Final Policy and Procedure SubmissionIt is time to synthesize the elements of your Policy and Procedure into a document. Your document should be a 3-4-page paper, written in APA format, which draws up

Sterile and Non-Sterile Compounding

Vondra Wesley

Rasmussen College

Author Note

This paper is being submitted on March 3,2019, for Stanley Sangar’s Pharmacy Technician Capstone course.

Sterile and Non-Sterile Compounding

The U.S. Pharmacopeia Convention (also called the USP) is a pharmacopeia (a compendium of drug information) was established in 1820 which is a nonprofit organization that owns the trademark and copyright. The United States Pharmacopeia is published annually and ensures the quality and safety of medications and foods. ("United States Pharmacopeia," 2019). USP <797> helps to guarantee patients receive quality formulations that are contaminant free and are consistent in anticipated Identity, strength, and potency. It defines various requirements, as well as responsibilities of compounding personnel, training, environmental monitoring, storage and testing of finished preparations. Compounding creates available access to medication for patients who may not be able to use commercially available preparations due to dosing requirements, allergies or rare illnesses. Medications that are necessary to be sterile include those administered through injection, intravenous infusion (IV), intraocular (injection in the eye) or intrathecal (injection in the spine). USP develops principles for preparing compounded sterile drugs to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. ("Compounding Standards | USP", 2019) Even though it was established in the US, its regulations are being practiced all over the world. The guidelines set by USP as well as the changes and updates on medication and food regulations that arise every five years is crucial to the pharmacy industry and the health of patients. Some guidelines will require pharmacies to make changes in their business management and to invest in advanced equipment, in the long run, will be beneficial to all parties involved (doctor, pharmacy, patients). One example is USP 797 that requires a pharmacy to acquire new technology to prepare sterile medication in facilities that encase an Anteroom for the staff to prepare themselves and supplies for sterile preparation techniques and a clean room for the compounding of sterile medication with an ISO Class 5 air quality environment certification. These requirements will ensure that quality medication is being produced and will prevent contaminations that will be detrimental to the patient’s health. ("How will new USP regulations impact the pharmacy? | Solid State Technology", 2019)

Consider this scenario: You receive a prescription for tramadol 5 mg/ml suspension. The compounding formula states the needed ingredients are: tramadol 50 mg tablets, ora-sweet syrup, and ora-plus suspension. You need to make 140 ml of suspension. Answer the following: List the compounding equipment you would need to prepare this product, and list what you would use each item for. Mortar and triturate – I will use these instruments to crush the tramadol 50 mg tablets into a fine powder.

Graduated cylinder – This is where I will transfer all the ingredients coming from the mortar.

1. Stirring Rod- I will use this to ensure that all ingredients are well mixed. (13 Sterile Compounding, n.d.) Your choices for bottles to dispense the suspension in are 2 oz, 4 oz, and 6 oz. Which size will you choose? I would use a 6 oz. bottle as per the USP medication packaging guidelines with a child safety cap. (Pharmacy Calculation, 2017)

COMPOUND RECORD- Name of the Pharmacy, Name, strength, and dosage form of the compounded sterile preparation (CSP), Master Formulation Record reference for the CSP, when used, Date and time of preparation of the CSP, Assigned internal identification number (e.g., prescription or lot number). Signature or initials of individuals involved in each step (e.g., technician or pharmacist). Name, vendor or manufacturer, lot number, and expiration date of each ingredient and container-closure system. Weight or measurement of each element, documentation of the calculations made to determine and verify quantities and concentrations of components, if appropriate. Documentation of quality control procedures in agreement with the SOP (e.g., filter integrity, pH, and visual inspection). Any deviations from the Master Formulation Record, if used, and any problems or errors experienced during the compounding of the CSP. Total quantity compounded, Assigned Beyond Use Date, duplicate container label if prepared in a batch. (Compound Record and Master Formula Record, n.d.) Most of the medication compounded by community pharmacies are nonsterile medications like ointments that are typically prescribed in small quantities for a short treatment period. While compound medications processed in a hospital pharmacy is generally made for inpatient and emergency patients, and it usually consists of sterile medications that require facilities such as a clean room. Some hospital pharmacies also outsource compound medication to community pharmacies with existing facilities to save on the cost of maintaining their facility and storing the medication per patient basis. Hospital pharmacies have the advantage of providing the correct compound medication since they have direct access to patient records and any changes in the patient’s condition that will also alter the course of treatment. Hospital Setting- Oral liquids, topicals or suppositories; the conversion of one dosage form into another; the preparation of selected dosage forms from bulk chemicals; the development of intravenous admixtures or parenteral nutrition solutions; the preparation of radioactive isotopes; or the preparation of cassettes, syringes and other devices for drug administration in the home setting. Some of the most frequently compounded products include lotions, ointments, creams, gels, suppositories, intravenously administered fluids, and medications, total parenteral nutrition products, oral suspensions, and Troches. Some therapies, such as hyaluronidase injection (used to increase dispersion and absorption of other drugs injected under the skin). ("Pharmacy and the value of compounding today," 2019) Retail Pharmacy Setting- Omeprazole or lansoprazole liquids (similar active ingredients to Prilosec or Prevacid).

A combination of two or more commercially available creams, ointments, lotions, or other topical medications. Some typical examples are diaper rash creams or other skin treatments.

Various types of prescription mouthwash, sometimes referred to as “Magic Swizzle” (this will often include an antacid, lidocaine, and diphenhydramine—the active ingredient in Benadryl). (Shye, 2015)

Cleaning A Horizontal Laminar Flow Hood: First, gather all the cleaning supplies needed in cleaning the horizontal laminar flow hood. To ensure that the container of the 70% alcohol is free of dust and other contaminants the pharmacy technician must first wipe or spray the container with a cleaning agent. The technician must then proceed with hand washing followed by wearing a sterile gown. The cleaning process begins with the pharma wipes being folded into four and sprayed with alcohol. Start wiping the top of the booth, beginning on side nearest to the HEPA filter towards the outer edge of the hood. To make sure that all surface is covered use long overlapping sweeping motions from right to left.

Then proceed with wiping the lens cover using another side of the pharma wipes. Follow the same movement used to clean the top portion. Then continue with cleaning the sides starting with the right side. The direction of wiping must be from top to bottom with same sweeping motion use on the top part of the hood. Perform the same process on the left side using another clean side of the pharma wipes. Once done with cleaning both sides, use another clean part of the pharma wipes to clean the suspension rod. Only wipe the rod once starting on the left side going to the right. And lastly, clean the work surface beginning on the back going to the front. Wipe the work surface, in the same manner starting from the back toward the edge. Once done the technician must go back to the anteroom to complete the hood cleaning checklist and then remove the sterile gown. (Durant, 2015)

Laminar Flow Hood And A Vertical Laminar Flow Hood: Horizontal laminar flow hood is commonly utilized between the two since its less expensive and it is ideal for compounding most sterile products. The air flows from back to front in a horizontal motion across the work surface. It can remove 99.97% of all particles that are 0.3 microns or larger.

Vertical laminar flow hood, on the other hand, directs the laminar flow downward. It is considered as the safest making it ideal in preparing hazardous types of medication such as anti-cancer drugs as it protects the pharmacist from exposure to airborne drug particles. Vertical LAFW is also more expensive than horizontal LAFW. ("Horizontal vs Vertical Laminar Flow Hoods", 2014).

References

United States Pharmacopeia. (2019). Retrieved from https://en.wikipedia.org/wiki/United_States_Pharmacopeia Compounding Standards | USP. (2019). Retrieved from https://www.usp.org/compounding How will new USP regulations impact the pharmacy? | Solid State Technology. (2019). Retrieved from https://electroiq.com/2004/03/how-will-new-usp-regulations-impact-the-pharmacy/ Paradigm Publishing, LLC. 13 Sterile Compounding [eBook]. Retrieved from http://resources.emcp.com/EPC_Books/EPC_Sterile_Compounding/ Paradigm Publishing, Inc. (2017). Pharmacy Calculation [eBook] (6th ed.). Retrieved from https://paradigm.bookshelf.emcp.com/lectern/book/Pharm_Calc_6e Compound Record and Master Formula Record. [eBook]. Retrieved from https://pharmacy.ky.gov/Documents/COMPOUND%20RECORD.pdf Pharmacy and the value of compounding today. (2019). Retrieved from http://www.hospitalpharmacyeurope.com/featured-articles/pharmacy-and-value-compounding-today Shye, R. (2015). What are Compounded Medications? [Blog]. Retrieved from https://www.goodrx.com/blog/what-are-compounded-medications/ Durant, K. (2015). Cleaning the Horizontal Laminar Flow Hood [Video]. Retrieved from http://www.slideshare.net/Kdurant36/cleaning-the-horizontal-laminar-flow-hood Horizontal vs Vertical Laminar Flow Hoods. (2014). [Blog]. Retrieved from https://www.terrauniversal.com/blog/all-terra-blogs/horizontal-vs-vertical-laminar-flow-hoods/ Standard Formulations. (2019). Retrieved from http://www.mipedscompounds.org/sites/default/files/standard-formulations/Tramadol_0.pdf COMPOUNDING RECORD Formula Number: 555555555 Product Drug Name and Strength Use/Dosage Form Date Tramadol 5mg/ml Suspension 3/03/2019 ---------------------------------------------------------------------------------------------- LOT BUD Quantity Control/Rx # 1234567891 3/06/2019 140ml 7777777-1049 --------------------------------------------------------------------------------------------------------------------- INGREDIENTS BREAKDOWN INGREDIENT NDC QTY LOT EXP Tramadol 50mg tablets 1444444444 12 7777777777 8/2020 Ora-Plus Suspension xxxxxxxx qs ad 70ml xxxxxxxxxx 8/2025 Ora-Sweet Syrup xxxxxxxx qs ad 70ml xxxxxxxxxx 8/2025 ______________________________________________________________________ DIRECTIONS: 1.Triturate tablets to a fine powder in a mortar and pestle. 2.Levigate with a small amount of base solution to form a paste. 3.Add base solution in increasing amounts while mixing thoroughly. 4.Transfer contents of the mortar to a graduated cylinder. 5.Rinse the mortar and pestle with base solution and pour into graduated cylinder. 6.Add base solution to the graduated cylinder to achieve the total volume 140ml. 7.Transfer contents of the graduated cylinder into an appropriate size plastic amber (6oz) bottle with Child Safety Cap 8.Shake well to mix. ("Standard Formulations", 2019)