PATIENT GROUP DIRECTION FOR THE SUPPLY OF ORLISTAT BY COMMUNITY PHARMACISTS

Transcription

1 PATIENT GROUP DIRECTION FOR THE SUPPLY OF ORLISTAT BY COMMUNITY PHARMACISTS November 2009 Orlistat PGD Page 1 of 7

2 Rationale Patient Group Direction For Supply Of Orlistat By Community Pharmacists To enable a pharmacist working in City and Hackney, who has received specific training and has been assessed as competent, to supply Orlistat in accordance with the following patient group direction (PGD). Professionals to whom this patient group direction may apply Qualifications Required Additional Requirements Continuing Training Requirements Pharmacist (registered with RPSGB or PSNI) Access to: British National Formulary, latest edition Orlistat (Xenical ) summary of product characteristics NHS City and Hackney medicines policies, if appropriate Information about services involved in providing healthy lifestyles It is the responsibility of the individual pharmacist to ensure that they and their staff are competent in all aspects of supply of Orlistat and are updated on current medicines policies. References Department of Health (1998): Review of Prescribing, Supply and Administration of Medicines. A report on the Supply and the Administration of Medicines under Group Protocol NICE (December 2006): Clinical Guideline 43: Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children THIS PATIENT GROUP DIRECTION WILL BE SUBJECT TO REGULAR REVIEW IN LINE WITH CURRENT CLINICAL PRACTICE AND AT TIMES OF MAJOR CHANGE Date of overall review of this document October 2011 Orlistat PGD Page 2 of 7

3 Patient Group Direction for the Orlistat supply/administration of to Obese and overweight patients in need of pharmacological treatment 1. Clinical Condition Define situation/condition Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of the following groups of clients: Patients who are obese (i.e. with a BMI 30kg/m 2 ) but who are actively participating in a weight management programme and who have demonstrated motivation to change dietary behaviour. Patients who are overweight (i.e. BMI 28kg/m 2 ) with one or more co-morbidity, such as hypertension, dyslipidaemia or type 2 diabetes who also are actively participating in a weight management programme and who have demonstrated motivation to change dietary behaviour. Orlistat should be used to support healthy lifestyle and behaviour changes and not in isolation. Treatment with Orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of drug therapy. Note: Rates of weight loss may be slower in people with type 2 diabetes, so less strict goals than those for people without diabetes may be appropriate. These goals should be agreed with the person and reviewed regularly. The decision to use drug treatment for longer than 12 months (usually for weight maintenance) should be made after discussing potential benefits and limitations with the patient. Treatment should be reviewed regularly Criteria for inclusion Patients must be registered with a GP based within City and Hackney, and be willing to accept treatment from a pharmacist. BMI with no co-morbidities BMI > co morbidities Age years First line treatment (lifestyle changes) must be tried before antiobesity drugs are to be used. Informed verbal consent to treatment and adherence to appropriate weight management programme. Criteria for exclusion BMI < 28 kg/m 2 Age under 18 years or over 75 years Refusal of consent Known hypersensitivity to Orlistat or its excipients Current cholestasis Breast feeding or pregnancy Concurrent administration of Acarbose, Amiodarone, Anticoagulants (coumarins), Ciclosporin, Sibutramine or other weight loss agents Orlistat PGD Page 3 of 7

4 Chronic malabsorption syndrome Concurrent administration of insulin* Post bariatric surgery Patient is already receiving Orlistat by prescription and part of a weight management service. Inadequate weight loss < 5% weight loss within three months of initiation of treatment *Within the terms of its SPC, Orlistat may be used in patients who are on insulin. However, there may be an increased risk of hypoglycaemia in these patients as weight loss can lead to improvement in glycaemic control. These patients therefore warrant special care so that the dose of insulin may be appropriately monitored. N.B. Vitamins and beta-carotene: Decreases in the absorption of vitamins D, E and beta-carotene should be taken into account. Action if excluded Action if patient declines Patients not eligible for treatment under this protocol will be recommended to refer to their GP for further assessment and advice. Pharmacists should consider referring clients to their GP: When patient is considered eligible for Orlistat therapy under a weight loss programme, but supply through pharmacy is not recommended through the exclusion criteria. This might include any of the conditions referred to as exclusion criteria above, but also: Previously unrecognised co-morbidities Uncontrolled symptoms Uncontrolled symptoms of other illnesses that are a cause for concern e.g. mental health, orthopaedic problems Offer a referral to their GP for further assessment and advice 2. Description of treatment Name of Medicine Orlistat (Xenical ) 120mg Capsules POM/P/GSL POM Dose/s The recommended dose of Orlistat is one 120mg capsule. See Appendix 1 for individual product details. Route/Method Orally administered Frequency 2-3 times daily but see advice below Advice Orlistat should be taken immediately before, during or up to one hour after each main meai. If a meal is missed or contains no fat, the dose of Orlistat should be omitted. The pharmacist should refer the patient to their GP for further advice if any of the following are measured: Random blood glucose > 9mmol/l BP > 140/85 or BP > 130/80 (known diabetes) on three consecutive occasions Total cholesterol (random) > 5mmol/L. Referral for advice, but accept re-referral once cholesterol is dealt with by GP Urine test analysis positive for glucose, protein or blood Records Patient s name, address, date of birth and GP details; Date supplied & Name of the pharmacist who supplied the Orlistat PGD Page 4 of 7

5 Orlistat PGD Page 5 of 7 medication Batch number and expiry date; Reason for inclusion Advice given to patient; Details of any adverse drug reaction and actions taken including documentation in the patient s medical record via GP Serious adverse reactions should be reported to the CSM using the Yellow Card reporting system.

6 Patient Group Direction For Supply Of Orlistat By Community Pharmacists DECLARATION DECLARATION by NHS City & Hackney : This PGD has been authorised by: Enquiries relating to this PGD should be addressed to: Jonathan Mason, Head of Prescribing and Pharmacy, Primary Care Commissioning Directorate, NHS City & Hackney, Louis Freedman Building, St Leonard s, Nuttall Street, London N1 5LZ. Tel: Fax: Date of review: October 2011 This PGD is available on the tpct intranet {click on Departments, then click on Primary Care Dev., then click on Prescribing, then click on Patient Group Directions } Orlistat PGD Page 6 of 7

7 Declaration by Pharmacist I have been appropriately trained to understand the criteria listed and the administration required to supply orlistat in accordance with this Patient Group Direction. I confirm that I am competent to undertake supply of this medicine. Pharmacist Name:. Pharmacy stamp: RPSGB/PSNI registration number: Signature:.. Date:. Orlistat PGD Page 7 of 7