Sterile Preparation and Admixture Programs

1. Sterile Preparation and Admixture Programs HOSPITAL PHARMACY Yasser M. Alatawi

2. Introduction • High risk medications are most commonly defined according to drug toxicity but may also be defined by the rout it is administered. • The USP reported that: IV rout of administration often result in the most serious medication error outcome. IV rout administration bypasses 3 physiological safeguards: the gut, liver and skin. The gut:brake down medications before they are absorbed. The liver:protects the patient from many toxic doses of medications. The skin:protects the patient from infections that might be caused by pathogenic microorganisms that are in the environment especially the hospital.

3. Quality assurance in compounding sterile preparation • Preparation used for parental, 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.

4. I. Components • The majority of compounded sterile preparations (CSPs) are comprised of component that are clean, sterile and pyrogen free as purchased from pharmaceutical manufactures. • Compounding policies and procedures (i.e. standard operating procedures) must be developed so that the final preparation meets the standards required for a sterile preparation, including sterility freedom from pyrogens and an acceptable particulate level. Sterility: must be achieved usually by appropriate filtration through sterile disposable nonreactive membrane filter devices. “During filtration particulate matter is removed to very low levels below visible levels.” Removing pyrogens: is more difficult the best approach is to obtain raw materials that are free from pyrogens as supplied.

5. 1. Compatibility and stability: • Information may be available from the commercial supplier of a component and from other literature resources. • The most widely used reference is Handbook of Injectable Drugs. • unexpected compatibility problems may be visible immediately or within a few hours after compounding, but not all incompatibilities are visible.

6. 2. Batch formulas and records: • There should be a Standard Operating Procedure in every pharmacy and two kinds of records: • Master formula sheet: it provides exact directions on the standard compounding of the batch preparation. • Batch control record: documents the completion of these tasks and identifies that each step has been followed for each individual batch of CSPs.

8. II . Environmental controls

9. 1. Primary engineering controls: • USP requires that all sterile compounding regardless of risk level be done in an ISO Class 5 environment. (fewer than 100 airborne particles large than .5 microns per cubic foot ) • This is maintained in a Horizontal Laminar Airflow Workbench, a suitable Biological Safety Cabinet or a suitable Compounding Aseptic Isolator. • all are designed to sweep the direct compounding area with High Efficiency Particulate Air (HEPA) filter.

11. 2 . Secondary engineering controls: • It is required to have a buffer area around these devices that meets ISO Class 7.(fewer 10000 arirborn particles .5 microns per cubic foot) • Low and medium risk preparations may be compounded in facilities where there is no physical separation between the ante area and the buffer area. • High risk preparations require an anteroomseparate from the buffer room.

13. 3 . Cleaning and disinfecting: • Mild detergent solution is used with a nonshedding, absorbent mop, wipe or sponge. • This should be followed by wiping work surface with an effective disinfectant like sterile 70% isopropyl alcohol (IPA). • That should be at least monthly but floors and surfaces should be cleaned and disinfected daily. • That should be done from the cleanest area outward.

14. 4 . Traffic control: • The flow must be rigidly controlled to prevent carrying contamination inward. • No personnel should be allowed to approach the primary engineering control device unless properly garbed and trained. This includes housekeeping personnel.

15. 5 . Environmental testing: • The focus of testing should be on the presence of microbiological contaminants in the environment. • Surface testing and air volume sampling should be preformed.

16. III . Compounding personnel: • Should have the minimal number required for the planned procedure. • Good personnel hygiene should be practiced through washing/disinfecting hands and donning garb to confine the particles as much as possible.

17. 1. Training and evaluating compounding personnel: • Personnel are recognized as the primary source of contaminants. • Pharmacists and technicians are expected to know: • Specification for facilities and devices. • Dynamics of airflow through a HEPA filter. • How to achieve the air pressure differentials to produce the cascading effect from the buffer room out through the less clean ante area. • Basic understanding of microbiology.

18. 2. Grab and behavior: • Before entering the buffer area personnel must: • Remove all outer garments. • Remove all cosmetics. • All hand, wrist and other visibly jewelry or piercings. • Wearing of artificial nails is prohibited while working in sterile compounding area and natural nails must be kept neat and trimmed.

19. IV . Packaging and labeling: • The final container needs to be sterile. • Plastic are preferred to reduce coast and to prevent breakage. • Proper labeling is an important component of safe medication system. • Labels may also include supplementary information to help assure the dose is administered properly.

20. V . Verification of compounding accuracy and sterility: • To assure that the content of the admixture matches what is ordered and printed on the label: • Weighing the admixture (the expected weight of the final preparation can be calculated using specific gravity of the component). • The person preparing an admixture is asked to place the syringes and vials/ampuls used on a tray for checking by a pharmacist.

21. VI . Storage and beyond use dating: • These are important because of chemical stability and sterility. • Stability issue can be determined from the package insert, a reliable reference such as “Extended Stability for Parenteral Drugs” or other published literature. • Sterility consideration are defined in USP chapter <797>.

22. VII . Maintaining quality after preparation leaves the pharmacy: • By proper storage conditions and temperature limits. • Reuse of the preparation for another patient: Redispensing of CSPs may avoid waste but requires oversight by pharmacy to avoid administering doses that may be contaminated or after the expiratory date.

23. VIII . Standard operating procedures: • It is required that every pharmacy have written and approved standard operating procedures SOPs

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