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Sept. 19, 2013Chapter 5

Dispensing Controlled Substances

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Controlled Substance (CS) Prescriptions

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

• Rx does not include orders for medication dispensed for immediate administration (i.e. hospital chart orders)

• Prohibition against prescriptions for office use

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Those Allowed to Prescribe CSs

• Individual practitioners (IP) authorized to prescribe (or issue medication orders) in their state and registered by DEA or exempt from registration

• Employees or agents of IP may communicate prescriptions to a pharmacist, or prepare the Rx for the signature of IP (c.f., refill request rxs by pharmacies not allowed ** See DEA letter** (separate slide))

• Delegation of prescriptive authority not legal unless agent also has prescriptive authority

• When suspicious, a pharmacist may want to check the validity of a DEA number by performing the calculations

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Those Allowed to Dispense Controlled Substances

• Only a pharmacist acting in usual course of professional practice and who is registered individually or employed by a registered pharmacy or institutional practitioner

• Ancillary personnel may engage in CS dispensing activities if permitted by state law

• Individual practitioners may dispense if permitted by state law

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Methods or Prescribing

• Written• Oral, reduced immediately to writing by

pharmacist• Faxed (a faxed rx is a paper rx and must be

manually signed)• Electronic [must comply with stringent

technical rules – not yet commonly used, some pharmacies have been certified as compliant]

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Information Requirements of CS Prescriptions

• Date of issuance required: No pre or post dating

• Must contain full name & address of patient, drug name, strength, dosage form, quantity prescribed, directions for use and name, address & registration number of practitioner ** See FR case against MD** (Separate slide)

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Correcting Errors and Omissions

• For C-III, C-IV & C-V Rxs, the pharmacist may add or change any information after consultation with practitioner and documentation, except 1. patient’s name, 2. the actual CS prescribed (except for generic substitution), or 3. prescriber’s signature

• For C-II Rxs, the DEA had maintained that additions or changes could be made the same as with other CS Rxs. Currently the DEA’s position is that a C-II Rx may not be modified orally (but now says look to state law because 2007 preamble in regulation allowing multiple CIIs said can’t make changes, but DEA had said you could make some changes, and this discrepancy created confusion, so DEA said to look to state law to see if changes could be made).

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Other Requirements of Written CS Rxs

• Must be signed on day of issuance• Written in ink, indelible pencil or typed

and manually signed• Contain name AND ADDRESS of patient

**See Fed. Register RE: MD Discipline**• Corresponding responsibility of

pharmacist and prescriber that a CS Rx comply with all requirements

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IPs Exempt from Registration

• Must include registration number of institution and special internal code number.

• Must include name of prescriber stamped, typed or handprinted, as well as signature of prescriber.

• IPs in armed services or public health must include on Rx service ID number in place of registration number if no DEA # because exempt

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Purpose of CS Prescription• A CS Rx must be for a legitimate medical purpose in the usual course

of professional practice • Corresponding responsibility upon the pharmacist • **See Separate Slide – Main Street Pharmacy – Fed. Register**• Knowingly prescribing or dispensing a Rx not for a legitimate medical

purpose violates the law– Knowingly standard is one of a conscious disregard for

the obvious– When suspicions should exist a pharmacist is expected

to exercise professional judgment and investigate• Legitimate medical purpose in the usual course of professional

practice generally means acting in accordance with accepted standards of medical practice

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Legitimate Medical Purpose & Usual Course of Professional Practice

• Examples of invalid prescriptions include:– narcotic Rxs written for the purpose of maintaining or detoxifying an

addict (remember, although ok if an OTP or DATA waived prescriber, it is still not “usual course of professional practice”)

– Rxs written for fictitious patients– Rxs written without a good-faith medical examination– Rxs written when there is no medical reason

• A facially valid Rx is not necessarily a valid Rx• Pharmacists face violations in situations where there is

blatant or glaring misconduct as opposed to isolated prescriptions

• DEA has published examples of situations that might be suspicious

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Exercise of Clinical Judgment and Pain Treatment

• Treatment of pain is a legitimate medical purpose• Drug tolerance and physical dependence as a

consequence of opioid use is normal and natural• Quantity of drugs prescribed and frequency of Rxs

are alone not indicators of improper prescribing• Pharmacists’ role is determining legitimacy of Rx

for pain as opposed to therapeutic appropriateness of using opioids

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Differentiating Treatment of Pain from Treatment of Addiction

• Important to determine whether the purpose of opioid treatment is legally for pain or illegally for addiction

• Important to ascertain whether taper down dosages are for detoxification of addiction or for withdrawal due to physical dependence

• Important to distinguish addiction from dependence• Exceptions allowing for treatment of addicts outside of licensed

addiction programs or DATA– Prescriber can administer opioids for up to 3 days while arranging for treatment– Hospitalized patients incidental to treating condition other than addiction

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Ascertaining the Legitimacy of Opioid Rxs in Pain Treatment

• Rxs from alleged pain clinics where several patients present several Rxs for large quantities of CS Rxs create special concerns for pharmacists

• Pharmacists should familiarize themselves with the medical standards of practice for diagnosing and treating pain

• Pharmacists should seek a collaborative practice relationship with pain physicians

• When necessary and appropriate pharmacists should interview both the patient and prescriber regarding the pain and the treatment

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Dispensing C-II Drugs• General rule: C-II prescriptions must be written and signed by

prescriber• Exceptions:– Emergency situations: Oral or fax Rx permissible

provided requirements are met. Original Rx must be received within 7 days (or postmarked if mailed)

– Narcotic compounded drug for direct administration by infusion. Faxed Rx serves as the original

– Long-term care facility patients: Faxed Rx serves as original

– Hospice patients for narcotic C-II drugs. Faxed Rx serves as original

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Partial Filling of C-II Drugs• In ambulatory setting pharmacist may partially fill if “unable to

supply” full quantity

– Balance must be filled within 72 hours after partial filling. If not, must notify prescriber and no further quantity may be supplied

– “Unable to supply” can be broadly interpreted to situations beyond out of stock (i.e., can’t afford, insurance limits)

• In LTCFs or for terminally ill patients, may partially fill for up to 60 days from date of issuance, provided recordkeeping requirements are met

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Multiple C-II Rxs for Same Drug and Patient on Same Day

Permitted provided:• Total quantity prescribed does not exceed 90-day supply• Practitioner determines legitimate medical purpose to do

this• Practitioner writes instructions on each Rx (other than

first) as to earliest date each Rx may be dispensed• Multiple Rxs do not create undue risk of diversion• Permissible under state law• Can be in any quantity (i.e., 3 rxs of 30 day supply each or

even 12 rxs of 7 day supply each [84 day supply])

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Dispensing C-III, C-IV and C-V Drugs

• May be dispensed pursuant to written, faxed, or oral order.

• Oral orders must be promptly reduced to writing• IPs may administer or dispense without a Rx

• [Discuss E-Prescribing regs and conflict with E-Sign law]

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Refilling C-III & C-IV Rxs

• For C-III and C-IV drugs, limit of 6 months after date of issuance or 5 times, whichever comes first

• Practitioner may orally authorize additional refills without new Rx if original was written for less than 5 and authorization is recorded on hard copy or in automated system

• Refill quantity plus originally authorized amount of refills cannot exceed the 5 refill limit

• No date limit on C v Rxs (or on C ii Rxs for that matter!)(under federal law)

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Transferring Prescription Information

• CS Rx information (except C-II) may be transferred one-time between pharmacies if state law allows and requirements are followed by both transferring pharmacy and receiving pharmacy.

• Rx information sharing among pharmacies participating in “real-time” common-electronic record systems are not subject to the transfer Rx requirements (CS Rxs may be transferred up to the maximum number of refills permitted (unless prohibited by state law)

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Internet Prescriptions• Rogue internet pharmacy businesses are those that sell Rx

medications to customers either without requiring Rxs or by issuing Rxs pursuant to online surveys.

• Ryan Haight Act law defines a valid Rx as one that has been issued for a legitimate medical purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient

• The Act establishes several requirements with which online pharmacies must comply

• Although the Act only applies to CS Rxs, most states consider any Rx not dispensed pursuant to a legitimate physician-patient relationship as invalid

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Central Filling of Rxs• Pharmacies that fill Rxs for other retail pharmacies

pursuant to contractual arrangement• May fill both new and refill Rxs• Any Rx dispensed for another pharmacy must be

transported to that pharmacy for furnishing to patient• Label of dispensed drug must indicate at which pharmacy

the drug was dispensed• Cannot accept Rxs directly from patient or practitioner

or deliver Rx directly to patient or practitioner• Corresponding responsibility doctrine applies to

pharmacists at both facilities.• Retail Pharmacy retains original, faxes copy to central fill

pharmacy

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Automated Dispensing Systems (ADS) in LTCFs

• ADS is a mechanical system that stores, packages, counts, labels and dispenses medications and maintains transaction information

• Purpose is to reduce stocks of excess CSs in LTCFs• DEA has taken the position that LTCSs cannot transfer CSs

back to the pharmacy• Pharmacy that installs ADS must maintain separate DEA

registration at LTCF location

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State Electronic Rx Monitoring Programs (PMPs)

• State PMP requires pharmacy to electronically transmit to the state a record of CS Rx dispensed

• Enables states to determine possible diversion and abuse situations

• Most PMPs allow practitioners to request patient-specific information upon request

• NASPER enabled states to obtain federal grant support for PMP programs

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Recordkeeping

• Every registrant must keep a complete and accurate record of all CSs

• Three types of records involved:– Inventory– Drugs received– Drugs dispersed

• Negligent recordkeeping is a violation of the CSA, up to a $10,000 fine per occurrence

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General Recordkeeping Requirements

• Records generally must be kept for 2 years• Certain records may be kept at a central location

with notification to the DEA (not 222 forms)• Centralized records must be able to be delivered to

registered location within 2 business days per DEA request

• C-II records must be maintained separately from other records, C-III, IV and V SHOULD be separate from others but need not be if “readily retrievable”

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Inventory Records• Prior to beginning business and subsequently every 2 years an

inventory must be conducted containing a complete and accurate record of all CSs “on hand”.

• “On hand” means in possession of or under the control of the registrant

• Inventory may be taken at beginning or end of business day and records must be written, typed or printed

• Newly scheduled drugs must be inventoried on date of scheduling• Exact count must be made of C-I or C-II drugs• Estimated count permissible for other schedules unless

container holds more than 1,000 units

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Records of Receipt

• Acceptable records of receipt include invoices and Form 222

• Pharmacy must record date of receipt on invoice and Form 222

• If invoice contains both CSs and nonCSs, the CSs must be identified in a manner so as to be readily retrievable

• Records of receipt must contain all required information

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Records of Dispersal

• Acceptable records of dispersal include Rxs, record books, Form 222, invoices, records of disposal, theft or loss, etc.

• Prescriptions may be filed in one of three ways and each Rx must contain all required information – 21 CFR 1304.04 (h)(2):– 1: a.Cii file; b. C iii, iv , v file c. Non-control file.– 2: a. Cii file b. Ciii, iv, v, and non-control file [need Red “C” on Ciii, iv and v]– 3: a. Cii , iii, iv and v file [need Red “C” on Ciii, iv and v] b. Non-control file– No red “C” needed in #2 and #3 if computer system allows for retrieval based on schedule.

• Conflict because one section says C-II rxs separate file then says C-III,IV and V can be with C-II if red “C”??

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Nonprescription Schedule V Sales

In some states C-V products may be sold without Rx provided:

• Dispensing done only by a pharmacist (getting product, recording in book, bagging, BUT non-pharmacist employee can do the actual sale (i.e., ring it out and take the cash). Intern can dispense under supervision.

• No more than 8 oz of an opium containing product or 4 oz of any other CS may be dispensed to same purchaser within a 48 hour period

• Purchaser is at least 18• Purchaser furnishes suitable identification• Sale recorded in a bound record book with all required

information

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Distributions from a Pharmacy to Another Practitioner

• Invoice required for C-III, C-IV and C-V products containing all required information

• Form 222 required for C-II products• Total number of dosage units distributed to

another registrant must not exceed 5% of total units of CSs distributed and dispensed in 1 year.

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Institutional Medication Records

• Medication or chart orders are distinguished from prescriptions and need only contain minimum information necessary to provide an acceptable dispersal record

• Must be readily retrievable• Discharge medication orders may only be

dispensed pursuant to Rx

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Disposal or Destruction

• Must request via a DEA Form 41 available online• Must record name of drug, number of containers and content

of each to be disposed or destroyed• DEA allows destruction without DEA presence in one of 3

manners

– Witnessed by 2 people who should be health care licensees or law enforcement officers

– Forward CSs to a DEA registered distributor– “Blanket authorization” for hospitals and clinics

that have to dispose of used needles, syringes or other injectables containing CSs

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Return of CSs to Pharmacy for Disposal

• DEA has taken position that CSs may not be returned by a patient or LTCF to a pharmacy for disposal

• DEA has issued an advance notice of rulemaking which would change this position

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Records of Theft or Loss

• Registrant must notify DEA within one day of discovery of any “theft or significant loss” of any CS

• DEA has listed several factors to be considered in determining whether a loss is significant

• Registrant must complete Form 106 which is available online.

• **New Massachusetts Law**

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Records Required of Individual Practitioners

• Must keep records of CSs they dispense, but not of those they prescribe.

• Need not keep records of CSs they administer unless the IP regularly engages in dispensing or administering and charges patients.

• Record must be kept of CSs administered in the course of maintenance or detoxification or treatment of addiction.

• May administer or dispense CS without a Rx

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DEA Form 222• Required for any distribution of C-I or C-II drugs• Forms obtained by requesting in writing from nearest DEA office• Forms issued in mailing envelopes containing either 7 or 14

forms• Each form is in triplicate titled Copy 1, Copy 2, Copy 3• Forms are serially numbered and issued with name, address and

registration number of registrant, authorized activity and schedules registrant is authorized to handle

• Registrant may not correct or change any information or errors on the forms

• May send a sticky note for supplier not to fill certain lines

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Execution of Form 222• All 3 copies must be executed simultaneously• 10 numbered lines on each form, only 1 item per line• Number of last line completed must be noted on each form• Form must contain required information. NDC# optional

(supplier must enter it)• Must be signed and dated by authorized person• Copy 1 to supplier, Copy 2 to DEA, Copy 3 retained by purchaser• Purchaser, upon receipt of order, must record # of containers

received of each item and date received• Partial order fills by supplier must be completed within 60 days• Important that purchaser submit complete, legible form

without errors, alterations or erasures

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Proposed Single Copy Form 222

• Books of 7 and 14 triplicate order forms would be replaced by a single sheet tamper resistant form

• Purchaser would send original completed form to supplier after making and retaining a copy. Supplier would then send original completed form to DEA after making and retaining a copy

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Electronic Order System (CSOS)

• May be used instead of Form 222• Purchaser can order any drug• Registrant must obtain a digital

certificate for each DEA registered location

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Power of Attorney (POA)

Required to allow person other than one who signed registration to execute Form 222

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Distributions of C-I and C-II Drugs Between Registrants

Whenever registrants distribute C-I or C-II drugs among themselves they must execute a Form 222 following proper procedure

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Lost Or Stolen Forms

• If unfilled order form is lost purchaser must execute another, together with statement noting serial number of lost form, date of lost form and that CS were not received

• Must maintain together copy 3 of second order form and lost order form with statement

• Copy of statement must be sent with Copies 1 & 2 to supplier

• If forms stolen or lost other than in transmission must notify DEA and provide serial #s of missing forms. If found, DEA must be notified immediately

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Preservation of Forms

Executed Form 222s must be maintained separately from all other records and retained for 2 years. Copy 3 must be kept at the registered location.

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Next Time – Ch. 5 cont & Ch 6