Review of Federal Pharmacy
Laws
Joe Bruno
Presentation to the Maine Pharmacy Association
3/21/2015
• Websites that you need to know and refer to
when needed
• http://www.maine.gov/pfr/professionallicensi
ng/professions/pharmacy/index.html
• http://www.deadiversion.usdoj.gov/21cfr/21u
sc/index.html
• http://www.deadiversion.usdoj.gov/pubs/ma
nuals/pharm2/pharm_manual.pdf#search=Ph
armacy
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
• http://www.accessdata.fda.gov/Scripts/cder/d
rugsatfda/index.cfm
• This website allows you to look up any drug
and gives lots of information on the drug
• Medicare and Medicaid
• What are the differences and what
do you need to know as a
Pharmacist?
• 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– Can’t compound a product that has been withdrawn or removed from the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 noncontrolled 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?
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•
•
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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 themmake 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
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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 signaturemany 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 substances
C. Hospitals who dispense and administer controlled
substances to inpatients
D. 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.