Narcotic and other controlled substances require special handling due to their high potential for abuse, dependence, and misuse. Hospitals must follow strict legal and professional standards to manage these medications safely. Proper documentation, secure storage, accurate dispensing, and accountability are essential to prevent diversion and ensure ethical use. The pharmacy department plays a central role in maintaining compliance with drug laws and ensuring patient safety.
What Are Controlled Substances?
Controlled substances include narcotic analgesics, psychotropic drugs, sedatives, and other medications regulated under national drug control laws such as the Narcotic Drugs and Psychotropic Substances (NDPS) Act. These drugs require special protocols for procurement, storage, dispensing, and record-keeping.
Categories of Controlled Substances
- Narcotic analgesics: Morphine, fentanyl, codeine.
- Psychotropic drugs: Benzodiazepines, barbiturates.
- Schedule drugs: Drugs listed under controlled drug schedules (e.g., Schedule H1, X).
- Other restricted-use medications: Ketamine, methadone, buprenorphine.
Objectives of Controlled Substance Management
- Prevent diversion, misuse, and unauthorized access.
- Ensure controlled drugs are used only for legitimate medical purposes.
- Maintain strict regulatory compliance.
- Ensure accurate documentation and audit trails.
- Provide safe and effective patient care.
Procurement of Controlled Substances
The procurement process involves:
- Purchase only from licensed suppliers.
- Use of government-approved order forms.
- Permission from drug control authorities, when required.
- Limited quantity procurement based on hospital usage trends.
Storage Requirements
Controlled substances must be stored under high-security conditions:
- Locked cupboards with double-lock systems.
- Restricted access to authorized personnel only.
- Separate storage away from regular medications.
- Temperature-controlled storage for sensitive items.
- Continuous surveillance through CCTV or access logs.
Record-Keeping and Documentation
Accurate records are mandatory to maintain compliance. Documents include:
- Receipt registers with batch number, strength, and quantity.
- Issue registers detailing patient name, ward, and prescriber information.
- Daily logbooks to track usage.
- Stock balance sheets updated in real time.
- Audit reports and reconciliation documents.
Dispensing Procedures
Dispensing controlled drugs requires strict verification and documentation:
- Valid, written prescription containing prescriber signature, diagnosis, and dose.
- Direct dispensing to nursing staff or authorized personnel.
- Patient-specific labeling with dose and administration frequency.
- Mandatory entry of every transaction in controlled drug registers.
Administration and Monitoring
Nurses are responsible for administering the medication and documenting:
- Time of administration
- Amount administered
- Balance remaining
- Signature of administering nurse
Pharmacists and nursing supervisors regularly audit these records to ensure accuracy.
Handling of Wastage and Returns
- Expired or partially used ampoules must be documented.
- Wastage must be witnessed by two authorized staff members.
- Returned drugs must be reconciled and recorded.
- Disposal must follow authorized biomedical waste rules.
Legal & Regulatory Compliance
Hospitals must adhere to national drug control regulations, including:
- NDPS Act and Rules
- Drugs and Cosmetics Act
- State drug controller guidelines
- Hospital standard operating procedures (SOPs)
Auditing and Inspection
Regular audits help ensure compliance:
- Daily checks of stock balances.
- Monthly pharmacy audits.
- Surprise inspections by drug control authorities.
- Cross-verification with consumption records.
Role of Pharmacists
- Ensure secure storage and access control.
- Monitor consumption trends and detect irregularities.
- Maintain complete and accurate records.
- Educate staff on legal requirements and safe practices.
- Assist in audits and regulatory inspections.
- Report discrepancies promptly to administration.
Consequences of Non-Compliance
- Legal penalties and regulatory action.
- Loss of hospital license for handling controlled drugs.
- Criminal charges for diversion or misuse.
- Patient safety risks due to improper access.
Detailed Notes:
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