Prescription Medications: Controlled Substances: Overview

Objectives

Upon completion of this module, the pharmacy technician should be able to do the following.

  • Differentiate among the various controlled substance Schedules.
  • Follow rules when dispensing controlled substance medications, including regulations governing refills, partial refills, and transfers.
  • Identify components of Drug Enforcement Administration (DEA) numbers and recordkeeping requirements for controlled substances.
  • Identify techniques and procedures for recognizing and preventing diversion of controlled substances.
  • Recognize ways to identify and respond to substance use disorder in patients and colleagues.

Controlled substance Schedules

The DEA regulates controlled substances at a national level. Each state also regulates controlled substances through state boards of pharmacy or another state agency.

If regulations governing Scheduled drugs in your state differ from the federal regulations, follow the stricter regulations.

Controlled substances are classified by federal law into five Schedules. The following Schedules are referred to in one of two ways.

  • Schedule I or C-I
  • Schedule II or C-II
  • Schedule III or C-III
  • Schedule IV or C-IV
  • Schedule V or C-V

Controlled substance classification

Schedule I (C-I) drugs have a high potential for abuse, have no currently accepted medical use in the U.S., and are unsafe for use under medical supervision. These products are not found in pharmacy departments.

Schedule II (C-II) medications have a currently accepted medical use in the U.S. and a high potential for abuse and physical or psychological dependence.

Schedule III (C-III) medications have an abuse potential less than that of the medications listed in Schedules I and II. Abuse of these medications can lead to moderate or low physical dependence or high psychological dependence.

Schedule IV (C-IV) medications have less potential for abuse than Schedule I, II, or III medications. Abuse of these medications may lead to only a limited physical or psychological dependence.

Schedule V (C-V) medications have low potential for abuse and limited physical or psychological dependence. Schedule V drugs are any compound, mixture, or preparation containing a limited amount of a controlled substance in combination with noncontrolled active ingredients. These products are generally used as cough suppressants or antidiarrheals.

Controlled substance comparison

The following table summarizes dispensing regulations for Scheduled and noncontrolled substances. Details will be covered in later lessons of this module.

Controlled substance Schedule I through V and noncontrolled prescription comparison1

Refills

Partial refills

Storage

Prescription needed

Stocked

Schedule I (C-I)

No

Schedule II (C-II)

None

Remainder must be dispensed within 72 hours or prescription is void.

Locked safe

Yes

Yes

Schedule III (C-III)

No more than 5 times (or 6 months from date the prescription was written if indicated on the original prescription)

Remainder must be dispensed before prescription expires if refills were indicated on the original prescription.

Regular stock

Yes

Yes

Schedule IV (C-IV)

No more than 5 times (or 6 months from the date the prescription was written if indicated on the original prescription)

Remainder must be dispensed before prescription expires if refills were indicated on the original prescription.

Regular stock

Yes

Yes

Schedule V (C-V)

Varies by state and medication2

Remainder must be dispensed before prescription expires if refills were indicated on the original prescription.

Regular stock

No3

Yes

Noncontrolled legend prescriptions4

As indicated on original prescription and varies by state (Generally, prescriptions written with refills as needed are valid for 1 year from date the prescription was written.)

Remainder must be dispensed before prescription expires.

Regular stock

Yes

Yes

Listed below are common controlled substances and their respective Schedules that the pharmacy technician should be familiar with.

Examples of controlled substances

Schedules

Common controlled substances

Schedule I

  • Heroin
  • LSD
  • MDMA (Ecstasy)
  • Peyote
  • Phencyclidine (PCP)

Schedule II

  • Amphetamine-dextroamphetamine (Adderall)
  • Cocaine (Although cocaine is most often considered a street drug, it has medical uses as a topical anesthetic and as a tincture to stop bleeding.)
  • Codeine
  • Dextroamphetamine (Dexedrine)
  • Fentanyl (Actiq, Duragesic)
  • Hydrocodone-APAP (Lortab, Vicodin)
  • Hydromorphone (Dilaudid)
  • Meperidine (Demerol)
  • Methadone (Methadose, Dolophine)
  • Methylphenidate (Ritalin, Metadate CD or ER, Concerta, Daytrana)
  • Morphine (MS Contin)
  • Oxycodone ER (OxyContin)
  • Oxycodone-acetaminophen (Percocet)
  • Oxycodone-aspirin (Percodan)

Schedule III

  • Acetaminophen-codeine (Tylenol with codeine)
  • Benzphetamine (Didrex)
  • Butabarbital (Butisol)
  • Dronabinol (Marinol)
  • Hydrocodone-homatropine (Hydromet)
  • Oxandrolone (Oxandrin)
  • Testosterone (Striant)

Schedule IV

  • Alprazolam (Xanax)
  • Chlordiazepoxide (Librium)
  • Clonazepam (Klonopin)
  • Clorazepate (Tranxene T-Tab)
  • Diazepam (Valium)
  • Eszopiclone (Lunesta)
  • Flurazepam (Dalmane)
  • Lorazepam (Ativan)
  • Midazolam (Versed)
  • Modafinil (Provigil)
  • Pentazocine (Talwin)
  • Phentermine (Adipex-P, Pro-fast)
  • Phenobarbital
  • Temazepam (Restoril)
  • Triazolam (Halcion)
  • Zaleplon (Sonata)
  • Zolpidem (Ambien)

Schedule V

  • Diphenoxylate-atropine (Lomotil)
  • Guaifenesin-codeine (Robitussin AC)
  • Pregabalin (Lyrica)
  • Schedule II
  • Schedule III
  • Schedule IV
  • Schedule V
  • The state board of pharmacy
  • The Drug Enforcement Administration
  • The Food and Drug Administration
  • The National Association of Boards of Pharmacy
  • The National Institute on Drug Abuse
  • Schedule V
  • Schedule IV
  • Schedule III
  • Schedule II
  • 0 refills
  • 1 refill
  • 5 refills
  • 6 refills
  • Summary

    Whereas the DEA regulates controlled substances on a national level, each state has its own regulations governing dispensing of drugs that are classified according to their level of abuse potential. Controlled substances are divided into five categories based on their potential for abuse.

    • Schedule I or C-I
    • Schedule II or C-II
    • Schedule III or C-III
    • Schedule IV or C-IV
    • Schedule V or C-V

    For each of these categories, there are stipulations on the number of refills, storage and transfer, and how prescriptions are accepted. The higher the category, the stricter the requirements for dispensing and a written prescription is required for each refill. It is vital the pharmacy technician recognizes each category and the medications that fall under it.

    Dispensing controlled substances

    In addition to classifying controlled substances and medications, the DEA and each state board also regulate how controlled substances and medications are dispensed.

    Proper labeling of Schedule medications

    The Controlled Substance Act requires the following statement be placed on the container for all prescribed controlled substances: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” This warning statement makes it illegal for an individual to give another individual any of their controlled substance medication. This statement may be on an auxiliary label similar to the one shown here. Sometimes it is preprinted on the prescription label.

    Schedule I

    Schedule I substances are never stocked in pharmacies. It is illegal in the U.S. to possess these substances. Marijuana is classified as a Schedule I controlled substance by the DEA. However, many states have legalized medical marijuana and several have legalized marijuana for recreational use. In those states where medical marijuana has been legalized, a physician is not permitted by law to prescribe it, but rather they may recommend it to the patient. Medical marijuana is purchased in a dispensary, not a pharmacy.

    Schedule II

    Prescriptions for Schedule II medications are highly regulated. Schedule II medications are only dispensed on written prescriptions personally signed by the prescribers or electronically prescribed where allowed. They must contain the full name and address of the patient, the date of issue, and the medication information.

    At the federal level, the DEA permits, but does not require, a prescriber to send a prescription for a Schedule II medication electronically to the pharmacy. Additionally, federal law allows a fax to serve as the original written prescription for long-term care residents or for hospice patients.

    Most states provide further specification as to how Schedule II prescriptions may be written and transmitted to pharmacies. In most states, these prescriptions must be on physical paper and personally signed by the physician. In others, they must be submitted electronically. Some states do not allow prescriptions for Schedule II drugs to be faxed. Others allow Schedule II prescriptions for parenteral use by a home infusion pharmacy to be faxed. Ask your pharmacist supervisor about the specific regulations of your state.

    Some states have additional regulations such as writing the quantity in words as well as numbers, making duplicate or triplicate copies of the prescription, and limiting the time during which the prescription may be dispensed. In the case of duplicate and triplicate forms, a copy of each Schedule II prescription must be sent to the appropriate state or government agency, usually each month. When the prescription has been dispensed, the pharmacist usually cancels the prescription form by drawing a line across its face, dating, and signing or initialing the prescription form.

    Depending on your state’s policy, you may need to confirm the patient’s identity when dispensing Schedule II drugs. Ask to see a driver’s license or ask the patient to sign the prescription form. Some pharmacy department policies require pharmacists to call prescribers to confirm orders for Schedule II drugs.

    Sometimes, only a limited amount of a Schedule II medication may be dispensed to patients. For example, some states only allow a 1-month supply to be dispensed. Check with a pharmacist about your state’s rules and regulations.

    The Comprehensive Addiction and Recovery Act

    The Comprehensive Addiction and Recovery Act (CARA) was signed into federal law in 2016 in response to the growing opioid epidemic in the United States. To support a targeted approach to dealing with the opioid crisis, CARA covers six key areas including prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal. CARA has numerous provisions including the launch of an evidence-based opioid treatment best practices, expansion of access to opioid overdose reversal medications, increases in educational efforts for the prevention of substance use disorder and to promote treatment options, and expansion of medication disposal sites. The provisions of CARA depend on individual states passing similar language.

    Refills, partial fills, storage, and ordering

    Refills

    Schedule II medications may not be refilled under any circumstances. If a patient requires more medication, the prescriber must write a new prescription.

    Partial fills

    Because pharmacy departments may stock only small amounts of Schedule II medications, you may only be able to partially fill these prescriptions. If this happens, a pharmacist must note the partial quantity dispensed on the face of the prescription order. A new supply of the medication must be ordered, and the remainder of the prescription must be filled within 72 hours of the partial filling. CARA permits partial fills, so long as the balance of the prescription is not filled past 30 days after the date of the original prescription.

    Pharmacists may also transfer the required quantity from another pharmacy using a government-issued Schedule II DEA order form (DEA Form 222), provided that the appropriate recordkeeping is completed. If your pharmacy fails to fill the balance of the prescription within the time limit (72 hours), a pharmacist must call the prescriber to request a new prescription. Federal regulations allow exceptions to these restrictions for patients in a long-term care facility or for patients who have a terminal illness. Check with your pharmacist supervisor about the requirements for partial filling of Schedule II medications.

    Emergency prescriptions

    In some states, prescriptions for Schedule II medications may be phoned in by prescribers in an emergency. Verbal prescriptions for Schedule II medications can only be received by a pharmacist, and it is the pharmacist’s responsibility to ensure that phoned-in prescriptions are legitimate.

    In such cases, only the amount needed to treat the patient during the emergency may be dispensed. Prescribers are required to furnish the pharmacy with a written, signed prescription order for the emergency dispensing within 7 days. However, some states may have more stringent regulations involving emergency prescriptions for these medications. Check with your pharmacist about the requirements in your state.

    Storage

    Federal regulations require Schedule II medications be stored so they are difficult to divert. There are many ways to do this, and acceptable methods of storage differ from state to state. The most secure method is to keep Schedule II drugs in a locked safe. A locked cabinet is also acceptable in some states. Many states allow pharmacy departments to dispense Schedule II medications with their regular stock. Check with a pharmacist about your pharmacy department’s method of complying with the law.

    Ordering

    All Schedule II medication orders and invoices must be maintained separately. Any order for a Schedule II medication must be placed on a DEA Form 222 or electronically using the DEA’s Controlled Substance Ordering System. All transfers of Schedule II drugs between pharmacy departments must be recorded on this form. These medication records are kept separately so they can be tracked easily.

    A pharmacy will have only one individual designated with a power of attorney to order Schedule II medications. Usually, it is the designated pharmacist in charge of the pharmacy. Typically, the pharmacist will fill out, sign, and date the form on the day the pharmacy department places the order. When the Schedule II order arrives, the pharmacist will check that the quantity and amounts ordered match those received, and log them on the order form.

    Perpetual inventory

    Some states require a perpetual (constant) inventory of Schedule II medications. Many pharmacy departments choose to keep a perpetual inventory, even when not required by law. This running inventory record immediately informs pharmacists if controlled substances are missing or unaccounted for. The perpetual inventory shows when Schedule II medications are added to stock, when and how much medication is removed from stock bottles to fill prescriptions, and the amount of product remaining in the stock bottles. Often, the pharmacy computer is used to automatically calculate these transactions.

    Most state boards of pharmacy require all pharmacies that dispense controlled substances to participate in prescription drug monitoring programs. These programs require the pharmacy to report all controlled substances dispensed during the month. The programs are also used to review medication information prior to prescribing and dispensing to a patient. Information collected on patients includes the number of controlled substance prescriptions written, the number of providers used, and the number of pharmacies used. Together these can identify potential drug-seeking or substance use disorder issues in a patient.

    DEA rules and regulations require a separate, manual inventory be conducted every 2 years to track all controlled substances. Federal law requires a manual inventory of all controlled substances be conducted when there is a change in the pharmacist in charge of the pharmacy. Inventories can also be taken more often than required by law.

    Schedule III, IV, and V

    Schedule III and IV prescriptions

    Written, faxed (if allowed by your state), verbal, and electronic prescription orders are permissible for Schedule III, IV, and V medications. Prescriptions for these substances may be refilled up to five times within 6 months after the prescription’s date of issue, if authorized by the prescriber.

    Schedule V

    Whenever a prescription is not required for the sale of a Schedule V medication, such as an exempt narcotic, the purchaser and the dispenser must sign the Schedule V records log. The following information must be provided in a bound Schedule V records log.

    • Dispensing date and time
    • Name of the product dispensed
    • Quantity dispensed
    • Name, signature, and address of the purchaser
    • Pharmacist’s signature

    Some of the regulations regarding the dispensing of Schedule V medications are as follows.

    • Only pharmacists can authorize the sale of nonprescription Schedule V medications. However, pharmacy technicians and department clerks can complete the cash or credit transaction or deliver the product.
    • The purchaser must be at least 18 years old.
    • In most cases, Schedule V cough medicines are limited to 4 ounces per patient within a 48-hr period. Products containing opium for the control of diarrhea are limited to 8 ounces per patient within a 48-hr period.
    • When pharmacists are not familiar with patients, they must ask for identification.
    • Ask a pharmacist if your state has additional restrictions on the sale of Schedule V medications.

    Some states do not allow the sale of Schedule V medications without a prescription. In these states, patients have to present a prescription to obtain the medication.

    Pseudoephedrine policy

    The Combat Methamphetamine Epidemic Act of 2005 classified pseudoephedrine, ephedrine, and phenylpropanolamine as Scheduled Listed Chemical Product (SLCPs). Medications containing these products are subject to sales restrictions, storage requirements, and recordkeeping requirements. The federal law only applies to over-the-counter products, not prescription medications. If your state has requirements that are stricter than the federal act, the stronger requirements take precedence. Be sure to ask your pharmacist supervisor about the requirements in your state.

    The law creates a sales limit of 3.6 g per day and 9 g per month to a single patient. A mobile seller is a person who makes sales at a stand that is intended to be temporary, such as a kiosk. These mobile sellers are allowed to sell 7.5 g per month per customer. The law also requires pharmacies to maintain a records log. This log must contain the product name, quantity sold, names and addresses of the purchasers, and dates and times of the sales. The purchaser must present a photo ID prior to all sales.

    Maintaining a records log may not be necessary if a patient purchases a product with a very small amount of an SLCP included. Each pharmacy selling SLCPs must be self-certified each year through the DEA’s Diversion website. Documentation from the self-certification must be maintained at the pharmacy.

    Partial fills

    If your pharmacy department does not have enough of a Schedule III, IV, or V medication in stock to completely fill a prescription, you may partially fill the order according to the following guidelines.

    • The partial filling must be recorded in the same manner as a refill.
    • The total quantity dispensed in all partial fillings cannot exceed the total quantity prescribed.
    • The medication may not be dispensed after the prescription expires (6 months after the date of issue).

    Transfers to another pharmacy

    In some cases, pharmacists may transfer a Schedule III, IV, or V prescription from one pharmacy to another. A controlled substance prescription may be transferred only one time by the pharmacy receiving the original prescription. After transferring the prescription, the receiving pharmacy is not permitted by law to transfer it to another pharmacy. Some state boards of pharmacy permit a pharmacy technician to transfer a prescription. Therefore, the pharmacy technician must be familiar with their state’s regulations. When in doubt, ask the pharmacist.

    Initiating the transfer

    For all transferred prescriptions, there are several steps a pharmacist must take as outlined by the DEA. The pharmacist must write the word VOID on the face of the original prescription that is being transferred. On the reverse of the transferred prescription, the following information must be noted.

    • The name, address, and DEA registration number of the pharmacy receiving the prescription
    • The name of the pharmacist receiving the prescription
    • The name of the pharmacist transferring the prescription
    • The date of the transfer

    All of this information must be added to the prescription record in the case of electronic prescriptions. After the prescription has been transferred to another pharmacy department, the pharmacist will make a note in the computer that the prescription has been transferred.

    Receiving the transferred prescription

    The word TRANSFER must be written on the prescription by the pharmacist receiving the transferred prescription. This applies to all prescriptions. The following information should be included on the prescription by the receiving pharmacist.

    • The date of issuance of the original prescription
    • The number of refills authorized on the original prescription
    • The date of original dispensing
    • The number of valid refills remaining and dates and locations of previous refills
    • The name, address, DEA registration number, and prescription number from the pharmacy that transferred the prescription
    • The name of the pharmacist who transferred the prescription
    • The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription

    Some states require the pharmacy to receive new prescriptions from physicians and do not allow dispensing from a copy of a prescription transferred from another pharmacy.

    Electronic transfers

    When transferring a prescription electronically, the transferring pharmacist must provide the receiving pharmacist with the following information in addition to the original electronic prescription data.

    • The date of original dispensing
    • The number of refills remaining and the dates and locations of previous refills
    • The transferring pharmacy’s name, address, DEA registration number, and prescription number for each dispensing
    • The name of the pharmacist transferring the prescription
    • The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different

    The pharmacist receiving a transferred electronic prescription must create an electronic record with the receiving pharmacist’s name and all the information transferred with the prescription (listed above). The original and transferred prescription(s) must be maintained for a period of 2 years from the date of last refill.

    If the transfer involves a Schedule II medication being transferred to another pharmacy in need of the medication, the official DEA Form 222 must be completed. This form is completed in triplicate. One copy is sent to the DEA, one copy is retained by the supplier, and one copy is retained by the receiver.

  • Dispensing date
  • Dispensing time
  • Purchaser’s name
  • Purchaser’s date of birth
  • Pharmacist’s signature
  • Pharmacy technician’s signature
  • Schedule I
  • Schedule II
  • Schedule III
  • Schedule IV
  • Schedule V
  • Schedule I
  • Schedule II
  • Schedule III
  • Schedule IV
  • Schedule V
  • The partial filling must be recorded in the same manner as a refill.
  • The DEA registration number must be recorded.
  • The patient must sign the Scheduled listed chemical product records log.
  • The total quantity dispensed in all partial fillings cannot exceed the total quantity prescribed.
  • The medication must not be dispensed after the prescription expires.
  • The word VOID must be written on the face of the invalidated prescription
  • The name and address of the pharmacy to which the prescription was transferred
  • The DEA registration number of the pharmacy to which the prescription was transferred
  • The name of the pharmacist receiving the prescription information
  • The number of refills remaining on the transferred prescription
  • The date of the transfer and the name of the pharmacist transferring information
  • Summary

    Controlled substance dispensing regulations set forth by the DEA and state boards vary by drug Schedule. These regulations affect refills, partial fills, storage, inventory, and ordering. Given the pharmacy technician’s central role in processing prescriptions and managing inventory, and because dispensing regulations vary from state to state, it is essential that the technician fully understand both their state and federal regulations to support appropriate medication management and compliance with the law. If the state regulations differ from federal laws, the technician should always follow the stricter regulations.

    Because Schedule II medications have the highest potential for abuse among Scheduled medications that are legal to dispense, they have the strictest regulations. Below are some examples of regulations that are unique to Schedule II medications.

    • Refills are not allowed
    • States may require Schedule II prescriptions to be handwritten
    • Schedule II medications must be stored in locked safes

    Schedule III and IV prescriptions have fewer restrictions, and in some states, Schedule V medications do not require a prescription. Schedule III, IV, and V medications may be transferred to another pharmacy following specific regulations set forth by both the DEA and the state.

    DEA numbers, recordkeeping, and destruction of controlled substances

    Well-organized prescription files not only make verifying prescription information easy, but also prepare you for audits. Your pharmacy department files could be inspected by a representative of the state board of pharmacy or by the DEA. The DEA focuses its attention on records for controlled substances. Making sure prescriptions for controlled substances meet all DEA requirements requires an understanding of DEA numbers and DEA regulations. Records must also be kept when any controlled substances must be destroyed.

    DEA numbers

    In addition to the standard information required for any prescription, prescription forms for controlled substances require the prescriber’s DEA number. The forms must contain the prescriber’s full name, complete address (street number, street name, suite number, city, state, and ZIP code) and DEA number. The forms must also contain the patient’s full name and complete address.

    Counterfeit DEA numbers on forged prescriptions can be detected using the formula that the DEA created to generate DEA numbers. DEA numbers are composed of two letters followed by seven digits.

    The first letter indicates the type of registrant.

    • A indicates the practitioner had a DEA number prior to 1985.
    • B and F are for DEA numbers registered after 1985.
    • M is reserved for midlevel practitioners, such as a physician’s assistant or nurse practitioner within scope of practice.
    • X is assigned to practitioners in a buprenorphine- and naloxone-prescribing program.

    The second letter in the DEA number matches the first letter of the prescriber’s last name. There are some exceptions. For example, a physician who changes their last name may retain an old DEA number.

    The seven digits provide a means of numerically validating the DEA number. This is done by adding the first, third, and fifth digits. Next, add the second, fourth, and sixth digits, and multiply the sum by two. Finally, add the results of the first two steps. The last digit of this sum should be the same as the seventh digit of the DEA number.

    DEA number examples

    Dr. Smith has the DEA number AS4967432

    AS4967432

    The first letter A meets the condition that the first letter must be an A, B, F, M or X.

    AS4967432

    The second letter S is the first letter of the last name Smith.

    AS4967432

    The sum of the first, third, and fifth numbers is: 4 + 6 + 4 = 14.

    AS4967432

    The product of the sum of the second, fourth, and sixth numbers is: 9 + 7 + 3 = 19. And 19 × 2 = 38.

    AS4967432

    The sum of the previous results is 14 + 38 = 52. The last digit matches the last digit of the DEA number, which means the number is legitimate.

    A practitioner (intern, resident, staff physician, or midlevel practitioner) working in a hospital may use the hospital’s DEA number followed by an internal code issued by the hospital.

    Recordkeeping for controlled substances

    After a prescription has been filled and checked by the pharmacist, the pharmacy technician may be asked to file the filled prescription. A pharmacy technician must be familiar with how the pharmacy files prescriptions to ensure they are readily retrievable.

    Paper prescription records

    Federal regulations allow two options for filing paper prescription records. Both require documenting medications dispensed in separate files based on Schedule.

    The first option requires the maintenance of three files: all Schedule II medications; all Schedule III, IV, and, V medications; and all noncontrolled medications.

    The second option requires two files: all Schedule II medications and all other medications (Schedule III, IV, V, and noncontrolled medications). Prescriptions for Schedule III, IV, and V medications should be made readily retrievable by marking them with a red C stamp, not less than 1 inch high.

    Electronic prescription records

    Pharmacies that use electronic prescription processing must retain all associated records electronically. These records should be maintained for at least 2 years. For electronic recordkeeping systems, a red C stamp is not necessary. However, all Scheduled prescriptions should be readily retrievable and readable.

    Destruction of controlled substances

    The destruction of controlled substances is most often completed by a reverse distributor. A reverse distributor is registered with the state and federal government to manage the removal and disposal of controlled substances for the pharmacy by transferring the controlled substance back to the manufacturer to facilitate disposal. If the pharmacy chooses to use a reverse distributor, a DEA Form 222 to transfer Schedule II controlled substances to the reverse distributor must be completed. A copy of the completed form should be retained at the pharmacy.

    A pharmacy may want to destroy controlled substances that are expired, damaged, or unwanted. However, this should be done only if reverse distributors are unable to accept the medications for destruction. In this case, the pharmacy must complete a DEA Form 41. A pharmacy can request DEA authorization to destroy controlled substances once each year.

  • The original distributor
  • A reverse distributor.
  • The local environmental authorities.
  • The DEA
  • Schedule I substances dispensed
  • Schedule II substances dispensed
  • Schedule III substances dispensed
  • Schedule IV substances dispensed.
  • Schedule V substances
  • Noncontrolled substances dispensed
  • MB6125341
  • BB6123401
  • BA6512012
  • XB6515431
  • AP7451422
  • AP7451420
  • AM7451423
  • AM7451424
  • Summary

    Because the DEA focuses its attention on controlled substances, it is crucial that all prescriptions for controlled substances meet DEA requirements, including DEA numbers. The prescriber’s information as well as the patient’s identifying information are both required on a prescription in order to dispense the medication. Fraudulent DEA numbers and prescriptions can be easily detected following the formula used to create a DEA number, two letters followed by seven digits with each letter representing a significant registrant identifier.

    Federal regulations mandate how paper prescriptions are filed and are specific to the controlled substance Schedule in a file marked with a red C. Electronic prescriptions, however, must be maintained electronically for 2 years. Likewise, when destroying controlled substances, a pharmacy is required to submit the mandatory forms and transfer through a reverse distributor. Pharmacies can request permission to destroy expired or tainted medications once a year.

    Diversion of controlled substances

    Audio differs from text due to recent content updates. Audio will be updated soon. The abuse of prescription medications, especially controlled substances, is a serious social and physical problem. As a health care professional, the pharmacy technician shares the responsibility for identifying and preventing prescription substance use disorder in patients and coworkers. The pharmacy technician must become aware of potential situations where drug diversion—the attempt to get drugs illegally—can occur and have safeguards that can help prevent this diversion.

    Theft and loss

    Both DEA and state authorities consider retail-level diversion a priority issue. Missing controlled substances must be reported to the DEA and local police as soon as the loss is known. Pharmacy technicians can assist the pharmacist in collecting the necessary information.

    The pharmacist will need the following information to complete a DEA Form 106.

    • Name and address of the pharmacy
    • DEA registration number
    • Date of theft
    • Name and telephone number of local police department notified
    • Type of theft (for example, night break-in, armed robbery)
    • List of symbols or cost codes used by pharmacy in marking the containers, if any
    • List of the controlled substances, with their national drug code (NDC) numbers, missing due to the theft or significant loss
    • Name and title of the individual filing the report
    • Name of the certifying individual who can attest to the validity of the information provided in the report

    The pharmacist will submit the DEA Form 106 online or in paper to the DEA diversion field office. A copy will be kept in the pharmacy’s records for at least 2 years.

    Forged prescriptions

    Common methods of forging prescriptions

    As a pharmacy technician, you should avoid viewing patients as criminals. However, it is important to recognize the following common methods that forgers use to obtain medications illegally.

    • Divert legitimate prescription pads from physicians’ offices and write prescriptions for fictitious patients.
    • Alter the physician’s legitimate prescription (e.g., change dose, strength, or instructions) in an effort to obtain additional amounts of prescribed medications.
    • Have prescription pads from a legitimate prescriber printed with a different call-back number. In these situations, an accomplice often answers the call and verifies the prescription.
    • Pretend to be a prescriber and attempt to call in their own prescriptions, providing their own telephone number as call-back confirmation.
    • Use computers to create prescriptions for nonexistent prescribers or to copy legitimate prescribers’ prescriptions.

    Characteristics of fraudulent prescriptions

    The following characteristics are commonly found in fraudulent prescriptions.

    • Prescription looks too good (a prescriber’s handwriting is too legible, for example).
    • Quantities, directions, or dosages differ from usual medical usage.
    • Prescription does not comply with acceptable standard abbreviations, or appears to be a copy of a textbook presentation.
    • Prescription appears to be photocopied.
    • Directions are written in full with no abbreviations.
    • Prescription is written in different color inks or written in different handwriting.
    • Zeroes are added to quantities.

    Characteristics of illegitimate prescriptions

    The following criteria may indicate that an alleged prescription was not issued for a legitimate medical purpose.

    • The prescriber writes significantly more prescriptions (or in larger quantities) compared with other practitioners in the area.
    • The patient appears to be returning too frequently. A prescription that should last for 1 month of legitimate use is being refilled biweekly, weekly, or even daily.
    • The prescriber writes prescriptions for antagonistic medications, such as depressants and stimulants, at the same time. (People who have substance use disorder often request prescriptions for depressants and stimulants at the same time.)
    • The patient presents a prescription written in the name of another person.
    • Multiple people appear simultaneously, or within a short time, all bearing similar prescriptions from the same physician.
    • Numerous strangers, or people who are not regular patrons or residents of the community, suddenly show up with prescriptions from the same physician.

    Diversion prevention

    The following techniques will help prevent diversion of controlled substances in your pharmacy.

    • Become familiar with patients.
    • Become familiar with prescribers and their signatures.
    • Know how to determine whether a DEA number is legitimate and verify prescribers’ DEA numbers.
    • Check the dates on prescriptions and confirm that they have been presented in a reasonable length of time since they were written.
    • When there is a question concerning any aspect of a prescription order, call the prescriber for verification or clarification.
    • Request proper identification. Many states require identification review when picking up a controlled substance prescription.
    • If you believe that you have a forged, altered, or counterfeit prescription, do not dispense it. Notify the pharmacist and they will verify legitimacy with the prescriber. If confirmed to be forged, the pharmacist will call the local police.
    • If you believe that you have discovered a pattern of prescription abuses, inform your pharmacist and they will contact your state board of pharmacy or local DEA office.

    Medicaid tamper-resistant prescription requirements

    Federal law requires handwritten Medicaid prescriptions be on tamper-resistant prescription pads. State laws may also have specific requirements for Medicaid prescriptions. Tamper-resistant pads must have at least one feature that prevents or discloses copying, one feature that prevents or discloses erasing or modifying, and at least one feature that prevents or discloses counterfeiting. Electronic prescriptions also have tamper-resistant features. Examples of prevention or disclosure methods for each of these categories are listed below.

    Prevention and disclosure of prescription-tampering examples

    Feature

    Handwritten prescription examples

    Electronic prescription

    Copying

    High-security watermark revealing words (e.g., VOID, ILLEGAL, or COPY) if photocopied

    Signature line containing words

    (such as “original prescription”) in small letters that are illegible if copied

    Erasing or

    modifying

    Tamper-resistant background

    Quantity checkbox, in addition to writing out the quantity

    Refill options in which the number of refills authorized is circled

    Spelling out the numbers instead of writing the number (for example, ONE instead of 1)

    Including asterisks around the numbers

    (***3***)

    Counterfeiting

    Unique prescription identifiers such as sequentially numbered prescriptions

    Spelling out the numbers instead of writing the number (for example, ONE instead of 1)

    Unique prescription identifiers such as sequentially numbered prescriptions

    Spelling out the numbers instead of writing the number (for example ONE instead of 1)

    Some states use either duplicate or triplicate blanks (or rotate between them), which are similar to the DEA Form 222 used to order Schedule II controlled substances, to produce tamper-resistant prescription pads.

    Exemptions to Medicaid tamper-resistant prescription requirements

    Medicaid prescriptions that do not require tamper-resistant prescription pads include the following.

    • Managed care prescriptions, items, or services
    • Prescriptions for patients in institutional and clinical settings, where total medical services are reimbursed together instead of reimbursing medications separately. Examples include skilled nursing facilities, intermediate care facilities for individuals with intellectual disabilities, inpatient and outpatient hospitals, and hospice, dental, laboratory, X-ray, and renal dialysis services.
    • Telephoned, faxed, or e-prescribed Medicaid prescriptions (although using methods to prevent diversion of electronic Medicaid prescriptions is highly encouraged)
    • Emergency prescriptions
  • DEA Form 41
  • DEA Form 106
  • DEA Form 222
  • DEA Form 224
  • Name and telephone number of the local police department notified
  • Name and title of individual filing the report
  • Name of individual responsible for the theft
  • Date of theft
  • Type of theft
  • The NDC numbers of the missing controlled substances
  • Using a tamper resistant background
  • Using asterisks around numbers
  • Using sequentially numbered prescriptions
  • Using a watermark if photocopied
  • No standard abbreviations used
  • Prescription written the day before.
  • Dosages differ from usual medical usage.
  • Prescription is written in different-color inks.
  • Prescriber is an obstetrician and patient is male
  • Electronic prescriptions
  • Emergency prescriptions
  • Telephoned prescriptions
  • Prescriptions for controlled substances
  • Prescriptions for patients in institutional care
  • Summary

    As a key member of the pharmacy team and a first point of contact with patients, the pharmacy technician has a central role in preventing diversion of controlled substances. To prevent diversion, the pharmacy technician must be aware of situations in which it can occur and take precautions to reduce opportunities for diversion. Actions the pharmacy technician can take include the following.

    • Assist the pharmacist in collecting information to report retail theft or loss
    • Be familiar with patients, prescriber signatures, and DEA numbers
    • Recognize characteristics of forged prescriptions, and notify the pharmacist if they suspect a prescription has been forged
    • Recognize patterns of prescription abuses and inform the pharmacist so they can be reported
    • Understand Medicaid’s tamper-resistant prescription regulation and know how to follow it

    The pharmacy technician should understand that by taking actions to identify and safeguard against controlled substance diversion, they are helping to prevent a serious social problem.

    Substance use disorder in patients and colleagues

    Pharmacy personnel have a responsibility to reduce substance use disorders when they are discovered in both patients and colleagues. There are times a legal and valid prescription may lead to the patient developing a substance use disorder. In light of the current opioid epidemic, it is extremely important for a pharmacy technician to recognize the symptoms of opioid abuse.

    Understanding substance tolerance and dependence

    Tolerance

    Tolerance is when a person’s body adapts to the medication, causing the medication to not work as well. Individuals experiencing tolerance may have the following symptoms.

    • They take more medication than prescribed.
    • They run out of medication early and trigger “refill too soon” messages on the computer.
    • They complain that their condition continues to get worse.

    Physical dependence

    Physical dependence is similar to tolerance in that both are normal processes in which the body adapts to a medication’s effect. However, with physical dependence symptoms occur when there is a sudden decrease in the amount of medication taken. The sudden decrease may be caused by decreasing the dose of the medication, taking other medications that interact with the current medication, or noncompliance (for example, the patient forgets to take the medication).

    Some of the withdrawal symptoms seen with physical dependence include the following.

    • Restlessness, aggressive behavior, sweating, insomnia
    • Dilated pupils (mydriasis)
    • Watery eyes, runny nose, sneezing
    • Muscle spasms, backaches, abdominal cramps
    • Hot and cold flashes
    • Nausea, vomiting, diarrhea
    • Rapid breathing
    • Sudden change in heart rate or blood pressure, irregular heartbeats

    Chemical dependence

    Chemical dependence, or substance use disorder, is serious. Just because an individual has medication-seeking or medication-craving behavior does not mean that they are addicted. As mentioned earlier, some individuals adapt to or tolerate the medication’s effect and still have pain. The following symptoms of chemical dependence can help differentiate whether a person has a substance use disorder or is simply tolerant to the medication.

    • Using multiple providers and pharmacies to receive narcotics
    • Escalating the dose or frequency of narcotic use without prescriber approval
    • Calling or visiting the clinic early for additional narcotic prescriptions
    • Visiting the emergency department for new prescriptions while waiting for their regular medications to be filled
    • Claiming to have lost prescriptions or medications
    • Claiming to have dropped and spilled their prescription medication
    • Presenting multiple prescriptions to be filled but only taking the prescriptions for controlled substances. An example might be a prescription for an antibiotic and narcotic, and only the narcotic is filled.

    Recognizing substance use disorder in patients

    The pharmacy technician is often the first person a patient encounters at the pharmacy. It is difficult at times to distinguish between legitimate use and intentional abuse of a medication. The medication-seeking individual may be unfamiliar to the pharmacy technician. They could claim to be from out of town and say they have lost or forgotten a prescription or medication. Recognizing characteristics in their appearance, behavior, responses, medication selection, and timing is the first step to identifying the medication-seeking patient who may be attempting to manipulate the pharmacy technician.

    Appearance

    As a pharmacy technician you should not judge a person by their appearance. However, there are certain observable physical signs that may indicate an individual is seeking medication for a nonlegitimate medical use. Some of these signs include the following.

    • Cutaneous signs of medication use, such as skin tracks and related scars on the neck, forearm, wrist, foot, or ankle. Such marks are usually multiple, hyperpigmented, and linear. New lesions may be inflamed.
    • Pop scars from subcutaneous injections
    • Exaggeration of medical problems or simulation of symptoms

    If you observe these signs you should bring it to the attention of the pharmacist.

    Behavior

    The pharmacy technician should be aware of the following behaviors that may indicate an individual is seeking medication for a nonlegitimate medical use.

    • Unusual behavior at the pharmacy counter
    • Overly assertive personality
    • Mood disturbances and lack of impulse control
    • Attempts to deceive the pharmacy staff by requesting refills early
    • Attempts at distraction by talking constantly about topics of no concern

    Responses

    When talking with a patient the technician may observe the following suspicious responses by an individual seeking medication for a nonlegitimate medical use.

    • Gives evasive or vague answers to questions regarding medical history
    • Contends to be a patient of a practitioner who is currently unavailable but will not give the name of the physician
    • States that a prescription has been lost or stolen and should be replaced
    • States that they are traveling through town or visiting friends or relatives (not a permanent resident)

    All concerning responses by the patient to the technician should be shared with the pharmacist.

    Medication selection

    An individual seeking medication for a nonlegitimate medical use may have the following suspicious responses regarding medications.

    • Requests a specific controlled medication, is reluctant to try a different medication prescribed for them
    • States that specific non-narcotic analgesics do not work, or that they have allergies to them
    • Shows unusual knowledge of controlled substances

    Timing

    As a technician, you may observe the following suspicious examples of a patient’s timing in having a prescription filled.

    • Demands to be seen right away
    • Demands immediate action and usually asks how long they will have to wait
    • Attempts to have a controlled substance medication filled shortly before the pharmacy is scheduled to close

    Responding to substance use disorder in patients

    Patients rely on the pharmacy during times when they feel their weakest. As a pharmacy technician, you have the ability to witness, document, and alert care providers to signals that a patient may have become chemically dependent on a substance. When working with a patient you suspect is attempting to gain narcotics as part of a substance use disorder, it is important to not ignore the signals.

    The following are some of the actions that a pharmacy technician can take.

    • Document questions you asked the patient.
    • Request identification. Photocopy these documents and include them in the patient’s record.
    • Call a previous practitioner, pharmacist, or hospital to confirm the patient’s story.
    • Confirm a telephone number, if provided by the patient.
    • Confirm the current address at each visit.
    • Make sure prescriptions are written for limited quantities.
    • Notify pharmacist and prescribers’ offices of multiple physicians being used so collaborative efforts can help patient receive therapeutic medication dosage.

    Recognizing substance use disorder in colleagues

    Coworkers with substance use disorder often exhibit similar suspicious behaviors as patients, and these should be reported to the pharmacist. Additionally, changes in attendance and punctuality, appearance, behavior, skill accuracy, and involvement with controlled substances.

    Timeliness and presence on the job

    • Absence from work without notification or excessive number of sick days used or both
    • Frequent disappearances from the work site, long unexplained absences, improbable excuses, frequent or long trips to the bathroom or stockroom where medications are kept

    Appearance

    • Progressive deterioration in personal appearance and hygiene
    • Wearing long sleeves when inappropriate

    Behavior

    • Unreliability in keeping appointments and meeting deadlines
    • Personality change, mood swings, anxiety, depression, lack of impulse control, suicidal thoughts or gestures
    • Decline in interpersonal relations with colleagues, staff, and patients
    • Difficulty admitting errors or accepting blame for errors or oversights

    Skill impairment

    • Confusion, memory loss, difficulty concentrating or recalling details and instructions
    • Taking more time and effort for ordinary tasks
    • Sloppy recordkeeping, suspicious ledger entries, medication shortages
    • Uncharacteristic deterioration of handwriting and charting
    • Alternating between periods of high and low productivity, making mistakes due to inattention, poor judgment, and bad decisions

    Increased controlled-substance involvement

    • Inappropriate prescriptions for large narcotic doses
    • Excessive wasting of medications
    • Excessive amounts of time spent near a medication supply (may volunteer for overtime and may be at work when not scheduled to be there)

    Responding to substance use disorder in coworkers

    If you suspect substance use disorder in a coworker, you should talk to your pharmacist, manager, or human resource department. For some employees, their supervisor talking to them about poor work performance or suspicious behaviors is enough motivation to help them change. The threat of losing a job may have more influence on a substance user than a loved one’s threat to end a relationship.

    Substance use treatment

    A number of state licensing boards, employee assistance programs (EAPs), state diversion programs, and peer assistance organizations will refer individuals and their families to appropriate counseling and treatment services. An EAP is work-based intervention program that assists employees who have personal problems, including substance use disorders that might have a negative impact on the employee’s work habits. These services maintain the confidentiality of those seeking assistance to the greatest extent possible. Benefits of these programs include improving an employee’s job performance, reducing employee tardiness, and improving employee morale. Many different medication treatments are used in to treat a variety of substance use disorders.

    Substance use treatment agents

    Generic name

    Brand name

    Indications

    Acamprosate

    Campral

    Alcohol dependence

    Disulfiram

    Antabuse

    Alcohol dependence

    Naltrexone

    Vivitrol

    Alcohol dependence, opioid dependence

    Buprenorphine

    Buprenex, Butrans, Probuphine, Sublocade, Belbuca

    Opioid dependence

    Buprenorphine-naloxone

    Suboxone

    Opioid dependence

    Naloxone

    Narcan

    Opioid overdose

    Bupropion

    Zyban

    Nicotine dependence

    Nicotine replacement therapy

    NicoDerm CQ, Nicorette gum, NicotrolNS

    Nicotine dependence

    Varenicline

    Chantix

    Nicotine dependence

  • Following up with his primary care physician
  • Waiting for prescription
  • Time of arrival to pharmacy
  • Paying cash for the prescription
  • Desire to obtain specific looking tablet
  • Document questions asked of the patient
  • Request photo ID and keep a copy with the patient’s record
  • Confirm the current address at each visit
  • Call a family member to confirm a patient’s story
  • Make sure prescriptions are written for limited quantities
  • Summary

    It is important for the pharmacy technician to recognize possible substance use disorder. Understanding the difference between tolerance and dependence will play an important part in addressing substance use disorders. Patients who have developed a tolerance for a medication might request early refills, take more medication than prescribed, and report that their condition is getting worse. A patient exhibiting tolerance does not necessarily mean they have a substance use disorder. If tolerance is suspected, notify the pharmacist. Providing early intervention can prevent physical and chemical dependence.

    Physical dependence is experienced when the medication has been suddenly decreased and is manifested by signs of withdrawal such as the following.

    • Restlessness, aggressive behavior, sweating, insomnia
    • Dilated pupils (mydriasis) and rapid breathing
    • Watery eyes, runny nose, sneezing
    • Hot and cold flashes
    • Nausea, vomiting, diarrhea

    Some signs of chemical dependence include the following.

    • Using multiple providers and pharmacies in an attempt to obtain more medication.
    • Obtaining prescriptions from the emergency department or other acute care settings in addition to current refills for the same or similar medications
    • Claiming to have lost prescriptions or medications to obtain additional medication.

    Many signs can alert the pharmacy technician to a patient experiencing a substance use disorder including altered behavior, disheveled appearance, vague or incongruent responses, demands for specific medication selection, and demands for quick turnaround. When substance use disorder is suspected request patient identification, document encounters, and alert the pharmacy. Colleagues will exhibit the same characteristics when facing substance use disorder and might have trouble being punctual and productive. Any signs of substance use disorder in a colleague should be reported to the pharmacist or supervisor for intervention.