcomes. Examples of clinically significant drug interactions: —aspirin/ibuprofen+ warfarin = enhanced anticoagulant effect —aspirin/ibuprofen + phenytoin = enhanced effect of phenytoin. Medication errors These may occur as a result of inappropriate drug prescribing. For example, cisapride was withdrawnfrom the market because the drug could not be used safely due to its interactionwith macrolides or due to inappropriate patient monitoring. Types of medication errors Prescribing error: medication prescribed is inappropriate. Dispensing error: medication dispensed is inappropriate (e.g. due to incorrect interpretation of the prescription). Omission error: dose skipped or medication is not being administered. 31 Clinical Pharmacy-I (PP517) Level 5 PharmD Program Wrong time error/improper dose error/wrong administration technique error: medication administered in an incorrect manner. Deteriorated drug error: medication dispensed is not of good quality. Practices to reduce medication errors Avoid unnecessary use of decimal points: — quantities less than 1 gram should be written in milligrams — quantities less than 1 milligram should be written in micrograms Avoid use of abbreviations: micrograms and not ug, nanograms and not ng Names of drugs written clearly and not abbreviated. 32

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