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ASSESSMENT OF INTRAVENOUS ADMIXTURES IN A HOSPITALISED PATIENT OF A RURAL TERTIARY CARE TEACHING HOSPITAL SYNOPSIS FOR M.PHARM DISSERTATION SUBMITTED TO RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BY HYMAVATHI. R B. Pharm UNDER THE GUIDANCE OF K.V. RAMANATH M.Pharm, MBA (HRM &HSM), PhD DEPARTMENT OF PHARMACY PRACTICE SAC COLLEGE OF PHARMACY BG NAGARA RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERATION 1 Name of the candidate & Address Ms. HYMAVATHI. R DEPARTMENT OF PHARMACY PRACTICE, SAC COLLEGE OF PHARMACY, BG NAGARA, NAGAMANGALA-TALUK, MANDYA-DIST, KARNATAKA-571448. PERMANENT ADDRESS: D/O R. CHANDRA MOHAN REDDY D.NO-3/1149,NEAR DCC BANK, Y.M.R COLONY,PRODDATUR, DIST-KADAPA, ANDHRA PRADESH-516360. 2 Name of the institute SAC COLLEGE OF PHARMACY BG NAGARA, NAGAMANGALA TALUK, MANDYA DISTRICT, KARNATAKA -571448 3 Course of the study MASTER OF PHARMACY IN PHARMACY PRACTICE 4 Date of admission 21/ 05/2010 5 Title of the topic ASSESSMENT OF INTRAVENOUS ADMIXTURES IN A HOSPITALISED PATIENT OF A RURAL TERTIARY CARE TEACHING HOSPITAL 6. 6. Need for the study: Intravenous Admixtures are the preparations consisting of one or more sterile drug products added to an intravenous fluid. Generally dextrose or sodium chloride solution alone or in combination can be used as intravenous fluid. Intravenous admixtures are used for drugs intended for continuous infusions. Drugs that may cause irritation or toxicity when given as rapid direct intravenous injections are also prepared as intravenous admixtures. Intravenous Incompatibilities occur when two are more drugs are administered through a single intravenous line or given in a single solution, resulting in an undesirable reaction. A patient who receives a preparation in which an incompatibility has occurred could experience toxicity or an incomplete therapeutic effect.1 There are three types of incompatibilities 1. Physical incompatibility. 2. Chemical incompatibility. 3. Therapeutic incompatibility.2 Intravenous therapy is a complex health care technology. In general, nurses prepare and administer intravenous drugs prescribed by doctors. Nursing staff doesn’t have enough knowledge regarding the compatibilities of intravenous drugs in infusions, leading to physical or chemical or therapeutic incompatibility of drugs. Sometimes this will result in severe adverse drug reactions in patients.3 Incompatibilities between infused drugs frequently occur in the hospitals. The Intensive Care Units (ICU) are particularly concerned since patients in these units are often subjected to treatment which includes numerous drugs. The complexity of pharmacotherapy, the particular dilution of drugs for intensive care as well as stress inherent units all will increase the probability of mistakes during intravenous admixtures. Availability of incompatibility charts on the wards and specific training on drug incompatibilities for nursing staff will certainly increase the security in the use of intravenous drugs.4 Implementing a system with more active involvement of hospital pharmacists or clinical pharmacists in this type of activities can lessen the errors during intravenous admixtures and thus enhance the patient safety to a substantial degree.5 Adichunchanagiri Hospital and Research Center (AHRC) is a 750-bedded tertiary care teaching hospital situated in a rural area of BG Nagara, Nagamangala taluk. There were no studies conducted previously in this rural hospital regarding assessment of intravenous admixtures in a hospitalised patient. Such a study could provide valuable information to the physicians and nursing staff regarding the safe usage of intravenous admixtures. With this aim the present study is taken to assess the intravenous admixtures in a hospitalized patient of a rural tertiary care teaching hospital. 6.2 Review of Literature: A study was conducted by Taxis K and Barber N on “Incidence and Severity of Intravenous Drug Errors in a German hospital”. The main objective of the study was to determine the incidence of errors in preparing and administering intravenous drugs and to identify the stages in the process at which errors occurred. This was a prospective ethnographic study carried out on two wards in one German Non-University Hospital. They observed 122 intravenous drug preparations and administrations. One or more errors occurred in the preparation and administration of 58 of 122 intravenous drug doses. In total 65 errors were identified. Four have potentially severe errors (3%), 38 (31%) potentially moderate errors and 16 (13%) potentially minor errors. Common errors included multiple step preparations and co-administration of potentially incompatible drugs as intermittent infusions. The study concluded that introduction of ward-based clinical pharmacy services, reduced the severity of intravenous drug errors.3 Gikic M, Di Paolo ER, Pannatier A et al. conducted a study on “Evaluation of Physicochemical Incompatibilities during Parenteral Drug Administration in a Paediatric Intensive Care Unit (PICU)”, in the 8-bedded PICU at University Hospital in Lausanne (Switzerland). The data was collected by a pharmacist over a period of 30-days. The study was a prospective study. The objective of this study was to identify the combinations of injectable drugs administered in the PICU of the hospital and to analyse them according to the information found in the literature. The methodology adopted was prospective method. In this study, 68.7% of drug combinations were observed and analysed. Among the 175 drugdrug/drug-solute combinations, 86.3% were compatible, 3.4% incompatible and 10.3% undocumented. In this study no clinical consequences resulting from drug incompatibilities were found. Specific training on drug incompatibilities for nurses increased the security in the use of injectable drugs in PICU.4 A study was conducted by Fahimi F, Sistanizad M, Abrishami R et al. on “An Observational Study of Errors Related to the Preparation and Administration of Medications given by Infusion Devices in a Teaching Hospital”. This study was designed to evaluate the medication errors associated with infusion pumps in intensive care unit (ICU). The study was a prospective, observational study. Forty three doses were observed. Twenty (7.8%) errors were detected, of which 14 (20%) were incorrect doses, 4 (20%) were labeling errors, 2 (10%) were unauthorized medication. This study concluded that usage of infusion pumps for drug delivery resulted in a number of errors.5 Valia HD, Pierre V, Laurent G et al. conducted a study on “Evaluation of Intravenous Drugs Compatibilities in an Adult ICU”. The main objective of the study was to evaluate whether if patients intravenous medications were administered according to known compatibility data. The study was a prospective study. The study was conducted for 72 days in an adult ICU of a 34 bedded university hospital in Switzerland. They assessed drug-drug/drug-solute combinations. Among the 6583 pairs recorded during the three months, 4242 pairs were analysed based on literature data and laboratory test. Among these 71.6% were considered compatible and 1.1% incompatible, 27.3% were undocumented. Teaching was done to the nursing staff regarding intravenous drug compatibilities, which reduced the incompatibility risks.6 A study was conducted by Serrurier C, Chenot ED, Vigneron J et al. on the “Assessment of Injectable Drugs’ Administration in a two Intensive Care Units and Determination of Potential Physicochemical Incompatibilities”. The study was done by prospective method for two months with an objective of determining potential physicochemical incompatibilities. They have observed 32 patients. Among 242 intravenous admixtures observed, 55 (23%) were physically compatible, 12 (5%) physically incompatible, 5 (2%) with conflict between two literature references and 170 (70%) without any data about stability or compatibility. They also made nurses and physicians aware of compatibility problems to minimize as low as possible.7 Bertsche T, Mayer Y, Stahl R et al. conducted a study on “Prevention of Intravenous Drug Incompatibilities in an Intensive Care Unit (ICU), in University of Heidelberg in 12 bedded ICU in a 1680 bed Teaching Hospital”. The aim of the study was to reduce the frequency of incompatibility errors during intravenous drug administration. They adopted both retrospective and prospective method. In retrospective analysis of 100 patients, 3617 brands of drug pairs were potentially given concurrently through one intravenous line and 7.2% of the drug pairs were incompatible. In the prospective study of 50 patients, the frequency of incompatible drug pairs was reduced by the time of intervention from 5.8% to 2.4%. This study concluded that the administration of incompatible intravenous drugs in critically ill patients was frequent but significantly reduced by procedural intervention with standard operating procedures.8 A study was conducted by Tissot E, Cornette C, Limat S et al. on “Observational Study of Potential Risk Factors of Medication Administration Errors”. The aim of the study was to assess the rate and the potential clinical significance of medication administration errors and to determine the associated risk factors. This was a prospective observational-based study carried out for two months in two units of the 1243 bed University Hospital of Besancon (France). The medication administration error rate was 14.9%, dose errors were the most frequent (41%) errors, followed by wrong time errors (26%), wrong rate errors (19%). According to these data, the quality of medication administration process needs to be optimized in hospitals in order to minimize medication administration errors.9 6.3 OBJECTIVES OF THE STUDY: Primary objective: To assess the intravenous admixtures in hospitalized patients. Secondary objectives: 1. To understand the intravenous admixtures used in the hospitalized patients. 2. To determine combinations. compatibility, incompatibility and undocumented drug 3. To determine the incidence and clinical consequences of intravenous admixtures. 4. To provide guidelines for nursing staff and physicians regarding the compatibilities of intravenous drug admixtures. 5. To assist the nursing staff in the preparation of intravenous admixtures. 7 MATERIALS AND METHODS: 7.1 Study design: The study is an observational based prospective study. 7.2 Source of data and Materials: Compatibility Charts. Drug Information Brochure. Patient Data Collection Forms. Patient’s Case Records. Compatibility Charts: These charts will be developed and used for assessing the most commonly used intravenous drug admixtures and to outline the potential for incompatibilities when these drugs are infused concurrently. Drug Information Brochure : This brochure will be used to write on specific drugs to provide information regarding preparation, dilution, stability and administration of intravenous drugs. Patient Data Collection Form : The following information will be collected like 1. Patient (name, age, reason for hospitalization) 2. Drugs and solutes (brand name, dose, dilution) 3. Drug administration (rate) 7.3 Inclusion Criteria: Patients receiving one or more drugs simultaneously through the same intravenous infusion line will be included in the study. Exclusion Criteria: When the drug delivery was interrupted and the infusion line was flushed with 0.9% sodium chloride, such patients will not be taken into the study. Out Patients who will stay for a short time in the hospital will not be included in the study. 7.4 Method of collection of data: This is an observational based prospective study which will be conducted among intravenous drug admixtures inpatients of the hospital. The intravenous drug admixtures patient data will be collected in the Patient Data Collection Form. When a single drug is delivered by infusion, the compatibility of the drug in the infusion solution will be checked and when two or more drugs are used in the same infusion line then drug-drug and drug-solute compatibilities will be checked. This obtained data will be compared with the information available in the literature, i.e., from Incompatibility Charts and by referring standard text books on Intravenous Admixtures. The identified incompatibilities will be documented in a suitable documentation form. Incompatibility charts on intravenous drug admixtures will be made available on each ward as a reference for nursing staff to increase the security in the use of intravenous drugs. Assistance will be given to the nursing staff regarding intravenous admixtures preparation by providing information if there is an incompatibility. This may contribute to prevent unsafe medication practices. 7.5. Does the study require any investigation or interventions to be on patients? conducted Yes 7.6. Has ethical clearance been obtained from your institution in case of above? Ethical committee clearance will be obtained by the Institutional Ethical Committee of Adichunchanagiri Institute of Medical Science (AIMS) before the initiation of the study. 7.7. Duration of the study: The study duration will be approximately 12 months. 7.8. Study site: The study will be conducted at Adichunchanagiri Hospital and Research Center (AHRC), BG Nagara, Nagamangala Tq, Mandya Dist. List of references: 8 1. John F. Sterile Products. In: Shargel L, Souney PK, Mutnick AH, Swanson LN. Comprehensive Pharmacy Review. 7th ed. New Delhi: Wolters Kluwer Pvt Ltd; 2010. p. 566-85. 2. Scott SA. The Prescription. In: Alfonso RG. Remington The Science and Practice of Pharmacy. 20th ed. New York: Lippincott Williams and Wilkins; 2000. p. 1687705. 3. Taxis K, Barber N. Incidence and severity of intravenous drug errors in a German hospital. European Journal of Clinical Pharmacology 2004;59:815-7. 4. Gikic M, Di Paolo ER, Pannatier A, Cotting J. Evaluation of physicochemical incompatibilities during parenteral drug administration in a pediatric intensive care unit. Pharmacy World and Science 2000;22(3):88-91. 5. Fahimi F, Sistanizad M, Abrishami R, Baniasadi. An observational study of errors related to the preparation and administration of medications given by infusion devices in a teaching hospital. Iranian Journal of Pharmaceutical Research 2007; 6(4):295-9. 6. Valia HD, Pierre V, Laurent G, Rene C, Andre P. Evaluation of intravenous drugs compatibilities in an adult ICU. 35th European symposium on Clinical Pharmacy 2006 Oct 21. 7. Serrurier C, Chenot ED, Vigneron J, May I, Demore B. Assessment of injectable drugs administration in two intensive care units and determination of potential physicochemical incompatibilities. The European Journal of Hospital Pharmacy Science 2006;12(5):96-9. 8. Bertsche T, Mayer Y, Stahl R, Hoppe-Tichy T, Encke J, Haefeli WE. Prevention of intravenous drug incompatibilities in an intensive care unit. American Journal of Health System Pharmacy 2008;65(19):1834-40. 9. Tissot E, Cornette C, Limat S, Mourand JL, Becker M, Etievent JP et al. Observational study of potential risk factors of medication administration errors. Pharmacy World Science 2003;25(6):264-8. 9 Signature of the candidate HYMAVATHI. R Remarks of the guide The proposed research work is original and designed on rational basis. It would be a good contribution. 11.1 Name and Designation of Guide K.V. RAMANATH 10 11 ACA/CDC/PGT-M.Ph/SACP/36/2008-09 M. Pharm, MBA (HRM &HSM), PhD. Associate Professor Department of Pharmacy Practice SAC College of Pharmacy BG Nagara, Karnataka -571448 11.2 Signature 11.3 Co-Guide NOT APPLICABLE 11.4 Signature NOT APPLICABLE 11.5 Head of the Department Dr. BJ MAHENDRA KUMAR M. Pharm, PhD. Prof. & H.O.D of Pharmacy Practice SAC College of Pharmacy, BG Nagara -571448. 11.6 Signature 12 12.1 Remarks of the Principal 12.2 Signature