Title An audit reviewing pregnant patients prescribed oral iron therapy and whether they were managed according to Glasgow Royal Infirmary protocol for Haemoglobin <105g/l Obstetric Management, before they were prescribed Cosmofer. Shehani Alwis1 Dr V Brace2 Dr E Ellis2 1. University of Glasgow, UK 2. Glasgow Royal Infirmary, UK Background Cosmofer, an intravenous iron therapy, is used for treatment of iron deficiency. The indications for its use include intolerance to oral iron preparations, ineffective oral therapy or in cases where rapid iron delivery is required. All the patients in this audit were given Cosmofer as out-patients in the day care unit in Glasgow Royal Infirmary. Oral iron therapy is the first line of treatment for patients with iron deficiency anaemia during their pregnancy. Oral supplements can include ferrous fumarate, ferrous sulphate or a triple iron therapy which is combination of ferrous fumarate or sulphate, folic and ascorbic acid. Glasgow Royal Infirmary produced and implemented a protocol called Haemoglobin <105g/l Obstetric Management for patients on oral therapy. This protocol was implemented to ensure oral therapy was having a desired effect, and an alternative treatment to be offered if the therapy was ineffective. The protocol at the Glasgow Royal Infirmary was on site by 30th November 2011 and the implementation date was 7th December 2011. Figure 1 are the areas of the protocol investigated in this audit. Haemoglobin <105g/l Obstetric management If Hb <105g/l, check FBC and blood film Serum ferritin If ferritin <50, commence oral replacement therapy Commence ferrous fumarate 210mg tid (contains 68mg elemental iron per tablet), 2nd line management ferrous sulphate 200mg tid to be used only when ferrous fumarate not available, ascorbic acid 100mg bd (assists absorption of iron) and folic acid 5mg od (as red cell production may rapidly increase) If ferritin>50 Consider other causes of anaemia If strong clinical suspicion of iron deficiency anaemia, consider checking serum iron and transferrin. Monitor response Check FBC every 4 weeks after commencing therapy Hb level may take up 6 weeks to respond Check reticulocyte count if no response in Hb after 4 weeks- this will increase prior to rise in Hb and will indicate that RBC production is responding to therapy If no response in reticulocyte count at 4 weeks, review diagnosis Monitoring of response may need to be more frequent if anaemia treatment does not commence until the late second or third trimester Haematinic replacement should continue until at least 6 weeks post-partum, longer if significant port-partum haemorrhage occurs If iron deficiency is confirmed and there is no response to oral iron replacement or oral iron cannot be tolerated, intravenous iron (Cosmofer) can be used. A Total Dose Infusion (TDI) should be given as long as the TDI does not exceed 20mg/kg. An increase in the reticulocyte count should be seen within a week of administrating the full dose. Figure 1: The protocol reviewed in this audit. Important: The protocol also had information on Vitamin B12 and folate deficiencies in pregnancy but was not investigated in this audit. The audit was completed to review whether the protocol was being followed for patients prescribed oral iron therapy and identify any similarities resulting in these patients requiring Cosmofer. The importance of using iron supplementation effectively and offering alternative treatment if iron deficiency persists was very clear. Complications include increased tiredness and increased risk of infections. Furthermore, severe anaemia can lead to cardiac and respiratory complications such as tachycardia or heart failure. 1,2 Additionally recent cohort studies show low and high maternal haemoglobin can lead to a poor outcome in pregnancy. There have been studies showing an association between maternal iron deficiencies and an increased risk of preterm delivery.3 Studies show iron supplementation during pregnancy improved haemoglobin and serum ferritin concentrations post-partum. Furthermore, it is important to consider the importance of iron supplementation post-partum as without supplementation, blood loss during the pregnancy can lead to women to become anaemic. A study in South Africa found anaemia post-partum had an association with infants scoring lower in overall developmental tests and delayed hand-eye movement at 10 weeks. 2 Aims and Objectives The main aim of this audit was to analyse patients given Cosmofer over the last 6 months and review whether protocol was followed after oral iron therapy was prescribed. Additionally, the audit reviewed: The types of oral iron therapy prescribed Areas of the protocol that were being followed and aspects of the protocol that were not being followed Various reasons patients required Intravenous Iron therapy Number of weeks or oral iron therapy prior to patients receiving Cosmofer Methodology The audit reviewed 16 patients who had received Cosmofer in the last 6 months, May 2014 September 2014. Firstly, patient’s initial referral letter to the antenatal clinic was reviewed. Haemoglobin and reticulocyte counts from the time of booking till Cosmofer fusion were obtained using Glasgow Clinical Portal. Details regarding type of oral therapy and reasons for Cosmofer initiation were obtained from clinical case notes. Medical records helped obtain length of oral therapy patients received and reason for Cosmofer. All the information needed for this audit was recorded on a form shown in Figure 2. Month Patient No for that month: Name Age Parity Haemoglobin Timing of blood test Booking 28 weeks 36 weeks Extra Haemoglobin results and reasons for request Timing of blood test Haemoglobin Haemoglobin Reason for request Ferritin Timing of blood test Serum/Assay Ferritin levels Treatment received Method of telling patient they required iron therapy Ferrous Fumarate Ferrous Sulphate Triple Iron Pregnacare FBC repeated after 4 weeks of oral iron Reticulocyte count checked after 4 weeks Length of treatment before IV iron Number of weeks at which Cosmofer given Reason for IV iron Figure 2: A template of the form used to record all patient information Results The ages of the 16 patients ranged from 22 years old to 41 years old. 94% (15 patients) had previous pregnancies and 18.75% had no children before this pregnancy, and 2 patients had experienced a miscarriage. At the booking appointment there was a range of gestation ages but all 16 patients had a full blood count and 37.5% patients had haemoglobin result less than 105g/l. Out of the 37.5% with a low HB result at booking; 83% had their serum ferritin checked and out of these 33% had already been prescribed iron therapy before serum ferritin was checked. Only one patient did not have a serum ferritin carried out. 43% were given iron treatment without checking serum ferritin. There are 4 different treatments options for patients requiring iron supplementation and there was range of different treatments prescribed in the 16 patients. The treatments prescribed prior to getting Cosmofer are documented in table 1 below, Treatment Ferrous Fumarate Number 2 Ferrous Sulphate 0 Triple Iron (ferrous fumarate or ferrous sulphate 13 and ascorbic acid and folic acid) Pregnacare 1 Not documented 1 Table 1: Different Oral Iron Therapies Prescribed to the 16 Patients Note: One patient was prescribed triple iron prior to Pregnacare. The patient with no documented treatment had a previous gastric surgery so the patient was unable absorb oral iron therapies. The reasons documented for requiring intravenous iron shown in Table 2 included non-compliance, not tolerating, inability to take oral iron and in many cases no reason was given. Reason given for being prescribed IV iron Numbers No Reason Given 8 Not tolerating 3 Non-compliance 3 Unable to take oral therapy 2 Unable to obtain 1 Table 2: The different reasons noted in medical records for patients being prescribed IV iron Note: One patient had both non-tolerance and non-compliance noted. Two patients were unable to take oral therapy; one had a gastric surgery therefore was unable to absorb oral supplements. The other patient had no reason for inability to take oral iron therapy but had tried liquid iron which was documented as ‘not helping’. The first step in the Glasgow Royal Infirmary Protocol was to ensure the full blood count was repeated after 4 weeks of oral iron. 25% had full blood counts checked after 4 weeks of oral iron therapy. 75% of the patients that had a full blood count checked still had haemoglobin results below 105g/l. One patient had been on oral iron therapy throughout her pregnancy and another had not been given oral iron therapy due to inability to tolerate. Another aspect of the protocol is to ‘check reticulocyte count if no response in Hb after 4 weeks’ but a reticulocyte count was not requested in any of the 4 patients who had low Hb after 4 weeks on oral iron therapy. A reticulocyte count was not conducted on any of the patients reviewed in this audit. There were differences in the length of time patients were on oral iron therapy before they were prescribed intravenous iron shown in Table 3 and Figure 3. Number of weeks Number of patients 0-10 6 11-20 8 Throughout Pregnancy 1 Undocumented/ N/A 1 Table 3: Number of Weeks Patients were taking Oral Iron Therapy before receiving Cosmofer Figure 3: Pie Chart showing the Percentages of Patients Receiving Oral Iron Therapy for Particular Time Periods Below Figure 4 shows the month a patient received Cosmofer and the length of time they received oral therapy. Figure 4: line graph showing the month each individual patient received Cosmofer and the length of time each patient received oral iron therapy. (Each month on the x-axis represents a different patient) There was a variety in the number of gestation weeks at which Cosmofer was given, shown below in table 4 and Figure 5. Number of weeks gestation Number of patients Under 30 weeks 4 Under 35 weeks 6 Under 40 weeks 6 Table 4: Number of Weeks Gestation at which Patients Received Cosmofer Figure 5: Bar Graph showing the number of weeks gestation when Patients Received Cosmofer Below Figure 6 shows each individual patient and the number of weeks gestation they were given a Cosmofer infusion. Figure 6: line graph showing each individual patient and the number of weeks gestation at which received Cosmofer treatment. (Each month on the x-axis represents a different patient) Conclusion To conclude the protocol after patients were prescribed oral iron therapy was not followed in any of the patients. No one had a reticulocyte count requested and only 4 patients had a full blood count done after 4 weeks of oral iron therapy. After reviewing the 16 patients there were differences regarding age, parity and the timing of their blood tests. There were differences in treatment, however most patients were prescribed triple iron after a low haemoglobin result and prior to Cosmofer infusion. It is important the audit results are distributed to all relevant departments to ensure every professional has a full understanding of the Glasgow Royal Infirmary Protocol when patients have low haemoglobin results. Furthermore a proforma will be introduced for completion at oral therapy initiation. Following this a reaudit will be conducted to complete the audit cycle. References 1. Patient.co.uk; Anemia in Pregnancy; http://www.patient.co.uk/doctor/anaemia-inpregnancy; Date of access October 2014 2. Oregon Evidence-based Practice Center; Screening for Iron Deficiency Anemia in Childhood and Pregnancy: Update of the 1996 U.S; Preventive Task Force Review; Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Apr 21; No. 40; 2, http://www.ncbi.nlm.nih.gov/books/NBK33398/; Date of access October 2014 3. Allen L, Anemia and iron deficiency: effects on pregnancy outcome; The American Journal of Clinical Nutrition; May 2000; Volume 71 No 5; http://ajcn.nutrition.org/content/71/5/1280s.full; Date of access October 2014