Pharmacy

How do pharmacy services impact infection control?

Pharmacy services play a key role in infection control by reducing infection transmission through proper preparation, handling, and storage of medications hospital wide. Strategies to prevent infection transmission include development and implementation of internal pharmacy policies and procedures, as well as quality control programs to prevent contamination of medications that are prepared or dispensed by the pharmacy.

Other areas of infection control that involve pharmacy include antimicrobial stewardship programs, vaccination programs, infection control committees, and pharmacy and therapeutics committees. In these roles, pharmacists are able to help ensure optimal antimicrobial selection, dosing, and monitoring, collaborate to develop treatment guidelines, therapeutic interchanges, and antimicrobial formulary selection, as well as provide health care worker and patient education. These clinical activities may help reduce antimicrobial resistance or infection persistence, prevent transmission of disease, improve patient outcomes, and decrease health system costs.

What elements of pharmacy services are necessary for infection prevention and control?

It is well documented that administration of a microbe-contaminated pharmacological agent may result in infection. Thus, elements of pharmacy for infection prevention and control include proper compounding, handling, and storage of sterile products. Standards for sterile compounding include International Standards Organization (ISO)-classified air environments, personnel gloving, garbing, training, and testing in aseptic technique, environmental quality specifications, and disinfection of gloves and surfaces.

In January 2004, universal practice standards for compounding sterile products (CSPs) were published as United States Pharmacopeia (USP) Chapter <797>. In December 2007, a revised bulletin of general Chapter <797> was published by USP, which allowed for an implementation deadline of June 1, 2008. Its two primary focuses are to reduce the risk of contact contamination and to provide more environmental controls. The standard emphasizes proper hand hygiene when working with CSPs. Other specific issues that USP Chapter <797> addresses include:

• Applicability to all health care settings

• Personnel training, competency, and evaluation of performances to ensure proper preparation, storage, and distribution

• Differentiation of microbial contamination risk levels (low, medium, high)

• Process and preparation quality controls

• Procedures to verify the accuracy and sterility of CSPs (checking and testing of CSPs before dispensing)

• Verification of automated compounding devices

• Environmental quality and control (e.g., direct compounding area, primary engineering control, buffer area, airflow displacement method of separation, ante room, HVAC design)

• Sterility and beyond-use dating

• Patient/caregiver training for optimal storage, administration, and disposal of CSP

• Monitoring system to track patient’s response to therapy

• Feedback mechanism for reporting concerns about CSPs

• Quality assurance program that documents CSP policies, processes, and procedures

Various professional organizations (e.g., American Society of Health System Pharmacists (ASHP), National Association of Boards of Pharmacy, American Society for Parenteral and Enteral Nutrition [A.S.P.E.N.]), as well as governmental and accreditation sources (e.g., Joint Commission on Accreditation of Health Care Organizations [JCAHO], Food and Drug Administration [FDA], Center for Disease Control [CDC] have also published best practices and guidance documents that address infection prevention and control within the health care setting. Several of these documents focus on quality assurance for pharmacy-prepared sterile products, safe use of automated compounding devices for the preparation of parenteral nutrition admixtures, handling hazardous medications, outsourcing sterile compounding services, and preparing ophthalmic products.

What are the consequences of ignoring key concepts related to pharmacy services and infection control?

Unwanted patient harm and scrutiny of the health care system may occur if key pharmacy processes for infection control and prevention are ignored. Administration of contaminated pharmacy-compounded medications has caused serious infections, which have resulted in patient morbidity and mortality. To prevent these adverse events from occurring, implementation and adherence to USP Chapter <797> is imperative when compounding, dispensing, and storing sterile products.

The USP/NF is the official standard for medications in the United States, thus, implementation of USP Chapter <797> is a pharmacy requirement. If USP Chapter <797> is not implemented then the health care facility risks losing accreditation by various organizations (e.g., JCAHO, Accreditation Commission for Health Care, Inc., and Community health Accreditation Program) as pharmacies may be subject to inspections against these standards.

Summary of current controversies regarding pharmacy services and infection control.

Standards and best practices for aseptic preparation of sterile products within pharmacy services have been established by USP Chapter <797> and other national regulatory agencies. However, the level for confirming sterility of CPSs remains controversial. Questions about the need to test all CPSs, regardless of risk level, that are prepared in the pharmacy and outsourced from vendors exist. USP Chapter <797> does address this question and recommends sterility testing for all high-risk level CSPs before dispensing and administering to patients when:

• Made in batches of greater than 25 identical individual single-dose packages

• Multiple-dose vials for use in multiple patients

• Exposure to temperatures of 2 to 8 degrees Celsius for more than 12 hours and temperatures greater than 8 degrees Celsius for more than 6 hours before being sterilized

At times high-risk CSPs need to be dispensed prior to the sterility testing results. In this situation, daily observations of the test specimens and an immediate recall of the dispensed CSPs if contamination of the test specimen is evident must occur. If potentially contaminated high-risk CSPs were administered to a patient, then the patient and provider must be notified of the potential risk.

Results of clinical trials have reported that rational use of antimicrobials can decrease pathogen resistance. Therefore, limitations on physician prescribing certain antimicrobials through restrictions or preauthorizations have been implemented by pharmacy. Though these limits have been shown to decrease pharmacy drug expenditures, controversy exists with regards to their impact on controlling antimicrobial resistance.

Controversies in detail.

Certain pharmacy practices may be considered controversial with regards to improving infection control measures.

Quality-control concerns (i.e., reduction of quality/sterility and qualifications or competencies of pharmacists) and questions about sterility/stability testing of CSPs from outside sterile compounding services (vendors) have been raised. Vendors may supply multiple hospitals, which could allow for dilution of a contamination when disseminated among many sites. For example, individual hospitals may not see any or only a single infection resulting from CSPs. Because of these concerns, the decision to utilize a vendor for CSPs by a pharmacy must come with many considerations including an internal needs assessment, a cost analysis, and a thorough inspection of the compounding pharmacy itself.

Formulary restrictions and preauthorization requirements are two methods that have been applied to antimicrobials to limit antimicrobial use, decrease pharmacy costs, and control antimicrobial resistance. Unfortunately, conflicting data exist for using these methods to control antimicrobial resistance long term. In fact, use of formulary restrictions and preauthorizations may simply shift utilization of other antimicrobials, which increase resistance. Nonetheless, formulary restrictions and preauthorizations have been successful when used with infection control practice and education for specific outbreaks of infection with antibiotic-resistant bacteria.

What national and international guidelines exist related to pharmacy services and infection control?

Several national guidelines and standards exist for pharmacy services and infection control that focus on compounding, handling, and storing of sterile products. These were developed to reduce contamination risks of CSPs, which may result in patient harm.

American Society of Health System Pharmacists. ASHP guidelines on outsourcing sterile compounding services.

American Society of Health System Pharmacists. ASHP guidelines on quality assurance for pharmacy-prepared sterile products.

American Society of Health System Pharmacists. ASHP guidelines on the safe use of automated compounding devices for the preparation of parenteral nutrition admixtures.

American Society of Health System Pharmacists. ASHP technical assistance bulletin on pharmacy-prepared ophthalmic products.

American Society for Parenteral and Enteral Nutrition (ASPEN). Safe practices for parenteral nutrition.

USP General Chapter <797> Pharmaceutical Compounding-Sterile Products Preparations. United States Pharmacopeia.

What other consensus group statements exist and what do key leaders advise?

Involvement of pharmacists within infection control efforts have evolved. Specifically, the role of a pharmacist in an antimicrobial stewardship program has been recognized by national committees.

ASHP statement on the pharmacist’s role in antimicrobial stewardship and infection prevention and control.

Infectious Disease Society of America and the Society of Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship.

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