© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Chapter 4 Comprehensive Drug Abuse and...

© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.

Chapter 4Comprehensive Drug Abuse and

Prevention Control Act:

A Closer LookJahangir Moini, MD, MPH, CPhT


Overview

• DEA established in 1973 as part of Department of Justice to enforce federal laws regarding use of illegal drugs

• Drugs or substances with potential for illegal use (and abuse) must be included in controlled substances list


Classification of Scheduled Drugs

• Drugs under jurisdiction of Controlled Substance Act (CSA) are categorized according to potential for abuse and addictiveness

• Divided into 5 schedules (Schedule I to Schedule V)


State vs. Federal Laws

• When state law conflicts with federal government’s position concerning a specific drug, stricter law takes precedence

• Discrepancies handled by contacting

closest DEA office to determine your state’s regulations and federal government’s


Schedule I

• Not accepted for medical use in U.S.

• Extremely high potential for abuse

• Examples: opiates, opium derivatives (e.g., heroin), crystal methamphetamine, hallucinogens, crack cocaine


Schedule II

• Have medical uses

• High abuse potential with severe physical or psychological dependence

• Examples: opiates and opioids (narcotics, including methadone, morphine, and oxycodone), stimulants, depressants


• Have accepted medical uses

• Less abuse potential than Schedule I and II drugs

• Examples: anabolic steroids, acetaminophen with codeine, butabarbital, other barbiturates combined with non-controlled drugs such as aspirin

Schedule III


Schedule IV

• Less abuse potential than Schedule III

• Can still lead to physical or psychological dependency

• Examples: long-acting barbiturates, certain hypnotics, minor tranquilizers (including benzodiazepines, phenobarbital, diazepam [Valium®])


Schedule V

• Lowest abuse potential

• Preparations containing limited quantities of certain narcotic drugs, generally antitussive or antidiarrheal

• Examples: cough syrups containing codeine, pseudoephedrine, analgesics


DEA Registration for Controlled Substances

• Individuals who manufacture, dispense, or distribute any controlled substance must register with DEA unless exempted

• Pharmacy registrations issued for 3 years• DEA number must be assigned to registered

manufacturers, distributors, wholesalers, and practitioners such as physicians, veterinarians, scientists, pharmacies, and hospitals


Pharmacy Registration

• All pharmacies must have valid DEA registration

• New pharmacy applicants required to complete DEA Form 224, and must renew application every 3 years

• DEA numbers may be checked for accuracy using simple mathematical calculation or online verification Web site


Registration Certificate

• Falsification of an application will result in suspension or revocation of registrationby DEA

• If applicant has previous felony conviction related to controlled substances suspended registration, or suspended state license, applicant will no longer be allowed to dispense controlled substances


Security of Personnel

• Background checks should be carried out for all potential employees who will work in proximity of controlled substances

• Interviewees must supply truthful information about past convictions, criminal charges, and illegal drug use


Regulation of Controlled Substances

• Specific CSA regulations govern record keeping, physician and pharmacy registrations, and inventory concerning controlled substances



• All scheduled drugs used in ambulatory care setting must have complete and accurate records kept concerning purchase, storage, management, and distribution

• Specific guidelines for controlled substances include:

– Most prescription forms must be written in ink or typed



– Individual states may require physical prescriptions

– Prescriptions must include date prescribed, patient’s name and address, and physician’s DEA number

– Amount prescribed should be written out to avoid using numerals which can cause errors

– Physician must physically sign every written controlled substance prescription


Ordering Controlled Substances

• DEA Form 222 used to order controlled substances from Schedules I or II

• Has been changed to single-sheet document instead of triplicate form

• Not used when ordering Schedule III, IV, or V substances


DEA Form 222 Details

• Max of 10 different items may be ordered on 1 form, with 1 item per numbered line

• DEA registrant must notate number of lines completed using a designated space

• Supplier can only ship to purchaser’s address as listed on Form 222 and

DEA certificate


e222

• Electronic version of Form 222

• Helps reduce illegal orders of controlled substances

• Identifiers are used that make it very difficult for non-authorized persons to use


Prescriptions for Controlled Substances

• Practitioner must issue prescription for a controlled substance for a valid medical purpose

• Practitioner cannot order drugs for the office using prescription pads—they must use order form or purchase order


Prescriptions for Controlled Substances

• Prescriptions for Schedule II drugs must be written, not faxed or called in, unless an absolute emergency exists


E-prescribing

• Electronic (e-)prescribing is instrumental in reducing medication errors

• Prescriptions generated electronically through automated data entry and pharmacy-linked transmission network

• System features warning/alert systems, access to medical histories, streamlined authorizations, and increased patient compliance


Filling Prescriptions for Controlled Substances

• Prescriptions for Schedule II drugs must be signed in ink, but prescription itself can be created on a computer or handwritten

• No refills allowed, but partial fillings are allowed if the portion dispensed can be used in a 7-day period

• Oral prescriptions only allowed in emergencies


Follow-up with a Written Prescription

• Pharmacist must identify physician, who must follow up with a written prescription within 72 hours

• Amount dispensed for an emergency should only be that which is necessary until the written prescription can be presented


File Systems

• All prescriptions for controlled substances must be maintained in one of the following:– A 3-file system

• 1 file for Schedule II, 1 for Schedules III–V, and 1 for all other types of prescriptions

– A 2-file system• 1 file for Schedule II, 1 for Schedules III–V

– An alternate file system• 1 file for all controlled drugs, 1 for all non-

controlled drugs


Labeling of Controlled Substances

• Federal law and state statutes regulate labeling of controlled substance prescriptions

• These orders must include:– Pharmacist’s name and address– Pharmacy name– Drug’s serial number


Labeling of Controlled Substances

– Date prescription was filled– Prescribing physician’s name– Patient’s name– Directions for use– Any cautionary statements


Container Labeling• Containers of controlled substances must

designate which schedule applies to contents

• Schedules labeled as follows:– CI or C-I– CII or C-II– CIII or C-III– CIV or C-IV– CV or C-V


Exemptions from Labeling Requirements – Schedule II Substances

• Unit doses dispensed to inpatient hospital, nursing home or other long-term care facility are exempt if:

– No more than 7-day supply dispensed– Patient does not possess the drug before he

or she can use it– Institution maintains appropriate security


– Directions for use, cautions, patient, product, and supplier identified by the pharmacist’s record-keeping system

– CSA Schedule number included on unit dose

Exemptions from Labeling Requirements – Schedule II Substances


Distribution

• Separate DEA registration needed for manufacturing, distributing, dispensing, and conducting research

• Pharmacy registered to dispense a controlled substance can distribute (without registering as a distributor) to a physician, hospital, nursing home, or another pharmacy for general dispensing


Distribution Conditions

• These distributions must meet the following conditions:– Pharmacy or practitioner to which controlled

substance is distributed must be listed– If substance is Schedule I or II, transfer must be

made using DEA Form 222


– Distribution is recorded as being distributed by pharmacy, and pharmacist or practitioner records substance as being received

– Total number of dosage units of controlled substances distributed does not exceed 5% of total dispensed during 12-month period in which pharmacy is registered

Distribution Conditions


DEA Controls

• DEA maintains strict controls concerning transfer of controlled substances

• DEA registrant receiving Schedule I or II drugs must issue a Form 222 to document the drug transfer


Record Keeping

• Any pharmacy that handles controlled substances must keep complete and accurate records of all drugs received and dispensed

• Records must be kept for 2 years, though some states require 5 years

• Schedule II drug records must be kept separately from all other records


Inventory Records

• CSA requires that, every 2 years, each registrant create a complete, accurate controlled substances stock record

• After inventorying, an exact count or measure of Schedule II substances must be made

• An “initial inventory” is a complete inventory made before a new pharmacy opens


Keeping Receipts

• DEA Form 222 is used as official form of receipt for all Schedule I and II substances

• Invoices are acceptable to use as receipts for all Schedule III–V substances

• Each type of receipt must have date item(s) were received


Receipt Information

• Receipts must contain:– Name and strength of each substance– Dosage forms– Number of dosage units– Container volumes– Number of received containers– Dates of receipt– Supplier’s name, address, and DEA number


Dispersal Record

• Records of all drugs dispensed from pharmacy and records of all drugs removed from pharmacy for any reason are considered “dispersal records”

• These include:− DEA Form 222− Invoices− Record books

− Disposal records− Theft or loss record


Returning Controlled Substances

• When controlled substances from Schedule II are returned, DEA Form 222 must be used

• These substances may only be returned from one DEA registrant to another

• Any facility that does not have a DEA number cannot return controlled substances


Dealing with Outdated Controlled Substances

• When controlled substances become out of date, DEA Form 41 must be used

• Pharmacist must write a cover letter explaining the situation and requesting DEA permission to destroy these substances

• Approval for destruction is not required from DEA if destruction is witnessed by Board of Pharmacy investigator


Theft or Loss of Controlled Substances

• DEA office nearest pharmacy must be notified if controlled substance is lost or stolen

• DEA Form 106 used, with pharmacy keeping original copy, 2 copies to DEA, and 1 copy to Board of Pharmacy or local police department

• Significant losses must be reported by phone immediately


Refilling Prescriptions for Controlled Substances

• Prescriptions for Schedule II controlled substance must not be refilled except in certain limited circumstances


Refilling Prescriptions for Controlled Substances

• Partial refills of Schedule III–V substances are permissible if each is dispensed and recorded in same manner as refilling, with total quantity not exceeding total quantity prescribed

• No dispensing can occur after 6 months past date of issue


Recording Refills

• Pharmacist must enter (on back of prescription) his or her initials, date of refill, and amount of drug dispensed after refilling any Schedule III or V substances

• Not required if using electronic data retrieval


Computerization of Refilling

• Pharmacy is allowed to use data processing system for storage and retrieval of prescription refill information for Schedule III and IV controlled substances

• System must provide immediate retrievalof original prescription information for prescriptions currently authorized for refilling


Facsimile Prescriptions

• DEA regulations permit prescriptionsfor Schedule II–V drugs via fax from practitioner directly to pharmacy

• Pharmacist must review original, signed prescriptions for Schedule II substances in most cases


Facsimile Prescriptions

• DEA allows fax of written signed prescription to be transmitted to serve as the authority for and record of dispensing of Schedule III–V substances


Storage and Security Requirements

• Except limited amounts of Schedule I substances being processed must be stored in secure cabinet

• Schedule II–V substances must be stored as above, though pharmacies can disperse them throughout non-controlled substances stock to obstruct theft or diversion


Security Measures

• The following help to ensure strict control and security concerning controlled substances:

– Electronic alarm system– Perimeter security– Self-closing and locking doors– System of key control– Controlled accessibility


DEA Inspections

• CSA specifically requires administrative search warrant for most non-consensual DEA inspections

• DEA agent must state purpose of inspection and present appropriate identification

• Pharmacy technicians should immediately refer any DEA agents to pharmacist in charge

© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Chapter 4 Comprehensive Drug Abuse and...

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Transcript of © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Chapter 4 Comprehensive Drug Abuse and...