Parenteral Admixture And Incompatibility: Parenteral Admixture And Incompatibility RATUL DEB, M.Pharm 2 nd sem (Pharmaceutics) : 2 Intravenous Admixture System: Intravenous Admixture System “Admixture system” refers to sterile IV solutions that are prepared by using one or more medications or electrolytes and will be administered via the parenteral route. It requires the measured addition of a medication to a 50 ml or larger bag or bottle of IV fluid. It can be provided to the patient in his/her home. Many hospitals involved in compounding IV solutions and medications to outpatient settings. 3 Intravenous Admixture System: Intravenous Admixture System Pharmacists are regarded as “ parenteral therapy expert”. Because they are expected to know how to compound parenteral solutions to meet a patient’s clinical needs. They are also involved in monitoring and administration of parenteral admixtures. The Joint Commission (JCAHO) Standard MM.4.20, EP 1 states: “When an on-site, licensed pharmacy is available, only the pharmacy compounds or admixes all sterile medications, IV admixtures, or other drugs except in emergencies.” 4 PowerPoint Presentation: 5 Pharmacist’s Roles in Admixture Preparations Intravenous Admixture System: Role of physician: A physician shall be responsible for ordering intravenous admixtures. Role of nursing stuff: The nursing unit shall be responsible for pulling a copy of all physician orders and scheduling of needed solutions. Nursing personnel shall be responsible for abiding by the labeled directions and precautions as noted on admixture. 6 Intravenous Admixture System In an emergency/urgent situation , an RN or RN Applicant may prepare IV admixtures. Rationale behind starting admixture program: Rationale behind starting admixture program Started with preparation of solutions not available commercially. 1971 FDA along with the USP established the National Coordinating Committee on Large Volume Parenteral (NCCLVP) to identify problems associated with large Volume Parenteral in hospitals (LVPs) . They developed procedures to be used by hospital personnel for preparing and administering LVPs It is no longer exist. 7 Rationale behind starting admixture program: Rationale behind starting admixture program However, they had set some important standards of practice which are still used today: Recommended methods for compounding IV admixtures in hospitals Established a system for the surveillance and reporting of problems with LVP’s in hospitals Proposed test methods for particulate matter in LVP’s Set forth recommendations for labeling of LVP’s and Recommended procedure for in use testing of LVP’s suspected of contamination or of producing a reaction in a patient. 8 Responsibilities of Pharmacist : Responsibilities of Pharmacist Contamination The pharmacy must maintain a clean area out of the direct flow of traffic with a vertical or horizontal laminar air flow hood to prepare IV admixtures. compatibility A pharmacist should be able to deal with problems of physical, chemical, and therapeutic incompatibilities , to design suitable alternatives when these problem arise. 9 Responsibilities of Pharmacist : 10 Stability Drug stability information must be readily accessible to the pharmacist in order to determine optimum conditions for drug storage prior and after preparation, The stability of a drug at ideal storage conditions will help to establish a reasonable expiration date for the product, Product sterility, overall integrity also inspected. Responsibilities of Pharmacist PowerPoint Presentation: Errors reduction Reduced in a pharmacy based admixture program. It has been less likely for the pharmacist to make errors in pharmaceutical calculation than the other health professionals. The use of standardized dosing charts, including pre-calculated drug doses and dilutions contained in admixture area reduce the chance of error significantly. 11 Advantages of Admixture Prepared by Pharmacists PowerPoint Presentation: 12 Quality Proper polices for inspecting solutions prior to and after preparation are an integral part of pharmacy based programs. Policies can be enforced more efficiently in centralized and decentralized pharmacy directed admixture programs Advantages of Admixture Prepared by Pharmacists Advantages of Admixture Prepared by Pharmacists: Safety Pharmacy based programs safety is enhanced The JCAHO refers the director of pharmacy services responsible for “preparing, sterilizing and labeling parenteral medications and solutions that are manufactured in hospitals” “the compounding and admixture of large volume parenterals is ordinarily the responsibility of a qualified pharmacist”- JCAHO 13 Advantages of Admixture Prepared by Pharmacists Advantages of Admixture Prepared by Pharmacists: 14 Cost Preparation in the pharmacy is more economically than individual nurses on a patient unit. The overall cost of drug, diluents procurement, storage, preparation time, and waste is less in pharmacy based admixture program. Nursing time associated with administration to patients is minimized. Advantages of Admixture Prepared by Pharmacists Admixture Pharmacy System Process: Admixture Pharmacy System Process 15 “Read the label three times” Components of IV Admixture system: Components of IV Admixture system 16 Preparation area: Preparation area Ideally a separate room in pharmacy. Size may vary. Requirements of room: Washable floor covered with vinyl or epoxy coating, Hand-washing facility, Refrigerator Preparation Tools Adequate Light Restricted Area Adequate Counter Space 17 Policies and Procedures: Policies and Procedures Guidelines for preparing parenteral products should be outlines in the pharmacy’s policy and procedure manual. Detailed information regarding preparation, labeling, storage and expiration dating of parenteral products should be readily available in the pharmacy. These policy help to provide quality control for the parenteral products. Stability stability is affected by place, environmental condition, diluents used and other drugs. 18 PowerPoint Presentation: Aseptic Technique It refers to the ability of personnel who prepare these IV solutions to handle these products in the clean environment of a laminar or vertical air flow hood without introducing viable microorganisms into the product. Quality assurance System to check aseptic environments and the pharmacist’s access to both patient’s profile and final product must be ensured; to provide more stringent quality control over parenteral therapy. Routine inspection of all laminar air flow hoods must be performed. 19 Policies and Procedures Policies and Procedures: IV profiling Review preparation against patient’s current profile. Labeling Labels should reflect the information provided in the prescription. Should include- patient’s name, ID no., room number, name and amount of drug added, name & volume of admixture solution, Approximate final total volume of the admixture, Prescribed flow rate, Date and time of preparation, Date and time of scheduled administration, Expiration date. 20 Policies and Procedures Policies and Procedures: Auxiliary label Required to avoid fatal errors. These include- “Note dosage strength” (for conc. solutions). “Protect from light”, “Do not refrigerate”, “Caution: chemotherapeutic agent” “For epidural use only.” 21 Policies and Procedures Personnel : Personnel Proper training in aseptic technique and sterile product information is necessary. Training courses, self study programs can be organised for this purpose. Training can be of varying levels (regular, intense or module based). Job description for each of the personnel should be well defined (who will do what?) 22 Storage area Will depend on the type of system one chooses to use. There should be proper refrigeration facility available. IV room requirement: IV room requirement Laminar air flow: HEPA filtration (vertical or horizontal), Checked in every 6 months. Refrigerator: For slowing down microbial growth. Reference: Handbook of injectable drugs Compatibility and compounding charts. 23 Steps Involved for Starting an IV Admixture Program: 24 Steps Involved for Starting an IV Admixture Program Incompatibilities in parenteral admixtures: Incompatibilities in parenteral admixtures A safe admixture is one that is free from micro-organisms, free from particulate matter, undecomposed and clinically compatible. Intravenous admixture incompatibilities are the undesirable reactions that can occur when two or more drugs are be administered through single IV line or given in a single solution. It is reported that an average of 18 – 20% of hospitalized patients suffer from adverse drug reactions (in USA). 25 Factors causing incompatibility: Factors causing incompatibility 26 Type Intervention Difference in pH Refer to drug incompatibility tables. High Temperature Refrigerate the IV admixture if not used within 1 hour after mixing. Order of Mixing Alternate the order Length of Time in Solution The IV drug should be mixed and discarded if not used within 24 hours. General Ways Of Prevention/ Minimization Of Incompatibilities: General Ways Of Prevention/ Minimization Of Incompatibilities 27 Mix thoroughly when a drug is added to the preparation Minimize the number of drugs mixed together in an IV solution. Solutions should be administered promptly after mixing so that occurrence potential reactions can be minimized. Always refer to compatibility references. Types : Types Physical Incompatibilities Chemical Incompatibilities Therapeutic Incompatibilities Drug -IV Container Incompatibilities 28 Physical Incompatibility: Physical Incompatibility The incompatibility that is mainly on solubility changes and container interactions. Examples: Insolubility, sorption, gas formation, change of pH of solution. Prevention: Do not administer a precipitate forming drug. Avoid mixing drugs prepared in special diluents with other drugs. In administration of multiple intravenous medications, prepare each drug in a separate syringe 29 Chemical Incompatibility: Chemical Incompatibility Results from the molecular changes or rearrangement and leads to chemical decomposition. 30 Reasons Prevention HYDROLYSIS Store drugs in relatively water-proof containers. OXIDATION REACTION Minimize the exposure time of the drug. REDUCTION REACTION Keep away from suspected reducing agents. PHOTOLYSIS Storing drugs in lightproof containers can usually prevent photolysis. Therapeutic Incompatibility: Therapeutic Incompatibility Result of antagonistic pharmacological effects of several drugs in one patient. Example: Heparin with antibiotics Intervention: It is best to avoid mixing heparin with antibacterial preparations because Heparin can affect the stability of certain antibiotics. 31 Drug-IV Container Incompatibility: Drug-IV Container Incompatibility Incompatibility that arise from the chemical reaction of the drug and the Intravenous container. 32 Type Definition ADSORPTION The property of a solid/liquid to attract and hold to its surface a gas, liquid, solute or suspension. ABSORPTION The act of taking up liquids or other substances through a surface of the body into body fluids and tissues. CONCLUSION: CONCLUSION Incompatibility of parenteral drug admixtures is a subject with such wide ramifications that correlating all the factors and finding exact cause and type of incompatibility is very tough job. Therefore automation of this system has already been started and in near future, compatibility will be checked with the help of computerized systems only. In the meantime, a knowledge of pH factors and a sound reference library , together with a pre-planned use of drug combinations wherever possible, will be helpful to minimise the problem. 33 Reference : Reference 1. Chemical Incompatibility of Parenteral Drug admixtures; T. J. McCARTHY ; S.A. MEDICAL JOURNAL 2 ( http://archive.samj.org.za/1974%20VOL%20XLVIII%20Jul%20-%20Dec/Articles/03%20September/4.9%20CHEMICAL%20INCOMPATIBILITY%20OF%20PARENTERAL%20DRUG%20ADMIXTURES.pdf ) 2. “Prescriptions usually needed in Egyptian community pharmacy” ( http://pharm.shams.edu.eg/departments/ceutics/elearning/4/Prescriptions%20usually%20needed%20in%20Egyptian%20community%20pharmacy.pdf ) 3. INTRAVENOUS (IV) ADMIXTURES (http://www.sh.lsuhsc.edu/policies/policy_manuals_via_ms_word/Nursing/I-45.pdf ) 34 THANK YOU !: THANK YOU !