THE PRACTICE OF PARENTERAL NUTRITION IN MALAYSIAN HOSPITALS by RIYADH ABDULLAH OMAR ALBAT ANI Thesis submitted in fulfillment of the requirements for the degree of Doctor of Philosophy June 2008 ACKNOWLEDGEMENTS I am extremely grateful to Dr.Mohd Baidi Bahari (School of pharmaceutical Sciences, Universiti Sains Malaysia) for introducing me to scientific research and helping me establish my overall direction. His advice and constructive criticism have been invaluable in the fruition of this doctoral thesis for maintaining my focus and for his insight guidance in picking up key findings that I may have overlooked. For his kinds of introducing me to the "hands-on" practical work of clinical research and for his help in conducting the studies which formed part of this doctoral thesis, I am thankful to his constant encouragement and support, his warm presence and for consistently reminding me to "Keep smiling". I am also thankful to Pn. Zalila Ali (USM Mathmatic School) for introducing me to new approaches in analysing data, also thanks to Dr.A.F Shammsuddin (Field-supervisor, HUKM Pharmacy Department), Mr. Amrahi Buang (UMMC) and Mr. Dellimin Che Abdullah (HUSM). Thanks to Dr. Mohd Izham Mohd Ibrahim (USM Social and Administrative Pharmacy) for assisting me in statistics. I am l especially appreciative of the Yemen Government and specifically University of Sana' a for granting me this opportunity to gain experience in a foreign country and to broaden my horizons. I have been fortunate to have a large number of friends and colleagues who have had a profound effect on me and on my research. Last, but not least, I would like to dedicate this thesis to my family, especially to my parents for providing me with the essential tools, during my formative years, to pursue and realise my dreams, my brothers Fatima, Sefan and Mohd and my wife Amina for her support and endless patience when I most needed it. They will always remain the guiding light in my life as I look forward to new challenges in the near future. II TABLE OF CONTENTS Acknowledgements 11 Table of contents Ill List of tables xi List of abbrevations XIV Abstrak xvi Abstract xviii Part 1 Survey ofTPN practice in Malaysian hospital 1.1 Introduction and literature review 1.1.1 Background 1.1.2 Practices of PN 3 1.1.3 Problem statement 8 1.1.4 Rationale ofthe study 10 1.1.5 Objectives 11 1.1.6 Justification of the study 12 1.2 Methodology 13 1.2.1 Introduction 13 1.2.2 Parenteral nutrition practice in Malaysian hospitals 13 1.2.3 Study design of survey of evaluation of PN Practice in 14 Malaysian hospital 1.2.4 Determination the sample size 14 1.2.5 Subjects (hospitals) 16 111 1.2.5 (a) Selection of hospitals 16 1.2.5 (b) Inclusion criteria 17 1.2.5 (c) Exclusion criteria 17 1.2.6 Data Analysis 17 1.3 Results and discussion 19 1.3.1 Response rate 19 1.3.2 Classification of hospitals 20 1.3.3 PN services in Malaysian hospital 21 1.3.4 Hospital size 22 1.3.5 Availability of PN services 23 1.3.5 (a) PN services and mean of pharmacist and 23 pharmacist assistant 1.3.5 (b) Mean of preparation per day 24 1.3.6 Type of specialties 25 1.3.7 Type of Clinical Pharmacy services offered 26 1.3.8 Clinical services offered pharmacy department 27 according to type of hospitals. 1.3.9 Year started parenteral nutrition services 28 1.3.1 0 Ward with PN services 29 1.3.11 Places for preparation ofPN 30 1.3.12 Type of services related to PN 31 1.3.12 (a) Individualization 32 1.3.12 (b) Standard formulas 33 1.3.12 (c) Computer program 33 IV 1.3.13 Extent of pharmacist involved in PN 34 1.3.13 (a) PN pharmacist compounding 34 1.3.13 (b) PN monitoring and nutrition support team 35 1.3.14 Quality control of PN compounding 36 1.3.15 The use of commercially available standard product 39 1.3.16 Suggestions of services offered by PN 40 pharmacists 1.3.17 Type of solution used in PN 41 1.4 Summary and conclusion 43 1.4.1 PN Practices in Malaysian Hospital 43 1.4.2 The extend of the PN services 43 1.4.3 The personnel involve in PN services 43 1.4.4 The load of pharmacist 44 1.4.5 The role of pharmacist 44 Part 2 Compare service provided in four hospitals 45 2.1 Introduction and literature review 45 2.1.1 Indication 45 2.1.1.1 Parenteral nutrition in malnutrition 46 2.1.1.2 (a) Parenteral nutrition in premature 47 2.1.1.2 (b) Special considerations in premature nutritional 4 7 supplement 2.1.1.3 Parenteral nutrition in children 48 2.1.1.4 Parenteral nutrition in surgical case 49 2.1.15 Parenteral nutrition in cancer 49 v 2.12 Nutrient and substrate requirments for PN 50 2.12.(a) Protien 51 2.12 (b) Carbohydrate 53 2.12.(c) Fat 54 2.1.2(d) Electrolytes, vitamin and trace elements 55 2.1.2 (e) Energy requirments 57 2.1.2 (f) Fluid requirment 57 2.1.3 1he parenteral nutrition product in Malaysian hospitals 58 2.1.4 Route of parenteral nutrition 59 2.1.5 Outcomes of parenteral nutrition 60 2.1.6 Complication of parenteral nutrition 61 2.1.6 (a) Mechanical 62 2.1.6 (b) Infection 63 2.1.6 (c) Metabolic 65 2.1.7 Monitoring of parenteral nutrition 66 2.1.8 Cost of parenteral nutrition 66 2.1.9 Problem statement 68 2.1.10 Rationale of the study 69 2.1.11 Objectives 70 2.1.12 Scope (contribution) of the study 70 2.1.13 Justification of the study 70 2.2 Methodology 72 2.2.1 Introduction 72 Vl 2.2.2 Development of data collection form 72 2.2.3 The pilot study 73 2.2.3 (a) Data analysis of the pilot study 73 2.2.3 (b) Result of the pilot study 73 2.2.3 (c) Discussion of pilot study 75 2.2.3 (d) Conclusion 76 2.2.4 The cost of solutions 76 2.2.5 Study design of the comparative study 79 2.2.6 Sites of the comparative study 79 2.2.7 Determination of sample size of comparatve study 79 2.2.8 Calculation of power and sample size of HPP 80 2.2.8 (a) Power calculation 80 2.2.8 (b) Calculation of power and sample size ofHUSM 82 2.2.8 (c) Calculation of power and sample size ofHUKM 84 l 2.2.8 (d) Calculation of power and sample size of UMMC 86 2.2.9 Subjects 87 2.2.10 Inclusion criteria 87 2.2.11 Execlusion criteria 88 2.2.12 Data analysis 88 2.2.12 (a) Two way ANOV A 88 2.2.12 (b) Pearson chi square 89 2.3 Results and discussions 91 2.3.1 Introduction 91 2.3.2 Characterstics ofPN patients according to hospital 91 Vll 2.3.3 Diagnosis of PN patients 92 2.3 .4 Reasons of PN patients 93 2.3.5 Diagnosis and reasons. 93 2.3.6 Outcome of PN patients 96 2.3.7 Complications due to PN 97 2.3.8 Type of complications & factors associated with complications 98 2.3.9 The route of PN 106 2.3.1 0 The cost per day 107 2.3.11 The duration ofPN 108 2.3.12 Energy requirements ofPN 109 2.3.13 Volume prepared ofPN 110 2.3.14 Macronutrient requirement 112 2.3.14 (a) Glucose supplement ofPN 112 2.3.14 (b) AA supplement of PN 113 2.3.14 (c) Lipid supplement ofPN 115 2.3.15 Vitamin requirements ofPN 118 2.3.16 Trace elements requirements ofPN 120 2.3.17 Electrolyte requirements of PN 121 2.3.17 (a) Sodium requirement of PN 121 2.3.17 (b) Potassium requirement of PN 123 2.3.17 (c) Magnesium requirement ofPN 125 2.3.17 (d) Calcium requirement ofPN 127 2.3.17 (e) Phosphate requirement ofPN 128 2.3.17 (f) Chloride supplement in PN 130 Vlll 2.3.18 Monitoring of body temperature 132 2.3.19 The monitoring of fluid input and output 133 2.3.20 The monitoring of fluid output in m1 135 2.3.21 The monitoring of fluid balance in ml 136 2.3.22 Monitoring of PC02 137 2.3.23 Monitoring of P02 138 2.3.24 Monitoring of 02 saturation 139 2.3.25 Monitoring of base excess BE 140 2.3.26 Monitoring of WBC 141 2.3.27 Monitoring of HB 143 2.3.28 Monitoring of platelet 144 2.3.29 The monitoring of PT 146 2.3.30 Monitoring of INR 147 2.3.31 Monitoring of APTT 148 2.4 Summary and conclusions 150 2.4.1 The outcomes of PN in four studied hospitals 150 2.4.2 Type of complication of PN patients 150 2.4.3 The cost per day and duration of PN patients 151 Bibliography 152 List of appendices 171 List of publications and seminars 186 IX LIST OF TABLES Page Table l.l.l Total number of government hospitals providing PN 3 Services Table 1.2.2 The total number of government and private hospitals 15 Table 1.2.3 The total number of government and private hospitals 16 Table 1.3.4 The classification ofthe hospitals 20 Table1.3.5 PN services in Malaysian hospital 21 Table 1.3.6 Hospital size in relation to hospital type 23 Table 1.3.7 Availability ofPN services according to class of hospital 23 Table 1.3.8 The specialties type offered by the Malaysian hospital 26 Table 1.3.9 Type of clinical pharmacy services offered pharmacy 27 department Table 1.3.1 0 Clinical pharmacy services offered by pharmacy 28 department according to hospital type Table 1.3.11 Year of PN service started 29 Table 1.3.12 Ward with PN services 30 Table 1.3.13 Places for preparation of PN 31 Table 1.3.14 Parenteral nutrition services offered by pharmacy 34 department Table 1.3.15 Pharmacist involvement in parenteral nutrition services 36 Table 1.3.16 Monitoring of quality control during PN compounding 37 Table 1.3.17 The use of commercially available standard product 40 Table 1.3.18 Type of recommendation by pharmacist 40 X