Anaemia - guideline for the use of Venofer in pregnancy and post partum for the treatment of iron deficiency anaemia () Approval Approval Group Job Title, Chair of Committee Date Maternity & Children s Services Mr Mark Selinger, Consultant 3 rd October Clinical Governance Committee 2014 Change History Version Date Author, job title Reason 1.0 2004 J Ablett, Consultant Trust requirement 2.0 June 2005 J Ablett, Consultant Review due 3.0 May 2008 J Ablett, Consultant Review due 4.0 Mar 2009 J Ablett, Consultant Review due 5.0 Aug 2011 J Ablett, Consultant Review due 6.0 March 2012 J Ablett, Consultant Flowcharts added 7.0 Sept 14 J Ablett, Consultant Bi-annual review due Author: Jill Ablett Date: October 2014 Job Title: Consultant Review Date: October 2016 Policy Lead: Group Director Urgent Care Version: 7.0 ratified 3 rd Oct 2014 Location: Maternity CG Shared Drive/ Obstetrics & Midwifery/ Medical conditions & complications/ This document is valid only on date Last printed 04.02.2015 15:02:00 Page 1 of 8
Overview:Venofer is an iron sucrose infusion which can be used both in pregnancy and post partum for treatment of iron deficiency anaemia Introduction Venofer is an iron sucrose infusion, which can be used as second line treatment when oral iron therapy is deemed inappropriate or has failed. This may be due to malabsorption, poor tolerance, unacceptable side effects or where there is a need to correct iron deficiency and ensuing anaemia urgently. Venofer is contra-indicated in the 1 st trimester of pregnancy, though data on a limited number of exposed pregnancies indicated no adverse effects. Animal studies do not indicate any direct or indirect effects at any stage of fetal development. Venofer is now licenced for use in the second and third trimester of pregnancy. Non metabolised iron sucrose is unlikely to pass into the mother's milk and therefore, Venofer is not contraindicated in breast-feeding. Early detection and appropriate management of iron deficiency anaemia may prevent otherwise young and healthy patients from receiving an unnecessary blood transfusion Patients with thalassaemia who are diagnosed with iron deficiency anaemia should be reviewed by a haematologist for appropriate management and treatment. Patients with thalassaemia or sickle cell disease should NEVER routinely receive iron therapy either oral or intravenous. In the absence of any other diagnosis of anaemia, iron deficiency in pregnancy is defined as: Hb < 10.5g/dl MCV < 80 fl Serum Ferritin < 15µg/l MCH < 25 pg Fe < 11µmol/l Transferrin saturation<15% Treatment a) Oral Iron Adequate iron therapy is oral iron of 160mg/day for 2 weeks. This can be either 2 tablets of Pregaday (ferrous fumarate 100mg, folic acid 350mcg), or ferrous sulphate 200mg tds with folic acid 5mg per day. It should be stressed that these should not be taken after food or tea/coffee as this will decrease absorption. Ideally they should be taken with orange juice or with a vitamin C tablet (ascorbic acid 50mg) to improve absorption. Following adequate treatment, the haemoglobin should rise by 0.1-0.2g/dl per day). Treatment should continue for 3 months after a normal level has been reached to replenish iron stores. This should be passed on to Community midwives and GPs to continue prescriptions post natally. This document is valid only on date Last printed 04.02.2015 15:02:00 Page 2 of 8
b) Venofer The dose of Venofer required may be easily calculated using the Ganzoni formula (see Ferinject guideline). Alternatively the dosage table can be used to calculate the total amount of Venofer required. This will also replenish the iron stores. Dosage Tables Increase in Hb required (g/dl) Body Weight 1 2 3 4 5 Kg 50 6 7 9 10 11 55 6 8 9 10 12 60 6 8 9 11 12 65 7 8 10 11 13 70 7 8 10 12 13 75 7 9 10 12 14 80 7 9 11 13 15 85 7 9 11 13 15 90 7 9 11 14 16 95 7 10 12 14 16 100 7 10 12 15 17 Dose of Ferinject / Venofer = number of ampoules (see table above) x 100mg NB max dose Ferinject = 1000mg / week (15mg/Kg) as a single dose Max dose Venofer = 600mg as 3 divided doses per week Venofer may be given up to 3 times per week (3x200mg = max 600mg/week). A repeat FBC should be taken 7 days after adequate treatment is given. This should show a rise in Hb in most women, but a rise in MCV and MCH is indicative that treatment is working and iron is being taken up into the red blood cells. A repeat FBC should then show improvement in Hb after a further 7 days. Serum Ferritin should also be taken to indicate the state of the iron stores and whether further treatment is required to replenish these. Safety data from over one million patients worldwide has indicated an incidence of side effects in 0.007% patients (hypotension, nausea, headache, oedema, funny taste) and serious anaphylactoid reactions as 0.002%. It is thus a safe preparation to use, though it is recommended that hydrocortisone, chlorpheniramine and adrenaline be available in case of a severe reaction. Venofer can be prescribed by any doctor. It can be drawn up and administered by midwives, and should be given in Day Assessment Unit, on Delivery Suite or Marsh and Iffley Wards. This document is valid only on date Last printed 04.02.2015 15:02:00 Page 3 of 8
Post Natal Venofer Post partum use of Venofer may be indicated and may avoid transfusion in some cases. The dose may be calculated in the same way and with treatment, increases in Hb of 2-3g by day 14 may be achieved. The Venofer can be given on sequential days if required (max 600mg/week) and then oral iron given at discharge. If symptomatic and Hb < 80g/l, transfuse. Aim to increase Hb to 80g/l only (1 unit is OK) If post natal Hb > 70 g/l and patient asymptomatic and not at significant risk of further haemorrhage, consider Venofer/ Ferinject If post transfusion Hb > 80 g/l and well, consider Venofer/ Ferinject If Hb > 90 g/l and well, for oral iron. If symptomatic, consider Venofer/Ferinject, rather than transfusion Ferinject should be used in place of Venofer for antenatal women who are outpatients, where the convenience of a single dosing regimen would be advantageous. It may also be used for postnatal women whose discharge would otherwise be delayed, whilst waiting for repeated doses of Venofer. Venofer should still be used in most cases for postnatal women as these patients can (usually) have the 2 required doses on consecutive days before discharge. Follow up FBC need to be arranged with the GP or community midwives for 7 days after treatment. Please ask the CMW to check the Hb at the routine 10 day post natal visit to ensure adequate treatment has been given. This document is valid only on date Last printed 04.02.2015 15:02:00 Page 4 of 8
Guideline for infusion of Venofer Equipment required: Venofer 200mg in 200mls Normal Saline 0.9% over 1 hour 1 x steret 1 x 21 gauge butterfly (blue) Tape or cannula dressing Vacutainer blood bottles FBC 2 x white needle 1 x 5ml syringe 5mls Normal Saline (to flush cannula) 1 x 10ml syringe 200mg Iron Sucrose (Venofer ) 2 vials Normal Saline 200mls Giving set (appropriate giving set if using a pump) Gauze Procedure for administration of Venofer infusion: Baseline observations: Prepare infusion of Venofer Prepare skin with alcohol steret Insert 22 gauge venflon (blue) Secure cannula in position with tape or cannula dressing Take blood samples from cannula Flush with 2mls Normal Saline Connect infusion of Venofer and infuse at pump rate of 210 ml/hr Observe patient for any adverse events Remove cannula, apply pressure, extend and elevate the arm Post injection observations: Intravenous Chlorpheniramine, Hydrocortisone and Adrenaline should be available for immediate use in the event of a severe adverse drug reaction. This document is valid only on date Last printed 04.02.2015 15:02:00 Page 5 of 8
References 1. Breymann C. Iron Supplementation during Pregnancy. Fetal and Maternal Medicine Review 2002; 13:1-29 2. Perewusnyk R. et al. Parentral Iron Therapy in Obstetrics: 8 years experience with iron-sucrose complex. British Journal of Nutrition 2002; 88, 3-10 3. Fernandes-Ballart J. Iron Metabolism during Pregnancy. Clin Drug Invest 2000; 19:9-19 4. Bayoumeu F. et al. Iron Therapy in Iron Deficiency Anaemia in Pregnancy: Intravenous Route Versus Oral Route. Am J Obstet & Gynae 2002:186, (3) 5. Al-Momen A. et al. Intravenous Iron Sucrose Complex in the Treatment of Iron Deficiency Anaemia during Pregnancy. Eur J Obstet & Gynae & Repro Bio. 69 (1996) 121-124 Author: Jill Ablett, Consultant, June 2005 Reviewed: May 2008, March 2009, August 2011, September 2014 Review October 2016 **Appendices added 27 th March 2012 This document is valid only on date Last printed 04.02.2015 15:02:00 Page 6 of 8
Appendix 1 Appendix 2 This document is valid only on date Last printed 04.02.2015 15:02:00 Page 7 of 8
Monitoring: The audit team that will audit the above auditable standards will be formed by: A midwife and/or a doctor and/or a maternity support worker Audit and quality midwife A clinical audit facilitator / assistant The audit will compare results with previous audits, if applicable. The audit will review documentation stated in the maternal health records as evidence of compliance with standards. The table below shows the plan to follow based on the audit results obtained. This would be subject to earlier re-audit if concerns are raised from risk management about this particular topic. Continuous and prospective audits might override this plan. Results If < 75% compliance If 75% compliance and results than previous audit (when applicable) If 75% compliance and results than previous audit (when applicable) Risk Priority 1 2 3 Minimum Plan Implement action plan and re-audit within 3 months from completion of report Implement action plan and re-audit within 6 months from completion of report Implement action plan and re-audit next financial year from completion of report The results will be disseminated depending on the risk priority. Risk Priority 1 2 3 Dissemination Reported in Maternity Audit Forum Uploaded in Maternity Intranet page RBHFT Maternity Newsletter Special measures identified in action plan Summary reported in Maternity Audit Forum Uploaded in Maternity Intranet page RBHFT Maternity Newsletter Summary reported in Maternity Audit Forum RBHFT Maternity Newsletter The dissemination on results and implementation of action plans and timely re-audit will be coordinated by the Audit and Quality Midwife and reported to the Maternity Clinical Audit Committee on a quarterly basis. This committee reports to Maternity Clinical Governance quarterly. This document is valid only on date Last printed 04.02.2015 15:02:00 Page 8 of 8