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METHODS OF PROPER STORAGE

Storage is an important phase of the total drug control system. Proper environment al
control such as temperature, light, humidity, conditions of sanitation, ventilation and segregation
should be maintained wherever medicines and supplies are stored. Stability of drug products
depend on the active ingredient which can be easily affected by its formulation and packaging.
Likewise, security is another important factor for the storage of medicines. Similarly, drug control is
among the pharmacists most important responsibilities. Thus, the following adequate methods are
developed and implemented:

I. Keep the Pharmacy and storeroom in good condition

A. Control the temperature in the Pharmacy/storeroom (use of room thermometer is necessary)


Pharmacy staff should consistently monitor the temperature of the different areas within
the Pharmacy/ Storeroom.
Thermometer must be kept at the hottest place of the Pharmacy/storeroom.
Temperatures must be checked during the hottest part of the day.
Temperatures of the cold rooms, refrigerators, and freezers should be monitored once daily
during the first working hour of the morning and again during the last working hour in the
afternoon on the Temperature Monitoring Chart.
Keep the Temperature Monitoring Chart updated to ensure good storage conditions.

B. Control Light in the Pharmacy/ Storeroom


Some health products are photosensitive and will be damaged if exposed to light. To protect such
products from degradation, the Pharmacy staff should:
Keep the photosensitive products in cartons.
Keep away products or not store or pack products in direct sunlight or light.
Use Window shade or curtains, if the window is in direct sunlight.

C. Keep the Pharmacy/ Storeroom clean and organized


Provide sufficient shelves.
Use a system for arrangement of medicines.
Use color- coding system to monitor drugs/ medicines movement.
Arrange medicines neatly and label shelves for each item.
Store medicines in a way that facilitates FEFO (First Expiry- First Out) or FIFO (First In- First
Out) rule for stock management.
Arrange cartons on plastic pallets pointing arrows up. Make sure that expiry and
manufacturing dates are visible on the label.
Keep expired medicines separate and label with NOT FIT FOR CONSUMPTION. Return
them to the Supply Officer for proper action and/or disposal in accord with the Procedures
stated in the Pharmacy Manual.
II. Drug Products that require special storage conditions.

A. Dangerous Drugs (controlled substances)


Pharmacist/s must keep these substances in an access- controlled location.
Pharmacist/s should hold the keys of the shelves or cabinets where theses medicines are
kept.
S/He is responsible in the monitoring of stocks and recording of dispensed products in
accordance to the regulatory standards of the Comprehensive Dangerous Act of 2002.
Access to these areas should be restricted to the staffs that are authorized to handle these
medicines.
ACTIONS PERSON/S RESPONSIBLE
Post data of delivered dangerous drugs in
the stock card.
Arrange dangerous drugs systematically in a Pharmacist
secured cabinet.
Keep keys in a secured drawer.
Monitor stocks daily.

B. Biological Products, vaccines requiring refrigeration


There should be sufficient biological refrigerator/s or improvised ordinary refrigerator/s to
store all necessary biological products, parenterals, suppositories and others requiring
refrigeration.
Pharmacist should implement Cold chain system to ensure the potency of vaccines from the
time of manufacture to the time it is given to the patient.
Vaccines are arranged according to type, expiry date, duration of storage and number of
times they have been brought out to the field. Vaccines with the earliest expiration date are
distributed or used first.
Ensure that Thermometers of modified or pharmaceutical refrigerators should be properly
calibrated twice a year to maintain the required storage temperature.

Terms Relating to Temperature and Proper Storage Conditions


NOTE: It is important to follow the manufacturers recommended storage conditions for all products.

Store Frozen: Some products, such as certain vaccines, need to be transported within a cold chain
and stored at -20C (4F).
Store at 2- 8C (36 -46 F): Some products are very heat sensitive but must not be frozen. These are
usually kept in the first and second part of the refrigerator (never the freezer).
Keep cool: Store between 8- 15C (45 -59 F).
Store at room temperature: Store at 15- 25C (59 -77F).
SANITATION PROGRAMME

A. Dirt and Garbage Disposal


Sweep and mop or scrub the floors of the Pharmacy/ Storeroom regularly. (Scheduled
cleaning is done by ProCare usually every after each shift).
Pharmacy aide/ assistant ensure that shelves, containers, bottles, stocks and other
pharmacy equipments/ apparatus are dusted and free from dirt.
Dispose garbage regularly and ensure that garbage bins have receptacles. (Done by
ProCare).

PROTECTING AGAINST PESTS


Modify the storeroom to facilitate cleaning and prevent moisture.
Maintain a clean environment to prevent conditions that favor pests. (i.e. Store garbage in
covered garbage bins. Regularly clean floors and shelves.)
Do not store or leave food inside the storage facility.
Keep the interior of the Pharmacy as dry as possible.
Paint or varnish wood, as needed.
Use pallets and shelving.
Inspect the storage facility regularly for evidence of pests.

Strategies for specific pests


1. Rodents: Rodent problems are best solves by prohibiting rodent entry and maintaining a
dry, clean facility. Other alternatives include keeping a traditional, spring loaded snap traps;
glue boards, which are disposable plastic or wood trays partially filled with non toxic,
adhesive glue; bait boxes, which are shoe sized boxes with lids and holes on each end
containing toxic rodenticide packets; electronic ultrasonic devices, which emit high-
frequency sounds, causing rodents to avoid the area; or rat poison.
2. Birds or Bats: If the facility has space beween the ceiling and the roof, cover all the
openings with fine wire mesh to prevent birds or bats from entering the storeroom.
3. Flying Pests: The best prevention is to keep all doors and windows of the facility closed.
Make sure that there are no holes in the walls, floor, or ceiling.
4. Termites/structural pests: The first treatment involves injecting a termiticide into the soil
in the ground beneath the facility. If the problem is severe, or if the first treatment is not
feasible, the building must be fumigated. All stored goods must be removed from the site
during fumigation. Replace wood severely damaged by structural pests.
HEALTHCARE WASTE MANAGEMENT- DISPOSAL OF USED EMPTY VIALS

The importance of healthcare waste management gained focus in compliance to the Clean
Air Act (CAA) of 1999 and Ecological Solid Waste Management (ESWM) Act of 2002. Hospital
Pharmacists play a vital role in such management. Protection of both personnel and environment
are taken into consideration.

Responsibilities of the Pharmacist


1. Waste Minimization through Proper Storage and Segregation
2. Advocacy of proper healthcare waste management procedure
3. Ensure adequate training for personnel assigned to segregation and disposal

Procedure for the proper disposal of used empty vials


a. Empty vials must be properly packaged, sealed, and labelled.
b. Containers of these wastes should be color coded and marked with symbol or labelled as USED
EMPTY VIALS
c. All personnel involved in the routine handling should wear appropriate protective clothing,
whether the waste appears properly packaged or not.
d. These waste should be removed immediately and disposed of accordingly.
COLD CHAIN MANAGEMENT

Steps to ensure the proper collection and transportation of vaccines:


The Pharmacist must obtain the right amount of vaccines needed by preparing an inventory
report and calculation vaccine requirements for a specific period.
Make sure that enough space/ storage is available for the said products.
Check the type and amount of vaccine diluents and ice packs.
Check the expiry date of the vaccines. Do not accept expired vaccines.
Put fully frozen ice packs of cold packs around the sides and bottom of the transport box.

TYPE OF VACCINE IDEAL STORAGE TEMPERATURE


Most Sensitive to Heat Oral Polio -15C to -25C
Measles (freeze dried) -15C to -25C
DTP 2C to 8C
Least Sensitive to Heat BCG 2C to 8C
Tetanus Toxoid (TT) 2C to 8C
Hepatitis B 2C to 8C
Vaccines like DPT and Tetanus Toxoid could be damaged by freezing. Hence, Pharmacist
should prioritize regular monitoring of these vaccines. Place frozen ice packs on the table for
five to ten minutes before packing so that the temperature of the ice packs will not be lower
than 0C.

Pack the vaccines and diluents into the cold chain container quickly and properly.
Transfer vaccines and diluents immediately to cold chain facilities. In case there are no
refrigerators or freezers then transport box maybe used for temporary storage for not more
than five days.
PROCEDURE IN HANDLING PRODUCT RECALL

Recalls are an appropriate alternative method for removing or correcting marketed consumer
products, their labelling, and/or promotional literature that violate the laws administered by the
Food and Drug Administration (FDA). The Pharmacy may initiate a recall at any time following
notification of a problem by FDA or a state agency, in response to a formal request by the FDA, or as
ordered by FDA, to fulfill their responsibility to protect the public health from products that present
a risk of injury or gross deception, or are otherwise defective. Thus, the following procedure must be
observed:

The Pharmacist upon his/her knowledge of the product recall through the issuance of
Notification of Public Warning from the FDA or upon the information through a Product
Recall Letter from the distributor company must coordinate or report the same with the
Central Supplies Office (in writing) for proper action regarding the products and to make
sure that there will be no further procurement for the meantime of the recalled product.
The Pharmacist collect copies of all labelling associated with the product, and notes all the
details of the product/s to be recalled.
The Pharmacist must be particular on the Batch No. or Lot No. of the product that is being
recalled from the market to facilitate removal of stocks in display and to prevent from
further dispensing of such.
Coordinate with the Central Supplies Office for further coordination with the Supplier for the
withdrawal of the recalled products.
Fill up Withdrawal Forms and keep it together with the Product Recall Letter for reference
and other purposes.
Wait for further pronouncement of the recall to be updated.
PRODUCT RECALL WITHDRAWAL FORM

Dr. Ronald P. Guzman Medical Center

PRODUCT RECALL WITHDRAWAL FORM

NAME OR PRODUCT: Generic Name (Brand Name) DATE:

QUANTITY BATCH /LOT NO. EXPIRATION DATE REMARKS

PREPARED BY: RECEIVED BY:


PROCEDURE ON HANDLING COMPLAINTS

Product complaint is defined as any product related complaint received from consumer
regarding efficacy/ quality/purity of the product which may/ may not affect the health of the
consumer. This may be classified into:

Critical Complaints: include those where efficacy of product is in question e.g. label mix ups,
overdosing or some critical side effect or adverse drug reactions which may cause death of the
patient.

Major Complaints: include those which may put patient at some risk but are not life threatening
and are quality related e.g. assay is low, broken/half tablets found, lamination problem, layer
separation in case of bilayer tablets, mottling, or colour defading problem in case of coated
tablets, molten tablets, broken capsules, microbial growth, insect or insect residue found,
deformed capsules, less volume, suspended impurities in solution, breaking of suspension,
leakage of tubes, carton/ foils without proper overprinting details, missed overprinting, etc.

Minor Complaints: include those which are not life threatening e.g. shortage or excess quantity
received by stockiest, empty pockets, improper sealing, etc.

To properly address such complaints, the following are Procedure to properly handle such:
Any product complaint received by the Pharmacy must be properly logged and must
have an assigned number and shall give complaint acknowledgement to the
complainant.
The Pharmacist shall identify the type of complaint and fill the information in Product
Complaint Form.
The Pharmacist shall forward a copy of the complaint to the Central Supplies Office and
the Administrative Office for proper investigation and for proper action regarding such
matter.
The Pharmacist shall keep the original copy of the complaint.
The concerned department(s), investigating the complaint shall document their findings
in the Product Complaint Form. If additional space is required, additional pages may be
used.
If during the course of investigation and final disposition, it emerges that there is a need
of product recall then the SOP for Product Recall shall be followed.
Once the investigation is complete, the Head of the investigating department shall send
reply to complainant and to the Pharmacy Head or his/her designee.
All forms, documents and correspondences associated with the complaint shall be filed
in the Product Complaint File.
Each written complaint shall be maintained for three (3) years after the expiry date of
the drug product.
There shall be an annual compilation and review of the entire market complaints
product.
PRODUCT COMPLAINT FORM

DR. RONALD P. GUZMAN MEDICAL CENTER

PRODUCT COMPLAINT FORM

PRODUCT COMPLAINT NO: DATE:


NAME:
ADDRESS:
NAME OF PRODUCT : Generic Name (Brand Name) BATCH NO:
EXPIRATION DATE:
BRIEF DESCRIPTION OF COMPLAINT:

This space to be filled up by the Pharmacist


TYPE OF COMPLAINT: RECEIVED BY: DEPARTMENT: DESIGNATION:

PRODUCT COMPLAINT INVESTIGATION FORM:

DR. RONALD P. GUZMAN MEDICAL CENTER

PRODUCT COMPLAINT
(INVESTIGATION FORM)

PRODUCT COMPLAINT NO: DATE:


NAME OF PRODUCT : Generic Name (Brand Name) BATCH NO:
EXPIRATION DATE:
INVESTIGATION:

NAME AND SIGNATURE OF HEAD OF INVESTIGATION:

PRODUCT COMPLAINT LOG BOOK:

PRODUCT DATE OF SOURCE/NAME TYPE OF NAME OF REMARKS


COMPLAINT RECEIPT OF OF COMPLAINT PRODUCT
NO. COMPLAINT COMPLAINANT (BN,GN,BATCH
NUMBER)