Practice Settings–Guidelines  617

ASHP Guidelines: Minimum Standard

for Pharmacies in Hospitals
Purpose services throughout the hospital, which every member of the
pharmacy team should cultivate at every opportunity.
The following minimum standard guidelines are intended to
serve as a basic guide for the provision of pharmacy services A. Pharmacy and Pharmacist Services
in hospitals. These guidelines outline a minimum level of Pharmacy Mission, Goals, and Scope of Services. The
services that most hospital pharmacy departments should pharmacy shall have a written mission statement that reflects
consistently provide. The reader is strongly encouraged to both patient care and operational responsibilities. Other as-
review the American Society of Health-System Pharmacy pects of the pharmacy’s mission may require definition as
(ASHP) guidance documents referenced throughout these well (e.g., educational and research responsibilities). The
guidelines for more detailed descriptions. Certain elements mission statement shall be consistent with the mission of the
of these guidelines may be applicable to other health care hospital and, if applicable, aligned with the health system of
settings or may be useful in evaluating the scope and quality which the hospital is a component. The development, priori-
of pharmacy services. tization, and implementation of the pharmacy’s goals should
be consistent with the mission statement. Determination of
short- and long-term goals and the undertaking of imple-
Elements of Care mentation activities should be performed in collaboration
with institutional leadership and other hospital staff (e.g.,
The mission of pharmacists is to help people make the
pharmacy, nursing, and medical staff), and these should be
best use of medications.1 Therefore, pharmacists shall be
integrated with the goals of the hospital. The mission state-
concerned with not only the provision but the outcomes of
ment may also incorporate consensus-based national goals,
pharmacy services. The elements of pharmacy services that
such as those expressed in the recommendations from the
are critical to safe, effective, and cost-conscious medica-
ASHP Pharmacy Practice Model Initiative.2
tion use in a hospital include (1) practice management, (2)
The pharmacy shall also maintain a written document
medication-use policy development, (3) optimizing medica-
describing the scope of pharmacy services. These services
tion therapy, (4) drug product procurement and inventory
should be consistent with the hospital’s scope of services and
management, (5) preparing, packaging, and labeling medi-
should be applied throughout the hospital in all practice sites.
cations, (6) medication delivery, (7) monitoring medication
The mission, goals, and scope of services shall be
use, (8) evaluating the effectiveness of the medication-use
clearly communicated to everyone involved in the provision
system, and (9) research. Although the scope of pharmacy
of pharmacy services, including pharmacists, residents, stu-
services will vary from site to site, depending upon the needs
dents, technicians, and support staff.
of patients and the hospital as well as the resources avail-
able, these core elements are inextricably linked to success-
24-Hour Pharmacy Services. Adequate hours of opera-
ful outcomes. Failure to provide any of these services may
tion for the provision of needed pharmacy services shall be
compromise the quality of patient care.
maintained; 24-hour pharmacy services should be provided
when possible. Twenty-four hour pharmacy services should
Terminology be employed in all hospitals with clinical programs that
require intensive medication therapy (e.g., transplant pro-
In these guidelines, the term “shall” is used to indicate a grams, open-heart surgery programs, neonatal intensive care
minimum standard of practice set forth in this document, in units, and trauma centers). When 24-hour pharmacy ser-
other ASHP policies, or in requirements established by laws, vices are not feasible, a pharmacist shall be available on an
regulations, accrediting bodies, or other binding authorities. on-call basis. Remote medication order processing may be
The term “should” is used to indicate a best practice that is employed (to the extent permitted by law and regulation) to
strongly encouraged by ASHP but which may not be appli- help provide pharmacy services but is not a substitute for an
cable to all institutions or in all circumstances. on-call pharmacist.3 Automated drug dispensing equipment
and computer databases are also not a substitute for the skills
Standard I. Practice Management and knowledge of a pharmacist and should not be considered
alternatives to 24-hour pharmacy services.4
Effective leadership and practice management skills are
necessary for the delivery of pharmacy services in a manner After-Hours Pharmacy Access. In the absence of 24-hour
consistent with the hospital’s and patients’ needs. Such lead- pharmacy services, access to a limited supply of medica-
ership should foster continuous improvement in patient care tions shall only be available to authorized, licensed health
outcomes. The management of pharmacy services should care professionals for use in carrying out urgent medica-
focus on the pharmacist’s responsibilities as a patient care tion orders. Access to such medications shall be carefully
provider and leader of the pharmacy enterprise through the monitored and documented, and after-hours access shall
development of organizational structures that support that be reviewed regularly to ensure appropriate use. The list of
mission. Development of such structures will require com- medications to be accessible and the policies and procedures
munication and collaboration with other departments and to be used (including subsequent review of all activity by a
618  Practice Settings–Guidelines
pharmacist) shall be developed by a multidisciplinary com- response (including evacuation), and the facility’s business
mittee of physicians, pharmacists, and nurses (e.g., by the continuity plan shall include procedures for providing safe
pharmacy and therapeutics [P&T] committee or its equiva- and efficient pharmacy services in case of emergencies.
lent).5 Access to medications should be limited to cases in Appropriately trained pharmacists should be members of
which the P&T committee (or its equivalent) determines emergency preparedness teams and participate in applicable
that the urgent clinical need for the medication outweighs preparations and drills.7 The pharmacy shall establish, in
the potential risks of making the medication accessible. The conjunction with the hospitalwide emergency plan, policies
potential safety risks of medications should be considered and procedures for the safe and orderly evacuation of phar-
in the decision to make them accessible, and medications, macy personnel in the event of an emergency in the hospital.
quantities, dosage forms, and container sizes that might en-
danger patients should be limited whenever possible. Medical Emergencies. The pharmacy shall participate in
Routine after-hours access to the pharmacy by non- hospital decisions about the contents of code carts, emer-
pharmacists for access to medications shall not be permit- gency medication kits and trays, and the role of pharma-
ted. The use of well-designed night cabinets, after-hours cists in medical emergencies. Pharmacists should serve on
medication carts, automated dispensing devices,6 and other cardiopulmonary resuscitation teams, and such pharma-
methods precludes the need for nonpharmacists to enter the cists should receive appropriate training and maintain ap-
pharmacy.4 propriate certifications (e.g., Basic Life Support, Advanced
Cardiopulmonary Life Support, Pediatric Acute Life
Practice Standards and Guidelines. The standards and Support).
regulations of all relevant government bodies (e.g., state
boards of pharmacy, departments of health) shall be met. Immunization Programs. The pharmacy shall participate
The practice standards and guidelines of ASHP, appropri- in the development of hospital policies and procedures
ate accrediting bodies (e.g., Joint Commission, American concerning preventive and postexposure immunization pro-
Osteopathic Association Healthcare Facilities Accreditation grams for patients and hospital employees.8 When practi-
Program, Det Norske Veritas), and the Centers for Medicare cal, pharmacists should participate as active immunizers for
and Medicaid Services shall be viewed as applicable, and the hospital and health-system-based preventive immunization
hospital should strive to meet all applicable standards. programs (e.g., influenza).

B. Laws and Regulations Substance Abuse Programs. The pharmacy shall assist in
Applicable local, state, and federal laws and regulations the development of and participate in hospital substance
shall be met, and relevant documentation of compliance abuse education, prevention, identification, treatment, and
shall be maintained. employee assistance programs.9

C. Policies and Procedures D. Human Resources

Policy and Procedures Manual. There shall be a policy and Position Descriptions. Areas of responsibility within the
procedures manual governing pharmacy functions (e.g., ad- scope of pharmacy services shall be clearly defined. The
ministrative, operational, and clinical), and all pharmacy responsibilities and related competencies of professional
personnel shall follow those policies and procedures. The and supportive personnel shall be clearly defined in written
manual may include a statement of the pharmacy’s mission, position descriptions. These position descriptions shall be
philosophy, or values (e.g., the pharmacy’s mission or vision reviewed and revised as required by the hospital’s policies.
statement), but it should concentrate on operational policies Position descriptions should reflect more general aspects of
and procedures to guide and direct all pharmacy services. The performance (e.g., communication, motivation, teamwork)
pharmacy’s policies and procedures should be consistent with in addition to specific responsibilities and competencies.
the hospital’s policies and procedures, and the manual should
be reviewed by a designated medical staff committee for po- Director of Pharmacy. The pharmacy shall be managed by a
tential conflicts and other medical issues. The manual shall be professionally competent, legally qualified pharmacist. The
reviewed by pharmacy staff on a regular basis and revised as director of pharmacy should be thoroughly knowledgeable
necessary to reflect changes in procedures, organization, ob- about and have experience in hospital pharmacy practice
jectives, or practices. The manual shall be accessible to phar- and management. An advanced management degree (e.g.,
macy department personnel as well as other hospital employ- M.B.A., M.H.A., or M.S.) or an administrative specialty
ees (e.g., through the hospital’s intranet), and all pharmacy residency10 is desirable.
personnel should be familiar with its contents. Appropriate The director of pharmacy shall be responsible for
mechanisms to ensure compliance with the policies and pro-
cedures should be established. • Establishing the mission, vision, goals, and scope of
services of the pharmacy based on the needs of the pa-
Personnel Safety. Pharmacy employees should be involved tients served, the needs of the hospital (and any health
in the development of the hospital’s plans for emergency system of which the hospital may be a component),
response, infection prevention and control, management of and developments and trends in health care and hospi-
hazardous substances and waste, and incident reporting, and tal pharmacy practice.
all pharmacy staff shall receive education about those plans. • Developing, implementing, evaluating, and updating
plans and activities to fulfill the mission, vision, goals,
Emergency Preparedness. Facility emergency preparedness and scope of services of the pharmacy.
plans shall describe the role of pharmacy staff in emergency
 Practice Settings–Guidelines  619

• Actively working with or as a part of hospital or shortages and fluctuation in workload and/or patient acuity.
health-system leadership to develop and implement Remote medication order processing may be employed to
policies and procedures that provide safe and effective help address staff shortages or workload fluctuations.3
medication use for the patients served by the institu-
tion. Performance Evaluation. There shall be procedures for regu-
• Mobilizing and managing the resources, both human larly scheduled evaluation of the performance of pharmacy
and financial, necessary for the optimal provision of personnel. The evaluation format should be consistent with that
pharmacy services. used by the hospital. The competencies of the position shall
• Ensuring that patient care services provided by phar- be well defined in the position description, short- and long-
macists and other pharmacy personnel are delivered term goals should be established for each employee, and the
in adherence to applicable state and federal laws and employee’s competency shall be assessed regularly. The phar-
regulations, hospital privileging requirements, and na- macy director shall ensure that an ongoing competency assess-
tional practice standards. ment program is in place for all staff, and each staff member
should have a continuous professional development plan.
A part-time director of pharmacy shall have the same ob-
ligations and responsibilities as a full-time director. Effective Communication. There should be established
methods for communicating important information to staff
Pharmacists. The pharmacy shall employ an adequate num- in a timely manner (e.g., electronic communications, staff
ber of competent, legally qualified pharmacists to meet the meetings, newsletters, bulletin boards). The pharmacy
specific medication-use needs of the hospital’s patients. should establish appropriate mechanisms to regularly assess
Pharmacists hired on a temporary or contract basis shall meet the effectiveness of such communications.
the same requirements as those employed by the hospital.
Ethical Conduct. Standards of ethical conduct shall be es-
Support Personnel. Sufficient support personnel (e.g., tablished, and there shall be procedures for educating all
pharmacy technicians and clerical or secretarial personnel) pharmacy staff regarding these standards. The institution’s
shall be employed to facilitate pharmacy services. Support conflict-of-interest and ethical conduct policies shall be
positions shall have a written job description that includes clearly communicated to all staff, with appropriate staff ac-
a statement of the competencies required for that position. knowledgement of conformance with these policies.13
Support staff shall be properly trained and supervised, and
professional development programs for them are desirable. E. Facilities
Pharmacy technicians should have completed an ASHP- Pharmacy. Adequate space, equipment, and supplies shall
accredited pharmacy technician training program, should be be available for all professional and administrative functions
certified by the Pharmacy Technician Certification Board, relating to pharmacy services. These resources shall meet
and shall meet the requirements of applicable laws and regu- all applicable laws and regulations; shall be located in areas
lations. Pharmacy technicians working in advanced roles that facilitate the provision of services to patients, nurses,
should have additional training and demonstrate competen- prescribers, and other health care providers; and shall be in-
cies specific to the tasks to be performed. tegrated with the hospital’s communication and delivery or
transportation systems.
Education and Training. All personnel shall possess the ed-
ucation and training required to fulfill their responsibilities Medication Storage and Preparation Areas. There shall be
and shall participate in relevant continuing-education pro- suitable facilities to enable the receipt, storage, and prepara-
grams and activities as necessary to maintain or enhance their tion of medications under proper conditions of sanitation,
competence.11 temperature, light, moisture, ventilation, segregation, and
security to ensure medication integrity and personnel safety
Recruitment, Selection, and Retention of Personnel. throughout the hospital.4
Personnel should be recruited and selected by the pharmacy
director on the basis of job-related qualifications and prior Compounding Areas. There shall be suitable facilities to en-
performance. An employee retention plan is desirable.12 able the compounding, preparation, and labeling of sterile
and nonsterile products, including hazardous drug products,
Orientation of Personnel. There shall be an established, in accordance with established quality-assurance proce-
structured procedure for orienting new personnel to the dures. The work environment should promote orderliness
pharmacy, the hospital, and their respective positions.9 and efficiency and minimize the potential for medication er-
Evaluation of the effectiveness of orientation programs rors and contamination of products.14–20
should be done in conjunction with the competency assess-
ment required before a new hire can assume full responsibil- Patient Assessment and Consultation Area. In outpatient
ity for the new position. settings, a private area for pharmacist–patient consultations
shall be available to confidentially enhance patients’ knowl-
Work Schedules and Assignments. The director of phar- edge of and adherence to prescribed medication regimens.21
macy shall ensure that work schedules, procedures, and as-
signments optimize the use of personnel and resources. There Office and Meeting Space. Adequate office and meeting
shall be a written departmental staffing plan that addresses areas shall be available for administrative, educational, and
how patients’ needs will be met during periods of staff training activities.
620  Practice Settings–Guidelines
Automated Systems. There shall be policies and procedures Electronic databases and convenient methods of data
for the evaluation, selection, use, calibration, monitor- dissemination (e.g., e-mail and handheld devices) are desir-
ing, and maintenance of all automated pharmacy systems. able. If such tools are employed, they should be made avail-
Automated mechanical systems and software can promote able to all health care practitioners who require access to
safe, accurate, and efficient medication ordering and prepa- the data.
ration, drug distribution, and clinical monitoring. Use of
such systems and software shall be structured so as to not Record Maintenance. All records shall be maintained in
hinder the pharmacist’s review of (and opportunity to in- accordance with applicable laws, regulations, and institu-
tervene in) medication orders before the administration of tional policies. Adequate space shall exist for maintaining
first doses. The maintenance, calibration, and certification of and storing records (e.g., equipment maintenance, controlled
all automated systems shall be performed and documented substances inventory, and material safety data sheets) to en-
as required by all applicable laws, regulations, and stan- sure compliance with laws, regulations, accreditation re-
dards.6,22,23 All automated systems shall include adequate quirements, and sound management practices. Appropriate
safeguards to maintain the confidentiality and security of licenses and permits shall be on display or on file as required
patient records, and there shall be procedures to provide es- by law or regulation. Equipment shall be adequately main-
sential patient care services in case of equipment failure or tained and certified in accordance with applicable practice
downtime. standards, laws, and regulations. There shall be documenta-
tion of equipment maintenance and certification.
Information Technology. A comprehensive pharmacy com-
puter system shall be employed and should be integrated to F. Committee Involvement
the fullest extent possible with other hospital information A pharmacist shall be a member of and actively participate
systems and software, including computerized provider- in hospital and health-system committees responsible for
order-entry, medication administration, electronic health establishing and implementing medication-related policies
record, and patient billing systems. Computer resources and procedures as well as those committees responsible for
should be used to support clerical functions, maintain patient the provision of patient care, including the P&T, infection-
medication profile records, provide clinical decision support, prevention and control, patient care, medication-use evalu-
perform necessary patient billing procedures, manage drug ation, medication safety, nutrition, and pain management
product inventories, provide drug information, access the committees (or their equivalents), as well as the institutional
patient medical record, manage electronic prescribing, and review board, quality-improvement, and information tech-
interface with other computerized systems to obtain patient- nology committees (or their equivalents).5,24–26
specific clinical information for medication therapy moni-
toring and other clinical functions and to facilitate the con- Standard II. Medication-Use
tinuity of care to and from other care settings. Pharmacists
should be involved in the development and maintenance of
Policy Development
order sets, templates, and dose ranges used in computerized
provider-order-entry and clinical decision-support systems.
A. Policy Development
Pharmacy computer systems should be integrated with the
All committees that make decisions concerning medication
hospital’s clinical, financial, and administrative information
management and use shall have at least one pharmacist as
systems. All computer systems shall include adequate safe-
a member. This includes the P&T, infection-control, patient
guards to maintain the confidentiality and security of patient
care, medication-use evaluation, medication safety, nutri-
records, and a backup system should be available to continue
tion, pain management, and information technology com-
essential computerized functions (e.g., those that support pa-
mittees, as well as the institutional review board (or their
tient care) during equipment failure.
equivalents).5,24–26 Pharmacists shall be involved in the de-
velopment, implementation, and assessment of care plans
Drug Information. Adequate space, current resources, and
(protocols, critical pathways, disease statement management
information-handling and communication technology shall
programs, or clinical practice guidelines), standing orders,
be available to facilitate the provision of drug information.
and order sets that involve medication therapy.27
The department of pharmacy shall select its drug information
resources, and pharmacists shall play a leadership role in the
B. Formulary Management
selection of drug information resources used by other health
Formulary. A well-controlled formulary of approved medi-
care providers in the hospital. Up-to-date, objective drug in-
cations shall be maintained and regularly updated by the
formation shall be available, including current print or elec-
P&T committee (or its equivalent). The impact of and com-
tronic periodicals, newsletters, best-practices guidelines, and
pliance with the formulary should be periodically reviewed
recent editions of reference books in appropriate pharmaceuti-
(e.g., through drug-utilization reviews), and the P&T com-
cal and biomedical subject areas. Electronic drug information
mittee should regularly review the formulary for safety
databases are preferred because they are frequently updated
information. The P&T committee shall be responsible for
and can be made available to all health care professionals,
developing and maintaining written criteria for drug prod-
but sufficient access to print information shall be available in
uct selection, which shall address formulary requests for
case of equipment failure or downtime. Electronic and print
medications intended for use in special populations (e.g.,
drug information may be supplemented with medical libraries
pediatric or geriatric populations). The P&T committee shall
and other available resources. Appropriate drug information
be responsible for developing and maintaining adequate
resources shall be readily accessible to pharmacists located in
product specifications to aid in the purchase of medications
patient care areas.
 Practice Settings–Guidelines  621
and related supplies. The pharmacy shall disseminate the ity of medication therapy. Clinical imperatives should be the
formulary by electronic (preferred) or other means to meet primary determinants of medication-use decisions.
the needs of all health care professionals.
There shall be policies and procedures that address the A. Creating a Relationship with the Patient
use of dietary supplements and other alternative therapies. Pharmacist Role in Direct Patient Care. Hospital and phar-
There shall be policies and procedures for the procure- macy department policies should encourage pharmacists to
ment, control, and use of nonformulary medications required provide direct patient care to the greatest extent possible in
for patient care.5 both inpatient and outpatient settings. Hospital and phar-
macy department policies should encourage pharmacists to
Medication Therapy Monographs. Medication therapy engage in medication therapy management,29 collaborative
monographs for medications under consideration for for- drug therapy management, immunization, medication order-
mulary addition or deletion shall be made available to the ing and administration, and other patient care activities to
P&T committee for use in the decision-making process. the extent permitted by law, regulation, and hospital require-
These monographs should be based on evidence gathered ments.
through review and evaluation of the pertinent literature.
Each monograph shall include a comparative therapeu- Continuity of Care. Pharmacists should assume responsibil-
tic, economic, and risk assessment (inclusive of black-box ity for continuity of care for patients’ medication therapy.
warnings) of each medication. The risk assessment should Pharmacists and pharmacy departments should take a lead-
address the likelihood of an error occurring and the risk of ership role in developing and implementing policies and
injury should that error occur.5 procedures for admissions, discharges, and transfers so that
patients’ medication therapy is well managed regardless of
Nondrug Substances. There shall be policies and proce- patient transitions across care settings (e.g., among differ-
dures that describe how the pharmacy shall seek and obtain ent components of a health system or between inpatient and
documented authorization from appropriate medical staff community pharmacies or home care services).
and hospital committees prior to the medical use of any
chemical substance that has not received Food and Drug Patient Confidentiality. Systems shall be in place to ensure
Administration (FDA) approval for use as a drug or medi- that patient confidentiality is maintained in accordance with
cal nutrition therapy. All chemical or biological substances applicable laws and regulations. All pharmacy personnel
whose administration is intended for pharmacological or shall respect and protect patient confidentiality by safe-
medical effect or as a substitute for or complement to ap- guarding access to all patient information. Patient informa-
proved drugs shall be under the control of the pharmacy. tion shall be shared only with authorized health professionals
Documentation shall exist to ensure that appropriate risk and others authorized within the hospital or health system as
management measures (e.g., obtaining informed consent) needed for the care of patients.30 Pharmacy personnel should
have been taken. periodically receive training in how to comply with patient
confidentiality laws and regulations.
C. Drug Information
Drug Information Requests. The pharmacist shall provide B. Acquiring Essential Patient Data
patient-specific drug information and accurate and compre- Pharmacists should obtain, prepare, or have immediate ac-
hensive information about drugs and drug therapy to health cess to comprehensive medication histories for each patient,
professionals, patients, and patients’ caregivers as appropri- from the patient’s medical record or other databases (e.g.,
ate. Responses to general and patient-specific drug informa- a medication profile), or both. A pharmacist-conducted
tion requests shall be provided in an accurate and timely medication history for each patient is desirable. Electronic
manner by a pharmacist, and there should be a process for medical records should be constructed so that medication
assessing and ensuring the quality of responses.28 histories and other data required for medication manage-
ment, including medication reconciliation, are available to
Dissemination of Drug Information. Pharmacists shall all health professionals caring for a patient.
keep the hospital’s staff and health care providers informed
about the use of medications on an ongoing basis through C. Consulting With Other Health Professionals About
appropriate publications, presentations, and programs. Medication Therapy
Pharmacists shall ensure timely dissemination of drug prod- Pharmacist’s Consultations. Pharmacists should provide
uct information (e.g., recall notices, labeling changes, and oral and written consultations to other health professionals
changes in product availability). Electronic communications regarding medication therapy selection and management.30
(e.g., websites, email newsletters, intranet postings) are pre-
ferred because of their timeliness and accessibility.28 Medical Record Documentation. There shall be policies
and procedures for pharmacist review of and documentation
Standard III. Optimizing Medication in patients’ medical records. Recommendations made by the
pharmacist and actions taken in response to those recom-
Therapy mendations should be documented in the patient’s medical
record so that other health care providers have access to that
An important responsibility of the pharmacist is optimizing
information.30
medication use. Pharmacists, in collaboration with medi-
cal and nursing staff, shall develop policies and procedures
Medication Therapy Decisions. The pharmacist’s preroga-
based on demonstrated best practices for ensuring the qual-
tives to initiate, monitor, and modify medication therapy for
622  Practice Settings–Guidelines
individual patients, and to order laboratory tests to exercise rating with physicians and other health care providers, and
those responsibilities, consistent with laws, regulations, and conducting an awareness campaign in the event of a drug
hospital policy, shall be clearly delineated and approved by product shortage.36
the appropriate committee (e.g., P&T, patient care, or medi-
cal executive committee). Samples. The use of medication samples shall be eliminated
to the extent possible. Medication samples shall never be used
Standard IV. Drug Product Procurement for inpatient treatment. If use of samples is otherwise permit-
ted, there shall be policies and procedures to ensure their safe
and Inventory Management use. The pharmacy shall oversee the procurement, storage,
and distribution of these products to ensure proper storage,
The pharmacy shall be responsible for the procurement, dis-
maintenance of records, product integrity, and compliance
tribution, and control of all drug products used in the hospi-
with all applicable packaging and labeling laws, regulations,
tal for inpatient and ambulatory patients. Policies and pro-
standards, and patient education requirements. Pharmacists
cedures governing these functions shall be developed by the
should be involved in hospital efforts to secure safe and ef-
pharmacy with input from other appropriate hospital staff
fective low-cost medications for low-income patients (e.g.,
and committees.4
through manufacturer patient assistance programs).4,5,33
A. Selecting Sources of Pharmaceutical Products
Patient Care Area Stock. The proper use of automated dis-
Medication Acquisition. There shall be policies and proce-
pensing devices reduces the need for medications to be stored
dures for managing medication acquisition. These policies
in nonpharmacy areas.6 Storage of medications in nonphar-
and procedures should address such issues as formulary
macy areas (e.g., patient care and procedural areas) shall to
development (including initial evaluation for formulary
the extent possible be limited to medications for emergency
consideration, medication-utilization review programs,
use and routinely used personal care items (e.g., mouthwash
and therapeutic interchange), competitive bidding, group
and antiseptic solutions). The list of medications to be ac-
purchasing, best practices, medication shortages, outsourc-
cessible and the policies and procedures regarding their use
ing, and cost-effective patient services. Benchmarking of
shall be developed by a multidisciplinary committee of phy-
medication costs should be performed to determine whether
sicians, pharmacists, and nurses (e.g., the P&T committee).5
medication expenses and the change in medication expenses
Access to medications should be limited to cases in which
over time are consistent with industry standards.4,31,32
the committee determines that the urgent clinical need for
the medication outweighs the potential patient-safety risks
Pharmaceutical Manufacturers And Suppliers. Criteria for
of making the medication accessible. A separate assessment
selecting drug product manufacturers and suppliers shall be
should occur for every location where a medication may be
established by the pharmacy to ensure the highest quality of
stocked.
and the best price for drug products. Although these duties
may be delegated in part to a group purchasing organization,
Controlled Substances. There shall be policies and proce-
the pharmacy maintains the sole responsibility for ensuring
dures to ensure control of the distribution and use of con-
the quality of drug products used in the hospital.31,32
trolled substances and other medications with a potential
for abuse. These policies and procedures shall be consistent
Pharmaceutical Manufacturers’ Representatives. There
with applicable laws and regulations and shall include meth-
shall be written policies governing the activities of manu-
ods for preventing and detecting diversion.4
facturers’ representatives or vendors of drug products (in-
cluding related supplies and devices) within the hospital.
Patient’s Own Medications. Drug products and related de-
Representatives should not be permitted access to patient
vices brought into the hospital by patients shall be identified
care areas and should be provided with written guidance on
by pharmacy and documented in the patient’s medical record
permissible activities within the hospital. All promotional
if the medications are to be used during hospitalization. They
materials and activities shall be reviewed and approved by
shall be administered only pursuant to a prescriber’s order
the pharmacy.33
and according to hospital policies and procedures, which
should ensure the pharmacist’s identification and validation
B. Managing Inventory
of medication integrity as well as the secure and appropriate
Medication Storage. Medications shall be received, stored,
storage and management of such medications.
and prepared under proper conditions of sanitation, tempera-
ture, light, moisture, ventilation, segregation, and security to
C. Inspecting Storage Areas and Inventory Items
ensure medication integrity and personnel safety.4
All stocks of medications shall be inspected routinely to
ensure the absence of outdated, unusable, recalled, or mis-
Drug Shortages. There shall be policies and procedures
labeled products. Storage conditions that would foster medi-
for managing drug product shortages. The pharmacy’s in-
cation deterioration, storage arrangements that might con-
ventory management system should be designed to detect
tribute to medication errors, and other safety issues shall be
subminimum inventory levels and alert the pharmacy to po-
assessed, documented, and corrected.4
tential shortages, and pharmacy staff should monitor reliable
sources of information regarding drug product shortages
D. Returning Recalled, Expired, and Other Unusable
(e.g., the ASHP34 and FDA35 drug shortages web resource
Items
centers). The pharmacy should develop strategies for identi-
There shall be a written procedure for the timely handling
fying alternative therapies, working with suppliers, collabo-
and documentation of a drug product recall. These proce-
 Practice Settings–Guidelines  623
dures should include an established process for removing code and that code should be used in inventory management,
from use any drugs or devices subjected to a recall, noti- dose preparation and packaging, dispensing, and administra-
fying appropriate health care professionals, identifying pa- tion. It is the responsibility of the pharmacy department to
tients who may have been exposed to the recalled medica- ensure the quality of all aspects of bar-code medication ad-
tion, and, if necessary, communicating available alternative ministration, including scanability of bar codes and database
therapies to prescribers. The pharmacy shall be notified of management.38,39
any defective drug products or related supplies and equip-
ment encountered by the nursing or medical staffs. All drug Standard VI. Medication Dispensing
product defects should be reported to the FDA’s MedWatch
reporting program.4
and Delivery

Standard V. Preparing, Packaging, and A. Medication Dispensing

Labeling Medications Prescribing. Medications shall be prescribed by individu-
als who have been granted appropriate clinical privileges in
the hospital and are legally permitted to order medications.
A. Preparing Medications The pharmacy shall advocate and foster practitioners’ con-
Compounding. Drug formulations, dosage forms, strengths, formance with standardized, approved, and safe terminology
and packaging that are not available commercially but are and abbreviations to be used throughout the hospital when
needed for patient care shall be prepared by appropriately prescribing medications and discourage use of nonstandard
trained personnel in accordance with applicable practice and unapproved terminology and abbreviations.4
standards and regulations. The pharmacy shall provide ad-
equate quality-assurance procedures for these operations. Diagnostic or Therapeutic Purpose. Pharmacists should
Written master formulas and batch records (including prod- have immediate access to the patient’s diagnosis or the in-
uct test results, as appropriate) shall be maintained, and a lot tended therapeutic or medical purpose of medications.
number or other method to identify each finished product
with its production and control history shall be assigned to Medication Orders. All patient medication orders shall be
each batch.14–20 contained in the patient’s medical record. A direct copy
of the prescriber’s order, either hard copy (including fac-
Sterile Preparations. When possible, manufactured sterile simile) or prescriber-entered electronic transmission (pre-
preparations should be preferred to compounding in the ferred method), shall be received by the pharmacist. Oral
pharmacy. All sterile medications shall be prepared and la- orders should be avoided to the extent possible. When
beled in a suitable environment by appropriately trained per- oral orders are necessary, they shall follow the organiza-
sonnel in accordance with established quality-assurance and tion’s established procedures for their use and documen-
expiration dating procedures.14,19 The use of sterile medica- tation. Order transmittal safeguards should be used to en-
tions compounded outside the pharmacy should be avoided sure the security of the prescriber’s order. Appropriate
to the extent possible; when they are used, there shall be pro- records of each medication order and its processing in the
cedures for aseptic preparation, quality assurance, expiration pharmacy shall be maintained in accordance with applicable
dating, and ongoing competency evaluations for compound- laws and regulations.
ing personnel.14,19,37 Sterile compounding outside the phar- A system shall exist to ensure that medication orders
macy or satellite pharmacies (e.g., on nursing units) should are not inappropriately continued.4
be minimized and occur only in emergency situations.14,19
Review of Medication Orders. All medication orders shall
Hazardous Drug Products. There shall be policies and pro- be prospectively reviewed by a pharmacist and assessed in
cedures that describe special precautions, equipment, and relation to pertinent patient and clinical information before
training for preparation, handling, storage, and disposal of the first dose is administered or made available in an auto-
hazardous drug products and products used in their prepara- mated dispensing device, except in emergent situations in
tion. These policies and procedures shall be consistent with which the treatment of the patient would be significantly
applicable laws and regulations and should be adequate to compromised by the delay that would result from pharmacist
ensure the safety of staff, patients, visitors, the community, review of the order. There shall be a procedure for retrospec-
and the environment.17 tive review of these orders.
Any questions regarding an order shall be resolved
B. Packaging Medications with the prescriber prior to administration, and any action
Unit Dose Packaging. Whenever possible, medications taken as a result of this intervention should be documented
shall be available for inpatient use in single-unit packages in the patient’s medical record. Information concerning
and in a ready-to-administer form. Manipulation of medica- changes shall be communicated to the appropriate health
tions before administration (e.g., withdrawal of doses from professionals caring for the patient.4
containers, reconstitution of powdered drug products, la-
beling of containers, and splitting of tablets) by final users B. Medication Delivery and Administration
should be minimized.15 Drug Delivery Systems, Administration Devices, and
Automated Distribution Devices. The pharmacy shall have
Bar-Coding of Unit Dose Packaging and Point of Care responsibility for developing policies, procedures, and qual-
Administration. Unit dose packages should contain a bar ity-assurance programs regarding drug delivery systems,
624  Practice Settings–Guidelines
administration devices, and automated distribution devices vices and departments as well as commercial sources should
that ensure safety, accuracy, security, and patient confiden- be reviewed by the pharmacy staff for accuracy, currency,
tiality. The potential for medication errors associated with literacy appropriateness, and completeness. If necessary,
such systems and devices should be thoroughly evaluated.4,6 interpretative language services (written or oral) should be
Pharmacy personnel shall supervise the stocking and docu- made available to patients.21
mentation of medications in automated dispensing devices.6
Whenever possible, automated dispensing cabinets should Standard VIII. Evaluating
employ profile-based technology integrated with remote
medication order-entry capabilities.
the Effectiveness of the
Medication-Use System
Medication Administration. Only personnel who are au-
thorized by the hospital in accordance with applicable laws There shall be an ongoing, systematic program for quality
and regulations and appropriately trained shall be permit- assessment and improvement of pharmacy services and the
ted to administer medications to a patient. All administered, medication-use system. The program should include rou-
refused, or omitted medication doses should be recorded in tinely evaluating the literature for new technologies or suc-
the patient’s medical record according to an established pro- cessful practices that have been demonstrated to enhance
cedure, and all medications that have not been administered safety in other organizations to determine if such technolo-
should be returned to the pharmacy. No medication should gies or practices can improve the hospital’s medication-use
be administered to a patient unless medical and nursing per- system. This program should be integrated with the hospi-
sonnel have been provided with adequate information about, tal’s or health system’s quality assessment and quality im-
and are familiar with, its therapeutic use, method of admin- provement activities. Quality-improvement activities related
istration, potential adverse effects, and dosage. to the selection, prescription, procurement, storage, prepa-
ration, dispensing, distribution, administration, documenta-
tion, monitoring, and use of medications shall be routinely
Standard VII. Monitoring Medication Use performed in cooperation with other health care providers.
Feedback to appropriate individuals or entities about the
quality achieved shall be provided.
A. Reviewing Patient Responses to Medication Therapy
Medication therapy monitoring shall be conducted by phar- A. Assessing Pharmacy Services and Practices
macists. Medication therapy monitoring includes a proactive Documentation of Pharmacist-Provided Patient Care
assessment of patient problems and an assessment of Services and Medication Therapy Outcomes. The phar-
macy shall have an ongoing process for consistent documen-
a. The therapeutic appropriateness of the patient’s medica- tation of the patient care services provided by pharmacists
tion regimen. and patient outcomes from medication therapy.30
b. Therapeutic duplication or omissions in the patient’s
medication regimen. Workload and Financial Performance. A process shall ex-
c. The appropriateness of the dose of the medication, as ist to routinely monitor and document workload and finan-
well as the route, method, and frequency of adminis- cial performance. Metrics should encompass the full scope
tration of the medication. of patient care services provided by pharmacists and the
d. Patient adherence to the prescribed medication regi- pharmacy enterprise. This process should provide for the
men. determination and analysis of hospital and systemwide costs
e. Medication–medication, medication–food, medica- of medication therapy. A pharmacist should be an integral
tion–dietary supplement, medication–laboratory test, part of the hospital’s leadership teams (e.g., administrative,
and medication–disease interactions. financial).
f. Adverse drug reactions and other undesired effects.40
g. Patient medication allergies and sensitivities. B. Improving the Medication-Use Process
h. Clinical and pharmacokinetic laboratory data to evalu- Medication-Use Evaluation. There shall be an ongoing pro-
ate the efficacy and safety of medication therapy and gram for monitoring drug utilization and costs to ensure that
to anticipate toxicity and adverse effects. medications are used appropriately, safely, and effectively
i. Physical signs and clinical symptoms relevant to the and to increase the probability of desired patient outcomes.
patient’s medication therapy. The P&T committee (or its equivalent) should define spe-
j. Assessment of the effectiveness of the patient’s medi- cific parameters for evaluation (e.g., disease state, pharma-
cation therapy. cological category, or high-use/high-cost drug products) as
appropriate for the organization. Through the ongoing evalu-
ation of medication use, areas in need of improvement in
B. Educating and Counseling Patients and Family medication prescribing and management can be identified
Pharmacists shall be available to participate in patient edu- and targeted for intervention.32,41
cation. Pharmacists should help to ensure that all patients
are given adequate information about the medications they Medication Safety. Pharmacists should provide leadership to
receive in order to help patients participate in their own and participate in collaborative, multidisciplinary efforts to
health care decisions and encourage adherence to medica- prevent, detect, and resolve drug-related problems that can
tion regimens. Patient education activities shall be coordi- result in patient harm. Pharmacists and other appropriate hos-
nated with the nursing, medical, and other clinical staff as pital personnel shall establish and regularly revise policies
needed. Medication-related material developed by other ser-
 Practice Settings–Guidelines  625
and procedures regarding medication error and adverse event tional drugs, including possible adverse effects and adverse
prevention and reporting. Monitoring, detecting, review, and drug reactions, to nurses, pharmacists, physicians, and other
analysis of the hospital and health system’s medication er- health care professionals called upon to prescribe, dispense,
rors and near-misses should be an ongoing process in a just and administer these medications.44,45
culture environment,42 and corresponding corrective actions
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 Practice Settings–Guidelines  627
ASHP gratefully acknowledges the contributions made by the fol- Kathleen M. Gura, Pharm.D., BCNSP, FASHP, FPPAG; Reginald
lowing individuals to various drafts of these guidelines: Thomas S. L. Hain, B.S.Pharm.; Thomas G. Hall, Pharm.D.; George Hatfield,
Brenner, B.S.Pharm., FASHP; Harold N. Godwin, M.S., FASHP, Pharm.D.; Jesse Hogue, Pharm.D.; Andrew Jarrell, Pharm.D.; Jack
FAPhA; William A. Gouveia, M.S., FASHP; Brian D. Hodgkins, G. Kitrenos, Pharm.D., FASHP; Jamie Kuo, Pharm.D.; Jim Lile,
Pharm.D., FCSHP, FASHP; Stanley S. Kent, M.S., FASHP; Patricia Pharm.D.; Charles “Kurt” Mahan, Pharm.D., Ph.C.; Linda Gore
C. Kienle, M.P.A., FASHP; Harold J. Kornfuhrer, B.S.Pharm., Martin, Pharm.D., M.B.A., BCPS (WSHP); Justine Medina, M.S.,
FASHP; Emory S. Martin III, Pharm.D., BCPS; J. Russell May, RN; Dayna Mitchell, Pharm.D., BCPS; Holly Monatt, Pharm.D.,
Pharm.D., FASHP; Gerald E. Meyer, Pharm.D., M.B.A., FASHP; BCPS; Selma Morrison; Robert J. Moura, M.S.; Jonathan M.
Thomas E. O’Brien, Pharm.D., M.S., FASHP; Sherri L. Ramsey, Mundy, M.B.A. (RISHP); Bruce A. Nelson, M.S.; Beth Norman,
D.Ph., BCPS; Frank G. Saya, Pharm.D., FCSHP, FASHP; Donna M.S., RN, CNS, ACNS-BC; Robert S. Oakley, M.S.; Fred J. Pane,
L. Soflin, B.S.Pharm., FASHP; David K. Solomon, Pharm.D., B.S.Pharm., FASHP; Shreya Parekh, Pharm.D.; Jennifer Phillips,
FASHP; Kasey K. Thompson, Pharm.D., M.S.; and Billy W. Pharm.D.; James Ponto, BCNP, FASHP; Curt W. Quap, M.S.,
Woodward, B.S.Pharm. FASHP; Todd Rowland, Pharm.D.; Renee B. Sager, Pharm.D.;
Joseph Sceppa, M.S., M.B.A.; Nicole Shumiloff, Pharm.D.; Nancy
ASHP also gratefully acknowledges the following organizations and R. Smestad, M.S.; Carolyn M. Smith, Pharm.D., M.B.A., BCPS
individuals for reviewing drafts of these guidelines (review does not (SCSHP); William E. Smith, Pharm.D., M.P.H., Ph.D., FASHP;
imply endorsement): American Nurses Association (ANA); Institute Richard L. Stambaugh, Pharm.D., M.S., BCPS; Therese Staublin,
for Safe Medication Practices (ISMP); Rhode Island Society of Pharm.D.; Marc Stranz, Pharm.D.; Timothy P. Stratton, Ph.D.;
Health-System Pharmacists (RISHP); South Carolina Society of Pamela Swarny, Pharm.D., J.D.; Jane Tennis, B.S.Pharm., M.B.A.;
Health-System Pharmacists (SCSHP); Wyoming Society of Health- Sherry Umhoefer, M.B.A.; Allen J. Vaida, Pharm.D., FASHP
System Pharmacy (WSHP); Tuesday Adams, RN-C, WCC; John A. (ISMP); Jody Jacobson Wedret, FASHP, FCSHP; Roger Woolf,
Armitstead, M.S., FASHP; Phil Ayers, Pharm.D., BCNSP; Ronald Pharm.D.; and Kevin Zak, Pharm.D.
Barnes, M.S.; Paul J. Barrett, Pharm.D., BCPS; Carol J. Bickford,
Ph.D., RN-BC, CPHIMS (ANA); P. Justin Boyd, Pharm.D., BCPS, Copyright © 2013, American Society of Health-System Pharmacists,
CDM; Tim Brown, Pharm.D., BCACP; Margaret Chrymko, Inc. All rights reserved.
Pharm.D.; Toby Clark, M.Sc., FASHP; Wayne F. Conrad, Pharm.D.,
FASHP; Gayle A. Cotchen, Pharm.D., M.B.A.; Debra Lynn The bibliographic citation for this document is as follows: American
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