Control Substances

Controlled Drugs Study Notes

Instructor Information

  • Presenter: Dr. Fatima Balquis, Pharm. D, M. Phil

  • Position: Lecturer at Shifa Tameer-e-Millat University, Islamabad

  • Reference: Hospital Pharmacy by Nadeem Irfan Bukhari

Objective

The notes aim to cover the following areas pertaining to controlled drugs:

  • Brief history of controlled drug use

  • Definition of controlled drugs

  • Different classifications of controlled drugs

  • Prescribing controlled drugs

  • Procurement, storing, and dispensing of controlled drugs

  • Disposing of controlled drugs

History of Controlled Drug Use

  • Overview by FDA:
    The Federal Drug Administration (FDA) has been overseeing drugs in the United States since the early 20th century.

  • Pre-1970s:
    Minimal regulation existed for many drugs, resulting in dangerous substances being sold without oversight.

Developments in the 1970s

  • Emergence of significant issues related to recreational drug use.

  • 1970:

    • Release of the Controlled Substance Act (CSA) by the FDA.

  • 1989:

    • Establishment of the Narcotics Control Division (NCD).

  • 1991:

    • Formation of the Anti Narcotics Task Force (ANTF), later merged with PNCB on February 21, 1995, to form Anti Narcotics Force (ANF).

  • 2013:

    • NCD became part of the Ministry of Interior and Narcotics Control.

The Controlled Substance Act (CSA)

  • Purpose of the CSA:

    • Classifies drugs into schedules based on their risk of abuse or harm.

    • Sets laws governing manufacture, import, export, distribution, and possession of controlled substances.

    • Details consequences—including fines and prison sentences—for legal violations.

  • Regulating Agencies:

    • Drug Enforcement Administration (DEA)

    • Food and Drug Administration (FDA)

  • Drug Law of 1976:

    • Includes Schedule B, listing specific controlled substances.

  • Current Drug Law:

    • The drug law from 1997 remains applicable.

  • Inspection Policies:

    • Inspections of controlled substances by DEA/Narcotic Task Force do not require consent.

Definition of Controlled Drugs

  • Legal Definition:
    Controlled substances are specifically substances regulated by federal or state laws.

  • CSA Definition:
    A "controlled substance" refers to a drug, other substance, or immediate precursor included in schedules I, II, III, IV, or V, excluding distilled spirits, wine, malt beverages, or tobacco.

  • Criteria for Scheduling:

    • Accepted medical use in treatment

    • Potential for abuse

    • Likelihood of causing dependency when abused

Classification of Controlled Drugs

Schedule I Drugs

  • Characteristics:

    • High potential for abuse.

    • No currently accepted medical use in treatment.

    • Safety for use under medical supervision is not established.

  • Examples:

    • Heroin

    • Lysergic acid diethylamide (LSD)

    • Marijuana (Cannabis)

    • Peyote

    • Methaqualone

    • 3,4-methylenedioxymethamphetamine (Ecstasy)

Schedule II Drugs

  • Characteristics:

    • High potential for abuse with accepted medical use but under severe restrictions.

    • Abuse may lead to severe psychological or physical dependence.

  • Examples:

    • Meperidine (Demerol®)

    • Oxycodone (OxyContin®, Percocet®)

    • Fentanyl (Sublimaze®, Duragesic®)

    • Morphine, opium, and codeine

    • Amphetamine (Dexedrine®, Adderall®)

    • Hydromorphone (Dilaudid®)

    • Methadone (Dolophine®)

    • Methamphetamine (Desoxyn®)

    • Methylphenidate (Ritalin®)

    • Amobarbital, glutethimide, pentobarbital.

Schedule III Drugs

  • Characteristics:

    • Potential for abuse less than schedules I and II.

    • Accepted medical use.

    • Abuse may lead to moderate or low physical dependence or high psychological dependence.

  • Examples:

    • Combination products containing < 15 mg of hydrocodone (Vicodin®)

    • Products containing not > 90 mg of codeine (Tylenol with Codeine®)

    • Buprenorphine (Suboxone®)

    • Benzphetamine (Didrex®)

    • Phendimetrazine

    • Anabolic steroids (e.g., Depo-Testosterone).

Schedule IV Drugs

  • Characteristics:

    • Low potential for abuse compared to schedule III.

    • Accepted medical use.

    • Abuse may lead to limited physical or psychological dependence.

  • Examples:

    • Alprazolam (Xanax®)

    • Carisoprodol (Soma®)

    • Clonazepam (Klonopin®)

    • Clorazepate (Tranxene®)

    • Diazepam (Valium®)

    • Lorazepam (Ativan®)

    • Midazolam (Versed®)

    • Temazepam (Restoril®)

    • Triazolam (Halcion®)

    • Tramadol (Dolonat®).

Schedule V Drugs

  • Characteristics:

    • Low potential for abuse relative to schedule IV.

    • Accepted medical use.

    • Abuse may lead to limited physical dependence or psychological dependence.

  • Examples:

    • Cough preparations with ≤ 200 mg of codeine per 100 mL or 100 g (Robitussin AC®, Phenergan with Codeine®)

    • Ezogabine.

Prescribing Controlled Drugs

General Requirements

  • Prescriptions must include:

    • Date of issue

    • Patient's name and address

    • Practitioner's name, address, and DEA registration number

    • Drug name

    • Drug strength

    • Dosage form

    • Quantity prescribed

    • Directions for use

    • Number of refills authorized

    • Prescriber's manual signature.

Schedule-specific Guidelines:

  • Schedule I:

    • No prescriptions permitted; production quotas imposed by DEA; illegality for scientific research without authorization.

  • Schedule II:

    • Requires a written or faxed prescription from a practitioner.

    • No refills allowed; a maximum of three prescriptions can be written at once.

  • Schedule III:

    • Written or oral prescription needed.

    • Prescription cannot be refilled past 6 months after the date of issue; up to 5 refills allowed in that timeframe.

  • Schedule IV:

    • Similar to Schedule III; refills may occur up to 5 times within 6 months.

  • Schedule V:

    • Available for medical purposes only; requires a written, oral, or faxed prescription; refills as instructed by the practitioner.

Policies and Procedures for Hospital-controlled Substances

Ordering Controlled Substances

  • Head Nurse Responsibilities:

    • Using a controlled drugs form to order from pharmacy.

  • Daily Administration Form:

    • Must maintain a 24-hour record of controlled drugs for inventory and error review.

  • Monthly Controlled Drugs Report:

    • Dispensing records for each nursing unit monitored monthly.

Order Preparation and Documentation

  • Order Signatures:

    • All orders signed and typed using ink or indelible pencil.

  • Ward Stock Orders:

    • Must specify in doctor’s order sheet; new prescriptions required if not in stock.

  • PRN Orders:

    • Discouraged except under special circumstances.

Telephone and Verbal Orders

  • Telephone Orders:

    • Allowed in necessity; documented by the nurse with the physician’s name and initial, signed by the physician within 24 hours.

  • Verbal Orders:

    • Used in emergencies with the same documentation rules as telephone orders.

Procurement, Storing, and Dispensing Controlled Drugs

Procurement

  • Licensing: Must possess a DEA license and utilize a specific DEA order form for schedules I and II.

  • Record Keeping: Maintain complete and accurate records of transactions for at least 2 years.

Storing Controlled Drugs

  • Security Requirements:

    • Stored in a double-locked, secured container anchored to an immovable object.

    • Only the license holder should possess the keys; containers must not bear external labels.

Dispensing Procedures

  • Usage Limitations:

    • Ward supply exclusively for patients in the ward; not typically permitted for home use unless in emergencies.

  • Employee Restrictions: Controlled drugs cannot be dispensed to hospital employees.

  • Dispensing Outside Working Hours:

    • Requires a signed physician's prescription for emergency measures only.

Inventory Control of Controlled Drugs

Log Books

  • Authorized User Signature Log:
    Tracks all users accessing the control drug storage.

  • Unopened Container Log:
    Maintains records in numerical order by acquisition date.

  • Opened Container Log:
    Continuity from unopened log, recording transfers in sequential order.

  • Biennial Controlled Drug Inventory Form:

    • Tracks drugs kept for 2 years, updated regularly.

Administration of Controlled Drugs

  • Responsibilities of Nursing Staff:

    • Administer correct dosages while documenting usage accurately on controlled drugs administration sheets.

  • Required Information on Daily Sheets:

    • Date, amount given, patient’s full name, hospital number, dosage, and filling out inventory column for pharmacy records.

Procedure for Waste Management

  • Aliquot Drug Solutions:

    • Unused drug solution should be properly disposed of in the sink.

  • Dose Refusal or Cancellation:

    • Documented reasons for non-administration, countersigned by the head nurse.

  • Accidental Destruction:

    • Documented incident with reasons specified on a designated form.

Disposing of Controlled Drugs

  • Expired Substances:

    • Must be returned to a Reverse Distributor licensed by the DEA; marked and stored until collection.

    • Receipt must be obtained and kept with drug logs for at least 2 years.

Roles and Responsibilities of Pharmacy Department

  • Pharmacist Duties:

    • Take responsibility for purchasing, storage, accountability, and dispensing of controlled substances.

  • Systems Implementation:

    • Controlled drug loss reporting systems, nursing station drug delivery protocols, and documentation procedures.

Protocol for Drug Abuse and Diversion

  • Collaborative Efforts:

    • Define which products are included and extend the scope to employees, patients, and visitors.

    • Report and file procedures for illegal usage cases, maintaining documentation for future measures and potential involvement of law enforcement.

Conclusion and Questions

  • Closing Remarks:

    • Thank you for participation!

    • Open for any questions regarding the materials presented.