Pharmaceutical Procurement

and Control Services

Purchasing and
inventory.

Packaging and labeling.

Manufacture and
compounding.
 Packaging and Labeling
 There are four basic functions that drugs
packages must fulfill:
◦ Identify their contents completely and precisely.
◦ Protect their contents from deleterious
environmental effects.
◦ Protect their contents from deterioration due to
handling.
◦ Permit their contents to be used quickly, easily, and
safely.
• Labeling of Medication Containers
• Labeling of products in a hospital includes
several essential items to ensure that
healthcare staff can safely and efficiently use
them.
– Drug labeling should be performed by a pharmacist or
under the supervision of a pharmacist.
– Medication labels should be typed or machine-printed.
– Labeling with pen or pencil, use of adhesive tape or
china marking pencils should be prohibited.
– A label should not be superimposed on a label.
COMMON ITEMS FOUND ON HOSPITAL
PRODUCT LABELS:
 1. Product Name
• Generic Name: Standardized name of the
active ingredient(s).
• Brand Name
• 2. Dosage Form
• Specifies the form of the product (e.g., tablet,
injection, suspension).
3. Strength/Concentration
Amount of active ingredient per unit (e.g., 500
mg/tablet, 100 mg/mL for liquids).
4. Route of Administration
(e.g., oral, intravenous, topical).
5. Batch or Lot Number
Unique identifier for tracking the product in case of a
recall or quality control.
6. Expiration Date
The date after which the product should no longer be
used.
7. Manufacturer’s Name and Address
Contact details of the product’s producer or distributor.
8. Storage Conditions
Guidelines for storing the product (e.g., “Store at 2°C-
8°C”, “Protect from light”).
9. Warnings and Precautions
Any necessary safety information such as potential side
effects, contraindications, or interaction with other
drugs.
10. Barcoding
Used for inventory management and to prevent
medication errors by ensuring the right product is
dispensed and administered.
11. Dilution or Reconstitution Instructions (if
applicable)
For products that require preparation before use, like
injectable drugs, details on how to reconstitute or
dilute.
12. Administration Date and Time (for compounded
or dispensed products)
Especially for IV bags or compounded medications,
when the product was prepared or dispensed.
13. Patient-Specific Information (for dispensed
medications)
For unit-dose medications or patient-specific products,
the patient’s name, medical record number, and dosing
instructions.
14. Pharmacist/Technician Initials
To indicate the professional who prepared, checked, or
dispensed the medication.
15. Hazardous Symbols or Special Handling
Instructions (if applicable)
If the product is hazardous (e.g., chemotherapy drugs),
labeling includes necessary symbols (e.g., cytotoxic
warnings) and handling instructions.
• Good Manufacturing Practice (GMP)
regulations provide guidelines for the safe and
proper storage of pharmaceutical products,
including medications and medical supplies,
within a hospital setting.
•
GMP GUIDELINES
 1. Storage Conditions
• Temperature Control: Products must be stored at
the correct temperature as specified by the
manufacturer (e.g., room temperature, refrigerated,
frozen). Monitoring devices like thermometers and
alarms must be used to ensure temperature ranges
are maintained.
• Humidity Control: Certain products require
controlled humidity levels to prevent degradation.
This is critical for some sterile products, injectables,
and sensitive medications.
• Lighting Protection: Some products are sensitive
to light (e.g., photosensitive drugs) and need to be
stored in light-resistant containers or areas.
 2. Segregation of Products
• Separation of Different Categories: Products
should be stored in separate areas based on their
risk category (e.g., hazardous drugs, flammable
materials, controlled substances, and high-alert
medications).
• Quarantine Storage: Products that are expired,
damaged, or recalled must be segregated from
usable stock and stored in a quarantine area to
prevent accidental use.
• Expired Products: Clear labeling and
separation of expired medications ensure they
are not administered to patients.
 Inventory Management
• First-Expire-First-Out (FEFO): Products
should be rotated based on their expiration
dates to ensure that those with the nearest
expiration are used first.

• Stock Rotation: Ensures that older stock is

used before new stock to avoid wastage and
prevent degradation.
 Controlled Substance Storage
• Secure Storage: Controlled substances (e.g.,
narcotics) must be stored in locked, secure
areas with restricted access. Typically, this
involves vaults or double-locked cabinets.
• Record-Keeping: Strict documentation of
the receipt, use, and disposal of controlled
substances is required. Logs must be
maintained for auditing purposes.
 5. Labeling and Identification
• Clear Labeling: All stored products must
be clearly labeled with the product name,
batch number, and expiration date.
Barcoding Systems: Many hospitals use
barcode systems to manage stock and
ensure the correct product is selected for
use.
 Documentation and Record Keeping
• Storage Records: Detailed records must be
kept to track the storage conditions of
products, including temperature and
humidity logs. This ensures products have
been stored under GMP-compliant
conditions.
• Inventory Records: Hospitals must keep
accurate records of products stored,
received, and dispensed to ensure full
traceability and compliance with GMP.
7. Cleaning and Maintenance of Storage
Areas
• Regular Cleaning: Storage areas should be
regularly cleaned and maintained to prevent
contamination or degradation of products.

• Pest Control: Effective measures must be in

place to prevent pests, which could damage
stored products.
 8. Stability and Expiry Monitoring
• Stability Testing: Hospitals may need to
conduct periodic stability tests for
compounded or reconstituted products to
ensure their effectiveness throughout their
storage period.
• Expiration Date Monitoring: Automated
systems or manual checks should
regularly verify that no expired products
remain in use.
 9. Staff Training
• Storage Protocol Training: Hospital staff
responsible for handling and storing
products should be adequately trained on
GMP regulations, including proper storage
conditions and monitoring requirements.

• Hazardous Materials Handling: Staff

dealing with hazardous drugs (e.g.,
cytotoxic agents) must be trained in proper
storage, handling, and disposal procedures.
 10. Handling of Damaged or Expired
Products
• Disposal Protocols: Damaged or expired
products must be disposed of according to
local regulations, with proper documentation
and record-keeping to maintain
accountability.
• Recall Procedures: Systems should be in
place to promptly remove recalled products
from storage areas and notify relevant
personnel.
 DRUG INFORMATION SERVICES
 A Drug Information Center (DIC) is a specialized facility

designed to provide accurate and up-to-date information

about medications.

 These centers are commonly utilized by healthcare

professionals, patients, and the general public for

guidance on drug use, interactions, side effects,

therapeutic effects, and other pharmaceutical-related

questions.
DRUG INFORMATION SERVICES
 These services include the following:
1. Answering questions allows the inquirer to have specific drug
information (adverse drug reactions, stability, bioavailability &
PKs) in a very short time.
2. Pharmacy & Therapeutic committee activity provide the
committee with all needs concerning drug evaluation, drug policy
and rational use of drugs.
3. Publications, Newsletters-Bulletins Journals.
4. Education and Student programs.
5. Drug use review important for pharmacy, medical staff &
research.
6. Investigational drug activity provides investigational drug
protocols for new drugs.
7. Coordination of reporting programs regarding adverse drug
reaction observed by individuals and different health institutions.
8. Poison information specialized division of drug information.
 FUNCTION OF DIC
•Access to Information: They provide
detailed drug information including dosage,
administration,pharmacokinetics,
pharmacodynamics, and contraindications.
•Here are some specific details about the types
of information typically accessible in a DIC:
 1. Drug Monographs
• Detailed descriptions of drugs, including
generic and brand names, formulations, and
uses.
• Information on pharmacology, including
mechanisms of action and therapeutic
classes.
 2. Dosage and Administration
• Guidelines on the appropriate dosage
based on age, weight, and condition.
• Instructions for special populations like
pediatrics, geriatrics, and pregnant
women.
 3. Pharmacokinetics and
Pharmacodynamics
• Information on absorption, distribution,
metabolism, and excretion of drugs
Understanding how drugs act in the body,
their onset of action, and duration of effects.
 4. Side Effects and Adverse Reactions
• Comprehensive lists of potential side effects
and how to manage or avoid them.
• Information on reporting adverse drug
reactions (ADRs) for pharmacovigilance.
 5. Drug Interactions
• Interaction checker tools to analyze potential
drug-drug, drug-food, or drug-disease
interactions.
• Prevention strategies for harmful interactions
or contraindications.
 6. Clinical Guidelines
• Information on the latest clinical guidelines
for disease treatment using drugs.
• Evidence-based recommendations on first-
line and second-line therapies.
 7. Toxicology Information
• Data on the toxicity of various drugs,
overdose management, and antidotes.
 8. New Drug Approvals and Research
Updates
• Information on recently approved drugs and
new therapeutic options.
• Access to recent research studies and clinical
trial data for cutting-edge treatments.
 9. Patient Information
• educational resources on drug use and safety.
• Instructions for proper storage, usage, and
disposal of medications.
 10. Regulatory Information
• Information on drug regulatory status,
recalls, and black box warnings.
• Guidelines on legal issues related to
medication use and controlled substances.
 11. Access to Digital Resources
• Online databases such as Lexicomp,
Micromedex, and UpToDate.
• Apps and platforms for easy access to drug
information on the go.
 Additional Tools and Features:
• Printed References: Textbooks, journals, and
formularies available at the center.
• Electronic Health Record (EHR)
Integration: Some centers are integrated with
hospital EHR systems for seamless drug
information access.
•Consultation Services: Pharmacists or
trained professionals assist in answering
specific drug-related inquiries.
•Educational Resources: They often offer
training materials for healthcare
professionals and awareness programs for
patients.
•Pharmacovigilance: They may participate
in monitoring and reporting adverse drug
reactions (ADRs).
•Drug Interaction Analysis: DICs can
analyze potential drug-drug interactions and
advise accordingly.
Guidelines to pharmacists for establishing drug
information center in hospitals
❑ Large hospitals have developed a new division of the department of
pharmacy, which is commonly referred to as the drug information
center. This is located in a separate section of the pharmacy and
contains large number of reference texts, journals & reprints.
 (A) Equipment required:
1. Office furniture. 2. Book cabinets.
3. Card files. 4. Reading tables & chairs.
5. Microfilm & microfiche storage cabinets.
6. Audiovisual equipments.
7. A telephone with an answering service.
 (B) Personnel:
All staff share during normal person’s hours, and one staff member
is on call after hours. Includes secretarial and technical assistance,
part time and full time.
Guidelines to pharmacists for establishing drug
information center in hospitals

 (C) Drug information resources: as a

pyramid divided into 3 levels,
Tertiary

Secondary

Primary sources
The base of the pyramid (primary literature):
It contains original reports of scientific studies on which the
knowledge of drugs and therapeutics is built.
 Clinical Trials and Research Studies: Original studies,
randomized controlled trials (RCTs), observational studies, and
case reports published in medical and pharmaceutical journals.
These provide first-hand evidence of drug efficacy, safety, and
new uses.
 Pharmacovigilance Databases: Systems like the FDA’s
Adverse Event Reporting System (FAERS) or the WHO's
VigiBase collect and track adverse drug reactions and safety
signals.
 Conference Proceedings: Presentations, posters, and abstracts
from professional medical and pharmacy conferences that
provide the latest research findings.
The middle of the pyramid (secondary
sources):
 2. Secondary Sources

 It contains publications that provide the user

with concise tools for gaining access to
primary literature.
 Databases and Indexes: Tools like PubMed,
Embase, and Scopus, which index scientific
literature, help retrieve primary studies and
reviews.
 Systematic Reviews and Meta-Analyses:
These sources synthesize data from multiple
primary studies to provide more robust
conclusions about drug efficacy and safety.
 Tertiary Sources
 They represent the condensation of basic
facts originally published in the primary
literature (1ry sources).
 Drug Compendia: Reference works such as:
◦ Micromedex: Offers drug monographs,
interactions, dosing, and toxicology information.
◦ Lexicomp: Comprehensive drug information
database used in clinical settings.
◦ Clinical Pharmacology: Provides drug
information, clinical data, drug interactions, and
clinical practice guidelines.
 ◦ AHFS Drug Information: American Hospital
Formulary Service’s authoritative reference for
drug monographs.
 Pharmacopoeias: Authoritative references
like the United States Pharmacopeia (USP)
and British Pharmacopoeia (BP), which
provide standards on drug purity, strength,
and quality.
 Medical Textbooks: Standard references
such as Goodman & Gilman's: The
Pharmacological Basis of Therapeutics and
Martindale: The Complete Drug
Reference.
 Pharmaceutical development services
Include quality control, clinical PKs & investigational drug
protocols.
(1) Quality Control (Q.C)
In hospital pharmacies, Q.C should only not include formulation,
compounding and dispensing but must also include packaging,
purchasing, storage and distribution of medication to the patient.
 Q.C Unit:
An important prerequisite unit for efficient functioning of Q.C. It
must have adequate facilities to perform all necessary analyses
and to maintain records.
 Interrelationship of assay and control and production sections:
*Production section: responsible of production of quality products.
*Assay and control section: to examine and approve the formula
and procedures by which products are produced and to approve
all final products, so that the goals of Q.C. may be attained.
 Pharmaceutical development services
 Records:
1. Good maintenance & an adequate number of records are
basic requirements of any well-designed Q.C. system.
2. All necessary reports can be generated from the data
stored by means of computer technology system.
 General considerations:
1.Buildings for manufacturing, testing & storage
✓ Provide for proper receipt & storage of raw materials.
✓ Allow proper segregation & identification of material
during manufacturing and packaging.
✓ Provide for ease cleanliness & avoiding contamination.
✓ Provide suitable sampling and laboratory facilities.
✓ Provide proper storage for final products.
 Pharmaceutical development services

2. Equipment is:
✓Properly located.
✓Adequate for required operations.
✓Constructed to facilitate cleaning.

3. Raw materials are controlled by:

✓Adequate test procedures.
✓Specific identification markings.
✓Proper storage conditions.
✓Adequate sampling & appropriate testing.
✓Maintaining records & samples whenever appropriate.
 Pharmaceutical development services

4. Manufacturing operations are controlled by:

✓Use of suitable batch numbering system.
✓Checking of ingredients, quality, yield against theory.
✓Maintaining appropriate records & samples.

5. Packaging and finishing are controlled by:

✓Specifications for packaging operations.
✓Use of suitable batch, lot, or control numbers.
✓Checking yield against theory.
✓Maintaining appropriate records & samples.
 Pharmaceutical development services

6. Finished stock quality is maintained by:

✓Providing proper storage conditions.
✓Collection & review of stability data.
✓Investigating or significant complaints concerning
quality of products.
✓Disposition of returning goods.

(2) Clinical Pharmacokinetics

Direct application of pharmacokinetic principle for
optimization of the management of the individual case.
 Pharmaceutical development services
(3) Investigational drugs in the hospital
 Before investigational new drugs are given to human subjects,
adequate preclinical research studies must be done in animals
or invitro.
 Preclinical studies include:
PK studies, to determine absorption, distribution, metabolism,
excretion, half-life & plasma drug concentration of new drugs.
Pharmacological studies, to determine the action of new drug in
animal (Therapeutic effect).
Toxicological studies, to predict relative safety in humans.

 These studies must be done to obtain data to show that there

will not be unreasonable risks in initiating human research.
 Clinical Functions of Hospital Pharmacists
 Pharmacist’s clinical functions:
1. Preparation of patient medication histories.
2. Monitoring drug therapy & patient’s drug therapy medical problems.
3. Participation in management of medical emergencies.
4. Participation in pharmacy & therapeutics committee.
5. Participation in formulary development.
6. Consultation in clinical PKs, TPN, I.V therapy, selection of drug
therapy and determination of end point.
7. Detection and reporting of adverse drug reactions.
8. Control of medication administration and drug distribution in patient
care area.
9. Management of patients with chronic diseases (hypertension, D.M. &
cancer).
10. Participation in the education of medical, pharmacy & nursing
personnel in the patient care areas.
 Clinical Functions of Hospital Pharmacists
 Patient medication profiles:
◦ Purposes:
the patient medication profile has, but is not limited to,
the following purposes
 To provide a medication history on the patient.
 To provide information about the patient’s drug
utilization.
 To provide a data to facilitate patient consultation,
such data include record of patient drug allergies,
record of previously administered drugs and data to
prevent drug interactions.
 Clinical Functions of Hospital Pharmacists
 Essential information (included in patient
medication profile): REFER TO PREVOUIS LECTURE
 The patient medication profile must be examined by the
pharmacist each time a service is performed (PROFILE
UTILIZATION).
 Rational & Irrational Use of Drugs and
Essential Drug List

Rational drug use:

1. The appropriate drug to be prescribed.
2. To be taken in the right dose, at the right intervals.
3. Administered by the right route.
4. It should be effective, acceptable quality, safe and has
high therapeutic index.
5. Available when needed and at a price people can afford.
 Irrational Use of Drugs
 Irrational drug use: results from:
1. Polypharmacy: patients come to expect 4 or 5 different drugs on each
prescription.
2. Compliance: 50% and in many cases as low as 20%.
3. Patient cannot afford the full treatment: so that the pharmacist will
dispense a dose for a day or two and advised for the unnecessarily of
taking expensive medication.
4. Incomplete pharmaceutical information about drugs.
5. Poor communication: between prescriber and patient.
6. Drugs with low bioavailability.
7. Incorrect prescribing: the drug prescribed of no efficacy of the
condition concerned or with wrong diagnosis.
8. Self-medication.
9. Patients don’t know much about the drugs they take: patients must
know the drug name, how to take it correctly, how much, with food or
on an empty stomach and how long.
 Essential Drug List
 Essential Drug List:
◦ Essential drugs are those of the most importance, basic,
indispensable and necessary for the health needs of the population
◦ Drugs included in such a list differ from country to country
depending on pattern of prevalent diseases, financial resources &
genetic and environmental factors.

The main concept behind the use of a list of essential drugs

is that a reduced number of drugs don’t imply a loss in the
quality of health care, rather the opposite.
Advantages of a reduced list:
1. Reduced number of pharmaceutical products. 2. Reduced cost.
3. Easy procurement, storage and distribution. 4. Fewer drugs for
Q.C.
5. Easy training.
6. Improvement in the quality of drug utilization, management,
information & monitoring.
 Essential Drug List
The essential drug list needed should have the following
characteristics:
1. Consistent with the pattern of prevalent diseases.
2. Simple drugs should be used always; combination of
drugs should be avoided.
3. Indicates priorities in drug needs.
4. Contain drugs, which should be available at all times, in
adequate amounts, in the proper dosage form & at a
suitable price.
5. Flexible enough to meet the changing priorities in health
needs.
6. The chosen drugs should be written in generic name,
accompanied by concise, accurate and comprehensive
drug information sheet.
WHAT IS THE DIFFRENCE BETWEEN EDL
AND FORMULARY
 The EDL focuses on essential public health needs,
while a formulary focuses on the medications
approved for use in a particular healthcare setting.
 The EDL contains a limited selection of essential
medications, whereas a formulary can contain a
broader range of drugs, including non-essential
and specialized medications.
 The EDL is often used by governments or
international organizations, while formularies are
managed by healthcare institutions, insurance
plans, or specific health networks.