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.
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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