.

OSCOR BUSINESS SOLUTIONS

OPERATIONS MANUAL FOR

PHARMACY AND RONPD

Version 1.0
OPERATIONS MANUAL VERSION 1.0

TOPIC OUTLINE

I. INTRODUCTION
A. OBJECTIVE
B. SCOPE
C. ROLES AND RESPONSIBILITY
II. PROCESSES AND PROCEDURES
A. DRUG MANAGEMENT
1. Selection of Drugs/Inventory Procedure (S.O.P. No. 1)
2. Procurement (S.O.P. No. 2)
3. Storage (S.O.P. No. 3)
3.1. Shelving of Products
3.2. Temperature Monitoring
3.3. Inventory Monitoring
3.4. Transporting Pharmaceutical Products
3.5. Documentation
4. Distribution
4.1. dispensing (S.O.P. No. 4)
5. Handlling Returned Goods (S.O.P. No. 5)
6. Handling Product Recall (S.O.P. No. 6)
7. Handling Expired Drugs (S.O.P. No. 7)
B. CUSTOMER MANAGEMENT
1. Handling complaints (S.O.P. No. 8)
2. Counselling (S.O.P. No. 9)
C. PHARMACOVIGILANCE/ADR REPORTING (S.O.P. No. 10)
D. HOUSEKEEPING
1. Saniitation Procedure (S.O.P. No. 11)
2. Pest Control (S.O.P. No. 12)
E. DOCUMENTATION (S.O.P. No. 13)
1. Filling-up of Prescription Book
2. Senior Citizen/PWD discount Record
F. SELF-INSPECTION (INTERNAL UDIT) (S.O.P. No. 14)
G. EMERGENCY PROCEDURES (S.O.P. No. 15)
6.1. Fire
6.2. Theft/Unauthorized entry
6.3. Injury or illness
H. RISK MANAGEMENT PROGRAM
III. HIERARCHY AND ROLES
IV. CONTACT DETAILS
V. REVISION HISTORY
VI. REFERENCES
VII. ANNEXES AND FORMS

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INTRODUCTION

This Operations Manual is created to serve as guide to all staffs and personnel of OSCOR’s
RONPD and Pharmacy franchise stores. This will set as standard in pharmacy operations and
drug management. The policies and procedures in this Manual will be the minimum guideline
intended to maximize benefits and minimize operational cost and does not cover all operation
procedures but only intended to standardize the operation.

The processes and procedures particularly in the drug management are based on the existing
guidelines and procedures set by the World Health Organization (WHO) and the Food and Drug
Administration (FDA).

SCOPE

This Operations Manual will serve as the standard for the drug management process only. It
will cover all aspects of drug management, from selection to utilization of drugs. All processes
and porcedures shall be mandatory and shall be implemented in all RONPD and pharmacy
franchise stores and is intended to promote efficiency and effectiveness in the management of
drugs.

THIS IS FOR EXCLUSIVE USE OF OSCOR-GLUO PHARMACY AND RONPD ONLY!

OBJECTIVE

The objective of this Operations Manual is to harmonize the processes and procedures in all
franchise branches and to serve as guide to all personnel and franchisees on how a particular job
is being done.

To serve as guide on how to manage drugs in order to maintain its integrity, potency, and
effectiveness; to abide to the existing laws and regulations on the proper handling of drugs; and
to learn how to identify risks which will affect directly or indirectly the pharmaceutical
products and business operation, and manage risks.

ROLES AND RESPONSIBILITIES

OSCOR BUSINESS SOLUTIONS

 Stablishes and provides the system of operation.

 Provides and supplies pharmaceutical products.
 Ensures availability and sustainability of pharmaceutical products.
 Ensures that the pharmaceutical products are delivered in good condition and complies
to storage requirement.
 Provides training to operators and staff prior to operation.

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FRANCHISEE/OWNER

 Over all in-charge for the implemetation of the system of operation in their respective
branches.
 As businees partner, the franchisee should comply and adhere to the terms and
conditions set by OSCOR.

PHARMACIST
 Responsible for quality drug management (drug selection, procurement, storage,
dispensation, and patient counselling) and regulatory compliance of the establishment.
 Responsible for maintaining the quallity, potency, and integrity of pharmacrutical
prducts.
 Monitors, provide guidance and training to pharmacy assistants and trainees.
 Give suggestions and contributions for the betterment of pharmacy operation and
system.
 Responsible for the implementation of Standard Operating Procedures.

PHARMACY ASSISTANT
 Responsible for temperature and inventory monitoring.
 Responsible for accurate and efficient dispensation process.
 Assists the pharmacist in the implementation of Standard Operating Procedures.
 Give suggestions and contributions for the betterment of pharmacy operation and system

PROCESSES AND PROCEDURES

I. DRUG MANAGEMENT
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S.O.P. No. 1: Selection/Inventory Procedure
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OPERATIONS MANUAL VERSION 1.0

In pharmacy operation, drug management is crucial because the potency, effectiveness, and
intregrity of a drug will depend on how the drugs are being handled and managed. This section
will tackle on the Five (5) major processes of drug management and how drugs are being
handled and managed in every stage of drug management: Selection, Procurement, Storage,
Distribution, and Utilization, and the sub processes which include inventory, product display,
temperature monitoring, dispensing of drugs, transporting, and patient counselling.

SELECTION OF DRUGS/INVENTORY PROCESS

In selecting drugs to be purchased, the only thing to consider is the inventory level. The process
of conducting an invemtory check is listed beow.

Definition Of Terms:
Buffer stock or safe stock means the quantity which is set apart to be dispensed when
there is a delay in product delivery.
Buffer stock level – is the quantity wherein only the buffer stock is left which means this
will be dispensed while waiting for the delivery.
Order level means the quantity above the buffer stock level enough to be dispensed until
product delivery.
Critical level means the quantity below the buffer stock level. This needs to be ordered
immediately.
Stock Card – a document where all deliveries and dispensation are recorded in real time.
Inventory – a list of all the available products to be sold. Products are identifiead by ????
Stock Adjustment – an act where the quantity at POS is adjusted to the actual quantity of
the product.
Discrepancy – the difference of quantity between the actual and the recorded.
Point of Sale (POS) – an inventory system...

DRUG MANAGEMENT
S.O.P. No. 1: Inventory Procedure
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Process:
1. Selection of Drugs/Inventory Procedure
1.1. Create a Stock Card for each product.
- Stock Card must contain the following information:
a. Date
b. Description
c. Batch Number
d. Expiry Date
e. IN and OUT
f. Initials of the personnel
1.2. Schedule a physical counting, at least once a week.
- Actual counting should be done every Wednesday and/or Thursday, then
submission of report on Friday.
1.3. Designate a person to do the acutal counting.
1.4. Do physical counting of all the stocks, reconcile the balance on the Stock Card
with the actual count.
1.5. Compare the actual count with the Point Of Sale (POS) System. Make stock
adjustment if necessary.
1.6. Make an Inventory Report.
- Inventory Report shall be submitted to [email protected]
1.7. Determine the products with buffer stock level, order level, and critical level.
1.8. Once the products to be purchased is determined, make a list in preparation for
the purchase.
2. Handling discrepancy
2.1. Conduct a recount on the product with discrepancies.
- Another person should do the recount.
2/2. If there is still discrepancy, a third recount should be done. The personnel-in-
charge should do the recount.
2.3. Record the recount as final and should be encoded at POS.
2.4. If possible, check the Delivery Receipts/Invoices for possible unrecorded
deliveries or dispensation.
2.3. If discrepancy is confirmed after checking and validating further investigation
shall be done.

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S.O.P. No. 1: Inventory Procedure
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INVENTORY/SELECTION OF DRUGS WORKFLOW

Create Stock Card

Schedule Inventory

Physical Counting

Compare with POS

No discepency w/ discepency

Determine products Recount

to be purchased

No discepency w/ discepency

2nd recount
w/ discepency

Stock Adjustment 3rd recount

w/ discepency

Investigate
DRUG MANAGEMENT
S.O.P. No. 2: Procuremen/ Replenishment of Drugs Process
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PROCUREMENT/REPLENISHMENT PROCESS
Definition of Terms:

Procurement – the process of restocking or buying the products from the supplier to
maintain good inventory level.

Purchase Order Form – A form used to transact with the supplier by listing the products
that needed to be purchased.

Delivery Receipt (DR) – a document where the purchased and delivered items is being
listed including its batch number and expiration date.

Lead Time – the time from order to delivery.

Process:
In the selection/inventory process, the product with critical level, order level, and buffer level
are determined. This will be the basis in the computation of quantity to be ordered in the
porurement process which is outlined below.
1. Compute for the quantity to be purchased. In computitng for the quantity, consider the
following factors:
a. Buffer stock
b. Average dispensation per day
c. Schedule of purchase (how frequent)
d. Lead time
e. Season
1.1. For Order Level Computation
1.1.1. Determine the frequency of purchase (Ex.: 2 times a month or equivalent to
15 days dispensation). This will be the “dispensing days covered until the
next order.”
1.1.2. Get the average dispensation per day. Compute only for the days covered
(15 days) until next order.
1.1.3. Multiply the average dispensation per day by the days of dispensation
covered (15 days) until next order to get the quantity needed.
Ex.: 100 tablets x 15 days = 1,500 tablets (quantity to be ordered)

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1.2. For Buffer Stock Level Computation

1.2.1. Determine the frequency of purchase (Ex.: 2 times a month or equivalent to
15 days of dispensing). This will be the “dispensing days covered until the
next order.”
1.2.2. Get the average dispensation per day (Ex.: 100 tablets per day)
1.2.3. Determine the lead time from order to delivery. Consider the maximum
which is 15 days.
1.2.4. Determine the quantity of buffer stock or safety stock by multiplying the
average dispensation per day by the lead time.
Ex.: 100 tablests x 15 days (maximum lead time) = 1,500 tablets (buffer)
1.2.5. Once the average per day, the lead time, and the buffer are determined,
compute for the quantity to be ordered by multipying the average per day
by dispensing days covered(15 days) until next order.
1.2.6. Once the quantty to be ordered is determined, add the quantity of the buffer
stock to get he total quantity to be oredered.
Ex.: 100 tablets x 15 days = 1500 tablets + 1,500 tablets = 3,000 tablet
1.3. For Critical Level Computation
The computation for critical level stock is same as the buffer level but the process
is expedited. It has to be ordered immediately.
1.3.1. After dertermining the total quantity to be ordered, immediate call the main
office of Oscor to inquire if the product is available.
1.3.2. If available, arrange for delivery (if the total amount meet the minimum
requirement for delivery). If not, the franchisee will shoulder the shipping
expenses.
2. Once the product to be purhased is determined, create a Purchase Order (PO). Indicate
the following information:
a. Date
b. Generic & brand names of the product
c. Dosage Form
d. Dosage Strength

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d. Quantity
e. Price and Total Amount
3. Send PO together with the Inventory Report to [email protected] or
4. Log-in to the portal and place order at the portal. No need to send an email.
5. When using the portal, just click on the desired product or type the name of the desired
product at the search portion and all products with same name will appear.
- A product may have one or more variants.
6. Choose with caution so as not to click on the wrong product.
- Wrong product may lead to wrong delivery and may cause more delays because of
product return.
7. Review order to avoid Bad Order.
- Bad Order means wrong product which may be caused by:
a. Wrong order by client
b. Right order but wrong product delivered
c. Damaged product
8. Finalize the order;
9. Send the order;
10. Follow-up order
11. Receiving of delivery
11.1. Compare P.O with the Delivery Receipt.
11.2. Check the quantity, batch number, and expiration date.
- If the expiration date is within a year or more, receive and sign the DR.
- If the expiration date is less than a year, do not recieve the product.
11.3. Receive and sign Delivery Receipt.

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PROCUREMENT FLOWCHART

Compute the quantity to be

ordered

Critical Inventory
Not Critical Inventory Level Make PO
(within buffer) Level (below buffer)

Receiving of Delivery

Expedite
Expring in less than a year

Expedite Purchase
Expring in 1 year or more
Purchase
Regular Purchase

Purchase
Regular

Receive & Sign the

Return to Supplier
Invoice

DRUG MANAGEMENT
S.O.P. No. 3: Storage of Pharmaceutical Products Process
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STORAGE

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Storage is the act of sroring the product in a secure place. For RONPD and pharmacy,
storage may include shelving, in-store stocks, and transporting the product. In all kinds of
storage, temperature monitoring should be done. Temperature should comply to the
requirement of the manufacturer so as not to compromise the potency, effectiveness, and the
integrity of pharmaceutical product. There are two types of storage: The regular storage or
room temperature storage (25°C or not exceeding 30°C), and cold storage (2°C - 8°C).

Definition Of Terms:

Shelving – the process of arranging the product is a shelf or a gondola in a certain manner.

Temperatoure Monitoring Log – a document where temperature readings are recorded in a

regular manner.
Temperature Excursion – is a temperature outside the range of the prescribed storage
and/or transport.
Therapeutic Classification – a typr of categorization of drugs from a medical perspective
and categorises them according to the disease they are used to
treat.
Temperature mapping – is a process of determining the temperature of different areas of a
given location (Ex.: a room) by putting a temperature
monitoring device at different areas and recording the
temperature. Used to determine which part of an area is cooler
or warmer.
1. Shelving of Product Procedure
1.1. Regular storage (Stored at Room Temperature or temperature not exceeding 30°C)

1.1.1. Place the newly arrived pharmaceutical product at the back of the pile.

- If the expiration date is later than the stock, follow the First-In First-Out
principle.
- If the expiration date is earlier than the stock, follow the First-Expiry
First-Out principle.

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1.1.2. Pile the according to product classification or therapeutic classification.

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1.1.3. Put labels to avoid confusion.

1.1.4. Make sure that the name/label of the pharmaceutical product is facing
outward or towards the person and can be read.
1.1.5. Make sure that the storage area is clean and free from vermin
1.1.6. Pediatric and adult preparation should be piled separately.
1.1.7. Place fast-moving products in a more accessible area to facilitate faster
dispensing.
1.2. Biological Preparation and Other Refrigerated Pharmaceutical Products
1.2.1. Place the products in the refrigerator or in a place with temperature ranging
from 2-8° Celsius. DO NOT FREEZE!
1.2.2. Make sure that the product does not touch the walls of the refrigerator.
Allow at least one inch space between the wall and the product. Do not
overcrowd.

2. Temperature Monitoring

2.1. Before any temperature reading activity is done, temperature mapping should be
performed first.

2.1.1. Place the temperature monitoring device in different areas of the storage
space. Take note of the temperature readings.
2.1.2. From the temperature readings, determine the lowest reading in storage
space.
2.2. Place the most sensitive pharmaceutical products in the place where there is
lowest temperature reading.
2.3. Check the temperature at least three times a day, in the morning, noon and in the
afternoon.
2.4. Morning reading should be done at 8:00AM, noon at 12PM, and afternoon at
5:00P
2.5. Record the temperature reading in the Temperature Monitoring Log.
- Indicate the date, time and reading in the respective column.

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- Temperature should not exceed 30ᴼ Celsius

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- In case of temperature excursion, immediately investigate and record

accordingly.
2.6. Write the three-letter initials of the person reading the temperature.
2.7. Temperature Monitoring Device should be calibrated regularly, ay least once a
year, and the Certificate of Calibration should be filed.
2.8. Another Temperature Monitoring Device should be provided as a back-up in case
of failure or malfunction.

3. Investigating Temperature Excursion

3.1. In case of temperature excursion/deviation, record the temperature in the
Temperature Monitoring Log, write “excursion” at the side of it, then put the three-
letter initials of the reader.
3.2. Check Temperature Monitoring Device if calibrated.
3.3. Record the deviation/excursion at the Risk Management Plan Tool
3.4. Report the incident to the pharmacist/manager.
4. Inventory Monitoring

4.1. Update the Inventory Log indicating the date of receipt, quantity, batch number,
and expiration date.
4.2. Reconcile the inventory. Make sure that the quantity indicated in the Inventory Log
is the same as the quantity of the stocks.
4.3. Indicate the three-letter initials of the personnel.
4.4. Update the POS and the Master list.
4.5. If there are discrepancies in the inventory, investigate.

4.6. Discrepancy in the Inventory:

Follow the procedure described in SOP No. 01, Handling Discrepancy section.

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S.O.P. No. 3: Storage of Pharmaceutical Products Process
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5. Transportation

5.1. Regular Non-Refrigerated Pharmaceutical Products

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5.1.1. Once bought, the product should be placed in a secure packaging and secure
it by sealing with packaging tape.

5.1.2. Avoid exposure to sunlight during transportation.

- Avoid putting the product at the trunk of the car. Place it inside where
there is air condition.

5.2. Biological Preparation and Other Refrigerated Pharmaceutical Products

5.2.1. Before the product is taken from the refrigerator make sure that there is a
container with refrigerants where the biological/refrigerated product will
be transferred. Add ice packs if necessary if travel time is longer.

6. Documentation and Record

6.1. File Temperature Monitoring Record in a folder, topmost is the latest.

6.2 Temperature Monitoring Log shall be kept for two (2) years after last entry.

6.3. Temperature Monitoring Device Calibration Certificate should be filed in a

separate folder. Topmost is the latest.

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S.O.P. No. 3: Storage of Pharmaceutical Products Process
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PRODUCT STORAGE FLOW CHART

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RECEIVING OF
PRODUCTS

STORAGE

Regular Storage Cold Storage

INVENTORY TEMPERATURE
MONITORING MONITORING

No
Discrepancy Deviation No Deviation
Discrepancy

Update Update Temp

Investigate Investigate
Inventory Log Monitoring
Log

DRUG MANAGEMENT
S.O.P. No. 4: Dispensing of Pharmaceutical Products
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DISPENSING
Definition of Terms:

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Drug Dispensing - It is the preparation, packaging, labeling, record keeping, and transfer of a
prescription drug to a patient.
Prescription - A written order, especially by a physician, for the preparation and
administration of a medicine or other treatment.
Prescription Refill - A prescription refill is a new installment of a patient’s medication by
the dispensing personnel. When all of the refills have been used, the patient needs a
new prescription.
Used In Full - means all the quantity of medication prescribed by the physician has been filled
or used
Meniscus – the curved upper surface of a column of liquid.

1. Receiving of Prescription

1.1. Check if the prescription is complete, legible, and not erroneous.

1.2. If erroneous or not legible, advise the patient to go back or contact the prescribing
physician for clarification and/or correction.
1.3. If the prescription is antibacterial, check the date of prescription and the quantity
prescribed.
1.4. If previously filled, make sure that the balance is correct. If correct, dispense as
appropriate.
1.5. If the date is not within the acceptable time frame (within a month), advise the patient
to go back to the doctor.
1.6. Read carefully, if in doubt, verify by asking the patient if he/she knew what the
medication is for or what the doctor say about the medication.
1.7. If the prescription is complete, legible, and correct proceed with the dispensation.
2. Refilling of Prescription
2.1. Regular Prescription
2.1.1. Once the prescription is verified, refill the prescription.

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2.1.2. Look for the prescribed medication, make sure that generic name, brand (if
indicated), and the dosage strength are correct.

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2.1.3. If the brand name is not available, suggest for the available generic equivalent
or other brand.
2.1.4. Ask the patient if he/she would want a generic one.
2.1.5. Once the prescribed medication is prepared, they are now ready to be
dispensed. Before dispensing, update the prescription.
- If the quantity of medication is not to be bought or used in full, indicate the
balance of the medication;
- If the prescription is bought or used in full, write “USED IN FULL” at the
bottom of the prescription.
- Keep the filled prescription and file.
2.2. Loose Tablets/Capsules
2.2.1. Check if the medicine is available and sufficient.
2.2.2. Read the label carefully to avoid medication error or dispensing error.
2.2.3. Count the desired quantity using a pill counter.
2.2.4. Pack the loose tablets/capsules in a secure and clean packaging.
2.3. Reconstitution of Powder for Suspension
2.3.1. Compute for the number of bottles to be dispensed.
Ex.: The Signa says: Take 2.5 tsp TID for 7 days.
Computation: 2.5 tsp = 12.5 mL (1 tsp = 5mL)
12.5 mL x 3 (dose is 3 times a day) = 37.5 mL (dose per day)
37.5 mL x 7 (taking for 7 days) = 262.5 mL (dose for 7 days)
262.5 mL / 60 mL (available stock preparation) = 4.4 bottles or 5 bottles.
2.3.2. Prior to reconstitution, make sure that area is clean and sanitized to avoid
contamination.
2.3.2. Make sure that the equipment to be used are clean and sterilized
2.3.3. Make sure that the water to be used for reconstitution is purified or
distilled.
2.3.4. Read the instruction at the label of the bottle.
2.3.5. Shake or tap the bottle to loosen the powder.

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2.3.6. Using a Graduated Cylinder, fill it with purified or distilled water to the
desired amount as directed at the label. DOT USE MINERAL WATER!

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2.3.3. Read the lower meniscus level of water.

2.3.4. Carefully pour the water to the bottle.
2.3.5. Shake until powder is well mixed and reach the desired consistency.
3. Labelling of Compounded Product
3.1. Loose Tablets/Capsules
3.1.1. Label the packaging indicating the following information:
a. Name of medicine
b. Dosage strength
c. Date of dispensation
d. Quantity
e. Expiry date (Expiry date shall be within 6 months from repackaging)
f. Storage condition
g. Name of dispenser (Pharmacist)
3.2. Reconstituted Powder for Suspension
3.2.1. Use a sticker pad to label bottle. Indicate the following information:
a. Name of patient
b. Signa (drug administration instruction)
c. Storage condition
d. Date of reconstitution
e. Expiration date (Must be within seven days from date of reconstitution)
“CONSUME WITHIN 7 DAYS ONLY’ must be written.
f. If more than one bottle, put the bottle number.
“BOTTLE No. 1 of 2”, if two bottles will be consumed.
g. Include “SHAKE WELL BEFORE TAKING” in the label.
4. Refrigerated Medicines and Biologicals
4.1. If the medicine is to be used immediately, just place the medicine in a
secure packaging with ice.
4.2. If the medicine is to be transported, use a styrobox or a cooler and put
packed ice or refrigerant.

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4.3. Place a refrigerant at the walls and the bottom of the styro box or cooler
before placing the medicine.

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4.4. Place the medicine at the center and cover it with another refrigerant.
4.5. Cover the styro box or cooler and seal.
5. Dispensing the drugs to customer
5.1. For Non- Prescription Drugs
5.1.1. After gathering all the medicines bought by the customer, give the
medicines to the right customer.
5.1.2. Do counselling if necessary.
5.2. For Prescription Drugs
5.2.1. Regular Customers
5.2.1.1. Before collecting the prescribed drugs, reiterate to the costumer
the medication: The name, dosage, quantity, and the storage of
the medicine.
5.2.1.2. Pick-up the prescribed medications carefully.
5.2.1.3. Give the medication to the RIGHT costumer.
5.3. Dispensing to Senior Citizen/PWD
5.3.1. Ask for the Senior Citizen/PWD identification card and booklet.
- If either ID or booklet is not present, no discount is applicable.
- Check if the name of the ID and booklet are the same.
5.3.2. Check if the medication is covered by the required 20% discount
5.3.3. Before dispensing, compute for the total amount less VAT first, and then
apply the 20% discount.
5.3.4. Write the medication in the booklet indicating the name, quantity
prescribed, quantity dispensed, the date of dispensing and the balance, if
there is.
5.3.4. Do patient counselling then give the medication to the costumer.

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6. Counselling

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6.1. Upon giving the medication, advise the costumer on how to take the medication
using the prescription as reference. This should be done by a pharmacist or
trained pharmacy assistant.
6.2. Further drug information and interactions are discussed when necessary.

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MEDICATION DISPENSING FLOW CHART

Correct
PRESCRIPTION NOT RECEIVING OF
REQUIRED PRESCRIPTION

TELL COSTRUMER THE Erroneous

AVAILABLE DRUGS

REFILL the VERIFY W/ THE

PRESCRIPTION PHYSICIAN

Partial Refill Used in Full

Senior WRITE THE MEDS

Citizen/PWD IN THE BOOKLET

DISPENSING OF MEDICATION

COUNSELLING

DRUG MANAGEMENT
S.O.P. No. 5: Handling Product Recall
Page 1 of 2

HANDLING PRODUCT RECALL

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Recall - is the process of bringing back or pulling-out of pharmaceutical products from the
market for a reason.

1. Receiving of Product Recall Notice

1.1. Read carefully the notice. If the products to be recalled is not carried by the
Pharmacy, ignore the notice and file the notification.

2. Inform the owner/manager regarding the Recall.

3. Preparing the products to be recalled.
3.1. Pull-out the invoice.
3.2. If the product is confirmed to be carried by the Pharmacy, pull-out the product
from the shelf. Update the Inventory Log if necessary.
3.3. Pack and secure in a place dedicated for recalled items.

4. Record the pharmaceutical product in the Recall Logbook. Indicate the following
information:
a. Generic Name of product being recalled.
b. Brand Name
c. Dosage Strength
d. Batch Number and Expiration Date.
e. Quantity and Unit
f. Supplier & Manufacturer
g. Reason for recall
5. Store the recalled product in an area designated for expired and destroyed products.

6. Notify supplier that the product to be recalled is ready for pick-up.

DRUG MANAGEMENT
S.O.P. No. 5: Handling Product Recall
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Product Recall Procedure

Receipt of Recall
Notification

Product NOT Carried Product Carried by

by Pharmacy Pharmacy

File the Inform all

notification. authorities

Pack the recalled Prepare the products

item for Recall

Recording of Recall

Storing the recalled product

Inform Supplier for Pick-up

DRUG MANAGEMENT
S.O.P. No. 6: Handling Expired Drugs
Page 1 of 3

HANDLING EXPIRED DRUGS

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1. Collection of pharmaceutical products

1.1. Collect and gather expired and damaged pharmaceutical products.
1.2. Update the Stock Card, if applicable
1.3. Separate from the good stocks immediate to prevent mixing-up.
1.4. Bring to a secure area for sorting.
2. Sorting
2,1. Prior to sorting, make sure to wear gloves and face mask to protect the
personnel.
2.1. Segregate and sort according to supplier.
2.2. Once segregated according to supplier, segregate according to dosage form.
2.3. Pack, seal, and label to identify per pack.

3. Recording/Documentation
3.1. List down all the expired and damage products by supplier to facilitate easy
return process. MAKE DUPLICATE COPY, one copy for filing, one copy for the
supplier.
3.2. Record them in the Expired and Damaged Pharmaceutical Products Record.
Indicated the following information:
a. Generic Name
b. Brand Name
c. Dosage Form
d. Supplier
e. Quantity
3.3. If possible, make a database record for further documentation.
3.4. Send the file thru email to the Pharmacy’s official email add to serve as back-up
file in case the computer breaks down.
4. Packaging
4.1. Pack the expired and damaged pharmaceutical products by supplier
4.2. Include a list of products inside each box.
4.3. Secure the box by sealing with a packaging tape.
4.4. Sign the box and the packaging tape for further security.

DRUG MANAGEMENT
S.O.P. No. 6: Handling Expired Drugs
Page 2 of 3

4.5. Label the box with “EXPIRED/DAMAGED, DO NOT OPEN”

4.6. Dedicate an area to store the box/es while waiting for pick-up.

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5. Storing
5.1. Bring the box/es to an area dedicated for expired and damaged pharmaceutical
products.
5.2. Make sure to restrict access to authorized person only.
5.3. Make sure that the area is free from vermin and rodents.
5.4. Visit the box occasionally to check if it is still intact.
6. Reporting
6.1. Inform the owner/manager regarding the incident. Provide a copy of the list of
expired and damaged pharmaceutical products.
6.2. Inform the supplier through phone, SMS, or email and arrange a schedule for
pick-up.
7. Returning
7.1. Before the pick-up schedule, make sure to check again the box if the seal and the
signature are intact.
7.2. Make a receiving copy of the list for filing.

DRUG MANAGEMENT
S.O.P. No. 6: Handling Expired Drugs
Page 3 of 3

WORLFLOW

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HANDLING EXPIRED AND DAMAGED PHARMACEUTICAL PRODUCT

COLLECTION

SORTING

RECORDING

PACKAGING

STORING

PICK-UP

CUSTOMER SERVICE
S.O.P. No. 7: Handling Returned Pharmaceutical Product
Page 1 of 2

HANDLLING RETURNED PHARMACEUTICAL PRODUCT

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1. Verification and validation of returned item.

1.1. Inform the customer of the return policy (No return, Change Item Only policy),
except for some considerations.
1.2. Check if the item was bought from the Pharmacy by asking for the invoice.
- If the invoice is not available, no return shall be made.
- If available, proceed with the process.
1.3. Check if the item is unopened and not damaged.
- DO NOT ACCEPT if the item has been opened or if seal is broken.
2. Re-compute the amount of the returned goods.
3. Accept the returned item.
3.1. Return the item to their container/box.
3.2. Update Inventory Card, if applicable.
3.3. Update POS
4. Preparation of items
4.1. Gather and prepare the items to be exchanged, provided that the items to be
exchanged does not require a prescription.
4.2. Re-compute the amount. It should be more or equal to the amount of the returned
goods.
5. Dispensation

5.1. Dispense the items to the customer.

5.2. Do counselling, if necessary
6. Counselling
a. The pharmacist should do the counselling again. Indicate storage condition, drug
interaction, and other relevant information, if necessary, and should also entertain
questions from the patient.
7. Recording
7.1. Record the return at the Returned Products Record Form/Book

CUSTOMER SERVICE
S.O.P. No. 7: Handling Returned Pharmaceutical Product
Page 2 of 2

HANDLING RETURN OF PHARMACEUTICAL PRODUCT

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Verify & Validate

Damaged Not Damaged

Do not accept Compute the amount of

returned items

Prepare items to be
exchanged

Dispensing

Counselling

Recording

CUSTOMER SERVICE
S.O.P. No. 8: Handling Complaints
Page 1 of 3

HANDLING COMPLAINTS
1. Receiving of Complaint
1.1. Damaged Pharmaceutical Product

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1.1.1. Verify the complaint of damaged pharmaceutical product by asking

the receipt and the product being complained.
1.1.2. If valid, receive the product and replace.
1.1.3. Take the responsibility, apologize and offer options to mend the
inconvenience the incident had caused the customer.
1.1.4. Reassure the customer that the incident will not happen again.
1.1.5. Record the incident in the Complaint Form.
1.2. Complaint against a Personnel
1.2.1. Listen to the customer’s complaint.
1.2.2. If the complaint is not valid, just reassure customer.
1.2.3. If the complaint is valid, take the responsibility and apologize.
1.2.4. Settle the complaint immediately.
1.2.5. Reassure the costumer that the incident will not happen again

1.3. Medication Error

1.3.1. Verify and validate the complaint by asking for the receipt and the
product.
1.3.2. If valid, check if the medication is still complete/unopened.
1.3.3. If the medication is still complete/unopened, replace with the right
medication.
1.3.4. Take responsibility, apologize, and offer options that would mend the
inconveniences, and the possible exposure to danger.
1.3.5. If the medication is opened and dose were taken by the patient, ask
the patient or relative for any possible Adverse Drug Reactions.
(Monitoring of ADR is covered by a separate SOP)
1.3.6. Take responsibility and apologize.
1.3.7. Reassure the patient/relatives and commitment to help if needed.
1.3.8. Consult a physician, the Pharmacovigilance, immediately for
guidance.
1.3.9. Call the attention of the staff involved.

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S.O.P. No. 8: Handling Complaints
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1.3.10. Staff involved shall write an Incident Report and, if necessary,

undergo retraining.
1.3.11. Record the incident in the Complaint Form.

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2. Recording of Complaint.

2.1. Record complaint in the Complaint Logbook. Indicate the following

information:
a. Date of complaint
b. Details of the complainant
c. Complaint (What, When, Where, Who, How)
d. If possible, include other supportive document like lab results.
e. Measures taken
f. Follow-up report
3. Reporting of Complaint (Escalation to Authority)
3.1. Write an Incident Report to the Manager using the data in the Complaint
Record.
3.2. Participate in meetings when called to participate.
3.3. Wait for the decision

4. Investigation of complaint
4.1. Take responsibility of the incident.
4.2. Participate in the investigation process.
4.3. Offer help and solution

5. Corrective Action/Preventive Action (CAPA)

5.1. Identify the problem. What causes the problem.
5.2. Determine the scope of the problem. What are the effects and the size of the
damage.
5.3. Make an immediate measure that can be done while looking for the ultimate
measures just to mitigate the effect when it happens again.
5.4. Plan and create corrective action targeting the root cause and expenses of
implementation.
5.5. Implement Corrective Action/Preventive Action
6. Follow-up and update the customer of the progress of the complaint.

CUSTOMER SERVICE
S.O.P. No. 8: Handling Complaints
Page 3 of 3

HANDLING COMPLAINT PROCEDURE

Receiving of Complaint

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Minor Complaint Major Complaint

Ask for authority’s

Settle immediately
intervention

Record the incident

Report the event

Investigate

Create CAPA Plan

Follow-up & Update the

customer of the
complaint

CUSTOMER SERVICE
S.O.P. No. 9: Patient Counselling
Page 1 of 2

Patient Counselling/Utilizaion of Drug

Utilization is defined as practical and effective use of pharmaceucal products. In order for
a drug to maximize its effect, patient should know first the proper way of taking the drug.

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Sometimes, patient would rely on what the pharmacist say about the drug. The doctor will
check the patient and give the prescription, but the pharmacist will provide the
information about the drug being prescribed. The process of giving drug information and
guiding the patient on the proper use of drug is called patient counselling.
To become effective in patient counselling, one must posses the knowledge and skills to
perform thte process.
Definition of Terms:
Signa – a doctor’s instruction on the proper usage of drug including the dosing and time.
Drug interaction – referring to the interaction between two or more drugs, between drug
and food, and anything that may interact with the drug.
Common Measures Used in Prescription:
1 tsp = 5 mL
1 tbsp = 15 mL
Common Abbreviations Used in Prescription:
OD – Once a day
BID – two times a day or every 12 hours
TID – three times a day or every 8 hours
QID – four times a day or every 6 hours
PRN – as needed
AD – as directed
ad – right ear
od – right eye
po – taken by moouth
q – every
hs – at bedtime

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S.O.P. No. 9: Patient Counselling
Page 2 of 2

1. Patient Counselling Procedure

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1.1. Upon giving the medication, advise the costumer on how to take the medication
using the Signa of the prescription as reference. This should be done by a
pharmacist or a trained pharmacy assistant.
Ex: Signa says: Take 1 tsp TID for 7 days.
Pharmacist or trained staff should say:
“Take 1 teaspoon or 5 mL every eight hours for seven days.
Further information can be included like:
“Take continuously without missing. In case of missed dose, take immediately
once remembered. Take the usual dose, do not double dose to compensate the
missed dose. Extend the days until the required dose is completed”

1.2. Further drug information and drug interactions are discussed when necessary.
1.3. The pharmacist or the trained pharmacy assistant should entertain questions
from the customer.
1.4. If the customer is a senior citizen, write down the instructions in a piece of paper
and put it inside the packaging together with the drug.
- Instructions can also be written directly at the packaging itself.
- Medications should be packed separately (for multiple drug dispensing) to
avoid confusion.

S.O.P. No. 10: PHARMACOVIGILANCE/ADR REPORTING

Page 1 of 4

PHARMACOVIGILANCE/ADR REPORTING

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Definition of Terms;

Adverse Drug reaction (ADR) – a response to a drug which is noxious and unintended, and
which occurs at doses normally used in man for prophylaxis, diagnosis, or
therapy of disease, or for the modifications of physiologic function.

Adverse Events - any untoward medical occurrence or clinical investigation subject who
administered a pharmaceutical product and that does not necessarily have a
causal relationship with the treatment. – ICH-GCP

- Any untoward medical occurrence associated with the use of a drug in

humans, whether or not drug related. – US Code of Federal Regulation
(CFR)

Serious Adverse Reaction (SAR) /Serious Adverse Event (SAE) - Any adverse reaction that is
classed in nature as serious and where there is evidence to suggest a causal
relationship between the drug and the adverse event.

Any adverse event or reaction that:

(a) results in death; or

(b) is life threatening - places the subject at immediate risk of
death from the experience as it occurred; or
(c) requires hospitalization or prolongation of existing
Hospitalization - hospitalization is defined as an
inpatient admission, regardless of length of stay, even if
the hospitalization is a precautionary measure for
continued observation. Therefore, subject does not need
to be hospitalized overnight to meet the hospitalization
criteria.
(d) Results in persistent or significant disability or incapacity –
substantial disruption of one’s ability to conduct normal
life functions; or
(e) consists of a congenital anomaly or birth defect.

S.O.P. No. 10: PHARMACOVIGILANCE/ADR REPORTING

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Process:

1. Receiving the Report

1.1 The pharmacist will receive the adverse event report from the
client/customer/patient and record it in the AE/ADR Report Form. The following
information should be present:
a. Name of patient
b. Age
c. Sex
d. Height and weight
e. Date of birth
f. Ethnic group
g. Pregnancy status
h. The reaction
i. Intervention, if any
j. Contact information
1.2. Check the ADR if listed in the product insert.
- If not, this will be considered as new ADR and should be reported for further
evaluation of the product.
2. Evaluation of ADR
2.1. The medical doctor shall evaluate the type of ADR, whether Serious Adverse
reaction or non- serious.
2.2. If serious, further evaluation will be performed to the patient.
2.3. If not serious, the doctor will manage the adverse drug reaction by giving
medication.
3. Recording
3.1. Record the ADR report at the ADR Report Log.
3.2. Record the findings and invention done. Include the following information;
a. Name of patient
b. Age
c. Sex
d. Date of birth
e. Pregnancy
f. History
g. Weight and height

S.O.P. No. 10: PHARMACOVIGILANCE/ADR REPORTING

Page 3 of 4

h. Address

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i. Ethnicity
j. Drug/s taken, batch number & expiry date
k. Type of reaction
l. Date & time of onset
m. Intervention
n. Result

4. Reporting
4.1. Prepare a report to FDA
4.1.1. If serious adverse event, report within 24 hours from receipt. The report
shall include the following information:
a. Initial of patient
b. Age
c. Sex
d. Date of Birth
e. Pregnancy
f. . History
g. Weight and height
h. Ethnicity
i. Drug taken
j. Suspected drug, if multiple drugs are being taken
k. Treatment and intervention
4.1.2. If not serious, report within 7 days from receipt.
4.1.3. Indicate information of the reporter
5. Monitoring the Patient
5.1. The pharmacist shall monitor the progress of the patient by calling or texting.
5.2. Record progress at the ADR Report Log
5.3. Update FDA of the progress

S.O.P. No. 10: PHARMACOVIGILANCE/ADR REPORTING

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PHARMACOVIGILANCE FLOW CHART

Receiving or ADR Report

Recording

Reporting (FDA)

Serious Non-Serious
(within 24 hrs) (within 48 hrs)

Monitoring

HOUSEKEEPING
S.O.P. No. 11: Sanitation Procedure
Page 1 of 3
Sanitation Procedure

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1. Schedule

1.1. Sanitation procedure is done daily for the counters, tables and within the vicinity
of the Pharmacy.

1.2. Sanitation is done weekly for the shelves and cabinets in a normal situation, but
often as necessary when needed like if there is a construction going within or
near the Pharmacy.

2. Preparation for sanitation procedure

2.1. Wear gloves, mask, apron or any protective material to protect you from being
stained or acquiring dusts and possibly bacteria.
2.2. Prepare the cleaning solution.
2.3. Gather materials to be used for cleaning and sanitation like cloth rugs, mops,
spray, etc.
2.4. Clear the area before starting the process to prevent contamination.

3. Cleaning the tables and chairs

3.1. Before business starts in the morning, the counter and tables must be
cleaned/wiped with clean cloth with soap solution.
3.2. Cleaning should also be done when during business hours the counter and or
tables have spills, when a customer put something wet on the surface, or have
dirty hands and left a mark on the surface.
3.3. Cleaning should be done when a customer put something wet on the surface, a
urine or blood sample or a customer with skin infections have contacted the
surface.
3.4. Cleaning should be done when a customer put a used tissue, a handkerchief, a
used mask, or anything that came from the hospital.
4. Cleaning the shelves and stocks:
4.1. Shelves and stocks are cleaned in a weekly basis.

HOUSEKEEPING
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4.1.1. Before cleaning the shelves the stocks should be removed.

4.1.2. Cleaning should start from both ends toward the center of the
shelf. Not form left to right or vice versa.
4.1.3. Stocks are cleaned as it is being returned to the shelf.
5. Cleaning Solution:
5.1. The solution used for cleaning is a mixture of 20% soap and water
solution. Detergents are used for this mixture. Dishwashing can also be
used as cleanser.
5.2. The Alcohol used for cleaning is 70% Volume.
6. Post Sanitation

6.1. Inspect for areas that might be left unclean and not sanitized.
6.2. Assemble all cleaning materials and make sure to treat or wash them
with soap and water and dry them after.
7. Record the procedure in the Cleaning and Sanitation Form with following
information:
a. Name of personnel
b. Date of procedure
c. Areas covered
d. Solution Used

HOUSEKEEPING
S.O.P. No. 11: Sanitation Procedure
Page 3 of 3

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CLEANING AND SANITATION PROCEDURE

Wear Protective
Equipment Prepare Cleaning Solution

Clear the area

Recording Cleaning all areas

HOUSEKEEPING
S.O.P. No. 12: Pest Control Procedure
Page 1 of 3

Pest Control

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A. Schedule
1. Pest control should be done at least once a month, or more often if necessary.
B. Pest Control Procedure
1. Preparation and Precautions
1.1. Clear the area to be treated.
1.2. Wear protective gear before conducting the procedure. A protective gear should
be at least a goggle, a mask, and hand gloves.
1.3. Make sure that the chemicals used in the procedure is non-toxic and water-based.
1.4. Make sure to clear the area or cover all the drugs and stocks before starting the
procedure to prevent contamination.

2. Pest control
2.1. Once the area is cleared, spray the area with water-based Baygon.
2.2. The procedure is done at night when everybody is gone, after the drugstore closed.
3. Rodent Control
3.1. This procedure is done by a private contractor.
3.2. Usually, there are no chemical being used in this process. Only finding out the
possible entry holes of rodents and seal it.
3.3. Putting mouse traps may be done.

4. Insect Control
4.1. This procedure should be done after everybody is gone and the Drugstore is
closed.
4.2. The area should be sprayed with a water-base spray like Baygon.

5. Post Treatment
5.1. Wash hands, after spraying insecticides.
5.2. The area should be cleaned again after the procedure.
5.3. Dead insects and pests should be removed from the area.

HOUSEKEEPING
S.O.P. No. 12: Pest Control Procedure
Page 2 of 3

5.4. Rodents may be buried.

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6. Recording
6.1. Record every procedure in the Pest Control Record Book.
Indicate the following information:
a. Date
b. Name of the person who conducted the procedure.
c. Chemical use
d. The procedure performed
e. Area where the treatment was done

HOUSEKEEPING
S.O.P. No. 12: Pest Control Procedure
Page 3 of 3

Pest Control Chart

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Preparation

Treatment

Pest Control Rodent Control Insect Control

Spray of water- Seal all entry point. Spray of water-

based Baygon based Baygon
No Chemicals Used.

Post Treatment

Recording

S.O.P. No. 13: DOCUMENTATION PROCEDURE

Page 1 of 2

DOCUMENTATION

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Documentation is an important process to trace and monitor events. As the golden rule says: If it is
not recorded it did not happen. In pharmacy operation and drug management, there are numbers
of records and forms that are used. These records and forms should filed and kept for two years.
1. Filling-up of Prescription Book
1.1. Once the prescription is fully served, keep the prescription for filing.
1.2. Fill-up the Prescription Book. Make sure that all information are filled:
- Date of dispensing
- Prescription Number\
- Name of Physician
- Name of Patient
- Generic & Brand Names
- Dosage Form
- Lot No/Batch No.
- Expiry Date
- Quantity Served
- Remarks (if partially or fully served).
1.3. File prescription accordingly.
2. Senior Citizen/PWD discount Record Book
2.1. Senior Citizen Record Book shall be filled-up upon dispensing of medication to the
customer.
2.2. Senior Citizen Record Book is filled-up in addition to the Senior Citizen Booklet which the
customer keeps.
2.3. Indicate the folllowing information.
- Date of dispensing
- Name of customer
- Senoir Citizen ID number
- Address
- Decription of drugs purchased
- Amount paid

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3. Other Records
a. Frequently asked medication that are not in stock

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b. Cash Advances and products advance

c. Daily sales signed by cashier
d. Correspondents (ex.: follow-up P.O/delivery)

S.O.P. No. 14: SELF-INSPECTION PROCEDURE

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SELF-INSPECTION (INTERNAL AUDIT)

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1. Schedule and prepare for self-inspection procedure. The procedure is done once a year.
2. Identify the person who will conduct the inspection.
3. Prepare the Self-Inspection Checklist.
4. Start self-inspection process.
4.1. Drug management

4.1.1. Storage
4.1.1.1. Cold Storage
- Check if the temperature is within the acceptable limits.
- Check if temperature reading is recorded in the Temperature
Monitoring Log
- Check if thermometer is calibrated.
4.1.1.2. Room Temperature Medicine
- Check if the stocks for damage of boxes due to vermin and
rodents and/or discoloration due to exposure to moisture.
- Check if the Inventory Monitoring Log is properly filled-up.
- Check for inventory discrepancies.
- Check for stocks expiring within one year.
- Check if there are expired stocks.
- Check room temperature is within the acceptable limit.
4.1.1.3. Storage Area
- Check if the area is clean and sanitized.
- Check for presence of rodents and vermin.
- Check if there is enough space for checking and inspecting of
stocks.
- Check if the area is well-lighted.
- Check if the labels are correct and in the right place.
4.1.2. Procurement
- Check if suppliers accredited and licensed by FDA.
- Check if LTO of supplier is update.
- Check if there is a need to add suppliers.
- Check if suppliers are Good Manufacturing Practices (GMP)
compliant.

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4.2. Premises of the office

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4.2.1. Check if air conditioning equipment is working. Adjust temperature if

necessary.
4.2.2. Check if the area is clean and sanitized.
4.2.3. Check if computer is working well.
4.2.3. Check if the office is well-lighted. Replace busted lights.
4.3. Documents
4.3.1. Check if files are well organized, with correct label, and updated.
4.3.2. Check if database is updated and have backup.
4.3.3. Check if Certificate of Product Registrations (CPRs) are updated and
complete. Coordinate with supplier/importer if necessary.
4.3.4. Check if all necessary documents needed for business operation are
appropriately displayed in a conspicuous area:
a. DTI/SEC Registration with Application Form
b. Certificate of Registration (COR)
c. PRC certificate of the Pharmacist
d. FDA Seminar certificate of the Pharmacist
e. License to Operate (LTO)
f. Business/Mayor’s Permit
g. Barangay Permit
4.3.5. Check if other documents are ready for inspection:
a. Batch notification record (for antibiotics)
b. Copy of LTO of the supplier
c. Copy of RAs 3720, 9711, 6675, 5921, 8203, 9502
d. Copy of WHO Annex 5 and Annex 9
e. Distribution record
f. Distributor Agreement
g. Duties and responsibilities of personnel
h. Invoice with BIR stamp
i. Lease of Contract
j. License of Pharmacovigilance (PVG) Officer (a medical doctor)

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k. List of products with FDA registration numbers and validities per

supplier (generic name, dosage, dosage form, brand name if
applicable)
l. List of suppliers
m. Mission and Vision
n. Organizational Chart
o. Reference Books
p. SOPs
q. Temperature Monitoring Log
r. Training certificate of personnel
4.3.6. Check if records of Recall, Product Return, Complaints, Incident Report,
and Adverse Dug Reactions (ADR) are appropriately filed.
4.4. Personnel
4.4.1. Check if personnel have appropriate training in handling pharmaceutical
products and documentation.
4.4.2. Check if personnel are aware of SOPs and can execute them as appropriate.
4.4.3. Check if Pharmacist has valid license and training.
4.4.4. Check if the custodian/driver of the vehicle or transport personnel is/are
trained in handling pharmaceutical products.
I. DOCUMENTATION/RECORDING
1. All self-inspections are done using the Self-Inspection Checklist.
2. Self-Inspection Checklist must be signed by the person who performed the self-
inspection procedure. Also indicate the date of self-inspection.
3. Using the Self-Inspection Checklist, record the self-inspection result in the Self-
Inspection Form.
4. Self-Inspection Form must be signed by the manager/owner and also dated.
5. All self- inspection findings shall be noted and CAPA shall be done if necessary.
6. For major findings, personnel in-charge will write an Incident Report.
7. All findings will be recorded in the Risk Management Tool Form. A copy of the
Self-Inspection Checklist must be attached.
8. Findings shall be treated as risk and shall be added to the Risk Management
Program (RMP).

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II. CORRECTIVE ACTION/PROTECTIVE ACTION (CAPA) PLAN

1. RMP Team will conduct a review of the findings and shall recommend addition to
RMP.
2. The RMP Team Lead will recommend a CAPA Plan.

III. REPORTING
1. All findings shall be reported to the manager/owner and the RMP Team Lead for
appropriate action.

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SELF-INSPECTION PROCESS

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Schedule the Inspection

Inform the Personnel

Involved

Prepare Self-Inspection
Checklist

Start Self-Inspection

No Findings With Findings

Recording/documentation Addition to RMP

Report to Authority Write Incident Report

CAPA

Compliance

S.O.P. No. 15: EMERGENCY PROCEDURES

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A. FIRE

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1. Fire Prevention
1.1. Do not overload electrical outlets.
1.2. Keep hallways, corridors, and exit areas clear.
- There should be no chairs, boxes, equiipmets, and other things that may
interfere during evacuation.
1.3. Remove any combustible materials like boxes, papers from electrical outlets or
anything that may start fire.
1.4. Place fire extinguishers in a conspicuous and accessible area.
1.5. Fire extinguishers must be charged and inspected regularly, at least once a year.
1.6. Electrical lines and equipments must be checked regularly.
1.7. Report any loose and exposed wires.
1.8. Disconnect any electrical equipment that may overheat when left unattended.
1.9. Purchase electrical equipments that are checked and approved by authorities like
the Department of Trade and Industries (DTI).
- Check the seal of approval if present.
1.10. Turn off any electrical equipment and heat producing appliances at the end of the
day.
1.11. Report any suspected gas leak, smell of burning material, and electrical and/or
appliance sparks.
1.12. Refrain from using open flames like candles during power outage. Use
rechargeable lamps instead.

- If using candles can not be avoided, do not leave it unattended or place it in

a non-flammablle material or in a glass and put it away from any flammable
materials.
1.13. Priority Items Identification
1.13.1. Identify items which have high value
1.13.2. Make a list of the priority items for inventory purposes
1.13.3. Mark the identified items with red flag
1.13.4. Priority items should be saved first

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B. THEFT/UNAUTHORIZED ENTRY
1. Limit entry to authorized persons only. In case of illegal entry/theft, the following steps
should be done:
1.1. Report immediately to authorities upon discovery.
1.2. Check the premises for any items lost.
1.3. Compute the amount lost for documentation and reporting purposes.
1.4. Write a incident report.
1.5. Record the incident at the RMP Tool for review by RMP team.
C. INJURY OR ILLNESS
1. Injury
1.1. Fall
1.1.1. Do not move the person. Wait until he/she recovers and able to compose
him/herself.
1.1.2. Check for injuries or fractures.
1.2. Fracture
1.2.1. Immediately call 911.
1.2.2. Stabilize the body part that have fracture by putting a splint or a straight, hard
wood or slab and tying it onto the affected body part.
- The purpose of this is to prevent further damage to fracture during
1.2.3. Avoid unnecessary movement to the affected area while waiting for the
rescuers.
1.2.4. Only the rescuers will move the person with injury.
1.2.5. Ventilate the victim by giving enough space and allowing the air to blow
freely to the victim.
1.3. Bleeding
1.3.1. If bleeding is due to an open wound, apply direct pressure on the cut or
wound with clean cloth or piece of gauze until bleeding stops.
1.3.2. Put more cloth if necessary.
1.3.3. If the woumd is in the leg, raise the leg above the heart to help slow the
bleeding

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1.3.4. Wash hands after giving first aid.

1.3.5. Use torniquet only if the bleeding does not stop during direct pressure.
1.3.6. If the bleeding is severe, Call 911 or the nearest ambulance.
2. Illness
2.1. If not feeling well, immediately inform the owner.
2.2. Consult a doctor for proper medication.
2.3. Ask for a medical certificate.
- This will be submitted to the owner/manager once aan employee is well and able to
work.
2.4. If the illness is severe and need a longer treatment and rest (ex.: Tuberculosis), advise
the owner.
2.5. Secure a fit-to-work certificationn from the attending doctor when applicable.

III. HIERARCHY AND ROLES (for editing)

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OSCOR CHAIRMAN

VICE-CHAIRMAN
(COO)

FRANCHISE BRANCH OPERATION HUMAN RESOURCE

OPERATION RELATED
RELATED FRANCHISEE/
OWNER

FRANCHISE
HUMAN RESOURCE
MANAGER PHARMACIST

PHARMACY
ASSISTANT

IV. CONTACT DETAILS

Contact
Name Position Information Mode

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FRANCHISEE/OWNER

PHARMACIST

FRANCHISE MANAGER

HUMAN RESOURCE

(02) 809 5596 Telefax

[email protected] Email

http://www. Online
FDA Pharmacovigilance Unit Pharmacovigilance fda.gov.ph/adr-report-new reporting

V. REVISION HISTORY

Revision
No. Date Description of Changes Requested by

1.0 Initial Release

VI. REFERENCES

Annex 5 WHO Guide to Good Distribution Practices for Pharmaceutical Products –Workd
Health Organization

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Annex 9 WHO Guide to Good Storage Practices for Pharmaceutical Products – World Health
Organization

University of Nebraska Lincoln Fire Safety – General Prevention and Fire Extinguishers

Participant Safety & Adverse Events - Good Clinical Practice (GCP)

Republic Act No. 7394 Consumer act of the Philippines

FDA Circular No. 2016-012 Guidelines on Product Recall

VII. ANNEXES AND FORMS

OSCOR-GLUO PHARMACY
TEMPERATURE MONITORING LOG

Report if Temperature Exceeds 30°C

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Date Temperature
Mo./Yr.
8AM 12PM 7PM Remark Initial

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OSCOR-GLUO PHARMACY

Generic Name: _____________________ Dose: ______________________

Brand Name: _____________________ Unit: ______________________

Date ExpDate/BatchNo. IN OUT Balance Initials

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Stock Card

OSCOR-GLUO PHARMACY

ADVERSE DRUG REACTION REPORT FORM

PATIENT’S INFORMATION
Initials___________________________ * Sex:  Male  Female Weight ______Kg Height
(cm) _____
Contact Number: ________________________ *Age________ Date of Birth
(mm/dd/yr)__________________

Medical History/Admitting Diagnosis: _______________________________________ Ethnic

group:  Filipino  Chinese  Caucasian

Any Known Allergy: No ____ Yes,

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Specify:________________________________________________________
Pregnancy Status: ___ No ___ Yes (1st, 2nd, 3rd trimester)
Hospital/facility , if
admitted:_____________________________________________________________________
ADVERSE REACTION DETAILS
Onset of Reaction: Time ________________ Date _____________
Do you consider the reaction to be serious?  Yes, if yes indicate why:
 No
 Patient died due to reaction
 Involved or prolonged in-patient hospitalization
 Life threatening
 Involved persistent or significant disability
 Congenital anomaly in the newborn
 Other outcome, please give details:
Describe the reaction, including pertinent laboratory Result:

Can the adverse reaction be due to :

1. Product quality defect ___No ___Yes, Specify, encircle: color change ; caking; powdering ;
counterfeit; odor change; defective container; contaminants; separation of components; undissolved
suspension/powder

2. Therapeutic failure: ___No ___Yes, Specify, encircle: antimicrobial resistance, drug interaction,
poor compliance, counterfeit, expired; improper storage; under-dosing, inappropriate medication;
inappropriate route of administration; excipients/preservatives *Suspected drug product(s) Indicate
brand name Daily Dose Route Date started Date stopped Reason (s) for using the product

Can this be due to Medication Error? No Yes, if yes, which type: ___Prescribing ___Transcription ___Dispensing
___Administration
List all other d rug/s taken at the same time and/ or 3 months before. If none, check box.  No
Other drug/s taken .

List of Drugs Taken Daily Dose Date Started Date Stopped Reason for Taking Batch & Lot #

Suspected Drugs:
List of Drugs Taken Daily Dose Date Started Date Stopped Reason for Taking Batch & Lot #

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*MANAGEMENT OF ADVERSE REACTION

Was treatment given?  No  Yes (If yes, please specify): _________________________

Outcome:  Recovered (Date of recovery):________________  Not Recovered

Other diseases: ___liver ___renal ___HPN ___Diabetes ___CVS ___Endocrine

____Cancer

Sequela/e: (any permanent complications or injuries as a result of the ADR)  Yes (Please
specify)_________________________  No  Unknown

 Fatal (Date of death):______________________  Unknown

Re-challenge?  Yes Result______________________  No

REPORTED BY:

Printed Name of Reporter: _______________________________________

Signature Over Printed Name

Date reported: _______________________________________

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OSCOR-GLUO PHARMACY
COMPLAINT FORM

COMPLAINANT INFORMATION

Name:  

Address:  

Contact No.  

COMPLAINT DETAILS

Type of Complaint: Major _______ Minor: ________

Narrative Details of Complaint (Who, What, When, Where, How)  

       

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CAPA PLAN

FOLLOW-UP

Reported by:  Date:

OSCOR-GLUO PHARMACY
SELF-INSPECTION CHECKLIST
CHECKLIST YES NO COMMENT
Drug Mangement      

Is temperature within the acceptable limits?      

Is temperature reading recorded in the Temperature Monitoring
Log?    
Is thermometer calibrated?      
Are boxes of stocks not damage due to vermin and rodents
and/or not discolored due to exposure to moisture?    
Is Inventory Monitoring Log properly filled-up?      
Is tere inventory discrepancies?      
Are there stocks expiring within one year?      
Are there expired stocks?      
Is room temperature within the acceptable limit?      
Is the area clean and sanitized?      
Are there presence of rodents and vermin?      

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Is there enough space for checking and inspecting the stocks?      

Is the area is well-lighted?      
Are labels correct and in the right place?      
Are suppliers accredited and licensed by FDA?      
Is LTO of suppliers update?      
Is there a need to add suppliers?      
Are suppliers/manufacturers compliant to Good Manufacturing
Practices (GMP)? Do they have GMP Certificate?      

Premises of the office      

Is/Are air conditioning equipment/s working?      
Is the area clean and sanitized.      
Is computer working well?      
Is the office well-lighted?      
Documents      
Are files well organized, with correct label, and updated?      
Is database updated and have backup?      
Are Certificate of Product Registrations (CPRs) updated and
complete?      
Are all necessary documents needed for business operation
appropriately displayed in a conspicuous area?      
a. SEC Registration with Application Form      
b. Certificate of Registration (COR)      
c. PRC certificate of the Pharmacist      
d. FDA Seminar certificate of the Pharmacist      
e. License to Operate (LTO)      
f. Mayor’s Permit      
g. Barangay Permit      
Are other documents ready for inspection?      
a. Batch Notification records (for antibiotics)      
b. LTO of the supplier      
c. RAs 3720, 9711, 6675, 5921, 8203, 9502      
d. WHO Annex 5 and Annex 9      
e. Distribution record      
f. Distribution Agreement      

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g. Duties and responsibilities of personnel      

h. Invoice with BIR stamp      
i. Lease of Contract      
j. License of Pharmacovigilance (PVG) Officer (a
medical doctor)      

k. List of products with FDA registration numbers and

validities per supplier (generic name, dosage, dosage form,
brand name if applicable)      
l. List of suppliers      
m. Mission and Vision      
n. Organizational Chart      
o. Reference Books      
p. SOPs      
q. Temperature Monitoring Log      
r. Training certificate of personnel      

s. Records of Recall, Product Return, Complaints, Incident

Report, and Adverse Dug Reactions (ADR) are appropriately
filed.      
Personnel      
Do personnel have appropriate training in handling
pharmaceutical products and documentation?      

Are personnel aware of SOPs and can execute them as

appropriate?      

Does Pharmacist has valid PRC license and training certificate?      

Does custodian/driver of the vehicle or transport personnel

is/are trained in handling pharmaceutical products?      

Inspected by: Date:

________________________________ _________________________
Signature Over Printed Name

Approved by: Date:

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________________________________ _________________________
Signature Over Printed Name

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Pest Control Record

Date Requested

Chemical Used

Procedure

Area Covered

Done by:

Name: ______________________________________
Signature Over Printed Name

Date: ______________________________________

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OSCOR-GLUO PHARMACY
INCIDENT REPORT FORM

Name of Reporter:  

Date:  

Narrative Report:
   
   
   
   
   
   
   
   
   
   
   
   
   
   
CAPA
   
   
   

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Approved by: (Manager/Owner)  

Date:  

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OSCOR-GLUO PHARMACY

Recall Log
Batch
No./Exp Reason for
Generic Name Brand Name Dosage Qty Unit Date Supplier Manufacturer Recall
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 

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PROODUCT RETURN FORM

. Dosage Qty . .
Generic Name Brand Name Dosage Form Supplier Reason of return Item Exchanged
               

               

               

               

               

               

               

               

               

Prepared by: _________________________________ Checked by: _________________________________

Date: _______________________________________ Date: _______________________________________

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OSCOR-GLUO PHARMACY

EXPIRED AND DAMAGED PHARMACEUTICAL PRODUCTS FORM

       
DOSAGE
GENERIC NAME BRAND NAME FORM SUPPLIER QTY

       

         

         

         

           

           

           

           

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Prepared by:_________________________________ Date: ___________________________________

Signature Over Printed Name

SELF-ASSESSMENT FORM
Attach Copy of Self-Assessment Checklist
Date of
Inspection Deficiencies Personnel In-Charge RMP Team Recommendation CAPA
         
         
         
         
         
         
         
         
         

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