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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:
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
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.
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
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
PRODUCT COMPLAINT
(INVESTIGATION FORM)