RECALLED DRUGS

There are three classes of recalls:

• Class 1 (CI): products that could cause serious harm or prove fatal

• Class 2 (CII): products found to cause a temporary health problem

  or pose a slight threat of serious harm

• Class 3 (CIII): products that may have a minor defect or other

  condition that would not harm the patient

CONTROLLED SUBSTANCES

Commonly known as narcotics, controlled substances are addictive.

They are derived from opium or opium-like substances. Opium comes

from the poppy seed plant and has analgesic effects that also affect

mood and behavior.

• Some examples of substances created from opium

  are codeine and morphine

Each type of narcotic is assigned a rating that depends on its

addictive and abuse potential.

RATINGS OF SCHEDULED (CONTROLLED) SUBSTANCES

There are five levels based on potential for abuse:

• CI - Strongest potential for abuse; no medicinal use in the USA.

  • Examples: Marijuana, LSD, Heroine, Peyote, Methamphetamine

• CII - Must be locked up because of high potential for abuse.

  • Examples: Cocaine, Ritalin, several amphetamines, dilaudid

• CIII - Has abuse potential, but not like schedule II.

  • Examples: Combinations of hydrocodone and codeine products

• CIV - Low potential for abuse.

  • Examples: Valium (diazepam), halcion (triazolam)

• CV - Has the lowest abuse potential. Consists of preparation with

  very limited amounts of controlled substance in each dose. It is kept

  OTC in some states because of low potential abuse.

  • Examples: Lamotil and some cough syrups containing codeine

The U.S. Attorney assigns the schedule for a drug. Individual states

cannot establish the schedule under which a drug should be placed.

TAMPER-PROOF PRESCRIPTIONS

New scripts have up to eight different tamper-proof

security marks on them.

• Prevents forgery and fraud

• REMS: Risk Evaluation and Mitigation Strategy

• No special prescribing requirement exists for Heroin

FORMS FOR CONTROLLED DRUG SUBSTANCES

The DEA has three main registration forms:

• Form 224: Dispensing controlled substances

• Form 225: Manufacturing or distributing controlled substances

• Form 363: To run a narcotic treatment program or compound narcotics

• Form 222: Used for the purchasing and returning of outdated CII drugs

• Form 41: Return to reverse distributor damaged, outdated or

  unwanted controlled substances

REFILLING CONTROLLED SUBSTANCES

Strict guidelines include:

• Drugs rated CIII through CV can be refilled a maximum of five times

  or within 6 months of the original order, whichever comes first

• Records must be kept with the pharmacist’s initials and

  the date the drug was dispensed

• Pharmacies must physically cont schedule II drugs every two years

ORDERING CONTROLLED SUBSTANCES

The Controlled Substance Act requires pharmacies to purchase

class-II controlled substances with DEA form 222. The pharmacy

obtains CII substances from a distributor and only one item may

be ordered per line when using DEA form 222.

• Copy 1 and 2 are sent to the supplier

  • Copy 1: (original, brown) Retained by the supplier

  • Copy 2: (first carbon copy, green) Forwarded to the DEA

• Copy 3: (second carbon copy, blue) Stays with the pharmacist (purchaser)

DEA Form 222 must be filled out with pen, typewriter, or an indelible

pencil and can be signed by the pharmacist who signed Form 224 or

the person who has been the legally designated Power of Attorney by

that pharmacist. Drugs must be checked in and an invoice stapled to

the completed DEA-222. Filing electronically is only possible for CV - CIII.

• Pharmacy retains bottom copy

Invoices and forms must be kept onsite and made readily available

for inspection for 2 years. It is recommended that records of

invoices and forms are kept for 5 years.

CONTROLLED SUBSTANCE INVENTORY

Perpetual inventory. The pharmacist must validate all counts done by a

technician. Discrepancies are investigated by the DEA. Controlled

substance inventory must be performed every 2 years.

REVERSE DISTRIBUTOR

All controlled substances that are unwanted, unusable, or outdated

that are returned to the distributor. It prevents drug diversion, or the

intentional misuse of a drug intended for medical purposes or

recreational use of a prescription or a scheduled drug.

FILLING, REFILLING, AND TRANSFERRING PRESCRIPTIONS FOR CONTROLLED DRUGS

Original fill of CII through CV:

• Written, oral, or fax

Emergency CII original fill:

• Verbal order only in emergency situations

Refills of CII through CV:

• CII - No refills

• CIII and CIV - 5 times within 6 months

• CV - No restrictions

PARTIAL FILLINGS OF CII THROUGH CV

CIII, CIV, and CV must have the remainder dispensed within 6 months.

CII must have remainder dispensed within 72 hours.

Transfer of prescriptions CII through CV may be transferred only

once. Write void on invalid prescription to inform that prescriptions

have been transferred.

Some states require Schedule V drugs to be dispensed by a pharmacist.

Controlled substances CII through CV may be mailed as long as the

contents are not identified on the packaging.

MONOGRAPHS/PACKAGE INSERTS

Contained in the Physician’s Desk Reference (PDR) in the doctor’s

office and Facts and Comparisons in the pharmacy.

Includes: Description, clinical pharmacology, indications and usage,

contraindications, warnings, precautions, drug abuse and dependence,

adverse reactions, dosage, and how its supplied. Box Warning is

also called Black Box Warning.

MedGuides: Printouts required for certain medications.

PREGNANCY CATEGORIES

FDA established five categories to identify a drug’s potential harm

to a fetus or pregnant woman.

• Category X - Not to be used during pregnancy.

  Can produce the highest degree of teratogenicity.

• Category A - No evidence of harm based on studies.

• Category B-D - Various levels of risk.

PRESCRIPTION REGULATIONS

Who can prescribe? The FDA and DEA have no

authority to determine prescribers.

• Prescribers are licensed by their individual state board

• Standard practitioners in all 50 states are physicians,

  surgeons, doctors of osteopathy, dentists, podiatrists,

  veterinarians, and optometrists

WHO CAN RECEIVE A PRESCRIPTION?

Pharmacy technicians take in prescriptions, interpret them and

fill them. Technicians cannot take phone orders. Pharmacists give

the final check and take verbal telephone orders and transfer

prescriptions to another pharmacy.

PRESCRIPTION LABELS

The information on a prescription label differs from a prescription

order. Two necessary components are pharmacy information

and patient information.

• Special labeling sometimes is required because of adverse

  effects or the possibility of teratogenicity to an unborn fetus.

• Labels Include: Name, address, and phone number of the

  pharmacy, name of prescriber and date prescription was filled;

  prescription number and precautions.

License or DEA number of the prescriber is only required for a CII drug.

REPACKAGING

Medication taken from bulk packages and placed into blister

packs or unit-dosing devices must include:

• Drug name

• Strength and dosage form

• Manufacturing and lot number

• Expiration date

DEA VERIFICATION

All prescribers must be registered with the DEA to write prescriptions

for controlled substances. Prescribers are given a nine-character

identification code, which is different for each prescriber.

• The first two characters will be the letter A, B, F, or M, followed by

  the first letter of the prescriber’s last name.

  • If the first character begins with the identifier P or R, they are typically

    from a manufacturer, distributor, researcher, analytical lab, importer,

    exporter, reverse distributor, or a narcotic treatment program.

• The next seven digits are composed of numbers added together.

All prescription orders for controlled substances must be verified for authenticity

by the pharmacist. Confirmation of a prescriber’s DEA number may aid in verifying

the authenticity of a controlled substance prescription order.

Verifying a DEA Number:

1. Add the 1st, 3rd, and 5th digits together. (SUM 1)

2. Add the 2nd, 4th, and 6th digits together, then multiply by two. (SUM 2)

3. Add SUM 1 and SUM 2 together. (SUM 3)

4. The last digit of SUM 3 should match the 7th digit of the given DEA number.

Example Number: AP5836727

1. 5 + 3 + 7 = 15

2. 8 + 6 + 2 = 16 x 2 = 32

3. 15 + 32 = 47

4. AP583672**7** = 4**7** ✓

SPECIAL PRESCRIBING PROGRAMS

Programs for opioid maintenance:

• Methadone Maintenance Treatment (MMT)

• Suboxone and Subtex

Risk management programs for prescription drugs:

• iPledge Program

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA)

MSDS is a U.S. government-managed entity that oversees safety in

the workplace. Safety Data Sheets must be available for all chemicals.

• Includes information on storage requirements, handling, and what

  to do in case of a spill or contact with the eyes.

THE JOINT COMMISSION

Their mission is to improve the safety and quality of care via the

accreditation of healthcare organizations. Areas of concern:

• How look-alike and sound-alike drugs are identified

• How communication, allergy notification, conflicting prescriptions.

  verbal orders, and other areas that may create an avenue for errors handled

LEGAL STANDARDS

State Law: differs by state

Liabilities include: negligence or tort

• Mistakes are made for many reasons

• Consider purchasing malpractice insurance

• Laws change regularly

FLASHCARDS HERE