Chapter XX

Pharmacy
( P H)

Introduction
This is an area where errors can lead to great consequences and this is why all
of the details have to be followed very closely.
The process involves many steps; from the prescription written by the physician
to the actual taking of the medication by the patient. All cooperation is
needed between physicians, nurses and pharmacists to make the medication
process accurate and reliable.
Unfortunately, the role of the pharmacist is forgotten at times, and this means
that physicians or nurses might be giving the medications to the patients
without the proper verification by the pharmacist.
This is very wrong and potentially dangerous, because the pharmacist is the
gate keeper. He evaluates and monitors for drug indications, adverse drug
reactions (ADR), correct route of administration, drug interactions, and
administration time. Also, inside the pharmacy, the right tools and equipments
are needed to ensure that the work is done properly. For example, the
intravenous admixture area and the chemotherapy preparation area require a
special separated and properly designed work area for each of them. The
hospital administration has to provide the necessary resources to conduct safe
pharmaceutical care to patients.

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Pharmacy
(PH)

Pharmacy
(PH)

Scoring:

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Standard
PH.1.

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NA

The hospital has a pharmacy service

department and headed by a qualified
pharmacist with appropriate experiences.
PH.1.1 The Pharmacy has a clear organization
structure.
PH.1.2 Pharmacy head holds Pharm.D, Master,
or Bachelor of Science degree in
Pharmacy.
PH.1.3 Pharmacy head has signed an
updated job description.
PH.1.4 Evidence of valid Saudi Council of
Health Specialties license to practice in
Saudi Arabia.
PH.1.5 The Pharmacy head has an updated
curriculum vitae.
PH.1.6 Evidence of work experience in hospital
setting.

PH.2.

The pharmacy has a clear mission, vision, and

values.
PH.2.1 Mission is clearly written, posted, and
verbalized by pharmacy staff.
PH.2.2 Vision is clearly written, posted, and
verbalized by pharmacy staff.
PH.2.3 Values are clearly written, posted, and
verbalized by pharmacy staff.

PH.3.

The pharmacy space is adequate. Hours of

operation are determined, announced and
followed.
PH.3.1 The space provided for pharmacy
services allows the principal functions to
be carried out in efficient and effective
manner.

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PH.3.2 Hours of operation of each pharmacy

section are clearly defined in the policy
and procedure, announced within the
hospital and posted at the pharmacy
entrance.

Pharmacy
(PH)

PH.3.3 Monthly work schedule is written and

announced.
PH.4.

The pharmacy has qualified and licensed

staffing.
PH.4.1 All Pharmacy staff has valid licenses
from the Saudi Council of health
Specialties to practice in Saudi Arabia.
PH.4.2. All staff have a current job description.
PH.4.3. Each staff signed his/her job
description.

PH.5.

The pharmacy actively participates in all

relevant hospital committees as evidenced by
meeting minutes.
PH.5.1 The pharmacy actively participates in
the Pharmacy and Therapeutics
committee.
PH.5.2 The pharmacy actively participates in
the hospital QM/TQM committee.
PH.5.3 The pharmacy actively participates in
the hospital Infection Control
committee.
PH.5.4 The pharmacy actively participates in
the hospital Fire and Safety committee.

PH.6.

The pharmacy has updated internal policy and

procedures for all available services (IPPs.)
PH.6.1 All approved IPPs are written according
to standard hospital format & updated
every 2 years.
PH.6.2 All multidisciplinary IPPs are established
by the combined effort of pharmacy,
medical, nursing, and hospital
administration.
PH.6.3 IPPs are made accessible to all
pharmacy staff all the time and staff is
familiar with IPPs.

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PH.7.

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The Pharmacy Director reports workload

statistics to the appropriate committee and
leadership. Number of FTE (full-time equivalent
staff) and actual workload are published.

Pharmacy
(PH)

PH.7.1 Standard time for each function/task is

determined.
PH.7.2 Monthly workload is reported for
inpatient pharmacy (Unit dose and/or
IV admixture).
PH.7.3 Monthly workload is reported for
Chemotherapy.
PH.7.4 Monthly workload is reported for
pharmacy storeroom.
PH.7.5 Monthly workload is reported for
extemporaneous compounding.
PH.7.6 Monthly workload is reported for
outpatient pharmacy.
PH.7.7 Monthly workload is reported for clinical
pharmacy services.
PH.7.8 Monthly manpower (staffing, FTE) is
reported
PH.7.9 Monthly workload is reported for other
activities (e.g. meetings, in-services,
floor inspections, etc.).
PH.7.10 Workload statistics are reported monthly
to the appropriate committee and the
leadership for future planning and
pharmacy staffing.
PH.7.11 The pharmacy has the necessary
manpower to operate the available
service as evidenced by the workload
statistics.
PH.8.

The pharmacy has administrative rules

regarding availability of medications 24-hours a
day.
PH.8.1 The Pharmacy is open 24 hr/day for
inpatient areas, EMS, and clinic
prescriptions.
PH.8.2 If the pharmacy is not open 24hr/day.

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PH.8.2.1 Availability of on-call

pharmacist within 20 minutes
whenever pharmacy is closed.

Pharmacy
(PH)

PH.8.2.2 On-call service is announced

to all hospital service areas
(written schedule,
communication numbers,
etc.) for use after working
hours.
PH.9.

PH.10.

The Hospital has an updated formulary system.

PH.9.1

The Hospital formulary is established in

collaboration with the pharmacy and
therapeutics committee.

PH.9.2

The Hospital formulary is updated

every TWO years at least.

PH.9.3

The Hospital formulary is available to

healthcare team (hardcopy or
electronic).

The Hospital formulary is very well structured.

PH.10.1. Hospital formulary has at least generic
& brand name information,
formulations, strength, therapeutic
classification, and prescribing
information.

PH.11.

PH.10.2

The Hospital formulary is properly

indexed using alphabetical indexing
for both generics- and brand-named
available drugs.

PH.10.3

An approved abbreviation list for

prescribing is included in a separate
section and there is evidence of
implementation.

The Hospital formulary provides guidance to

antibiotic use.
PH.11.1

Antibiotic utilization guidelines and/or

restriction are included in a separate
section.

PH.11.2

Evidence of implementation by
prescribers of the antibiotic utilization
guidelines.

PH.11.3

Antibiotic dispensing as per antibiotic

hospital policy (dosing, duration,
restriction, etc.).
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PH.12.

PH.13.

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The pharmacy has infection control guidelines

that include:
PH.12.1

Written policies and procedures.

PH.12.2

Guidelines verbalized by pharmacy

staff.

PH.12.3

Guidelines adhered to by pharmacy

staff.

PH.12.4

No food, drink, or smoking allowed in

the pharmacy.

PH.12.5

A sink, soap, and antiseptic hand

scrub are available in the pharmacy.

PH.12.6

Separate housekeeping materials of

the IV admixture room

Pharmacy
(PH)

The pharmacy has a system for accepting

verbal orders.
PH.13.1 There is a written multidisciplinary IPP
for accepting and transcribing verbal
orders by medical staff.

PH.14.

PH.13.2

IPP clearly defines

urgency/emergency situation for
accepting verbal orders code and
time frame for order authentication.

PH.13.3

IPP clearly defines restriction on drugs

that may be ordered verbally.

PH.13.4

IPP clearly defines non-medical staff

who may accept a verbal order.

PH.13.5

IPP defines proper procedure for

receiving and documenting verbal
orders.

PH.13.6

Staff (pharmacy and/or nurse) clearly

understands how to handle verbal
orders.

The pharmacy has a system for accepting

telephone orders:
PH.14.1 Written multidisciplinary IPP for
accepting and transcribing
telephone orders by medical staff.
PH.14.2 IPP clearly defines urgency situation
for accepting telephone orders and
time frame for order authentication.

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PH.14.3 IPP clearly defines restriction on drugs

that may be ordered by telephone.
PH.14.4 IPP clearly defines staff who may
accept a telephone order.

Pharmacy
(PH)

PH.14.5 IPP defines proper procedure for

receiving and documenting
telephone orders.
PH.14.6

PH.15.

Staff (pharmacy and nurse) clearly

understand how to handle telephone
orders.

There is a list of Medical staff signatures who are

authorized to prescribe medication.
PH.15.1 The list contains medical staff name,
signature, ID number, specialty, and
stamp or code (if available) and
updated every year.
PH.15.2 Clear copy of the signature list is
available to pharmacy staff in each
drug dispensing area.
PH.15.3 Pharmacy staff is aware of the list.

PH.16.

PH.17.

There is an updated list of prescribers and their

prescribing privileges.
PH.16.1

The list contains medical staff

specialties and their prescribing
privileges.

PH.16.2

The list clearly defines prescribing

privileges especially for narcotics,
controlled drugs, psychotropics,
chemotherapeutics, and high risk
medications, etc.

PH.16.3

The list is updated every year and

whenever a new medical staff joins.

PH.16.4

Clear copy of the privilege list is

available to pharmacy staff in each
drug dispensing area.

PH.16.5

Pharmacy staff is aware of the list.

PH.16.6

There is clear evidence of proper

implementation.

The pharmacy has a system for handling drug

recall.

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PH.17.1

PH.18.

PH.19.

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Clearly written IPP including

identification and handling drug
recalls, time frame, and procedures
for informing patients who received
any recalled drug.

PH.17.2

Evidence of proper recall is

documented (memos, recall forms,
hospital exit documents).

PH.17.3

None of the recalled drugs is

available in the pharmacy or patient
care areas.

Pharmacy
(PH)

The pharmacy has a system for identifying and

handling expired medications.
PH.18.1

Written policy clearly defines expiry

date, expired medications, nearly
expired medications, and proper
procedure for handling expired
drugs, and inspection form(s).

PH.18.2

All expired and/or nearly-expired

medications are properly labeled
and stored separate from other
medications.

PH.18.3

No expired drugs are found in any

patient care area.

PH.18.4

Documents of return of expired drugs

to supplier or manufacturer are
maintained on file or evidence of
proper destruction.

The pharmacy has a system for handling

pharmaceutical sales representatives and free
medical samples.
PH.19.1

Written multidisciplinary IPP to outline

the relationship of pharmaceutical
sales representatives with healthcare
professionals.

PH.19.2

Written multidisciplinary IPP for

handling and dispensing free medical
samples that has been approved by
the Pharmacy and Therapeutic
committee.

PH.19.3

All free medical samples are kept

under tight inventory control in a
separate and properly labeled
cabinet in the pharmacy.

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PH.19.4

PH.20.

PH.21.

PH.22.

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No free medical samples are found in

the inpatient areas or the outpatient
clinics (OPD).

Pharmacy
(PH)

The pharmacy has a system for handling nonformulary drug requests.

PH.20.1

Written multidisciplinary IPP for

handling non-formulary drugs
including clearly defined time frame
for drug procurement.

PH.20.2

Non-formulary drug request form is

available.

PH.20.3

Clear evidence of proper handling of

non-formulary drug request is
available.

The pharmacy has a system for using formulary

drugs for un-approved indications.
PH.21.1

Written multidisciplinary IPP for using a

formulary drug for an un-approved
indication and/or investigation.

PH.21.2

Request form for using formulary drug

for an un-approved indication is
available.

PH.21.3

Clear evidence of proper adherence

to the IPP for using formulary drugs
for an un-approved indications.

The pharmacy has a system for handling out-ofstock medications and PRN.
PH.22.1 Written IPP for handling out-of-stock
formulary medications including
clearly defined time frame for drug
procurement.
PH.22.2 Written IPP and evidence of
implementation for handling PRN
drugs e.g. NTG, S.L Isordil, Voltaren,
etc.

PH.23.

The pharmacy has a system for handling

patients own medications (brought from
home).
PH.23.1

Written multidisciplinary IPP for

handling patients own medications
(brought from home).

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PH.24.

PH.25.

PH.23.2

Patients own medications are

properly labeled by the pharmacy
before use.

PH.23.3

Evidence of proper implementation of

patients own medication
(documentation in patients drug
profile and nursing MAR).

PM MM NM
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NA

Pharmacy
(PH)

The pharmacy has a system for ensuring

preparedness of crash cart medications.
PH.24.1

Developing and maintaining a set of

guidelines for crash cart medication
(all drugs on crash carts throughout
the hospital are standardized) multidisciplinary policy.

PH.24.2

Updating the crash cart drug list in

accordance to the Saudi
Heart/American Heart Association
recommendation.

PH.24.3

Protecting emergency medications

from loss or theft using safety plastic
seal.

PH.24.4

Keeping plastic seals stocked in a

safe place under supervision of
pharmacy or nursing.

PH.24.5

Monitoring emergency medications

and replacing them in a timely
manner after use or when expired or
damaged.

PH.24.6

Performing documented monthly

inspection of crash cart medications
and maintaining records in the
pharmacy.

The pharmacy has a system for ensuring stability

of medication available in multi-dose
containers.
PH.25.1

Developing and maintaining a set of

guidelines for ensuring stability of
multi-dose vials, multi-dose oral
liquid, and other multi-dose
medications (e.g., eye, ear, and
nose drops, creams, ointments,
nebulization solution, etc.).

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PH.26.

PH.27.

PH.25.2

Ensuring that all open multi-dose

containers carry open date, expiry
date, initials, and time (if necessary).

PH.25.3

Ensuring that no expired open or

unlabeled open multi-dose
containers are available in patient
care areas.

PM MM NM
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NA

Pharmacy
(PH)

The pharmacy has a system for managing floor

stock medications
PH.26.1

An approved list of floor stock

medication is allowed on each unit or
clinic.

PH.26.2

Floor stock supply is available in

limited quantities.

PH.26.3

Floor stock supply is not accessible to

patients or visitors.

PH.26.4

Floor stock medications are stored

under proper condition (temperature,
light protection). Storage area is
clean and organized.

PH.26.5

No expired medications are available.

PH.26.6

All floor stock medications are well

separated and properly labeled.

The pharmacy has a system for handling highrisk medications.

PH.27.1

Written guidelines for handling highrisk medications (including a defined

list).

PH.27.2

Concentrated intravenous potassium,

magnesium and hypertonic saline are
not allowed as floor stock except as
part of the crash cart medication as
per Saudi Heart recommendation.

PH.27.3

Only, if necessary, critical care areas

may stock limited quantities of
intravenous potassium, and
magnesium in a separate, locked
and properly labeled cabinet.

PH.27.4

Standard drug concentrations of all

intravenous drips in the hospital.

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PH.28.

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The pharmacy has a system developed for

handling outpatient prescriptions which
includes:
PH.28.1

Pharmacy
(PH)

A policy for filling, refilling

prescriptions, discharge medications,
and self-medication of healthcare
professionals.

PH.28.2 All prescriptions have the patients

name, hospital number, age, sex,
diagnosis, prescriber's name, pager #
or code & signature, clinic name and
date.
PH.28.3 Any prescription is double-checked
by another pharmacist before
dispensing.
PH.29.

PH.30.

PH.31.

The outpatient pharmacy has a system

developed for proper labeling of drugs which
includes:
PH.29.1

All outpatient drugs are labeled in

Arabic and/or English according to
patient preference.

PH.29.2

Outpatient label reflects Hospital

name, patient name, drug name,
strength, dosage, and directions.

PH.29.3

Colored auxiliary labels that stick out

are used whenever applicable (e.g.
refrigerate, do not refrigerate, shake
before use, external use, etc).

The outpatient pharmacy has a system

developed for patient and family education
before going home which includes:
PH.30.1

Patients and families are offered

education for dispensed medications.

PH.30.2

Written drug counseling materials are

available in easy understandable
language (Arabic and English).

PH.30.3

There is a private area for patient

counseling.

The pharmacy shows evidence of continuing

education and staff training by:
PH.31.1

Written policy and well defined

pharmacy orientation and continuing
education program.
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PH.32.

PH.31.2

Evidence of completion of pharmacy

orientation by all newly hired
pharmacy staff.

PH.31.3

Evidence of continuing education

activities (provision or attendance of
lectures, in-services, conferences &
symposia, or distant learning e.g.,
internet or CE articles).

PH.31.4

Each pharmacy section has the

following reference manuals and/or
policies (relevant policy and
procedure manual, infection control
manual, safety manual, operating
manual of equipments, MSDS
manual).

PH.31.5

The pharmacy staff operates

equipment safely by maintaining skills
in the use of equipment including
trouble-shooting.

PH.31.6

The pharmacy staff knows how to

report and properly label
malfunctioning equipment so that
staff do not use it.

PM MM NM
(2) (1) (0)

NA

Pharmacy
(PH)

The pharmacy has a system for drug storage

(inpatient, outpatient, store, patient care areas)
and includes:
PH.32.1

Storage of items requiring

refrigeration at a temperature of 2-8
C and those requiring freezing at 20 to -10 C.

PH.32.2

All medication refrigerators and

freezers are equipped with
appropriate thermometers (digital
and non-digital) and temperature
log sheet and temperature is
recorded at least once daily.

PH.32.3

Vaccine refrigerator is connected to

emergency power source, (electric
outlets are marked) and
temperature is recorded 24-h daily.

PH.32.4

Food, drinks, biological samples,

culture media are not allowed in
medication refrigerators.

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PH.32.5

PH.32.6

PH.33.

PH.34.

PH.35.

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Storing antiseptics, disinfectants and

drugs for external use separately
from internal and injectable
medications.

Pharmacy
(PH)

All medications are well separated

and properly labeled upon display
on the shelves.

The following rules are written and

implemented as to the dispensing mechanism
for inpatient:
PH.33.1

There is a quiet, adequately

illuminated and low-noise working
environment that does not permit
interruption of work.

PH.33.2

A log is maintained as to the person

pre-packing & the person checking
all unit doses made. If Unit-dose prepacking is not available, doses of
each drug are placed in plastic bag
and properly labeled.

PH.33.3

No more than 24-h supply is

dispensed at a time except for bulk
(liquids, ointments, etc.)

The following rules are written and

implemented as to handling inpatient drug
orders.
PH.34.1

A copy or fax of the original physician

order or electronic version is sent to
the pharmacy.

PH.34.2

Any new physician order, reorder or

changing order is made in writing.

PH.34.3

Stat orders are separated from regular

and filled within 30 minutes of
transmittal.

The pharmacy maintains updated drug profiles

for all admitted patients.
PH.35.1

Each patient has a drug profile

maintained in the inpatient
pharmacy (electronic or hard copy).

PH.35.2

Drug profile reflects patient name,

MRN#, age, sex, weight/height,
allergies, diagnosis, and location in
the hospital.

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PH.35.3

PH.36.

PH.37.

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Drug profile reflects all active and

inactive medication orders during
current admission (drug name,
strength, formulation, dosage,
special instruction).

PH.35.4

Drug profile reflects the start date,

stop date, number of dispensed
doses and pharmacist signature.

PH.35.5

Drug profile reflects any stat, single

dose, PRN, controlled/narcotics, and
floor stock medications.

PH.35.6

Drug profile reflects IV fluids, TPN, and

chemotherapy.

Pharmacy
(PH)

There is a system to monitor drug allergies and

includes the following:
PH.36.1

There is a written mechanism to

ensure allergies are identified by the
attending physician and
immediately communicated to the
pharmacy in writing.

PH.36.2

Allergies are documented in each

patient drug profile before
dispensing any medication.

PH.36.3

There is a written mechanism in place

that allows for pharmacy
intervention including stop
dispensing when patient is identified
as being allergic to prescribed
drug(s).

There is a process for monitoring, detecting,

and reporting adverse drug reactions (ADRs)
and includes:
PH.37.1

Written policy and procedure for ADR.

PH.37.2

Definition of a significant or serious

ADR and timeframe for reporting.

PH.37.3

ADR reporting forms are available

PH.37.4

Intensive analysis is performed for all

significant or serious ADRs.

PH.37.5

Notification of treating physician.

PH.37.6

There is evidence that the patient

receives appropriate care for the
ADR.
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PH.38.

PH.39.

PH.37.7

There is evidence that the medical

record has been flagged for known
allergies.

PH.37.8.

Process for improving ADR reporting.

PH.37.9.

Evidence of reporting any serious or

unexpected ADR to the MOH.

PM MM NM
(2) (1) (0)

NA

Pharmacy
(PH)

There is a process for monitoring, identifying

and reporting significant medication errors &
includes:
PH.38.1

Written policy and procedure for

medication error reporting.

PH.38.2

Definition of a significant medication

error, timeframe for reporting, and
reporting format.

PH.38.3

Evidence of active reporting exists.

PH.38.4

Intensive root-cause analysis is

performed for all significant
medication errors.

PH.38.5

Evidence for using reported data to

improve medication use process and
reduce error rate.

PH.38.6

Mechanisms to prevent serious

medication errors (e.g. removal of
concentrated intravenous potassium,
magnesium, hypertonic saline, other
high risk stocks from nursing units).

The pharmacy evaluates & monitors for drug

indications, correct route of administration,
drug interactions, and administration time.
PH.39.1

There is a procedure for pharmacy

intervention /clarification of physician
orders.

PH.39.2

The pharmacy notifies the prescribing

physician if a drug prescribed is not
available.

PH.39.3

Evidence of evaluation, monitoring,

and documentation of drug-drug
and drug-food interactions.

PH.39.4

Drugs are prescribed and dispensed

for their approved indications as
evidenced by the given diagnosis.

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PH.39.5

PH.40.

PH.41.

PH.42.

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Standard administration time is

announced and adopted by
pharmacy & nursing.

Pharmacy
(PH)

The pharmacy has a system for automatic stop

orders (ASO):
PH.40.1

Written policy and procedure for

handling automatic stop orders.

PH.40.2

All physician orders are valid for 7

days unless shorter period is specified.

PH.40.3

ASO for all drugs at time of surgery.

PH.40.4

ASO for antibiotics as per hospital

policy.

PH.40.5

Daily orders for anticoagulants (e.g.

intravenous heparin, warfarin).

PH.40.6

Daily order for any continuous

intravenous drips (e.g. dopamine,
dobutamine, KCL, NTG, fentanyl,
midazolam, etc.)

PH.40.7

ASO for IV, IM, and oral controlled

medications.

There is a system for verification of prescriptions:

PH.41.1

A qualified pharmacist initially verifies

all physician orders.

PH.41.2

A pharmacist or technician fills

medication trolley according to a
dispensing list, patient drug profile or
physician orders.

PH.41.3

All medications dispensed for

inpatients are checked by another
licensed pharmacist.

PH.41.4

Generic equivalent may be

dispensed for brand name for the
same strength or concentration and
dosage form.

There is evidence for safe packaging of the

medications given to patients by:
PH.42.1

Using unit-dose packaging system for

solid dosage forms.

PH.42.2

Using unit-dose packaging system for

liquid dosage forms.

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PH.43.

PH.44.

PH.42.3

Using plastic Ziploc bags for tablets

or capsules.

PH.42.4

Using plastic Ziploc bags for

ampoules, vials, or suppositories.

PH.42.5

Using plastic or umber-colored glass

for bulk liquids.

PH.42.6

Properly labeling all unit-dose, plastic

Ziploc bags or original bulk liquids.

PH.42.7

The expiry date of repackaged unit

dose should comply with the current
American Society of Health-System
Pharmacists (ASHP) guidelines.

PM MM NM
(2) (1) (0)

NA

Pharmacy
(PH)

There is a system to ensure safe labeling of all

Inpatient medications and includes the
following:
PH.43.1

Printed or hand written label for any

dispensed medication.

PH.43.2

Unit-dose pre-pack is labeled with

drug name, strength, formulation, lot
# and expiry date.

PH.43.3

If Unit-dose pre-packing is not

available, doses of each drug are
placed in plastic bag & labeled with:
Patient MRN #, Location (ward #, Bed
#), drug name, dosage, lot # and
expiry date.

PH.43.4

Label is affixed to the immediate

container after removal of outside
carton.

PH.43.5

Colored auxiliary label (stick out) is

used as appropriate (e.g. refrigerate,
do not refrigerate, shake before use,
external use only, etc.).

PH.43.6

Inpatient drug cassettes are labeled

with patient Name, MRN#, and bed
number.

The pharmacy has a safe system for

Extemporaneous Preparations and:
PH.44.1

Written IPP for extemporaneous preps.

PH.44.2

Only Oral and Topical preparations

are extemporaneously prepared.

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PH.44.3

PH.45.

PH.46.

PM MM NM
(2) (1) (0)

NA

There are adequate equipment and

glass wares (e.g., weighing scale,
bottles, jars, mortar, filters, electric
heater, thermometer, etc).

PH.44.4

There is a sink with water supply and

stainless steel surface.

PH.44.5

Working bench is clean with a smooth

surface.

PH.44.6

A log is maintained as of preparation

name, strength, quantity prepared,
batch number, preparation and
expiration date, prepared by &
checked by, etc.

PH.44.7

Printed or hand written label should

reflect preparation name, strength,
batch number, and expiration date.

PH.44.8

Preparation manual (formula book) is

available and properly referenced
(ASHP, BP and or USP Guidelines).

PH.44.9.

If compounding is done by an
outside vendor, a copy of contract,
registration license, and formulation
should be available.

Pharmacy
(PH)

There is a system for handling Narcotics and

Psychotropic Drugs (Controlled Drugs) in
accordance with MOH regulations and
includes but is not limited to:
PH.45.1

There is a written policy and

procedure for handling narcotics and
psychotropics.

PH.45.2

Receiving, storing and dispensing

controlled drugs by the pharmacy.

PH.45.3

Keeping controlled drugs behind steel

doors with double locks.

PH.45.4

Keeping limited floor stock supply in a

double door, double locked cabinet.

There is a system for auditing Narcotics and

Psychotropic Drugs in accordance with MOH
regulations:
PH.46.1

Auditing every shift in the pharmacy.

PH.46.2

Auditing every shift in each nursing

unit.
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PH.47.

PH.46.3

Maintaining proper documentation of

drug count and accountability in the
pharmacy.

PH.46.4

Maintaining proper documentation of

drug count & accountability in each
nursing unit.

PH.46.5

Maintaining proper documentation of

empty containers of narcotics.

PH.46.6

Evidence of proper disposal of unused

portion of an ampoule or a tablet.

PM MM NM
(2) (1) (0)

NA

Pharmacy
(PH)

There is a system for Prescribing Narcotics and

Psychotropic Drugs (Controlled Drugs) in
accordance with MOH regulations and
includes but is not limited to:
PH.47.1

Using the MOH approved

prescriptions.

PH.47.2

Not allowing physicians to prescribe

controlled drugs for self or family
members.

PH.47.3

Allowing only clinical privileged

physicians to prescribe.

PH.47.4

Allowing only psychiatrists and

specialists to prescribe psychotropics
(except during emergency).

PH.47.5

Not allowing injectable narcotics and

controlled drugs for outpatients.

PH.48.

The pharmacy provides all Intravenous

admixture services in the hospital.

PH.49.

The Pharmacy Intravenous admixture service is

safe and:
PH.49.1

There is a written policy and

procedure for IV admixture services.

PH.49.2

There is a manual for proper aseptic

technique & IV room cleanliness.
Aseptic techniques are strictly
followed.

PH.49.3

There are written guidelines for drug

stability and compatibility. Guidelines
are strictly followed.

PH.49.4

The IV pharmacy staff is well trained

and certified.
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Standard

PH.50.

PH.51.

PH.49.5

There are policy and procedures for

recycling of returned IV admixtures in
accordance with ASHP guidelines.

PH.49.6

There are guidelines for drugs that

may be safely given IV push.

PM MM NM
(2) (1) (0)

NA

Pharmacy
(PH)

The Pharmacy Intravenous Admixture section is

fully equipped and well maintained.
PH.50.1

The IV room space, design, floor

cover, wall painting, air flow and
pressure are in compliance with ASHP
requirements for clean room.

PH.50.2

The LAFH has HEPA filter (99.97%

efficiency) and has visible pressure
gauge for detecting leaks or defects.

PH.50.3

The LAFH is tested in accordance with

the manufacturer requirements and
in accordance with ASHP guidelines.

PH.50.4

The IV admixture area is separate

form chemotherapy area.

PH.50.5

All IV Products are labeled to show:

patient name, MRN#, location, drug
name(s) and concentration, diluents
name and volume, infusion rate,
date and time of preparation,
prepared and checked by.

PH.50.6

All I.V. admixtures are checked by

another licensed pharmacist.

If no Pharmacy-based IV admixture program is

in place, pharmacy provides:
PH.51.1

A manual for proper aseptic

technique & area cleanliness.

PH.51.2

Assurance that aseptic techniques

are strictly followed.

PH.51.3

Written guidelines for drug stability

and compatibility. Guidelines are
strictly followed.

PH.51.4

That IV admixture area is completely

separate from the chemotherapy
area.

PH.51.5

Guidelines for drugs that may be

safely given IV push.

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PH.51.6

PH.52.

NA

That dispensing area is appropriate

(location, space, cleanliness, traffic,
etc).

Pharmacy
(PH)

If no Pharmacy-based IV admixture program is

in place, the pharmacy is responsible for:
PH.52.1

Training and monitoring performance

and qualifications of non-pharmacy
personnel forming parenteral
products.

PH.52.2

Monitoring IV admixture areas all over

the hospital (cleanliness, proper
storage, etc).

PH.52.3

All IV Products are labeled to show:

(patient name, MRN#, location, drug
name(s) and concentration, diluents
name and volume, infusion rate,
date and time of preparation,
prepared and checked by).

PH.53.

Only Pharmacy Department provides

Chemotherapy admixture services.

PH.54.

Chemotherapy Preparation Service is provided

by certified pharmacy staff in a fully equipped
and properly designed place according to
Occupational Safety and Health Administration
(OSHA) Standards.

PH.55.

PM MM NM
(2) (1) (0)

PH.54.1

Written policy and procedures for

handling chemotherapy.

PH.54.2

Preparation is done under a biological

safety cabinet (Vertical LAFH) type B.
Exhaust is separated from air
circulation to outside the building.

PH.54.3

Work is done by well-trained and

certified chemotherapy pharmacist.

PH.54.4

Aseptic techniques are strictly

followed.

PH.54.5

Chemotherapy area is isolated from

IV admixture area.

There is a safe system for handling

Chemotherapy Preparation and includes but is
not limited to the following processes:
PH.55.1

OSHA guidelines are adopted.

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Standard
PH.55.2

PM MM NM
(2) (1) (0)

NA

All preparations are double checked

by a certified pharmacy staff and
records of dispensed prescription are
kept for at least 30 days.

PH.55.3

All preparations are placed inside a

Ziploc plastic bag and labeled
"Cytotoxic".

PH.55.4

All wastage and spillage are handled

separately according to OSHA.

PH.55.5

Special chemotherapy protective

gloves, masks and gowns are in use.

PH.55.6

Chemotherapy spill kit is available

and staff is trained on how to use it.

PH.56.

Only the pharmacy provides Total Parenteral

Nutrition (TPN) services.

PH.57.

There is a safe system for Total Parenteral

Nutrition (TPN) Services which includes but is not
limited to the following:
PH.57.1

Written IPP for handling TPN

PH.57.2

Work is done under LAFH-type A.

PH.57.3

Aseptic techniques are strictly

followed.

PH.57.4

Work is done by well-trained &

certified TPN pharmacy staff.

PH.57.5

Availability of macro- & micronutrients and TPN filters.

PH.57.6

Stability / compatibility references are

available.

PH.57.7

Double check policy at each stage of

admixture is implemented.

PH.57.8

Final product passes visual inspection

for particles.

PH.57.9

Proper labeling to reflect ingredients

and their quantities, volume, infusion
rate, expiry date, patient
demographics, etc.

Pharmacy
(PH)

PH.57.10 All TPN orders are monitored by

qualified pharmacist.

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(3)

Standard
PH.58.

PM MM NM
(2) (1) (0)

NA

Drug Information Service is available and

includes:
PH.58.1 Written policies and procedures.

PH.59.

PH.58.2

Drug information center is staffed by

qualified pharmacist with special
training in drug information.

PH.58.3

A good collection of up-to-date

information resources: Micromedex,
IOWA drug information system, local
and international pharmacy and
therapeutics journals, pharmacy
textbooks and manuals, Saudi
national formulary, specialty
references as needed.

PH.58.4

Being equipped with: Microfiche

reader/ printer, photocopier
machine, computer with printer,
reading table with chairs, storage
shelves & cabinets, telephone line
with internet connection, quiet and
well illuminated reading area.

PH.58.5

All questions being logged in with

date and time of arrival. All answers
are documented and filed in order.

PH.58.6

Giving priority to poisoning and critical

care patients.

PH.58.7

Posting and making available

telephone number for the nearest
poison control center and poison
antidote information.

Pharmacy
(PH)

If drug information service is not available,

pharmacy areas should have adequate drug
information resources and includes but is not
limited to:
PH.59.1

Saudi National Formulary (SNF).

PH.59.2

British National Formulary (BNF).

PH.59.3

Middle East Medical Index.

PH.59.4

Martindale the extra

pharmacopoeia.

PH.59.5

Specialty drug references according

to available services.

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Standard
PH.59.6

PH.60.

PH.61.

PM MM NM
(2) (1) (0)

NA

Posting and making available

telephone number for the nearest
poison control center and poison
antidote information.

Pharmacy
(PH)

The pharmacy shows evidence of Quality

Improvement by:
PH.60.1

Appointing a Quality Management

Coordinator who reports to the
pharmacy head.

PH.60.2

Having standards for all the

pharmaceutical care processes.

PH.60.3

Subjecting current standards to

evaluation.

PH.60.4

Having a Pharmacist who is actively

involved with drug utilization
committee process/function.

PH.60.5

Developing and maintaining a plan

and documented performance
improvement program.

PH.60.6

Continually determining areas for

improvement.

PH.60.7

Immediately reporting life threatening

issues to the pharmacy head and
hospital TQM department (e.g.
morbidity, mortality, teratogenicity),
drugs required immediate surgical
intervention, any new ADR or toxic
events of a new drug(s).

PH.60.8

Reporting any questionable drug

quality to pharmacy head (e.g.
ineffective medication, inconvenient
size, shape, volume or color, package
or label, etc.).

Security measures are in place and include:

PH.61.1

Limited access to pharmacy.

PH.61.2

Visible name tags for all personnel.

PH.61.3

Proper locking procedures for any

pharmacy not open 24h a day.

PH.61.4

The pharmacy doors and windows

being locked during operation.

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Standard

PH.62.

PH.61.5

Identification of which pharmacy

personnel have keys to pharmacy.

PH.61.6

Having an IPP for non-pharmacy staff

accessing pharmacy after hours in
case of emergency (fire, flood, etc.)

PM MM NM
(2) (1) (0)

NA

Pharmacy
(PH)

Safety measures are in place and include but is

not limited to:
PH.62.1

Having an IPP for safe handling of

dangerous substances and changing
the HEPA filter of biological safety
cabinets.

PH.62.2

Keeping a list of hazardous materials

readily available in areas where they
are stored or used.

PH.62.3

Storing all chemicals in a separate

place on low shelves, & in the original
labeled container.

PH.62.4

Keeping material safety data sheets

(MSDS) available in areas where
hazardous materials are stored or
used.

PH.62.5

Keeping all flammables in a wellventilated area where no smoke is

allowed.

PH.62.6

Keeping spill kits available in areas

where hazardous materials are stored
or used.

PH.62.7

Keeping personnel protective

equipment (gowns, gloves, eye &
face protection) readily available.

PH.62.8

Storing Cancer chemotherapy drugs

separately.

PH.62.9

Not allowing pregnant and lactating

mother to work with chemotherapy.
Regular medical checks for chemo
worker (Family Medicine).

PH.62.10 Having eye wash stations and shower

rooms available in appropriate area.
PH.62.11 Collecting all chemotherapy wastes
in orange plastic bags to be
incinerated.

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Standard

FM
(3)

PM MM NM
(2) (1) (0)

NA

PH.62.12 Training all staff on how to handle

spills.

Pharmacy
(PH)

Page 186