STANDARD OPERATING PROCEDURES

THIS SOP MANUAL CONTAINS THE FOLLOWING SOP’s

I. SOPs for Housekeeping

II. SOPs for Good Dispensing Practice

III. SOPs for Good Storage Practice

IV. SOPs for Disposal of Expired/Damaged/Returned/Rejected Medicines

V. SOPs for Pest and Rodent Control

VI. SOPs for Pharmacovigilance

a. Reporting of Adverse Drug Events/Adverse Drug Reactions

b. Product Recall

c. Product Complaints

VII. Cold Chain Management

VIII. SOPs for Staff Training and Assessment

 STANDARD OPERATING PROCEDURES

HOUSEKEEPING

I. OBJECTIVE: To produce proper guidelines regarding the cleanliness of the drugstore.

II. SCOPE: Within the vicinity of the drugstore and cleaning of the shelves and good
housekeeping.

III. RESPONSIBILITY:

a. Pharmacist
b. Pharmacy Assistant

IV. PROCEDURE:
1. Use clean cloth for cleaning shelves, clean mop with detergent or bleaching
agent to clean the floors.
2. Transfer the medicines from the shelves to an empty box.
3. Wipe the shelves and clean it with cloth to remove any dust.
4. In case of rigid smudges/stains, use damp cloth to clean them.
5. After completion, place the medicines back to where they belong.
6. Wash and dry up the cloth used for cleaning. Repeat cleaning every 3 weeks.
7. Clean the floor with mop. Clean the floor every day.
8. Throw the garbage when the collection is near. Do not place it outside because
scavengers might scatter it.
9. Try to search for pest and make necessary action to eliminate them.

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 STANDARD OPERATING PROCEDURES

GOOD DISPENSING PRACTICE

I. OBJECTIVE: To provide Standard Operating Procedure for Dispensing Prescription

Drugs.

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

III. RESPONSIBILITY:
a. Pharmacist
b. Pharmacy Assistant

IV. PROCEDURE
1. Greet customer with a smile.
2. Receive the prescription in a dignified manner.
3. Read the prescription properly the name, strength, dose and quantity. If in case
of doubt, ASK THE PHARMACIST.
4. Check legality and legibility of the prescription.
5. If the prescription is illegible or in case of doubt, confirm with the doctor over
the phone. DO not dispense a prescription drug without a proper prescription
order and do not dispense when doubting.
6. Check for the availability of the stock and make sure the product is the one that
is written on the prescription order. Make sure that the product is under good
condition and the expiration date is still far.
7. Give the client the chance to choose what is the cheapest medicine but is in
good quality and effective drug.
8. Obtain the medicines from the gondola/shelves, double check if it is the
medicine in the prescription order, and ask for the quantity to be bought.
9. Check the product in front of the customer and interpret the instruction of the
doctor to the patient or give relevant information regarding the storage and
administration.
10. Proceed to billing and an official receipt should be issued.

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 STANDARD OPERATING PROCEDURES

DISPOSAL OF EXPIRED, DAMAGED, RETURNED OR REJECTED PRODUCTS

I. OBJECTIVE: To execute the disposal of damage, expired, returned or rejected

products.

II. SCOPE: Products that are expired, damage, returned or rejected by customers due
to defect.

III. RESPONSIBILITY:
a. Pharmacist
b. Owner
c. Pharmacy Assistant

IV. PROCEDURE
1. Pharmacy assistants are assigned to specific shelves for checking nearly
expired products. Nearly expired products that are 3 months before expiry
shall be removed from shelves.
2. Checking of expiry date shall be done every month and shall be recorded.
3. Pharmacist will ask the supplier to return nearly expired drugs, damaged,
returned or rejected so that the product will be pulled out and disposed.
4. When the supplier does not accept the return of the product, the pharmacy
shall dispose them in an environmentally conscious way. It can be done by
coordinating with the garbage disposal collector for proper disposal.

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 STANDARD OPERATING PROCEDURES

GOOD STORAGE PRACTICE

I. OBJECTIVE: To provide Standard Operating Procedure for storage of medicines.

II. SCOPE: All products within the drugstore.

III. RESPONSIBILITY:
a. Owner
b. Pharmacist
c. Pharmacy Assistant

IV. PROCEDURE
1. After initially checking the medicines delivered, all products shall be wrapped
by clear plastic to avoid accumulation of dust particulates.
2. Transfer the goods to their respective areas.
3. Store the goods in an organized and orderly manner with the label bearing
the name of the product in front.
4. First-Expiry-First-Out will be the basis of dispensing drugs.
5. Avoid direct contact to the sun or on the walls to avoid moisture
accumulation.
6. Store controlled drug substances and other potent drugs in the designated
areas. Access in this area should only be allowed to the owner and the
Pharmacist.
7. Store expired goods in the storage room, marking it with “Expired” to
prevent dispensing and usage.
8. Store medicines at stipulated temperature areas, protected from excessive
light, dust and humidity.
9. The room temperature should not exceed 30 degrees Celsius to maintain the
stability of drugs and 8 degrees Celsius for drugs inside the refrigerator.
10. Store the other stocks in separated areas. Maintain all sales invoice records
for returned and exchanged products to the suppliers.
11. Clean and maintain the storage areas neat and tidy at all times.

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 STANDARD OPERATING PROCEDURES

PEST AND RODENT CONTROL

I. OBJECTIVE: To prevent and control the entrance and predators and eradicate
infestations.

II. SCOPE: Within the vicinity, shelves and storage room of the drugstore.

III. RESPONSIBILITY:
d. Pharmacist
e. Pharmacy Assistant

IV. PROCEDURE
1. Maintain the cleanliness of the drugstore and storage room, dispose all the
garbage and other things (spoiled foods and unwashed dishes) that might be
a source of insects or rodents to enter inside the facility.
2. Check all the cabinets, shelves and storage area of medicine if there’s a way
for the pests and rodents to enter the drawers. If there’s an open way on the
cabinets, block it immediately with wood and seal it using wood glue.
3. If the pests and rodents already contaminated the cabinets, and storage
area, put the medicines inside plastic bag or box, mark it as damaged
medicines and dispose it properly.
4. Clean the shelves from pests’ and rodents’ droppings using Lysol Disinfectant
spray and clean rag.
5. The treatment for pests mainly comprise of using insecticidal spray in all the
nooks and corners of the entire premises and other vulnerable places
harbouring cockroaches and other insects. Use water-based insecticidal spray
like Baygon multi-Insect Odorless Spray.
6. Before spraying, put the medicines away from the shelves by using separate
boxes temporarily to prevent contamination.
7. Spray it 15-20cm away from the corners of the shelves or the areas that pests
might pass through. Put the medicines back after 20 mins minimum.
8. If a pest was killed, put it in a thick plastic bag and dispose it properly.
9. Place the insecticide in a safe place and far from the medicines.
10. In the treatment of management of rodents, glue board traps should be
used. Food or poison baits are not allowed to use because it is dangerous to
the personnel handling the medicines and might contaminate the medicines
inside the drugstore.
 STANDARD OPERATING PROCEDURES

11. If a rodent was caught in a trap, Lysol Disinfectant Spray should be used
while wearing latex gloves and by using a thick plastic bag, catch the rodent
in the trap and put it inside the plastic bag and dispose it properly.
12. Wash your hands thoroughly after and use a hand sanitizer or hand
disinfectant.

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 STANDARD OPERATING PROCEDURES

REPORTING OF ADVERSE DRUG REACTION/EVENTS (ADR/ADE)

I. OBJECTIVE: To detect and report possible adverse drug reaction and to properly
address customer concern in case ADR occurred.

II. SCOPE: All personnel present in the receiving the report of ADR/ADE occurrence.

III. RESPONSIBILITY:
a. Owner
b. Pharmacist
c. Pharmacy Assistant

IV. PROCEDURE
1. Ask the customer of the medicine involved in the ADR.
2. Check the labelling of medicine to verify information on the suspected
ADR/ADE.
3. Ask probable questions such as the manner of administration, any allergies
that the customer may have, food eaten before/after taking the complained
medicine.
4. Give the customer an ADR form and instruct the customer on how to fill up
the form.
5. Collect the filled out ADR form from the customer and submit to FDA.
6. Keep a copy of the form for proper filing.

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 STANDARD OPERATING PROCEDURES

PRODUCT COMPLAINTS

I. OBJECTIVE: To ensure that complaints concerning our product be resolved in an

efficient and professional manner to ensure customers satisfaction.

II. SCOPE: All drug products offered in our pharmacy and all personnel employed in our
pharmacy.

III. RESPONSIBILITY:
a. Owner
b. Pharmacist
c. Pharmacy Assistant

IV. PROCEDURE
1. Check the product being complained.
2. Ask the customers of the nature of complaint and check the label of the
product.
3. Answer each complaint in a positive and understanding manner.
4. Listen and empathize to what the customer is saying.
5. Repeat your understanding of the situation to prevent misunderstanding.
6. Offer a resolution to the situation, while being sure you are still following the
guidelines of the pharmacy and then consult it with the Pharmacist, or in
case of the Pharmacist, consult it with the owner.
7. Resolve the complaint if possible or commit to doing something immediately,
but not creating false expectations.
8. Check whether the customer is satisfied with the proposed action, and if not,
advise alternative actions.
9. Terminate the conversation in a positive approach. The Pharmacist should
forward a complain form for the client to sign. The document should have
clearly state the complete and accurate record of complaint and subsequent
discussions.
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 STANDARD OPERATING PROCEDURES

PRODUCT RECALL

I. OBJECTIVE: To provide Standard Operating Procedure for carrying out effective

method of removing or correcting violative products that may represent a health
hazard to the consumer or customer.

II. SCOPE: All products within the drugstore.

III. RESPONSIBILITY:
a. Owner
b. Pharmacist
c. Pharmacy Assistant

VI. PROCEDURE
1. Check FDA website daily for any advisories regarding product recall, or as
announced or initiated by the supplier.
2. Check all inventories of the presence of the medicine for recall.
3. Transfer the recalled items in the storage area on its proper box to avoid
dispensing to customer. Make sure that the box is labelled correctly.
4. Record the inventories of recalled items in separate logbook for recording
purposes.
5. Inform the supplier of the recalled products.
6. Arrange pick up of the recalled products for return to the supplier.

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 STANDARD OPERATING PROCEDURES

COLD CHAIN
MANAGEMENT

I. OBJECTIVE: To provide Standard Operating Procedures in proper storage

of medicines requiring low temperature to maintain their quality and their
proper usage.

II. SCOPE: All staff within the pharmacy.

III. RESPONSIBILITY:
a. Pharmacist
b. Pharmacy Assistant

IV. PROCEDURE:

1. The Pharmacist and Pharmacy staff shall ensure that the vaccines they dispense
have been correctly stored.
2. The refrigerator for storage of biologicals should be specifically designed for this purpose
and should have a lock.
3. Vaccines are sensitive biological products; protection of vaccine potency and
stability is important. The recommended temperature for vaccine storage is, at all
times, +2ºC to
+8ºC.

4. All biological products freeze at temperatures below 0°C; products that have been
exposed to temperatures below 0°C should not be used.
5. A temperature monitoring system shall be placed in the refrigerator and calibrated
from time to time.
6. A cool pack/ box must be used in transporting biologicals.
7. All acquired biologicals shall be recorded properly by the Pharmacist or the
Pharmacy staff.
 STANDARD OPERATING PROCEDURES

STAFF TRAINING AND ASSESSMENT

I. OBJECTIVE: To define the procedure on training a personnel.

II. SCOPE: All staff within the pharmacy.

III. RESPONSIBILITY:
a. Owner
b. Pharmacist
c. Pharmacy Assistant

IV. PROCEDURE:

1. Training program for personnel should be planned by the owner of the

pharmacy. Then he/she will assign one personnel as training coordinator.
2. Training programs should include all standard operating procedures of the
pharmacy, as well as trainings and lectures on basic pharmacy terms and the
medicines present in the drugstore.
3. Training should also include basic customer service.
4. Trainee will undergo through probationary period.
5. Trainee will be assessed every third, fifth and twelfth of the month.
6. A written assessment shall be recorded and filed, with signature of both
training coordinator/owner and person being trained.

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