"Putting Patient Safety First: How We Manage Recalled Medications"

 

Dr Madhav Madhusudan Singh

MBBS, MHA (AIIMS) , MBA (Finance), Ph.D. ( Hosp Mx)

Introduction

Recalled medication management policy is a crucial aspect of healthcare facilities to ensure patient safety and quality of care. The policy aims to outline the procedures for handling recalled medications in healthcare facilities. The Joint Commission International (JCI) and National Accreditation Board for Hospitals & Healthcare Providers (NABH) have set certain medication management standards that healthcare facilities need to adhere to. This policy aims to provide guidance for the management of recalled medications, incorporating the JCI and NABH standards.

Policy Statement:

The healthcare facility will establish and maintain a recalled medication management policy to ensure that recalled medications are identified, removed from use, and disposed of properly. This policy applies to all medications and medical devices that have been recalled by the manufacturer or regulatory authorities due to safety concerns.

Definitions:

Recalled medication - Medications or medical devices that have been recalled by the manufacturer or regulatory authorities due to safety concerns.

Recall - A notice issued by the manufacturer or regulatory authorities to withdraw or remove a product from the market due to safety concerns.

Currently, the FDA categorized recalls into three classifications:

• Class I: A dangerous or defective medication that can potentially result in severe health complications or death if administered.
• Class II: A medication that could cause a temporary or serious health problem.
• Class III: A medication that violates an FDA labeling or manufacturing law but is unlikely to result in any health reaction.

Since 2012, ~90% of drug recalls fell under Classes I and II, at 10.3% and 79.5% respectively.

 

Policy:

1. Identification of Recalled Medications:

The healthcare facility will establish a system to identify recalled medications. The system will include procedures for receiving and reviewing recall notices from manufacturers, regulatory authorities, or other reliable sources. The facility will ensure that all staff members are trained to identify and report recalled medications.

2. Removal of Recalled Medications:

Once a recalled medication has been identified, the healthcare facility will immediately remove it from use. The facility will ensure that all staff members are informed about the recall and that the recalled medication is clearly labeled and separated from other medications. The facility will maintain a log of all recalled medications removed from use, including the name of the medication, batch number, and date of removal.

3. Disposal of Recalled Medications:

The healthcare facility will dispose of recalled medications in accordance with local regulations and guidelines. The facility will ensure that all recalled medications are segregated from other medications and that they are not used or dispensed to patients. The facility will also ensure that recalled medications are not returned to the manufacturer or redistributed to other healthcare facilities or pharmacies.

4. Communication with Patients:

The healthcare facility will establish procedures to communicate with patients who have been prescribed a recalled medication. The facility will inform patients of the recall, advise them to stop taking the medication, and provide alternative treatment options. The facility will also document all communications with patients related to the recall.

5. Reporting of Recalled Medications:

The healthcare facility will report all recalled medications to the manufacturer, regulatory authorities, or other appropriate agencies. The facility will maintain a log of all reported recalls, including the name of the medication, batch number, and date of report.

Applicable Medication Management Standards:

The JCI and NABH have set certain medication management standards that healthcare facilities need to adhere to. The following are the applicable medication management standards for recalled medication management:

1. JCI Standard MM.03.01.01: The healthcare facility must establish and maintain a process for the selection, procurement, storage, distribution, and disposal of medications.
2. NABH Standard HCO MOM 4: The healthcare facility must establish and maintain a process for the management of recalled products.
3. JCI Standard MM.04.01.01: The healthcare facility must establish and maintain a process for the management of medication-related incidents and errors.
4. NABH Standard HCO 2.3: The healthcare facility must establish and maintain a process for the management of adverse events and reactions related to medications.

Medication Recall Management Standard MOM 4 as per NABH Standard

The applicable objective element of the Medication Recall Management Standard MOM 4 as per NABH Standard are as follows:

1. Policy and Procedure - The healthcare organization should have written policies and procedures for medication recall management, including the identification of recalled medications, notification of patients, and retrieval of affected medications.
2. Recall Team - The healthcare organization should establish a recall team consisting of qualified personnel responsible for identifying, evaluating, and responding to medication recalls.
3. Recall Procedure - The healthcare organization should have a documented recall procedure that outlines the steps to be taken in the event of a medication recall, including communication with suppliers, notification of patients, and retrieval of affected medications.
4. Patient Notification - The healthcare organization should establish a process for notifying patients who have received affected medications, including providing clear instructions for the return or disposal of medication.
5. Documentation - The healthcare organization should maintain documentation related to medication recalls, including the recall notice, communication with patients, and the retrieval and disposal of affected medications.
6. Evaluation - The healthcare organization should periodically evaluate its medication recall management process to identify opportunities for improvement and to ensure compliance with applicable laws and regulations.

 

How to Track and Manage Recalled Drugs

In a hospital setting, tracking and managing recalled drugs is critical to ensure patient safety. Here are some steps hospitals can take to track and manage recalled drugs effectively:

1. Develop a Recall Policy: Hospitals should have a recall policy in place that outlines the process for managing drug recalls. The policy should include procedures for identifying recalled drugs, removing them from inventory, and notifying staff and patients.
2. Identify Recalled Drugs: Hospitals should monitor FDA drug recall announcements regularly and have a system in place to identify recalled drugs quickly. This can include using software solutions that can scan barcodes or RFID tags on drug packages to check recall status.

                                                    

3. Remove Recalled Drugs from Inventory: Once a recalled drug has been identified, it must be removed from inventory immediately to prevent it from being dispensed or administered. Hospitals should have a system in place to ensure that recalled drugs are removed from all storage locations, including automated dispensing cabinets, patient care areas, and operating rooms.
4. Notify Staff and Patients: Hospitals must notify staff and patients affected by a drug recall promptly. The recall policy should outline the notification process, which may include alerts through the hospital's electronic health record system or other communication channels.
5. Dispose of Recalled Drugs Properly: Hospitals must dispose of recalled drugs properly to prevent them from being reintroduced into inventory. This may involve returning the drugs to the manufacturer or following specific disposal procedures outlined by the FDA or other regulatory agencies.
6. Implement Automated Inventory Management Solutions: Automated inventory management solutions can help hospitals track and manage drug recalls more efficiently. These systems can scan barcodes or RFID tags on drug packages to check recall status and automatically remove recalled drugs from inventory. They can also generate alerts to notify staff of drug recalls and track the disposition of recalled drugs.

                                                              

Hospitals must have effective systems and procedures in place to track and manage recalled drugs to ensure patient safety. By implementing a recall policy, monitoring FDA drug recall announcements, identifying recalled drugs quickly, removing them from inventory, notifying staff and patients, disposing of recalled drugs properly, and implementing automated inventory management solutions, hospitals can reduce the risk of recalled drugs being administered or dispensed to patients.

  

Conclusion:

In conclusion, the Medication Recall Management policy is an essential component of ensuring patient safety and quality of care in healthcare organizations. The policy should be comprehensive and address all aspects of medication recall management, including identifying and retrieving affected medications, notifying patients, and maintaining documentation. The recall team should consist of qualified personnel who are responsible for evaluating and responding to medication recalls promptly. The policy should also include a process for communicating with suppliers and regulatory agencies to ensure compliance with applicable laws and regulations. Regular evaluation and improvement of the medication recall management process can help to identify opportunities for enhancing the policy's effectiveness and promote continuous quality improvement in patient care.

 

Dr Madhav Madhusudan Singh MBBS, MHA , MBA , Ph.D

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Disclaimer: The views expressed in this text are solely the personal opinions of the author and do not represent the views of any organization or entity with which the author may be affiliated.

 

 

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