(SOP) Handling of Narcotic Drugs and Psychotropic Substances (NDPS)..

  

 

Standard Operating Procedure (SOP)

Handling of Narcotic Drugs and Psychotropic Substances (NDPS) – Hospital Pharmacy

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1. Purpose

To ensure safe, legal, secure, and controlled handling of narcotic drugs and psychotropic substances in the hospital pharmacy in compliance with applicable laws, regulations, and patient safety standards.

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2. Scope

This SOP applies to all narcotic drugs and psychotropic substances stored, dispensed, administered, returned, or disposed of by the Hospital Pharmacy, including OPD, IPD, ICU, OT, and Emergency services.

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3. Responsibility

• Hospital Management: Ensuring compliance with legal requirements
• Pharmacy Manager / Chief Pharmacist: Overall control, supervision, and accountability
• Authorized Pharmacists: Procurement, storage, dispensing, and record keeping
• Nursing Staff / Medical Officers: Administration and documentation
• Quality / Audit Team: Periodic audit and compliance monitoring

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4. Definitions

• Narcotic Drugs and Psychotropic Substances (NDPS): Medicines regulated under the NDPS Act and relevant drug rules
• Authorized Person: Pharmacist or staff officially designated to handle NDPS
• Controlled Drug Register: Mandatory record for NDPS transactions

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5. Procedure

5.1 Authorization

• Only licensed hospitals and authorized pharmacists shall handle NDPS
• Authorization shall be documented and approved by Hospital Management
• The list of authorized staff shall be displayed or maintained in pharmacy records

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5.2 Procurement

• NDPS shall be procured only from licensed and approved suppliers
• Purchase shall be against:
• Valid purchase order
• Supplier invoice
• Quantities received shall be verified and recorded immediately

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5.3 Receipt and Verification

• Received NDPS shall be checked for:
• Drug name, strength, and quantity
• Batch number and expiry date
• Integrity of packaging
• Entries shall be made on the same day in the Narcotic Drug Register
• Receipt shall be countersigned by an authorized pharmacist

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5.4 Storage

• NDPS shall be stored:
• In a separate, locked cupboard or safe
• With restricted access
• Keys shall be held only by authorized personnel
• Temperature-sensitive NDPS shall be stored as per the manufacturer's instructions

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5.5 Prescription and Dispensing

• NDPS shall be dispensed only against a valid prescription by a registered medical practitioner
• Prescription must include:
• Patient name and identification details
• Drug name, strength, dosage, and duration
• Prescriber’s name, signature, and registration number
• Quantity dispensed shall be recorded immediately in the NDPS register
• Balance stock shall be updated after each issue

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5.6 Inpatient (IPD) and Ward Issue

• NDPS issued to wards shall be:
• Against authorized indent
• Recorded in the ward NDPS register
• Ward stock shall be checked daily by nursing staff
• The pharmacy shall reconcile ward stock regularly

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5.7 Administration and Return

• Administration shall be documented in patient medication charts
• Unused or partially used NDPS shall be:
• Returned to the pharmacy
• Recorded in the register
• Wastage shall be documented and witnessed

5.8 Record Keeping

• A separateNarcotic Drug Register shall be maintained for each drug
• Registers shall include:
• Date
• Quantity received/issued
• Patient/ward details
• Balance stock
• Signature of authorized person
• Registers shall be maintained daily without delay

5.9 Stock Verification and Reconciliation

• Physical stock shall be verified:
• Daily (shift-wise or end of day)
• During audits
• Any discrepancy shall be reported immediately to the Pharmacy Manager and Hospital Management

5.10 Expired, Damaged, or Unusable NDPS

• Expired or damaged NDPS shall be:
• Segregated and labeled
• Stored securely until disposal
• Disposal shall be done:
• As per legal requirements
• With proper documentation and witnessing

5.11 Loss, Theft, or Diversion

• Any loss, theft, or suspected diversion shall be:
• Reported immediately
• Investigated
• Documented
• Authorities shall be informed as per legal requirements

6. Training

• All authorized staff shall receive:
• Initial training
• Periodic refresher training
• Training records shall be maintained

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7. Audit and Monitoring

• Regular internal audits shall be conducted
• Non-compliance shall lead to corrective and preventive actions (CAPA)

8. Record Retention

• NDPS records shall be retained for a minimum of 5 years or as per law
• Records shall be available for inspection by regulatory authorities

9. References

• NDPS Act and Rules
• Drugs and Cosmetics Act & Rules
• NABH Standards for Pharmacy Services
• Hospital Pharmacy Policy

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10. Approval

• Prepared by: __________________
• Reviewed by: __________________
• Approved by: __________________
• Effective Date: ________________
• Review Date: __________________