MATERNITY GUIDELINES MANAGEMENT OF ANAEMIA IN PREGNANCY INCLUDING TOTAL DOSE INFUSION (COSMOFER)

Transcription

1 MATERNITY GUIDELINES MANAGEMENT OF ANAEMIA IN PREGNANCY INCLUDING TOTAL DOSE INFUSION (COSMOFER) Version: V1.0 Ratified by: Maternity Quality Board Date ratified: 2 nd September 2010 Name and Title of originator/author: Latika Narang SpR Obstetrics Date issued: 2 nd September 2010 Review due date: September 2013 Target audience: Superseded documents Relevant Standards(e.g. NHSLA, CQC, HSE) Acknowledgements All Maternity & Gynaecology staff None None Date September Page 1 of 17

2 CONTENTS 1 INTRODUCTION 3 2 PURPOSE 3 3 DEFINITIONS 3 4 ACCONTABILITIES & RESPOSIBILITIES 4 5 DIAGNOSIS 4 6 MANAGEMENT PARENTERAL IRON INDICATIONS CONTRA-INDICATIONS SIDE EFFECTS INTERACTIONS 6.6 SPECIAL WARNING & PRECAUTIONS 5 7 PATIENT INFORMATION & CONSENT 5 8 DOSE TOTAL DOSE INFUSION MANGEMENT OF ADVERSE SIDE EFFECTS MILD ALLERGIC REACTIONS SERIOUS ANAPHYLACTIC OR ALLERGIC RAECTION FOLLOW UP BLOOD TRANSFUSION INTRAPARTUM ANAEMIA POST-PARTUM TREATMENT TRAINING MONITORING COMPLIANCE REFERENCES ASSOCIATED DOCUMENTATION VERSION HISTORY TABLE APPENDIX A: EQUALITY IMPACT ASSESSMENT CONSULTATION TEMPLATE 17 Date September Page 2 of 17

3 1. INTRODUCTION CROYDON HEALTH SERVICES NHS TRUST MATERNITY GUIDELINE MANAGEMENT OF ANAEMIA IN PREGNANCY The most common cause of anaemia in pregnancy is iron deficiency. This is as a result of increasing maternal iron requirements and an increase in red cell mass. In normal pregnancy maternal plasma volume increases by up to 50% and the red cell mass gradually increases by about 20%. Hence, the haemoglobin (Hb) concentration drops. Iron deficiency anaemia is a risk factor for preterm delivery and low birth weight in the newborn. 2. PURPOSE To ensure that healthcare professionals recognise and treat anaemia in pregnancy. This guideline provides information as to the management of total iron infusion to anaemic pregnant women in the out patient setting. 3. DEFINITIONS In the UK, accepted pregnancy haemoglobin (Hb) levels should not fall below Gestation Hb Up to 12 weeks 11 g weeks 10.5 g There are no strict criteria for mild, moderate or severe anaemia. Reference can be taken from WHO-1989 Hb Mild anaemia Moderate Severe <7 Other causes of anaemia include folate deficiency, vitamin B12 deficiency, bone marrow suppression, sickle cell disease, chronic blood loss and underlying malignancies. In the event of diagnosis of folate deficiency or vitamin B12 deficiency shared care of the woman between a Consultant Obstetrician and Haematologist is recommended. 4. ACCOUNTABILITIES AND RESPONSIBILITIES The decision to give Intravenous iron sucrose rather than a blood transfusion or oral iron supplements is made on an individual basis and at a senior obstetric level. 5. DIAGNOSIS Pregnant women are offered screening for anaemia and haemoglobinopathies at their booking appointment and again at 28 weeks gestation. If the Haemoglobin level is less than 10.5g/dl in the antenatal period, consider iron deficiency once haemoglobinopathies have been excluded. Date September Page 3 of 17

4 Estimation of the haemoglobin level is used as the first indicator of anaemia However, because of the diverse pathogenesis of anaemia (e.g., iron deficiency anaemia, thalassaemia, sickle cell anaemia) the use of haemoglobin as the sole means of diagnosing anaemia is not recommended, thus more sensitive and specific tests should beundertaken. Serum ferritin is the most sensitive single screening test to detect adequate iron stores. Using a cut-off of 30 micrograms/litre sensitivity of 90% has been reported. 6. MANAGEMENT Oral iron is the preferred first line treatment for iron deficiency mg of elemental iron is recommended. Higher doses are not beneficial. There are 3 types of iron supplements: Ferrous Sulphate, Ferrous Gluconate and Ferrous Fumerate. 200mg of ferrous sulphate provides 40 mg of elemental iron. To minimize side effects of oral iron, commence with half the recommended dose, gradually increasing to the full dose. Ascorbic acid enhances absorption, women should either be prescribed vitamin C supplement or advised to take iron tablet with orange juice about one hour after food. Oral iron can cause gastrointestinal side effects resulting in poor compliance. Slowrelease polysaccharide preparations improve absorption and improve compliance. The threshold for commencing oral iron supplements should be lower in cases of multiple pregnancies. Women must be given dietary advice. Heme Iron, found in animal sources, is highly available for absorption. Non-heme iron on the other hand, found in vegetable sources, is less available. Iron rich foods include lean red meat, fish, poultry, dried fruits, whole-grain breads and iron fortified cereals. Failure to respond to iron therapy should prompt further investigation and may suggest an incorrect diagnosis, co-existing disease, malabsorption, non-compliance or blood loss. 6.1 Parental iron: Cosmofer is a solution of iron (III) hydroxide dextran complex used to treat iron deficiency anaemia. Iron dextran compounds are stable, strong complexes of relatively high molecular weight and consequent relatively long half-life and relatively slow release. Cosmofer is suitable for total dose infusion. 6.2 Indications: 1. Persistent iron deficiency anaemia due to oral iron intolerance e.g. inflammatory bowel disease (Hb < 10g, 2 nd or 3 rd trimester) 2. Demonsrated patient non-compliance to oral iron therapy 3. Treatment failure after four week trial 4. Blood transfusion declined e.g. Jehovah s Witness. 5. Anaemia near term (36 weeks gestation or more, Hb < 10g) 6.3 Contra-indications: 1. Non iron deficiency anaemia 2. Iron overload or disturbances in utilisation of iron. 3. History of hypersensitivity to parenteral iron preparations. 4. Clinical or biochemical evidence of liver damage 5. Acute/ chronic infection 6. First trimester of pregnancy Date September Page 4 of 17

5 6.4 Side effects: Approximately 5% of patients can be expected to experience adverse reactions. 1 Acute, severe anaphylactoid reactions are uncommon. They usually occur within the first few minutes of administration and are generally characterised by the sudden onset of respiratory difficulty and/or cardiovascular collapse. 2 Less severe manifestations of immediate hypersensitivity are also uncommon and include urticaria, rashes, itching, nausea and shivering. 3 Delayed reactions are well described and may be severe. They are characterised by arthralgia, myalgia and sometimes fever. The onset varies from several hours up to four days after administration. Symptoms usually last two to four days and settle spontaneously or following the use of simple analgesics, such as paracetamol. 4 Exacerbation of joint pain in rheumatoid arthritis can occur. 5 Local reactions reported are soreness and inflammation at or near injection site and local phlebitic reaction. 6.5 Interactions 1 Cosmofer injection should not be administered concomitantly with oral iron preparations as the absorption of oral iron will be reduced. Oral iron therapy should not be started earlier than 5 days after the last injection of Cosmofer. 2 Large doses of iron dextran (5ml or more) have been reported to give a brown colour to serum from a blood sample drawn four hours after administration. 3 The drug may cause falsely elevated values of bilirubin. 6.6 Special warning and precautions for use The use of Cosmofer, as with the parenteral use of other iron-carbohydrate complexes, carries a risk of immediate, severe and potentially lethal anaphylactoid reactions. 1 Women should be closely observed during the infusion and for one hour after completion. Risk is enhanced with known (medical) allergy. 2 Cosmofer should only be administered where emergency anaphylactic measures are available. In the event of an anaphylactic reaction, 0.5ml adrenaline 1:1000 solution should be administered by IM injection. If there is no clinical improvement within five minutes, administer further injections in line with your Trust s policy. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate. 3 Facilities for cardio-pulmonary resuscitation should be available. 4 Administration to patients with (auto) immune disorder or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis) may cause a type III allergic reaction. 5 When parenteral iron therapy is considered essential in patients with asthma, allergic disorders and inflammatory disorders, the intramuscular route is to be preferred. 6 Hypotensive episodes may occur if intravenous injection is administered too rapidly. 7. PATIENT INFORMATION & CONSENT Prior to administration of cosmofer, the woman must be given all relevant information in relation to the drug and verbal informed consent obtained. Date September Page 5 of 17

6 8. DOSE The dose of Cosmofer required to correct iron deficiency anaemia is dependent on the patient s body weight and haemoglobin status. To calculate the appropriate dose you will need to determine: a) the target haemoglobin concentration (g/dl) b) the actual haemoglobin concentration (g/dl) c) the patient s weight (kg): pre-pregnancy weight if known or body weight at booking visit The required dose of iron in milligrams is given by the formula: {(Target Hb g/dl Actual Hb g/dl) x Weight x 2.4} + 500mg* e.g. {(Target 11.0g/dl Actual 8.0g/dl) x 65Kg x 2.4} + 500mg =968mg *(PLEASE NOTE: the additional 500mg is to replace iron stores and is applicable to patients with a body weight of 35kg or more). Alternatively, the dose of iron required may be calculated using the tables (see below). Dose Calculation Using Tables 1 The required dose of Cosmofer to correct iron deficiency anaemia has to be individually calculated according to the haemoglobin deficit and patient s body weight. 2 Choose the table for the target haemoglobin that you require. 3 In the left hand column, find the body weight that most closely matches the patient's bodyweight. If calculating the dose for an obese patient whose body weight exceeds 90kg, use the ideal body weight. 4 Read across this row to the column headed by the haemoglobin value that matches the patient's current state. The reading at this point is the dose required, expressed as milligrams of iron. Cosmofer provides 50mg iron per ml. 5 If the dose that you arrive at is printed in red, then the dose must be divided for administration because it is above the upper limit for Total Dose Infusion of 20mg/kg body weight. All dosages printed in black may be added to 500ml 0.9% saline and infused as stated below. THE DOSES OF COSMOFER GIVEN IN THESE TABLES ARE EXPRESSED AS MILLIGRAMS OF IRON Date September Page 6 of 17

7 Target Haemoglobin of 11g/dL Date September Page 7 of 17

8 Target Haemoglobin of 12g/dL Date September Page 8 of 17

9 Target Haemoglobin of 13g/dL Date September Page 9 of 17

10 Target Haemoglobin of 14g/dL Date September Page 10 of 17

11 9. TOTAL DOSE INFUSION OF COSMOFER Test dose for a new patient: Before administering the first dose to a woman who has never received Cosmofer before, a test dose corresponding to 25mg of iron (0.5ml) is required. This is infused over a 15 minutes period with a further 45 minutes observation time (1 hour in total). If no adverse reactions are seen during this time, the remaining dose can be given. The patient should be closely monitored during this first hour and BP and pulse should be recorded every 15 minutes. For subsequent infusions, 25mg of iron must be infused over 15 minutes and if no adverse reactions are seen, the remainder of the infusion can be administered. Once the correct dose of Cosmofer (maximum 20mg/kg body weight) has been determined by calculation or from the dosage tables, it should be added aseptically to 500ml of normal saline. There is no upper concentration limit for the infusion to maintain product stability. Once made up, the infusion should be used immediately but is stable for 24 hours. If the determined dose of Cosmofer required exceeds 20mg/kg, then it should be given on two separate days. This can be done by giving half of the dose on each day, or by giving up to 20mg/kg in the first infusion and the remainder in the second infusion. 1 Record baseline observations: BP, pulse, temperature. 2 Insert appropriate cannula and infuse 25mg of Cosmofer over 15 minutes, via an infusion pump, then stop. 3 The volume of liquid (ml) in the bag that contains 25mg of iron is equal to: 25mg x Total volume in bag (ml) Total iron in bag (mg) 4 If the patient has never received Cosmofer previously, pause the infusion for 45 minutes to complete the test dose. 5 If the patient has received Cosmofer previously, there is no need to pause the infusion. After the 25mg has been infused over 15 minutes, the infusion rate can be increased gradually. 6 The remainder of the infusion should be given at the following rates: 50mls per hour for first hour 100mls per hour for next hour 150mls per hour until infusion is complete. Repeat BP and pulse every 30 minutes until infusion is completed. Flush the cannula with normal saline prior to removal. Observe the patient for one hour following the infusion. Fetal monitoring is not required during the infusion as long as the patient is feeling enough fetal movements. Women can go home an hour after the infusion if all observations are stable. Cosmofer can be administered on FAU or Hope ward as long as there are staff available for appropriate monitoring. There is no need for overnight stay on the ward. Date September Page 11 of 17

12 10. MANAGEMENT OF ADVERSE SIDE EFFECTS Facilities for cardio-pulmonary resuscitation must be available. Patients with low iron binding capacity and/folic acid deficiency are particularly at risk of an allergic or anaphylactoid reaction Mild allergic reactions 1. Stop infusion 2. Record temperature, pulse, blood pressure, respirations, O2 saturations. 3. Chlorpeniramine 10mg iv slowly can be given as prescribed by the doctor if mild reactions such as itching do not abate. 4. Recommence infusion at a slower rate and observe the woman closely Serious anaphylactic or allergic reaction: 1. Stop infusion 2. Crash call for medical emergency 3. IM adrenaline should be administered immediately and after supportive cardiopulmonary resuscitation procedures initiated. 11. FOLLOW-UP A plan must be in place before the woman goes home. An appointment must be given to the woman to have her haemoglobin and ferritin level checked in 3-4 weeks. Oral iron can be prescribed if needed and should be started at least 5 days after the last injection. An increase in haemoglobin concentration of about 1.5g/week is anticipated. 12. BLOOD TRANSFUSION There are no firm criteria for initiating red cell transfusion. The decision to give a blood transfusion should be made on both a clinical and haematological basis. Transfusion is rarely indicated in a stable woman when the Hb is greater than 10 g/dl and is almost always indicated when less than 6 g/dl Intrapartum anaemia: If the Hb is less than 7 g/dl in labour or in the immediate postpartum period, the decision to transfuse should be made according to the individual s medical history, age and symptoms Post-partum treatment: If the Hb is less than 7 8 g/dl in postnatal period, where there is no continuing or threat of bleeding, the decision to transfuse should be made on an informed individual basis. In fit, healthy, asymptomatic patients there is little evidence of the benefit of blood transfusion. Cosmofer can also be given for treatment of post-partum anaemia. Date September Page 12 of 17

13 It is not known whether the complex iron-dextran is excreted in human or animal breast milk. It is preferable not to use Cosmofer during breast feeding. 13. TRAINING Staff administering Cosmofer infusion must be trained in the administration of intravenous infusions. They must be aware of the management of side effects of total dose infusion of Cosomfer. Basic Life Support skills and anaphylaxis skills are required in the event of an adverse reaction and all obstetric and midwifery staff must be up to date with this mandatory training. Date September Page 13 of 17

14 14. MONITORING COMPLIANCE Element to be monitored Lead Tool Frequency Reporting arrangements Action Lead(s) Change in practice and lessons (What needs Monitoring Dietary advice offered when anaemia identified Oral iron prescribed when iron deficiency anaemia diagnosed Parental iron prescribed when indicated Procedure to be followed for Total dose iron infusion Number of staffing attending basic life support training (Who will lead on this aspect of monitoring Obstetric SpR Obstetric SpR Obstetric SpR Obstetric SpR Practice Developme nt midwives (What tool will be (How often will we (Who or what used to need to monitor) committee will I monitor/check that everything is working according report the results to for information and action) to the element of this policy) Audit tool Annually Clinical Governance meeting Audit tool Annually Clinical Governance meeting Audit tool Annually Clinical Governance meeting Audit tool Annually Clinical Governance meeting TNA Database Six monthly Risk Management Committee (Who will undertake the action planning for deficiencies and recommendations) Clinical Midwifery Managers Clinical Leads Clinical Midwifery Managers Clinical Leads Clinical Midwifery Managers Clinical Leads Clinical Midwifery Managers Clinical Leads Clinical Midwifery Managers Clinical Director (How will changes be implemented and lessons shared Changes to practice will be discussed at the Clinical Governance meeting and implemented via the Quality Board Changes to practice will be discussed at the Clinical Governance meeting and implemented via the Quality Board Changes to practice will be discussed at the Clinical Governance meeting and implemented via the Quality Board Changes to practice will be discussed at the Clinical Governance meeting and implemented via the Quality Board Findings reported to the Risk Management meeting. Clinical midwifery managers and the Clinical Director follow up staff who do not attend training Date September Page 14 of 17

15 15. REFERENCES Royal College of Obstetricians and Gynaecologists. Blood transfusion in obstetrics. Green-top guideline No. 47. London: RCOG; 2007 National Institute for Health and Clinical Excellence. Antenatal Care: routine care for the healthy pregnant woman. Clinical guideline CG62. London: NICE; 2008 Gravier A (1999) How to avoid transfusion in the postpartum: Intravenous iron supplementation. J Gynecol. Obstet. Biol. Reprod 28, Reveiz L, Gyte GML, Cuervo LG. Treatments for iron deficiency anaemia in pregnancy. Cochrane database of Systematic Reviews 2007, Issue 2. Bashiri A, Burstein E, Sheiner E, Mazor M. Anaemia during pregnancy and treatment with intravenous iron: review of the literature. Eur J Obstet Gynecol Reprod Biol. 2003; 110:2-7 Perewusnyk G, Huch R, Huch A. Parenteral iron therapy in obstetrics: 8 years experience with iron sucrose complex. Br J Nutr. 2002;88: ASSOCIATED DOCUMENTATION Croydon Health Services NHS Trust- Maternity Guideline: Obstetric haemorrhage 2010 Croydon Health Services NHS Trust- Maternity Guideline: Women who refuse Blood Transfusion and Blood Products VERSION HISTORY TABLE Version Date Author Ratified by Comment/Reason for change 1.0 September 2010 Latika Narang, Obstetric SpR Maternity Quality Board New document This guideline has been developed, reviewed and approved in line with Trust policy. It has been to the Practice Review Group and then ratified at the Maternity Quality Board meeting by Head of Midwifery and Lead Obstetric Consultant. Name Job Title Signature Date Sally Brittain Head of Midwifery Deborah Caffull Rosol Hamid Practice Development Midwife Lead Obstetric Consultant Guideline review Date: September 2013 Date September Page 15 of 17

16 18. APPENDIX A EQUALITY IMPACT ASSESSMENT To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval. Yes/No Comments 1. Does the policy/guidance affect one group less or more favourably than another on the basis of: Race No Ethnic origins (including gypsies and travellers) No Nationality No Gender No Culture No Religion or belief No Sexual orientation including lesbian, gay and bisexual people No Age No Disability - learning disabilities, physical disability, sensory impairment and mental health problems 2. Is there any evidence that some groups are affected differently? 3. If you have identified potential discrimination, are there any exceptions valid, legal and/or justifiable? 4. Is the impact of the policy/guidance likely to be negative? No No N/A N/A 5. If so can the impact be avoided? N/A 6. What alternative are there to achieving the policy/guidance without the impact? 7. Can we reduce the impact by taking different action? N/A N/A Date September Page 16 of 17

17 19. APPENDIX B CONSULTATION TEMPLATE 1. Procedural Document s Name: 2. Procedural Document Author: 3. Group/Committee Consulted: 4. Date of Consultation: 5. Comments Received: 6. Highlight where policy changed following consultation or state reasoning why comments not incorporated: Date September Page 17 of 17