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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!