Review of Federal Pharmacy Laws

Joe BrunoPresentation to the Maine Pharmacy Association

3/21/2015

• Websites that you need to know and refer to when needed

• http://www.maine.gov/pfr/professionallicensing/professions/pharmacy/index.html

• http://www.deadiversion.usdoj.gov/21cfr/21usc/index.html

• http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf#search=Pharmacy

Some historical federal laws

• Remember that laws are meant to protect the public• Pure Food and Drug Act of 1906• Food, Drug and Cosmetic Act of 1938• Durham-Humphrey Amendment of 1951• Kefauver-Harris Amendment of 1962• Medical Device Amendment of 1976• Orphan Drug Act of 1983• Drug Price Competition and Patent Term Restoration

Act

More federal laws

• Prescription Drug Marketing Act of 1987• Omnibus Budget Reconciliation Act of 1990

(OBRA 90)• FDA Modernization Act of 1997• Medicare Prescription Drug Improvement and

Modernization Act of 2003• Patient Protection and Affordable Care Act of

2010

Medicare vs. Medicaid

• Medicare and Medicaid• What are the differences and what do

you need to know as a Pharmacist?

• http://www.accessdata.fda.gov/Scripts/cder/drugsatfda/index.cfm

• This website allows you to look up any drug and gives lots of information on the drug

• Medicare Prescription Drug Improvement and Modernization Act of 2003

• Medicare Part A- Hospitalization Insurance• Medicare Part B- Medical Insurance for physician

service and some prescription drugs including diabetic testing strips, some chemotherapeutics, insulin for pumps, and nebulizer drugs

• Medicare Part C- Medicare managed care (Medicare Advantage)

Medicare

• Medicare Part D-Medicare Prescription Drug Program

• Acronyms to know-CMS, TrOOP, MTM• Any Willing Provider???

Compounding vs. Manufacturing

• Frequently debated between pharmacists and FDA. New England Compounding Center tragedy brought this to the forefront!

• FDA Compliance Policy Guide of 1992– The quantity prepared is reasonable for filling existing Rxs or those

anticipated based upon local prescribing habits or Rxs on file– The compounded product cannot be sold to other pharmacies or a third

party like a physician office ( this is a big issue)– They can’t be already available from commercial sources(another big issue)– The 1997 FDA Modernization Act includes the fact that compounding

pharmacies are exempt from FDA regulation– Can’t compound a product that has been withdrawn or removed from the

market because they were unsafe or ineffective– The pharmacy limits its interstate distribution to not more than 5% of the

total prescriptions filled by that pharmacy (think NECC violations)

• Filling and Dispensing Prescriptions• Federal vs State Regulations- sometimes there

may be a conflict between the two. Who has precedence?

• The stricter regulation predominates and must be followed!

• State laws specify who is allowed to prescribe and what drugs they can prescribe.

• Can a prescriber self prescribe for themselves?

• Prescription refills• How do you determine whether a prescription

may be refilled?• Controlled substances have specific limitations• What is the time limit in Maine for non-

controlled drugs?• A prescription for an OTC product is bound by

the limit indicated by the prescriber even though it is OTC

• Who owns the prescription?• Once it is filled and dispensed the pharmacy

owns the prescription!• It should not be removed except by court

order• A copy of the prescription can be provided to

the patient or the prescriber

• Expiration dates vs Beyond Use Dating• What is the requirement in Maine?• In all cases it is not longer than the expiration

date n the original packaging from the manufacturer

• If the manufacturer selects an expiration date with month and year only-is it the first or last of the month?

• Poison Prevention Packaging Act (PPPA)• 1970• To prevent accidental poisoning in children• Overseen by Consumer Product Safety

Commission(CPSC)• One size of an OTC product is not required to

have a safety closure• All new and refill Rxs must be dispensed in child

resistant closures unless:

• The Prescriber specifies that none is to be used-it is only for that specific Rx-not a blanket waiver

• The patient indicates they do not want them-make sure you have something signed by the patient indicating that for your protection and verify occasionally!!! This is a blanket waiver

• When refilling a prescription new containers and caps must be used. Glass containers may be reused but the cap must be replaced.

• Mailing Prescription Drugs• Virtually no restrictions• In the past controlled drugs could not be mailed

but that restriction has been lifted• It must meet DEA requirements and the person

mailing it must be registered with the DEA• The USPS has its own regulations. UPS and

FedEx have their own rules.

• Health Insurance Portability and Accountability Act (HIPAA) Look smart and don’t call it HIPPA!

• What is PHI?• Requires a written privacy policy. Get the patient

to sign an acknowledgement form that they received the notice and must be kept for 6 years. Organizations must have a HIPAA Privacy Officer! Must be training provided concerning HIPAA!

CSA of 1970

• One of the most important federal laws you need to know

• Anyone or anything that possesses controlled substances must be registered with the DEA

• Pharmacists working in a registered establishment do not have to register with the DEA

• DEA registrations are valid for 36 months (3 years)• Renewal forms are sent 60 days before expiration• Registrants must notify DEA in Writing if they have

not received renewal within 45 days of renewal date

• DEA can deny applications or revoke a license if you have an action against your pharmacy license. This is why it’s important to never appear before the Board of Pharmacy!!!

• Know what makes a drug Schedule I through V. It is a simple definition.

• Remember that states can make a drug a different schedule, just stricter NOT more lenient

• A 222 form filled out incorrectly will be returned without the order being filled! No alteration may be made on the form!

• If forms are lost you must notify the DEA regional office• Forms must be kept separate from all other records. They must be

kept for two years!• If you close a pharmacy or the registrant expires all the unused forms

must be sent back to the DEA• CSOS is the electronic version of using a 222 form. Much less

paperwork and less errors. No limit on number of drugs ordered. Paper copies limit you to ten items.

• It requires a digital certificate and technology called Public Key Infrastructure. Your private key is yours and it should not be given to anyone else

• Who can issue controlled substance prescriptions???

• Must be authorized by the jurisdiction they are licensed to practice their profession. An employee or agent may communicate a prescription to a pharmacist

• Writing a prescription for office use is not permissible. If the prescriber wants to dispense them they must be purchased from a supplier!

• Prescriptions must be for a legitimate medical purpose• Proper prescribing of controlled substances lies with the

prescribing practitioner, but a corresponding responsibility rests with the pharmacist that fills the prescription.

• Filling a prescription not issued in the usual course of professional treatment is in violation of the CSA and the prescriber and the dispenser are both on the hook.

• Prescriptions can’t be issued for maintenance or detox treatment. Think Methadone! This applies only to Schedule II drugs

• Can prescribers self prescribe for themselves???

What must be on a controlled substance Rx

– Full name and address– Drug name, strength, and dosage form– Quantity prescribed– Directions for use– Name, address, and registration number (DEA number) of the practitioner– Must be a legal signature. Electronic signatures are not valid! This

especially happens with faxed prescriptions!!!– An agent can prepare the Rx for signature. The practitioner signing it is

responsible for the legitimacy and there is a corresponding responsibility to the pharmacist!

– Hospitals and other institutions can apply suffix numbers to practitioners that don’t have their own DEA registration

– There must be a legible name of the prescriber on the RX whether it is stamped, typed, or hand written

• Military or Public Health Service are exempted from having to register with the DEA. They can use their Service identification number as their ID which is usually their SSN. It also requires the legible name printed.

• Only a pharmacist acting in the usual course may fill a prescription for a controlled substance. They must be registered individually or employed in a registered pharmacy or institution

• As of June 2010 Prescribers had the option of sending controlled prescriptions electronically

• Maine finalized its rules (2013) allowing pharmacies to accept electronic controlled substance prescriptions

• It is complicated and costly to do all this and has very limited use so far. It must be certified, encrypted, and be identity protected.

• Any electronic prescription can’t be altered at the pharmacy, just like paper Rxs

• What can be added to a CII prescription if information is missing?

• DEA is wishy washy on this and tells you to adhere to state and federal law

• Use common sense-address, name clarification, generic substitution is allowed

• NEVER change quantity, drug, or signature!!! This would require a new prescription

• Faxing CII prescriptions• Allowed for home infusion pharmacy, resident of a

LTCF, or a patient enrolled in hospice, certified by or licensed by the State. It must be noted on the Rx that the patient is in hospice. They can still reside in a personal residence or a hospice facility

• The fax serves as the original Rx and filed accordingly• In all other cases a fax is informational only and can

only be filled when the original is presented!• Schedule II Rxs can never be refilled!

• Partial filling of CII prescriptions– Can you partially fill a CII Rx? When is it allowable

if you can?– Can a patient request a partial fill and come back

for the rest of the Rx?– What does Maine law allow? Is it in conflict with

federal law?– How long do you have to fill the rest of the Rx?

• Exceptions to partial fill rules – LTCF patients or with a terminal illness diagnosis. It is a violation if the pharmacist does not confirm the terminal illness diagnosis

• All partial fills can not exceed the total number prescribed. Must keep very accurate records!

• Partial fill Rxs are valid for 60 days from the date of issue!

• Schedule III, IV, V prescriptions• Biggest differences from a CII Rx– Can be faxed with written prescription that has

original signature- can’t be electronic signature-many pharmacists don’t know this!

– Can be electronic Rx if it meets all the requirements– Can be phoned in – A prescriber may dispense or administer directly to

consumer

• If refills are indicated it can be for up to 5 times or 6 months from when the prescription was issued. Schedule V is different and is state dependent. Important to note the 6 month limit if from when the Rx was issued not when it was presented to the pharmacist to fill!

• Oral authorization of additional refills is OK as long as it adheres to 5 refill or 6 month limits

• Records must be kept for 2 years• Computerized records must be signed by a pharmacist

and kept separately within 72 hours of the date dispensed

• If there is centralized record keeping records must be able to be retrieved with 48 hours!

• Partial filling of CIII, IV, V is allowed as long as it doesn’t exceed the total quantity and not beyond 6 months

• Remember that the DEA issues registration numbers to the practitioner because they are licensed by specific states

• What about storage of controlled drugs in a pharmacy– Locked cabinet or dispersement– Security camera requirement

• What form is used to report a theft or significant loss of controlled drugs?

• What defines significant?• What does Maine law require?• Remember that pharmacy robberies are now

a violation of federal law

• Methamphetamine Anti-Proliferation ACT of 2000

• Name me the 3 precursor drugs restricted under this act-Schedule Listed Chemical Products

• What are the limits that may be sold?• What are the Maine requirements?• Remember that this is only for OTC sales

Treating Dependence

• Methadone• Buprenorphine (Suboxone or Subutex-what’s

the difference between the two?) limited how? Who can prescribe? How many patients may the practitioner treat?

• What is an OTP? How are they treated under Maine law?

• Who has jurisdiction over OTPs?

Questions• Which one of the following would be lawfully in possession

of controlled substances without being registered under the CSA.

A. Pharmacists dispensing controlled substance Rxs in a DEA registered pharmacy

B. Physicians who prescribe controlled substancesC. Hospitals who dispense and administer controlled

substances to inpatientsD. Joe’s friend who took Joe’s Vicodin prescription because

Joe didn’t want it any more.

Answer

• Pharmacists dispensing controlled substance Rxs in a DEA registered pharmacy

• A physician has an office in Biddeford, Maine, Portland, Maine, and Portsmouth, New Hampshire. She prescribes from all three locations. She does some minor medical procedures in the Biddeford office and stores a small supply of controlled substances for administration to patients at the Biddeford location, but not the Portland location nor at the Portsmouth, NH, location. How many DEA registrations must the practitioner have?

• – 1 (one): Since it is the same practitioner she needs only one DEA registration.– 2 (two): Since she has an office in two different states she needs two different

DEA registrations under the facts in the statement above. If she were also administering controlled substances from the Portland location then she would need 3 DEA registrations.

– 3(three): Since she has 3 offices she needs 3 registrations.•

Answer

• 2 (two): Since she has an office in two different states she needs two different DEA registrations under the facts in the statement above. If she were also administering controlled substances from the Portland location then she would need 3 DEA registrations

• A physician may write a prescription for a vicodin prescription in the name of his secretary for the purpose of obtaining that controlled substance to keep in the office to administer to patients for pain following minor, in office surgical procedures that he performs as long as the practitioner maintains proper records of the ultimate use that receives the vicodin.

• • True• False

Answer

• False

• Which one of the following best describes the “corresponding responsibility” doctrine?

• – It requires that the prescriber correspond with the pharmacist prior to

selecting any controlled drugs for a patient.– It requires that the prescriber correspond with other practitioners the

patient sees prior to prescribing any controlled drugs for a patient.– It requires that the prescriber and pharmacist keep corresponding

documentation regarding a patient’s controlled drugs.– It requires that both the physician and the pharmacist take reasonable

steps to ensure that a controlled substance is issued for a legitimate medical purpose in the usual course of professional practice.

•

Answer

• It requires that both the physician and the pharmacist take reasonable steps to ensure that a controlled substance is issued for a legitimate medical purpose in the usual course of professional practice.