Standard Operating Procedure - PharmaSave Pharmacy

Standard Operating Document No.
Procedure Revision No.

Page
Adverse Drug Reaction
Revision History
Revised on: Prepared by: Reviewed by: Approved by:
Issue No.:
Daniel Yves A. Paez IV, Daniel Yves A. Paez IV, Daniel Yves A. Paez IV,
RPh RPh RPh
Pharmacist/Owner Pharmacist/Owner Pharmacist/Owner
Effective Date: May 6, 2021 May 6, 2021 May 6, 2021
References
Document No.: Title No.:
I. OBJECTIVE:
1. To participate actively in phamacovigilance.
2. To provide procedure on handling ADRs.
II. SCOPE: All complaints that caused from the unusual side effects of drugs that may
appear after the clinical studies of the drug and/or phase IV and that only specific group of
individuals can experience it.
III. RESPONSIBILITY
 Pharmacist
IV. PROCEDURE
1. Give courtesy greetings to the customer and ask their concerns.
2. After hearing the complaint, conduct an interview.
3. The interview should be personal and private.
4. While interviewing the client, there should be a documentation of it, and if possible,
there must be proof of the adverse reaction of the drug such as pictures of it,
recording of the talk and so on to forth.
5. Ask about his lifestyle and other medicines that he is taking.
6. The answers should be true and valid.
7. The ADR should be categorized according to its type and classification.
8. A form must be filled up and let the interviewee sign it to prove that all written
complaints are true and original.
9. Keep the ADR form and report it to the company that involved and to the nearest
FDA office, so that analyses, tests, and studies on that event can be performed.
V. QUALITY OF RECORDS: Shall be written on the ADR record book and kept it for proof.
VI. FORMS:
See figure 1A.
VII. END OF DOCUMENT
Fig. 1A Types of ADRs:

 Type A – Dose-related effects (Augmentation)
 Type B – Non-dose-related effects (Bizarre)
 Type C – Dose- and time-related effects (Continuous or Chronic)
 Type D – Time-related effects (Delayed)
 Type F – Therapeutic failure (Failure of Efficacy)
Page
Cold Chain Management
Revision History
Issue No.:
RPh RPh RPh
References
I. OBJECTIVE:
1. To ensure proper storage of pharmaceuticals
2. To provide proper equipment that will maintain the stability and efficacy of drug
products.
3. To achieve unbroken cold chain from shipment to transient storage
II. SCOPE: All pharmaceutical products requiring storage under special storage condition
e.g., biologicals, vaccines.
III. RESPONSIBILITY
 Pharmacist
 Owner/Manager
 Pharmacy Assistants
 Forwarder
IV. PROCEDURE
A. Pharmaceutical Refrigerator/Chiller/Freezer
1. Required for vaccines, biologicals, and pharmaceuticals needing cold storage
condition.
2. Temperature is monitored and cleanliness is observed.
3. Contents is organized and icepack is provided when dispensed or delivered.
B. Temperature
1. Minimum of two thermometers are needed. Thermometers must be calibrated
at least twice a year.
2. Thermometer is read at least twice daily preferably once in the morning and
once in the afternoon.
3. The pharmacist or personnel should monitor and record temperature on the
temperature monitoring sheet.
4. Room temperature is monitored at least twice daily.
C. Dispensing
1. An icepack should be provided if customer's location is too far away.
2. Medicine must be dispensed under desired temperature condition.
D. Stocking
1. Stocking of medicine shall be organized.
2. Plastic containers may be used to maintain good appearance and freshness
of the product.
E. Emergency and Safety Measures

1. Delivered products should be closely monitored as to manufacturer,
specification, and expiration dates to ensure the safety and welfare of the
consumers.
2. Refrigerated products such as ampules/vials accidentally broken should be
cleaned and the cleaning person must be careful.
3. In the event of a power interruption, electric generator should be used to
sustain the ranged temperature of the drug products.
F. Product Returned/Complaint
1. The product should be in proper temperature and storage upon return.
2. If the product is not in well-monitored temperature and storage, acceptance of
the said product will be denied.
3. In case cold chain is maintained, the buyer is asked for the receipt and
necessary action is done.
G. Product Recall
1. In the event of product complaint arises, customers are advised to return the
product with the accompanying receipt for inspection and cold chain should
be maintained as the veracity of the complaints.
V. QUALITY OF RECORDS:
A. Systematic actions necessary to ensure adequate confidence that the product and
documentation will satisfy the requirements for quality assurance.
B. Temperature monitoring chart should be checked regularly to ensure the stability of
the medicines.
VI. FORMS:
A. Temperature Monitoring Sheet
B. Logbook

Disposal of Expired, Page
Damaged, Returned, or
Rejected Products
Revision History
Issue No.:
RPh RPh RPh
References
I. OBJECTIVE: To execute proper disposal of damaged, expired, returned, or rejected

products.
II. SCOPE: Products that are expired, damaged, rejected, or returned by customers due to
defect.
III. RESPONSIBILITY
 Pharmacist
 Owner/Manager
IV. PROCEDURE
1. Pharmacy assistants are assigned to specific shelves for checking of expiration dates
of medicines.
2. Medicines 3 months before the expiration date shall be removed and stored.
3. Checking of expiration dates will be recorded and inventoried every month.
4. Pharmacist-in-charge will request the supplier to return nearly expired medicines,
damage, returned, and rejected for pull-out and proper disposal.
5. When supplier denies return of the products, the pharmacy must then dispose the
products in an environmental-conscious way. It can be done by coordinating with the
city waste management for disposal.
V. QUALITY OF RECORDS: N/A
VI. FORMS:
 Logbook

Page
Good Dispensing Practice
Revision History
Issue No.:
RPh RPh RPh
References
I. OBJECTIVE:
1. To enforce standard operating procedure for dispensing prescription drugs
2. To promote use of generic equivalent drugs which are cost-effective.
II. SCOPE: All prescription, generic equivalent, and over-the-counter drugs
III. RESPONSIBILITY
 Pharmacist
IV. PROCEDURE
1. Greet the client with a smile.
2. Receive prescription for requested medicines in a dignified manner.
3. Read the prescription carefully and properly. Take note of the name, strength, dose,
and quantity of the medicine needed. If in doubt, ask the pharmacist.
4. Check the legality and legibility of the prescription.
5. If the prescription is illegible, confirm with the doctor over the phone.
6. Do not dispense a prescription drug without proper prescription and do not dispense
if in doubt of the validity.
7. If prescription is valid for dispensing, check for the availability of the stock and ensure
that the product is the one in the prescription order.
8. Make sure that the product is in good condition and the expiration date is still far.
9. Give the client the chance to choose between generic equivalent medicines.
10. Ask the patient for the quantity to be bought, retrieve the requested quantity, and
double check if it is the medicine in the prescription.
11. Check the product in front of the customer, interpret the doctor's instruction to
him/her, and give relevant information regarding storage, administration, precautions,
etc.
12. Proceed to billing and issue an official receipt.
V. QUALITY OF RECORDS:
1. The pharmacist will file the fully filled prescription and shall be input in the
prescription book.
2. The prescriptions will be kept for at least 2 years.
VI. FORMS:
 Prescription order
 Prescription book

Page
Good Storage Practice
Revision History
Issue No.:
RPh RPh RPh
References
I. OBJECTIVE: To ensure proper storage of medicines.
II. SCOPE: All products available in the drugstore.
III. RESPONSIBILITY
 Pharmacist
 Owner/Manager
IV. PROCEDURE
1. After initial checking of the delivery, all products should be wrapped with a clear
plastic to prevent accumulation of dust particles and to protect from pests.
2. Goods shall be transferred to their respective areas.
3. Store the items in an organized and orderly manner with the label bearing the name
of the product in front.
4. First-expiry first-out (FEFO) will be the basis of dispensing or disposing of drugs.
5. Avoid direct sunlight or contact on the walls to avoid moisture accumulation, thus
preserving the integrity of the containers and stability of the medicines.
6. Store controlled substances/medicines and other potent drugs in designated areas
which the be only accessible to the pharmacist and owner.
7. Expired products should be stored in the in the storage room and be labeled
"Expired" to prevent dispensing.
8. Medicines are stored at areas protected from excessive light, dust, and humidity.
Room temperature and cold chain storage is monitored by the personnel regularly
and recorded in the monitoring sheet.
9. Store the other stocks in a separated area. Invoice records are kept for return or
exchange of products with the supplier.
10. Clean and always maintain the storage areas neat and tidy.
VI. FORMS: N/A

Page
Housekeeping
Revision History
Issue No.:
RPh RPh RPh
References
I. OBJECTIVE: To create proper guidelines in the sanitation of the drugstore.
II. SCOPE: Within the vicinity of the drugstore, cleaning of the shelves, and good
housekeeping
III. RESPONSIBILITY
 Pharmacist
IV. PROCEDURE
1. Use a clean dry cloth for cleaning the shelves, a damp cloth for smudges or stains,
and clean mop with detergent or bleaching agent in cleaning the floors.
2. Temporarily transfer contents of the shelves to an empty box.
3. Wipe the shelves and clean it with cloth to remove the dust and stains.
4. After completion, place the contents back on their respective shelves.
5. Wash and dry the cloth used in cleaning. Repeat cleaning at least once a week.
6. Clean the floor with mop.
7. Contain the trash in garbage bags preferably segregated between biodegradable and
non-biodegradable. Throw the garbage when time of collection is near. Do not place
garbage bags outside as scavengers might scatter it.
8. Try to search drugstore vicinity of pests and make necessary action to eliminate
them.

VI. FORMS:
 Logbook for cleaning

Page
Pests and Rodents Control
Revision History
Issue No.:
RPh RPh RPh
References
I. OBJECTIVE: To create proper guidelines in the sanitation of the drugstore.
II. SCOPE: Within the vicinity of the drugstore, cleaning of the shelves, and good
housekeeping
III. RESPONSIBILITY
 Pharmacist
IV. PROCEDURE
1. House Pests Management:
1. The treatment is for the management of cockroaches and other pests such as
silver fish, red and black ants.
2. Treatment is mainly comprised of thorough insecticidal spray in all nooks and
corners of the premises and areas harboring or may harbor cockroaches and
other insects.
3. Water-based insecticides and cockroach paste baits is used on this
treatment.
2. Rodent Control:
1. Treatment is for the management of rodents i.e., rats, mice in the pharmacy
ground floor, toilets, cashier, and manager's office.
2. Rodent traps and rodenticide bait paste are set around the periphery of the
main building, none of which will be used inside the building.
3. For indoor control of rodents, glue board traps are placed along the walls in
areas close to doors and other openings into an area. No food or poison baits
are used, and the catch are disposed of without the dead rodent causing
odor/contamination problems from inaccessible areas.
3. Intelligent Fly Management:

1. Treatment is for the management of flies i.e., house flies, flesh flies, and gnat
house flies.
2. Water-based multi-insect insecticide will be sprayed directly at flying insects
and thoroughly on areas of infestation. This will only be done outdoors to
prevent contamination of products.
3. Insect light traps or fly traps are installed inside the premises as needed.
4. Barrier Treatment:
1. Treatment is for crawling pests i.e., ants, millipedes, centipedes which come
crawling from outside the premises.
2. Prophylactic treatment is recommended and only for external periphery of the
premises.
3. The thorough runoff spray of a water-based insecticide spray will cover a
band of 2 meters i.e., one-meter-wide floor and one-meter-high wall sides.
This is done by a pharmacy assistant.
Note: Face mask and latex gloves should be used will involve in spraying activity to prevent contamination and
inhalation.
VI. FORMS:
 Logbook for pests and rodents control

Page
Product Complaint
Revision History
Issue No.:
RPh RPh RPh
References
I. OBJECTIVE: To describe the response given to a customer when a product complaint is

presented.
II. SCOPE:
1. Complaints are expressed by customers and other involved parties.
2. DOH-FDA or local regulator body has authority to review actual complaint and other
related cases.
3. Procedure is applied in a case-to-case basis only.
III. RESPONSIBILITY
 Pharmacist
 Owner/Manager
IV. PROCEDURE
1. Upon in receipt of the complaint, the pharmacy assist immediately calls the attention
of the pharmacist-in-charge.
2. Ask the complainant for the official receipt to make certain that the product was
bought in the pharmacy.
3. An interview will be made, and the pharmacist will inquire for details concerning the
complaint.
4. Verify the batch number, lot number, expiration date, and condition of the medicine.
5. Pharmacist will prepare a record of the complaint.
6. If the complaint is justified, the following will be done:
a. Investigate proper action to prevent recurrence.
b. Replace the medicine or refund the money.
c. Inform the supplier.
7. If the complaint is not justified, inform the customer about the findings.
8. Submit a report to the authority.
V. QUALITY OF RECORDS: The pharmacist will file the complaint and keep for at least 1
year in case another incident happens.
VI. FORMS:
 Logbook

Page
Product Procurement
Revision History
Issue No.:
RPh RPh RPh
References
I. OBJECTIVE: To provide guideline in procurement of stocks.
II. SCOPE: Applied to all products sold in the pharmacy.
III. RESPONSIBILITY
 Pharmacist
 Owner/Manager
IV. PROCEDURE
1. The purchaser will put together an order through phone call, SMS, facsimile, sales
representative, and/or other media.
2. Procurer should prepare a copy or list of the products to facilitate checking of items
delivered.
3. Upon arrival of items ordered, check the item count, amount, batch number and
make sure that the expiration date is far to certify the safety and efficacy for use.
4. The procurer pays in through the deliver personnel and ask for the official receipt and
copy of the sales invoice. The receipt/sales invoice will be filed for future reference.
5. The procurer will price the products through an acceptable price mark-up.
6. Items will either be displayed in the shelves or kept stock if the same items are still
available for selling.
V. QUALITY OF RECORDS: Purchaser will file the invoice for future reference and other
cases.
VI. FORMS:
 Logbook

Page
Product Recall
Revision History
Issue No.:
RPh RPh RPh
References
I. OBJECTIVE:
1. To provide proper action about product recalls.
2. To establish coordination with supplier(s) when a certain product is recalled.
II. SCOPE: All products subjected to product recall under the DOH-FDA declaration.
III. RESPONSIBILITY
 Pharmacist
 Owner/Manager
IV. PROCEDURE
1. The pharmacist is the primary personnel to accomplish this task.
2. Distributor(s) will inform the pharmacy about the product recall through a product
recall letter containing the details of product(s) to be recalled.
3. The pharmacist-in-charge must be particular on the batch number or lot number of
the product being recalled from the market to assist removal of stock in the shelves
and the store.
4. Upon checking of the batch number, make certain that the product is removed from
the shelves to prevent further sales of the item in question.
5. Coordinate with the supplier when will be the items be withdrawn.
6. Wait for further pronouncement of the recall to be updated.
V. QUALITY OF RECORDS: The letter and withdrawal form should be kept for further
purposes.
VI. FORMS:
 Logbook

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Standard Operating Document No.

Procedure Revision No.

Effective Date: May 6, 2021 May 6, 2021 May 6, 2021

VII. END OF DOCUMENT

Fig. 1A Types of ADRs:

Effective Date: May 6, 2021 May 6, 2021 May 6, 2021

E. Emergency and Safety Measures

VII. END OF DOCUMENT

Effective Date: May 6, 2021 May 6, 2021 May 6, 2021

I. OBJECTIVE: To execute proper disposal of damaged, expired, returned, or rejected

V. QUALITY OF RECORDS: N/A

VII. END OF DOCUMENT

Effective Date: May 6, 2021 May 6, 2021 May 6, 2021

II. SCOPE: All prescription, generic equivalent, and over-the-counter drugs

VII. END OF DOCUMENT

Effective Date: May 6, 2021 May 6, 2021 May 6, 2021

I. OBJECTIVE: To ensure proper storage of medicines.

II. SCOPE: All products available in the drugstore.

V. QUALITY OF RECORDS: N/A

VI. FORMS: N/A

VII. END OF DOCUMENT

Effective Date: May 6, 2021 May 6, 2021 May 6, 2021

I. OBJECTIVE: To create proper guidelines in the sanitation of the drugstore.

V. QUALITY OF RECORDS: N/A

VII. END OF DOCUMENT

Effective Date: May 6, 2021 May 6, 2021 May 6, 2021

I. OBJECTIVE: To create proper guidelines in the sanitation of the drugstore.

3. Intelligent Fly Management:

V. QUALITY OF RECORDS: N/A

VII. END OF DOCUMENT

Effective Date: May 6, 2021 May 6, 2021 May 6, 2021

I. OBJECTIVE: To describe the response given to a customer when a product complaint is

VII. END OF DOCUMENT

Effective Date: May 6, 2021 May 6, 2021 May 6, 2021

I. OBJECTIVE: To provide guideline in procurement of stocks.

II. SCOPE: Applied to all products sold in the pharmacy.

VII. END OF DOCUMENT

Effective Date: May 6, 2021 May 6, 2021 May 6, 2021

VII. END OF DOCUMENT

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