Received: ; Accepted: HOME PARENTERAL NUTRITION IN STERILE PRODUCTS. SenthilKumar Krishnan *, D. R.Nagesh

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1 International Journal of Universal Pharmacy and Bio Sciences 1(2): November-December2012 INTERNATIONAL JOURNAL OF UNIVERSAL PHARMACY AND BIO SCIENCES Pharmaceutical Sciences Review Article!!! Received: ; Accepted: HOME PARENTERAL NUTRITION IN STERILE PRODUCTS SenthilKumar Krishnan *, D. R.Nagesh Department of Pharmaceutics, Sri Adhichunchanagiri College of Pharmacy, B.G. Nagara, Mandya District, Karnataka, India. Pin KEYWORDS: Intravenous mixtures, Sterile compounding, Home Parenteral Nutrition. For Correspondence: SenthilKumar Krishnan * Address: Department of Pharmaceutics, Sri Adhichunchanagiri College of Pharmacy, B.G. Nagara, Mandya District, Karnataka, India. Pin Mb No ABSTRACT Professional personnel in the pharmaceutical industry may have little awareness of the pharmacist responsibilities concerning sterile dosage forms in the hospital. It is also for hospital pharmacists as an aid in the design of quality services and in the evaluation of program or operational performance. With the practice of hospital pharmacy and have seen ways to apply their knowledge and experience to the hospital setting. Institutional markets use virtually every commercially available sterile dosage forms. The scope of the inventory and usage rates varies among individual facilities, intensity of care and formulary policies. 59 Full Text Available On

2 1. INTRODUCTION : About 40% o all the drugs administrated in the hospitals are given in the form of injections and their use is increasing. Part of this increase in parenteral therapy is due to the wider use of intravenous (IV) fluids. The IV fluids continues to remain as means of fluid replacement, electrolyte balance restoration and supplementary nutrition and they also used as the vehicles for vary finding greater use as the means of administering other drugs because of convenience, the means to reducing the irritation potential of drugs and the desirability for continues and intermittent drug therapy. The use of IV fluids for this purpose requires the compounding of specific IV admixtures to meet the clinical needs of the given patient. The combination of drug substances in an IV Fluid can promote parenteral incompatibilities and give rise to conditions not favorable for drug stability. So a new area of specialization has been created for the hospital pharmacist who can develop the expertise to prepare this solutions- recognizing their compatibility and stability profiles and the potential for contamination- and also participate n the administration of the solutions. When one or more sterile products are added to IV fluids, the resulting combination for administration known as IV admixture or IV additives. The U.S.P permits the addition of suitable substance to the official preparations intended for injection for the purpose of increasing their stability or usefulness, provide the substances are not interdicted in the individual monographs and harmless in the amount administrated and do not interfere with the therapeutic efficacy of the preparation or with specified assays and tests. Many of the added substances are antibacterial preservatives, buffers, solubiliser, anti oxidants and other pharmaceutical adjuvant. Agents employed solely for coloring effects are strictly prohibited in parenteral products. The U.S.P also requires that one or more suitable substance be added to parenteral products that are packaged in multiple dose containers, to prevent the growth of micro organisms regardless of the method of sterilization employed, unless otherwise detected in the in the individual monograph or unless the injections active ingredients themselves as bacteriostatic so such substances can be used in concentrations that prevent the growth or kill of microorganisms in the preparation. Because many of the usual preservatives agents are toxic when given in toxic amount or is irritating when parenterally administered and special care must be taken in the selection of appropriate preservative agents. The maximum limits for some of the preservatives are; 60 Full Text Available On

3 For agents containing necessary and the cationic surface active compound 0.01%. For agents like chlorobutanol, cresol, and phenol 0.5% For sulphur dioxide as an anti oxidant 0.2%. In addition to the stabling affects of additives the air with in an Injectable product is frequently replaced with an inert gas such as nitrogen, to enhance the stability of the product by preventing chemical reaction between the oxygen in the air and the drug. Chelating agents: It may be added, to bind in non ionisible form, trace amounts of heavy metals, which if free, would catalyzes degrdative changes. The agent most commonly used is disodium or calcium disodium salt of EDTA in a concentration of 0.05%. An example of this chelating agent is the stabilization of thimersol in poliomyelitis vaccine. Thimersol is a present as a bacteriostatic agent but its unstable in presence of cupric ions, the breakdown product of which destroy the antigenicity of the vaccine. The chelating agent stabilizes the thimersol and thereby stabiles the vaccine. The heavy metals extracted from rubber closures also may be bound by the presence of a chelating agent, reducing the possibility of reactions with the ingredients in the formulation. Sometimes complexion occurs between an added ingredient and a macromolecule in the formulation. The methyl and propyl esters of p- hydroxybenzoic acid have been found to complex with polysorbate so with a corresponding decrease in the antibacterial activity. Their effectiveness can be regained by the non ionic surfactant. The additives are the injections packed in the ampoules, vials, or sterile solutions and the latter is reconstituted with suitable diluents before addition of to the IV fluid. All transferring and admixture preparations should be done aseptically. Certain injections are light sensitive and are protected against photolysis by the container packaging and in case of drug substances having poor stability in aqueous solutions, the drug is packaged as a sterile solid either dry filled or lyophilized. In order to increase the efficacy of i.v admixture programmes, a number of hospital pharmacist have found it convenient to freeze the reconstituted drugs, particularly antibiotics. In cases where published information is available, close adherence must be observed as to freezing temperature, storage conditions and packaging. When one or more additives are combined with an IV fluid, their presence together may modify the inherent characteristics of the drug substance present: resulting in a parenteral incompatibility. 61 Full Text Available On

4 Risk Levels and Associated Risks in Sterile Compounding Risk Level Risks Low Risk product is compounded with commercially available components compounding involves few aseptic manipulations "closed system" transfers are used High Risk, Category I prepared from commercially prepared compounds closed system pooling of sterile drug products complex, numerous manipulations over a long period of time multiday infusion via a portable pump or reservoir High Risk, Category II prepared from non sterile drug substance "open systems" Comparison of USP Section <1206> and ASHP Technical Assistance Bulletin Categories USP Section <1206> Low Risk Category Sterile drug products transferred from vials or ampoules into sterile final containers with syringe and needle. Sterile drug products transferred into sterile elastomeric infusion containers with aid of mechanical pump and appropriate sterile transfer device, with or without subsequent addition of sterile drug products with sterile syringe and needle Sterile nutritional solutions combining dextrose injection and amino acid injection via gravity transfer into sterile empty containers, with or without addition of sterile drugs to final container with sterile syringe and needle. High Risk Category I Sterile nutritional solutions compounded with automated compounder, involving repeated attachment of fluid containers to proximal openings of compounder tubing set and of empty final containers to distal opening. Additive transfers into filled final container from individual drug products containers or from pooled additive solution Ambulatory pump reservoirs prepared by adding more than one drug product, with evacuation of air from reservoir prior to dispensing Ambulatory pump reservoirs prepared for multiday (ambient temperature) administration High Risk Category II Injectable morphine solutions prepared from non-sterile morphine substance and suitable vehicles. Sterile nutritional solutions prepared from non-sterile ingredients, with initial mixing in non-sealed or nonsterile reservoir ASHP Technical Assistance Bulletin Risk Level I Single patient admixtures Single patient ophthalmic with preservatives Single patient syringes without preservatives used in 28 hours Batch prefilled syringes with preservatives Risk Level 2 TPNs for administration after 7 days Injections for use in portable pump or reservoir Batch reconstituted antibiotics without preservatives Batch prefilled syringes without preservatives Risk Level 3 Alum bladder irrigations Morphine injections made from powder or tablets TPNs made from dry amino acids 62 Full Text Available On

5 IV Additive Program: International Standard Serial Number (ISSN): It consist of polices and procedures for both the preparation and administration of intravenous fluids to which drugs are to be added under specific conditions, on around the clock basis, and controlled as to location and person preparing the product. IV Additive Services: It refers only to the preparation of the product by individuals who may not necessarily be the same as those who will administer them and assume the responsibility for monitoring of its clinical effect. The conclusion is arrived is that an additive service is a part of an IV additive programmes. Though the implementation of an IV additive service, the hospital pharmacist might be expected to achieve the following objectives: The preparation of final product is accomplished under aseptic conditions. Drug interactions are avoided through judicious choice of additive and mixing technique. The final product is appropriately labeled, dispensed, stored. The preparations IV solutions with their additives were a task performed by nurses or interns or residents. The concept that these products requires the skills of the pharmacist has raised many other questions not the least of which is availability of the product at odd hours particularly if the site of preparation is moved to the main pharmacy. Thus has evolved the satellite pharmacy, staffed by a clinical pharmacist and pharmacy technicians/. On final analysis, it is relevant where the additives re added so long as definite polices are formulated which spell out the responsibilities. In addition, it is imperative that the pharmacist become involved in the preparation of these products in an environment conductive to the efficient and safe preparation of them. Preparation of IV additive solutions: In the preparation of these solutions, the pharmacist should work from the physicians original sheet or from a direct copy. Upon receipt order label must be prepared which involves the following information: Patient identification Patient location Physician s name Name of the drug and quantities added Date of compounding Expiry date Identification of pharmacist preparing the product 63 Full Text Available On

6 If necessary any auxiliary labeling should also be prepared at this time. When Appling label to the container, it must be positioned in an upside down order to facilitate the reading when container is hung from iv solution pole on the patient bed. Preparations of the solution always take place under laminar flow hood using sterile needles and syringes. Once transfer is made, the metal disc must be replaced and a new seal crimped on to the container. As a safety device, a different colored seal should be used in view of the fact that it warns individuals that drugs have been added. Before permitting the admixture sent to ward pharmacist must carry out a final inspection of the product. The inspection should include a review of label, clarity of solution, and mathematics involved in the preparation. ASHP guide lines for pharmacist participation in home Parenteral nutrition programmes: Home Parenteral Nutrition (HPN) programs have been developed to meet the needs of the patients who require prolonged or lifelong IV feeding. In many hospitals, pharmacist has assisted in the solution preparation and supply; in patients training in solution preparation, infusion technique, and catheter care and in monitoring the side effects of HPN. Certain constitutional, personal and the patient resources needs are necessary to provide services to patents safety. The following guide lines will assist pharmacist in deciding whether they should develop an HPN program. INSTITUTIONAL QUALIFICATION The hospitals should have an IV admixture program. Because in an around the clock, long term form of the therapy, the institution must able to provide for a 24 hour service. The institution must be able to respond to HPN related concerns, such as catheter and pump repair, fluid and electrolyte imbalance, sepsis and support of the patients underlying disease. Reimbursement arrangements for supplies and services should be established. The institution must have criteria by which patients can be selected for HPN. Criteria should embrace patients learning ability, physical capability, family support, medical condition and prognosis. 64 Full Text Available On

7 PERSONAL QUALIFICATIONS The pharmacist should have understanding of parenteral feeding therapy, including a knowledge of acid base balance, fluid and electrolyte therapy, metabolic and mechanical complications, total parenteral nutrition delivery systems, catheter care and management, and drug nutrient and drug laboratory interactions. PERSONAL QUALIFICATIONS The pharmacist should have understanding of parenteral feeding therapy, including a knowledge of acid base balance, fluid and electrolyte therapy, metabolic and mechanical complications, total parenteral nutrition delivery systems, catheter care and management, and drug nutrient and drug laboratory interactions. Good aseptic technique and experience in preparing IV admixture is essential. A sufficient understanding of infectious disease is needed to differentiate HPN related sepsis from underlying disease or drug reaction. The pharmacist must also be aware of current standards recommendations on sterile admixtures and quality assurance. The pharmacist should be knowledgeable in the unique aspects of HPN, such as chronic infections, nutrient requirements, and effects of parenteral nutrition. A caring, patient oriented attitude and good teaching skills are important in teaching HPN techniques to patients. Other personnel such as physicians, nurses, dieticians and medical social workers are important in assuring success with a patient on HPN. RESOURCE REQUIREMENT Substantial personal and equipment are needed for HPN programs. Tough the time will vary; available information indicates that 7-44hrs are the time requires training the patient. Staff must be available on 24 hr basis to answer questions for inpatients and out patients. Teaching procedures may extend from early morning to late evening so as to involve both patient and families. Therefore, involvement of more than one pharmacist may be required.the following types of equipment are required for HPN programs. Infusion devices HPN base solutions. Drug additives. Needles, syringe, and alcohol wipes Dressing change kits IV sets, cassettes, and filters IV pole, Catheter accessories. 65 Full Text Available On

8 DISCUSSION: Knowledge of alternative sources of HPN drugs and supplies is important. Procedures for dealing with emergency shortage must be established. Pharmacist must take their own decisions as to whether they elect to participate in HPN programs. They need to determine the financial, social and professional impact of an HPN program upon their institution. They need to consider the availability of these services from other hospitals or through private providers of home health care. These guidelines are intended to help pharmacist make these decisions. REFERENCES: 1. Merchant S.H. and Quandrys J. S. ( ), Manufacture of pharmaceutical preparations; the text book of hospital pharmacy, 6 edition, page no: William. E, Hassen. J.R.; Manufacturing of bulk and sterile; In Hospital pharmacy; 5 edition; 1986; page no: Remington: The science and practice of pharmacy. Page no: Guidance for nurses and midwives in practice development units who are involved in the education of staff in the preparation and administration of injections in nearpatient areas. August 2007 Review Date August Full Text Available On