| Abstract|| |
This study was performed to evaluate the attitude of the physicians in Saudi Arabia towards iron supplementation in hemodialysis patients treated by recombinant human erythropoietin (r-HuEPO). A questionnaire was sent to 174 physicians in the 133 active dialysis centers in Saudi Arabia; 99 (74.5%) centers in Ministry of Health (MOH), 14 (10.5%) in governmental non-MOH institutions and 20 (15%) in the private sector, who collectively looked after more than 7300 chronic hemodialysis patients of whom 4745 (65%) were on erythropoietin therapy. A total of 149 out of 174 (85.6%) physicians answered the questionnaire. Of them, 90 (60.4%) had a protocol for intravenous (i.v.) iron administration, 117 (78.5%) utilized serum ferritin and 75 (50.3%) utilized transferrin saturation (TS) ratio for the evaluation of iron stores in their patients. There were 97 respondents (88%) who would initiate i.v. iron during the induction therapy of r-HuEPO in case of absolute iron deficiency, 44 (54.3%) in case of borderline iron deficiency, 38 (48.1%) in case of functional iron deficiency and only eight (10.6%) in case the values of the ferritin and TS were higher than normal. There were 100 respondents (76.3%) who believed that i.v. iron supplements could decrease the dose of r-HuEPO and 123 (91.1%) believed that i.v. iron could improve the hematocrit response to r-HuEPO. Furthermore, there were 95 (87.2%) respondents who would use iron saccharate as the iron preparation of choice, 70 (52.2%) believed that iron saccharate caused less hypersensitivity than iron dextran while 84 (75%) had no idea about the cost of i.v. iron preparations. There were 74 (55.6%) respondents who would administer high iron loading dose over a short period and 87 (66.9%) would follow the guidance of the lab tests during the maintenance phase of the r-HuEPO replacement therapy. Our study suggests that a protocol for i.v. iron supplementation is lacking in many centers. There is a need to increase awareness of the physicians working in those centers to the importance of i.v. iron therapy.
Keywords: Erythropoietin, Chronic renal failure, Iron, Therapy
|How to cite this article:|
Souqiyyeh MZ, Shaheen FA. Attitude of Physicians Towards Iron Supplementation in Hemodialysis Patients Treated with Erythropoietin. Saudi J Kidney Dis Transpl 2003;14:134-44
|How to cite this URL:|
Souqiyyeh MZ, Shaheen FA. Attitude of Physicians Towards Iron Supplementation in Hemodialysis Patients Treated with Erythropoietin. Saudi J Kidney Dis Transpl [serial online] 2003 [cited 2020 Aug 4];14:134-44. Available from: http://www.sjkdt.org/text.asp?2003/14/2/134/33022
| Introduction|| |
Surveys of attitude of the treating physicians about their practice in the dialysis units are one of the tools available to evaluate the quality of care provided to the patients on regular dialysis.,,
Iron supplementation has become an important adjuvant therapy in patients treated with recombinant human erythropoietin (rHuEPO), either during the induction or the maintenance phases or both.  A decreased response to erythropoietin (EPO) has been attributed primarily to inadequate iron stores or decreased utilization of these stores forming what is called "functional iron deficiency".  Thus, some authorities recommend routine iron supplementation, especially the intravenous (i.v.) form, during the induction period based on the observation of a better response to r-HuEPO therapy in patients on iron supplimants. , The frequency of administration of i.v. iron is usually lower during the maintenance phase of r-HuEPO. , Oral iron is generally inadequate due to non-compliance of the patients as well as the gastrointestinal side effects of the oral preparations available in practice. ,
We attempt in this study to evaluate the attitude of the physicians in Saudi Arabia towards iron supplementation in hemodialysis patients treated by r-HuEPO. This includes the preferences of the physicians to the preparations of iron, the laboratory tests to evaluate the iron stores, the protocol for iron supplementation besides the strategies for iron dosing. We also attempt to conclude guidelines for administration of the iron supplements in Saudi Arabia.
| Methods|| |
We sent a questionnaire to 174 nephrologists working in the 133 active dialysis centers in Saudi Arabia. These doctors catered cumulatively to more than 7300 chronic hemodialysis patients of whom 4745 (65%) were on erythropoietin therapy. The questionnaire was mailed in March 2002 and responses were received at the Saudi Center for Organ Transplantation, Riyadh in May 2002.
The questionnaire was intended to evaluate the following categories in the practice of physicians who take care of the dialysis patients in Saudi Arabia:
a) The perception of the physicians to the significance of iron supplementation and their preference to oral versus i.v. routes for iron supplementation.
b) The laboratory (lab) tests that guide the physicians in their decision about starting and maintaining the iron supplementations.
c) The interpretation of the physicians of the tests that evaluate iron stores and the need for a protocol for i.v. iron supplementation during the r-HuEPO therapy.
d) The preferences of physicians of the i.v. iron preparation that is safe, efficient and cost-effective.
e) The strategies of the physicians towards the i.v. iron dosing during the induction and maintenance phases of r-HuEPO therapy.
Furthermore, we compared the responses according to the affiliation of the dialysis center [Ministry of Health (MOH), nonMOH, private], presence of a protocol for i.v. iron supplementation in the dialysis centers, the availability of lab tests for assessing iron stores and the availability of i.v. iron preparations. The answers were compared with the common denominator of the standard European and American (Dialysis outcome quality initiative, DOQI) guidelines.
| Statistical Methods|| |
Data were entered in a Microsoft Excel file, and the description of data and analysis was done by using the statistical program SPSS.
Pearson Chi-Square test was used throughout the analysis to test the significance of differences between groups and sub-groups. Significance is set as P< 0.05.
| Results|| |
All the 133 (100%) active dialysis centers, having 174 physicians participated in the study. They included 99 (74.5%) MOH centers, 14 (10.5%) Governmental nonMOH centers and 20 (15%) private centers. The questionnaire was answered by 149 of the 174 physicians (85.6%) of whom 105 (70.5%) belonged to MOH, 24 (16%) to Governmental non-MOH and 20 (13.4%) to private. Not all the questions were answered by all the 149 respondents, hence the results are computed accordingly. Regarding the usage of iron supplements, four of the 144 respondents (2.8%)to this question used iron only during the induction period, 18 (12.5%) during the maintenance phase while 122 (84.7%) used in both phases. The route of iron administration was oral in 45 of 148 respondents (30.4%) intravenous (i.v) in 23 (15.5%) and both oral and i.v. in 80 (54.1%). Sixty of the 134 respondents (44.8%) were using oral iron supplements in all patients while 74 (55.2%) said that their use of oral iron would be guided by the lab reports. When asked what should be ideally done, 134 (93.1%) said their use of i.v. iron would be guided by lab reports while only 10 (6.9%) would use this drug on all patients. A protocol for use of i.v. iron was available for 90 (60.4%) respondents while 57 (38.8%) did not have any guiding protocol.
[Table - 1] shows the usage of the lab investigations to evaluate the iron stores in the patients who receive i.v. iron supplements. Serum ferritin was used by 84 (63.6%) respondents, 75 (50.3%) used transferrin saturation ratio and 35 (50.7%) used hypochromic red cell ratio to guide the administration of i.v. iron. Of the respondents, 48 (32.2%) measured the iron parameters monthly, 72 (48.3%) three monthly and 11 (7.4%) six monthly.
Regarding the practical aspects of use of i.v. iron use, 100 of the 131 respondents (76.3%) believed that this drug reduces the dose requirements of EPO while 31 (23.7%) did not. Additionally, 123 of 135 respondents (91.1%) believed that i.v. iron improves the response to EPO in relation to the hematocrit while 12 (8.9%) did not believe so. Regarding discontinuation of i.v. iron, 21 of 116 respondents (18.1%) would discontinue if serum ferritin is > 300 ng/ml, 11 (9.5%), if serum ferritin saturation is >30%, 81 (69.8%), based on both parameters while three (2.6%) followed neither of the parameters.
Of the 109 physicians who responded to the question on the type of iron preparation used, 12 (8.1%) used iron dextran, 95 (87.2%) used iron saccharate and interestingly, two (1.8%) had no idea. Regarding hypersensitivity reactions, 70 (52.2%) thought it was more with iron dextran than with iron saccharate, 10 (7.5%) said that it was less with iron dextran, one (0.7%) felt it was same with both preparations while 53 (39.6%) had no idea. The vast majority of the respondents, 84 of 127 (75%), had no idea about the cost of i.v. iron, 13 (10.2%) felt iron dextran is costlier than iron saccharate, 14 (12.5%) felt it was cheaper while three (2.7%) felt they both costed the same. When asked about the dosage of i.v. iron in the induction phase, 74 (55.6%) would give 10 doses of 100 mg each over 10 dialysis sessions, 21 (15.8%) would give the dose every week for 10 doses while 34 (25.6%) would give iron twice weekly for 10 doses. The dosage of iron during the maintenance phase was 100 mg weekly in 26 (20%), 100 mg monthly in 15 (11.5%), and dictated by lab reports in 87 (66.9%).
[Table - 2],[Table - 3],[Table - 4],[Table - 5] show the comparison of the answers of the study participants, mentioning only the significant differences, after regrouping the respondents according to their dialysis center affiliation, adoption of protocols for administration of i.v. iron, usage of tests that evaluate iron stores during i.v. iron supplementation and the availability of the i.v. iron preparation.
[Table - 2] shows the comparison according to the dialysis center affiliation. Overall, centers affiliated to the MOH were found to have a lesser prevalence of a protocol for administration of i.v. iron (59.5%), lesser availability of laboratory tests to evaluate iron stores (28.8%), lesser inclination to initiation of i.v. iron in case of absolute, borderline or functional iron deficiency (43.1%, 35.3% and 94% respectively); lesser belief that i.v. iron could decrease the dose of r-HuEPO and lesser inclination to the aggressive administration of iron during the induction phase of r-HuEPO therapy. Furthermore, physicians in the MOH centers were less inclined to use iron saccharate as the i.v. iron preparation than those in other health sectors.
[Table - 3] shows the comparison according to the presence of protocols for administration of i.v. iron. Those who had set protocols for i.v. iron adjuvant therapy administered iron supplements orally and i.v., generally guided by laboratory tests. Also, these respondents also had laboratory tests available to evaluate iron stores. Also, they would initiate i.v. iron in cases with absolute, borderline or functional iron deficiency and believed that i.v. iron could decrease the required dose of, as well as improve the hematocrit response, to rHuEPO. Furthermore, they believed that iron dextran caused more hypersensitivity and agreed to the aggressive administration of iron during the induction phase of rHuEPO therapy. They were more inclined to use iron saccharate as the i.v. iron preparation, in comparison to those who did not have a protocol for i.v. iron administration.
[Table - 4] shows the comparison according to the usage of the tests that evaluate iron stores during i.v. iron supplementation. Those who had all, or some of, the tests available to evaluate iron stores had significantly higher percentage of administration of iron through oral or i.v. routes, guided by laboratory tests. They also had a protocol for i.v. iron supplementation during r-HuEPO therapy and would initiate i.v. iron therefore in case of absolute, borderline or functional iron deficiency. Furthermore, individuals who had access to tests to assess iron stores had significantly greater inclination to use iron saccharate than those who did not have access to such tests.
[Table - 5] shows the comparison according to the availability of i.v. iron preparations. The respondents for whom these were available had a higher inclination to administer iron through oral or i.v. routes and had adopted a protocol for i.v. iron supplementation. They would initiate i.v. iron in case of absolute, borderline or functional iron deficiency and believed that i.v. iron supplementation could decrease the dose of r-HuEPO as well as improve the hematocrit response. They also believed that iron dextran caused higher hypersensitivity than iron saccharate.
| Discussion|| |
The current study attempted to detect the attitudes of physicians in-charge of hemodialysis centers in Saudi Arabia towards iron supplementation in chronic hemodialysis patients during replacement therapy with rHuEPO.
The results of this study are compatible with the general practice guidelines in the USA and Europe which are as under:
- Iron supplement can be given during both the induction and maintenance phases of erythropoietin therapy. ,
- Iron supplement can be given as either oral or i.v. routes and not exclusively oral route. ,
- Due to its safety, oral iron can be given to all patients on r-HuEPO therapy and lab investigations are required in order to evaluate the necessity for i.v. iron. 
- A protocol is essential for administration of i.v. iron in dialysis patients guided by laboratory tests. ,,
- Availability of ferritin, serum iron and iron binding capacity (transferrin saturation ratio) is essential to evaluate the iron stores. ,
- Hypochromic ratio of the red cells needs special equipment and is not available in most hospitals. Thus it is still not part of the current lab battery for the evaluation of iron stores in patients who need i.v. iron supplementation. ,
- The patients with absolute iron deficiency (ferritin < 100 ng/ml and transferrin saturation (TS) ratio < 20%) , as well as those with functional iron deficiency (ferritin > 100 ng/ml and TS ratio < 20%) or borderline deficiency (ferritin < 100 ng/ml and TS ratio > 20%) are candidates for i.v. iron supplementation.  Patients with ferritin > 100 ng/ml and TS ratio > 20% may not need iron supplementation during the induction phase of erythropoietin replacement therapy. ,,,
- i.v. iron adjuvant therapy can decrease the required dose of erythropoietin and increase the response to it in terms of the achieved hematocrit in the treated patients. ,,
- Although both iron dextran ,,, and iron saccharate are available there is increased interest in i.v. iron saccharate due to the lesser incidence of hypersensitivity reactions than iron dextran although iron saccharate is marginally more expensive. ,,
- There is consensus on aggressive administration of i.v. iron during the induction phase of the erythropoietin replacement therapy ,,,,, and to use laboratory tests that evaluate the iron stores to guide the administration of iron supplementation during the maintenance phase of the erythropoietin therapy.
The majority of respondents in our study concurred to the importance of iron supplementation guided by laboratory tests both during the induction and maintenance phases of r-HuEPO therapy. They would use serum ferritin, iron and iron binding capacity frequently (every 1-3 months). Furthermore, they would initiate i.v. iron supplementation in patients with absolute iron deficiency, but would not do so in patients with elevated serum iron ferritin > 100 ng/ml and TS > 20%, during the induction phase of r-HuEPO therapy. They also believed that i.v. iron decreases the dose required of r-HuEPO, to achieve the target hemoglobin level. They would discontinue the i.v. iron supplements in patients with elevated ferritin (> 300 ng/ml) and TS (> 30%) during the maintenance phase of r-HuEPO. The majority of the respondents preferred iron saccharate to iron dextran and would administer i.v. iron, where indicated, aggressively during the induction phase of r-HuEPO and continue the drug during the maintenance phase of the EPO therapy guided by lab results.
On the other hand, some responses reflect uncertainty about some important aspects of i.v. iron supplementation as addressed by the American and European guidelines. Almost half of the respondents did not have protocols for i.v. iron therapy in their centers. Despite the use of serum ferritin, serum iron and iron binding capacity for evaluation of iron stores, the respondents were split, rather evenly, about using the transferrin saturation ratio (serum iron/ iron binding capacity) and only a small percentage claimed using the hypochromic red cell ratio.
The response rate to the question related to interpretation of the lab data was low (around 50%), which reflects decreased awareness of the respondents. Less than half of the respondents said they would initiate i.v. iron supplements in case of functional or borderline iron deficiency. Moreover, there was high lack of awareness on the availability of more than one i.v. iron preparation in the formulary of the medical centers in Saudi Arabia. Also, less than 40% of the respondents had any idea about the properties or cost of these preparations.
The comparisons in our study showed important observations. The great majority of the dialysis centers in Saudi Arabia which belong to the Ministry of Health, lagged behind the centers of the other health sectors. They had less availability of the tests to evaluate iron stores and the staff were less aware of the importance of the iron supplementation (interpretation of the tests, the use of protocols, and aggressiveness of the treatment with IV iron supplementation). The presence of a protocol and the availability of iron preparations in a center imposed a significant positive impact on the practice of i.v. iron supplementation.
We conclude that the current practices concerning iron supplementation during rHuEPO therapy in the dialysis centers in Saudi Arabia require refinement. There is a need to enforce the use of a protocol to guide i.v. iron supplementation in each dialysis unit. There is also a need to increase awareness among the physicians to the importance of treatment of functional and borderline iron deficiency with a more aggressive approach.
| Acknowledgement|| |
We thank the Saudi pharmaceutical industries & medical appliances corporation (SPIMACO) for their grant that made this study possible.
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Muhammad Ziad Souqiyyeh
Saudi Center for Organ Transplantation, P.O. Box 27049, Riyadh 11417
[Table - 1], [Table - 2], [Table - 3], [Table - 4], [Table - 5]