Dispensing Controlled Substances

Controlled Substance (CS) Prescriptions

Defined as an order for medication dispensed to or for an ultimate user

Are hospital chart orders for immediate medication administration considered prescriptions?

No. Orders for medication dispensed for immediate administration (e.g., hospital chart orders) are excluded from the definition of a prescription.

Are controlled substance prescriptions allowed for office use?

No. Prescriptions for office use are prohibited.

Who is authorized to prescribe controlled substances?

Individual practitioners (IPs) who are authorized to prescribe or issue medication orders in their state and are registered with the DEA or exempt from DEA registration.

What can employees or agents of individual practitioners do with controlled substance prescriptions?

They may communicate prescriptions to a pharmacist or prepare a prescription for the individual practitioner's signature.

Can prescriptive authority be delegated to an agent who does not have prescriptive authority?

No. Delegation of prescriptive authority is illegal unless the agent also has prescriptive authority.

How can a pharmacist check the validity of a suspicious DEA number?

The pharmacist can perform the DEA number calculations or search a national database.

Who is allowed to dispense controlled substances?

A pharmacist acting in the usual course of professional practice who is either individually DEA-registered or employed by a registered pharmacy or institutional practitioner.

Can ancillary personnel participate in controlled substance dispensing?

Yes, if permitted by state law.

Can individual practitioners (IPs) dispense controlled substances?

Yes, if permitted by state law.

What are the date requirements for a controlled substance prescription?

The prescription must include the date of issuance. Predating and postdating are not allowed.

What information must be included on a controlled substance prescription?

• Patient’s full name and address

• Drug name, strength, dosage form, and quantity

• Directions for use

• Practitioner’s name, address, and DEA registration number

What information must be added to a controlled substance prescription before filing?

• Dispensing pharmacist’s written or typed name or initials

• Date dispensed

• Units or volume dispensed

When must a written controlled substance prescription be signed?

It must be signed on the day it is issued.

How must a written controlled substance prescription be prepared and signed?

It must be written in ink, indelible pencil, or typed, and then manually signed.

What is the corresponding responsibility of the pharmacist and prescriber?

Both the pharmacist and prescriber are responsible for ensuring that the controlled substance prescription complies with all requirements.

What numbers must be included on a controlled substance prescription issued by an IP exempt from registration?

The institution’s registration number and a special internal code number.

What prescriber identification is required on a prescription issued by an IP exempt from registration?

The prescriber’s name must be stamped, typed, or hand-printed, and the prescription must include the prescriber’s signature.

What number must armed services or public health practitioners include instead of a registration number?

Their service ID number.

What is the current status of DEA rules for correcting errors or omissions on controlled substance prescriptions?

The DEA is waiting to issue a rule on this topic.

How could pharmacists correct C-III, C-IV, and C-V prescriptions under past rules?

Pharmacists could add or change information after consulting the prescriber and documenting the changes, with certain exceptions.

What information could NOT be changed on C-III, C-IV, and C-V prescriptions under past rules?

• Patient’s name

• Controlled substance name, except for generic substitution

• Prescriber’s signature

What can a pharmacist do if a controlled substance prescription needs correction?

Obtain a new verbal prescription if needed, where permitted.

How has the DEA’s position on correcting C-II prescriptions changed?

The DEA previously allowed corrections similar to other controlled substance prescriptions, but its position has changed over time. Currently, corrections may follow state law or policy until a DEA rule is proposed or passed.

What is the required purpose of a controlled substance prescription?

It must be for a legitimate medical purpose and issued in the usual course of professional practice.

Who has corresponding responsibility for ensuring a CS prescription is legitimate?

Both the prescriber and the pharmacist.

Is it illegal to knowingly prescribe or dispense a CS prescription without a legitimate medical purpose?

Yes. Knowingly prescribing or dispensing a CS without a legitimate medical purpose violates the law.

What should a pharmacist do when a CS prescription raises suspicions?

Exercise professional judgment and investigate the prescription.

In Massachusetts, there are ___ schedules of Controlled substances

6

Under the federal controlled substance act, there are ___ schedules of controlled substances

5

Which of the following are schedule I drugs?

LSD, peyote, heroin

Which of the following are schedule II drugs?

codeine 30 mg tablets, hydrocodone/APAP, methylphenidate

Which of the following are schedule III drugs?

APAP/codeine, secobarbitol suppositories, anabolic steroids, fiorinal

Which of the following are schedule IV drugs?

alprazolam and tramadol

T or F: robitussin with codeine is an example of Schedule V

true

T or F: a retail pharmacy can dispense methadone for addiction purposes

false

daily sales limit of pseudoephedrine is limited to

3.6 g

mail order limit for pseudoephedrine

7.5 g

T or F: a pharmacy can mail a prescription for oxycodone to a patients house

true

which form is used to register with the DEA ?

224

which form is used to order CII?

222

What schedule is pregabalin?

CV

In Massachusetts, what schedule is gabapentin?

CVI

Which form is used by authorized Drug Enforcement Administration (DEA) registrants (such as pharmacies, hospitals, clinics, and research labs) to record and report the destruction of controlled substances in Schedules I through V?

41

T or F: in mass, pharmacies sell hypodermic syringes and needles to any person, of any age, without a prescription and without an ID

true

which form is used to report the theft or significant loss (diversion) of controlled substances?

106

methylphenidate brand name

Ritalin and Methylin

codeine brand name

Tylenol with Codeine (acetaminophen and codeine) and Guaiatussin AC (codeine and guaifenesin)

hydrocodone/APAP brand name

Vicodin

secobarbital brand name

Seconal

anabolic steroids examples

Testosterone

butalbital / aspirin / caffeine brand name

fiorinal

alprazolam brand name

Xanax and Xanax XR

tramadol brand name

• Ultram

• Ultram ER

• ConZip

can a PA authorize refills for the doctor if a prescription appears suspicious?

No, a Physician Assistant (PA) should not blindly authorize a refill for a doctor if a prescription appears suspicious

under federal law, when do CII prescriptions expire?

they do not have a hard federal expiration date

under mass law, when do CII prescriptions expire?

30 days from the date it was issued

CII prescriptions issued from out-of-state are valid for only ____ from the date of issuance

5 days

What does “legitimate medical purpose in the usual course of professional practice” generally mean?

Acting in accordance with accepted standards of medical practice.

What are examples of invalid controlled substance prescriptions?

• Narcotic prescriptions written to maintain or detoxify an addict.

• Prescriptions written for fictitious patients.

• Prescriptions written without a good-faith medical examination.

• Prescriptions written without a medical reason.

Are prescriptions that appear valid on their face always legally valid?

No. A prescription that looks valid may still lack a legitimate medical purpose or violate professional practice standards.

When are pharmacists more likely to face enforcement action for suspicious CS prescriptions?

When there is blatant or glaring misconduct rather than isolated prescriptions.

Has the DEA published examples of potentially suspicious controlled substance prescriptions?

Yes. The DEA has published examples of situations that may be suspicious.

Why is it important to distinguish pain treatment from addiction treatment?

To determine whether opioid treatment is legally intended for pain or illegally intended to treat addiction.

Why is it important to understand why opioid dosages are tapered down?

To determine whether the taper is for addiction detoxification or to manage withdrawal caused by physical dependence.

What is happening to overdose deaths in the U.S.?

Overdose deaths in the U.S. continue to rise.

What are the three main types of efforts used to address the opioid epidemic?

revention, treatment, and enforcement.

What are examples of federal and state efforts to address the opioid epidemic?

• Prescribing guidance and laws

• Prescription Drug Monitoring Programs (PDMPs)

• Naloxone access

• FDA Risk Evaluation and Mitigation Strategies (REMS)

• Medication disposal

• Expansion of partial fills

• Mandated electronic prescribing

What is the purpose of federal and state efforts addressing the opioid epidemic?

To help address the opioid epidemic while balancing appropriate pain treatment with overdose prevention and enforcement.

What is the general rule for C-II prescriptions?

They must be written and signed by a prescriber.

What does CMS require for Medicare Part D prescriptions?

Electronic prescribing (e-prescribing or eRx).

What are the exceptions to the general written-prescription rule for C-II drugs?

• Emergency situations

• Narcotic compounded drugs administered directly by infusion

• Long-term care facility (LTCF) patients

• Hospice patients receiving narcotic C-II drugs

• Electronic prescriptions that meet the required regulations

When can a faxed C-II prescription serve as the original prescription?

• Narcotic compounded drugs for direct administration by infusion

• Prescriptions for long-term care facility (LTCF) patients

• Prescriptions for hospice patients for narcotic C-II drugs

What does the 2016 CARA law allow for partial filling of C-II prescriptions?

Partial fills may be requested by the patient or prescriber and completed within 30 days of the prescription date, unless state law prohibits it.

How can a C-II emergency prescription received verbally be partially filled?

The remaining quantity must be provided within 72 hours.

What is the partial-filling time limit for C-II prescriptions for LTCF or terminally ill patients?

Partial fills may occur for up to 60 days from the date of issuance, provided recordkeeping requirements are met.

What does “unable to supply” mean for a C-II partial fill?

It includes situations where the pharmacy cannot supply the full quantity or needs to verify information with the prescriber.

What happens if the remaining quantity of a C-II partial fill is not obtained within 72 hours?

No more may be dispensed under that partial fill, and the pharmacist must contact the prescriber to inform them.

Does the patient have to pick up the remaining C-II medication within 72 hours?

No. The pharmacy must obtain the remaining quantity within 72 hours, but the patient may pick it up later.

What must a pharmacist do when partially filling a C-II prescription?

Document the details of the partial fill and meet the applicable recordkeeping requirements.

Can a practitioner issue multiple C-II prescriptions for the same drug and patient on the same day?

Yes, if all required conditions are met.

How must multiple C-II prescriptions issued on the same day be written?

Each prescription must be written on a separate prescription blank.

What is the maximum total supply allowed for multiple C-II prescriptions issued on the same day?

The total quantity prescribed cannot exceed a 90-day supply.

What must the practitioner determine before issuing multiple C-II prescriptions for the same day?

that there is a legitimate medical purpose for issuing them

What instructions must be written on multiple C-II prescriptions after the first prescription?

Each prescription after the first must state the earliest date it may be dispensed.

Can multiple C-II prescriptions be issued if they create an undue risk of diversion?

No. The multiple prescriptions must not create an undue risk of diversion.

What state-law condition applies to issuing multiple C-II prescriptions on the same day?

The practice must be permitted under state law.

What types of prescriptions can be used to dispense C-III, C-IV, and C-V drugs?

Written, faxed, electronic, or oral orders

What are the exceptions to the general prescription requirements for controlled substances?

• Emergency situations.

• Narcotic compounded drugs for direct administration by infusion.

• Long-term care facility (LTCF) patients.

• Hospice patients receiving narcotic C-II drugs.

• Electronic prescriptions that meet applicable requirements.

When does a faxed prescription serve as the original prescription?

• Narcotic compounded drugs for direct administration by infusion.

• Prescriptions for LTCF patients.

• Prescriptions for hospice patients for narcotic C-II drugs.

How long can C-III and C-IV prescriptions be refilled?

Up to 6 months after the date of issuance or 5 refills, whichever comes first.

Can a practitioner authorize additional refills for a C-III or C-IV prescription?

Yes. If the original prescription was written for fewer than 5 refills, the practitioner may orally authorize additional refills.

How must an oral authorization for additional C-III or C-IV refills be documented?

The authorization must be recorded on the hard copy or in an automated system

Can the quantity of a C-III or C-IV refill exceed the original quantity authorized?

No. The refill quantity cannot exceed the quantity originally authorized.

How must refills be recorded when a pharmacy uses a nonautomated system?

Record the required information on the back of the prescription or another readily retrievable document.

What must an automated system provide for C-III and C-IV refill records?

Online retrieval by display or hard-copy printout of:

• The original prescription information.

• The up-to-date refill history.

What alternatives may be used instead of a hard-copy printout for refill records?

A bound logbook or separate refill file.

How long must C-III and C-IV refill records be maintained?

2 years

What additional system must pharmacies have for documenting refills?

An auxiliary system for documenting refills.

Are partial fills of C-III, C-IV, and C-V prescriptions permitted?

Yes, as long as all applicable requirements are met.