Antipsychotic Medication: Monitoring Side Effects

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1 Antipsychotic Medication: Monitoring Side Effects

2 Aims Review national practice guidelines and evidence regarding current standards of care. Discuss clinical implications of AP side effects. Reflect on personal practice. Consider how to address challenges associated with monitoring AP tolerability.

3 Context: Scope of the Problem Individual response to AP treatment unpredictable. Lack of reliable data on prevalence of side effects. Survey data indicate that side effects are common and distressing.

4 Second-generation ( atypical ) AP Side Effect Profiles Amisulpride (Solian ) Aripiprazole (Abilify ) Drug Clozapine (Clozaril, Denzapine, Zaponex ) Olanzapine (Zyprexa ) Paliperidone (Invega ) Risperidone (Risperdal ) Usual daily dose mg 15-30mg Sedation Movement problems Weight gain Antichol inergic Sexual problems Usually mg 10-20mg 6mg 4-6mg Quetiapine (Seroquel ) Zotepine (Zoleptil ) Around 600mg Up to 300mg

5 First-generation ( typical ) AP Side Effect Profiles Drug Chlorpromazine Haloperidol Levomepromazine Pericyazine Perphenazine Usual daily dose mg 5-20mg mg 5-20mg 12-24mg Sedation Movement problems Weight gain Anticholinergic Sexual problems Sulpiride 400-1,600mg Trifluoperazine 5-15mg

6 Long-acting injectable AP Side Effect Profiles Drug Usual dose Sedation Movement problems Weight gain Antichol inergic Sexual problems Flupenthixol decanoate (Depixol ) Fluphenazine decanoate (Modecate ) Haloperidol decanoate (Haldol decanoate ) Pipothiazine palmitate (Piportil ) Zuclopenthixol decanoate (Clopixol ) Risperidone (Risperdal Consta ) mg a fortnight mg a fortnight mg a month 25-50mg a fortnight 25-50mg a fortnight 25-50mg a fortnight

7 Reflection on Current Practice How do you typically monitor the side effects associated with AP medication? How do you evidence any monitoring that you undertake? Are there any side effects that you do not tend to ask patients about? If so, why? Are there any factors that may prevent you from monitoring AP side effects on a routine basis?

8 National Practice Guidance AP side effects should be monitored routinely and regularly (NICE, 2002). People receiving depot preparations should be maintained under regular clinical review, particularly in relation to the risks and benefits of the drug regimen (NICE, 2002). Where a potential to cause weight gain or diabetes has been identified (or included in the Summary of Product Characteristics) for the atypical antipsychotic being prescribed, there should be routine monitoring in respect of these potential risks. (NICE, 2002) Note: The NICE guidance for the treatment of Schizophrenia is currently under review. The revised guideline is due to be published in 2009.

9 Current Practice Standards: The National Picture June 2008: National audit of side monitoring for patients prescribed depot AP medication. Participants: 500 clinical teams from 38 specialist mental health trusts. Sample: 5,804 patient case notes reviewed. Audit standard: All patients prescribed depot/long-acting injectable antipsychotic (AP) medication should have a review of side effects at least once a year.

10 Key findings from POMH-UK audit Total number of patient case notes reviewed = 5,804 Nature of documented evidence: % No documented evidence 35% General statement that side effects are not present 26% General statement that side effects are present 28% Physical examination to assess side effects 11% Blood tests related to side effects 12% Local Trust checklist or rating scale 4% Published side effect rating scale 8% Scale designed by pharmaceutical company 1%

11 Evidence of assessment of specific side effects during the previous year Total number of patient case notes reviewed = 5,804 Evidence of assessment of movement disorders Evidence of assessment of weight/bmi/waist circumference Evidence of assessment of sexual side effects Evidence of assessment of menstrual disturbance (female patients under 50) % 31% 27% 9% 15% (Total no. of women <50: 1,043)

12 Clinical implications of AP side effects Physical health complications. Confound assessment of clinical condition. Functional impairment Social stigma. Negative attitudes towards AP treatment.

13 Monitoring AP side effects: A challenging clinical task Have you experienced any difficulties identifying or monitoring AP side effects when working with patients? Please describe any examples.

14 Monitoring AP side effects: A challenging clinical task Side effects can be difficult to distinguish from symptoms of the illness or other conditions. Baseline assessment. Ongoing monitoring. Use of symptom checklists or side effect rating scales.

15 Be specific! Monitoring AP side effects: A challenging clinical task Reliance on observation, or waiting for patients to report problems with their medication. Ongoing patient education. Written materials supported by open discussion. Involve carers/relatives.

16 Monitoring AP side effects: A challenging clinical task Communication barriers. Self-report symptom checklists. Written information - a way in to discussions about intimate side effects. Make routine questioning about medication the norm.

17 Monitoring AP side effects: A challenging clinical task Raising a patient s awareness of side effects may prompt them to stop taking their AP medication. No evidence to support this assumption. Patients appreciate open communication about their medication. Unexpected side effects may be more frightening.

18 Monitoring AP side effects: A challenging clinical task Physical health monitoring Know who is responsible for routine physical health checks. Ensure service user knows and agrees who should be responsible. Ensure responsibilities for physical health monitoring are documented.

19 Monitoring AP side effects: A challenging clinical task You just have to put up with AP side effects because there is little that can be done about them. Medication changes. Practical advice. Identify physical health complications early.

20 Practical tips for managing side effects Side effect Constipation Urinary retention Dry mouth Weight gain Movement disorders Sexual side effects Menstrual disturbance Examples of practical management tips Dietary advice: plenty of fruit and veg, high-fibre foods and fluids, preferably water. Medication options, e.g. lactulose, Fibogel. Older men may need to see their Doctor to rule out prostrate problems. Sip water regularly. Advise against too many sugary drinks. Recommend regular dental check-ups. Try sucking sugar-free sweets or sugar-free gum. Try an artificial saliva spray (e.g. Glandosane spray). Food diaries to spot eating habits. Control calorie intake weigh portions. Support service user to set realistic weight loss targets. Referral to a dietician. Referral to prescriber for review of dose/type of medication. Distraction techniques (e.g. exercise to alleviate subjective symptoms of akathisia). Work with patient to identify likely cause of problem. Consider weight, depression, stress, relationship problems and health issues (e.g. diabetes for men). Recommend use of a lubricant if female patients complain of painful sex. Refer patient to prescriber for a medication review. Consider whether patient may need contraceptive advice.

21 Reflection on Current Practice Could you improve the way in which you monitor AP side effects? How? What problems do you think you may encounter if you have identified steps that you can take to improve your practice? Is there anything you can do to address these? Do you need any additional support (e.g. systems, training) to enable you to monitor AP tolerability more effectively?

22 Summary Baseline assessment. Routine monitoring. Specific questions. General enquiry and observation are not enough. Document. Ongoing patient education. Involve carers/relatives. Know who is responsible for physical health monitoring.

23 Online resources General information about medication: Website of the UK Psychiatric Pharmacy Group. Enables you to search for information by condition and contains frequently asked questions about psychiatric medication. (At the time of writing, this website was still in the process of being developed, so some sections may not yet be complete). Enables you to search for information about specific drugs by name, including patient information leaflets and Summaries of Product Characteristics. Information about mental health conditions and drug treatment: National Institute of Mental Health (USA) website. Select the Health and Outreach tab at the top of the home page. The website of the Royal College of Psychiatrists. Contains easy-to-read information leaflets designed for the general public. Select Mental Health Information. User organisation websites with information about drug treatment: Click on about mental illness, then select the condition you are interested in from the drop-down menu where it says mental illnesses and disorders. Select information, then factsheets and booklets. Select about mental illness.

24 Online resources General information about health conditions NHS clinical knowledge website, which allows you to search by a specific illness or medical topic. Contains information leaflets for patients. The guide to diabetes link (at the top of the home page) contains information about diabetes that may be useful for patients who have recently been diagnosed with the condition. Healthy eating & lifestyle advice Food Standards Agency website contains lots of advice about healthy eating and how to interpret labels on food. Contains a BMI calculator. Website of the British Dietetic Association. Contains a publications and resources section with information leaflets that you can download free of charge.

25 References describing side effect checklists or rating scales Dassori, A.M., Miller, A.L., Weiden, P.J. (2003) The Approaches to Schizophrenia Communication (ASC) Tool. Including the Patient Perspective in Treatment. Disability Management and Health Outcomes, 11, Day, J.C., Wood, G., Dewey, M., & Bentall, R.P. (1995). A self-rating scale for measuring neuroleptic side-effects. Validation in a group of schizophrenic patients. The British Journal of Psychiatry, 166, (Describes the development and testing of the Liverpool University Neuroleptic Side Effect Rating Scale, known as the LUNSERS). Jordan, S., Knight, J., & Pointon, D. (2004) Monitoring adverse drug reactions: Scales, profiles, and checklists. International Nursing Review, 51, Waddell, L. & Taylor, M. (2008) A new self-rating scale for detecting atypical or second-generation antipsychotic side effects. Journal of Psychopharmacology, 22,

26 Terminology First-generation APs Typicals Second-generation APs Atypicals Depot Extrapyramidal symptoms/side effects (EPS) Dystonia Parkinsonism Akathisia Tardive dyskinesia Term sometimes used to refer to older APs developed during the 50s/60s). Haloperidol and chlorpromazine are examples of first-generation APs. See above. Another term used to described older APs. Term used to refer to newer APs developed since the late 1980s. Examples include: clozapine, olanzapine and risperidone. See above. Another term used to describe the newer APs. An long-acting injectable form of medication. Depot APs are injected intramuscularly, usually every 2 to 6 weeks. Movement disorders associated with APs. These include parkinsonian symptoms, dystonic reactions, akathisia and tardive dyskinesia. Sustained muscle contractions, resulting in contorted, twisting or repetitive movements or abnormal postures. These typically affect the muscles of the head and neck. Symptoms characteristic of Parkinson s Disease: rigid muscles, tremor and slow movement. An unpleasant sense of inner restlessness, which often leads patients to feel as if they need to be moving all the time. Abnormal repetitive movements that the patient has no control over, which may appear strange to others. These usually affect the mouth and face, but can affect any body part.

27 Terminology (cont.) Anticholinergic (also known as antimuscarinic ) side effects Metabolic syndrome Body Mass Index (BMI) Hyperprolactinaemia Amenorrhoea Gynaecomastia Galactorrhoea A group of side effects that are believed to be caused when medicines block cholinergic receptors in the brain. The following are anticholinergic side effects associated with some APs (e.g. olanzapine, clozapine) and some medicines prescribed to treatment movement disorders (e.g. procyclidine): constipation, urinary retention, blurred vision, dry mouth, cognitive/memory problems. A cluster of symptoms, each of which is independently associated with an increased risk of developing cardiovascular disease and type 2 diabetes mellitus. Different diagnostic criteria have been proposed for the metabolic syndrome, but they all share the following components: glucose intolerance, obesity, hypertension and dyslipidaemia (low plasma levels of high-density lipoprotein cholesterol and elevated levels of triglycerides). Weight (kgs) divided by height (metres squared). Healthy BMI: Overweight: Obese = > 30. Abnormally high levels of the hormone prolactin. Symptoms associated with hyperprolactinaemia include menstrual irregularities (female patients), tender, swollen nipples and a milky discharge from the nipples (both sexes). Loss of periods for three months or more. (Symptom of hyperprolactinaemia). Sore, swollen, uncomfortable nipples or chest. (Symptom of hyperprolactinaemia). A milky discharge from the nipples. (Symptom of hyperprolactinaemia).

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