"Initial and Renewal Application for Podiatrist Permit to Dispense Prescription Drugs" - Maryland

"Initial and Renewal Application for Podiatrist Permit to Dispense Prescription Drugs" - Maryland Download Pdf
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MARYLAND STATE BOARD OF
PODIATRIC MEDICAL EXAMINERS
4201 Patterson Avenue, Baltimore, Maryland 21215
Phone 410-764-4785; Fax 410-358-3083
INITIAL AND RENEWAL APPLICATION FOR PODIATRIST PERMIT
TO DISPENSE PRESCRIPTION DRUGS
NOTE: Continuing Education Requirement for
INSTRUCTIONS
Permit Renewal. A drug dispensing permit is valid
Review the FAQs to determine whether you need a dispensing permit. Complete this
for 5 years. Before you may renew the permit you
form, read and initial each letter after the certification; and sign and date the
must provide documentation of completion of at
application. If prescriptions will be dispensed in more than one location, a copy of
least 10 hours of continuing education relating to
the dispensing permit is required at each location. Permit is valid for 5 years from the
the preparing and dispensing of prescription drugs
offered by the Accreditation Council for Pharmacy
date of issue. Submit the completed, signed form with a check or money order for
Education (ACPE), or as approved by the Secretary
$1,050.00* payable to the Maryland State Board of Podiatric Medical Examiners.
of the Department of Health. No other continuing
Mail to above address.
education sponsors will be accepted. A renewal
permit will not be issued if these requirements are
not met. See D.i. through
D.v. below for your specific continuing education
requirement, depending upon the year you are
required to renew your permit.
Application for (check one)
Initial
Renewal (For renewal proof of continuing education as discussed in the Note above
must accompany this form.)
If renewal, Permit #
Expiration Date
/
/_
1. Podiatrist’s license number
Email address:_
2. Podiatrist’s name
Last
First
Middle
3. A drug dispensing permit may only be issued if the drugs are dispensed “In the public interest.” Will you be dispensing
prescription drugs “in the public interest”? The phrase “in the public interest” is defined in the law to mean that you will be dispensing
prescription drugs “when a pharmacy is not conveniently available to the patient.”
YES
NO
4. Primary Practice address where drugs will be dispensed.
Facility Name and Street Address
City
State
Zip Code
Telephone #
5. Additional Practice address(es) where drugs will be dispensed.
Facility Name and Street Address
City
State
Zip Code
Telephone #
Facility Name and Street Address
City
State
Zip Code
Telephone #
Facility Name and Street Address
City
State
Zip Code
Telephone #
Facility Name and Street Address
City
State
Zip Code
Telephone #
1
MARYLAND STATE BOARD OF
PODIATRIC MEDICAL EXAMINERS
4201 Patterson Avenue, Baltimore, Maryland 21215
Phone 410-764-4785; Fax 410-358-3083
INITIAL AND RENEWAL APPLICATION FOR PODIATRIST PERMIT
TO DISPENSE PRESCRIPTION DRUGS
NOTE: Continuing Education Requirement for
INSTRUCTIONS
Permit Renewal. A drug dispensing permit is valid
Review the FAQs to determine whether you need a dispensing permit. Complete this
for 5 years. Before you may renew the permit you
form, read and initial each letter after the certification; and sign and date the
must provide documentation of completion of at
application. If prescriptions will be dispensed in more than one location, a copy of
least 10 hours of continuing education relating to
the dispensing permit is required at each location. Permit is valid for 5 years from the
the preparing and dispensing of prescription drugs
offered by the Accreditation Council for Pharmacy
date of issue. Submit the completed, signed form with a check or money order for
Education (ACPE), or as approved by the Secretary
$1,050.00* payable to the Maryland State Board of Podiatric Medical Examiners.
of the Department of Health. No other continuing
Mail to above address.
education sponsors will be accepted. A renewal
permit will not be issued if these requirements are
not met. See D.i. through
D.v. below for your specific continuing education
requirement, depending upon the year you are
required to renew your permit.
Application for (check one)
Initial
Renewal (For renewal proof of continuing education as discussed in the Note above
must accompany this form.)
If renewal, Permit #
Expiration Date
/
/_
1. Podiatrist’s license number
Email address:_
2. Podiatrist’s name
Last
First
Middle
3. A drug dispensing permit may only be issued if the drugs are dispensed “In the public interest.” Will you be dispensing
prescription drugs “in the public interest”? The phrase “in the public interest” is defined in the law to mean that you will be dispensing
prescription drugs “when a pharmacy is not conveniently available to the patient.”
YES
NO
4. Primary Practice address where drugs will be dispensed.
Facility Name and Street Address
City
State
Zip Code
Telephone #
5. Additional Practice address(es) where drugs will be dispensed.
Facility Name and Street Address
City
State
Zip Code
Telephone #
Facility Name and Street Address
City
State
Zip Code
Telephone #
Facility Name and Street Address
City
State
Zip Code
Telephone #
Facility Name and Street Address
City
State
Zip Code
Telephone #
1
Please read and initial the space on the left of each lettered paragraph as your acknowledgment and
agreement.
A.
I am thoroughly familiar with and will comply with all statutes and regulations which govern a podiatrist’s
dispensing of prescription drugs.
B.
I understand that I must follow the requirements regarding dispensing, labeling, record keeping, and patient
notifications in order to receive and maintain a permit to dispense. Failure to comply with these
requirements or other conditions included in the laws and regulations is a violation of the Podiatry Practice Act
and its regulations.
C.
I will annually report to the Board whether I have personally prepared and dispensed prescription drugs within
the previous year. I understand that I will be contacted by the Board either by e-mail or by letter to provide
this information to the Board and I will provide the requested information in an expedited manner. I further
understand that my failure to respond to Board inquiries regarding my dispensing of prescription drugs in an
expedited manner is a violation of the Podiatry Practice Act and its regulations.
(Initial only if you are seeking renewal; Skip this question if you are seeking an initial permit).
D.
With the exceptions below, I have completed ten continuing education (CE) hours over a 5 year period
relating to the preparing and dispensing of prescription drugs, offered by the Accreditation Council for
Pharmacy Education (ACPE) or as approved by the Secretary of the Department of Health. Documentation
of continuing education credits is attached to this application. The required continuing education hours will
be phased in as follows:
i.
For permits that expire in 2014, the podiatrist shall complete two continuing education hours;
ii. For permits that expire in 2015, the podiatrist shall complete four continuing education hours;
iii. For permits that expire in 2016, the podiatrist shall complete six continuing education hours;
iv. For permits that expire in 2017, the podiatrist shall complete eight continuing education hours;
v. For permits that expire in 2018, the podiatrist shall complete ten continuing education hours.
I understand that I must submit documentation of completed continuing
education with my renewal application
E.
I do not have a substantial financial interest in a pharmacy.
F.
I do not direct patients to a single pharmacist or pharmacy.
G.
I personally prepare and dispense prescription drugs.
H.
I ensure that signs are conspicuously posted at each dispensing location regarding the process for resolving
incorrectly filled prescriptions or which includes written information regarding the process with each
prescription dispensed.
I.
I will allow the Office of Provider Engagement and Regulation to enter and inspect the dispensing office(s) at all
reasonable hours.
Applicant’s
Signature
Date
2
Senate Bill 603 (Chapter 267, Laws of Maryland 2012)
Health Care Practitioners – Licensed Dentists, Physicians, and
Podiatrists –
Personally Preparing and Dispensing Prescription Drugs and Devices
FREQUENTLY ASKED QUESTIONS
1.
Under what circumstances is a podiatrist required to hold a drug dispensing permit?
Licensed podiatrists are required to obtain a drug dispensing permit if they dispense prescription drugs to
patients under their direct care who have informed the podiatrist that a pharmacy is not conveniently available.
A dispensing permit is not required if the podiatrist dispenses “samples” or a “starter dosage.” A starter
dosage is defined as an amount, sufficient to begin therapy, of short duration of 72 hours or less.
The podiatrist shall maintain documentation that should include a single form in each patient's chart for each
patient to whom prescription drugs are dispensed. At a minimum, the form shall:
(1) Indicate the reason, as stated by the patient, that a pharmacy is not conveniently available to that patient;
(2) Include a statement signed by the patient indicating that the patient understands that the
determination that a pharmacy is not conveniently available is made solely by the patient; and
(3) Be signed and dated by the patient before dispensing prescription drugs to the patient for the first time.
2.
Are all podiatrists licensed in Maryland required to hold a dispensing permit?
No. There is no
requirement that every podiatrist hold a drug dispensing permit. A podiatrist may dispense “samples” without
a permit. In addition, a podiatrist may dispense, without a permit and at no charge to patients, a “starter
dosage” which is defined as an amount, sufficient to begin therapy, of short duration of 72 hours or less.
Samples and starter dosages may be dispensed without regard to whether a pharmacy is “conveniently
available” to the patient .
3.
What is the difference between administering and dispensing?
Administering is treating the patient in the podiatrist’s office with the prescription drug. Dispensing is
giving the prescription drug to the patient to take home. As noted above, giving samples and starter doses
to patients to take home does not require a dispensing permit. Administering a prescription drug in the
podiatrist’s office does not require a drug dispensing permit.
4.
Is a dispensing permit required for the dispensing practitioner for each location where
prescription drugs are dispensed?
No. However, if prescriptions will be dispensed in more than one location, a copy of the dispensing
permit is required to be displayed at each location where prescription drugs are dispensed.
5.
What is the definition of public interest?
Public interest means the dispensing of prescription drugs by a licensee to a patient when a pharmacy
is not conveniently available to the patient.
6.
Are there certain items patients receive by prescription that do not require a dispensing permit?
No. If the drug is dispensed so that the patient can take the drug home, and if it can only be obtained by
prescription, it falls within the purview of the drug dispensing laws. The permit exceptions such as
“samples” and “starter dosages” are discussed above.
7.
How does a podiatrist apply for a dispensing permit?
A podiatrist applies for a dispensing permit by submitting a completed application and the appropriate fee to the
Podiatry Board.
8.
Dispensing Requirements
The dispensing requirements are:
• A podiatrist shall submit an application to the Podiatry Board.
• A podiatrist may not dispense prescription drugs until a written permit is received from the Podiatry
Board except that a written permit is not required in order to dispense starter dosages of short duration of 72
hours or less, or samples provided without charge.
• A podiatrist shall dispense prescription drugs only to the patients of the licensee.
• A podiatrist shall comply with all labeling requirements.
• A podiatrist shall record the dispensing of the prescription drug on the patient's chart.
• A podiatrist may not have a substantial financial interest in a pharmacy.
• A podiatrist shall allow the Office of Provider Engagement and Regulation to enter and inspect the
licensee's office at all reasonable hours.
• A podiatrist shall, provide the patient with a written prescription except for starter dosages of short duration of
72 hours of less, or samples provided without charge.
• A podiatrist shall maintain a separate file for Schedule II prescriptions. All other prescriptions shall be
kept: (1) In another file; and (2) For 5 years.
• A podiatrist shall dispense prescription drugs to a patient only when a pharmacy is not conveniently
available to the patient. The decision whether a pharmacy is conveniently available shall be made by the
patient based upon factors to be determined solely at the discretion of the patient.
• A podiatrist shall display prominently a sign which informs the patient that prescription drugs can be
purchased from the permit holder only if the patient determines that a pharmacy is not conveniently
available to the patient.
• The sign must also describe the process for resolving incorrectly filed prescriptions, unless this
information is provided in writing with each prescription.
9.
Will I be required to meet the new continuing education requirement in order to renew my
dispensing permit when my current permit expires?
Yes. Under the new law podiatrists are required to complete 10 continuing education hours over a 5- year
period relating to the preparing and dispensing of prescription drugs as a condition of permit renewal. The
classes must be offered by the Accreditation Council for Pharmacy Education (ACPE), or as approved by the
Secretary of the Department of Health. No other continuing education sponsors will be accepted. A renewal
permit will not be issued if these requirements are not met. See the continuing education schedule under D.i.
through D.v. above to determine which specific continuing education requirements depending upon when you
are scheduled to renew your drug dispensing permit.
10.
What happens if a licensee fails to comply with the dispensing laws and regulations?
A licensee who fails to comply with the requirements governing dispensing of prescription drugs may be subject to
.
disciplinary action
11.
What is the fee for a dispensing Permit?
On July 1, 2013, a new law went into effect. Senate Bill 603, Chapter 267, Laws of Maryland 2012 requires
the Board to charge a fee to approximate, but not to exceed the documented costs to the Division of Drug
Control for inspections of dispensing permit holders.
If you have any questions you are urged to contact
Ms. Elizabeth Kohlhepp, Licensing Coordinator at 410-764- 4785, or
Eva Schwartz at 410-764-4784.
The Board’s website is
https://health.maryland.gov/mbpme/
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