Parenteral Admixture & Incompatibility PRINCE SATTAM BIN ABDUL AZIZ UNIVERSITY COLLEGE OF PHARMACY Sterile Dosage Form (PHT 434) Parenteral Admixture & Incompatibility PRESENTED BY : Dr shahid Jamil

Pharmacist’s Roles in Admixture Preparations Introduction Pharmacist’s Roles in Admixture Preparations Rationale behind starting admixture program Responsibilities of pharmacist Components of IV Admixture system Incompatibilities Types of Incompatibility

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. that

Pharmacist’s Roles in Admixture Preparations

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.

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.

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.

Responsibilities of Pharmacist 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.

Components of IV Admixture system Preparation Area Storage Personnel Policies and Procedures Admixture system

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

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.

Policies and Procedures 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.

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.

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.”

Personnel Storage area Proper training in aseptic technique and sterile product information is necessary. Training courses, self study programs can be organized 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?) Storage area Will depend on the type of system one chooses to use. There should be proper refrigeration facility available.

IV room requirement Laminar air flow: Refrigerator: Reference: 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.

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).

Factors causing incompatibility 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 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 Physical Incompatibilities Chemical Incompatibilities Therapeutic Incompatibilities Drug -IV Container Incompatibilities

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

Chemical Incompatibility Results from the molecular changes or rearrangement and leads to chemical decomposition. 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 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.

Drug-IV Container Incompatibility Incompatibility that arise from the chemical reaction of the drug and the Intravenous container. 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.

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)

THANK YOU !