Pharmacy Policy: Drug Recall System

Pharmacy Policy: Drug Recall System

What is the drug recall system?

Drug recall system is part of the pharmacy policy and procedures.

As usual, with most of the policies sample posted here, there is some default data that should be listed in the policy header and footer. Below are some of the info that you need to include in your drug recall system policy header:

  • Hospital name, obviously.
  • Pharmacy department operational policy and procedure, this header just to notify the reader that the following policy belongs to which department.
  • Policy code or Number, for filing/indexing purposes.
  • Edition Number, same purpose as above.
  • The title of the policy, in our case; would be drug recall system.
  • Important dates [date reviewed, approved date, effective date, and due for review date].
  • Applies to [department] in this case, it should be pharmacy department
  • And last but not least, you’ll mention the nature of the policy, whether it’s going to be multidisciplinary or department-specific. (Multidisciplinary policy)

Storage of pharmaceuticals
Drug recall system

Drug recall system policy

Definitions

  • Drug recall procedure is a method by which defective medications likely to adversely affect patients are immediately removed from the pharmacy stock and recalled from patients, if applicable.

Class I- Situation in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

Class II- Situation in which the use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

Class III– Situation in which the use of or exposure to the product is not likely to cause adverse consequences.

  • Defects in medications include, but are not limited to, the following:
  1. Inadequate or faulty packaging or containers.
  2. Inadequate or confusing labeling.
  3. Deteriorated or contaminated drugs.
  4. Drugs are professionally considered being defective or undesirable.
  • Pharmacy stock includes main stock in outpatient pharmacy and inpatient pharmacy, stock kept in unit dose & non-unit dose units.

Purpose

  1. To ensure that any defective or sub-standard drug is removed from pharmacy stock and recalled from patients.
  2. To protect patients from defective, sub-standard drug products.

Policy

  • For Class I and Class II recall, the product will be removed immediately from pharmacy stock and inpatient area and patients will be called immediately to stop using the product and return it to pharmacy.
  • For Class III recall, the product will be removed within/not exceeding 24 working hours from receiving time of the notification.

Procedures and responsibilities

  • Pharmacy Director will receive all notification of drug recall, which is usually received from one of the following:
  1. Drug manufacturers or suppliers.
  2. Pharmacy publications.
  3. The Ministry of Health.
  4. Food & Drug Authority (FDA).
  5. Professional Internet websites.
  • The pharmacy Director will notify the following parties by sending the Drug Recall form:
  1. Medical Directors.
  2. Nursing Directors.
  3. Assistant pharmacy director.
  4. Outpatient Pharmacy Supervisor.
  5. Inpatient Pharmacy Supervisor.
  6. Pharmacy purchasing supervisor.
  7. Pharmacy store supervisor.

NOTE: Copy of the drug recall notification will be sent to the chairperson of the P&T committee.

  • Pharmacy Central Store Supervisor will:
  1. Receives the notification of drug recall from the Pharmacy Administration.
  2. Physically removes the drug in question from the shelves.
  3. Receives all returned stock of the drug in question from all pharmacy sections.
  4. Label all packages of the drug in question “not to be issued until further notice” and keep it on a separate place.
  5. Notifies the Pharmacy Purchasing Supervisor, through the usual channels, to place an order to expedite an open order to replace the recalled drug.
  6. Disposes the recalled drug in accordance with the instructions outlined in the recall notification as follows:

*If the drug was procured from a local vendor:

1-Fills the Ministry of Health “Drug Quality Report” (see attachment) and sends a sample of the recalled drug with the report to Regulations Authorities.

2-Coordinates with the Pharmacy Purchasing Supervisor to replace the defective batch by the local Vendor.

* If the drug was procured from an abroad vendor:

1-Communicate with Pharmacy Purchasing Supervisor to notify the supplier for possible replacement.

2-Ensures that the recall is fully documented and the documents are kept in the recalled medication file.

  • Inpatient Pharmacy Supervisor will:
  1. Receives the notification of drug recall from Pharmacy Administration.
  2. Physically removes the drug in question from the shelves.
  3. Ensures the removal of the drug in question from the patient’s medication drawer.
  4. Notifies the treating physician of the drug recalled.
  5. Assigns a Pharmacist to check all patient care areas, including the floor stock medication in Nursing units, crash carts, outpatient clinics, E.R, O.R, M.D. bags, anaphylactic kits, Emergency kits, poison& antidote trays to remove all supplies of the recalled drug using return to stock sheet in order to return the recalled drug to computer inventory system.
  6. Returns all stocks of the recalled drug to Pharmacy Central Store for disposition with a print out of “Return to Store” computer slip to adjust the Pharmacy stock.
  7. Coordinates with pharmacy store supervisor to replace the defective batch.
  • Outpatient Pharmacy Supervisor will:
  1. Receives the notification of drug recall from the Pharmacy Administration.
  2. Physically removes the recalled drug from the shelves.
  3. Reviews all prescriptions dispensed since the date of the notification and separates those prescriptions of the recalled drug.
  4. Using the information on the prescriptions.
  5. Notify the treating physician about the recalled drug.
  6. Contact the patient(s) by telephone at work or at home using computer hospital information system (HIS).
  7. Instruct patient (s) to stop administering the drug immediately.
  8. Ask patient to return remaining supplies of the drug to the Pharmacy.
  9. Instruct patient to arrange an appointment to see his physician as soon as possible.
  10. Returns all stocks of the recalled drugs (including supplies returned by patients) to Pharmacy central store for disposition with a printout of “Return to Store” computer slip to adjust the Pharmacy Stock.
  11. Coordinate with pharmacy store supervisor to replace the defective batch.

Attachments

  1. Attachment A- Drug Recall Notification /Pharmacy Drug Recall Form.
  2. Attachment B- FDA Pharmaceutical Products quality reporting form.
  3. Attachment C- Return to Stock Slip.

You’re almost done and the pharmacy drug recall system policy is almost ready. What’s remaining is just a few basic policy layout filling.

  • References.
  • Revisions: Revised as per timescale.
  • Distribution: Here you should mention where this policy will be sent, and which departments will get a notification for it:
    • Medical/Hospital Director.
    • Nursing Director/All Nursing Units.
    • Quality Management Department.
    • Pharmacy Department.
    • Signed original is maintained in Manual & Indexing Office.

The policy is now finished, and it’s time to get proper signatures, whether your hospital is implementing electronic signatures, or manual signs and stamps.


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