Medications,  as an important resource in patient care, must be organized effectively and efficiently. A safe

medication management system addresses an organization’s medication processes, which in many organizations includes the following (as applicable):

a) Planning

b) Selection and procurement

c) Storage

d) Ordering

e) Preparing and dispensing

f ) Administration

g) Monitoring

h) Medication error and adverse event reporting

i) Evaluation

Medication management is not only the responsibility of the pharmaceutical service, but also of managers and health care practitioners. How this responsibility is shared depends on the hospital’s structure and staffing. In those cases in which a pharmacy is not present, medications may be managed on each clinical unit according to hospital policy. In other cases, in which a large central pharmacy is present, the pharmacy may organize and control medications throughout the hospital. Effective medication management includes all parts of the hospital inpatient, outpatient, and specialized units. Medication Management and Use (MMU)  However, medication is organized within the hospital, a qualified individual directly supervises the activities of the pharmacy or pharmaceutical service. (Also see GLD.9) The individual is trained and, if required, appropriately licensed and/or certified. Applicable laws and regulations are incorporated into the organizational structure and the operations of the medication management system used in the hospital.  To ensure efficient and effective medication management and use, the hospital conducts a systems review at least once a year. The annual review identifies how well the system is working by pulling together all information and experience related to medication management, as identified in a) through i) above. The review allows hospitals to understand the need and priority of continued system improvements in quality and safety of medication use

The overuse and misuse of antibiotics has resulted in the growth of superbugs that are increasingly resistant to available antibiotics. According to the US Centers for Disease Control and Prevention (CDC), drug-resistant bacteria cause 23,000 deaths and 2 million illnesses each year. The Institute for Healthcare Improvement reported that 25,000 people die each year in Europe from antimicrobial resistance, and microbial resistance is growing in the Middle East, Africa, and Asia. Some estimate that more than 700,000 deaths occur worldwide per year due to antibiotic resistance. In addition to resistance and the growth of superbugs, there are often side effects and/or complications to antibiotic treatment, including acquiring Clostridioides difficile (C. diff ), kidney or liver damage, hearing loss,hemolytic anemia, and other such complications. The proper use of antibiotics is important in the prevention of unnecessary complications due to improper antibiotic use. Health care practitioners are contributing to the development of antimicrobial resistance in several ways. For example, continuing antibiotics when they are no longer necessary, using a broad-spectrum antibiotic when it is not required or continuing the broad-spectrum antibiotic unnecessarily after the sensitivity results are received, using the wrong antibiotic or prescribing the wrong dose, or continuing the prophylacticantibiotic after it is no longer recommended. In order to reduce the development and spread of resistant bacteria and deliver better patient outcomes,hospitals must implement measures to ensure optimal use of antibiotics.  (Also see PCI.5; PCI.5.1; and GLD.11.2) Implementation of an antibiotic stewardship program will help hospitals reach the goal of providing patients requiring antibiotic treatment with the right antibiotics, at the right time, at the right dose,and for the right duration. An antibiotic stewardship program may include the following elements: tracking patterns of antibiotic prescribing and resistance, informing staff on antibiotic use and resistance on a regular basis, and educating staff about optimal antibiotic use. It is imperative for the program to have the support of hospital leadership,which includes leadership’s commitment to providing support that includes staffing, financial resources,evidence-based resources, and information technology to ensure an effective stewardship program. In addition to infection prevention and control professionals, the antibiotic stewardship program involves physicians, nurses, pharmacists, trainees, patients, families, and others. (Also see PCI.2)  Tracking the effectiveness of the program is an important element of the program’s success. Examples of identifying effectiveness may include evidence of a decrease in the inappropriate use of antibiotics and a decrease in multidrug-resistant organisms, documentation that prescribers are following accepted practice guidelines, and appropriate optimal use of prophylactic antibiotics. Successful tracking of the effectiveness of the program requires a mechanism for oversight. Oversight may include an individual, a small work group, a coordinating committee, a task force, or some other mechanism.

Every hospital must decide which medications to make available for prescribing and ordering by the healthcare practitioners. This decision is based on the hospital’s mission, patient needs, and types of services provided.The hospital develops a list (often referred to as a formulary) of all the medications it stocks or that are readily available from outside sources. In some cases, laws and regulations may determine the medications on the list or the source of those medications. Medication selection is a collaborative process that includes patient need and safety as well as economics. (Also see GLD.7.1) Medications are occasionally out of stock due to delayed delivery, national shortages, or other reasons not anticipated through normal inventory control. There is a process to notify prescribers of the shortage and suggested substitutes. The hospital has a method, such as designating a committee, to maintain and to monitor the medication list and to monitor the use of medications in the hospital; for example, monitoring the use of antibiotics. Those involved in the oversight of the list include health care practitioners involved in the ordering, dispensing, administering, and monitoring processes for medications. Decisions to add or to remove medications from the list are guided by criteria that include the indication for use, effectiveness, risks, and costs. There is a process or mechanism to monitor patient response to newly added medications. For example, when the decision is made to add a new type of medication or a new class of drugs to the list, there is a process to collect, aggregate, and monitor data related to appropriateness of indication, how the drug is prescribed(dosage or route, for example), and any unanticipated adverse events or conditions associated with the new drug during the introductory period. The list is reviewed at least annually based on emerging safety and efficacy information and information on usage and adverse events.

Medications may be stored within a storage area, in a pharmacy or pharmaceutical service, or on the patient care units in unit pharmacies or the nursing station in the clinical unit. Standard MMU.1 provides the

oversight mechanism for all locations where medications are stored. There are some types of medications that require special handling; for example, radioactive medications and hazardous medications pose a safety risk,

and investigational medications may require special storage and/or consent. In all locations where medications are stored, the following is evident:

• Medications stored in the pharmacy are stored under the conditions suitable for product stability as identified by the manufacturers.

• When medications are stored on individual patient care units, ambulances, or other areas outside of the pharmacy, the organization performs a risk assessment to identify the conditions suitable to

maintain product stability for the length of time the medications are stored outside the pharmacy, as applicable. (Also see ACC.6)

• Controlled substances are accurately accounted for according to applicable laws and regulations.

• Medications or products requiring special handling, such as radioactive medications, investigational medications, and other similar medications or products, are accurately labeled and safely stored, administered, and monitored.

• Medications and chemicals used to prepare medications are accurately labeled with contents, expiration dates, and warnings. (Also see FMS.7)

• Concentrated electrolytes are not stored in care units excluding the exceptions identified in the intent of IPSG.3.2 (scored at IPSG.3.2).

• Medications are protected from loss or theft throughout the hospital.

When patient emergencies occur, quick access to appropriate emergency medications is critical. Each hospital plans the location of emergency medications and the medications to be supplied in these locations. For example, agents to reverse anesthesia are found in the operating theatres. Emergency cabinets, carts, bags, or boxes can be used for this purpose. Emergency medications are stored uniformly to facilitate quick access to the correct medications. For example, in each emergency cart in the hospital, the emergency medications are in the same drawer, and the medications are laid out in the same manner within the drawer of each cart.This is particularly important for staff who may need to access an emergency medication from a cart they donot typically use. Storage of medications in pediatric emergency carts is different from adult emergencycarts; however, the medications are stored uniformly within each type of cart.To ensure access to emergency medications when needed, the hospital establishes a procedure or process toprevent abuse, theft, or loss of the medications. The process ensures that medications are replaced when used,damaged, or out of date. For example, incorporating emergency cart checks into the daily work of the unitstaff can help to ensure the integrity of the cart and its contents. The hospital understands the balance between ready access and security for locations where emergency medications are stored. For example, if access to emergency medications requires a specific individual(s) on the unit to unlock the emergency cart, and the individual(s) is unavailable, the medications are not readily accessible even though they may be secure. (Also seeFMS.6)Emergency resuscitation is a highly stressful situation in which time is a crucial element. As a result, the risk of medication errors occurring during emergency resuscitation may be higher. The Institute for Safe MedicationPractices (ISMP) identifies that commonly reported contributing factors to this higher risk of errors include look-alike product packaging or drug names; disorganized and nonstandard emergency carts; excessive stock in emergency carts; distractions caused by the hectic environment; poorly communicated verbal orders; inexperienced staff; alternative drugs in emergency carts; confusing or missing information about drugs; and multiple concentrations of a drug in emergency cart drawers. Therefore, when patient emergencies occur, quickaccess to appropriate emergency medications is critical. (Also see COP.3.3)

Consistency and uniformity in the approach to emergency resuscitation may significantly reduce the risks and

improve patient outcomes. For example, the hospital can take a risk-based approach to increase safety

and improve patient outcomes by looking at internal data from previous emergency situations to review the

availability of emergency medications or reviewing public literature on the subject. Examples of

strategies identified in the literature include the following:

• Use a strategy to differentiate between adult and pediatric medications; for example, using

separate adult and pediatric carts or, when using a universal cart, storing the medications andequipment in separate adult and pediatric drawers.

• Keep a designated medication box for neonates in areas that care for neonates.

• Standardize cart and drawer layout throughout the hospital.

A medication  recall occurs when a drug is removed from the market because it is found to be either defective or

potentially harmful. Defects to a medication may be related to incorrect packaging, potential contamination,

or poor manufacturing, resulting in impurities or errors in strength/potency. Sometimes, the makers of the

drug will identify a problem with their drug and voluntarily recall it. Other times, a government agency will

request that the medicine be recalled after receiving reports of problems from the public. Communications of

medication recalls may come directly from the manufacturer or from regulatory authorities. Hospitals must

ensure that they have a process for receiving notifications of medication recalls and for identifying, retrieving,

and returning, or safely and properly destroying, medications recalled by the manufacturer or supplier. The

recall process includes any medications compounded within the hospital in which products that have been

recalled have been used.

There is a policy or procedure that addresses any use of or the destruction of medications known to be expired

or outdated. An expired medication is one that is past the expiry date listed on the original packaging from the

manufacturer. An outdated medication is one that is opened and is typically safe and effective to use for a short

period of time after opening (shelf life). These outdated medications should be marked with a date of expiry

based on when they were opened so that staff know the end date of use.

Medication reconciliation is an important process of safe medication management for the patient and for

reducing the risks for adverse events. Patients entering a hospital are often taking multiple medications at

home and may be at risk of an adverse event if an accurate list of those medication is not documented in the

patient’s record. Medication discrepancies can affect patient outcomes. It can be difficult to obtain a

complete list from every patient in an encounter, and accuracy is dependent on the patient’s ability and

willingness to provide this information. A credible effort to collect this information is recognized as meeting

the intent of the requirement. Examples of a credible effort may include contacting the patient’s pharmacy

and/or family members or consulting with the patient’s primary physician.

The types of information that clinicians use to reconcile medications include, but are not limited to,

medication name, dose, frequency, route, and purpose. Organizations should identify the information that

needs to be collected to reconcile current and newly ordered medications and to safely prescribe medications

in the future. Good medication management includes a review of a proposed new medication against the list

of medications the patient is currently taking. (Also see ACC.4.3 and AOP.1.1) The goal of this review is to

improve the quality and safety of adding a new medication to the patient’s treatment plan and reduce the risk

of an adverse medication event. A listing of all current medications is recorded in the patient’s medical record

and is available to the pharmacy, nurses, and physicians. The hospital establishes a process to compare the

patient’s list of medications taken prior to admission against the initial orders.

Selecting a medication to treat a patient requires specific knowledge and experience. Each hospital is

responsible for identifying those individuals with the requisite knowledge and experience and who are

also permitted by licensure, certification, laws, or regulations to prescribe or to order medications.

(Also see COP.2.1; SQE.10; MOI.2; and MOI.9) A hospital may place limits on prescribing or ordering

byan individual, such as for controlled substances, chemotherapy agents, or radioactive and investigational

medications. (Also see SQE.12) Individuals permitted to prescribe and to order medications are known to the

pharmaceutical service or others who dispense medications. In emergency situations, the hospital identifies anyadditional individuals permitted to prescribe or to order medications.

A common cause of adverse events in the hospital setting is medication errors. One recent study reported that

“Medication errors are most common at the ordering or prescribing stage. Typical errors include the healthcare

provider writing the wrong medication, wrong route or dose, or the wrong frequency. These ordering errors

account for almost 50% of medication errors.” In paper records, illegible medication prescriptions or orders

are one cause of medication errors that jeopardize patient safety and may delay treatment. Strategies to

reduce illegibility of written orders are important in reducing the risk of medication errors. Safe prescribing,

ordering, and transcribing are guided by hospital policies and procedures. Medical, nursing, pharmacy, and

administrative staff collaborate to develop and to monitor the policies and procedures. Relevant staff are

trained in correct prescribing, ordering, and transcribing practices.

To reduce the variation and improve patient safety, the hospital defines the required elements of a complete

order or prescription.  (Also see MOI.9) All orders and prescriptions contain the name of the drug, the dose,

and the frequency and route of administration.  Also, the following additional elements are included in the

prescription and order when appropriate to the order:

a) The data necessary to accurately identify the patient (Also see IPSG.1)

b) When generic or brand names are acceptable or required (Also see MMU.2)

c) Specific guidelines for the use of PRN (pro re nata, or “as needed”) orders that include indications for

use and detailed directions for overlapping orders, such as more than one medication for pain

d) The types of orders that are weight based or otherwise adjusted, such as for children, frail elderly, and

oncology patients e) The types of orders that are adjusted for therapeutic range; for example, dosages may need to be

updated based on laboratory values for specific medications, such as heparin infusions or phenytoin

f ) Rates of administration when intravenous infusions are ordered

g) Other special orders such as titrating, tapering, or range orders

There are processes in place to manage

•  medication orders that are incomplete, illegible, or unclear; (Also see MOI.10)

•  precautions for ordering medications with look-alike or sound-alike names; (Also see IPSG.3.1)

•  special types of orders, such as emergency, standing, or automatic stop, and any elements unique to

such orders; (Also see COP.2.1) and

•  verbal, telephone, and text medication orders and the process to verify such orders (scored at IPSG.2

and MOI.12).

Thus, this standard sets hospitalwide expectations for medication orders. The processes are reflected in

complete orders entered in the medical record, the pharmacy or dispensing unit receiving the information

needed for dispensing, and the administration of the medication based on a complete order. (Also see MOI.8)

The pharmacy or pharmaceutical service and others with proper training and experience prepare and dispense medications in a clean and safe environment  that complies with laws, regulations, and professional practice standards. The hospital identifies the standards of practice for a safe and clean preparation and dispensing environment. (Also see PCI.4) For example, standards of practice can include how medication preparation areas are to be cleaned and when a mask should be worn or a laminar airflow hood should be used in the preparation of a medication. Some medications and solutions require preparation under very specific guidelines. Staff compounding  and preparing these medications are trained in the principles of medication preparation and aseptic technique. Similarly, positive-pressure rooms and laminar airflow hoods are available and used when indicated by professional practices; for example, in the preparation of sterile compounding, total parenteral nutrition (TPN) admixtures, chemotherapy, epidurals, and hazardous medications such as cytotoxic drugs. Due to the need for positive pressure capabilities and laminar airflow hoods to prepare thesemedications, it is recommended that they be exclusively prepared in the pharmacy unless the patient care unitis specialized with the needed safety equipment and staffed with trained individuals (for example, aspecialized oncology unit). A common situation in medication preparation that carries a risk of transmitting contagious diseases is the use of single-use and multidose vials on more than one patient. The misuse of these vials has caused harm to

individual patients through occurrences and outbreaks of bloodborne pathogens and associated infections in

both inpatients and outpatients—including hepatitis B and C virus, meningitis, and epidural abscesses. The

literature identifies standards and safe practices for the use of single-dose and multidose vials; for example,

ensuring that all needles and syringes are single patient use only and never reentering a vial with a used needle or used syringe. Medications that do not require pharmacy-specific safety measures such as sterile compounding  rooms orlaminar flow hoods and that are stored in and dispensed from areas outside the pharmacy (for example,patient care units) comply with the same cleanliness measures required in the pharmacy. In addition,medication dispensing areas located on patient care units should be free from clutter and distraction.

Good medication management includes two reviews of each prescription or order:

•  The appropriateness of the medication for the patient and his or her clinical needs performed at the

time the medication is prescribed or ordered

•  The verification at the time of administration that the medication is exactly as ordered or prescribed

(Also see MMU.6.1)

Each newly prescribed or ordered medication is reviewed for appropriateness, including a) through g) below. A

new appropriateness review should be conducted when the dosage or other appropriateness factors noted below

changes; for example, when new drugs are prescribed and therapeutic duplication may be an issue or when a

potential medication interaction may occur. The hospital defines what patient-specific information is required

for the appropriateness review of the order or prescription. For example, if a newly prescribed medication can

affect the kidneys or liver, the appropriateness review includes specific clinical information about the patient’s

renal and liver function, as well as when these organ functions change. The process to conduct an appropriateness review (the first review) for an order or prescription prior to

dispensing includes evaluation of

a) the appropriateness of the drug, dose, frequency, and route of administration;

b) therapeutic duplication;

c) real or potential allergies or sensitivities;

d) real or potential interactions between the medication and other medications or food;

e) variation from hospital criteria for use;

f ) patient’s weight and other physiological information; and

g) other contraindications.

The hospital determines the manner in which the appropriateness review is conducted. For example, the

appropriateness review may be conducted by individuals competent to do so by virtue of education and

training, such as licensed pharmacists, or as specified by privileging specific to performing appropriateness

reviews for licensed independent practitioners with training and competency in performing an appropriateness

review process; or for nurses or other professionals with training and demonstrated competency in the

review process. (Also see SQE.5; SQE.10; SQE.14; and SQE.16) The hospital may choose to use clinical

decision support programs associated with medication management to enhance the process. (Also see MOI.6)

Alternatively, the hospital may choose to use clinical decision support programs to conduct the appropriateness

review process. (Also see QPS.3) For example, many electronic medication ordering systems are designed

to review the order for the complete elements of an appropriateness review, including patient-specific clinical

information, and provide an alert to the ordering individual of a contraindication to prescribing the

medication. When the ordering individual overrides the alert, the hospital develops a process for a full

review

of the order by a health care practitioner who is trained and demonstrates competence in a full appropriateness

review.

Appropriateness reviews must be conducted even when circumstances are not ideal. For example, if the central

pharmacy or a unit pharmacy is not open, or the drug will be dispensed from stock on the ward or clinic,

the appropriateness review may be conducted in conjunction with the verification review when the ordering

individual will administer the medication and monitor the patient.

When the ordering individual is not available to administer the medication and monitor the patient, critical

elements of the appropriateness review may be performed by other trained and competent individuals for

administration of the first dose of the medication. The entire appropriateness review must be performed by a

licensed pharmacist, or other licensed professional, such as a nurse or physician, competent in the knowledge

required for a full appropriateness review within 24 hours. Critical elements of an appropriateness review

include at least the following:

h) Allergies

i) Lethal drug-drug interactions

j) Weight-based dosing

k) Potential organ toxicity (for example, administration  of potassium-sparing diuretics in patients with

renal failure)

The critical elements of the appropriateness review may be conducted by other licensed trained individuals

during times when the pharmacy is not available. These individuals require documented training in conducting

the critical elements of the appropriateness review and will be supported by reference materials, computer

programs, and other resources. Thus, when a physician calls in a new medication order during the night for a

patient, the trained individual will write down and read back the order and then conduct an appropriateness

review for the identified critical elements. (Also see IPSG.2) A second review will be required by a licensed

pharmacist or other licensed professional, such as a nurse or physician competent in the knowledge required

for a full appropriateness review, within 24 hours.

There may be circumstances in which the full appropriateness review is not practical, such as in an emergency

or when the ordering physician is present for ordering, administering, and monitoring of the patient (for example, in the operating theatre or the emergency department), or with oral, rectal, or injectable contrast in

interventional radiology or diagnostic imaging where the medication is part of the procedure.

To facilitate the appropriateness review, those performing the review require access to the patient’s medication

record as well as to the clinical information that is pertinent to the review process; for example, information

related to the patient’s renal or liver function when a medication can affect or be affected by those organs. This

information is essential to the appropriateness  review. (Also see ACC.3)

When computer programs are used to cross-check drug-drug interactions and drug allergies, the programs are

current and updated according to recommendations of the program manufacturers. In addition, when print

reference materials are used, the most current versions of the materials are utilized.

Medication use has become increasingly complex, and medication errors are a major cause of preventable

patient harm. A uniform system for dispensing and distributing medications can help reduce the risk of

medication errors. The hospital dispenses medications in the most ready-to-administer form possible to

minimize opportunities for error during distribution and administration. The issue of the most ready-to-

administer form becomes crucial during emergent situations in which immediate administration of the

medication is lifesaving (for example, during resuscitation). The central pharmacy and other medication-

distribution points throughout the hospital use the same system. The system supports accurate dispensing of

medications in a timely manner.

When medications are prepared by someone different from the person administering the medication, the risk

of a medication error is increased. Thus, when a medication is removed from its original packaging or prepared

and dispensed in a different form/container—and not immediately administered—the medication must be

labeled with the name of the medication, the dosage/concentration of the medication, the date of preparation, the date of expiration, and two patient identifiers. When medications are prepared for use during a surgical

procedure in the operating theatre and unused portions are discarded immediately following the surgical

procedure, the patient’s name and expiration date may not be necessary. (Also see IPSG.1)

Administering a medication to treat a patient requires specific knowledge and experience. Each hospital is

responsible for identifying those individuals with the requisite knowledge and experience and who are also

permitted by licensure, certification, laws, or regulations to administer  medications.  (Also see SQE.3 and

SQE.10) A hospital may place limits on medication administration by an individual, such as for controlled

substances or radioactive and investigational medications. In emergency situations, the hospital identifies any

additional individuals permitted to administer medications.

The medical record of each patient who receives medication contains a list of the medications prescribed or

ordered for the patient and the dosage and times the medication was administered. (Also see COP.2.1) Included

are medications administered “as needed.” If this information is recorded on a separate medication form, the

form is inserted in the patient’s medical record at discharge or transfer.

The safe administration  of medications includes verifying the

•  medication with the prescription or order; (Also see MMU.5.1)

• 

time and frequency of administration with the prescription or order;

•  dosage amount with the prescription or order;

• 

route of administration with the prescription or order; and • 

identity of the patient (scored at IPSG.1).

The hospital defines the verification process to be used in administering medications. When the medication is

prepared and dispensed on the patient care unit, the process of appropriateness review described in MMU.5.1

must also be carried out by a qualified individual.

In support of the patient’s engagement in all aspects of his or her medical care and treatment, patients are

informed about the medication they are being given and provided with an opportunity to ask questions about

the medications. (Also see PCC.2) Medications are administered to the patient on a timely basis and noted in

the patient’s medical record. (Also see COP.2.1)

Overseeing medication use in a hospital requires an understanding of the sources and uses of medications

that are not dispensed from the hospital pharmacy, such as medications  brought in by the patient or family or

medication samples. These types of medications require special processes for labeling, storage, and control of

use. The ospital controls the availability and has a process for determining the identity, safety, and any other

relative contraindications to use patient-supplied or sample medications. The hospital must be aware of current

regional trends related to the prevalence of counterfeit medications and active recalls for medications and the

associated active pharmaceutical ingredients. (Also see MMU.3.2 and GLD 7.1)

Written documentation of the medications brought in by the patient/family and sample medications must

address

a) receipt (denoting how the hospital received the medication from the patient or other source);

b) identification;

c) labeling;

d) storage; and

e) control and distribution.

In addition, the hospital performs a risk assessment for medications brought in by the patient that addresses

where the patient obtained the medication, when the medication was obtained, and how the medication was

stored at home. Medications brought into the hospital by the patient or his or her family or prescribed within

the hospital for self-administration are known to the patient’s physician and noted in the patient’s medical

record.

The hospital has a process to identify and to report medication errors and near misses.  (Also see QPS.7.1

and QPS.8) The process includes defining a medication error and near miss, using a standardized format

for reporting, and educating staff on the process and importance of reporting. Definitions and processes are

developed through a collaborative process that includes all those involved in the different steps in medication

management. The reporting process is part of the hospital’s quality and patient safety program. The reports

are directed to one or more individuals who are accountable for taking action. The program focuses on

preventing medication errors through understanding the types of errors that occur in the hospital and in other

organizations and why near misses occur. (Also see IPSG.3) Improvements in medication processes and staff

training are used to prevent errors in the future. The pharmacy participates in such staff training.