Controlled Substances Part 3: Prescribing and Dispensing

Question 1

A Rx for a controlled substance for a legitimate medical purpose may only be issued by a physician (MD/DO), dentist (DDS/DMD), podiatrist (DPM), veterinarian (DVM), mid-level practitioner (MLP) or another registered practitioner who is:

Answer 1

• Authorized to prescribe controlled substances by the jurisdiction or state in which the practitioner is licensed to practice
• Registered or exempt from DEA registration
• An agent or employee of a hospital or institution acting in the normal course of business under the DEA registration of the hospital or institution

Question 2

Physicians, dentists, veterinarians, podiatrists, and optometrists are healthcare providers who can prescribe controlled substances independently within their scope of practice. MLPs must prescribe…

Answer 2

under a physician-directed protocol

Question 3

Each DEA number is unique and is assigned to an individual healthcare provider or an institution. The DEA number permits the individual to write controlled substances prescriptions and authorizes an institution to order and manage controlled substances. Each DEA number is randomly generated and consists of the following:

Answer 3

• Starts with 2 letters
• First letter: identifies the type of practitioner or institution (i.e. registrant type)
• Second letter: first letter of the prescriber’s last name
• Letters are followed by 7 numbers

Last number is the “check digit”

Question 4

If a practitioner is authorized to prescribe narcotics (such as buprenorphine) for opioid addiction treatment, the practitioner will receive a DATA 2000 waiver unique identification number (UIN). The number is the same as…

Answer 4

the practitioner’s DEA number, except that the letter “X” replaces the first letter.

Question 5

Prescribers in a hospital or other institution, including medical interns, residents, and visiting physicians, can prescribe medication under the DEA registration of that hospital or institution. The hospital or institution will assign a specific internal code number to each practitioner authorized to prescribe. The internal code number will follow…

Answer 5

the last number of the hospital’s DEA number.

Question 6

First letter of DEA number for each registrant type:

Answer 6

• A/B/F/G: Hospital, clinic, practitioner, teaching institution, pharmacy
• M: Mid-level practitioner (e.g. nurse practitioner, PA, optometrist)
• P/R: Manufacturer, distributor, researcher, analytical lab, importer, exporter, reverse distributor, narcotic tx program
• X: DATA-waived practitioner

Question 7

In order for a Rx to be considered valid, it must be issued in the usual course of professional tx for a legitimate medical purpose. The condition being treated must be one that the prescriber would be expected to treat. The pharmacist has a corresponding responsibility to…

Answer 7

ensure a controlled substance Rx is valid prior to filling. A pharmacist is not required to dispense a Rx if he/she has concerns about the legitimacy.

Question 8

Pharmacists should be aware of potential “red flags” when filling controlled substances Rxs to prevent drug abuse and diversion. Additional signs of drug abuse or misuse may include:

Answer 8

irregularities on the face of the Rx

prescriptions for unusually large quantities

or an initial Rx for a strong opioid

Question 9

NABP “Red Flags” of Diversion:

Answer 9

• Frequent requests for early refills
• Prescriber and/or patient located an unusual distance from pharmacy
• Patient profile reveals multiple prescribers for duplicate therapy (eg, “doctor shopping”)
• Similar or identical prescriptions for multiple patients from same prescriber (eg, “pill mill”)
• Prescription is not within the prescriber’s scope of practice (eg, opioid analgesic from a psychiatrist)
• Patients presenting to the pharmacy in groups
• Unusual patient behavior (eg, nervous demeanor)
• Patient pays cash for an opioid Rx
• Use of street slang to refer to a medication
• Patient is prescribed a “drug cocktail” (eg, opioid + benzodiazepine + muscle relaxant)
• A pending federal or state action against prescriber

Question 10

Many drugs that are used illicitly, including opioids, are stolen from another family member. Community pharmacist that dispense schedule II, III, and IV drugs must have medication lock boxes or medication locks available for purchase. The products should have a locking mechanism, such as password or key and they should be displayed near the pharmacy. Pharmacies where a licensed pharmacist is the majority owner and manager of no more than…

Answer 10

4 pharmacies are exempt from this law

Question 11

The Controlled Substance Utilization Review and Evaluation System (CURES) is California’s Prescription Monitoring Program (PDMP). Prescribers and pharmacists can access CURES to review all schedule II-V drugs that have been prescribed and dispensed for a given patient. A prescriber can request from CURES a list of…

Answer 11

all patients that have designated them as their prescriber. A patient report lists all scheduled drugs the patient has received, the prescribers, the dispensing pharmacist, and other dispensing information.

Question 12

Each pharmacy must…

Answer 12

submit dispensing data for schedule II-V drugs to CURES within one working day after the Rx was dispensed.

All California pharmacists with active licenses must be registered to access CURES.

Question 13

All California pharmacists with active licenses must be…

Answer 13

registered to access CURES.

Question 14

Prescribers must check CURES to review a patient’s history for the past 12 months before prescribing schedule II-IV drugs for the first time and at least 6 months thereafter. Pharmacists are not mandated, but are…

Answer 14

highly encouraged, to check CURES before dispensing schedule II-IV prescriptions.

Question 15

A practitioner must review a patient’s history in the CURES database no earlier than 24 hours, or on the previous business day, before…

Answer 15

prescribing, ordering, or administering a schedule II-IV drug for the first time, and every 6 months if the drug is still being used.

There are some exceptions (eg, a CURES review is not required for veterinarians).

Question 16

All controlled substance prescriptions are valid for 6 months and must include the prescriber’s DEA number. All controlled substance prescriptions must be…

Answer 16

dated and signed by the prescriber on the date it is issued to the patient.

Pre-signing prescription blanks is illegal.

Pharmacists should not fill prescriptions that are suspected to be pre-signed.

Question 17

Any agent of the prescriber (eg, nurse or office staff) can orally or electronically transmit a Rx for a schedule III-V drug. The name of the agent…

Answer 17

transmitting the Rx must be recorded.

Question 18

In order to fill a controlled substance from an out-of-state prescriber, the prescription must meet the controlled substance Rx requirements of the state in which the prescriber practices, and the prescriber must be registered with the DEA. The schedule of the drug will determine if the prescription can be dispensed directly to the patient at the pharmacy or mailed to the patient:

Answer 18

• Schedule II drugs: a California pharmacy can fill the Rx, but it can only be delivered (mailed) to an out-of-state patient (ie. the drug cannot be dispensed directly to the patient at the pharmacy)
• Schedule III-V drugs: a California pharmacy may dispense the Rx directly to the patient or deliver it by mail

Question 19

A California security form must be used for all written controlled substances prescriptions (schedules II-V), with a couple of exceptions. Prescribers can write a Rx for both controlled and non-controlled drugs on the security forms or…

Answer 19

they can choose to use separate forms for each type.

Question 20

A California security Rx form must have the following features:

Answer 20

• The word “void” appears across the front of the Rx when photocopied or scanned due to heat exposure
• A chemical void protection that prevents alteration via chemical washing
• A watermark is printed on the back of the Rx blank that reads “California Security Rx.” Watermarks are not duplicated by copy machines.
• A feature printed in the thermochromic ink which reacts to changes in temperature. Commonly, if a thermochromic image is touched or blown on it will disappear and reappear after it cools. This effect is not duplicated by copy machines.
• An area of opaque writing that causes the writing to disappear if the Rx is lightened.
• A description of the security features included on each form.
• Six quantity check-off boxes printed on the form: 1-24, 25-49, 50-74, 75-100, 101-150, 151 and over.
• Quantity boxes must be checked by the prescriber to correspond to the written quantity of the drug)
• A space to designate the units referenced in the quantity boxes when the drug is not in tablet or capsule (eg. mL)
• Statement that the “Prescription is void if the number of drugs prescribed is not noted.”
• The preprinted name, licensure category, license # and DEA # of the prescriber
• Check boxes that indicate the number of refills ordered
• The date of issue
• A check box indicating the prescriber’s order not to substitute
• A check box by each prescriber’s name when a Rx form lists multiple prescribers. A prescriber who signs a multiple prescriber form will need to check the box by his or her name
• An identifying number assigned to the approved security printer by the Department of Justice
• A unique serial number on each security form, which permits the form to be traced. The # has 15 digits (3 letters, followed by 12 numbers). The prescriber’s serial numbers are reported to CURES.

Question 21

Each batch of security Rx forms has a lot # printed on the form. The forms…

Answer 21

are printed sequentially, beginning with the number one.

Question 22

Hospitals often have physicians from the surrounding communities who are granted privileges to see their patients at the hospital. Many hospitals have medical residents rotating through the facility for short periods of time. Both types of prescribers need to write prescriptions, but may not have their own forms for each hospital in which they work. For this purpose, the boards of medicine and pharmacy permit a designated prescriber at a facility that has >25 physicians to order security Rx forms for their facility that do not include:

Answer 22

• pre-printed prescriber information:

• prescriber’s name
• category of licensure
• license number
• DEA number
• Address of the prescribing practitioner

These security forms will be signed out by the designated prescriber in a record book that includes the name to whom they are given, the category of license and number, the DEA number, and the quantity of security forms issued. The record must be kept in the health facility for 3 years.

Question 23

A Rx for a controlled substance is exempt from using a security form in 2 instances:

Answer 23

1. A patient is terminally ill (i.e. life expectancy ≤ 1 year) and the Rx is for medication to manage pain/other symptoms of the terminal illness
   • The prescriber must write “11159.2 exemption” on the Rx form used
2. During a declared emergency when the California Board of Pharmacy has issued a notice of this exemption:
   • The prescriber must write “11159.3 exemption” or a similar statement indicating the patient is affected by the declared emergency
   • No more than a 7-day supply can be dispensed for a schedule II drug
   • Prescriptions filled pursuant to this exemption cannot be refilled

Question 24

A pharmacy can accept schedule III-V prescriptions verbally (over the phone) if the pharmacist reduces the Rx to writing (i.e. writes the Rx on the pharmacy’s Rx form). The prescription must include all information required for…

Answer 24

a valid Rx (with the exception of the prescriber’s signature). Oral prescriptions for schedule II drugs are not valid except in emergency situations.

Question 25

Faxed prescriptions are acceptable for schedule III-V drugs as long as all the information required for a valid Rx is included for a valid Rx is included and the prescriber…

Answer 25

manually signs the fax before sending it to the pharmacy. Prescribers should use a regular Rx form to write for schedule III-V drugs before faxing it to the pharmacy. If the prescriber uses a security form, the text “VOID” (written in thermochromic ink) can appear due to the heat emitted by the fax machine during transmission. This is acceptable to fill as long as the pharmacist validates the faxed Rx by contacting the prescriber’s office for verification.

Question 26

In general, faxed prescriptions for schedule II drugs cannot serve as the original Rx. However, a prescriber can provide a patient with a written Rx for a schedule II drug and fax the same Rx to the pharmacy in order to alert the pharmacy that the patient is on the way. This allows the pharmacy to fill the Rx before the patient arrives. The pharmacist cannot…

Answer 26

dispense the schedule II drug to the patient until the patient brings the written Rx to the pharmacy and it is verified against the faxed Rx before dispensing. It is not acceptable, even as an alert, for patients to fax Rxs to a pharmacy.

Question 27

The only time a faxed Rx for a schedule II drug is valid is if it’s written for a patient of a licensed skilled nursing facility, an intermediate care facility, a home health agency or a hospice facility. The pharmacist…

Answer 27

will need to produce, sign, and date a hard copy of the Rx before filling it

Question 28

When prescriptions are electronically transmitted entirely through software, safeguards must be in place to prevent unauthorized persons from hacking into the system and illegally transmitting controlled substance prescriptions. In 2010, the DEA released final rules that permit electronic prescriptions for controlled substances (EPCS) for schedule II-V drugs. Prescribers and pharmacies must use:

Answer 28

• DEA-approved software to send and receive EPCS. The credentials that are permitted for DEA-sanctioned validation will be 2 of the following factors:
• Something you know (eg, password or response to a question)
• Something you have (eg, hard token containing a cryptographic key stored on a hardware device separate from the computer being accessed)
• Something you are (biometric information, such as an iris or fingerprint scan)

Question 29

Prescribers must use a two-factor authentication method to sign and transmit EPCS. As an alternative to using two-factor authentication to sign the EPCS, the prescriber can use a…

Answer 29

digital certificate. A digital certificate contains the user’s credentials and is issued by the DEA.

Question 30

In California, all prescriptions for controlled and non-controlled drugs must be…

Answer 30

transmitted electronically (i.e.. e-prescriptions) by Jan 1, 2022, unless specified exceptions are met.

Question 31

All prescriptions for controlled subtances must be signed and dated by the prescriber. However, if the date is printed out on a Rx, the prescriber only needs to sign the form. Controlled substance prescriptions that have…

Answer 31

not been signed and dated cannot be filled

Question 32

For schedule II drugs, the pharmacist cannot make any changes to:

Answer 32

• Issue date
• Prescriber name
• Prescriber signature
• Patient name
• Drug name

Minor misspellings can be revised at the pharmacist’s discretion. The pharmacist or intern can make changes to any other information on the Rx, as long as the pharmacist verifies the change with the prescriber first. It is acceptable to verify with the prescriber if the “void if quantity is not indicated” has not been completed. The pharmacist can complete the form and fill the Rx when reasonable.

Question 33

In an attempt to keep patients off long-term opioids, Medicare Part D has limited initial opioid Rxs to a 7-day supply. The Rx is considered “initial” if…

Answer 33

the patient has not received any opioids in the last 60-90 days.

Question 34

Prescriptions for schedule II drugs cannot be refilled even though some patients may require schedule II drugs as maintenance therapy. When there are no federal quantity limits, providers generally avoid…

Answer 34

prescribing more than a 30-day supply for schedule II drugs due to the risk of abuse and misuse. The inability to provide refills for patients requiring chronic treatment (such as stimulants for ADHD) necessitates frequent office visits.

Question 35

In 2007, the DEA authorized prescribers to issue multiple Rxs at one time for schedule II drugs. These prescriptions can be filled sequentially, but cannot exceed a 90-day supply. The prescription cannot be post-dated. Instead, the prescriber must…

Answer 35

include two dates on each Rx: the date the prescription is written (i.e. the issue date), and the earliest acceptable fill date. The prescriber can write any phrase to indicate the earliest fill date, such as “Do not fill before” or “Do not fill until.” This is necessary to prevent a patient from filling the prescriptions at the same time at multiple pharmacies.

Question 36

The DEA allows for scenarios in which a schedule II prescription may be partially filled. Similar to partial filling of any other drug, the total quantity dispensed from the partial fills cannot…

Answer 36

exceed the total quantity prescribed. When a pharmacist fills less than the full amount prescribed, he or she must document the quantity dispensed on the Rx. The remaining balance must be filled within a specific time frame; otherwise, the remaining balance is forfeited.

Question 37

There are 3 circumstances in which a schedule II Rx may be partially filled: the pharmacy does not have enough stock of the drug, as requested by the patient or the practitioner who wrote the Rx, terminally ill patients or LTCF residents

Answer 37

1. If the pharmacy cannot supply the full quantity, a portion of the Rx can be dispensed to hold the patient over until the remaining balance can be obtained.
   • This partial fill can be provided pursuant to a written or an emergency oral Rx
   • The quantity supplied must be documented on the face of the hard copy or in the electronic Rx record
   • The remaining portion must be filled within 72 hours of the first partial filling. After 72 hours, a new Rx is required.
   • If the remaining portion is not or cannot be filled within 72 hours of the first partial filling, the pharmacist must notify the prescriber.

Question 38

There are 3 circumstances in which a schedule II Rx may be partially filled:

Answer 38

2. Under the 2016 Comprehensive Addiction and Recovery Act (CARA), pharmacists can partially fill schedule II drugs at the request of the patient or prescriber. This was enacted to help prevent stockpiling of unused schedule II drugs, which can lead to misuse or abuse.
   • Additional partial fills can only be dispensed up to 30 days from the date the Rx was issued.
   • There is no limit on the number of partial fills a patient can receive pursuant to one Rx, as long as the total quantity dispensed does not exceed the total quantity prescribed.

Question 39

There are 3 circumstances in which a schedule II Rx may be partially filled:

Answer 39

3. Schedule II prescriptions can be partially filled for patients residing in a LTCF or patients diagnosed with a terminal illness (eg, hospice patients). This is to reduce drug diversion and waste that can occur if the patient expires before the medication is finished.

• The pharmacist must document “terminally ill” or “LTCF patient” on the Rx.
• Partial fills can be dispensed for up to 60 days from the date the Rx was issued.

Question 40

Generally, prescribers cannot call in prescriptions for schedule II drugs. However, the DEA permits dispensing a schedule II drug pursuant to an oral Rx if…

Answer 40

the drug’s immediate administration is necessary to avoid patient harm, and there is no reasonable alternative. If the pharmacist is not familiar with the prescriber, they must make a good faith effort to determine that the oral Rx came from a DEA registered practitioner. This can be done by calling the prescriber using the phone # listed in the public directory. The pharmacist must reduce the Rx to writing immediately and it must contain all necessary information except for the prescriber’s signature.

Question 41

Central fill pharmacies are…

Answer 41

prohibited from preparing emergency fills for schedule II drugs under any circumstance.

Question 42

Criteria for dispensing pursuant to an oral schedule II Rx:

Answer 42

• Dispense the minimum necessary amount (must use professional judgment)
• Prescriber must provide the original Rx within 7 days of oral authorization
• Original can be written or electronic
• Written Rx can be hand-delivered or mailed (must be postmarked by 7th day)
• Face of the original must include the statement “Authorization for Emergency Dispensing” and the date of the oral Rx.
• Pharmacist must attach the written Rx to the emergency oral Rx.
• Electronic prescriptions: must annotate the electronic Rx record with the emergency authorization and the date of the oral order.
• If the original Rx is not received, the pharmacist must report to the California Bureau of Narcotic Enforcement within 144 hours and must also report to the local DEA office.

Question 43

Schedule V drugs can be refilled up to 6 months from the date of issue. There is no refill or day supply limit as long as…

Answer 43

the refills are authorized by the prescriber.

Question 44

Schedule III and IV prescriptions can be refilled up to 5 times within 6 months of the date written, but the total of all refills dispensed cannot exceed a 120-day supply. The original fill does not count as a refill toward the 120-day supply limit. For example, if a Rx for a schedule II drug is written as “Take 1 tablet by mouth daily, #30 tablets, 5 refills), the patient can…

Answer 44

receive an initial fill of 30 tablets and up to 4 refills of 30 tablets each (for a 120-day supply, not counting the original fill)

Question 45

A pharmacy can use one of the two systems for storage and retrieval of prescription refill information of schedule III and IV controlled substances:

Answer 45

• Paper recordkeeping system
• For each refill dispensed, the pharmacist must notate on the back of the Rx his or her initials, the date dispensed, and the quantity dispensed. If the amount dispensed is not notated for each refill, it is assumed that the pharmacist dispensed a refill for the full refill amount.
• Electronic recordkeeping system
• A daily, hard copy printout of refills for controlled substances with the date and signature of all the pharmacists involved with the dispensing. This signifies that the pharmacists agree that the printout is correct and that is what they refilled for the day. The printout must be provided to the pharmacy within 72 hours of the date the refill was dispensed.
• A bound logbook or separate file documenting each day’s refills. Each dispensing pharmacist during the shift signs a statement saying that what they dispensed is listed correctly.

Question 46

Partial fills for refills of schedule III-V controlled substances are permitted if it is recorded in the same manner as a refill and if the total quantity dispensed in all of the fills does not exceed the total quantity prescribed. No dispensing can occur beyond…

Answer 46

6 months from the date of issue. Partial fills are not considered refills. For example, a patient is prescribed Ultram #60, with two refills. This is equivalent to 180 tablets to be dispensed over a six-month period form the date of issue. Theoretically, the patient could come into the pharmacy every day for 90 days and receive 2 tablets.

Question 47

As discussed in the Pharmacy Practice Part 1 chapter, emergency refills without the prescriber’s authorization is allowed for non-scheduled and schedule III-V drugs if the prescriber is…

Answer 47

unavailable to authorize the refill and if, in the pharmacist’s judgment, failure to refill the drug could cause signficant harm. The pharmacist must attemt to contact the prescriber.

Question 48

Schedule II prescriptions cannot be transferred. Prescriptions for schedule III, IV, and V drugs can be transferred one time only, by two licensed pharmacists. The only exception is…

Answer 48

if the phamacies share a “real-time, online database of the patients” (e.g., pharmacy stores in the same chain). With this type of database, pharmacies can transfer as many times as there are available refills.

Question 49

If the transferring pharmacy, the prescription hard copy is pulled and “void” is written on the face (front side) of the Rx. For the receiving pharmacy, the Rx is reduced to writing by the pharmacist and “transfer” is written on the face of the transferred prescription. The DEA number of each pharmacy must be…

Answer 49

recorded and all other information is recorded and required. Alternatively, the required information can be documented electronically. Records must be kept for 3 years.

Question 50

The following auxiliary labels are highlighted by the board as important warnings for safety and addiction prevention:

Answer 50

• Opioid. Risk of overdose and addiction. Flag/label required on outpatient containers.
• Impaired ability to operate a vechicle or vessel. Label required.
• Substantial risk when drug is taken in combination with alcohol. Label is required.

Question 51

If a controlled substances Rx is orally or electronically transmitted, the patient or the patient’s representative must provide proof of identity to pick up the medication if he or she is unknown to the pharmacy. The United States Postal Service (USPS) permits pharmacies to mail controlled substances, with 2 requirements:

Answer 51

• The Rx is placed in a plain outer container or securely wrapped in plain paper
• The Rx label contains the name and address of the pharmacy, practitioner or other person dispensing the Rx.

• Most other delivery services use the same requirements as USPS; only the USPS is mentioned by name in the DEA’s requirements for mailing controlled substances.

Question 52

Methadone is an effective schedule II drug used to treat opioid dependence, but it must be dispensed and administered through a registered opiod tx program (OTP). Methadone 40 mg soluble tablet is only FDA-approved for…

Answer 52

detoxification/treating opioid addiction; the lower doses are indicated for the tx of pain and opioid dependence.

Question 53

Clinics must register with the DEA using DEA Form 363 in order to operate as an OTP. In addition to registering with the DEA, a practitioner must obtain approval and cerification by the Center for Substance Abuse Treatment (CSAT). Once registered with the required parties, an OTP can…

Answer 53

dispense and administer methadone for the treatment of opioid dependence. An OTP practitioner cannot prescribe methadone, meaning they cannot provide patients with a methadone Rx for dispensing at a retail pharmacy. Likewise, when used for the tx of opioid dependence, methadone can only be dispensed by an OTP.

Question 54

In general, patients must visit an OTP every day to receive a supervised dose of methadone. There are instances when patients can receive take-home doses for self-administration. A single take-home dose can be…

Answer 54

provided for a day the OTP clinic is closed (eg, Sundays or State and Federal holidays). Patients can also receive a take-home supply in increasing quantites over time if they are deemed eligible.

Question 55

Methadone Take-Home Supply Dispensing Restrictions:

Answer 55

• First 90 days: can receive up to 1 take-home dose/week
• Second 90 days: can receive up to 2 take-home doses/week
• Third 90 days: can receive up to 3 take-home doses/week
• Treatment beyond 270 days and <1 yr: can receive a max 6-day supply of take-home medication
• After 1 yr: can receive a max 2-week supply
• After 2 yrs: can receive a max one-month supply of take-home medication, but must have monthly visits

Question 56

Despite the option for treatment at OTPs, opioid abuse and dependence continue to be an increasing problem. Several regulations have been passed since 2000 that…

Answer 56

expand the treatment of opioid-use disorder to office-based settings.

Question 57

Drug Addiction Treatment Act of 2000 (DATA 2000):

Answer 57

• Permits qualified physicians to treat opioid dependence with narcotic medications (eg, buprenorphine) in an office-based settings
• Required completion of specific training to become a “DATA-waived practitioner”
• Assigns a DATA 2000 wavier unique identification number (UIN); the UIN is the same as their DEA number except an “X” replaces the first letter
• Limits the number of patients the physician can treat for opioid addiction at a time to 30 patients in the first year and with potential eligibility to treat 100 patients after the first year

Question 58

Comprehensive Addiction and Recovery Act (CARA) of 2016:

Answer 58

• Expanded DATA-waived practitioners to include qualified nurse practitioners (NPs) and physician assistants (PAs)
• Authorized NPs and PAs can prescribe buprenorphine for a 5-year period

Question 59

Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018:

Answer 59

• Granted NP and PAs permanent prescribing authority of buprenorphine for opioid addiction
• Expanded DATA-waived practitioners to include qualified clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives (only eligible to prescribe buprenorphine until October 1, 2023)
• Expanded the eligilibity to treat up to 100 patients at a time in the first year as a DATA-waived practitioner
• Allows eligible practioners to apply to increase the treatment limit to 275 patients after treating 100 patients for one year

Question 60

SUPPORT allows DATA-waived practitioners to prescribe and dispense schedule III-V drugs that are FDA-approved for treating opioid addiction. DATA-waived practitioners do not need to register as an OTP. Prescriptions for treating opioid dependence must contain the prescriber’s UIN and DEA number. Pharmacists can verify a prescriber’s DATA waiver online to…

Answer 60

determine the validity of the Rx

Question 61

A practitioner without a DATA waiver may administer (but not prescribe) a one-day supply of medication at a time to a patient while arranging the proper referral to an opioid tx program. This can be done for up to…

Answer 61

72 hours and cannot be extended

Question 62

Buprenorphine-containing products are schedule III drugs available in various formulations. The prescribing requirements differ based on the indication for use. The combination of buprenorphine and naloxone is only FDA-approved for treating opioid dependence. Prescribers do not need a DATA waiver to prescribe buprenorphine products for…

Answer 62

treating pain, but they must specify the indication on the Rx.

Question 63

Opioid Addiction:

Prescriber must have DATA waiver (“X” in DEA number)

Answer 63

FDA-approved formulations

Buprenorphine: Probuphine, Sublocade
Buprenophine/naloxone: Suboxone, Bunavail, Zubsolv

Question 64

Pain Management:

Prescriber must specify the Rx is indicated for pain

Answer 64

Buprenorphine: Butrans, Belbuca, Buprenex

Question 65

Some drugs legally classified as OTC by the FDA are stored behind-the-counter (BTC) so that customers must…

Answer 65

ask the pharmacist or another staff member to retrieve the drug. The sale of some BTC drugs, such as pseudoephedrine, must be documented.

Question 66

The Combat Methamphetamine Epidemic Act (CMEA) was passed in 2005 to limit the widespread availability of these precursor drugs, thereby reducing the production of methamphetamine. These include:

Answer 66

• Pseudoephedrine (eg, Sudafed): in many cough and cold products
• Ephedrine (ingredient in Bronkaid, Primatene): For asthma symptom relief (not gl recommended)
• Norpseudoephedrine: not availabe in the U.S.
• Phenylpropanolamine: By Rx only for veterinary use

Question 67

Pseudoephedrine, ephedrine and their transaction logbook must be kept behind the counter or in a locked cabinet. All sales should be recorded, with the customer signing the logbook. The exception to this requirement is…

Answer 67

the purchase of a single-dose package of pseudoephedrine, which contains a max of 60 mg (two 30 mg tablets)

Question 68

The daily and monthly limits for ephedrine and pseudoephedrine sales are derived from the base amoount of drug. For example, pseudoephedrine HCl 30 mg tablets contain 24.6 mg of pseudoephedrine base. Therefore, an individual can…

Answer 68

purchase a max of 146 pseudoepherine HCl 30 mg tablets in one day.

(3,600 mg max pseudoephedrine base per day/24.6 mg pseudoephedrine base/tablet= 146 tablets)

Question 69

Quantity limits for OTC sales of pseudoephedrine and ephedrine:

Answer 69

• 3.6 grams per day
• 9 grams in a 30-day period
• 7.5 grams in a 30-day period for each mail-order purchase
• 3 packages per transaction

These limits are for OTC sales only. A larger quantity can be dispensed with a valid Rx.

Question 70

All pharmacies that sell ephedrine or pseduoephedrine products must “self-certify” to the Attorney General of the US that they are trained in the sales regulations for these drugs. Purchase requirements include:

Answer 70

• Documentation of the customer name, address, date and time of sale and signature in the logbook
• Photo identification issued by the state or federal govenment (eg, driver’s license, passport, state identification card)
• Verification of customer identity by the store staff
• Documentation of the product name and quantity sold

The DEA requires that the logbook be kept in a secure location for at least 2 years. Information in the logbook cannot be shared with the public.

Question 71

Dextromethorphan is an OTC cough suppressant used in in more than 120 cough and cold medications. Dextromethorphan is not currently scheduled under the Controlled Substances Act (CSA), but the DEA has…

Answer 71

indicated that dextromethorphan may become a scheduled drug in the future.

Question 72

Dextrometorphan-containing products cannot be sold to anyone under 18 years old with a Rx in California. The purchaser must provide…

Answer 72

government-issued ID (with name, DOB, description, and picture of the purchaser), unless the pharmacy staff reasonably believes that the purchaser looks at least 25 years old. Dextromethorphan products can be kept on the floor shelves outside of the pharmacy area with other OTC products, and the cashier staff can check for the age requirement.

Question 73

A pharmacist can furnish hypodermic needles and syringes to patients without a Rx in the following situations:

Answer 73

• The pharmacist knows the patient and the pharmacist has previously been provided with a Rx or other proof of legitimate medical need (eg, administering insulin)
• To a person > 18 years or older, as a public health measure to prevent the transmission of HIV, viral hepatitis, and other bloodborne disease among persons who use syringes and hypodermic needles, and to prevent subsquent infection of sex partners, newborn children or other persons. There is no limit on the # that can be provided.
• Use for animals, as long as the animal’s owner is known to the pharmacist or the person’s identity can be properly established.
• For industrial use, as determined by the board.

Question 74

Pharmacies that sell syringes without a Rx must:

Answer 74

• Store needles and syringes in a manner that ensures that they are not accessible to unauthorized persons
• Provide for the safe disposal of needles and syringes
• Sell or furnish sharps containers or mail-back sharps containers
• Provide on-site sharps collection and disposal (pharmacies can take back used syringes only if enclosed in a sharps container)
• Provide written or verbal information to customers at the time of sale on how to access drug addiction treatment or testing and treatment for HIV and HCV, information about how to safely dispose of sharps waste.