Research PaperDiscuss USP Chapter <797> and the importance of the standards that were created, focus on revisions made in 2008 (include requirements for garbing, environmental quality control, beyond

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    • Discuss USP Chapter <797> and the importance of the standards that were created, focus on revisions made in 2008 (include requirements for garbing, environmental quality control, beyond use dating and training and testing).
    • The new USP Chapter <800> guidelines are still in the development stage. However, a great deal of information is available. What are some of the suggested changes and what will be added to the current guidelines?

Your final paper must 4-5 pages long and include both in-text citations and a reference page in APA format. You must have at least 5 references.                                                                                                                                           These are some of the requirements that the instructor will be looking for in this research document. Please, nothing too technical, pretty much layman terms but proper grammar and English with professionalism. These also must be entwined into the research paper as they all pertain to USP 797 and 800.for Pharmacy Technician class. Thank you. (PS.- I placed a starting pay, but I know this is extensive, so I’m willing to negotiate.) –                                                     Some files are enclosed.

Research PaperDiscuss USP Chapter <797> and the importance of the standards that were created, focus on revisions made in 2008 (include requirements for garbing, environmental quality control, beyond
Running head: CONTAMINATION RISK AND PREVENTION 0 Contamination Risk and Prevention Vondra Wesley Rasmussen College Author Note This paper is being submitted on January 27, 2019, for Jessica Howard’s Sterile and Non-Sterile Compounding course. Contamination Risk and Prevention Pharmacy carries out an essential role in preparation and storage of compound sterile and non-sterile preparations. The functions of pharmacy in preparing aseptic compounds range from infection prevention and control activities, and sterile fluid preparation. Whether the formulation is completed by pharmacy staff, there are particular programs used in parental preparation of sterile compounds. Parenteral preparation should be done in entirely sterile conditions preventing harm and other risks such as death that the patient receiving the compound might suffer after receiving treatment. Generally, preparation of sterile parenteral products needs a lot of care in control of material, ingredients, and materials to ensure the purity and quality of the product. USP (797) is recommended as the appropriate and applicable guidance to apply in pharmacy to install quality training and suitable equipment. There are several types of contamination of the sterile compound that might occur. They include physical or chemical contaminants unintentionally involved in the process. Also, including ingredients of inappropriate quality to the mixture prepared is another common sterile compound contaminant. More so, microbial contamination might occur in the process of developing the sterile compound. Lastly, an increase in bacterial endotoxins is a common contaminant in the development of sterile compound preparation (Fetter et al., 2017). These contaminants can lead to harm, minor infection as well as death. For example, parenteral nutrition bags which were contaminated caused the outbreak of Serratia marcescens bacteremia in 2011 (Fetter et al., 2017). The occurrence led to the death of 9 patients among the infected 19 at several Alabama hospitals. The sterile compound was compounded in California which later in 2012 led to the meningitis outbreak. The USP (797) also known as the U.S. Pharmacopeia chapter (797) provides the improved safety outcomes of patients receiving sterile compound preparation. The main aim of USP 797 is to prevent and minimize possibilities of patients’ harm through quality standards and minimum practice applied in any individual or object regardless of the compounding risk level. This practice assists in eliminating the risk of Touch Contamination. Touch Contamination is the most common form of contamination and the easiest to prevent. Follow proper hand washing guidelines and gloving procedures. All supplies, utensils and packaging materials must be appropriately sterilized before being introduced into the DCA (Direct Compounding Area) to prevent this type of contamination. (Anderson & Ballington, 2014), (McCartney, 2012). USP 797 standard requires training, monitoring and evaluating competence and skills used in compound sterile preparations handling, storage, preparation as well as transportation (Cooper et al., 2017). The standards used by USP 797 covers three critical entities which include personnel, engineering design, and environmental controls. The guidelines help avoid contamination when compounding sterile preparations. Under Personnel, USP 797 requires that routine monitored and well-trained staff should perform the process. Proper personal hygiene should be maintained at all times. No staff member that is sick or in poor health is to be allowed to enter into the compounding area, neither participate in the compounding procedures. This is a very crucial barrier to enforce since water contamination from coughing and sneezing in the laminar flow hood can introduce moisture droplets into the air and contaminate the compounded product. It is also essential that only sterilized water be used since it is free of microorganisms. The recommended practices include wearing sterile gloves; proper garbing such as wearing shoe covers, hair covers, face masks and gown of the personnel. Also, it is required that there should be a clear line of division in the segregated compounding area separating the clean and dirty areas. USP 797 compliance also requires a properly designed facility to avoid contamination in the process of sterile compound preparation. Under engineering or facility design, USP 797 compliance requires air ventilation of high-quality and installation and maintenance of high-efficiency HEPA air filters are to be used only. Cleanliness and air quality impact microbial contamination significantly making it an area of concern. Since Air contamination occurs through dust particles or moisture droplets in the air, working in the laminar flow hoods within the zone of turbulence help to prevent this type of contamination. Shadowing is a form of contamination that involves improper placement of products in the laminar flow hood or interruption of the air flow by your hands or another object. The zone of turbulence continually provides sterilized air flow into the Direct Compounding area and must be allowed to flow without any obstructions. Environmental management enables the pharmacy to adjust in the case of unfavorable results (Cooper et al., 2017). USP 797 standards require environmental sampling plan including location sample, sampling frequency, air sample volume, time of the day concerning compounding, collection methods and action levels. Lastly, USP 797 compliance under environmental control requires monitoring of particulate and microbial contamination and is a requirement to be completed semi-annually. Particulate matter contamination occurs when there is a solid substance within the IV solution, including coring or precipitation. To prevent coring, proper techniques are in use when withdrawing from a vial. Particulate matter contamination is preventable if the compatibility is verified before mixing the compound. (Anderson & Ballington, 2014), (McCartney, 2012). However, USP (797) does not offer the necessary protection in the mass production of drugs which need GMP control. (Fetter et al., 2017). As I conclude, environmental management, monitoring, and aseptic techniques are essential to track facility’s air quality, levels of microbial contaminants and prevention of pathogenic organisms from entering into the sterile environment or preparation procedures. References Cooper, J. F., Petry, N. A., & Director, B. C. N. P. (2017). USP Chapter< 797> Pharmaceutical compounding; sterile preparations potential impact on handling radiopharmaceuticals. University of New Mexico Continuing Education Program for Nuclear Pharmacists, 13, 19. Fetter, C. W., Boving, T., & Kreamer, D. (2017). Contaminant hydrogeology. Waveland Press. Anderson, R., & Ballington, D. (2014). Pharmacy Practice for Technicians [eBook] (5th ed.). St. Paul, MN: Paradigm Publishing. McCartney, L. (2012). Sterile Compounding and Aseptic Technique: Concepts, Training, and Assessment for Pharmacy Technicians [eBook]. St. Paul, MN: Paradigm Publishing.
Research PaperDiscuss USP Chapter <797> and the importance of the standards that were created, focus on revisions made in 2008 (include requirements for garbing, environmental quality control, beyond
Running head: THE DRUG QUALITY AND SECURITY ACT 0 The Drug Quality and Security Act Vondra Wesley Rasmussen College Author Note This paper is being submitted on, January 6, 2019, for Jessica Howard’s Sterile and Non-Sterile Compounding course. The Drug Quality and Security Act The Drug Quality and Security Act was signed into law by President Obama in November 2013 in response to a fatal outbreak of fungal meningitis through a contaminated medication named Methyl prednisone which is used as an epidural injection. Forty-eight people died, and 720 were still being treated for persistent fungal infections as March 2013. Upon further investigation by The Centers of Disease Control and Prevention, it was revealed that three lots of this medication was contaminated and had been disbursed to 75 medical facilities in 23 states and had been administered to 14,000 patients. It was discovered that this medication had been packaged and marketed by The New England Compounding Center (NECC), a compounding pharmacy in Massachusetts. Since this incidence, the Pharmacy filed for bankruptcy, and at various times different employees, Pharmacists, Technicians, and The Co-Founder and President of the company has been indicted on various federal charges. The FDA came under hard scrutiny by members of the Congressional Committee who were investigating the outbreak. The FDA stood accused of failing to prevent the crisis by moving to slow against the Massachusetts Pharmacy Company. The statement was made “that the FDA knew about this rogue compounding pharmacy for several years and did nothing to stop them.” After this public tragedy, Congress put pressure on the FDA to make major changes. The establishment and the formation of The Drug Quality and Security Act expanded the powers of the FDA over compounding pharmacies. With this act into place, it serves to ensure providers and patients access to safe compounded medications. The Act is designed to clarify that The FDA oversees the responsibilities for both small and large volume compounding Pharmacies and require higher quality standards for these facilities, especially the large volume compounders. There are two Acts in place: The Compounding Act is for “Outsourcing Facilities” which is aimed primarily at largely scaled compounders who ship compounded drugs to multiple states. It has stricter provisions than the standard pharmacy and is closely monitored for drug safety, monitoring of stability and usage and potency. Used to establish that the medications are kept and stored properly and used in accordance to recommendations without risk of contamination, handling, and meet compliance. No excessive amounts allowed to be kept or released. The Drug Supply Chain Security Act is intended to create a national standard for drug supply chain security for non- Outsourcing facilities by establishing requirements for tracing a product through the distribution system. It also establishes standards for federal licensure of wholesale distributors and third-party logistics providers. The Drug Supply Chain Security Act enables the FDA to monitor manufacturing to dispensing, to be able to prevent counterfeit drugs from entering the system, recalls and require product identifiers to be stamped or imprinted to package or case. To establish uniform standards and to ensure manufacturers, wholesale distributors, dispensers, repackagers, and trading partners are authorized. FDA publicly encourages healthcare providers and health networks to purchase products from FDA-registered outsourcing facilities. 503A Traditional Compounding Pharmacies are required, by state boards of pharmacy, to abide by United States Pharmacopeia (USP) Standards, especially the ones that apply to compounding.  USP <795> applies to non-sterile compounds like creams, lozenges and capsules. USP <797> covers sterile compounds like injections, eye drops, irrigations, implantable pellets, etc..503B Outsourcing Facilities are licensed by FDA and required to meet current Good Manufacturing Practice (cGMP) standards for pharmaceutical manufacturing.  cGMP standards are similar to USP <795> and USP <797> standards, but are considered more stringent, more detailed and requiring greater testing.  The process of becoming an FDA licensed outsourcing facility is a considerable expense that is out of reach for most smaller compounding pharmacies. (2019) What are some of the changes that were a result of this Act being signed that effect the compounding industry? Outsourcing Facilities are required to keep and file biannual reports of compounding activities with all applicable information such as drug names, strengths, dosage, adverse events and risk- based inspections. Provide verification of no misleading or false information in the promoting of drugs and no solicitations. The close monitoring of storage, preparation and packaging of drugs in a sterile environment and distribution. Do you believe this tragedy would have been prevented had this bill already been in place? How? Yes, with the biannual reports and proper inspection of the facility to ensure proper policies and procedures were being put into practice. Also, a physical inspection of the facility by a quality assurance representative could have investigated to ensure that the facility was clean, sterile and all medications were up to date as well as making sure everything was kept in a sterile environment. How could it prevent an outbreak like that which occurred in 2012 from happening again? The Act contains different regulations that must be strictly adhered to. By the FDA reviewing reports and doing random inspections on a regular basis will prompt the Pharmacy Manager or owner to make sure everything is kept up to the most- high standard otherwise they can suffer possible business lost and loose licensure and possibly fines or imprisonment. What drawbacks do you see if any and in what ways could this law be improved? The only drawbacks I for-see as being a problem is the high cost of maintaining a compounding pharmacy can be very costly. But in order to maintain business and stability in that area of pharmacy one must be willing to sacrifice and not at the expense of a Life. The Law in itself is good, but there needs to be more in- depth training to all Pharmacy Staff in the current policies, procedures and laws governing the pharmacy and should be done yearly. Also, an informal visitation and possible meeting for updates from a member of the FDA to answer any questions and give advice. References New England Compounding Center meningitis outbreak. (2019). Retrieved from https://en.wikipedia.org/wiki/New_England_Compounding_Center_meningitis_outbreak The Drug Quality and Security Act: Implications of the Proposed New Law for Compounding Pharmacies and the Pharmaceutical Supply Chain | Hall Render. (2019). Retrieved from https://www.hallrender.com/2013/11/26/the-drug-quality-and-security-act-implications-for-drug-compounding-and-the-pharmaceutical-supply-chain/ Drug Quality and Security Act. (2019). Retrieved from https://www.mcguirewoods.com/Client-Resources/Alerts/2013/12/Drug-Quality-and-Security-Act.aspx (2019). Retrieved from https://www.quora.com/What-FDA-guidelines-do-compounding-pharmacies-follow
Research PaperDiscuss USP Chapter <797> and the importance of the standards that were created, focus on revisions made in 2008 (include requirements for garbing, environmental quality control, beyond
Running head: PREVENTING MEDICATION ERRORS IN COMPOUNDING 0 Preventing Medication Errors in Compounding Vondra Wesley Rasmussen College Author Note This paper is being submitted on January 1, 2019, for Jessica Howard’s Sterile and Non-Sterile Compounding Course Preventing Medication Errors in Compounding In September 2016, A mother and daughter went to a Walgreen’s Pharmacy to pick up her daughters’ prescription for a medication to treat her daughters’ seizures but instead received the wrong medication. After the mother administered the medication to her daughter, she began to notice adverse symptoms appearing in the child. The child was taken to the hospital emergency room where she was admitted and received treatment for an overdose of the incorrect medication. On May 30, the same family went to another Walgreens Pharmacy in another location to get their prescription filled. Upon the mother arriving home, she checked the medication and found that there were two different pills in the bottle. Since then the mother obtained a Lawyer and filed a lawsuit against Walgreen’s accusing them of negligence by failing to take proper care, failing to warn of danger and overall negligence of the employees who filled the prescription incorrectly. (Slappey & Sadd & Slappey & Sadd, 2019) This parent experienced not just one, but maybe two medication errors on behalf of Walgreen’s for a prescription she had received from her daughter’s health provider for the treatment of seizures. Had the proper measures and precautions been practiced, this error would have been avoided. It is also essential to focus and pay close attention to detail. Even though the case doesn’t state whether or not this happened due to lack of correct information being processed into the system at the beginning, we must look at all the necessary steps that should have taken place. First, the In-take Technician should have verified all pertinent information about the patient, including reference into any allergies or other medications prescribed to the patient that may cause adverse effects and interactions. Before inputting the prescription information into the system, verify that there are clear and concise understanding and pronunciation and spelling of the name of the medication, administration, dosage. If it’s a weight-based medication, obtain current weight and any other pertinent information. Proceed with the input. Once all information was input into the system, pass all information to the filling technician. The filing technician should review all the information on the prescription and compare it to what was input into the system especially spelling and grammar. If there are any discrepancies or questions, seek the advice of the Pharmacist. Once all is verified as being correct, proceed with retrieving of the medication to fill the order. Compare the name of the medication and the NDC number with the prescription request labels. Once everything passes verification, proceed to fill the medication request and transfer over to the Pharmacist for the final check and verification. According to the second incidence, it doesn’t clearly state if there was a wrong medication provided or changes due to more than one manufacturer such as medication color, texture or shape. In either case, the filling technician should have notified the Pharmacist along with medication packaging and information about the changes. The Pharmacist should have noticed the difference and made necessary corrections and made a special notation in the patient’s profile. In the case of it being two different drug manufacturers but the same drug, the Pharmacist should have given the patient/caretaker informed notice of this event along with any information about adverse effects, drug or food interactions if any, or allergies. Always inform patient/caretaker if they have any concerns, please feel free to ask. Given the completion of this research, I’m more compelled to stay more focused and alert to all pertinent information involving the process of filling medication order requests and the ever-changing status and appearance of medications to ensure the proper care and safety of the patients and the overall well-being of my employment as a professional in Healthcare. References Slappey & Sadd, L., & Slappey & Sadd, L. (2019). Walgreen’s Facing Lawsuit After Allegedly Filling Prescriptions Incorrectly. Retrieved from https://www.georgiainjurylawyersblog.net/walgreens-facing-lawsuit-allegedly-filling-prescriptions-incorrectly/
Research PaperDiscuss USP Chapter <797> and the importance of the standards that were created, focus on revisions made in 2008 (include requirements for garbing, environmental quality control, beyond
Running head: STERILE COMPOUNDING AREAS 0 Sterile Compounding Areas Vondra Wesley Rasmussen College Author Note This paper is being submitted on January 20, 2019, for Jessica Howard’s Sterile and Non-Sterile compounding course. Sterile Compounding Areas In the Pharmacy area, there should not be any unauthorized personnel. The compounding area is a very critical and important sterile environment where the best personal hygiene is encouraged. The compounding staff should remove all outerwear, no artificial nails or polish, no makeup or piercing or jewelry. Hair should be well groomed and appropriate for the profession. Any person or staff with a cold or illness are not allowed in the compounding area or allowed to compound under no circumstances to avoid the spread of contamination. The first aseptic practice is to have a sticky mat at the entrance of the Anteroom doorway. The sticky mat will allow for the Pharmacist or technician to clean their feet before entering the sub-sterile environment by removing any dirt or debris from footwear. (“13 Sterile Compounding”, 2019) Upon entering the Anteroom, the proper procedure for preparation is a requirement. The first one is Garbing. Garbing is the practice of dressing appropriately in Personal Protective Equipment (PPE) to enter into a sterile environment without transporting or taking in any germs, contaminants or potential hazards that could pose a direct danger to medications, staff or patient care. Apply 70% isopropyl alcohol to both hands in washing motion. Put on booties front to back, apply alcohol to hands again. Apply hair net over entire head, ensuring no hair is uncovered. Tie the top first over the ears, then the bottom. Apply alcohol to hands again. Apply face mask, ensuring to completely cover nose, mouth and chin. Men are to put on beard mask if applicable. Apply goggles if required to avoid possible eye contamination or injury from splashing of liquids. Get a package of the aseptic soap and walk over to sink (Never use hands to control faucet, but use provided foot pedals for operation) squeeze the package twice to activate the soap, then open. Discard packaging. Always start with left hand, clean fingernails on both hands first with the enclosed pic to remove any dirt or debris, discard pic. Wet the sponge and scrub under each fingernail. Scrub thumbs on the outer side and all four surfaces. Clean the webbing between all fingers of both hands. Then scrub the palms of both hands (left then right), then scrub the back of both hands with the sponge. Then starting on the left, clean left forearm gradually in a circular motion up towards the elbow, then proceed to right arm ensuring that your scrubbing wrist to elbow (upward motion). The handwashing technique should last for two-four minutes. Dispose of sponge, but never touch the trash receptacle, use foot pad. Rinse left hand and forearm under water with fingertips pointing up circulating the rinse water up the forearm towards elbow, then repeat same steps for the right arm. Use aseptic, lint free paper towel to dry left hand and forearm, then repeat for the right arm. Dispose of paper towel. Open sterile gown and remove from package. Do not let it touch the floor. Insert one arm at a time and pull up to shoulder and repeat. Secure neck closure and wrap waist ties around and secure in the back. Sterilize hands again with alcohol and let dry. Open sterile glove package, place inner packet onto sterile surface. Put left glove on first, pull up arm and place over cuff of gown and repeat for right hand. Upon removal, remove gloves first, gown(roll-up), facemask, hairnet then shoe coverings and dispose properly. (2019) Now you may enter the Cleanroom. The Cleanroom is a regulated environment created to provide an aseptic environment for preparing and creating compounded medications and special formulations. The Cleanroom has a minimal level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. A Cleanroom is a secured space specifically designed where provisions are allowed to reduce contamination by particles and control other environmental factors such as temperature, humidity, and pressure. (“What is a Cleanroom? Cleanroom Classifications, Class 1, 10, 100, 1,000, 10,000, 100,000, ISO Standard 14644, Cleanroom Definition”, 2019). Majority of the industries currently use cleanroom’s where small particles can adversely affect the manufacturing process. Sterile compounding is one of the highest risks of the Pharmacy practice. Dust and other low-level environmental pollutants, such as airborne microbes, aerosol particles, and chemical vapors require strenuous control. (2019) All of the air delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness performance is necessary. Cleanrooms maintain particulate-free air through the use of HEPA filters employing laminar or turbulent airflow principles. Laminar air flow systems direct filtered air downward in a constant stream. Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow. The quality control guidelines and regulations protect healthcare personnel who receive, prepare, administer, transport, or otherwise come in contact with hazardous drugs from possible negative acute and chronic health effects of exposure to hazardous drugs and decrease the potential risks of the patients from obtaining contaminated medications. (“What is a Cleanroom? Cleanroom Classifications, Class 1, 10, 100, 1,000, 10,000, 100,000, ISO Standard 14644, Cleanroom Definition”, 2019) Air entering a cleanroom from the outside must be filtered to exclude dust. The air inside a cleanroom receive constant recirculation through high-efficiency particulate air (HEPA) filters to control contaminants that are generated inside the room. Particle levels are tested using a particle counter, and microorganisms are detected and counted using environmental monitoring methods.  (“Contamination Control in Pharmaceutical Cleanrooms,” 2019) In the Cleanroom is where the Pharmacist and Pharmacy Technicians prepare aseptic compound medications, dilutions, mixing and injections of various medical products. This practice is commonly used in hospitals and home healthcare settings for patients who are unable to swallow oral medications, whose digestive systems preclude the use of oral medications, or whose system necessitates a more rapid delivery of medication into the blood supply. Intravenous (IV), Intramuscular (IM), Subcutaneous (SQ) and Intrathecal (IT) are the major routes of medication administration prepared in compounding pharmacies. Total Parenteral Nutrition intravenous feedings (TPN) are also prepared in compounding settings. In the cleanroom mass quantities of vaccines can be prepared without risks of contamination if the proper procedures are used effectively with precautions. Some Physicians may request some topical ointments, creams, and gels that require compounding with highly potent medications that need mixing in a sterile environment. Daily cleaning of the entire compounding environment which includes the clean rooms and ante-rooms require disinfection on a regular basis. Including floors, hoods, and countertops. Make sure compounding staff uses the proper cleaning agents so that any microorganisms are eliminated. (Cathy Thompson, 2019) Why it is necessary that we have both an anteroom and a cleanroom? The reason we have the Anteroom is pretty self-explanatory. The Anteroom is pretty much the same as a surgical prep room. It is used as a prep and sterilization room by the immediate pharmacy staff to ensure that no virus, microorganisms or bacteria enter into the cleanroom where the process of compounding of the medication requested and to ensure staff doesn’t take in any contaminants or germs that would render the whole process as contaminated and unusable. The Cleanroom is a sterile environment with its components to keep out air-borne germs and contaminants and should be cleaned and sanitized daily and after each use. Strict adherence to this practice is essential to the production of medication to maintain its integrity and to provide safety to the patients and the staff. References 13 Sterile_Compounding. (2019). Retrieved from http://resources.emcp.com/EPC_Books/EPC_Sterile_Compounding/ (2019). [Image]. Retrieved from https://www.youtube.com/watch?v=QyiNoC5oYto What is a Cleanroom? Cleanroom Classifications, Class 1, 10, 100, 1,000, 10,000, 100,000, ISO Standard 14644, Cleanroom Definition. (2019). Retrieved from https://www.cleanairtechnology.com/cleanroom-classifications-class.php (2019). Retrieved from http://www.rld.state.nm.us/uploads/files/Personnel%20Metrics.pdf Contamination Control in Pharmaceutical Cleanrooms. (2019). Retrieved from https://www.rdmag.com/article/2018/03/contamination-control-pharmaceutical-cleanrooms Cathy Thompson, M. (2019). 7 USP 797 Clean Room Guidelines You Need to Know. Retrieved from http://blog.pharmacyonesource.com/7-usp-797-clean-room-guideline-you-need-to-know
Research PaperDiscuss USP Chapter <797> and the importance of the standards that were created, focus on revisions made in 2008 (include requirements for garbing, environmental quality control, beyond
The Old Vs. The New: Providing safer drug compounding Techniques to enhance patient and healthcare worker safety Safer Medication, Healthier Living Vondra Wesley Rasmussen Student The Old Vs. The New: Providing safer drug compounding Techniques to enhance patient and healthcare worker safety USP 797 VS USP 800 Safer Medication, Healthier Living Sterile Preparations are needed to protect the health of patients by reducing the potential for microbial contamination caused by unsanitary environments and toxic microorganisms. The New era of safer and enhanced health protocols to protect the consumer and the healthcare industry. Reducing Contamination The policy requires environmental rules to include a separate area for compounding that meets a strict level of cleanliness and monitoring for regulation obedience. The Anteroom The Cleanroom The anteroom is located in a secure area and ensures a safe airflow barrier zone between the controlled pressurized room and an unclean area. This designated area is for use by Pharmacy compounding personnel to exercise personal sterilizing procedures before entering the Cleanroom to compound medications. In this area garbing is performed, but when USP 800 starts a more sterile process will exist with improvements to sterile safety garments. This area is used to perform sterilization procedures on any equipment or supplies required to complete compounding Preventing Pharmacist error Pharmacy management is required to practice the standards set by U.S. Pharmacopeia (USP) Chapter 797. It defines the process, procedures and compliance prerequisites for pharmacies participating in compounding sterile preparations (CSPs). The pharmacist is to keep accurate records of all compounding practices, medication changes, and updates and stay informed of any drug changes, interactions or adverse effects. 2. Pharmacists are to ensure that all compounding staff receive proper training in sterile compounding USP 797 means Accountability Pharmacists will be deemed accountable to the compliance requirements located in USP 797. As the educated professionals in sterile compounding, the maximum levels of accountability rest upon the pharmacist. Quality Control a structure of maintaining standards in manufactured products by testing a sample of the output against the specification. The pharmacist must ensure that each component has its correct identity, quality, and purity Preserving appropriate cleanliness conditions, labeling, and instructions for proper clinical administration. Quality assurance (QA) is a method of counteracting errors and imperfections in factory-made products and stopping complications when supplying solutions or services to customers or patients. Quality Assurance reports conducted to check for accuracy and precision of measuring, weighing and strength of ingredients Ensure proper sterile techniques were applied both before and after compounding procedure and the monitoring of the quality of the air flow in the compounding area to filter out potential hazards and contaminants. Conclusion With the ever-growing population increase we have, also comes the potential for more diseases and illnesses. New drugs and compounds are constantly on the rise of production. With this increase the need for advances to the sterility, productivity and overall protection of the integrity of medications is essential. Sterile Compounding is an unseen essential that we don’t normally consider. But it is just as important for a lot of patients who may not be able to be administered oral medications. Compounding is a reliable source, but it can only be beneficial upon proper production and properly maintained in a sterile environment. Now chapter USP 797 and 800 come into force. They both require strict regulations including the environment in which the medications are developed. Methods of sterility in production, accurate records of ingredients, storage, beyond use dates, the safety of human consumption is of chief importance. The training of pharmaceutical staff in aseptic preparations and its policies and procedures are required. For the consumer to maintain healthy living while on medication, the medications have to be safe.

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