CoP: Pharmaceutical Services
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A-0489 482.25 The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.
Interpretive Guidelines §482.25
A hospital must provide pharmaceutical services that meet the needs of its patients. The services must include either a pharmacy that is directed by a pharmacist, or, when appropriate, a drug storage area that is competently supervised. The hospital’s medical staff is responsible for developing pharmaceutical policies and procedures that minimize the potential for medication errors, but may delegate this function to the pharmaceutical service.
The manner or degree of noncompliance with the requirements of this Condition and its component standards must be evaluated to determine whether there is substantial noncompliance with the Condition, warranting a Condition-level citation.
A-0490 482.25 The hospital must have pharmaceutical services that meet the needs of the patients.
Interpretive Guidelines §482.25
What is included in pharmaceutical services?
Pharmaceutical services encompass the functions of procuring, storing, compounding, re-packaging, and dispensing all medications, biologicals, chemicals and medication-related devices within the hospital. They also include providing medication-related information to care professionals within the hospital, as well as direct provision of medication-related care.
Meeting patient needs
Hospitals must provide pharmaceutical services that meet the needs of their patients. The scope and complexity of pharmaceutical services available in the hospital must be consistent with the volume and types of patients the hospital serves. Except in unusual circumstances, the pharmaceutical service is expected to make available in a timely manner the volume and types of medications typically needed. These would be those medications typically prescribed by the hospital’s practitioners for hospital patients receiving inpatient services, surgical services, diagnostic services involving medications as a component of testing, and outpatient drug therapies administered while the patient is in the hospital.
Not every hospital is expected to offer the same level of pharmaceutical services. For example:
• It would not be uncommon for a psychiatric hospital to maintain a relatively limited pharmaceutical service, due to minimal need for compounding, and/or dispensing multiple types and forms of medications and biologicals.
• On the other hand, a short-term acute care hospital with a busy oncology outpatient service and other complex medical and surgical departments would be expected to provide a wider range of pharmaceutical services that are ready to be furnished when needed.
A-0491 482.25(a) The pharmacy or drug storage area must be administered in accordance with accepted professional principles.
Interpretive Guidelines §482.25(a)
Pharmaceutical services must be administered in accordance with accepted professional principles. Accepted professional principles includes compliance with applicable Federal and State laws, regulations, and guidelines governing pharmaceutical services, as well as, standards or recommendations promoted by nationally recognized professional organizations, such as those found in the U.S. Pharmacopeia/National Formulary (USP/NF).
The hospital’s pharmacy service must ensure safe and appropriate procurement, storage, preparation, dispensing, use, tracking and control, and disposal of medications and medication-related devices throughout the hospital, for both inpatient and outpatient services.
Hospitals may choose how to set up the pharmaceutical services utilizing various methods including, but not limited to:
• a unit dose system (i.e.; single unit package, dispensed in most ready to administer form possible),
• individual prescription (i.e.; instruction for a single patient, written by a medical practitioner for a medication or treatment),
• floor stock system (i.e.; storage of pharmaceutical and over-the-counter drugs on the patient care unit), or
• a combination of these systems, as long as they are properly stored.
However, hospitals with only a drug storage area must only use drugs that are pre-packaged and need no further preparation beyond that required at the point of care.
The hospital must develop, implement and periodically review and revise as needed policies and procedures governing provision of pharmaceutical services. The regulation makes the hospital’s medical staff responsible for the policies and procedures, but also permits the medical staff to delegate this function to the hospital’s pharmaceutical services. The policies and procedures must reflect accepted professional pharmacy principles, and the pharmacy director must be able to identify the source(s) used when developing and adopting the policies and procedures. There must also be a process to train staff on the applicable policies and procedures and to monitor their adherence.
Policies and Procedures for Minimizing Drug Errors
Medication errors are a substantial source of morbidity and mortality risk in the hospitalized setting. Therefore, hospitals must take steps to prevent, identify, and minimize these errors. These steps must be based on accepted professional principles. This includes not only ensuring that the pharmacy processes conform to of accepted standards of pharmacy practice but also proactively identifying and reviewing Adverse Drug Events (ADE) that occur. Pharmacies also need to be aware of external alerts to real or potential pharmacy-related problems in hospitals.
The pharmaceutical services policies and procedures must be designed to minimize drug errors and are expected to address:
• High-alert medications - are considered inherently high risk for adverse drug events. High alert drugs may include controlled medications, medications not on the approved FDA list, medications with a narrow therapeutic range, psychotherapeutic medications, look-alike/sound-alike medications and those new to the market or new to the hospital. Although mistakes may or may not be more common with these drugs, the consequences of errors are often harmful, sometimes fatal, to patients. Examples of ways to minimize high alert medication errors include, but are not
limited to, the following: dosing limits, administration guidelines, packaging, labeling and storage.
• Investigational medications - hospitals that conduct research involving investigational medications must have a policy and procedure in place to ensure that investigational medications are safely controlled and administered. Procedures for the use of investigational medications include, but are not limited to, the following: A written process for reviewing, approving, supervising and monitoring investigational medications specifying that when pharmacy services are provided, the pharmacy controls the storage, dispensing, labeling, and distribution of the investigational medication.
• Adherence to professional standards of practice for all compounding, packaging dispensing and drug disposal activities;
• Standardizing medication-related devices and equipment where feasible. For example, limit the types of general-purpose infusion pumps to one or two;
• Availability of up-to-date medication information and pharmacy expertise on-call when pharmacy does not operate 24 hours a day;
• Standardization of prescribing and communication practices to include:
o Avoidance of dangerous abbreviations;
o All elements of the order – dose, strength, units (metric), route, frequency, and rate;
o Alert systems for look-like and sound-alike drug names;
o Use of facility approved pre-printed order sheets whenever possible.
o Prohibition of orders to “resume previous orders;”
• Availability of patient-specific information to all individuals involved in provision of pharmaceutical services. The patient information must be sufficient to properly order, prepare, dispense, administer and monitor medications as appropriate;
• Identification of when weight-based dosing for pediatric populations is required; and
• A voluntary, non-punitive, reporting system to monitor and report adverse drug events (including medication errors and adverse drug reactions);
• Monitoring drug alerts and/or recalls. The hospital should have a means to incorporate external alerts and/or recommendations from national associations and
governmental agencies for review and facility policy and procedure revision consideration. National associations could include Institute for Safe Medications Practice and National Coordinating Council for Medication Error Reporting and Prevention. Governmental agencies may include: Food and Drug Administration, Med Watch Program; and
• The hospital’s pharmacy services must be integrated into its hospital-wide QAPI program and therefore, it is important to flag new types of mistakes and continually improve and refine policies and procedures as a result of analyses of errors and adverse events.
A-0492 482.25(a)(1) A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.
Interpretive Guidelines §482.25 and §482.25(a)(1)
Pharmaceutical services offered throughout the hospital must be under the direction of a pharmacist, who may be full-time, part-time, or consulting. This is required even in the case of a hospital that has a drug storage area instead of a pharmacy. The director must have documented training or expertise in hospital pharmacy practice and management. The hospital must have written criteria for the qualifications of the pharmacy director in accordance with the scope of services provided.
The extent of pharmaceutical services provided by the hospital determines whether a part-time director of the services is sufficient. Depending on the volume and complexity of the hospital’s services, oversight may not require full-time on-site management at the hospital’s pharmacy, but may be accomplished through regularly scheduled visits, and/or use of telecommunications in accordance with Federal and State law and accepted professional principles. If the hospital does not have a full-time pharmacist, it must be able to provide evidence of how a part-time or consulting pharmacist is able to perform all functions relating to developing, supervising and coordinating all pharmacy services activities.
In general, hospital pharmacies are staffed with registered pharmacists and pharmacy technicians who perform various functions, including, but not limited to, compounding, labeling, and dispensing of various drugs and biologicals.
There may be instances of small hospitals that do not have a pharmacy but utilize a drug storage area for dispensing pre-packaged drugs only. If the hospital has a drug storage area in lieu of a pharmacy, the day-to-day operations of pharmaceutical services must be under the supervision of an individual who, if not a pharmacist, nevertheless has documented competency to oversee compliance with all the pharmaceutical services regulatory requirements (e.g., security, access to locked areas, etc.). The hospital must establish in writing the qualifications of the drug storage area supervisor.
The job description or the written agreement for the responsibilities of the pharmacist director should be clearly defined and include development, supervision and coordination of all the activities of pharmacy services, including active leadership of those committees responsible for establishing medication-related policies and procedures.
A-0493 482.25(a)(2) The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.
Interpretive Guidelines §482.25(a)(2)
There must be sufficient personnel to respond to the pharmaceutical needs of the patient population being served.
The pharmaceutical services staff must be sufficient in types, numbers, and training to provide quality services, including 24 hour, 7-day emergency coverage, or there is an arrangement for emergency services, as determined by the needs of the patients and as specified by the medical staff.
The number of pharmacists and/or the number of hours of services provided by pharmacists at the hospital, or at each location of the hospital that provides pharmaceutical services, must meet and be in accordance with the needs of its patients and accepted professional principles (as previously defined), and reflect the scope and complexity of the hospital’s pharmaceutical services.
There must be sufficient numbers and types of personnel to provide accurate and timely medication delivery, ensure accurate and safe medication administration and to provide appropriate clinical services as well as the participation in continuous quality improvement programs that meet the needs of the patient population being served.
A-0494 482.25(a)(3) Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.
Interpretive Guidelines §482.25(a)(3)
Components of a record system to maintain current and accurate records of the receipt and disposition of scheduled drugs would include:
• Accountability procedures to ensure control of the distribution, use, and disposition of all scheduled drugs.
• Records of the receipt and disposition of all scheduled drugs must be current and must be accurate.
• Records trace the movement of scheduled drugs throughout the service.
• The pharmacist is responsible for determining that all drug records are in order and that an account of all scheduled drugs is maintained and reconciled.
• The record system, delineated in policies and procedures, tracks movement of all scheduled drugs from the point of entry into the hospital to the point of departure either through administration to the patient, destruction or return to the manufacture. This system provides documentation on scheduled drugs in a readily retrievable manner to facilitate reconciliation of the receipt and disposition of all scheduled drugs.
• All drug records are in order and an account of all scheduled drugs is maintained and any discrepancies in count are reconciled promptly.
• The hospital system is capable of readily identifying loss or diversion of all controlled substances in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion?
• Facility policies and procedures should minimize scheduled drug diversion.
A-0500 482.25(b) In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law.
Interpretive Guidelines §482.25(b)
Drugs and biologicals must be controlled and distributed in accordance with applicable Federal and State laws and regulations, and in accordance with applicable standards of practice. Applicable standards of practice include compliance with all Federal and State laws, regulations, and guidelines. The procedures established to prevent unauthorized usage and distribution must provide for an accounting of the receipt and disposition of drugs subject to the Comprehensive Drug Abuse Prevention and Control Act of 1970.
Other sources of additional guidelines could include, but are not limited to: American Society of Health-System Pharmacists, American College of Clinical Pharmacy, American Pharmacists Association, United States Pharmacopeia, etc.
NOTE re: US Pharmacopeia/National Formulary (USP/NF)
According to the Federal Food, Drug and Cosmetic Act (FCDA), the official compendia of the United States for excipients, drug substances, and drug products is the USP/NF. It is published every year in November by the United States Pharmacopeial Convention (http://www.usp.org/) and includes two supplements published in February and June.
The USP is a not-for-profit, non-governmental organization that since 1820 has established quality standards for, among other things, drug substances, drug products and compounded preparations. Congress established a role for USP standards in the adulteration provision of the 1906 Food and Drug Act. That role was expanded in the modern Food, Drug and Cosmetic Act (FDCA) beginning in 1938, with a role for USP compendial standards for naming and identity; strength, quality, and purity; and packaging and labeling, in both the adulteration and misbranding provisions of FDCA. (See, for example, §501(b) of the FDCA regarding compendial standards for strength, quality and purity, §502(g) for compendial standards for packaging and labeling). Under the FDCA, a drug with a name recognized in the USP/NF must comply with compendial identity standards, or be deemed adulterated, or misbranded, or both. To avoid being deemed adulterated, such drugs must also comply with compendial standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs.
The hospital must have a process in place for medication orders to be received in the pharmacy and dispensed in a safe and timely manner. Safe dispensing of medications must be in accordance with accepted standards of practice and includes, but is not limited to, the following:
• Implementing systems such as dose limits, pre-printed orders, special labeling, or double checks to minimize adverse drug events, especially for high alert medications;
• Reviewing all medication orders (except in emergency situations) for appropriateness by a pharmacist before the first dose is dispensed. A process is established for resolving questions with the prescribing practitioner and the discussion and outcome are documented in the patient’s medical record or pharmacy copy of the prescriber’s order;
This review should include:
• Therapeutic appropriateness of a patient’s medication regimen;
• Therapeutic duplication in the patient’s medication regimen;
• Appropriateness of the drug, dose, frequency, and route of administration;
-- NOTE re: US Pharmacopeia/National Formulary (USP/NF)
According to the Federal Food, Drug and Cosmetic Act (FCDA), the official compendia of the United States for excipients, drug substances, and drug products is the USP/NF. It is published every year in November by the United States Pharmacopeial Convention (http://www.usp.org/) and includes two supplements published in February and June.
The USP is a not-for-profit, non-governmental organization that since 1820 has established quality standards for, among other things, drug substances, drug products and compounded preparations. Congress established a role for USP standards in the adulteration provision of the 1906 Food and Drug Act. That role was expanded in the modern Food, Drug and Cosmetic Act (FDCA) beginning in 1938, with a role for USP compendial standards for naming and identity; strength, quality, and purity; and packaging and labeling, in both the adulteration and misbranding provisions of FDCA. (See, for example, §501(b) of the FDCA regarding compendial standards for strength, quality and purity, §502(g) for compendial standards for packaging and labeling). Under the FDCA, a drug with a name recognized in the USP/NF must comply with compendial identity standards, or be deemed adulterated, or misbranded, or both. To avoid being deemed adulterated, such drugs must also comply with compendial standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs.--
• Real or potential medication-medication, medication-food, medication-laboratory test and medication-disease interactions;
• Real or potential allergies or sensitivities; and
• Other contraindications.
• Medications dispensed by the hospital are retrieved when recalled or discontinued by the manufacturer or the Food and Drug Administration (FDA) for safety reasons;
• Policies and procedures that address the use of medications brought into the hospital by patients or their families when self-administration of medications is permitted by hospital policy; and
• Having a system in place to reconcile medications that are not administered (e.g., left in the patient’s medication drawer) when the pharmacy inventories patient medications or restocks patient medications. For example, did the patient refuse the medication, was there a clinical or treatment reason the medication was not used, or was the medication not used due to an error?
Monitoring the Effects of Medications
The pharmaceutical service may be responsible for monitoring the effects of medication(s) specified per hospital policy to assure medication therapy is appropriate and minimizes the occurrence of adverse events. Typically this occurs with anticoagulant therapy and antibiotics prescribed for the pharmacy to establish or adjust the dosage (i.e.; “pharmacy to dose” order). In such cases, the pharmacy’s monitoring process includes:
• Clinical and laboratory data to evaluate the efficacy of medication therapy to anticipate or evaluate toxicity and adverse effects;
• Physical signs and clinical symptoms relevant to the patient’s medication therapy;
• Assessing the patient’s own perceptions about side effects, and, when appropriate, perceived efficacy.
(See also the Nursing CoP discussion regarding monitoring of patients at §482.23(c)(4)).
A-0501 482.25(b)(1) All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws.
Interpretive Guidelines §482.25(b)(1)
All pharmaceutical services involving compounding, packaging, or dispensing of drugs and biologicals, must be conducted by or under the supervision of a pharmacist and performed consistent with State and Federal laws. The hospital must adopt and implement written policies and procedures to ensure all medications are prepared by authorized personnel.
Hospitals use many medications that need to be reconstituted, mixed or which otherwise may be considered “compounded” preparations. Some may be compounded in the hospital pharmacy and/or the hospital may obtain some or all from external sources. The external sources could include:
• registered outsourcing facilities, and/or
• compounding pharmacies.
Regardless of the source, if accepted standards for safe compounding are not met, compounded medications may contain less or more than the intended dose and/or may be chemically or microbiologically contaminated, with potentially devastating or even lethal consequences for the patients who receive them.
Use of Registered Outsourcing Facilities
The Drug Quality and Security Act (DQSA), signed into law on November 27, 2013, contains provisions relating to the oversight of compounding of human drugs. The DQSA created a new section 503B in the FDCA under which a compounder may elect to become an “outsourcing facility.” The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B of the FDCA. Facilities that elect to register as outsourcing facilities, per section 503B:
• Must comply with the FDA’s Current Good Manufacturing Practice (CGMP) requirements, which contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The CGMP requirements make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. The FDA’s publishes the most current versions of its draft and final regulations and guidance related to compounding on its website: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm ;
• Will be inspected by FDA according to a risk-based schedule; and
• Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
In a January 2014 letter to purchasers of compounded medications (available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm380596.htm ), the Commissioner of the FDA encouraged the use of registered outsourcing facilities and noted that,“[a]s a purchaser of compounded drugs, you can play an important role in improving the quality of compounded drugs by requiring compounding pharmacies that supply drugs to your facility to register as outsourcing facilities. Once they register, you and the patients you serve can be assured that FDA will inspect these facilities on a risk-based schedule, hold them to CGMP requirements, monitor the adverse event reports they are required to submit to the agency, and require appropriate labeling.”
FDA has posted a list of Registered Human Drug Compounding Outsourcing Facilities, including the end date of the last FDA inspection related to compounding, whether investigators observed any significant objectionable conditions, and whether other FDA actions were taken based on the last inspection, at: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm378645.htm
Note that these registered outsourcing facilities are also popularly referred to as “503B pharmacies.”
Use of Compounding Pharmacies
Compounding pharmacies, not registered as an outsourcing facility with the FDA, are popularly referred to as “503A pharmacies” and generally are subject to oversight only by their State pharmacy board. If a hospital obtains compounded medications from a compounding pharmacy rather than a manufacturer or a registered outsourcing facility, then the hospital must demonstrate how it assures that the compounded medications it receives under this arrangement have been prepared in accordance with accepted professional principles for compounded drugs as well as applicable State or Federal laws or regulations. For example, does the contract with the vendor include provisions:
• Ensuring that the hospital has access to quality assurance data verifying that the vendor is adhering to current USP <795> and <797> requirements, and can the hospital document that it obtains and reviews such data?
• Requiring the vendor to meet the requirements of Section 503A of the FDCA concerning pharmacy compounding of human drug products?
"For Information – Not Required/Not to be Cited"
--ASHP Research and Education FoundationTM “Outsourcing Sterile Products Preparation: Contractor Assessment Tool”
The ASHP Research and Education FoundationTM offers a tool that hospitals may find useful for assessing vendors that provide compounded sterile preparations. The tool can be found at:
http://www.ashpfoundation.org/MainMenuCategories/PracticeTools/SterileProductsTool.aspx and click on "Start using Sterile Products Outsourcing Tool now."--
Medications Compounded by the Hospital’s Pharmacy
Only the pharmacy compounds or admixes all sterile medications, intravenous admixtures, or other drugs except in emergencies or when not feasible (for example, when there is a need for emergency or immediate patient administration of a compounded sterile preparation). In addition, all compounding of medications used or dispensed by the hospital must be performed consistent with standards of practice equivalent to or more stringent than those described in the compounding-related chapters in the United States Pharmacopeia and the National Formulary (USP) published by the U.S. Pharmacopeial Convention, which are recognized as authoritative guidance regarding minimum standards of safe practice applicable to both sterile and non-sterile compounding.
The definition of compounding as that term is used in the USP is found in USP Chapter <795> (USP <795>):
“The preparation, mixing, assembling, altering, packaging and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following:
• Preparation of drug dosage forms for both human and animal patients;
• Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns;
• Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients;
• Preparation of drugs or devices for the purposes of, or as incident to, research (clinical or academic), teaching or chemical analysis;
• Preparation of drugs and devices for prescriber’s office use where permitted by federal and state law.”
Compounded medications, whether non-sterile or sterile, may be subject to physical and chemical contamination and unintended variations in strength. Microbial contamination and bacterial endotoxins are particularly hazardous with respect to compounded medications that are intended to be sterile.
USP <797> outlines minimum standards of practice to be followed by all health care personnel in any setting when preparing, storing and transporting “compounded sterile preparations” (CSPs). Its stated objective is “to describe conditions and practices to prevent harm, including death, to patients that could result from…microbial contamination…excessive bacterial endotoxins…variability of intended strength of correct ingredients…unintended chemical and physical contaminants…and ingredients of inappropriate quality….” Contaminated CSPs are especially hazardous if administered into body cavities, the central nervous system, vascular system, eyes, joints, and/or used as baths for live organs and tissues. “All compounded dosage forms that must be sterile when they are administered to patients” are considered by USP <797> to be CSPs, including but not limited to:
• “Aqueous bronchial and nasal inhalations;
• Baths and soaks for live organs and tissues;
• Injections [and infusions];
• Irrigations for wounds and body cavities;
• Ophthalmic drops and ointments;
• Tissue implants.”
USP <797> specifies differing standards for the physical layout and structure of the locations in which compounding takes place as well as processes, precautions and quality assurance practices to be implemented during the preparation, transport and storage of CSPs. The standards differ in part based on the level of risk of microbial contamination of the CSP, and the risk level has implications for whether a CSP must be terminally sterilized before being dispensed and for how long a CSP may be stored before use. The risk categories and accompanying standards are based on specific criteria, including but not limited to, factors such as:
• The structural design, environmental controls, air quality levels (based on International Organization for Standardization (ISO) standards for particulate matter in air) and air flow patterns in and surrounding the environment to which the contents of the CSP as well as the surfaces of devices and containers for the preparation, transfer, sterilization and packaging of CSPs are exposed.
• The sterility of the original ingredients and/or device(s) used in compounding, the number of containers that need to be entered, how many times they need to be entered, the nature and complexity of the manipulations and length of time required to prepare the CSP.
• Whether compounding personnel are appropriately garbed and gloved.
• Whether multiple doses of sterile products are pooled to produce a CSP that will be administered on more than one occasion or to more than one patient.
The goal of the USP <797> standards is to prevent and/or minimize the risk of microbial contamination of CSPs, whether by direct contact, exposure to particles in air generated by personnel or objects, or other mechanisms. A major concern is preventing contamination of “critical sites,” which include “any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, needle hubs) exposed or at risk of direct contact with air…moisture…or touch contamination.”
USP <797> describes two basic structural designs for the physical layout and environmental controls intended to minimize airborne contamination of critical sites during preparation of CSPs. The risk level of the CSPs a facility can produce depends, in part, on which USP <797> environmental quality and control/facility design standards the hospital (or its vendor) is able to meet (low-risk level, medium-risk level and high-risk level are discussed here; see §482.23(c) for a discussion of “immediate-use” CSPs):
• Some facilities may only prepare low-risk level nonhazardous and radiopharmaceutical CSPs pursuant to a physician order for a specific patient, and administration must commence within the lesser of 12 hours of preparation or as recommended in the manufacturer’s package insert. Such a facility would have a designated, demarcated room or space that is the “segregated compounding area (SCA),” which contains a device that provides unidirectional airflow of International Standards Organization (ISO) Class 5 air quality (quality class ranges from class 0, the most stringent, to class 9, the most relaxed). The SCA may not be in an area with unsealed openings/potential openings to high traffic locations, the outdoors and other proscribed environmental conditions, and the SCA area may not contain any materials or be the site of any activities unrelated to preparing low-risk CSPs.
• If a facility is preparing high- or medium-level risk CSPs or low-risk CSPs with a beyond-use date of greater than 12 hours, it must meet additional environmental design and monitoring/testing standards in the buffer and ante-areas.
• USP<797> contains separate standards for the safe compounding of hazardous medications (defined as “...if studies in animals or humans indicate that exposures to them have a potential for causing cancer, development or reproductive toxicity, or harm to organs…”), radiopharmaceuticals and allergen extracts.
In addition, USP <797> includes standards for various processes, precautions and quality assurance practices required and recommended for the safe preparation of all risk levels of CSPs. These address issues such as:
• The responsibilities of compounding personnel and their supervisors to implement and maintain proper procedures and quality assurance checks;
• Issues specific to “immediate use” CSPs; single- and multiple-dose containers; CSPs containing hazardous drugs; radiopharmaceuticals; allergen extracts; and automated compounding devices used for parenteral nutrition compounding;
• Methods for sterilization, depyrogenation and for verifying compounding accuracy and sterility;
• Specifications for environmental quality and control, including but not limited to;
• Specifications and related personnel training, including competency assessment and evaluation of skill in aseptically preparing CSPs using visual observation as well as bacterial sampling of glove fingertips and “media-fill testing” at specified intervals;
• Evaluation and monitoring/testing of the environment in which compounding takes place and, if applicable, the adjacent “ante-” and “buffer” areas, including facility layout, design, environmental controls, restricted access, air quality standards and testing, surface characteristics, furnishings, cleaning and disinfection procedures, and standards for personnel health, attire/cosmetics, cleansing/garbing/gloving, aseptic work practices, etc;
• Suggested standard operating procedures to protect the quality of the environment in which CSPs are prepared;
• Quality control related to ingredients, devices and equipment used in relation to CSPs;
• Quality checks to be performed before CSPs are dispensed or administered;
• Issues related to beyond-use dating and packaging, storage and transportation conditions for CSPs;
• Protecting dispensed and distributed CSPs;
• Patient education issues;
• Monitoring for and reporting adverse patient events related to CSPs;
• Requirements for a formal quality assurance program to be maintained by providers of CSPs.
"For Information – Not Required/Not to be Cited"
--USP <797> Appendices I and III-V contain summaries and assessment tools that hospitals may find helpful. However, there is no requirement to use specific forms or materials as long as the hospital and/or its external sources of CSPs are implementing plans, procedures, testing and documentation consistent with applicable standards for safe compounding. These USP <797> materials are referenced here only as examples:
• “Appendix I: Principal Competencies, Conditions, Practices, and Quality Assurances That Are Required…and Recommended in USP Chapter <797>”
• “Appendix III:“Sample Form for Assessing Hand Hygiene and Garbing Related Practices of Compounding Personnel”
• “Appendix IV:“ “Sample Form for Assessing Aseptic Technique and Related Practices of Compounding Personnel”
• “Appendix V:“ “Sample Form for Assessing Cleaning and Disinfection Procedures”--
Packaging and Labeling of Medications
Safe medication use includes proper packaging and labeling to reduce the risk of error. For individual drug containers: each floor stock drug container is expected to be labeled with the name and strength of the drug, lot and control number equivalent, and expiration date. Appropriate accessory and cautionary statements are included as well as the expiration date and/or, if applicable, a beyond-use date (BUD). It should be noted that, for multi-dose medication vials with antimicrobial preservatives which have been opened or entered (e.g., needle-punctured), the USP standard is that the BUD is 28 days, unless otherwise specified by the manufacturer. In addition, where applicable, each patient’s individual drug container is expected to be labeled with the patient’s full name and quantity of the drug dispensed.
If the unit dose system is utilized, each single unit dose package is expected to be labeled with the name and strength of the drug, lot and control number equivalent, expiration date and/or, if applicable, a BUD.
"For Information Only"
--Certain provisions of the FDCA address the labeling of prescription drugs generally (e.g., section 503(b)(2) of the FDCA). Section 503B of the FDCA includes labeling requirements for drugs compounded by registered outsourcing facilities (see section 503B(a)(10)). Although hospitals are expected to comply with these requirements, surveyors conducting a Medicare survey do not assess compliance with other Federal laws.--
Dispensing of Medications
Medications must be dispensed by the hospital in a manner that is safe and meets the needs of the patient:
• Quantities of medications are dispensed which minimize diversion and potential adverse events while meeting the needs of the patient;
• Medications are dispensed in a timely manner. The hospital must have a system that ensures that medication orders get to the pharmacy and medications get back to patients promptly;
• Whenever possible, medications are dispensed in the most ready to administer form available from the manufacturer or, if feasible, in unit dose that have been repackaged by the pharmacy;
• The hospital consistently uses the same dose packaging system, or, if a different system is used, provides education about the use of the dose packaging system;
• All concerns, issues or questions are clarified with the individual prescriber before dispensing; and
• Medications dispensed by the hospital are retrieved when recalled or discontinued by the manufacturer or the Food and Drug Administration (FDA) for safety reasons.
Medications must be available for administration to patients when needed, including when the pharmacy is not open. Methods to accomplish this when the pharmacy is not open could include, but are not limited to, one or more of the following: automated dispensing units outside the pharmacy, night cabinets, contracted services after hours via telepharmacy contracting, on-call pharmacists, etc.
• Automated Dispensing Cabinets (ADCs) for medications are a secure option for medication storage since they ensure locked storage of medications and allow for electronic tracking of controlled substances and other drugs. These cabinets often have embedded security features, such as login and password or biometric identification so that they can only by accessed by authorized personnel.
• Policies and procedures must address who can access medications during after-hours.
"For Information Only – Not Required/Not to be Cited"
--When utilizing automated dispensing cabinets (ADCs), the Institute for Safe Medication Practices recommendations include the following:
(See: http://www.ismp.org/Newsletters/acutecare/articles/20090212.asp and http://www.ismp.org/Tools/guidelines/ADC_Guidelines_Final.pdf )
Security processes are established to ensure adequate control of medications outside of the pharmacy and to reduce the potential for medication diversion from ADCs.
• Utilize biometric user identification or, at a minimum, change user passwords quarterly.
• Link the ADC to the pharmacy computer to allow for patient “profiling,” so that a pharmacist can review each medication order and screen it for safety before the drug is dispensed or accessed by the nurse or other healthcare professional.
• Limiting the availability of overrides to the ADC system.
• Limiting access to drugs based on the patients profile so to decrease medication selection errors.
• Store each medication and strength in an individual lidded ADC compartment
that opens only when the specific medication is selected.
• Document the destruction of medication waste at the time of removal of the medication whenever possible. Record this waste via the ADC, and match the administered dose with ordered dose. Have a process to routinely review/reconcile the documented medication waste.
• Return all medications to a common secure one-way return bin that is maintained by pharmacy, not to an individual pocket or bin within the ADC.--
A-0502 482.25(b)(2)(i) All drugs and biologicals must be kept in a secure area, and locked when appropriate.
Interpretive Guidelines §482.25(b)(2)(i)
A secure area means that drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals. Drugs and biologicals must not be stored in areas that are readily accessible to unauthorized persons. For example, if medications are kept in a private office, or other area where patients and visitors are not allowed without the supervision or presence of a health care professional (for example, ambulatory infusion), they are considered secure. Areas restricted to authorized personnel only would generally be considered “secure areas.” If there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the hospital is expected to evaluate its current medication control policies and procedures, and implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained. (71 FR 68689)
All controlled substances must be locked. Hospitals are permitted flexibility in the storage of non-controlled drugs and biologicals when delivering care to patients, and in the safeguarding of drugs and biologicals to prevent tampering or diversion. An area in which staff are actively providing care to patients or preparing to receive patients, i.e., setting up for procedures before the arrival of a patient, would generally be considered a secure area. When a patient care area is not staffed, both controlled and non-controlled substances are expected to be locked.
Generally labor and delivery suites and critical care units are staffed and actively providing patient care around the clock, and, therefore, considered secure. However, hospital policies and procedures are expected to ensure that these areas are secure, with entry and exit limited to appropriate staff, patients and visitors.
The operating room suite is considered secure when the suite is staffed and staff are actively providing patient care. When the suite is not in use (e.g., weekends, holidays and after hours), it would not be considered secure. A hospital may choose to lock the entire suite, lock non-mobile carts containing drugs and biologicals, place mobile carts in a locked room, or otherwise lock drugs and biologicals in a secure area. If an individual operating room is not in use, the hospital is expected to lock non-mobile carts, and ensure mobile carts are in a locked room. (71 FR 68689)
This regulation gives hospitals the flexibility to integrate patient self-administration of non-controlled drugs and biologicals into their practices as appropriate. When a hospital allows a patient to self-administer selected drugs and biologicals, the hospital authorizes the patient to have access to these medications. This regulation is consistent with the current practice of giving patients access at the bedside to urgently needed medications, such as nitroglycerine tablets and inhalers. It supports the current practice of placing selected nonprescription medications at the bedside for the patient’s use, such as lotions and creams, and rewetting eye drops. Hospitals are expected to address patient self-administration of non-controlled drugs and biologicals in their policies and procedures (see self-administration discussion at §§482.23(c)(6)(i) and 482.23(c)(6)(ii)). This regulation supports hospital development, in collaboration with the medical staff and the nursing and pharmacy departments, of formal patient medication self-administration programs for select populations of patients, including hospital policies and procedures necessary to ensure patient safety and security of medications. The policies and procedures are expected to include measures to ensure the security of bedside drugs and biologicals. They are also expected to address both the competence of the patient to self-administer drugs and biologicals as well as patient education regarding self-administration of drugs and biologicals. (71 FR 68689)
Due to their mobility, mobile nursing medication carts, anesthesia carts, epidural carts and other medication carts containing drugs or biologicals (hereafter, all referred to as “carts”) must be locked in a secure area when not in use. Hospital policies and procedures are expected to address the security and monitoring of carts, locked or unlocked, containing drugs and biologicals in all patient care areas to ensure their safe storage and to ensure patient safety. (71 FR 68689)
Medication automated distribution units with security features, such as logon and password or biometric identification, are considered to be locked, since they can only be accessed by authorized personnel who are permitted access to the medications. Such units must be stored in a secure area.
A-0503 482.25(b)(2)(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area.
Interpretive Guidelines §482.25(b)(2)(ii)
All Schedule II, III, IV, and V drugs must be kept locked within a secure area. A secure area means the drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals. Medication automated distribution units with logon and password/biometric identification are considered to be locked, since they can only be accessed by authorized personnel who are permitted access to Schedule II –V medications.
Mobile nursing medication carts, anesthesia carts, epidural carts and other medication carts containing Schedule II, III, IV, and V drugs must be locked within a secure area.
A-0504 482.25(b)(2)(iii) Only authorized personnel may have access to locked areas.
Interpretive Guidelines §482.25(b)(2)(iii)
The hospital must assure that only authorized personnel may have access to locked areas where drugs and biologicals are stored.
A hospital has the flexibility to define which personnel have access to locked areas, based on the hospital’s needs as well as State and local law. For example, a hospital could include within its definition of “authorized personnel” ancillary support personnel, such as engineering, housekeeping staff, orderlies and security personnel as necessary to perform their assigned duties. The hospital’s policies and procedures must specifically address how “authorized personnel” are defined for purposes of this section. It is not necessary for the policy to name specific authorized individuals, but the policy should be clear in describing the categories of personnel who have authorized access, as well as whether there are different levels of access authorized in different areas of the hospital, or at different times of day, or for different classes of drugs and biologicals, etc.
The hospital’s policies and procedures must also address how it prevents unauthorized personnel from gaining access to locked areas where drugs and biologicals are stored. Whenever unauthorized personnel have access, or could gain access, to those locked areas, the hospital is not in compliance with this requirement and is expected to re-evaluate and tighten its security measures.
A-0505 482.25(b)(3) Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.
Interpretive Guidelines §482.25(b)(3)
The hospital must have a pharmacy labeling, inspection, and inventory management system that ensures that outdated, mislabeled, or otherwise unusable drugs and biologicals are not available for patient use. This would include drugs that are the subject of a manufacturer’s recall.
A drug or biological is outdated after its expiration date, which is set by the manufacturer based on stability testing under specified conditions as part of the FDA approval process. It should be noted that a drug or biological may become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s approved labeling.
A drug or biological is also outdated after its “beyond-use date” (BUD), which may be reached before the expiration date, but never later. The BUD takes into account the specific conditions and potential for deterioration and microbial growth that may occur during or after the original container is opened, while preparing the medication for dispensing and administration, and/or during the compounding process if it is a compounded medication.
The BUD is to be based on information provided by the manufacturer, whenever such information is available. The hospital must maintain and implement policies and procedures that provide clear and consistent direction to pharmacy staff regarding how to determine a BUD when complete BUD information is not available from the manufacturer. The policies and procedures must be based on accepted professional principles which are equivalent to, or more stringent than, those described in the United States Pharmacopeia-National Formulary (USP).9
According to Chapters <795> and <797> of the USP, the BUD must be safe for patients, and determined conservatively. The section in USP <797> entitled “Determining Beyond-Use Dates,” which addresses sterile compounding, notes that “the truly valid evidence for predicting beyond-use dating can be obtained only through product-specific experimental studies.” It provides an example of testing considered more appropriate for certain types of compounded sterile preparations (CSPs) such as “CSPs with a narrow therapeutic index, where close monitoring or dose titration is required to ensure therapeutic effectiveness and to avoid toxicity….” It also provides examples of important issues that a pharmacist must be able to critically interpret and evaluate when consulting literature sources in the process of determining a BUD; and distinguishes between reviewing literature specific to a particular drug, composition, concentration of ingredients, fill volume, container, storage conditions and duration of use, etc., versus merely reviewing available publications or tables. The former is the preferred approach, while the latter results in a “theoretical BUD,” which has an inherent likelihood of inaccuracy or error.
For individual drug containers: each floor stock drug container is expected to be labeled with the name and strength of the drug, lot and control number equivalent, and expiration date. Appropriate accessory and cautionary statements are included as well as the expiration date and/or, if applicable, a BUD. It should be noted that, for multi-dose medication vials with antimicrobial preservatives which have been opened or entered (e.g., needle-punctured), the USP standard is that the BUD is 28 days, unless otherwise specified by the manufacturer. In addition, where applicable, each patient’s individual drug container is expected to be labeled with the patient’s full name and quantity of the drug dispensed.
If the unit dose system is utilized, each single unit dose package is expected to be labeled with the name and strength of the drug, lot and control number equivalent, expiration date and/or, if applicable, a BUD.
--Footnote: 9All references to “USP” herein are from: United States Pharmacopeial Convention. USP on Compounding: A Guide for the Compounding Practitioner. Current with USP 37-NF32 through First Supplement. Rockville, MD: United States Pharmacopeial Convention, 2014.--
A-0506 482.25(b)(4) When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and State law.
Interpretive Guidelines §482.25(b)(4)
Routine after-hours access to the pharmacy by non-pharmacists for access to medication should be minimized and eliminated as much as possible. The use of well-designed night cabinets, after-hours medication carts, and other methods may preclude the need for non-pharmacist to enter the pharmacy. Policies and procedures should be consistent with Federal and State Law.
If an urgent or emergent patient need occurs, the hospital must be able to provide medications to the patients in its facility.
The hospital must have a process for providing medications to meet patient needs when the pharmacy is closed.
When non-pharmacist health care professionals are allowed by law and regulation to obtain medications after the pharmacy is closed, the following safeguards are applied:
• Access is limited to a set of medications that has been approved by the hospital. These medications can be stored in a night cabinet, automated storage and distribution device, or a limited section of the pharmacy.
• Only trained, designated prescribers and nurses are permitted access to medications.
• Quality control procedures (such as an independent second check by another individual or a secondary verification built into the system, such as bar coding) are in place to prevent medication retrieval errors.
• The hospital arranges for a qualified pharmacist to be available either on-call or at another location (for example, at another organization that has 24-hour pharmacy service) to answer questions or provides medications beyond those accessible to non-pharmacy staff.
• This process is evaluated on an on-going basis to determine the medications accessed routinely and the causes of accessing the pharmacy after hours.
• Changes are implemented as appropriate to reduce the amount of times non-pharmacist health care professionals are obtaining medications after the pharmacy is closed.
A-0507 482.25(b)(5) Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff.
Interpretive Guidelines §482.25(b)(5)
In accordance with accepted standards of practice, the medical staff, in coordination and consultation with the pharmacy service, determines and establishes the reasonable time to automatically stop orders for drugs and biologicals not specifically prescribed as to time or number of doses. The hospital must implement, monitor, and enforce this automatic stop system.
It is important to note that hospitals with an electronic health record (EHR) system may have time and dose parameters automatically built into computerized provider order entry (CPOE) screens. These may be part of the hospital’s plan for addressing automatic stop orders.
A-0508 482.25(b)(6) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’s quality assessment and performance improvement program.
Interpretive Guidelines §482.25(b)(6)
Hospitals are required to ensure that the attending physician is made immediately aware of drug administration errors, adverse drug reactions, and incompatibilities. When the attending physician is unavailable, the covering physician must be notified. When the covering physician must be notified, the patient’s attending physician must be notified as soon as he/she is available. In addition, when appropriate, such events must also be reported to the hospital-wide Quality Assessment and Performance Improvement (QAPI) program.
The hospital must adopt policies and procedures that identify the types of events that must be reported immediately to the attending physician, as well as those to be reported to the QAPI program.
• Drug administration error:
The National Coordinating Council Medication Error Reporting and Prevention definition of a medication error is “Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.” In the context of this regulation, however, “drug administration error” is limited to those errors in administration that actually reach the patient, i.e., a medication actually is administered to a patient when it should not be, or the wrong dose is administered, or the wrong root of administration is used, etc., or a medication that should have been administered to the patient has not been administered in a timely manner, as discussed in the medication administration standard at 42 CFR 482.23(c).
• Adverse drug reaction:
The American Society of Health-System Pharmacists (ASHP) defines an adverse drug reaction (ADR) as “Any unexpected, unintended, undesired, or excessive response to a drug that:
1. Requires discontinuing the drug (therapeutic or diagnostic)
2. Requires changing the drug therapy
3. Requires modifying the dose (except for minor dosage adjustments)
4. Necessitates admission to a hospital
5. Prolongs stay in a health care facility
6. Necessitates supportive treatment
7. Significantly complicates diagnosis
8. Negatively affects prognosis, or
9. Results in temporary or permanent harm, disability, or death.
Consistent with the definition, an allergic reaction (an immunologic hypersensitivity occurring as the result of unusual sensitivity to a drug) and an idiosyncratic reaction (an abnormal susceptibility to a drug that is peculiar to the individual) are also considered ADRs.”
• Drug incompatibilities
A drug incompatibility occurs when drugs interfere with one another chemically or physiologically. Drugs known to be incompatible must not be mixed, administered together, or administered within a timeframe where they will interfere with each other.
When IV medications are administered with known incompatibilities, an error has occurred and it needs to be reported to the attending physician immediately. Any unexpected reaction that occurs between IV medications not previously identified as incompatible also needs to be reported.
Hospitals can minimize the risk of administering incompatible medications by making available pertinent resources, such as drug incompatibility charts and online incompatibility references. The incompatibility information needs to be readily available to staff administering medications. The information needs to be kept up-to-date as the information is frequently updated by drug manufacturers.
The immediate reporting requirement applies to drug administration errors, adverse drug reactions or incompatibilities that have harmed or have the potential to harm the patient. If the outcome of the drug administration error is unknown, the physician must also be notified without delay.
Drug administration errors that result in no or insignificant harm to the patient must also be documented in the medical record but do not require immediate reporting to the attending physician. For example, if an analgesic dose is missed during the night shift, it can be reported first thing in the morning. Hospital staff is expected to use their clinical judgment, based on patient presentation and assessment in accordance with hospital policy and procedures, to determine whether immediate reporting is required.
On the other hand, for purposes of reporting to the hospital’s QAPI program, hospitals must, in accordance with the requirements of the QAPI CoP at 42 CFR 482.21(c)(2), track and report not only the errors that cause or risk harm to the patient, but also those which do not. Such “near misses” and suspected ADRs may reveal important information about systems vulnerabilities that the hospital should address in order to avoid events that result in harm.
Hospitals must establish policies and procedures for reporting of medication errors, ADRs, and incompatibilities, and ensure that staff is aware of the reporting process. For those events that require immediate reporting, the hospital’s policies must establish timeframes for reporting that are based on the clinical effect of the error on the patient.
To improve staff willingness to report medication error incidents, hospitals are encouraged to adopt a non-punitive approach that focuses on system issues rather than individual health care professionals. A non-punitive approach is likely to encourage reporting by those who otherwise may fear retribution or hospital disciplinary action.
In addition to employing broad definitions of medication errors and ADRs for QAPI tracking purposes and encouraging the reporting of medication errors, ADRs and drug incompatibilities, the hospital must take additional steps to identify these events as part of its QAPI program where medical errors and adverse patient events are measured, analyzed and tracked. Reliance solely on incident reporting fails to identify the majority of errors and adverse reactions. Proactive identification includes observation of medication passes, concurrent and retrospective review of a patient’s clinical records, ADR surveillance team, implementation of medication usage evaluations for high-alert drugs, and identification of indicator drugs that, when ordered, automatically generate a drug regimen review for a potential adverse drug event.
The hospital must have a method by which to measure the effectiveness of its systems for identifying and reporting to the QAPI program medication errors and ADRs. Such methods could include use of established benchmarks for the size and scope of services provided by the hospital, or studies on reporting rates published in peer-reviewed journals. Hospitals are encouraged, and may be required by State law, to participate in statewide and national reporting of drug administration errors, adverse drug reactions, and incompatibilities. National organizations include, but are not limited to, the Food and Drug Administration’s (FDA) MedWatch Reporting Program and the Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program.
A-0509 482.25(b)(7) Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate.
No information available
A-0510 482.25(b)(8) Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff.
Interpretive Guidelines §482.25(b)(8)
The pharmacy must be a resource for medication-related information to the hospital’s health-care practitioners and other health care personnel to optimize therapeutic outcomes and minimize adverse drug events. Information must be available concerning drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration. The pharmacy may also assist other health care professionals with the following medication-related functions:
• Collection and organization of patient-specific information (height, weight, allergies);
• Identification of the presence of medication-therapy problems, both potential and actual, such as drug-drug interactions, excessive doses;
• Identification and specification of pharmaco-therapeutic goals;
• Implementation of a monitoring plan in collaboration with the patient, if applicable, and other health-care professionals;
• Monitoring the effects of the pharmacotherapeutic regimen – could include adjusting doses based on lab values (i.e.: Coumadin dosing); or
• Redesigning the regimen and monitoring plan as indicated.
For example, practitioners may write an order for “pharmacy to dose” an antibiotic. The pharmacist would then take patient-specific information, review the patient’s current medication therapies for any problems, and then calculate the dose required to meet therapeutic goals.
Increasingly, as hospitals move to computerized physician-order entry (CPOE) of medication orders, much of this consultation function (e.g.; dosage, path of administration, drug-drug interactions and other contraindications, etc.) is built in to the electronic health record (EHR) system. However, the pharmacy service remains responsible for the provision of accurate, up-to-date information to meet the needs of the hospital’s practitioners, nursing staff and patients.
The hospital must also have immediately available sufficient up-to-date reference material on drug therapy, whether in electronic or hard copy format. A pharmacist also should be readily available by telephone or other means to respond to questions from practitioners and nursing personnel.
A-0511 482.25(b)(9) A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs.
Interpretive Guidelines §482.25(b)(9)
The medical staff must establish a formulary system. The formulary lists medications for dispensing or administration that the hospital maintains or that are readily available. In accordance with accepted standards of practice, the medical staff, in consultation with the pharmacy service, should develop written criteria for determining what medications are available for dispensing or administration. At a minimum, the criteria include the indication for use, effectiveness, risks (including propensity for medication errors, abuse potential, and sentinel events), and costs.
Processes and mechanisms should be established to monitor patient responses to a newly added medication before the medication is made available for dispensing or administration within the hospital.
Medications designated as available for dispensing or administration are reviewed periodically based on emerging safety and efficacy information.
The hospital should have processes to approve and procure medications that are not on the hospital’s medication list.
The hospital should have processes to address medication shortages and outages,
including the following:
• Communicating with appropriate prescribers and staff;
• Developing approved substitution protocols;
• Educating appropriate LIPs, appropriate health care professionals, and staff about these protocols; and
• Obtaining medications in the event of a disaster.