Transcript File

Chapter 7
State Laws and Pharmacy
Practice
Jahangir Moini, MD, MPH, CPhT
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Overview
• State laws vary widely
• They regulate pharmacy practice, minimum
requirements, and how pharmacists and
pharmacy technicians are qualified to
legally practice
• Pharmacists and pharmacy technicians must
learn and understand how their state laws
differ from federal law
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
State Laws Affecting
Pharmacy Practice
• State agencies, including state boards of
pharmacy, regulate pharmacy practice on a
daily basis
• National Association of Boards of Pharmacy
(NABP) has created tables of information that
enable personnel to quickly find their state’s
position on various pharmacy-related activities
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Model Pharmacy Practice Act
• Developed and published by NABP to
promote, preserve, and protect public
safety, health, and welfare by effectively
controlling and regulating pharmacy
• Addresses licensure, registration, and
controls that focus on manufacturers,
sellers, and distributors of drugs and related
equipment and materials
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Minimum Requirements
for a Pharmacy
• Required to have enough space to conduct
needed activities
• Must have designated patient counseling areas
• Must supply educational reference materials
for patients
• Facilities, equipment, and personnel must
adhere to OSHA requirements
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Minimum Requirements
for a Pharmacy
• Patients must be able to privately disclose
PHI
• Pharmacist must be on duty while pharmacy
is open, though a sign may be placed at
counter for short periods if pharmacist is
temporarily unavailable
• Licensure must be maintained continually
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Processing of Prescriptions
• Role of pharmacy technicians in processing
of prescriptions requires concentration to
ensure all steps are completed properly
• Next slide shows a list of activities
pharmacy technician must complete when
prescription is submitted for processing
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Pharmacy Technicians and
Processing of Prescriptions
1. Receive prescription and verify all
information is completed and clear
2. Translate prescription for entry in computer
system
3. Enter information completely and ensure it
matches printed labels
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Pharmacy Technicians and
Processing of Prescriptions
4. Verify patient’s insurance and eligibility
5. Fill prescriptions and verify it is packaged
correctly
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Points to Remember
• Check stock bottle’s labeling and NDC number
and compare to prescription
• Never physically touch medication
• Verify correct type of lid is used
• Check labels for accuracy before applying
• Apply auxiliary labels if required
• Verify packaging is correct and initial it
• Arrange packaged medication with original
prescription so the pharmacist can check
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Patient Counseling
• After pharmacy technician completes
packaging prescription, pharmacist can
counsel patient
• Pharmacist is the only person allowed to
counsel patient
• Pharmacy technicians must always refer
patients to pharmacist with questions about
prescriptions
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Computerized Dispensing
• Can greatly improve dispensing time and
accuracy
• Contain many built-in functions that
cross-check and verify information
• Also interact with computer inventories and
robotic dispensing equipment to ensure
better accuracy
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Prescribing Regulations
• State law regulates prescribers of medications
• Each practitioner must be state-licensed
• They may also have to register with DEA if they
prescribe controlled substances
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Prescription Drug Orders
• Prescription drug orders should be written by
prescribers for diseases and conditions they
directly deal with
• Pharmacists should be aware of any prescription
that appears to be outside scope of practice of
prescriber
• Prescription drug orders for controlled
substances should contain standard prescription
information plus prescriber’s DEA number
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Electronic Files
• Most states have adopted their own regulations
for electronic transmission of prescriptions
• Most states now allow faxed controlled
substance prescriptions, and require prescriber’s
full information to appear
• Regulation of computer transmission of
prescriptions is changing as they become more
popular
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Drug Product Selection
• Drug product selection, drug product
substitution, and generic substitution laws
designed to regulate ability of pharmacists
to dispense different drug product than
prescribed drug
• Cost savings can be attained by substitution
of generic drugs for brand name drugs
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Generic vs. Brand Name
• Law requires that generic drug must be
identical to drug contained in brand-name
drug for substitution to be allowed
• If generic drug is prescribed, pharmacist can
dispense any product pursuant to generically
written prescription
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Labeling
• Single-unit packages of individual-dose or
unit-dose drug products must include:
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Drug’s generic or trade name
Route of administration if other than oral
Strength and volume of drug
Drug’s control number and expiration date
Re-packager’s name or license number
Any special storage conditions
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Labeling
• Multiple-use drug packages must include:
– Identifying information for dispensing
pharmacy
– Patient’s name
– Dispensing date
– Generic and/or trade name of drug
– Strength of drug
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Labeling
• Ambulatory or outpatient drug packages
must include:
– Name and address of
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dispensing pharmacy
Name of patient
Name of prescriber
Directions for use
Dispensing date
Any Federal or State
cautions
– Prescription number
– Name or initials of
dispensing pharmacist
– Generic or trade name of
drug
– Strength of drug
– Manufacturer or
distributor of drug
– Beyond-use date of drug
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Patient Records and Drug Review
• Maintenance of patient medication records is
intended to facilitate monitoring of patient’s
drug therapy
• Good record keeping is important
• Patient records should contain full name,
address, telephone number, age or date of birth,
and gender
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Patient Records and Drug Review
• Each pharmacy should make sure every
patient record shows entire available drug
history, at least past 5 years, with most
recent prescriptions listed first
• Any comments by pharmacists should be
included, including information about
allergies, reactions, diseases, and conditions
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Patient Records and Drug Review
– Pharmacist is responsible for reviewing
each patient’s medication use and verifying
no abuse or misuse of medications
– Allergies must always be verified to avoid
medication errors
– Drug dosages must be checked for
effectiveness
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Patient Counseling
• Patient counseling to be performed only by
licensed pharmacists
• Under OBRA-90, most states have enacted
“mandatory” patient counseling
requirements for pharmacists
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Patient Counseling
• OBRA-90 requires pharmacists to offer
counseling to all Medicaid patients
– Pharmacist must explain the name of drug,
dosage form, route of administration, duration
of drug therapy, directions for use, and side
effects
– Pharmacist should also emphasize how to
properly store medication, and discuss refill
information if required
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Computer Regulations
• Secure computer systems required more
than ever for pharmacy record keeping
• NABP publishes rules for use of computer
systems for protection and confidentiality of
PHI
• PHI must be retrievable online for all
refillable prescriptions
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Computer Regulations
• Pharmacists have final authority and
responsibility to ensure correct decisions are
made for patient refills if automated
computer system is not properly operating
• Any prescriptions filled or refilled during
computer “downtime” must be entered in
system within four business days of it
becoming operable
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Pharmacy Ownership
• In general, anyone who has proven their
qualifications and is of good moral character
may own a pharmacy in most states
• Unlicensed or untrained individuals should not
manage the pharmacy
• Business practices must be ethical, dignified,
correct, informed, and have no conflicts of
interest
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Sale of Hypodermic
Needles and Syringes
• Sale of hypodermic needles and syringes
must be carefully controlled by pharmacist
to prevent illegal use
• Individual states regulate sale of OTC
needles and syringes
• Some states require physician's prescription
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Compounding
• Both state and federal law regulate practice of
pharmacy compounding
• Supreme Court has ruled advertising of
compounding services cannot be prohibited
because of rights to commercial free speech
• FDA has stepped in regarding cases of
community pharmacies compounding certain
drugs available in commercial preparations
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Compounding
• Pharmacists must closely follow state laws
as well as FDA’s guidelines concerning
compounding
• Pharmacy technicians will be affected and
see duties increase in assisting pharmacists
with compounding activities, and will need
to follow FDA guidelines
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
United States Pharmacopoeia (USP)
• USP has consistently updated sterile
compounding regulations
• USP <795> is an enforceable set of
standards for nonsterile compounding
• USP <797> is an enforceable set of
standards for sterile compounding
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
USP Guidelines
• USP guidelines cover retail, hospital, and
even home health care compounding
• Main goals of continually improving
regulation are to reduce contamination
potential and keep unwanted particles in air
from infiltrating compounded mixtures
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Sterile Compounding
• Sterile compounding of eye drops and
parenterals requires barrier isolators that use
positive pressure to keep airflow from less
sterile areas into more sterile areas
• Buffer areas or “anterooms” that must
maintain certain “clean” levels are used for
putting on and removing protective garb and
equipment, and for disinfection of equipment
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Gowning
• Gowning includes:
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Gloves
Gowns or coats
Hair covers
Masks
Shoe covers
Personal protective equipment as required
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
State Regulation of
Long-Term Care
• Both state and federal law regulate certain
components of long-term care
• Licensing of operators of long-term care
pharmacies regulated by state law in most cases
• Certain states require pharmacists to have a
more specialized license to practice in a longterm care pharmacy
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Ultimate Goals
• Ultimate goal of state laws concerning
pharmacy practice is to provide quality
therapeutic care and prevent patient harm
• Pharmacists must remember they have ultimate
responsibility for patient’s health
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.
Ultimate Goals
• Pharmacy technicians must remember there are
more regulations than ever before, which can
affect their careers
• Complete understanding of state laws and strict
ethical practice is required
© 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED.