Patient safety is a crucial component to patients receive the most benefit from their medications Pharmacist have historically

played a critical role in protecting patients from harm that may result from drug therapy. High-risk medications are most commonly defined according to drug toxicity but may also be defined by the route by which they are administered. High- Alert Medications: Safeguarding against Errors in the text Medication Errors. 16 medications or drug categories are listed; 14 of which are administered intravenous route. Intravenous route of administration was the most common in medication errors detected in pediatric inpatients, and was also cause the most serious medication error outcomes

Intravenous route of administration bypass three physiologic safeguards the gut, the liver, and the skin. The gut may break down medications before they are ever absorbed, or the drug may not even be absorbed through the gastrointestinal tract. The liver protects patients from many toxic doses of medications and can safeguard patients through the first pass effect when medications are administered orally. The skin protects patients from infections that might be caused by pathogenic microorganisms that are in the environment 1960s Recommended that pharmacy assume responsibility for compounding intravenous admixtures doses. (Patterson et al.) Observed nurses preparing parenteral admixtures in patient care areas and reported an error rate of 21% rate of wrong doses prepared was 9%; incompatible drugs mixed was 6%; wrong drug or solution used was 3%; preparation of drugs not orders was 3%. Deviations from accepted sterile technique were observed, with counters not being cleaned 99%; hands not washed 97%; touching sterile areas of the IV container 47%; vial or bottle tops not being cleaned 31%. (Thur et al.) Disguised observer method to evaluate error in preparation and administration of intravenous medications by physicians and nurses, and found that physicians made at least one error in 98% of the doses prepared and 83% of these doses were administered by nurses. (OHare et al.) To reduce errors was to decrease the amount of preparations on the ward. (Taxis & Barber) Calculation errors are also a root cause of error in preparing medications. (Thompson et al.) Pharmacists made fewer errors than nurses and physicians. (Perlstein et al.)

As a result of these reports, pharmacy based centralized intravenous admixture programs have emerged as a fundamentally safer medications-use system. (ASHP)

In spite of the safer medication-use system, there is some evidence that complacency can arise in pharmacies undermining the potential benefits of a pharmacy-based intravenous admixture program. Pharmacists had an error rate of 7.24% and a contamination rate of 7%. These errors and contamination rate were higher than that observed for pharmacy technicians. (Sanders et al.) High error rates in pharmacy-based intravenous admixture programs were also reported. They found an error rate of 9% in five hospital pharmacies studied using an observation-based method. (Flynn et al.) Evaluated the aseptic technique of pharmacists and technicians when compounding complex USP medium-risk sterile preparations using media fill tests. Pharmacist compounding resulted in a contamination rate of 4.4% compared to rate of 6.2% for technicians. The overall contamination rate was 5.2%. (Trissel et al.) Quality Assurance in Compounding Sterile Preparations Preparations to be used for parenteral, ophthalmic, and irrigation purposes must be free from chemical and physical contaminants, accurately and correctly compounded, sterile and free of pyrogens, stable until their beyond use date, and properly packaged and labeled for use. Components Compounded Sterile Preparations (CSP) is mainly compromised of components that are clean, sterile, and pyrogen-free as purchased from pharmaceutical manufacturers. The extemporaneous compounding of concentrated morphine sulphate injection from the powder is a high-risk compounding involves the use of components that are not sterile and may not be pyrogen-free, and it is essential to use USP grade chemical or to obtain a certificate of quality analysis from the supplier of the chemical. Sterility must be achieved, usually by appropriate filtration, through sterile, disposable, nonreactive, 0.2-micron porosity membrane filter device. Compatibility and Stability The most widely used reference is Trissels Handbook of Injectable Drugs. Unexpected compatibility problems may be visible immediately or within a few hours after compounding, but not all incompatibilities are visible. Stability considerations are broader and include overall assurance that the activity and chemical/physical integrity of the formulation is maintained until the preparation is administered to a patient. Batch Formulas and Records Master formula sheets and batch control records establish a uniform approach to the compounding process. Master formula sheet provides exact directions on the standard compounding of the batch

preparations. The batch control then documents the completion of these tasks and identifies that each step has been followed for each individual batch of CSPs. Environmental Controls Primary Engineering controls USP Chapter <797> requires that all sterile compounding, regardless of risk level, be done in an ISO Class 5 environment that is maintained in a horizontal laminar airflow workbench (LAFW), a suitable biological safety cabinet (BSC) or a suitable compounding aseptic isolator. These are key engineering control devices designed to continuously sweep the direct compounding area, The HEPA filter should be protected from damage during use and its efficiency certified at least 6 months. BSCs and Compounding Aseptic Containment Isolator must be used to maintain sterility of the preparations and to protect compounding personnel when hazardous drugs are being compounded.