Standard Operating Procedure for. the Safe Administration of Dalteparin (Fragmin), Tinzaparin (Innohep) and Enoxaparin (Clexane) in the Community

Transcription

1 Standard Operating Procedure for the Safe Administration of Dalteparin (Fragmin), Tinzaparin (Innohep) and Enoxaparin (Clexane) in the Community DOCUMENT CONTROL: Version: 2. Ratified by: Quality Assurance Sub-Committee Date ratified: 27 February 2018 Name of originator/author: Senior Pharmacist Name of responsible Medicines Management Committee committee/individual: Date issued: 29 March 2018 Review date: February 2021 Target Audience Community Nursing Services

2 1. Aim This SOP represents current acceptable practice for community nursing services staff for the safe administration of dalteparin (Fragmin), tinzaparin (Innohep) and enoxaparin (Clexane). This procedure also outlines how to manage patients for whom the administration of dalteparin (Fragmin), tinzaparin (Innohep) and enoxaparin (Clexane) has been delayed. Licensed indications Dalteparin: Cancer patients undergoing cancer therapies or with metastatic malignancies. Injectable drug users. Patients in whom it has not been possible to stabilize on oral anticoagulant therapy. Patients who are being treated for Deep vein thrombosis or pulmonary embolism or both. Unstable angina and non-q wave myocardial infarction (unstable coronary artery disease-ucad), administered concurrently with aspirin. Tinzaparin: For the prevention of thromboembolic events, including deep vein thrombosis, in patients undergoing general and orthopaedic surgery. For the prevention of clotting in the extracorporeal circuit during haemodialysis in patients with chronic renal insufficiency. Patients in whom it has not been possible to stabilize on oral anticoagulant therapy. Enoxaparin: Patients requiring extended thromboprophylaxis following surgical procedures according to NICE guidelines or acute illness. Cancer patients undergoing cancer therapies or with metastatic malignancies. Injectable drug users Patients in whom it has not been possible to stabilize on oral anticoagulant therapy Patients who are being treated for Deep vein thrombosis or pulmonary embolism or both. Unstable angina and non-q wave myocardial infarction (unstable coronary artery disease-ucad), administered concurrently with aspirin. 2. Link to overarching policy and/or procedure This SOP is to be used in conjunction with the Injectable Medicines Page 2 of 6

3 Policy. Safe and Secure Handling of Medicines, Standard Infection Prevention and Control precautions, Waste management, and Risk Management Policy. 3. Procedure All patients will have: An appropriate form of authorisation from the prescriber which includes dose prescribed and proposed duration of treatment, including dose changes if applicable, Date to commence treatment. Stop date. Other relevant clinical information, including current medication. Any specific patient instructions, for example repeat blood tests. Explore patient s ability to self-administer to maintain independence. Staff should have an awareness of potential Side effects so appropriate action is taken. (See Summary of Product Characteristics for dalteparin, tinzaparin and enoxaparin Section 4.8 Undesirable effects). Dalteparin: Common side-effects ( 1/100, <1/10): Mild thrombocytopenia (type I), which is usually reversible during the treatment Haemorrhage Transient elevation of transaminases Subcutaneous haematoma at the injection site Pain at the injection site Uncommon side-effects (need reporting) ( 1/1000, <1/100): Hypersensitivity Urticaria Pruritus Tinzaparin: Very common side-effects (:>1/10): Haemorrhage. Haemorrhagic complications may affect any organ, and may have different degrees of severity. In some cases haemorrhage has resulted in death or permanent disability. Haemorrhagic complications can occur in particular when high doses are administered. Anemia can occur as a consequence of haemorrhage. Common side-effects ( 1/100, <1/10): Injection site reactions (local irritation, pain, bruising, ecchymosis) Page 3 of 6

4 Uncommon side-effects (need reporting) ( 1/1000, <1/100): Thrombocytopenia (type I) Allergic reactions (of all types and severities have been reported) Headache Raised transaminases. These increases are reversible after drug withdrawal Rash (such as erythematous or maculopapular), pruritus, urticaria Enoxaparin: Common side effects ( 1/100, <1/10): Diarrhoea and nausea Mild pain, bleeding irritation, swelling redness or bruising at the injection site. Severe side effects (need reporting): Rash, hives, itching, difficulty breathing, tightness of the chest, swelling of the mouth, face lips or tongue. Bloody, black or tarry stools, vomit that looks like coffee ground which may indicate internal bleeding. Confusion, severe or persistent dizziness, tiredness or weakness. Difficulty walking and muscle weakness. Pink or red urine. Unusual bleeding or bruising Administration of dalteparin (Fragmin), tinzaparin (Innohep) and Enoxaprin (Clexane) Site of Injection The products are recommended to be administered between left and right anterolateral or posterolateral abdominal wall, or the lateral part of thigh If the patient wishes it in another site, such as the arm, they should be advised this is outside the terms of the licence, this should be agreed with the prescriber, and the instructions updated. This should be the exception, and the where appropriate the patient asked to accept it in the normal place, whilst understanding the risks of no drug vs off licensed location. This should then be documented in the patients notes. Technique Ensure patient s comfort and dignity Ideally dalteparin, tinzaparin and enoxaparin should be administered when patient is lying down by deep subcutaneous injection. Check that injection fluid is clear and free of particles. If not clear, return to pharmacist. To avoid losing any of the drug, do not expel air bubble, unless wastage is required to obtain correct dose. The whole length of the needle should be introduced vertically into Page 4 of 6

5 a skin fold held between the thumb and the index finger. The skin fold should not be released until the injection is complete. Do not rub injection site following administration as this will minimise risk of bruising. Rotate injection site for subsequent doses. Document site of injection and skin condition. Time of Administration DBH policy is to administer at 6 pm; this is to allow at least 12 hours before any invasive procedure is carried out. It has been advised by DBH pharmacy that a single daily dose could be repeated between hours. On occasions where the time of administration is reduced, then it is essential to monitor the patient for signs of bleeding as the risk is increased. If time reduction is 6 hours or less: reduce by single time interval to suitable administration time:- If time reduction is 6-8 hours: reduce by 3 hours day 1 3 hours day 2 2 hours day 3 If time reduction is 8-10 hours : reduce by 4 hours day 1 4 hours day 2 2 hours day 3 If time reduction is 12 hours; reduce by 4 hours day 1 4 hours day 2 4 hours day 3 Once a regular time of administration has been agreed with the patient, wherever possible this should be adhered to. This will help to maintain optimum therapeutic levels. However, there may be occasions when this is not possible for example, the patient may have another appointment and therefore the dalteparin, tinzaparin and enoxaparin may not be administered at the agreed time. It may be possible to ask the patient to take their injection with them to be administered by an appropriately qualified professional. The patient should also take the written instruction to administer to ensure safe practice. In the event that the above is not possible and these alternative arrangements cannot be made, then the dalteparin, tinzaparin and enoxaparin can be given up to 6 hours after the usual time of administration. This may require that the patient is referred to twilight nursing service or CICT to administer. The usual time may be resumed the next day Please note that if the time delay of administration exceeds 6 hours, then please consult patient s GP or out of hours GP for further advice. Page 5 of 6

6 4. References Summary of Product Characteristics. Electronic Medicines Compendium. Community Nursing Services Injectable Medicines Policy Safe and Secure Handling of Medicines Policy Standard Infection Prevention and Control precautions Waste management and Risk Management Policy Page 6 of 6