CHI Drug Formulary Master

Excel Sheet User Guide

June 2023

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Welcome to the official User Guide of the CHI- Unified Drug Formulary (UDF).
This meticulously crafted guide is intended to provide comprehensive support
in navigating the UDF Master Excel Sheet. Its purpose is to equip healthcare
professionals, providers, institutions, researchers, and individuals seeking
pharmaceutical information with the necessary guidance and resources.

The User Guide encompasses crucial components that enhance understanding

and utilization of the CHI Drug Formulary. It begins with an Introduction to the
formulary, offering an insightful overview of the formulary's objectives and
purpose. This contextual understanding lays the foundation for interpreting
and effectively utilizing the information contained within the formulary.

The formulary development process section outlines the meticulous procedures

employed to curate and maintain the CHI Drug Formulary. It elucidates the
methodologies, guidelines, and expert consultations involved in its
comprehensive content creation and updates. Familiarizing oneself with this
process instills confidence in the formulary's accuracy, reliability, and relevance.

Successful navigation of the Master Excel Sheet Drug Formulary requires a clear
comprehension of the various sheets it encompasses. The User Guide provides
detailed explanations for each sheet, including their specific purposes and the
information they offer. This section empowers users to efficiently locate and
extract the precise data required, streamlining research and practice
endeavors.

In addition, a comprehensive understanding of the field definitions utilized

within the CHI Drug Formulary is vital for accurate interpretation of the data.
The User Guide meticulously defines each field, elucidating their meanings,
units of measurement, and any pertinent notes or considerations. This
knowledge enables users to confidently interpret the data and make informed
decisions based on it.

We trust that this User Guide will prove indispensable as you explore the CHI
Drug Formulary. Whether you seek drug information for patient care, academic
research, coverage information or any other purpose, this guide will facilitate
your navigation and comprehension of the formulary's contents.

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CONTENTS
List of Abbreviateion ................................................................................. 4
List of tables ............................................................................................ 4
List of figures ........................................................................................... 4
Introduction to Formulary ..................................................................... 5
What is a Drug Formulary? ......................................................................... 5
What is CHI Drug Formulary (ISF)? ....................................................................5
What is the Objective of CHI Formulary? ...................................................... 5
Development of the Formulary ............................................................... 6
How to Use the Formulary ...................................................................... 7
UDF WorkSheet Definitions and USE ............................................................ 7
UDF Navigation ........................................................................................ 9
Evidence Level Used ................................................................................. 9
UDF coverage Essentials ............................................................................ 9
UDF Prescribing Edits Tools ...................................................................... 10
UDF Fields Definitions ............................................................................. 11
Useful Links ............................................................................................... 15

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LIST OF ABBREVIATEION

AHCPR: Agency for Healthcare Research and Quality

CHI: council of Health Insurance
FGC: CHI Formulary Governance Committee
GTIN: Global Trade Item Number
HCP: Health Care Provides
UDF: Unified Drug Formulary
KSA: Kingdom of Saudi Arabia
MDD: Maximum Daily Dose
NCE: New Chemical Entity
OTC: Over the Counter
PE: Prescribing Edits
PTC: Pharmacy and Therapeutic committee
SFDA: Saudi Food and Drug Administration
ST: Step Therapy

LIST OF TABLES

Table 1 Prescribing Edits Tools List ........................................................................................ 10

Table 2 Mapped UDF to SFDA Fields Definitions ....................................................................... 13

LIST OF FIGURES
Figure 1 Formulary Development Process................................................................................. 6
Figure 2 Indication Sheet Fields List ........................................................................................ 7
Figure 3 Mapped UDF to SFDA Sheet Fields List ......................................................................... 8
Figure 4 Prescribing Edits Examples ...................................................................................... 10

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 INTRODUCTION TO FORMULARY

WHAT IS A DRUG FORMULARY?

A Drug formulary is a continually updated list of medications and related

information, representing the clinical judgment of physicians, pharmacists, and
other experts in the diagnosis, prophylaxis, or treatment of diseases and
promotion of health.

WHAT IS CHI DRUG FORMULARY (UDF)?

CHI Formulary is an evidence-based disease focused open Formulary which

provides an essential drug list, either prescription or over the counter (OTC), that
is necessary to treat a certain disease. CHI Formulary Governance Committee
(FGC) with the Pharmacy and Therapeutic committee (PTC) govern, maintain
and continually update the Formulary to make sure that all SFDA drugs are
available based on the most recent clinical national and international guidelines
to ensure drug safety, efficacy and efficiency for the community of Saudi Arabia.

WHAT IS THE OBJECTIVE OF CHI FORMULARY?

The Objective of this Formulary is to provide impartial and objective information

to insurance companies in the Kingdom of Saudi Arabia, as well as to service
providers and patients to promote safe, effective and rational use of medicines,
which is based on evidence and global best practices. Other objectives include:
• Rationalize use of medicine (therapeutically accurate and cost-effective)
Promote the use of generics
• Provide a comprehensive resource to insurance companies and Health
Care Professionals (HCPs).
• Standardize the prescribing practices in Kingdom of Saudi Arabia (KSA)by
using the best selected evidence-based guidelines.
• Promote affordable and equitable access to healthcare.
• Improve governance in the private health care insurance sector.
• Decrease healthcare expenditure using therapeutically equivalent but
more affordable treatment options.”

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 DEVELOPMENT OF THE FORMULARY
TAC

Figure 1 UDF Maintenance & Monitoring Process Flowchart

For additional details refer to the UDF MAINTENANCE & MONITORING PROCESS (IDF-FR-Pr-01-01)
retrieved through CHI website https://chi.gov.sa/en/pages/default.aspx

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 HOW TO USE THE FORMULARY

UDF WORKSHEET DEFINITIONS AND USE

Indication Sheet: this sheet includes the list of approved indications mapped
with the corresponding scientific molecules and relative scientific description
code root number. The main end users are healthcare providers who can use
it to identify the approved indications with their respective ICD 10 codes, in
addition to the corresponding approved scientific molecule, dosage form,
strength, and prescribing edits.

Mapped UDF to SFDA Sheet: this sheet includes the list of scientific molecules
regularly mapped with SFDA medication list to identify trade names and
related prices. The main end users are insurance companies, hospitals,
pharmacies and others.

Appendix Sheet: Appendices describing protocols and step therapies that

users should refer to whenever mentioned in the notes provided within the
Indication Sheet as PE for protocol edit and ST for step therapy.

What Information Does the Indication Sheet Provide?

Drug Drug
Indication ICD 10 AM Code pharmacologic pharmacologic Scientific Name
al Class al subclass

Scientific
Pharmaceutical Pharmacuetical
Description Substitutable ATC Code
Form Form Code root
Code Root

Description Administration Prescribing Quantity Limit

Strength
Code Rout edits Adults

SFDA
Quantity Limit
Notes Patient type Registration
Pediatrics
Status

Figure 3 Indication Sheet Fields List

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 What Information Does the Mapped UDF To SFDA Sheet Provide?

Scientific
Pharmaceutical
Scientific Name Description Code ATC Code
Form and Code
Root

Administration Strength and

Description Code Trade Name
Rout Strenght unit

Registration
Number (new GTIN Last Update Date RegisterYear
and old)

DrugType and Scientific Name Trade Name

Product Type
Sub-Type Arabic Arabic

PackageTypes
ATC Code 2 Size and SizeUnit Legal Status
and Size

Product Control Distribute area Public price shelfLife

Marketing Manufacture Secondary

Storage
Company and Name, DMS ID package
conditions
Country and country manufacture

Agent (main, 2nd Authorization

Marketing Status
and 3rd) Status

Figure 4 Mapped UDF to SFDA Sheet Fields List

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UDF NAVIGATION

The CHI Formulary is provided on an excel sheet platform that users can filter
by Indication, ICD 10 AM code, Drug Pharmacological classes, Scientific name
Scientific description code root, pharmaceutical form, pharmaceutical form
code root, description code and, ATC code.

Formulary provides Appendices with various tables and protocols that users
should refer to whenever mentioned in the notes. Hyperlinked Appendices
are provided on a separate column for each disease or indication.

EVIDENCE LEVEL USED

Categories of evidence (adapted from AHCPR):

- Ia: evidence from meta-analysis of randomized controlled trials
- Ib: evidence from at least one randomized controlled trial
- IIa: evidence from at least one controlled study without randomization
- IIb: evidence from at least one other type of quasi-experimental study
- III: evidence from non-experimental descriptive studies, such as
comparative studies, correlation studies and case-control studies
- IV: evidence from expert committee reports or opinions and/or clinical
experience of respected authorities

UDF COVERAGE ESSENTIALS

Medication Prescribing must
1. Medications should be covered if it is mentioned as part of the Indication
"ICD-10 AM" coverage.
2. Prescribing must be done based on the Scientific Name, and automatic
substation will be done except for generics not therapeutically
equivalents as per SFDA list, Prescriber Place do not substitute note
"Insurance coverage deductible will be based on the EBP criteria"
https://www.sfda.gov.sa/sites/default/files/2023-02/SFDADDD.pdf
3. For Further details on the Insurance Drug formulary related regulations
can be found through of the Updated Essential Benefit package through
the below link:
https://www.CHI.gov.sa/Rules/Pages/document1-7.aspx

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 UDF PRESCRIBING EDITS TOOLS

Table 1 Prescribing Edits Tools List

Prescribing edits Tools Description

AGE (Age Edit) Coverage may depend on patient age

Coverage may depend upon concurrent use of another
CU (Concurrent Use Edit)
drug
G (Gender Edit) Coverage may depend on patient gender
MD (Physician Specialty Coverage may depend on prescribing physician’s
Edit) specialty or board certification
PA (Prior Authorization) Requires specific physician request process
Coverage may be limited to specific quantities per
QL (Quantity Limit)
prescription and/or time period
ST (Step Therapy) Coverage may depend on previous use of another Drug

EU (Emergency use only) This drug status on Formulary is only for Emergency use.
Use of drug is dependent on protocol combination, doses
PE (Protocol edit)
and sequence of therapy

Prescribing Edits Examples:

Age edits: Desmopressin in Nocturnal Enuresis should not be prescribed for children < 5 years.
Concurrent Use Edit: Flavoxate in Nocturnal Enuresis should be used as add on to
desmopressin after desmopressin failure and cannot be used alone.
Gender Edit: Exemestane in Endometriosis should be used only by Females.
Physician Specialty Edit: Fentanyl in Endometriosis should be prescribed by a gynecologist or
pain management specialist.
Prior Authorization: Desmopressin in Nocturnal Enuresis: The prescriber must check the
following before prescribing:
- Failure of combination of behavioral and alarm therapy.
- Serum Na at the start of therapy, every 3-7 days and if stable every month then every 3
months thereafter.
Quantity Limit: Idarubicin in Acute Leukemia: Cumulative dose should not exceed 150 mg/m2.
Please note that this Quantity Limit is different than the one based on maximum daily dose as
this is not necessary based on Maximum Daily Dose.
Step Therapy: Aripiprazole in Social Anxiety: should be used as third line after:
- First-line: Escitalopram, fluvoxamine, fluvoxamine CR, paroxetine, paroxetine CR, pregabalin,
sertraline, venlafaxine XR
- Second line: Alprazolam, bromazepam, citalopram, clonazepam, gabapentin
Emergency use only: Furosemide IV form in Hypertension is used only in emergency setting.
Protocol edits: Bendamustine Hydrochloride, Cyclophosphamide, Ifosfamide, Dacarbazine
should be used in Lymphoma as per a specific protocol.

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Figure 5 Prescribing Edits Examples

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UDF FIELDS DEFINITIONS

Indication Worksheet Fields Definitions

The indication is the medical condition that leads to the recommendation of a

treatment, test, or procedure and it’s associated with the below fields.

ICDE 10 AM Code
International Classification of Diseases (ICD) code, based on WHO definition, is “the international
standard for defining and reporting diseases and health conditions. It allows the world to compare
and share health information using a common language. The ICD defines the universe of
diseases, disorders, injuries, and other related health conditions. These entities are listed in a
comprehensive way as a list of codes with their corresponding descriptions.

Drug Pharmacological Class and Sub-Class

“Pharmacological Sub Class” is a sub class of "Pharmacologic class".

Scientific Name and Scientific Description Code Root

“Scientific name” is the active ingredient of the product that is responsible for the beneficial health
effects experienced by consumers e.g., Acetaminophen.
“Scientific Description Code Root” is a code generated by the SFDA and is unique per scientific
name (active ingredient)

Substitutable
Non substitutable drugs as defined per the SFDA will be specified within the UDF as
''NO''

ATC Code
The Anatomical Therapeutic Chemical (ATC) Classification is an internationally accepted
classification system for medicines that is maintained by the World Health Organization (WHO).
The WHO assigns ATC codes to all active substances contained in medicines based on the
therapeutic indication for the medicine.

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 Pharmaceutical Form and Pharmaceutical Form Code Root
“Pharmaceutical Form” is the Dosage Form (DF) which is defined as the physical form of a dose
of a chemical compound used as a drug or medication intended for administration or
consumption. Common dosage forms include pill, tablet, syrup, aerosol, liquid injection.
“Pharmaceutical Form code Root” is Unique numerical SFDA generated code for each Dosage

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 Description Code
Unique numerical SFDA generated code for each registered scientific name that is composed of
3 main blocks representing (Active ingredient code- strength -dosage form) name including its
strength, route of administration and dosage form, maintained on the list to guide users when
updating the mapping of the product.

8
Administration Route
Refers to the method in which a medication is introduced to the body e.g., Oral, Intravenous,
Intramuscular, rectal.

Strength and Strength Unit

“Strength” is the amount of drug in each dosage form, for example, 500 mg/tablet.
“Strength unit” is the unit of measurement used by the SFDA to describe the product strength
e.g., mg, G, mmol.

Prescribing Edits
Some covered drugs may have additional requirements, rules, or limits on coverage. These
requirements and limits are detailed in section “UDF PRESCRIBING EDITS TOOLS”

This is either the adult or pediatric maximum amount of a drug that can be administered per day
based on a maximum daily dose. If there is no clinical evidence supporting the quantity limit for
that relevant indication, this column will be left as Blank.

“Notes” section provides details of the prescribing edits, extra important drug information and
special warnings and precautions.

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 Patient type

Specify the inpatient setting (IN)- Coverage is restricted to hospital use.

SFDA Registration Status

Define if the scientific name is registered within the SFDA or not (Yes/No)

Mapped UDF to SFDA Worksheet

Table 2 Mapped UDF to SFDA Fields Definitions

Field Name Definition

it is an abbreviation used by the SFDA to describe the product marketing
status for brand (new chemical entity (NCE), biological) generic,
Radiopharmaceutical.
Drug Type
Drug type: NCE (New Chemical Entity) = Brand
Drug type: Biological, Sub-Type: Biosimilar = Generic
Drug type: Biological, Sub-Type: Biological = Brand
it is an abbreviation used by the SFDA to sub categorize the product
Sub-Type marketing status biosimilar (= Generic biological), allergen product, IV
solution, biotechnology product, blood product
it is the trademark name given to a specific medication and can be either
Trade Name
brand or generic
Trade Name Arabic the Arabic discerption of the product trade name
initial replaced code generated by the SFDA for each registered drug
Registration Number product specific to the drug trade name including its strength, route of
old administration and dosage form, maintained on the list to guide users
when updating the mapping of the product
Last update Date The date of the last update done for the medication
Updated code that is unique numerical SFDA generated code for each
Registration number registered drug product specific to the drug trade name including its
new strength, route of administration and dosage form, maintained on the list
to guide users when updating the mapping of the product
Register Year Year of registration of the product by the SFDA: 2020, 2021 ….
Global Trade Item Number (GTIN) is an identification key that uniquely
GTIN identifies products worldwide. It can be encoded in various types of data
carriers, including Data Matrix.

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Scientific Name
the Arabic discerption of the Active ingredient (scientific name)
Arabic
AtcCode2 it is the additional ATC code given to a product
Size amount available in a product
Size Unit the unit of measurement used for describing the size
describe the method that the medication is packet for utilization e.g.,
Package Types
Bottles, Blister packs, Sachets, Syringes, Ampoules, Vials
Package Size the amount of unites available in each package
describe the method that this medication can be dispensed by the
Legal Status pharmacist either requiring a prescription or over the counter (OTC) not
requiring a prescription
describe the SFDA assigned marketing status for the product as
Marketing Status
marketed, or non-marketed
describe the SFDA assigned authorization of the product in local market
Authorization Status as Valid, Invalid, suspended, withdrawn by MAH, withdrawn by regulatory
authority
describe the status of the pharmaceutical product monitoring and
prescription either uncontrolled substance or controlled substance
Product Control
following the SFDA regulation for narcotic and controlled substance
related to prescribing, storage, distribution, and dispensing
describes the area authorized by the SFDA to stock and utilize the
Distribute area
medication either as hospital item or pharmacy "retail"
the maximum price set by the SFDA that a pharmacy can sell the product
Public price
to consumers.
The true but unknown limit on the period of storage time during which
shelf Life
the pharmaceutical or drug product is considered fit for use and effective.
Describes a climatic condition or a general storage condition under
Storage conditions
which a substance or product is stored
the company name of the company authorized by the SFDA to market
Marketing Company
and disrepute the product in KSA.

Marketing Country ‫دولة الشركة المسوقة‬

Manufacture Name ‫المصنع المعتمد‬

Manufacture Country ‫دولة المصنع‬

Manufacturer DMS Id ‫رقم الشركة الصانعه في النظام الداخلي لدى الهيئة نظام إدارة االدوية‬
Secondary package
‫مصنع التغليف الثانوي‬
manufacture
Main Agent ‫الوكيل األول‬

Second Agent ‫الوكيل الثاني‬

Third agent ‫الوكيل الثالث‬

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 USEFUL LINKS

1. SFDA Drug Shortage list [https://www.sfda.gov.sa/en/currentlyInShortageList]

2. SFDA Vigilance (‫[ )تيقظ‬https://ade.sfda.gov.sa/]
3. SFDA Risk minimization measure list [https://www.sfda.gov.sa/en/RMM]
4. SFDA Drug news
[https://www.sfda.gov.sa/en/news?keys=&date%5Bmin%5D=&date%5Bmax%5D=&tags=2]
5. SFDA safety alerts [https://www.sfda.gov.sa/en/safety_alert]
6. SFDA drug warning
[https://www.sfda.gov.sa/en/warnings?keys=&date%5Bmin%5D=&date%5Bmax%5D=&tags=2&
field_warning_number=]
7. SFDA drug list [https://www.sfda.gov.sa/en/drugs-list]
8. CHI Essential benefits package
[https://www.chi.gov.sa/en/Rules/Documents/Updated%20Essential%20Benefit%20Package%
20%20%28%20effective%201%20October%202022%29.pdf]
9. UDF first-year implementation guide [https://shorturl.at/ajs06]

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