Pharmacy Law: The Ins and Outs of Controlled Substances...

Pharmacy Law: The Ins and Outs of Controlled SubstancesPharMEDium Lunch and Learn Series

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Pharmacy Law: The Ins and Outs of Controlled Substances

LUNCH AND LEARN

January 8, 2016

Featured Speaker: Joseph J. Bogdan, Pharm.D., R.Ph., J.D.

Pharmacist – AttorneyLisle, Illinois

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ProCE, Inc. (Pharmacist and Tech CE)

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It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Bogdan has no relevant commercial and/or financial relationships to disclose.



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Pharmacy Law: The Ins and Outs of Controlled Substances

J 8 2016

LUNCH AND LEARN

January 8, 2016

Featured Speaker: Joseph J. Bogdan, Pharm.D., R.Ph., J.D.

Pharmacist – AttorneyLisle, Illinois

6



Outline the differences in state vs federal pharmacy law

Identify the role of the Drug Enforcement Administration Identify the role of the Drug Enforcement Administration concerning controlled substances under the Federal Controlled Substance Act

Compare and contrast the five schedules of controlled substances

Describe the ordering and recordkeeping requirements for S h d l II V t ll d b tSchedule II-V controlled substances

Discuss the professional and legal ramifications of controlled substance diversion

Drug Enforcement Administration (DEA)

Controlled Substances Act (CSA)

Controlled Substance Ordering System (CSOS)

Food & Drug Administration (FDA)



Controlled substances are drugs with high to moderate potentials

for abuse and so are strictly regulated by state and federal lawsfor abuse and so are strictly regulated by state and federal laws

Abuse of these drugs may have detrimental effects on the

physical, psychological, and social welfare of individuals.

The law that regulates the manufacture, dispensing, distribution

and possession of all controlled substances is referred to as the

C ll d S b A (CSA)Controlled Substances Act (CSA).

The goal of the CSA is to ensure that these drugs are not

accessed readily by inappropriate means.

Enforce the controlled substances laws and regulations of the United Statesregulations of the United States

Pursue criminal and civil justice of the US organizations involved in the growing, manufacture, or distribution of controlled

b t i i d ti d f illi itsubstances appearing in or destined for illicit traffic in the US



The Controlled Substances Act gives the DEA the authority to enforce rules that dictate prescribing

d di i f ll d band dispensing of controlled substances to patients.

Pharmacies that dispense scheduled medications must obtain a state license from the DEA and must be renewed every 3 years.

The DEA is responsible for making sure p gregistrants abide by security codes and storage requirements set forth by the controlled substance act.

Controlled substances are classified into CI, CII CIII CIV and CVCII, CIII, CIV, and CV

The DEA and FDA are responsible for determining which drug is placed into which schedule

The classifications are based on abuse potential, and accepted and approved medical use in the US



.Classification Definition

Schedule I: Heroin, (LSD), Marijuana No accepted medical use, and high potential for abuse

Schedule II: Fentanyl, Sufentanil, Remifentanil, Meperidine, Methadone, Hydromorphone, Morphine

High potential for abuse that may lead to psychological or physical dependence

Schedule III: Ketamine, Buprenorphine

Moderate potential for abuse, low physical or psychological dependencedependence

Schedule IV: Methohexital, Lorazepam, Phentermine

Low potential for abuse as compared to schedule III

Schedule V: Promethazine VC, Cheratussin AC

Low potential for abuse as compared to schedule IV

Pharmacies that dispense scheduled meds must obtain a state license from the DEAo Form 224: used to register a new pharmacy

Pharmacy registration must be renewed every 3 yearso Form 224a: Registrant can renew online no more than 60 days

prior to the current expiration date

Corporations that own or operate a chain of pharmacies may submit a single DEA Form



Schedule II medications

• Receiving registrant must issue a DEA Form 222 or an electronic Receiving registrant must issue a DEA Form 222 or an electronic equivalent to the registrant transferring the drugs

Schedules III-V

• Must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred

• Document must include names, addresses, and DEA registration n mbers of parties in ol ed in the transfer of controlled s bstancesnumbers of parties involved in the transfer of controlled substances

Records involving the transfer must be kept readily available by the pharmacy for 2 years

Complete inventory– Documents the drug name, dosage form, strength, quantity, and g , g , g , q y,

date transferred

DEA Form 222 or the electronic equivalent must be prepared to document the transfer of schedule II controlled substances

A copy of the inventory must be included in the records f h hof each pharmacy



Pharmacist must maintain a written record showing:• Date of transactionDate of transaction

• Name, strength, dosage form, and quantity of controlled substance

• Supplier or manufacturer’s name, address, and registration number

F 222 th l t i i l t Form 222 or the electronic equivalent

Drugs should be sent to a DEA-registered reverse distributor who handles the disposal of controlled substances

Schedule II• Reverse distributor must issue Form 222 or the electronic equivalent to

the pharmacy

Schedules III-V • Pharmacy must maintain a record of distribution that lists the drug name,

dosage form, strength, quantity, and date transferreddosage form, strength, quantity, and date transferred

Registered reverse distributor • Responsible for submitting DEA Form 41 (Registrants Inventory of

Drugs Surrendered)



The mission of the office of diversion control is to prevent, detect and investigate the diversion of pharmaceutical controlled substances and chemicals from legitimate channels of distribution. While ensuring adequate and uninterrupted supply of controlled substances to meet legitimate medical, commercial and scientific needs.

Diversion is the movement of legitimate controlled substances into other legitimate channels for other than legitimatemedical scientific and/or research purposesmedical, scientific and/or research purposes.

Diversion can occur at ANY TIME, ANY PLACE, under ANY circumstance by ANYONE. The common denominator is the HUMAN FACTOR.



If theft occurs• Report within 1 business day of the discovery ofReport within 1 business day of the discovery of

the theft or loss

• Notify in writing the local DEA Diversion Field Office

• Notify local law enforcement and state regulatory agencies

Pharmacy must also complete a DEA Form 106

Records for purchased, received, stored, distributed, dispensed, or otherwise disposed of

Must be readily retrievable• Records kept by automatic data processing systems or other

electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time, and/or

• Records kept in such a manner that certain items are asterisked, redlined, or in some other manner visually identifiable apart from y pother items appearing on the records

Maintained for at least 2 years for inspection and copying by duly authorized DEA officials



• Schedule II• Maintained separately from all other records of the registrantMaintained separately from all other records of the registrant

• Schedules III, IV, and V• Must be maintained either separately from all other records

OR in such a form that the information required is readily retrievable from the ordinary business records

• Must be made readily retrievable by use of a red "C" stamp not less than 1 inch high

If a prescription is created, signed, transmitted, and received electronically, all records related to that

i i b i d l i llprescription must be retained electronically

The electronic application must be capable of printing out or transferring the records in a format that is readily understandable to an administrative or other law enforcement agent at the registered location

Electronic copies of prescription records must be sortableby prescriber name, patient name, drug dispensed, and date filled



Executed and unexecuted official C-II order forms Power of Attorney authorization to sign order formsy g Receipts and/or invoices for schedules III, IV, and V

controlled substances Records of controlled substances dispensed (i.e.,

prescriptions, schedule V logbook) Reports of Theft or Significant Loss (DEA Form 106),

if applicableif applicable Inventory of Drugs Surrendered for Disposal (DEA

Form 41), if applicable

All inventory records of controlled substances, including initial and biennial inventories, dated as of beginning or l f b iclose of business

Records of controlled substances distributed (i.e., sales to other registrants, returns to vendors, distributions to reverse distributors)

Records of transfers of controlled substances between pharmaciesDEA i i ifi DEA registration certificate

Self-certification certificate and logbook (or electronic equivalent) as required under the Combat Methamphetamine Epidemic Act of 2005



Required to be performed with initial DEA registration and bienniallyy

No requirement to submit a copy of inventory to DEA

Schedule II controlled substances must be kept separate from all other controlled substancesfrom all other controlled substances

Date of inventory

Whether inventory was taken at the beginning or close of business

Name of each controlled substance inventoried

Finished form of each of the substances• E.g., 10-milligram tablet

Number of dosage units of each finished form in the commercial container• E.g., 100-tablet bottleE.g., 100 tablet bottle

Number of commercial containers of each finished form• E.g., four 100-tablet bottles

A count of the substance



Schedule I and II controlled substances• Official order formOfficial order form

– DEA Form 222

• Electronic equivalent– Controlled Substance Ordering System (CSOS)

DEA form or electronic equivalent required for each• Distribution

• Purchase

• Transfer

Controlled Substance Ordering System (CSOS)• Allows for secure electronic transmission of schedule II drugsAllows for secure electronic transmission of schedule II drugs

• Public Key Infrastructure (PKI) technology – Users must obtain digital certificate for electronic ordering

CSOS certificates are free of charge

May be a charge for use of ordering software by the suppliers

• Must be signed using digital signatureIssued by Certification Authority run by the DEA– Issued by Certification Authority run by the DEA

www.DEAecom.gov or (877) 332-3266



Schedules III, IV, and V controlled substances• Registrant must keep a receipt (invoice or packing slip) documentingg p p ( p g p) g

– Date drugs were received

– Accuracy of order confirmation

– Name of each controlled substance

– Finished form

– Number of dosage units of finished form in each container

– Number of containers ordered

– Number of containers received

• Receipts must be maintained in a readily retrievable manner , in the event of a DEA inspection

Pre-Employment Screening• Background checks, drug screeningBackground checks, drug screening

Updated Background Checks Every Five Years

Random Drug Screening

Physical Security Controls

SOP’s for Handling Controlled Substances

Limited Access to Controlled Substances Limited Access to Controlled Substances

Limited Access to Alarms, Keys, Pass Codes



Limited Access to Dispensing Areas

At Least two employees at all times

Cameras in all areas where CS are being dispensed

Secure access to CS ordering systems (CSOS)

Do not post the password for ordering CS electronically on the wall of the pharmacy

Limited Power of Attorney status for signing DEA 222 y g gorder forms

Tell Physicians to secure their prescription pads

Limited Access to Dispensing Areas

Must be dated and signed on the date issued Must be written in ink, indelible pencil, or typewritten Prescription must include:

• Patient’s full name and address• Practitioner's full name, address, and DEA registration number• Drug name• Strength• Dosage form• Quantity prescribed• Directions for use• Number of refills authorized



May not be changed:• Patient name

• Drug name (except for generic substitute permitted by state law)

• Name of prescribing practitioner (including signature)

May be changed: • Strength of drug, quantity of drug, directions for use

Pharmacist must contact prescribing practitioner and obtain verbal permission for change

Ph i t t d t th i ti Pharmacist must document on the prescription:• Change that was authorized

• Name or initials of individual granting authorization

• Initials of pharmacist

Physician Dentist Podiatrist Veterinarian Mid-level practitioner (MLPs): nurse practitioners,

physician assistants, optometrists, midwives• Authority to prescribe varies greatly by state• Pharmacist is responsible for verifying prescribing parameters p y g p g p

per state• Pharmacist may check DEA diversion website

– www.DEAdiversion.usdoj.gov

– Registration Registration Resources MLP Authorization by State



Practitioner Prescribing Rights

A i l Sh lt2N & 3NLi 1 A i l Sh ltAnimal Shelter Line 1: Animal ShelterLine 2: Euthanasia Technician’s Name

Nurse Practitioners 2N, 3, 3N, 4, 5 Prescribe, Dispense & Administer Only Prescribe 30 day supply for C-II Optometrists

Optometrists3, 4, 5Prescribe

2N, 3, 3N, 4, 5Physician Assistants

2N, 3, 3N, 4, 5Prescribe, Dispense & Administer OnlyPrescribe 30 day supply for C-II

Ambulance Services, Doctors of Oriental Medicine, Euthanasia Technicians, Homeopathic Physician, Medical Psychologists, Naturopathic Physician, Nursing Homes, Registered Pharmacists

No Authority

Verification of practitioner registration• Pharmacist has a responsibility to ensure that a prescription has been

issued by an appropriately registered practitionerissued by an appropriately registered practitioner Construction of a valid DEA registration number

• First letter– A, B, or F for physicians, dentists, veterinarians– M for mid-level practitioners

• Second letter– First letter of registrants last name

• Verifying the numbers

Example: DEA Number

B J 6 1 2 5 3 4 1

1. Add together the 1st, 3rd and 5th digits2. Add together the 2nd, 4th and 6th digits; double it3. Add the two totals together4. The second digit in that total is the check digit



Valid purpose of issue• Legitimate medical purpose • Practitioner acting in the usual course of professional practice

Corresponding responsibility and “good faith dispensing”• A prescription issued not in the usual course of professional

treatment is invalid• The pharmacist is required to exercise sound professional judgment• The law does not require a pharmacist to dispense a prescription of• The law does not require a pharmacist to dispense a prescription of

doubtful, questionable, or suspicious origin• A pharmacist who deliberately ignores this, may be prosecuted

– Such action is a felony offense, which may result in loss of license

Rule became effective June 1, 2010• Provides practitioners with option of writing prescriptions for

controlled substances electronicallycontrolled substances electronically• Permits pharmacies to receive, dispense, and archive prescriptions• Ability to use technology while maintaining “closed system”

Pharmacy application requirements• Must be able to import, display, and store required contents• Must be able to digitally sign• Must allow the pharmacy to limit access for annotation, alteration, or

deletion to specific individuals or rolesdeletion to specific individuals or roles• Must have an internal audit trail that documents each processing step

When a prescription is received electronically, it must be stored electronically



Written prescription must be manually signed

Electronic prescription must meet all DEA Electronic prescription must meet all DEA requirements

Oral order is only permitted in emergency situation • See “emergency dispensing”

Refills• Prohibited for schedule II controlled substancesProhibited for schedule II controlled substances

New regulation became effective December 19, 2007 Practitioner may issue multiple prescriptions y p p p

authorizing the patient to receive up to a 90-day supply of a schedule II drug• Each prescription must be issued on separate prescription

blank• Practitioner must indicate the earliest date on which it may be

filled• Should not create an undue risk of diversion of abuse• Individual practitioner must comply with all requirements

– This includes state laws



May be sent through facsimile to expedite filling process Original prescription must be presented to the pharmacist

and verified against the facsimile at time of dispense Pharmacy may consider the facsimile prescription as the

original in 3 cases:1. To be used in a compound for direct administration to a patient

– Parenteral, intravenous, intramuscular, subcutaneous, or intraspinal

2. Used for a resident of a long-term care facility3. Patient enrolled in a hospice-care program

– Program needs to be certified and/or paid by Medicare, or

– Program licensed by the state

– Prescription should note that it is for a hospice patient

Prescription may be transmitted by facsimile • Facsimile is considered equivalent to an original prescription

– Practitioner must manually sign the prescription

Telephone authorization• Oral prescription made by the practitioner and promptly

reduced to writing by the pharmacist is considered valid

Refills• May be refilled if authorized on the prescriptionMay be refilled if authorized on the prescription

– Only up to 5 times within 6 months after the date of issue

• Pharmacist must initial, date, and state the quantity filled on the back of the prescription



Pharmacy may transfer original prescription information to another pharmacy for the purpose of refill dispensing

C b d i b i l• Can be done on a one-time basis only

Pharmacies electronically sharing an online database may transfer up to the maximum amount of refills allowed by law

Transfer must be communicated between 2 licensed pharmacists Pharmacist must record the following information:

• Write the word “VOID” on the face of the invalidated prescription• On the reverse of the prescription record:• On the reverse of the prescription record:

– Name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving information

• Record date of transfer and name of the pharmacist transferring

Pharmacist dispensing a prescription for a controlled substance must affix to the package a label showing:

Ph d dd• Pharmacy name and address

• Prescription number

• Patient name

• Name of prescribing practitioner

• Directions for use

FDA requires that drugs in schedules II, III, or IV must contain:

• “CAUTION: Federal law prohibits the transfer of this drug to any person other p g y pthan the patient for whom it was prescribed”

Controlled substance must be dispensed to the patient or a member of the patient’s household

• Otherwise would be distribution and not dispensing



Emergency prescription is defined as:• Immediate administration of the drug is necessary for proper treatment

• No alternative treatment is available (a drug that is not schedule II)

• Not possible for the practitioner to provide written prescription

In case of an emergency, a practitioner may telephone a schedule II prescription to the pharmacist who may dispense it• A written and signed prescription must be provided within 7 daysg p p p y

• Prescription must have written on the front:

– “Authorization for Emergency Dispensing” and the date of oral order

• Pharmacist must notify DEA if prescription not received within 7 days

Partial quantity may be dispensed if full quantity cannot be filled

Pharmacist should document quantity supplied on the front of the prescription

Remaining portion may be dispensed within 72 hours of the first partial dispensing• If not filled or cannot be filled, the pharmacist must notify

practitioner– No further quantity may be supplied beyond 72 hours



Pharmacy may distribute controlled substances, without being registered as a distributor, for the purpose of general dispensing • Pharmacy or practitioner that will receive the controlled substances

must be registered to dispense the controlled substances

• Distribution and receipt of the controlled substance must be recorded

• Transfer must be documented on an official DEA Form 222 or electronic equivalent

• Total number of dosage units of all controlled substances distributed may not exceed 5 percent of all controlled substances dispensed by the pharmacy within a calendar year

Pharmacy Law: The Ins and Outs of Controlled Substances...

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