Controlled DrugsDARYA OSMAN HUSSEIN DAOUD

Objective

Brief History of controlled drug use Define Controlled Drugs Different classifications of controlled drugs Prescribing of controlled drugs Procurement, Storing and Dispensing of controlled drugs Disposing of controlled drugs

History

The FDA has been overseeing drugs in the US since the beginning of the 20th century

Before the 1970’s there were very little if any laws on the use and control of many drugs

This meant many dangerous drugs were sold without any control

History Cont.

During the 1970s recreational drug use began becoming a huge problem in the USA

President Nixon recognized this as a problem and encouraged his administration to act on this issue

In 1970 the FDA released the Controlled Substance Act (CSA)

The CSA

This act contains “schedules” which are classifications of drugs based on risk of abuse or harm

It contains laws on the manufacture, import, export, distribution and possession of controlled substances

It also contains the fines and prison terms for violations of the laws

Controlled drugs

“Controlled substance” is a legal term referring specifically to substances controlled by federal or state laws.

CSA Definition: The term "controlled substance" means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V …… The term does not include distilled spirits, wine, malt beverages, or tobacco,….”

Substances are placed in their respective schedules based on: Whether they have a currently accepted medical use in treatment in the United States, Their relative abuse potential, and Likelihood of causing dependence when abused.

Classification: Schedule I drugs

Drugs or other substance with high potential for abuse

Have no currently accepted medical use in treatment

Lack of accepted safety for use of the drug or other substance under medical supervision

Classification: Schedule I drugs

Examples Heroin lysergic acid diethylamide (LSD) marijuana (cannabis) Peyote methaqualone 3,4-

methylenedioxymethamphetamine (“Ecstasy”).

Classification: Schedule II Drugs

Drug or other substances has high potential for abuse

Has currently accepted medical use in treatment in the USA with severe restrictions

Abuse of drug or other substances may lead to severe psychological or physical dependence

Classification: Schedule II Drugs

Examples hydromorphone

(Dilaudid®) methadone

(Dolophine®) meperidine (Demerol®) oxycodone (OxyContin®,

Percocet®), fentanyl (Sublimaze®,

Duragesic®).  morphine, opium, and

codeine

amphetamine (Dexedrine®, Adderall®),

methamphetamine (Desoxyn®)

methylphenidate (Ritalin®).

Amobarbital Glutethimide pentobarbital.

Classification: Schedule III Drugs

Drug or substance has a potential for abuse less than those in schedule I and II

Drug or substance has currently accepted medical use in the USA

Abuse of drug or substance may lead to moderate or low physical dependence or high psychological dependence

Classification: Schedule III Drugs

Examples combination products containing less than 15

milligrams of hydrocodone per dosage unit (Vicodin®)

products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with Codeine®)

buprenorphine (Suboxone®). benzphetamine (Didrex®) phendimetrazine anabolicsteroids such as Depo®-Testosterone.

Classification: Schedule IV Drugs

Drug or other substance has a low potential for abuse relative to those in schedule III

Drug or substance has currently accepted medical use in treatment in the USA

Abuse of may lead to limited physical dependence or psychological dependence relative to schedule III drug

Classification: Schedule IV Drugs

Examples alprazolam (Xanax®) carisoprodol (Soma®) clonazepam (Klonopin®) clorazepate (Tranxene®) diazepam (Valium®) lorazepam (Ativan®) midazolam (Versed®) temazepam (Restoril®) triazolam (Halcion®).

Classification: Schedule V Drugs

Drug or other substance has a low potential for abuse relative to schedule IV substances

Drug or substance has currently accepted medical use

Abuse of drug or substance may lead to limited physical dependence or psychological dependence relative to schedule IV drugs

Includes primarily preparations containing limited quantities of certain narcotics

Classification: Schedule V Drugs

Examples cough preparations containing not more than 200

milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, Phenergan with Codeine®), and ezogabine.

Controlled Drug Prescription • 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 (if any)

authorized; and• Manual signature of prescriber.

Prescribing: Schedule I

No prescriptions allowed

They are also subject to production quotas which the DEA imposes

It is illegal (a class 1 felony) even to conduct otherwise legitimate scientific research of any kind of schedule I substance

Prescribing: Schedule II

Must have a written (can also be faxed) prescription from a practitioner

There is no refilling of prescription but can write max. of 3 prescription when refill is required

Prescribing: Schedule III

Requires a written or oral prescription

Can not be filled or refilled more than 6 months after date

Max. number of refills is 5 in 6 month period

Prescribing: Schedule IV

Similar to schedule III

May be refilled up to 5 times within a six-month period

Prescribing: Schedule V

Must be distributed or dispensed for medical purpose only

Requires a written, oral or faxed prescription from a practitioner

Can be refilled as instructed by practitioner

Procurement of Controlled Drugs

Must have a DEA license

Must use special DEA order form (for schedule I and II)

Must be shipped to address on licence and once received become the responsibility of the licence holder

Shipments must be insured against theft and damage

CD Order Form ExampleForm contains detailed information about drug, supplier and receiver

Schedule I and II drugs must be ordered separately from schedule III, IV and V drugs

Storing of Controlled Drugs

Must be stored in a double locked, secured container

Box must be secured to an immovable object

Licence holder should have possession of storage box keys

There should be no label on the outside

Dispensing and Inventory Control of Controlled Drugs A log book is maintained for each drug

Log book includes Authorized users signature log Unopened container log Opened container log

One log book should be maintained for all drugs

Authorized User Signature Log• Records all users

accessing the CD storage cabinet

Unopened Container Log• Each drug must have its

own log

• Reordered in numerical order according to date acquired

• Containers moved from unopened to opened log must be recorded

Opened Container Log• Continuous from

unopened container log

• Objects moved from unopened to opened container in sequential order

• Must have same record number in both log books

Biennial CD Inventory Form• Used to track all drugs

• Kept for a 2 year period

• Must be updated frequently

Disposing of Controlled Drugs

All expired or unused controlled substances must be turned over to a Reverse Distributor licensed by the DEA.

If you have expired controlled substances, mark them accordingly and store them in the controlled substances cabinet until they can be relinquished to the reverse distributor.

You will get a receipt for your controlled substances. Record this in your drug logs (opened or unopened container).

Keep the receipt in a notebook with your order packing slips/invoices for at least 2 years

Questions?

Thank you!