Earn1 CE credit

This course was written for dentists, dental hygienists,

and assistants.

This educational activity was developed by PennWell’s Dental Group with no commercial support.This course was written for dentists, dental hygienists and assistants, from novice to skilled. Educational Methods: This course is a self-instructional journal and web activity. Provider Disclosure: PennWell does not have a leadership position or a commercial interest in any products or services discussed or shared in this educational activity nor with the commercial supporter. No manufacturer or third party has had any input into the development of course content.Requirements for Successful Completion: To obtain 1 CE credit for this educational activity you must pay the required fee, review the material, complete the course evaluation and obtain a score of at least 70%.CE Planner Disclosure: Heather Hodges, CE Coordinator does not have a leadership or commercial interest with products or services discussed in this educational activity. Heather can be reached at hhodges@pennwell.comEducational Disclaimer: Completing a single continuing education course does not provide enough information to result in the participant being an expert in the field related to the course topic. It is a combination of many educational courses and clinical experience that allows the participant to develop skills and expertise.Registration: The cost of this CE course is $20.00 for 1 CE credit. Cancellation/Refund Policy: Any participant who is not 100% satisfied with this course can request a full refund by contacting PennWell in writing.

Supplement to PennWell Publications

Author ProfileLeslie S.T. Fang received his PhD degree in Physiology and Biophysics from the University of Illinois, Champaign-Urbana. He did his medical training at Harvard Medical School and is board certified in Internal Medicine and Nephrology. He has been on the staff of Massachusetts General Hospital and on the faculty of Harvard Medical School. A clinician and a teacher, he maintains an active inter-national practice in Internal Medicine and Nephrology and is a leading teacher at Harvard Medical School. He has received numerous awards for excellence in teaching from Harvard Medical School and has served and chaired the Medical Internship Selection Committee at the Massachusetts General Hospital for two decades. He is the co-author of the major textbook Principle and Practice of Oral Medicine, Oral Medicine Secrets and has been heavily involved in the clinical teaching of Oral Medicine. Dr. Fang. He has been the featured speaker at many of the major dental meetings and can be reached at lesliefang@mac.com .

Author DisclosureLeslie S.T. Fang is the founder and the Executive Chairman of FerruMax Pharmaceutical, a biotechnology company.

Educational Objectives:At the conclusion of this educational activity the participant will be able to:1. Describe Pradaxa® (dabigatran) and Xarelto®

(rivaroxaban) and why are they increasingly prescribed

2. Discuss how these newer oral anticoagulants differ from Coumadin®

3. Manage simple and complex dental procedures in a patient on newer oral anticoagulants

4. Safely utilize drugs commonly prescribed by dentists for patients on newer oral anticoagulants

5. Describe the drugs commonly prescribed by dentists which should be avoided in patients on newer oral anticoagulants

Publication date: Oct. 2013 Expiration date: Sept. 2016

AbstractPradaxa® (dabigatran) and Xarelto® (rivaroxaban) are two new oral anticoagulants that are striving to replace Coumadin® in the management of patients with non-valvular atrial fibrillation. The drugs have rapid onset of action, are taken in a fixed dose, do not require PT/INR monitoring and there are no dietary restrictions for the patients on these agents. This has led to a rapid adoption by physicians. It is therefore important for the dental professional to understand the mechanism of action of these drugs in order to intelligently manage these patients when they need dental intervention. The pros and cons of interruption of therapy are discussed as they apply to patients needing simple and complex dentistry. Medical consultation is mandatory prior to interruption of anticoagulant therapy.

Pradaxa® and Xarelto®: Coming Soon to Your Practice!!A Peer-Reviewed Publication Written by Leslie S.T. Fang, MD, PhD

PennWell designates this activity for 1 Continuing Educational Credit

Dental Board of California: Provider 4527, course registration number CA# 01-4527-13088“This course meets the Dental Board of California’s requirements for 1 unit of continuing education.”

The PennWell Corporation is designated as an Approved PACE Program Provider by the Academy of General Dentistry. The formal continuing dental education programs of this program provider are accepted by the AGD for Fellowship, Mastership and membership maintenance credit. Approval does not imply acceptance by a state or provincial board of dentistry or AGD endorsement. The current term of approval extends from (11/1/2011) to (10/31/2015) Provider ID# 320452.

INTRINSIC(surface contact)

EXTRINSIC(tissue damage)

Coumadin

Xarelto

Pradaxa

HMWKF XII F XIIa

KAL

F XI F XIa

F IX

F Va+PF-3

Fx

F Xa

F VII

F VIIa

Tissue factor

Prothrombin (F II)

Fibrinogen (F I)

Thrombin (F IIa)

Fibrin

F VIIIa+PF-3

F IXa

112 10.2013 | www.DENTALECONOMICS.com

Educational Objectives:At the conclusion of this educational activity the partici-pant will be able to:1. Describe Pradaxa® (dabigatran) and Xarelto®

(rivaroxaban) and why are they increasingly prescribed 2. Discuss how these newer oral anticoagulants differ

from Coumadin® 3. Manage simple and complex dental procedures in a

patient on newer oral anticoagulants 4. Safely utilize drugs commonly prescribed by dentists

for patients on newer oral anticoagulants 5. Describe the drugs commonly prescribed by dentists

which should be avoided in patients on newer oral anticoagulants

AbstractPradaxa® (dabigatran) and Xarelto® (rivaroxaban) are two new oral anticoagulants that are striving to replace Couma-din® in the management of patients with non-valvular atrial fibrillation. The drugs have rapid onset of action, are taken in a fixed dose, do not require PT/INR monitoring and there are no dietary restrictions for the patients on these agents. This has led to a rapid adoption by physicians. It is there-fore important for the dental professional to understand the mechanism of action of these drugs in order to intelligently manage these patients when they need dental intervention. The pros and cons of interruption of therapy are discussed as they apply to patients needing simple and complex dentistry. Medical consultation is mandatory prior to interruption of anticoagulant therapy.

IntroductionWhen new drugs that are likely to gain significant utilization in the populace appears on the marketplace, particularly those that are associated with bleeding diathesis, it is important for the dental professionals to be familiar with these drugs and to under-stand the best way of managing these patients when they need dental intervention.

While the majority of dentists are comfortable in the manage-ment of patients on Coumadin®, they are probably just beginning to see patients coming in on the two newer oral anticoagulants, Pradaxa® (dabigatran) and Xarelto® (rivaroxaban). These agents have now been approved for use in anticoagulating patients with non-valvular atrial fibrillation.

In order to be able to intelligently manage these patients, an understanding of the indications for Pradaxa® (dabigatran) and Xarelto® (rivaroxaban), their mechanisms of action, their advan-tages and disadvantages is important.

Similar to the management of patients on Coumadin® (warfa-rin), these drugs can be continued for simple dental procedures. In instances where complicated dental procedures are planned, consultation with the patient’s physician is critical to discuss the feasibility of temporarily withholding these drugs to avoid exces-sive bleeding.

Indications for new oral anticoagulantsMany patients are on the oral anticoagulant Coumadin® (war-farin) for atrial fibrillation, deep venous thrombophlebitis and pulmonary embolism.

Atrial fibrillation puts patients at 5 times the risk for stroke and Coumadin® decreases the risk significantly. However, over-anticoagulation can result in bleeding complications, includ-ing hemorrhagic stroke. Patients on Coumadin® are therefore carefully monitored by PT/INR and the doses of the drug are continuously changing according to the INR value. Patients and physicians have found this process tedious and inconvenient. There has; therefore, been a continuous search for agents that can more precisely titrate the degree of anticoagulation. As a result drugs have been developed that can be given in a fixed dose and do not require continuous monitoring.

These new oral anticoagulants, Pradaxa® (dabigatran) and Xarelto® (rivaroxaban), have been approved for use in patients with non-valvular atrial fibrillation and for prophylaxis against deep venous thrombophlebitis after hip and knee surgery.

Mechanism of action of traditional and newer oral anticoagulantsThe new oral anticoagulants work at sites different from couma-din and are gaining acceptance because of their ease of use.

Coumadin® interferes with coagulation by acting on 4 vita-min-K dependent coagulation factors (Figure 1). These factors are quite sensitive to changes in vitamin K availability. Minor changes in diet or the use of antibiotics can affect these factors. It is therefore important to meticulously manage the level of antico-agulation (measured by PT/INR) in patients on Coumadin® and doses have to be carefully adjusted.

Unlike Coumadin®, both Pradaxa® and Xarelto® act at sites quite close to the formation of the fibrin clot (Figure 1). The level of anticoagulation is therefore more predictable and both drugs can be given at a fixed dose without monitoring of blood tests. There are also no dietary restrictions with either agent (Table 1). Patients and physicians find these features attractive and an increasing number of patients are now on Pradaxa® and Xarelto®.

Figure 1. Sites of action of Coumadin, Xarelto and Pradaxa

113www.DENTALECONOMICS.com | 10.2013

In clinical trials, both agents have been as, or more efficacious than Coumadin® in the prevention of stroke in patients with non-valvular atrial fibrillation. In these trials, where patients have been carefully screened, the bleeding complications were similar to those observed with Coumadin®.

Pradaxa® is taken twice a day and Xarelto® is taken once a day, usually in the evening. Pradaxa® is available as 75 mg or 150 mg capsules, while Xarelto® is available as 15 mg or 20 mg doses. Both drugs have to be adjusted according to the patient’s renal function and patients with compromised renal function usually receive the lower dosage of the drugs.

Table 1. Comparison of the Three Oral Anticoagulants

Coumadin® (warfarin)

Pradaxa® (dabigatran)

Xarelto® (rivaroxaban)

Requires regular blood tests

No need for regular blood monitoring tests

No need for regular blood monitoring tests

Some dietary restrictions

No restrictions No restrictions

Dose available 75 mg or 150 mg 10 mg or 15 mg

Taken once a day Twice a day Once a day (evening)

Variable dose according to PT/INR

Fixed dose Fixed dose

Reversal agentsPatients with significant clinical bleeding on Coumadin® can be reversed with vitamin K or fresh frozen plasma. There are no reversal agents for Pradaxa® or Xarelto®. The absence of a reversal agent makes both of the newer oral agents a less attractive choice in patients with a known bleeding diathesis.

Fortunately, both agents have relatively short half-lives. In general, Pradaxa® or Xarelto® are withheld when there is clini-cally significant bleeding. Patients may need blood transfusion if there are clinical indications. The drugs are usually restarted at a lower dose when the bleeding has stopped.

Bleeding complications of the new oral antico-agulantsLike Coumadin®, both Pradaxa® and Xarelto® can be associated with bleeding complications.

Pradaxa® is 80% cleared by the kidneys. In patients on Pradaxa®, the risk of bleeding is higher in patients:• 75yearsoldorolder• Withrenaldysfunction• Withahistoryofgastrointestinalbleeding• Onanti-inflammatorydrugs• Onaspirinproducts• Onketoconazole• Ondronedarone

Xarelto® has a dual mode of excretion, with 1/3 of the drug excreted by the kidneys unchanged and 2/3 metabolized by the liverviatheCYP3A4pathway.Ofthemetabolicproducts,halfis

excreted by the kidneys and half by the liver via bile. In patients who are on Xarelto®, the risk of bleeding is higher in patients:• Withrenaldysfunction• Withliverdysfunction• Onanti-inflammatorydrugs• Onaspirinproducts• OnconcomitantuseofdrugsthatarecombinedP-gpand

CYP3A4 inhibitors such as ketoconazole and ritonavirNeither agent is approved for use in pregnant females or nurs-

ing mothers.

Dental management of patients on Pradaxa® and Xarelto®Figure 2 is a quick reference guide for management of dental patients in Pradaxa®.

Although the degree of anticoagulation by Pradaxa® and Xarelto® can be measured by Ecarin Clotting Time (ECT), this test is rarely necessary since both drugs provide relatively predict-able levels of anticoagulation. For the dentist, the only decision is whether interruption of anticoagulation therapy is necessary. This is obviously based upon the procedure planned, the clinical scenario and the likelihood of bleeding complications.

For most non-surgical and simple surgical procedures, it would be reasonable to proceed with attention to local hemostatic mea-sures without interruption of anticoagulant therapy. This is based upon an analogy drawn from the management of patients on Cou-madin®, where interruption of Coumadin® was found to have more risk than benefit. However, one should bear in mind that both Pradaxa® and Xarelto® have much faster onset and washout than Coumadin®. A patient who is taken off of either agent for 24 hours has only a very short period without anticoagulation and the risk of thrombus formation in patients with non-valvular atrial fibril-lation during this short window is not very high. It is theoretically safer to interrupt Pradaxa® or Xarelto® therapy than Coumadin® therapy. However, the risk benefit ratio of transient interruption of therapy has not been clearly defined as yet. It is therefore impor-tant to include the patient’s physician in any decision with regard to interruption of anticoagulation. In a patient with significant risk of thrombosis, the patient has to be managed without interruption of therapy by careful use of local hemostatic measures.

Local hemostatic measures should include:• Extrasutures• Compressivepackinganddressing• Microfibrillarcollagenhemostat• Oxidizedcellulose• 4.8%tranexamicacidmouthwash(ingredientinteabags)• Topicalthrombin

For complex surgical procedures, it would be reasonable to consult with the patient’s physician to determine if it is safe to stop the agents on the day before and the morning of the planned surgical procedures.

For Pradaxa®, the oral anticoagulant should be withheld the day before the procedure and the day of the procedure. Pradaxa® should be resumed the evening after the procedure.

114 10.2013 | www.DENTALECONOMICS.com

For Xarelto®, the medication should be withheld the evening be-fore the procedure and resumed on the evening after the procedure.

ONE SHOULD NOT STOP ORAL ANTICOAGU-LANTS WITHOUT DOCUMENTATION OF THEOPINION OF THE MEDICAL CONSULTANTS. If it is deemed by the consulting physician that the risk of interrup-tion of the oral anticoagulants outweighs the benefit, it is then up to the dental professional to decide if the intended procedures can be done safely in the presence of full anticoagulation.

Use of commonly prescribed drugs in dentistry for patients on Pradaxa® or Xarelto®As is often the case, the dental professional should be aware of potential drug-drug interactions with these new oral anticoagu-lants. Drugs that interfere with the metabolism of these drugs should be avoided. Similarly, drugs that can increase bleeding complications should also be avoided.

Table 2 is a quick reference guide for drugs that are safe to use and drugs that should be avoided in patients on Pradaxa® and Xarel-to.® Table 2 includes only drugs commonly prescribed by dentists.

In instances where a drug prescribed is not on the list, it would be important to consult a source such as Lexi-Comp® to be sure there are no drug-drug interactions with Pradaxa® and Xarelto®.

Acceptance of the newer oral anticoagulantsIt is clear that the fixed dosage of these new oral anticoagulants, the elimination of PT/INR monitoring and the lack of dietary restrictions is attractive for patients and physicians alike. It is also clear that there are no concerns over the efficacy of these drugs. Clinical trials have demonstrated the ability of these drugs to prevent embolic strokes is similar, if not superior to, that of Coumadin®. More prescriptions are written on a daily basis for the newer oral anticoagulants because of these reasons.

However, there are concerns for bleeding complications with both agents. Although the clinical trials conducted for FDA drug approval demonstrated bleeding complications to be at a level similar to Coumadin®, there are increasing concerns about significant bleeding complications with the newer oral anticoagulants. When these cases are carefully scrutinized, it is clear that elderly patients with renal or hepatic compromises might have received inappropriate doses. Nonetheless, the absence of a reversal agent makes bleeding in these instances more problematic.

The eventual acceptance of these drugs will depend upon the balance between the safety of these drugs and the ease of use.

References1. Ezekowitz MD, Reilly PA, Nehmiz G, Simmers TA, Nagarakanti R,

Parcham-Azad K, Pedersen KE, Lionetti DA, Stangier J, Wallentin L Dabigatran with or without concomitant aspirin compared with warfarinaloneinpatientswithnonvalvularatrialfibrillation(PETROstudy). Am J Cardiol 100 , 1419-1426 (2007)

2. Soheir S. Adam, MD; Jennifer R. McDuffie, PhD; Thomas L. Ortel,MD, PhD; and John W. Williams Jr., MD Comparative Effectiveness ofWarfarinandNewOralAnticoagulantsfortheManagementofAtrialFibrillation and Venous Thromboembolism: A Systematic Review. Ann Intern Med. 28 (2012)

Reprinted from the Ultimate Cheat Sheets: The Practical Guide for Dentists®

Figure 2: Dental management of patients on Dabigatran (Pradaxa)

Reprinted from the Ultimate Cheat Sheets: The Practical Guide for Dentists®

Table 2: Drugs for patients on Darbigatran

115www.DENTALECONOMICS.com | 10.2013

Author ProfileLeslie S.T. Fang received his PhD degree in Physiology and Biophysics from the University of Illinois, Champaign-Urbana. He did his medical training at Harvard Medical School and is board certified in Internal Medicine and Nephrology. He has been on the staff of Massachusetts General

Hospital and on the faculty of Harvard Medical School. A clinician and a teacher, he maintains an active international practice in Internal Medicine and Nephrology and is a leading teacher at Harvard Medical School. He has received numerous

awards for excellence in teaching from Harvard Medical School and has served and chaired the Medical Internship Selection Committee at the Massachusetts General Hospital for two decades. He is the co-author of the major textbook Principle andPracticeofOralMedicine,OralMedicineSecretsandhasbeenheavilyinvolvedintheclinicalteachingofOralMedicine.Dr. Fang. He has been the featured speaker at many of the major dental meetings and can be reached at lesliefang@mac.com .

Author DisclosureLeslie S.T. Fang is the founder and the Executive Chairman of FerruMax Pharmaceutical, a biotechnology company.

1. Why is there a need for these new oral anti-coagulants, Pradaxa® and Xarelto®?a. Convenienceb. Safetyc. Costd. All of the above

2. Pradaxa® is:a. A direct thrombin inhibitorb. A vitamin K inhibitorc. A Factor Xa inhibitord. none of the above

3. Xarelto® is:a. A direct thrombin inhibitorb. A vitamin K inhibitorc. A Factor Xa inhibitord. none of the above

4. Pradaxa® is prescribed:a. As a fixed dose at 150 mg BIDb. As a fixed dose at 10 mg QHSc. No monitoring blood tests are necessaryd. a and c

5. Xarelto® is prescribed:a. As a fixed dose at 150 mg BIDb. As a fixed dose at 10 mg QHSc. No monitoring blood tests are necessaryd. b and c

6. The major concern over current use of Coumadin® is:a. Costb. Need for continuous monitoringc. Bleeding complicationsd. b and c

7. Which of the following is true regarding dental patients on Pradaxa® or Xarelto®?a. Can be continued for simple proceduresb. Complex procedures do not require physician

consultationc. Cannot be continued for simple dental proceduresd. None of the above

8. Which of the following is true regarding the metabolism of Pradaxa®?a. 80% renally clearedb. Dose should be adjusted in patients with renal

dysfunctionc. Dose should be adjusted in elderly patientsd. All of the above

9. Which of the following is true regarding the metabolism of Xarelto®?a. Dose should be adjusted in patients with renal

dysfunctionb. Dose should be adjusted in patients with liver

dysfunctionc. Xarelto® has a dual mode of excretiond. All of the above

10. Which of the following is true regarding the dental management of patients on Pradaxa®?a. Drug cannot be stopped without consultation with the

referring physicianb. If Pradaxa® were to be held, it should be held the night

before and the morning of planned procedurec. It should be resumed the evening after the procedure,

unless there is clinical concern over bleedingd. All of the above

11. Which of the following is true regarding the dental management of patients on Xarelto®?a. Drug cannot be stopped without consultation with the

referring physicianb. If Xarelto® were to be held, it should be held the night

before planned procedurec. It should be resumed the evening after the procedure,

unless there is clinical concern over bleedingd. All of the above

12. With the transient discontinuation of Pradaxa® or Xarelto® just prior to the procedure, the patient should have:a. No bleeding diathesisb. Modest bleeding diathesis c. Local hemostatic measuresd. b and c

13. Which of the following properties of Xarelto® and Pradaxa® are true?a. Act close to the fibrin clotb. No dietary restrictionsc. Predictable anticoagulationd. All of the above

14. Which of the following is true regarding anticoagulant drugs?a. Coumadin® does not require regular blood testsb. Pradaxa® is taken once a dayc. Xarelto® has a fixed dosed. Coumadin® has a fixed dose

15. Local hemostatic measures should include:a. Oxidizedcelluloseb. Extra suturesc. Topical thrombind. All of the above

Questions

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ANSWER SHEET

Pradaxa® and Xarelto®: Coming Soon to Your Practice!!

Name: Title: Specialty:

Address: E-mail:

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Lic. Renewal Date: AGD Member ID:

Requirements for successful completion of the course and to obtain dental continuing education credits: 1) Read the entire course. 2) Complete all information above. 3) Complete answer sheets in either pen or pencil. 4) Mark only one answer for each question. 5) A score of 70% on this test will earn you 1 CE credit. 6) Complete the Course Evaluation below. 7) Make check payable to PennWell Corp. For Questions Call 216.398.7822

Educational Objectives1. Describe Pradaxa® (dabigatran) and Xarelto® (rivaroxaban) and why are they increasingly prescribed

2. Discuss how these newer oral anticoagulants differ from Coumadin®

3. Manage simple and complex dental procedures in a patient on newer oral anticoagulants

4. Safely utilize drugs commonly prescribed by dentists for patients on newer oral anticoagulants

5. Describe the drugs commonly prescribed by dentists which should be avoided in patients on newer oral anticoagulants

Course Evaluation1.Weretheindividualcourseobjectivesmet? Objective#1: Yes No Objective#4: Yes No

Objective#2: Yes No Objective#5: Yes No Objective#3: Yes No

Please evaluate this course by responding to the following statements, using a scale of Excellent = 5 to Poor = 0.

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6. Please rate the instructor’s effectiveness. 5 4 3 2 1 0

7. Was the overall administration of the course effective? 5 4 3 2 1 0

8. Please rate the usefulness and clinical applicability of this course. 5 4 3 2 1 0

9. Please rate the usefulness of the supplemental webliography. 5 4 3 2 1 0

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11. Would you participate in a similar program on a different topic? Yes No

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INSTRUCTIONSAll questions should have only one answer. Grading of this examination is done manually. Participants will receive confirmation of passing by receipt of a verification form. Verification of Participation forms will be mailed within two weeks after taking an examination.

COURSE CREDITS/COSTAll participants scoring at least 70% on the examination will receive a verification form verifying 1 CE credit. The formal continuing education program of this sponsor is accepted by the AGD for Fellowship/Mastership credit. Please contact PennWell for current term of acceptance. Participants are urged to contact their state dental boards for continuing education requirements. PennWell is a California Provider. The California Provider number is 4527. The cost for courses ranges from $20.00 to $110.00.

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The PennWell Corporation is designated as an Approved PACE Program Provider by the Academy of General Dentistry. The formal continuing dental education programs of this program provider are accepted by the AGD for Fellowship, Mastership and membership maintenance credit. Approval does not imply acceptance by a state or provincial board of dentistry or AGD endorsement. The current term of approval extends from (11/1/2011) to (10/31/2015) Provider ID# 320452.

RECORD KEEPINGPennWell maintains records of your successful completion of any exam for a minimum of six years. Please contact our offices for a copy of your continuing education credits report. This report, which will list all credits earned to date, will be generated and mailed to you within five business days of receipt.

Completing a single continuing education course does not provide enough information to give the participant the feeling that s/he is an expert in the field related to the course topic. It is a combination of many educational courses and clinical experience that allows the participant to develop skills and expertise.

CANCELLATION/REFUND POLICYAny participant who is not 100% satisfied with this course can request a full refund by contacting PennWell in writing.

© 2013 by the Academy of Dental Therapeutics and Stomatology, a division of PennWell