Assignment on clinical pharmacy prospects

It is an assignment for my master's coursework.

1. Clinical Pharmacy Prospects & Adverse effects of drugs on the liver. Assignment for Advanced Pharmacology & Clinical Pharmacy Presented To Dr. Kallol Debnath Associate Professor Presented By Jahid Hasan Azad ID: 522211064 Batch 26 Masters of Pharmacy Department of Pharmacy Assignment on

2. What is Clinical Pharmacy? Clinical pharmacy comprises a set of functions that promote the safe, effective and economic use of medicines for individual patients . 2

3. Importance of Clinical Pharmacy The emergence of clinical pharmacy has allowed pharmacists to shift from a product-oriented role towards direct engagement with patients and the problems they encounter with medicines. The practice of clinical pharmacy is generally an essential component of pharmaceutical care. 3

4. Pharmaceutical care Pharmaceutical care is a co-operative, patient centred system for achieving specific and positive patient outcomes from the responsible provision of medicines . The three key elements of the care process are patient assessment , determining the care plan and evaluating the outcome. 4

5. Enhancement of Pharmaceutical care The ability to consult with patients is a key process in the delivery of pharmaceutical care and requires regular review and development regardless of experience. The clinical pharmacy process has been incorporated into a professional development framework that can be used to enhance skills and knowledge. 5

6. Medicine Management Medicine management encompasses the way in which medicines are selected, procured, delivered, prescribed, administered & reviewed to optimize the contribution that medicines make to producing informed & desired outcomes of patient care. 6

7. Development of Clinical Practice in Pharmacy practice has been attributed to the poor medicines control systems that existed in hospitals during the early 1960s (Cousins and Luscombe , 1995 ). In the USA, the approach was to adopt unit dose dispensing and pursue decentralization of pharmacy services. In the UK, the unification of the prescription and the administration record meant this document needed to remain on the hospital ward and required the pharmacist to visit the ward to order medicines . This was initially termed ‘ward pharmacy’ but participation in medical ward rounds in the late 1970s signalled the transition to clinical pharmacy 7

8. Rational and effective prescribing • Prescribers need to assess and manage the potential benefits and harms of treatment . • Patients should receive cost-effective medication appropriate to their clinical needs, in doses that meet their requirements and for an adequate period of time. 8

9. Aims of Prescriber The prescriber should have the following four aims: • Maximise effectiveness • Minimise risks • Minimise costs • Respect the patient's choices 9

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11. Another popular framework to support rational prescribing decisions is known as STEPS ( Preskorn , 1994 ). The STEPS model includes five criteria to consider when deciding on the choice of treatment : • Safety • Tolerability • Effectiveness • Price • Simplicity. 11

12. Inappropriate or irrational prescribing: Good prescribing is sometimes defined as the lack of irrational prescribing. Prescribing can be described as irrational for many reasons : • Poor choice of a medicine •  Polypharmacy or co-prescribing of interacting medicine • Prescribing for a self-limiting condition • Continuing to prescribe for a longer period than necessary • Prescribing too low a dose of a medicine • Prescribing without taking account of the patient’s wishes. 12

13. Pharmacists as prescribers and the legal framework Independent prescribing Independent prescribing is defined as ‘prescribing by a practitioner (doctor, dentist, nurse, pharmacist) who is responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and for decisions about the clinic management required including prescribing’ (DH, 2006). 13

14. Pharmacists as prescribers and the legal framework Supplementary prescribing:( Non Medical Prescriber) The Health and Social Care Act 2001 allowed pharmacists and other health care professionals to prescribe. Following this legislation, in 2003, the Department of Health outlined the implementation guide allowing pharmacists and nurses to qualify as supplementary prescribers (DH, 2003). In 2005, supplementary prescribing was extended to physiotherapists, chiropodists/podiatrists, radiographers and optometrists 14

15. Accountability Prescribers have the authority to make prescribing decisions for which they are accountable both legally and professionally. Accountability when prescribing covers three aspects – the law, the statutory professional body and the employer 15

16. Ethical framework Four main ethical principles of biomedical ethics have been set out for use by health care staff in patient–practitioner relationships (Beauchamp and Childress, 2001). These principles are respect for - autonomy , - non-maleficence , - beneficence , - justice and veracity and need to be considered at all points in the prescribing process. 16

17. Autonomy Autonomy recognises an individual patient's right to self-determination in making judgements and decisions for themselves and encompasses informed patient consent . - Confidentiality : Confidentiality is a fundamental right with respect to patient autonomy. - Consent : Obtaining consent from a patient for treatment can be divided into three components: voluntariness, information and competency 17

18. Non-maleficence the principle of non-maleficence is the concept of not knowingly causing harm to the patient . The harmful effect is allowed if proportionally it is less than the good effect . 18

19. Beneficence principle of doing good and refers to the obligation to act for the benefit of others that is set out in codes of professional conduct. 19

20. Justice and veracity The principle is related to the distribution of resources to ensure that such division or allocation is governed by equity and fairness. a prescriber should also assess with the patient that the medication prescribed can be accessed by them. Veracity or ‘truth telling’ underpins both effective communication and patient consent. 20

21. Adverese drug Reaction: An adverse drug reaction (ADR) is an effect that is unintentional, noxious and occurs at doses used for diagnosis, prophylaxis and treatment. A hepatic drug reaction is an ADR which predominantly affects the liver. 21

22. Occurance : Drugs can induce almost all forms of acute or chronic liver disease. Although not a particularly common form of ADR, drugs should always be considered as a possible cause of liver disease. Approximately 20–30% of acute liver failure cases are attributed to drugs. 22

23. Epidemiology The incidence of drug-induced liver disease (DILD) has continued to rise steadily since the late 1960s. Risk of drug-induced liver disorders increases with age and is generally more common in women. Generally , drug-induced liver damage is either dose-related or idiosyncratic. Drugs can cause all types of liver disorder and should always be considered in patients presenting with liver-related problems. 23

24. Hepatotoxicity The clinical features of drug-induced hepatotoxicity vary widely, depending upon the type of liver damage caused. Treatment of drug-induced hepatotoxicity relies on correct diagnosis, prompt withdrawal of the causative agent and supportive therapy. Patients given potentially hepatotoxic drugs should be monitored regularly and taught how to recognize signs of liver dysfunction and advised to report symptoms immediately. 24

25. Risk factors: - Pre-existing liver disease . - Age - Gender Genetics Enzyme induction - Polypharmacy - Concurrent diseases and pregnancy 25

26. Figure: Examples of host factors that predispose to drug hepatotoxicity 26

27. Figure: Characteristics of intrinsic and idiosyncratic hepatotoxic reactions 27

28. Figure : Examples of dose-related drug-induced hepatotoxicity 28

29. Necrosis Necrosis is characterized by cytotoxic cellular breakdown (hepatocellular destruction) and is generally associated with a poor prognosis. Drugs commonly associated with DILD have a variable propensity to cause hepatic necrosis. Steatosis - hepatocytes become filled with small droplets of lipid ( microvesicular fatty liver) or occasionally with lipid droplets that are much larger ( macrovesicular fatty liver). - Tetracyclines are thought to cause steatosis by interfering with synthesis of lipoproteins that normally remove triglycerides from the liver . Cholestasis - Cholestasis caused by anabolic and contraceptive steroids is due to inhibition of bilirubin excretion from the hepatocyte into the bile. 29

30. Figure: Examples of adverse drug reactions on the liver 30

31. Clinical manifestations Acute hepatocellular necrosis Steatosis Acute hepatitis Chronic active hepatitis Cholestasis Veno -occlusive disease Hepatic tumours 31

32. Investigations Various types of investigation: Biochemical tests Serological markers Radiological investigations Liver biopsy 32

33. Treatment Diagnosis Withdrawal Rechallenge Management Antidotes: acetylcysteine and methionine for paracetamol , and desferrioxamine for iron overdose Corticosteroids Supportive treatment Pruritus Coagulation disorders Long-term treatment 33

34. Paracetamol -induced hepatotoxicity Paracetamol causes a dose-related toxicity resulting in centrilobular necrosis. It normally undergoes the phase II reactions of glucuronidation and sulphation . However , paracetamol is metabolised by cytochrome P450 2E1 to N-acetyl-pbenzoquinoneimine (NABQI) if the capacity of the phase II reactions is exceeded or if cytochrome P450 2E1 is induced After normal doses of paracetamol , NABQI is detoxified by conjugation with glutathione to produce mercaptopurine and cysteine conjugates . - Following overdose, tissue stores of glutathione are depleted, allowing NABQI to accumulate and cause cell damage. Illness, starvation and alcohol deplete glutathione stores and increase the predisposition to paracetamol toxicity, 34

35. Figure: Practice points for the diagnosis of drug-induced liver disease 35

36. Figure: Examples of drugs associated with the development of chronic liver disease 36

37. Patient care: Patients may be at risk of drug-induced hepatotoxicity from prescribed drugs or from purchased drugs. Additionally, children may be at risk from medicines that are not stored properly. Parents should be reminded to store all medicines in child resistant containers and out of reach. Deaths from liver failure have occurred in children following overdose with drugs commonly available, such as iron tablets. 37

38. Patient counselling Patients who purchase preparations containing paracetamol should be made aware of the danger of overdosing . All patients should be advised of potential side effects . Patients and their carers should be helped to recognise signs of liver disorder and know to report immediately symptoms such as malaise, nausea, fever and abdominal discomfort . Patients who recover from drug-induced hepatotoxicity should be informed of the causative agent, warned to avoid it in the future, and advised to inform their doctor, dentist, nurse and pharmacist . 38

39. Minimising the risk of DILD Minimise DILD by ensuring appropriate monitoring of drugs associated with hepatotoxicity. Minimise DILD by following recommendations, for example, use co- amoxiclav for penicillin β-lactam resistant infections only, counsel all patients on paracetamol not to exceed 4g/day and to be alert to other preparations containing paracetamol . Counsel all patients (or carers of patients) on potentially hepatotoxic medicines to recognise and report signs of liver damage. Inform all patients who have DILD of the causative agent, and the importance of avoiding this in future. 39

40. Reference: Clinical-Pharmacy-and-Therapeutics - By Roger-Walker - 5th-Edition 40

41. My humble gratitudes to you for giving me the chance to learn by this assignment Thank You Sir! 41