III.
Legislative Interest & Positions
Revised 02/14/14
For
Legislation
House & Senate Bills
Primary Sponsor(s)/
Annapolis Address
Original House
Committee(s)
and
Hearing Dates
HB 100 - Dental Hygienists - Practice in LongTerm Care Facilities - Repeal of Termination Date
Delegate Nicholaus R. Kipke
Republican, District 31, Anne
Arundel County
House Office Building
Room 212 (410) 841-3421
Health and
Government
Operations
01/23/14
2pm
Delegate Nicholaus R. Kipke Republican, District 31, Anne
Arundel County
House Office Building
Room 212 (410) 841-3421
Health and
Government
Operations
01/23/14
2pm
Senator Roy P. Dyson DemocratDistrict 29, Calvert, Charles & St.
Mary's Counties
James Senate Office Building
Room 102 (410) 841-3673
Education, Health,
and Environmental
Affairs
02/05/14
Delegate Kirill Reznik DemocratDistrict 39, Montgomery County
House Office Building
Room 225 (301) 858-3039
Health and
Government
Operations
01/30/14
1:30pm
Senator Roy P. Dyson DemocratDistrict 29, Calvert, Charles & St.
Mary's Counties
James Senate Office Building
Room 102 (410) 841-3673
Education, Health,
and Environmental
Affairs
02/05/14
For the repeal of the sunset provision to allow a
Maryland licensed dental hygienists to perform
dental hygiene care to residents of Long Term Care
Facilities under general supervision of a Maryland
licensed dentist.
HB 101 - Dental Hygienists - Nitrous Oxide Repeal of Termination Date
For repealing the termination date of specified
provisions of law relating to the authority of a
dental hygienist to monitor a patient to whom
nitrous oxide is administered.
HB 301 & SB 413- Health Occupations - Dentists
With Permits to Dispense Dental Products – For
the exclusion from Maryland Pharmacy Act
For providing that the Maryland Pharmacy Act
does not apply, under specified circumstances, to a
licensed dentist who obtains a specified permit
from the State Board of Dental Examiners and
dispenses specified dental products or rinses; and
providing that specified provisions of law do not
apply to a licensed dentist who obtains a specified
permit under a specified provision of the Act; etc.
HB 303 & SB 412 - Health Occupations - Licensed
Dentists Who Dispense Antibiotics – For the
exclusion from Maryland Pharmacy Act
For providing that the Maryland Pharmacy Act
does not prohibit, under specified circumstances, a
licensed dentist from dispensing a full course of
treatment of antibiotics to a patient for infection
control.
&
&
Delegate Kirill Reznik DemocratDistrict 39, Montgomery County
House Office Building
Room 225 (301) 858-3039
Health and
Government
Operations
01/30/14
4
HB 657- State Board of Dental Examiners Dentists and Dental Hygienists - Grounds for
Discipline
For authorizing the State Board of Dental
Examiners to take disciplinary actions against
applicants for a license to practice dentistry or
dental hygiene, licensed dentists, or licensed dental
hygienists if the applicant or licensee demonstrates
a course of conduct or provides a service that is
inconsistent with the standard of care for their
profession.
HB 709 & SB 642 - Health Insurance Assignment of Benefits and Reimbursement of
Non-preferred Providers - Repeal of Reporting
Requirement and Termination Date
For repealing the requirement that the Maryland
Health Care Commission, in consultation with the
Maryland Insurance Administration and the Office
of the Attorney General, conduct a specified study
and submit specified reports to the General
Assembly on or before specified dates; and
repealing the termination date of specified
provisions of law relating to the assignment of
benefits and reimbursement of non-preferred
providers.
HB 799 & SB 703 - General Provisions Commemorative Months - Children's Dental
Health Month.
For requiring the Governor annually to proclaim
February as Children's Dental Health Month.
Delegate Joseline A. Pena-Melnyk
Democrat – District 21
Prince George’s County & Anne
Arundel County
House Office Building,
Room 157
(410) 841-3205
Delegate Wade Kach, Republican
District 5B, Baltimore County
House Office Building
Room 201 (410)841-3359
Senator James N. Mathias, Jr.,
Democrat- District 38, Somerset,
Worcester, and Wicomico Counties
Miller Senate Building
Room 401 (410)841-3645
Health and
Government
Operations
02/13/14
Health and
Government
Operations
02/20/14
1:00 pm
&
Finance
02/25/14
1:00 pm
Delegate Shawn Z. Tarrant
Democrat –
District 40 Baltimore City
House Office Building
Room 151 (410) 841-3545
Delegates
Cullison, Glass, Ivey, A. Kelly,
and Pena-Melnyk
Senator Joanne C. Benson James
Democrat, District 24, Prince
George's County
Senate Office Building
Room 214 (410) 841-3103
Health and
Government
Operations
02/19/14
&
Finance
02/28/14
Opposing Diversion of Dental Medicaid Increases, Budget Subcommittee Hearings, House
2/20/14 1pm
Senate 2/21/14 1pm
Monitoring Pharmacy Board Regulations on Compounding Prescriptions.
Dentist Day presentation to be done by Dr. Arthur Jee, Member of the
Maryland State Board of Dental Examiners.
5
Position
MONITORING
Legislation
House & Senate Bills
Primary Sponsor(s)/
Annapolis Address
HB 693 & SB 504 Health Insurance –
Essential Health Benefits – Pediatric
Dental Benefits –
Delegate Eric M. Bromwell
Democrat - District 8, Baltimore
City
House Office Building
Room 415 Baltimore County
This provision to allow a health benefit
plan offered by a health insurance
carrier outside the Maryland Health
Benefit Exchange to exclude individuals
or small employers from being required
to include certain pediatric dental
benefits under certain circumstances;
making this Act an emergency measure.
HB1009 & SB 789 Civil Actions Noneconomic Damages - Catastrophic
Injury
MONITORING
Altering the maximum amount of
noneconomic damages that may be
recovered in health care malpractice
and other civil actions for a
catastrophic injury under specified
circumstances; etc.
Dentist Day presentation by
Dr. E. Duston Mersinger
MSDA Immediate Past President
HB1254 Dental Amalgam – Reduction
in Use
Against declaring that it is the policy of
the State to reduce the use of dental
amalgam;
requiring
a
specified
manufacturer or wholesaler of dental
amalgam to submit a specified plan to
the Department of the Environment on
or before September 30, 2014;
prohibiting
a
manufacturer
or
wholesaler of dental amalgam from
selling or offering for sale dental
amalgam in the State on or after
October 1, 2014, unless specified
conditions are met; etc.
Original House
Committee(s)
and
Hearing Dates
Finance
Senator Delores G. Kelley
Democrat - District 10 Baltimore
County
James Senate Office Building
Room 302 (410) 841-3103
Delegate Jill P. Carter Democrat District 41, Baltimore City
House Office Building
Room 317 (410) 841-3268
Delegates
Anderson, Rosenberg, Simmons,
Smigiel, Summers and Vallario
Judiciary
3/5/2014 - 1:00
Senator Victor R. Ramirez
Democrat District 47, Prince
George's County
Senator Jamie Raskin Democrat
District 20 Montgomery County
Senator Norman R. Stone, Jr.
Democrat District 6, Baltimore
County
James Senate Office Building
Rooms 303, 122 & 216
Delegate Alfred Carr Democrat –
District18 ,Montgomery County
House Office Building
Room 222 (410) 841-3638
Environmental
Matters
Delegate Tom P. Hucker Democrat
District 20, Montgomery County
House Office Building
Room 210 (301) 858-3474
6
POSITIONS/HISTORICAL BACKGROUND
The Maryland State Dental Association Supports HB 301 and SB 413 – Health
Occupations - Dentists with Permits to Dispense Dental Products
- Exclusion from Maryland Pharmacy Act.
Respectfully Submitted by Frances and Daniel T Doherty on behalf of the
Maryland State Dental Association
Currently, in order for a dentist to dispense any prescription medication, the dentist must obtain a
dispensing permit from the State Dental Board of Examiners and is regulated by the pertinent
provisions of the Maryland Pharmacy Act. A dentist who acquires this permit 1) does so at an
approximate cost of $1075 for a 5 year permit; 2) agrees to submit to at least 2 inspections by the
Division of Drug Control over the 5 year permit cycle at a cost that is still undetermined; 3) and must
take 10 hours of continuing education credits offered by the Accreditation Council for Pharmacy
Education.
Few dental offices have a dispensing permit because it is costly, and the required pharmacy record
requirements are administratively prohibitive. A major rationale for the regulation/limitation of the
dispensing of prescription drugs by dentists, physicians and podiatrists was the perceived need to
oversee and maintain control of the dispensing of narcotics. While dental offices may prescribe some
pain medications, in general they do not dispense them. Their primary need is to provide their patients
with needed dental specific medications, medications that have a relatively short shelf life.
These complex and burdensome dispensing requirements resulted in few dentists dispensing any
prescription medications to their patients, including necessary, beneficial dental specific products.
These products are fluoride rinses, enamel re-mineralizing agents, and antimicrobial rinses. A
pharmacy cannot anticipate how many prescriptions for each dental product they will be asked to fill.
Thus, few pharmacies stock any of the products, and many stock none. A dental practice knows the
needs of their patient base, can estimate with some accuracy the demand for each of these products,
and can order and maintain sufficient product without it going beyond the shelf life. Experience has
shown that demonstrating the appropriate use and application of the product, and dispensing the
product at the conclusion of the dental visit, increases the usage of the medication and enhances the
improvement of the patient’s dental health. The current dispensing laws, however, undermine these
results.
HB 301/SB 413 establishes a new class of dispensing permit which will authorize a dentist to dispense
only three classes of dental specific products. These are fluoride rinses, enamel re-mineralizing agents,
and antimicrobial rinses. The permit would not require a high fee. It would not necessitate inspections
by the Division of Drug Control, and thus the assessment of significant fees to approximate the cost of
inspections by the Division of Drug Control would be avoided and not passed on to the patient in the
cost for dental care. Finally, SB 301 will exempt the dentist from the requirement to take 10 hours of
pharmacy continuing education courses, which in the context of a dental practice are irrelevant.
The Maryland State Dental Association (MSDA) submits that the passage of HB 301/SB 413 will
enhance the benefits of dental care at a reasonable cost to the dentist, while maintaining reasonable
oversight. It will assure ready access for dental patients to needed dental products thus leading to
better oral health. It will make more readily available products that are of benefit to pediatric patients,
to aging dental patients, and to those patients that need help in controlling oral infections.
For these reasons, The MSDA respectfully requests that HB 301/SB 413 receive a favorable report.
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The Maryland State Dental Association Supports HB 303 and SB 412 - Health
Occupations - Licensed Dentists Who Dispense Antibiotics - Exclusion from Maryland
Pharmacy Act
Submitted by Frances Doherty and Daniel T Doherty on behalf of the MSDA
HB 303 and SB 412 will allow a dentist who treats a patient pro bono to give that patient - at no
charge - an antibiotic needed to treat an oral infection. HB 303 will exempt that dentist under
those circumstances from the dispensing permit requirements of the Maryland Pharmacy Act.
Many patients who are treated at no charge are unable to afford the cost of an antibiotic. This is
an especially critical factor when the patient has a severe infection and is in considerable pain.
Currently, unless a dentist has acquired a dispensing permit at considerable expense and is
willing to be subjected to intense regulation, a patient may not be given a needed antibiotic.
Since it is estimated that the number of dentists who hold a dispensing permit is 50 or less,
many patients who are indigent fail to receive these needed life saving drugs.
Currently there is no medical assistance coverage for adult recipients, and Medicare provides no
dental benefits. If a dentist does not provide the medication at no charge to an indigent patient,
the patient’s infection may go untreated. In 2011 an Ohio patient was treated by a dentist who
prescribed an antibiotic and a pain medication. Since the patient was able to afford only one, he
chose the relief provided by the pain medication over the curative qualities of the antibiotic. His
infection worsened and spread with the result that he subsequently died. In Maryland we want
to avoid that type of result occurring solely because the law prohibits the dispensing of free
antibiotics by a dentist to a poor patient. HB 303 is a bill that is needed and it makes sense.
For these reasons, MSDA respectfully requests that SB 303 and HB 412 receive a
favorable.
Contact: Daniel T. Doherty, Jr.
410-263-8325
.
8
Information on HB 301, SB 413 & HB 303, SB 412
From the Maryland State Dental Association
Legislative Affairs Committee
February 10, 2014
Current law stipulates that a dentist who wants to dispense prescription products needs 1)
A Dispensing Permit ($1,075/5 years), 2) two inspections from the Maryland Department of
Drug Control during that 5 year period, and 3) Ten hours of required continuing education
as approved by the Maryland Board of Pharmacy. Exemptions to this are 1) Starter dosages
(example, antibiotic premedication before a dental appointment for specific heart
condition or joint replacement), 2) Prescription regiments lasting less than 72 hours, and 3)
Prescriptions labeled “samples, not for resale”.
HB 301 (and companion bill SB 413) is legislation to develop a dispensing permit for
dentistry-specific products that require a prescription (fluoride, enamel re-mineralizing
agents and antimicrobial rinses). The legislation states that the “Prescription Dental
Products Dispensing Permit” would be issued by the Maryland State Board of Dental
Examiners (MSBDE) under three conditions:
1) A nominal fee to the MSBDE less than the former prescription dispensing permit fee of
$75/5 years and substantially less than the current $1000/5 year fee to the Maryland Board
of Pharmacy that was imposed in 2013.
2) No mandated office inspections by the Maryland Department of Drug Control.
3) No mandated Board of Pharmacy continuing education.
HB 303 (and companion bill SB 412) is legislation to allow dentists to dispense a full course
of antibiotics to treat infections of dental origin for patients they are treating pro bono
(without compensation) without charge to the patient. Current law will only allow a dentist
to dispense prescription medication up to 72 hours without the prescription dispensing
permit (current permit fee $1,075/5 years).
Q & A:
Q: Are these products usually provided at no cost or is there typically a charge for them?
A: Charges for dental products varies between offices and between procedures performed and
treatment goals. Most dental offices charge a nominal fee ($10-$20) for dental prescription strength
products. In most instances, it is provided to patients with little to no mark up from the cost the
dentist pays to obtain the product from a dental supply company who are also licensed wholesale
distributors of prescription medicine in Maryland. Most dental disease is preventable or severely
reduced with the use of these dental prescription products. In cases of treating the indigent, a
population of patients very prone to dental disease, many dentists will give the dental prescription
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product away at no charge. Many dentists include the prescription product as part of the procedure
for they know the use of the product will speed healing and produce better post operative results. A
good example is the use of chlorhexidine, a prescription strength anti-microbial rinse pre and post
operatively in treating periodontal disease cases. If these products are not immediately available,
compliance and results will suffer. Studies indicate that 20 to 31% of prescriptions go unfilled
(reference 1-4) and that percentages may be higher for dental prescription products as patients
may not realize the important value of the prescription use and/or the product as prescribed are
often not be readily available as prescribed at pharmacies. With the current dispensing permit fee
of $1,075/5 years, most dental offices have stopped dispensing the products as it would be unfair to
past that permit fee on to the price of providing the product to our patients. The current permit fee
does not help to contain health care costs. Dental disease rates would be expected to rise in the
State of Maryland as patients access to dental prescription would be reduced under the current
situation.
Q. How common or uncommon are reports of patients overdosing or becoming sickened by
inappropriate use of these products?
A. No cases of complications have been reported with the proper use of these products. All
these dental prescription products are used topically and not injected nor swallowed. These
products should be used according to manufacturer’s instructions and dentists and dental
hygienists will typically review the use of these products with the patient in the dental chair
(“Tell, Show & Do”) prior to dispensing these products. Proper prescribing practices and
proper usage of dental prescription products is taught in all U.S. dental schools. As with any
dental product (example, OTC tooth paste), a very rare contact dermatitis/stomatits to the
oral mucosa could occur and dentists are trained to handle these conditions should they
arise. Ingestion of large amounts of fluoride can result in fluorosis of developing teeth
and/or fluoride intoxication. For this reason, use of supplemental fluoride is not indicated
under the age of 6 (reference 5). Dental Remineralization agents contain casein
phosphopeptides and amorphous calcium phosphate and are contraindicated in children
under 6 and individuals with milk protein allergy (reference 6-8). Chlorhexidine gluconate
oral rinse can cause staining of oral surfaces that comes off during a dental cleaning. It
should be noted the concentration sold in the US (0.12%) is about half the concentration of
the product sold in Europe and much less staining is noted in the US. Most chlorhexidine
gluconate oral rinses contain 11.6% alcohol and as such are contraindicated in patients who
may have a chemical dependency on ethanol (reference 9). There is one FDA approved
Chloraxeidine without alcohol but it is not available in pharmacies (Sunstar Gum Paroex). It
should be noted that the above listed side effects are exceedingly rare as the products are
intended for oral topical use only on patients for high risk of dental disease and not to be
swallowed. Side effects would occur whether the product where dispensed by a pharmacist
or dentist. Dentist have the advantage in reducing side effects for we review the patients
health history each visit and can directly instruct the patient of how best to use each
product. When patients are unable to obtain dental prescription strength products from
dental offices or pharmacists, they turn to internet where sales are unregulated and quality
10
of the product is suspect.
Q. Anecdotally, Would it be fair to say that some patients, particularly the indigent, are not
going to have a prescription for one of these products filled at a pharmacy?
A. It has been estimated that 20 to 31% (reference 1-4) of ALL prescriptions in the U.S. go
unfilled. The percentage may be higher for dental prescription strength products if not
available in dental offices or not directly available “as prescribed” at pharmacies. Data to be
published later this year in the Journal of the American Dental Association estimates 60% of
antibiotics to treat dental infections goes unfilled (reference 10). Certainly, the indigent
have additional financial pressures that would prohibit them from getting a prescription
filled. Many Maryland dentists provide pro bono dental care to the indigent. Patients, who
do not have a dental home, typically seek dental care at Maryland emergency rooms (ER’s)
when they have dental pain. ER’s are not set up to provide dental care and typically
palliatively treat by providing two prescriptions, an antibiotic and a pain killer. The
estimated cost of this ER service is $600-$700 per visit, not a very efficient use of health
care dollars. Worse, indigent patients will often get one (the pain pill) or no prescriptions
filled. This scenario resulted in the death from an infected wisdom tooth of a Cincinnati man
in 2011. Currently, the Maryland State Dental Association is developing an ER Dental
Diversion Pilot project where ER’s would make direct referrals to dental offices to provide
actual needed dental care to these patients. HB 303 & SB 412 would allow dentists to
dispense a full course of antibiotic at no charge to indigent patients that are being treated
gratis.
Q. Why is it not necessary for the Maryland Division of Drug Control (DDC) to insect dental
offices that dispense “Prescription Dental Products”?
A. These products covered under HB 301/SB 413 have no abuse potential. These are all
topical products purchased through dental supply companies who are licensed wholesale
distributors of prescription drugs in Maryland. Dental offices purchase small quantities of
the prescription products with well defined safety labels and product expiration dates.
Dental offices maintain small inventories and dispensing dentists are required to maintain a
copy of the Rx in the patients chart. It would be a most inefficient use of Maryland taxpayer
dollars to send DDC inspectors into dental offices. Between December 14, 2011 and May
30, 2013, the DDC conducted 43 on-site inspections of dentists with dispensing permits,
among which only nine (21%) indicated that they are actively dispensing. Of these dentists,
all nine reported that they dispense only limited quantities of home fluoride, antimicrobial
rinse, and antibiotics to prevent infection after dental extraction or surgery. The DDC
therefore did not observe any violations or risks to the public’s health and safety (reference
11). The justification of the permit fee increase from $75 to $1,075 was to cover the cost of
two DDC inspections every 5 years. This 1333% fee increase is unjustified given the fact that
the three classes of dental prescription products referred to in HB 301/SB 413 have no
abuse potential and past safety record. The dentistry profession takes very seriously the
11
responsibility of proper prescribing, dispensing, and disposal of prescription medication.
The Maryland State Board of Dental Examiners has recently developed a course on this
topic and the Board reserves the right and does conduct inspections of dental offices.
Q. Why not have required Continuing Education in order to dispense these products from a
dental office?
A. All U.S. dental school (currently 64 including Puerto Pico) teach prescription writing and
proper use of these dental products as part of their curriculum and required for
accreditation. Dental hygienists are also taught to instruct patients on the proper use of
these dental products. Required CE would be a duplication of what is already taught.
Nobody knows the proper use of dental prescription products better than dentists and
dental hygienists. Attending a pharmacy board mandated course would not be a good use
of resources.
Q. Why not require that the “Prescription Dental Product” dispensed in dental offices be
purchased from distributers or pharmacies licensed in Maryland?
A. Dental offices purchase prescription strength dental products usually from dental supply
companies. These dental supply companies that sell prescription products in Maryland are
already mandated licensed wholesale distributors of prescription medication. This assures
tamper resistant packaging, child resistant caps, FDA approved labeling, and expiration
dates on prescription strength dental products. Manufactures such as Butler/Star, GC
America, Colgate, 3M, and Phillips/Sonicare have small sales forces that call on dental
offices but the prescription products are only available through licensed dental supply
distributers. These dental manufacturing companies only manufacture dental specific
products and many products are not included in the Maryland Prescription Formulary and
hence are not often found on pharmacy shelves. To mandate purchase dental specific
products from a pharmacy would add unnecessary cost to purchase the products and that
cost would most likely be passed on to the patient. Many products are “filled as directed,
do not substitute” for the dentist knows what product would work best for that patients
particular condition. An example of this is an “alcohol free” chlorhexidine prescription. This
particular product is only manufactured by a dental company and not available in
pharmacies or listed in Maryland pharmacy formularies.
Q. Is dispensing a prescription dental product a “money” issue for dentistry?
A. No! Dental offices provide these specific dental prescription products as a convenience
for our patients and to ensure the best outcome for our patients we serve. Most dental
offices provide this service at cost with little or no up charge. Providing dental prescription
products in office is not an income producer for dental offices.
References:
1) National Association of Chain Drug Stores NACDS Economics Dept 2007, “20% average
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2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
rate of unfilled prescriptions.”
“Taken As Directed: A Prescription Not Followed”. National Community Pharmacist
Association, December 2006, “31% had not filled a prescription they were given.”
“Primary Medication Non-Adherence: Analysis of 195,930 Electronic Prescriptions”,
Journal of General Internal Medicine, April 2010, Vol. 25, Issue 4, pp 284-290. “Eprescriptions for new medication 72% were filled.”
“Trouble Getting Started: Predictors of Primary Medication Nonadherence”, The
American Journal of Medicine, Nov. 2011 Volume 124, issue 11, p. 1081, “24% of eprescriptions for new medication were not filled.”
“Fluoride supplements, dental caries and fluorosis: A systematic review”. Journal of the
American Dental Association, Nov. 2008 pp. 1457-1468.
“Casein Phosphopeptide-Amorphous Calcium Phosphate; the Scientific Evidence”,
Advances in Dental Research, Aug. 2009, 21; pp. 25-29.
www. MI-paste.com
Current Evidence for Remineralizing Therapeutics in Caries Management” The Journal
of Dental Hygiene, Vol. #86 #1, Winter 2012, pp. 36-36
“Chlorhexidine Official FDA information, Side Effects and Used” www.drugs.com
Personal communication with Dr. Glick, editor of Journal of the American Dental
Association, “National Oral Health Hearing on Drug Use and Abuse” to be published
later in 2014.
Maryland Department of Health and Mental Hygiene, 2014 Session Position Paper in
support of Senate Bill 413.
13