Transcript Pharmacy Management in MD office

Laws
Records
Medication
Dispensing
s
Disposal
Pharmacy
Management
Review
(for those who do not come to training)
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Laws Affecting Prescription Dispensing
Approval of Medications for Use in the United States
The Food and Drug Administration (FDA) is the federal agency
that supervises the development, testing, purity, safety, and
effectiveness of prescription and OTC medications. The FDA
must approve medications before they can be sold in the US.
The FDA also regulates the advertising of prescription
medications and the labeling of prescription and OTC
medications.
Controlled Substances
Controlled substances are medications with significant potential
for abuse. The Comprehensive Drug and Control Act of 1970,
referred to as the Controlled Substance Act (CSA) regulates
manufacturing, distribution, prescribing and dispensing of
controlled substances through the Drug Enforcement
Administration (DEA). Prescribers are assigned DEA
numbers which authorize them to prescribe controlled
substances.
Child-Resistant Containers
The Consumer Product Safety Commission (CPSC) oversees the
Poison Prevention Packaging Act. The CPSC requires most
prescriptions for oral use to be dispensed in child-resistant
containers unless patients or prescribers request otherwise.
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State Agencies (BOP, DOH)
Medical providers, such as Physicians (MD) and osteopaths
(DO) are authorized to prescribe prescription medications
for use within the practitioners’ area of expertise as
granted by the State Board of Pharmacy and/or other
state agencies such as the Department of Health (DOH).
Some states permit physicians assistants (PA), nurse
practitioners (NP) to prescribe certain medications
according to specific guidelines. These type of
practitioners may be assigned a DEA number like an MD
representing authorization for them to prescribe
controlled substances.
Medication dispensing by practitioners varies by state. For
example, some states allow for dispensing but only for
medication samples. It is imperative that your healthcare
attorney verify what type of medications (controlled
schedules, non-controlled substances, medication
samples) can be dispensed in your office. You must also
verify who is authorized to distribute these.
For example, in the State of ____, PA’s are authorized to
distribute Schedule III-V medications in the clinic but
ONLY with a physician on-site.
When both the federal and
state government address a
particular situation, the
stricter law applies.
Inspections
Boards employ
inspectors/investigators to inspect
medication dispensing locations for
compliance with state pharmacy or
department of health laws and
regulations. Inspectors conduct
regular inspections.
TIPS:
1. Be friendly with your local inspectors. They are very
busy professionals. Some see up to 800 sites a
quarter.
2.
Ask for identification if an inspector comes to your
clinic.
3.
Notify the clinic owner or MD on site if an inspector is
present.
State pharmacy boards can revoke,
suspend, or place on probation
licenses of those who are found
guilty, after due process, of
violating laws or regulations.
Security
Because of the presence of medications in
the clinic, the staff must take
precautions to keep the prepackaging
area and narcotic cabinet secure. Here
are some general guidelines about
how to maintain security. The staff
must:
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Keep the narcotic cabinet door closed
when not in use.
Not allow patients or non-MWLC
personnel into the prepackaging/narcotic
cabinet storage area.
Never have both sets of keys in their locks
when not in use.
Medications
Medications arrive from PDRx in the
manufacturer’s packaging, called
stock bottles. The FDA requires all
prescription medication stock
bottle labels to contain certain
information. The three pieces you
are most concerned with are:
 Lot#
 NDC#
 Expiration Date
Manufacturer Bottles
Medications
Prepackaged Vials
The first child-proof safety cap was suggested by Dr. Jay Arena, a pediatrician at Duke Hospital who
persuaded the producer of St. Joseph's Aspirin to place a safety cap on its product. Their aspirins had
been colored and flavored to appeal to children, but of course, they thought they were sweets.
PDRx occasionally ships a small bag of non-child proof caps with your empty vial orders – NEVER USE
THESE for liability reasons.
Guidelines for Repackaging
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Only one medication should be repackaged at a time. This reduces chances of
contaminating one medication with residues of another where a patient may have
severe allergies.
Repackaged medications should not be released for distribution to patients until
checked and approved by a medical provider.
Electronic pill counters should be maintained according to manufacturers’
instructions and cleaned after each repackaging session.
Do not cross-contaminate by packaging in an area where food or drinks are
consumed.
Practice GCP’s by wearing gloves, and not eating or drinking during session.
Maintain written records for each batch for at least a year. (Some state require a
longer time period.) These records should include:
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The date of repackaging
Name of the medications repackaged
NDC number of the medications repackaged
Lot numbers
Initials of the provider who checks the batch
Name of the person repackaging the medication
Guidelines for Repackaging
Expiration dates assigned to repackaged medications ensure that
products dispensed are effective at the time of use.
Repackaging and exposing the medication to the environment
may affect the medications shelf-life. Therefore, the expiration
date you put on the label is not the same as the
manufacturer’s date. The expiration date should follow one of
the following rules:
1.
2.
The repackaged expiration date cannot be more than six months after the
repackaging date; or
The repackaged expiration date cannot be more than 25% of the time
between the original manufacturer’s expiration date and the date of
repackaging.
For example:
If you are repackaging some Testosterone on 1/31/10 and the expiration date on
the manufacturer’s original container is four months later on 4/30/10. The
repackaged medication must show an expiration date no later than 2/28/10,
which is one month (25% of 4 months) after the manufacturers expiration
date.
Hispac Pill Counter tips
This cover pops
up and the black
round knob in the
middle pulls up
to help with
cleaning after
each use.
Use a large
measuring cup in
counting out
1000 quantity
bottles.
Ensure this silver
tab is pushed
down in position.
Recordkeeping
It is important to keep records organized and readily retrievable.
They can be key for you having a passing inspection grade.
You may organize the records in any manner you see fit as long as
they are retained in the appropriate timeline that meets Federal and
State specific guidelines.
We recommend a 3-Binder system which consists of:
Working Inventory Binder: Contains all prepackaging inventory
sheets and pre-printed repackaging labels with tabs separating
different lot #’s.
Daily Report Log: Contains signed and dated daily prescription
reports and/or the daily signature log.
Master Records Binder: Holds important information that is not
accessed on a daily basis such as Biennial Inventory reports, Master
Signature log sheet, DEA-41 Forms, copies of licenses or
registrations and receipts from reverse distributors.
Confidentiality
It is crucial that you keep personal or
health information about patients
strictly confidential at all times.
Discussing a patient’s health information
with anyone other than the patient, the
patient’s caregiver or the providers you work
with is a serious violation of ethics and could
expose the clinic to a law suit.
The training in Tampa provides you with the
“bare bones” federal overview of the Privacy
Rule within HIPAA. Make sure you obtain
specific information with regards to policies
and procedures from your clinic owner.
Each state may have specific privacy
requirements – become familiar with these
state-required procedures as well.
HIPAA
HIPAA + Pharmacy Management
Although your responsibilities may incorporate more procedures than what is outlined
here, the following is a checklist of some of the procedures you should know to
comply with the Privacy Rule.
How should you handle patient requests for access to their PHI such as Rx History?
2) How do you handle transferring prescription records to another clinic?
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a. What forms are required for this process?
How should you dispose of PHI such as a duplicate Rx label?
Where do I place the prescription vial in the check out area so PHI cannot be
seen by other customers? (in this case vial was not directly handed to patient)
How should you handle a patient who begins talking about their medical history
while standing in a hallway or checkout area?
What is PHI?
Protected Health Information (PHI) is any
information that is collected in the clinic that
can be used to identify a patient. Billing
invoices, prescriptions records and patient
charts are some examples.
When it comes to pharmacy management, PHI
includes :
The patient’s name
The patient’s address
Prescription number
Telephone number
Date of birth
Name of employer as Wellness partner
Medication Returns
Return of dispensed medication to the prescriber is not allowed in
most states. Check your state specific requirements.
At no time should medications be taken back otherwise, unless
it was a dispensing error.
Patients can be directed to www.whitehousedrugpolicy.gov
to read the publication Federal Guidelines on Personal Rx
Drug Disposal. Flushing of medications has been prohibited
in most states due to contamination of water tables. The
FDA has released permissions allowing high abuse
medications such as Oxycodone to be immediately
flushed, if necessary.
Theft or Losses
TITLE 21 CODE OF FEDERAL
REGULATIONS, PART 1301.74 (c)
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The registrant shall notify within the DEA within one
business day of discovery of the theft of loss.
All in-transit losses of controlled must be reported.
The registrant shall complete and submit a DEA Form
106.
What Is a Significant (Meaningful) Loss?
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The actual quantity of controlled
substance lost in relation to the
type of business.
 The specific controlled
substances lost.
 Whether the loss of the
controlled substances can be
associated with access to those
controlled substances by specific
individuals, or whether the loss
can be attributed to unique
activities that may take place
involving the controlled
substance.
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A pattern of losses over a
specific time period whether the
losses appear to be random, and
the results of efforts taken to
resolve the losses; and if known;
whether the specific controlled
substances are likely candidates
for diversion; local trends and
other indicators of the diversion
potential of the missing
controlled substances.
DEA Form 106 – now an online process
REPORT OF THEFT OR LOSS
OF CONTROLLED
SUBSTANCES
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Date of Theft or Loss
Notifying Police
Number of Thefts
Type of Theft or Loss
Purchase Value of the Controlled
Substances
Pharmaceuticals or Merchandise
Taken
Back or second page of DEA 106
• Trade Name of Substance or Preparation
• Name of Controlled Substance in
Preparation
• Dosage Strength and Form
• Quantity
Lower Portion of second page
•Signature
•Title
•Date of Form
DEA Diversion Contact Information
For Additional
Information
www.DEAdiversion.usdoj.gov
or www.dea.gov