Controlled Substances: Review and Update

What are the daily and monthly limits on the purchase of pseudoephedrine?

3.6 grams per day and 7.5 grams per month

Prescription Drug Monitoring Program (PDMP)

A PDMP is a statewide electronic database that collects designated data about the substances dispensed throughout the state. As of 2011, 37 states have operational PDMP's that have the capacity to receive and distribute controlled substance prescription information to authorized users.

A valid DEA Number

A valid DEA number consists of 2 letters, 6 digits, and 1 check digit. The first letter is a code identifying the type of registrant. The second letter is the first letter of the registrant's last name.(e.g. AW3611577)

DEA Numbers

All prescribers of controlled substances must be registered with the DEA. When prescribers register with the DEA they are issued a unique number. This number must appear on the prescription form. All DEA numbers consists of TWO letters followed by seven single-digit numbers.

What is the Controlled Substances Ordering System?

An electronic program established by the DEA used for ordering controlled substances. CSOS allows for the secure ordering of controlled substances, without the (previously required) supporting DEA 222 form. The program is primarily used by manufacturers and distributors.

Schedule Three (C-3) Drugs: These drugs have a MODERATE potential for abuse and may lead to low or moderate dependence. These drugs are available by prescription in limited quantities.

Anabolic steroids and various compounds containing codeine are included in this schedule.

Controlled Substance Analogue

Any drug, chemical, or substance that is substantially structurally or pharmacologically similar to, or represented as being similar to a controlled substance, or is not an approved medication in the United States.

Schedule Five (C-5) Drugs: These drugs have a low potential for abuse. This group generally consists of preparations used for antitussive, antidiarrheal, and analgesic purposes. These preparations contain limited quantities of certain narcotics.

Certain compounds containing less than 200 mg/100 ml of codeine are included in this schedule. Diphenoxylate, difenoxin, pregabalin, and atropine are also included in this schedule.

CSOS

Controlled Substances Ordering System

A valid prescription for a controlled substance should include all of the following information:

Date of issue; the patients name and address; the practitioners name, address, and DEA number; the drugs name, strength, and dosage form; the quantity prescribed and directions for use; the number of refills (NOT C2), and the MANUAL signature of the prescriber

Schedule One (C-1) Drugs: Drugs, substances, or chemicals with no currently accepted medical use and a high potential for abuse. These drugs are considered Schedule Two (C-2) Drugs: These drugs have a HIGH potential for abuse and may lead to dependence. dangerous and may not be prescribed.

Examples include: Heroin, peyote, various opium derivatives, LSD, and other hallucinogenic substances.

Prescriptions for Controlled Substances

In order for a prescription for a controlled substance to be VALID, it must be issued for a legitimate medical purpose by a registered practitioner acting in the usual course of sound professional practice.

Emergency Contraceptives

In some states, pharmacists have the authority to prescribe and dispense emergency contraceptives under that states established protocol.

Manufacturers Stock Label

Manufacturers of controlled substances must clearly indicate the drug's schedule number on the stock label.

There are special record keeping requirements for controlled substances!

Manufacturers, distributors, and pharmacies are required to maintain accurate records of all controlled substance activity, including accurate records of inventory and drugs dispensed.

Can a prescription for a C-2 controlled substance be refilled?

No, prescriptions for C-2 drugs cannot be refilled. Patients are required to obtain a new prescription for each dispensing.

Benefits of the Controlled Substances Ordering System (CSOS):

Ordering Freedom, Faster Transactions, Accurate Orders, and Decreased Costs

Schedule Four (C-4) Drugs: These drugs have a low potential for abuse and a low risk of dependence.

Phenobarbital is included in this group, other examples include alprazolam, diazepam, lorazepam, and zolpidem.

These drugs have an accepted medical use and may be prescribed.

Prescriptions for drugs in this schedule may not be refilled. Some of the drugs in this schedule include cocaine, hydromorphone, meperdine, oxycodone, fentanyl, and methylphenidate.

Drug Enforcement Administration (DEA)

The Drug Enforcement Administration was established in 1973, combining the Bureau of Narcotics and Dangerous Drugs (BNDD) and Customs' drug agents.

NAMSDL

The National Alliance for Model State Drug Laws - this congressionally established commission was charged with creating a model code of laws to help states effectively address alcohol and drug abuse.

What should a Pharmacy Technician do if presented with a prescription that does not contain all of the required information?

The technician should refuse to fill the prescription.

Exempt Narcotics

These medications contain habit forming ingredients but can be sold by a pharmacist without a prescription to individuals at least eighteen years old (subject to certain rules).

The Comprehensive Drug Abuse Prevention and Control Act of 1970

This FEDERAL act, more commonly known as the Controlled Substances Act, identified five schedules of drugs (controlled substances) that have the potential for abuse and risk of dependence.

The Combat Methamphetamine Epidemic Act (CMEA)

This act set daily and monthly limits on the sale of ephedrine and pseudoephedrine (3.6 grams per day and 7.5 grams per month). The act also established reporting and record keeping requirements for pharmacies.

DEA Form 106

This form is used to report a loss or theft of a controlled substance.

DEA Form 41

This form is used when an inventory of drugs is surrendered.

DEA Form 222

This form must be used to order C-1 or C-2 substances. The forms must be completed by an authorized person- in triplicate- using an ink pen. Each form has a unique serial number

Are there any special record keeping requirements for C-2 drugs?

YES, C-2 prescription records must be kept separate from non-controlled drug records. They may however be kept with records of other schedule drugs. All records relating to C-2 drugs must be kept on hand for seven (7) years.

Are refills of other controlled substances allowed?

YES, C-III and C-IV drugs may be refilled up to five (5) times in six (6) months from the date the prescription was written.

Can a pharmacy technician verify a DEA number?

YES, add the sum of the first, third, and fifth digits to twice the sum of the second, fourth, and sixth digits. The total should be a number whose last digit is the same as the last digit of the DEA number on the prescription.

Can a prescription for a C-2 controlled substance be "telephoned" to a pharmacy?

YES, in certain emergency situations, a prescription for a C-2 medication may be telephoned to a pharmacy. In these instances, the prescriber is required to follow up with a written prescription within 7 days.

Can a practitioner provide a patient with multiple prescriptions for a single C-2 drug to be filled sequentially?

YES, it is legal for a practitioner to provide a patient with multiple prescriptions for a C-2 substance. The prescriptions must be valid (as previously defined) and each individual prescription must include the earliest date a pharmacy may fill the prescription (subject to state laws).

Can an individual be prosecuted for abusing a previously unknown substance?

Yes, a substance does not need to be listed as a controlled substance to be treated as a C-1 substance for criminal prosecution. (ex. Controlled substance analogues)