Endodontic Record Excellence
Endodontic therapy records serve as an important map to document and guide the clinician’s journey down the correct diagnostic and treatment path. Documentation is essential to attaining endodontic excellence.
The dental record must contain sufficient information to identify the patient, support the diagnosis, justify the treatment, and document the course and result of treatment, and it should be designed to protect the patient’s welfare. Records also are fundamental means of communication among health care professionals.
Endodontic treatment records should include the following information:
Name of patient
Date of visit
Medical (periodically updated) and dental history
Allergies and adverse drug reactions
Radiographs of diagnostic quality
Pulpal and periodontal diagnostic tests performed
Clinical examination findings
Differential diagnoses and final diagnosis
Referrals, including patient refusals (if any)
Communications with other health care providers
Progress notes (including complications)
Canceled or missed appointments and stated reasons
Patient concerns and dissatisfactions
Drug and laboratory prescriptions
Consent and informed refusal forms
Name or initials of author for each treatment entry
E-mail address of patient
Emergency contact persons, addresses, and phone numbers
Patient phone numbers including home, work, and cell
Log of records and radiographs received or sent
Dental records should document the following information:
Course of therapy by recorded diagnosis including differential diagnoses, informed consent or refusal, treatment, and prognosis
Communications among the treating clinician, other health care providers, consultants, subsequent treating practitioners, and third-party carriers
Necessity and reasonableness of diagnosis and treatment capable of peer review and dental insurance carrier evaluation
Standard of care compliance
Adverse reactions or events with explanation
Follow-up comments to medical history–positive responses
Patient Information Form
A patient information form provides essential data for patient identification and office communication, which should be updated periodically ( Fig. 29-1 ). The patient’s name; home, business, and e-mail addresses; and telephone and fax numbers are needed to contact the patient for scheduling purposes and inquire about postoperative sequelae. Location information about the patient’s spouse, relative, or a close friend who can be notified in an emergency is also suggested. In the event the patient is a minor, the responsible parent or guardian should provide the information. Questions about dental insurance and financial responsibility are included on the form to avoid any later misunderstandings and help fulfill federal requirements of the Truth in Lending law, applicable if four or more installment payments are arranged (whether or not there are interest or late-payment charges).
Medical Health History
The clinician should thoroughly review the patient’s past and present health status before proceeding so that dental treatment can be safely initiated. Health questionnaires open avenues for discussion about problems of major organ systems and important biochemical mechanisms, such as blood coagulation, allergy, immunocompromised status, need for antibiotic prophylaxis, and disease susceptibility. The clinician may request that the patient be examined by a physician or undergo laboratory testing under medical supervision to determine whether a suspected medical problem may require attention before endodontic therapy proceeds or if drug sensitivity or an allergy mandates treatment modifications. Knowledge about current medications, medical therapy, and the name and address of the treating physician is essential.
Medical histories must be updated periodically (or at least annually or sooner as the need arises). The patient should be asked to review the previous and current medical history ( Fig. 29-2 ). If no changes are necessary, the patient should date and sign the history form. If any changes occurred, the patient should identify each updated medical change, the date, and sign the form where indicated for medical update information. Periodically the patient should provide an entirely new updated form rather than changing data on the old form. Earlier medical histories should be retained in the chart for future reference. If physician communication for treatment occurs, the clinician should record these contacts. In addition, the clinician should verify physician approvals for treatment by fax, with verification of receipt or letter or preferably both, and retain copies in the chart.
Updating the medical history requires the practitioner to be apprised of changes in the patient’s medical condition and any new medications the patient is taking, including over-the-counter or herbal medications or supplements. A patient untrained in medical science may not appreciate the fact that new medications may suggest new diseases or changes in existing disease status. For instance, certain regurgitating valvular heart diseases may require antibiotic prophylaxis. New medications may also cause a synergistic effect with other medications the patient is using or another treating clinician is prescribing.
Clinicians who pass the buck by claiming, “Oh it was my secretary or my new assistant—I could do nothing about it,” are nonetheless legally liable for their staff’s actions or inactions. A clinician exclusively relying on staff members to obtain medical histories in a waiting room full of patients is making a mistake. Instead, the clinician must check and then follow up regarding the accuracy of the histories. Training and monitoring staff are duties clinicians cannot afford to ignore. President Harry Truman’s sage advice, “The buck stops here,” applies to treating clinicians who overdelegate to nonclinician staff members who lack the requisite dental education for adequate medical history follow-up.
The dental history should include past dental difficulties, name and address of current or most recent treating clinician, chief complaint (including onset, duration, frequency, type, and intensity of any pain or numbness), relevant prior dental treatment, and attitude regarding teeth retention. Positive responses suggest further patient consultation and consideration for obtaining records (by written release) for elucidation from the patient’s previous or present treating clinician. After receiving positive responses, the clinician may also wish to obtain prior and concurrent treaters’ radiographs for current comparison with any progressive changes ( Fig. 29-3 ).
Diagnostic and Progress Records
Diagnostic and progress records often combine fill-in and check-off types of forms. Fill-in or essay forms allow greater latitude of response to a question, resulting in a more detailed description. However, one drawback is that these forms are open to oversights unless a clinician is conscientious in following up with further clinical information.
Using only an essay-type health history is insufficient. Often a patient may not appreciate the significance of important symptoms. A check-off format is efficient and more practical. Forms with questions that reveal pertinent data alert the clinician to medical or dental conditions that warrant further evaluation or consultation. Moreover, such records can document any missing medical information the patient failed to provide orally. At the end of the check-off portion of the medical history, an essay question allows the patient to provide any omitted pertinent medical information or elaborate on checkmarked items.
Electronic records represent current methodology for recording patient information (see Chapter 30 for details). Several safeguards are essential for their use. First, patient confidentiality and security must be protected. Consider using AES encryption with at least 2048 bit key. Be certain that only the clinician and authorized staff view patient data in conformance with the Health Insurance Portability and Accountability Act (HIPAA) security standards, effective April 2005. Second, data backup of patient records, including digital radiographs and account ledgers, should be stored off site. The entire hard drive should be periodically backed up for additional protection, which can be accomplished with cloud technology autosave backup systems. Multiple copies of the backup data should be stored in more than one geographic location, and fault protection such as RAID level 1 or 5 should be installed to prevent data loss.
Radiographs are essential for diagnosis and also serve as additional documentation of the patient’s pretreatment condition. A panographic radiograph is not diagnostically accurate for endodontics and therefore should be used only as a screening device (see Chapter 2 ). Diagnostic-quality periapical plain film or digital radiographs are essential aids for diagnosis, for working films (e.g., measuring the length of root canals, fitting gutta-percha cones), to verify the final fill, and for follow-up comparisons at recall examinations. Therefore, the clinician should retake any radiographs that lack diagnostic quality. Retain all radiographs including working films.
Digital radiography is recommended because it increases endodontic efficiency at the chair. Also images may be forwarded via e-mail to either the patient or another clinician. No developing time is needed, so procedural radiographs can be viewed instantly and approved or retaken with little time in between (no downtime is required to wait for a film to exit the film processor). Newer digital x-rays with improved sensor technology use high-resolution charged coupling device (CCD) chips, rather than complementary metal-oxide semiconductor (CMOS) technology, and provide close-up zooming with improved image quality as described in Chapters 3 and 30 .
Three-dimensional (3D) cone-beam computerized tomography (CBCT) imaging has greater information compared with conventional radiography. Conventional periapical radiographs do not facilitate accurate predictions in the preoperative assessment for the potential perforation of the maxillary sinus. CBCT has greatly aided the diagnosis of pain sources caused by root fractures or incompletely filled, overfilled, or missed extra canals that two-dimensional (2D) periapical imaging may obscure. *
* References .
According to the U.S. Food and Drug Administration (FDA), switching from D to E speed results in a 30% to 40% reduction in radiation exposure. F-speed film reduces exposure 20% to 50% compared to E-speed film, without compromising diagnostic quality. Digital imaging reduces radiation dose by 40% to 60%.
A rectangular collimator decreases the radiation dose by up to fivefold compared with a circular one. Radiographic equipment should provide rectangular collimation for exposure of periapical and bitewing radiographs.
Evaluation and Differential Diagnosis
Diagnosis includes evaluating pertinent history of the current problem, clinical examination, pulpal testing, periodontal probe charting, and recorded radiographic results. If therapy is indicated, the reasons should be discussed with the patient in an organized way. When other factors affect the prognosis (e.g., strategic importance, restorability of the tooth, or proximity to vital structures), the clinician should consider further consultation with the referring clinician or specialists, including a prosthodontist, periodontist, or radiologist with CBCT imaging, before initiating endodontic treatment.
Diagnosis is essential in treatment decisions. Recommending extractions for undiagnosed pain etiology is generally contraindicated. Chronic idiopathic orofacial pain warrants referrals and consultation with other health care professionals, lest wholesale extractions worsen the patient’s dental state and not relieve pain (see Chapter 17 ). For instance, in a long-term follow-up study of patients with chronic facial pain and without a recognizable odontologic pathosis, some patients were subsequently diagnosed with maladies ranging from cracked-tooth syndrome to medication-mediated illnesses. Accordingly, referral to other specialists is essential, lest a patient be misdiagnosed with idiopathic or atypical facial pain when instead the pain etiology was misdiagnosed.
About 5.3% of patients have postendodontic pain 6 months or more after nonsurgical and surgical endodontic treatment. Nonodontogenic pain may account for about 57% to 64% of the total causes of postendodontic pain that persists after 6 months. Therefore, of patients being treated with endodontic procedures, about 3.4% (64% of 5.3%) will have posttreatment pain that arises from a nonodontogenic cause.
Fig. 29-4, A and B , demonstrates the advantage of CBCT 3D imaging compared to 2D imaging. In A , the nail appears inside the cranium, contrasted with B , which shows the nail taped outside the skull.
Sound endodontics begins with a proper diagnosis. Otherwise, unnecessary or risky treatment with a compromised prognosis follows. Generally, as described in greater detail in Chapter 1 , the following endodontic tests should be performed to arrive at a correct and accurate endodontic diagnosis:
Electrical testing (optional)
Periodontal assessment (pockets, mobility, furcations, gingival recession)
Both positive and negative pulpal testing results should be recorded. Juries, peer-review committees, and insurance consultants often disbelieve unrecorded test results. Uncharted test findings may be regarded as never having been done. Consequently, reasonable clinicians should record all testing results, both positive and negative. An evaluation of the temporomandibular apparatus is necessary to diagnose or rule out temporomandibular disorders (TMDs).
Treatment records should contain a written plan that considers all aspects of the patient’s oral health. Treatment plans should be coordinated, preferably in writing, with other concurrent or jointly treating clinicians. For instance, endodontic treatment will probably fail if underlying periodontal pathosis is ignored or untreated. Thus, the clinician should assess the patient’s entire dentition and not just a single root canal system. The clinician should also recommend a periodontal consultation to both the patient and the referring clinician if periodontal therapy is required. The patient should approve the treatment plan. Remember the maxim: If you fail to plan, plan to fail.
After gathering the dental and medical history, findings obtained from the various phases of the clinical and radiographic examinations are recorded as shown in Figure 29-5 . Lists in each category afford the clinician a systematic format for recording details pertinent to an accurate diagnosis. Appropriate descriptions are circled, followed by the necessary notations in the accompanying spaces. Tabular arrangement allows easier recording and comparison of diagnostic test data acquired from one tooth on different dates or from different teeth on the same visit. A pain intensity index (i.e., 0 to 10) or pain classification (i.e., mild +, moderate ++, severe +++) should be used to differentiate diagnostic test results.
Careful analysis of accumulated examination data should result in the determination of an accurate pulpal and periapical diagnosis. Clinical conditions and the probable etiologic factors for the presenting problem are circled. Alternative modalities of therapy are considered and analyzed. The recommended treatment plan is circled, followed by a prognostic assessment of the intended therapeutic course.
Patients should be advised of each diagnosis and should consent to the treatment plan before therapy is instituted. Consultation should include an explanation of reasonable alternative treatment approaches and rationales and treatment consequences of each alternative therapy, including risks from nontreatment or delayed treatment that may affect the outcome of intended therapy. This discussion is documented by completing the checklist items.
All treatment provided on a given date is documented by placing a checkmark (✓) within the designated procedural category. Only the most frequent retreatment procedures are included for tabulation. Descriptions of occasional procedures or explanatory treatment remarks should be entered in writing. A separate dated entry should be made for each patient visit, phone call, e-mail message, and fax communication (e.g., consultations with the patient or other clinicians) or correspondence (e.g., biopsy report, treatment completion letters).
Individual root canal lengths are recorded by (1) circling the corresponding anatomic designation and the method of length determination (e.g., radiograph or electronic measuring device), (2) writing the measurement (in millimeters), and (3) indicating the reference point. For any medication prescribed, refilled, or dispensed, the treatment record should show the date and type of drug (including dose, quantity, and instructions for use) in the treatment table under the heading “Rx.” Figure 29-6 also shows a sample medication log. Periodic recall intervals, dates, and findings are entered in the spaces provided.
If the scope of the examination or treatment is intentionally limited, such as a screening examination or emergency endodontic therapy, the limited scope of the visit should be recorded. Otherwise, the chart appears as if the examination were superficial and treatment incomplete. If a suspicious apical lesion requires subsequent reevaluation, the clinician should record the future reevaluation date and differential diagnosis—for example, “Small apical lesion on #28. Reevaluate for changes in 2 months. Also, check for any root fractures.” If this is not done, it appears (on the chart) as if the clinician ignored potential pathosis, such as suspected root fracture. A soft-tissue examination (including cancer check) is a standard part of any complete dental examination. E-mail, prescriptions, and correspondence should be documented with hard copies in the chart unless virtually all treatment records are stored in electronic format.
Informed Consent Form
After endodontic diagnosis, the benefits, risks, treatment plan, and alternatives to endodontic treatment—including any patient refusal of recommended treatment and consequences of refused treatment—should be presented to the patient or the patient’s guardian. This will document acceptance or rejection of treatment recommendations. The patient or guardian, along with a witness (who can be a staff member), should sign and date the consent form. Any informed-consent video should similarly be noted, if viewed. Subsequent changes in the proposed treatment plan should also be discussed and initialed by the patient to indicate continued acceptance and acknowledge the patient’s understanding of any newly disclosed risks, alternatives, or referrals.
Despite a patient’s confirmed signature on an informed consent form, a jury is free to decide that the patient never read the informed consent form’s content before signing. For instance, the patient may claim it was impossible to have read the consent form, because he or she did not have reading glasses when signing and no clinician ever explained the form contents. Another frequent factual scenario is when the patient claims the staff stated it was a standard consent form that was a mere procedural formality requiring patient signature, rather than a detailed informed consent form. Consequently, numerous legal cases have been lost at trial on the issue of inadequate informed consent despite a signed patient consent form.
To obviate a patient’s claim that no explanation ever occurred, a patient questionnaire can additionally be used. Patients can be instructed that unless they score 100%, proposed procedures will not be done (because patient understanding is imperative and essential for cooperation, including postoperative care). To be effective, the patient questionnaire should be relatively short and simple ( Fig. 29-7 ). Also, the patient should be given an opportunity to correct any incorrect answers after the clinician reviews with the patient the reasons why the patient answered incorrectly. Note that the majority of answers are false. This precludes a patient from guessing the correct answer by assuming that all test questions are necessarily true.
Treatment Record: Endodontic Chart
A suggested chart is presented in Figure 29-8 to facilitate recording of information pertinent to the diagnosis, recommendations, and treatment of the endodontic patient. Systematic acquisition and arrangement of data from the patient questionnaire, along with clinical and radiographic examinations and careful recording of treatment performed, expedites accurate diagnosis and maximizes clinician efficiency. Suggested chart format and use are described in the sections that follow.
General Patient Data
Patient name, address, phone numbers, referring clinician, and chief complaint are printed or typed in the corresponding space at the patient’s initial office visit. The patient’s appointment and financial record are divided into two parts as follows:
The treating clinician or staff completes the first portion after the diagnosis and treatment plan have been formulated and presented to the patient. Tooth number and quoted fee are posted. The treatment plan is recorded by circling the appropriate description. Under “Special Instructions,” specific treatment requests by the referring clinician are circled. Details of planned adjunctive procedures (e.g., hemisection, root resection) may be written in the adjacent space, along with information from the patient data section. The clinician can then use this information for general reference during future treatment. The secretary or treatment coordinator can also use this information when scheduling appointments and establishing financial arrangements.
Business personnel complete the second portion. Financial agreements, third-party coverage, account status, and appointment data (including the day, date, and scheduled procedure) are recorded.
Either the clinician or the assistant may complete portions of the diagnosis and treatment sections, but the clinician should review and approve all entries .
Chief complaint should include whether the patient is symptomatic at the time of examination or in the recent past and what medications the patient is currently taking for pain relief. Narrative facts regarding the presenting problem are then recorded. Additional details of the chief complaint obtained during successive questioning are recorded by circling the applicable word within each symptom parameter. The pain intensity index (i.e., 0 to 10) or pain classification (i.e., mild +, moderate ++, severe +++) should be registered alongside the appropriate description. For accurate assessment of the effects of prior dental treatment pertaining to the examination site, a summarized account of these procedures should be documented. In addition, all pretreatment signs and symptoms should be described. It is essential that the patient comprehend all communications with the clinician and staff. If there is any language comprehension difficulty, the clinician should ask the patient whether he or she understands completely the language the clinician is speaking. To verify patient comprehension, the clinician should ask the patient to repeat important information that has been conveyed. A clinician- or patient-provided interpreter may be necessary if language problems exist.
More medical history information is obtained from a patient-administered questionnaire than from the clinician obtaining an oral history solely from the patient. Maximum information is obtained if the clinician reviews with the patient the written health history form the patient has completed.
Information (e.g., personal physician’s name, address, and phone number; patient’s age; date of last medical examination) is recorded for reference. The clinician can obtain a detailed medical history by completing a survey of common diseases and disorders along with a comprehensive review of corresponding organ systems and related pathosis. Specific entities that have affected the patient are circled. Essential remarks regarding these entries (e.g., details of consultations with the patient’s physician) should be documented on an attached blank sheet with dated treatment notes attached to the back of the chart (see Fig. 29-2 ). A review of the patient’s medical status (including recent or current conditions, treatments, and medications) completes the medical history. Updated medical histories that the patient signs or initials should be done at least annually and at reevaluation visits.
Excessive alcohol consumption can contribute to a higher incidence of restoration corrosion from chronic regurgitation and vomiting from gastritis associated with alcohol abuse. Corrosion can lead to coronal marginal leakage predisposing to endodontic failure. Accordingly, medical histories should include histories of gastric reflux disease, bulimia with associated habitual vomiting, gastritis, and excessive alcohol intake.
Nearly half of American adults older than age 30 years have periodontal disease. Periodontal disease was higher in men than in women (56.4% versus 38.4%) and was highest among Mexican Americans (66.7%).
Competent endodontic treatment begins with adequate diagnostic procedures. An adequate periodontal evaluation must accompany each endodontic diagnosis, which requires a diagnostic radiograph, clinical visualization, mobility recordings, evaluation of the periodontal tissues, and probing for periodontal pockets with a calibrated periodontal probe, particularly in furcation areas.
Periodontal chart documentation should include pocket recordings, extent of furcation, bleeding on probing, mobility, areas of gingival recession, and any inadequate attached gingiva.
Although endodontic treatment may be successful, tooth loss may result from progression of any residual, untreated periodontitis. Consequently, periodontal evaluation and prognosis are mandatory so that the patient and clinician can make an informed and intelligent choice about whether to proceed with endodontics, a combination of periodontal and endodontic treatment, or extraction.
Each tooth undergoing endodontic therapy (and adjacent teeth) should be probed with a calibrated periodontal instrument to obtain six measurements per tooth. Pockets of 4 mm or greater should be recorded on the patient’s chart. If no pockets exist, WNL (within normal limits) or a similar abbreviation should be noted. Mobility should also be charted and classified class I, II, or III. Gingival recession, furcations, and mucogingival deficiencies should also be recorded.
A clinician who treats with endodontic success but ignores loss of periodontal attachment may misdiagnose or fail to appreciate the risk of failure because of poor periodontal prognosis. It bears repeating that the endodontic treating clinician should not assume an adequate periodontal evaluation has been performed by another clinician or the referring clinician. Instead, an independent periodontal evaluation should be done with a calibrated periodontal probe and results recorded before initiating endodontics, including noting absence of pockets or within normal limits.
If clinically significant periodontal disease is present, the endodontic treating clinician should consult with the restorative clinician to determine whether the periodontal disease will be properly treated or referred to a periodontist in conjunction with endodontic treatment. A patient should be advised of any compromise of the endodontically treated tooth’s periodontal status to comply with required informed consent disclosure.
A current drug history, both written and oral, is necessary to alert the clinician to any potential for interaction between any newly prescribed drugs and any other medication, supplements, or over-the-counter medication the patient is already taking.
In patients aged 57 through 85, 40% potentially are at risk of a major drug reaction—half involving various prescription medications and the other half involving anticoagulant drug reactions. About half of prescription users also concurrently take over-the-counter medications plus dietary supplements.
Risks of drug interactions or side effects incidence may not be discovered or appreciated in premarket research-controlled drug trials for newly marketed drugs, despite FDA approval. For example, rofecoxib (Vioxx) was withdrawn from the market in September 2004 after increased incidences of myocardial infarcts and strokes manifested in a postmarket research study of 2600 patients. Merck’s voluntary recall followed an FDA researcher’s claim that the FDA tried to ostracize and intimidate him after he raised safety concerns over Vioxx. Currently, pharmaceutical manufacturers budget more for marketing than research and development. Some drug manufacturers have suppressed publication of adverse research. The Patient Protection and Affordable Care Act of 2010 (Section 6002) requires drug companies to disclose payments to medical/dental professionals who tout their drugs in seminars or publications and receive compensation greater than $500.
For newly marketed drugs, the small number of premarket patients studied may lack sufficient statistical power to expose serious side effects that occur infrequently but are nonetheless life threatening. For instance, mibefradil (Posicor) was withdrawn from the market after 1 year because it increased plasma concentrations of 25 other co-administered drugs, including erythromycin. In another example, the popular prescription nighttime heartburn drug Propulsid (cisapride) was linked to 70 deaths and more than 270 significant negative reactions. Other examples include the risk of esophageal cancer with bisphosphonate and bisphosphonate-associated osteonecrosis. In 2008, the FDA added a black box warning label for Levaquin-associated risks of tendonitis ( www.levaquin.com/levaquin/medication ).
Preoperative and Postoperative Radiographs
Pretreatment, midtreatment, and posttreatment radiographs or digital images are essential for endodontic diagnosis and treatment:
A current, pretreatment, interpretable periapical radiograph of adequate diagnostic quality is mandatory.
Measurement films or digital images are necessary to verify canal length (which can be supplemented with an electronic canal-measuring device) and the apical extent of the gutta-percha fill to the radiographic apex.
Posttreatment radiographs are essential for determining the adequacy of the endodontic seal or if further treatment is necessary (see Chapter 8 ).
Digital radiographic endodontic applications are ever increasing in accuracy. The standard of care does not currently require digital imaging, because traditional silver halide radiographic film is a reasonable alternative. When there is more than one reasonably acceptable practice modality, a clinician who chooses either modality meets the standard of care. Figure 29-9, A , represents a distal open margin on tooth #30 (shown digitally) that is not evident in part B with plain-film radiography.
Advertised claims of 80% reduction in radiation with direct digital radiography (rather than film) assume the following :
Ultraspeed D-speed film is used. (Ektaspeed E-speed film and the newer F-speed film reduce radiation 50% and 60%, respectively, while producing images of comparable quality to D speed.)
No rectangular collimation is used, which reduces exposure another 30%.
No extra radiographs are taken to compensate for a smaller area. For instance, a 2 charged-coupling device (CCD) sensor has an active area smaller than size 1 film and may require an extra image with additional radiation exposure.
A digital x-ray image should never be modified to “enhance” the radiographic appearance of the original image. X-ray modification can be detected. In litigation, it can prove devastating to the clinician’s defense because the clinician’s credibility of events or recorded entries are not believable, particularly if the radiograph is Photoshopped.
Periapical (PA) radiography is limited to only two dimensions. Newer 3D imaging systems for dental radiology use x-ray beams that are cone shaped. Cone-beam computed tomography can provide a more nearly accurate diagnosis. In Figure 29-10, A to C , the PA does not show the transported canal and extent of short fill, which is more evident in the CBCT. Each CBCT scan produces three image views: axial, coronal, and sagittal.
The American Dental Association (ADA) Council on Scientific Affairs recommends the dentist recognize the importance of keeping radiation exposure as low as reasonably achievable (ALARA). Accordingly, CBCT imaging should not be performed for screening purposes but rather for specific diagnostic and treatment usage.
The Food and Drug Administration provides recommendations for dental cone-beam computed tomography. The American Academy of Oral and Maxillofacial Radiology provides indicated use of the CBCT for implant placement. In the future, magnetic resonance imaging (MRI) may supplant or augment CBCT because its imaging quality equals and in certain instances surpasses that of CBCT.
Children have greater radiosensitivity because of developing cells in their young bodies. Thus, CBCT imaging radiation dosage should be considered for young patients in assessing the need for a CBCT.
Computed tomography (CT) scans enable evaluation of the true extent of lesions and their spatial relationship to important anatomic landmarks. Figure 29-11, A to C , shows a bifid inferior alveolar nerve canal (IANC) that is not apparent on Panorexes. CT scans may provide information important for retreatment decisions, especially apical surgery. CBCT showed significantly more lesions than PA radiography, including expansion of lesions into the maxillary sinus, sinus membrane thickening, and missed canals; PA radiography missed 34% of these lesions. Artificial bone defects in the antral surface were not detected with PA radiography. Because of overlapping roots, only 1 out of 14 furcation defects in upper molars were seen on PA radiography, but CT scans were able to identify all furcal defects. Second molars proved to be the most difficult for detecting lesions with PA radiography alone. Twenty-three teeth with lesions expanding into the maxillary sinus were detected by CBCT, of which only two teeth were seen with PA radiography. Thirty-five teeth with membrane thickening were identified with CBCT, of which 16 teeth were also detected with PA radiography. Fifteen teeth with missing canals were detected with CBCT, of which only four teeth were identified with PA radiography. In a study that compared the efficacy of PA radiography and CBCT in detecting periapical lesions in maxillary premolars and molars for apical surgery, Lofthag-Hansen showed that 38% of maxillary posterior teeth lesions were undetected by PA radiography, despite the fact that an additional different angulated PA radiograph was taken. Lesions associated with apices near the sinus floor had a higher probability of being missed with PA than lesions associated with apices located away from or overlapping the sinus floor. Expansion of the lesion into the maxillary sinus, thickening of the sinus membrane, missed canals, and presence of apicomarginal communications were more frequently detected with CBCT than with PA radiography.
Apicomarginal communication is an important predictor for the success rate of apical surgery, including evidence of undetected vertical fractures necessitating extraction; 83% of apicomarginal communications were not seen with PA radiography in the Lofthag-Hansen study.
If the radiograph shows a small distance between the periapical lesion and the sinus floor when the bony wall is thin, there is a high probability that an oral antral communication (OAC) can result, unless skillful care avoids sinus penetration during apical surgery. CBCT also allows the clinician to study the topography of the bony defect and assess whether the use of guided tissue membranes would be beneficial. Precise morphometric assessment of osseous relationships to the sinus is often inadequate with periapical radiography. Thus, CBCT is invaluable in treatment planning for apical surgery, as 70% of cases studied revealed clinically relevant information not found in PA radiography.
The probability of detecting lesions with PA alone was limited for teeth with apices in close contact with the floor of the maxillary sinus, for molars (in particular second molars), and when bone thickness between lesion and sinus was less than or equal to 1 mm. Findings of lesion expansion into the sinus, sinus membrane thickening, missed canals, and presence of apicomarginal defects are more frequently diagnosed with CBCT than PA.
Endodontics and Heart Disease
Associations between chronic infections such as periodontal diseases and coronary heart disease (CHD) have been suggested. Conversely, supporting evidence linking root canal–filled teeth or teeth with periapical disease to CHD is lacking.
If a patient’s medical history shows valvular heart defects with regurgitation, the clinician should consult with the patient’s physician to determine the necessity of antibiotic prophylaxis against infective endocarditis in accordance with current American Heart Association (AHA) guidelines. If the physician does not appear knowledgeable about those guidelines, the clinician should provide a copy of the guidelines to the physician. If the physician advises deviation from AHA guidelines, the clinician should inquire why the physician feels that this is appropriate. The clinician should also record any discussions with the physician in the patient’s chart and confirm the discussion and the physician’s recommendation in writing (by fax and letter to the physician).
Communications with the physician should be specific, because dental treatment risks, such as overextension of files or filling material sealants that occur nonsurgically and may enter the bloodstream, may not be fully understood or appreciated. A sample format is shown in Figure 29-12 .
Abbreviated records can be frustrating if the clinician is unable to decipher one’s own or other clinicians’ handwritten entries, so the clinician should use standard or easily understood abbreviations. Pencil entries are legally valid, but ink entries are less vulnerable to a plaintiff’s claim of erasure or alteration. A short pencil is better than a long memory; records remember, but patients and clinicians may forget.
|AG or AmAL||=||Amalgam|
|B-U||=||Buildup of tooth|
|Canal||=||Identify canal that has been cleaned and shaped|
|CBCT||=||Cone-beam computed tomography|
|Cotton||=||Placed in pulp chamber between treatments|
|EPT||=||Electric pulp test|
|I & D||=||Incision and drainage|
|L.A. or local||=||Local anesthetic|
|O+D||=||Open and drain|
|Post||=||Preformed, custom, or transilluminated post|
|Rel occ||=||Relieved occlusion|
|S/D||=||Single insurance or dual coverage|
|Sealer||=||Sealer type used|
|tech.||=||Technique for canal obturation|
|WNL||=||Within normal limits|
Computerized Treatment Records
Clinicians are increasingly using computerized record storage as described in this chapter. To avoid a claim of record falsification, whatever computer system is used should be able to demonstrate that records indicating earlier treatment were not recently falsified. Software technology, such as the “write only read memory” (WORM) system, used to identify computer data tampering, is not foolproof because it cannot detect tampering where an entire disk of recent origin has been substituted for an earlier version. Periodically, a hard copy of computer data should be printed out, hand initialed, dated in ink, and stored in the chart to provide written verification of the computer records if the office is a virtual paperless office.
Health Information Technology for Economic and Clinical Health (HITECH) Act Pitfalls
Affected patients must be notified if there is a breach in the electronic record storage system. Electronic records have the following pitfalls:
Data entry in the wrong patient record
Incorrect data entry in the patient record
Incorrectly entered information or information that was not entered at all was reported as the cause of the majority of errors. The absence of an undecipherable scrawl is designed to reduce errors. Whether the result of fat fingers or providers pushed for time, mistakes will still occasionally occur. Some of the things that make paperless electronic records desirable—transparency, the ability of more people to view the same information, and more immediate accessibility—may cause any electronic record mistakes risk to be amplified.
Health Insurance Portability and Accountability Act (HIPAA)
The Department of Health and Human Services’ Security and Electronic Signature Standards rule is part of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. This act emphasizes the safeguarding of clinicians’ health care information and permits a patient to obtain a copy of the requesting patient’s records. Most states have authorized digital electronic signatures as binding for most contracts and orders. Digital signatures with electronic transactions are authorized by the Third Millennium Electronic Commerce Act (also called the Electronic Signature in Global and National Commerce Act).
Pertinent HIPAA requirements follow:
Original records and radiographs should not be released but only copies provided to the patient. A reasonable copying charge may be requested before or after release of the copies.
A patient may amend health information in the chart that the patient believes to be incorrect or incomplete. The clinician may respond to the patient’s proposed chart amendments.
Notice of office privacy practices should be provided to the patient, and the patient should acknowledge receipt in writing.
If privacy rights are violated, the patient can file a grievance with the secretary of the Department of Health and Human Services. Patients cannot be penalized for complaining.
Confidential dental and medical information may be shared with other clinicians, based on a need to know.
All e-mail communications between clinician and patient must use a secure network and be stored on a secure server.
Although there is little harm in recording too much information, there is great danger in recording too little. Standard inch or larger clinical records possess the advantage of providing the treating clinician adequate space for clinical notes.
Identity of Entry Author
Either a clinician or an auxiliary can chart clinical entries unless state law indicates otherwise. Some states require clinicians and assistants to sign or initial each treatment entry. What is important is that the correct clinical information is recorded. Each person who makes a clinical chart entry should record the date and initial the entry. Otherwise, the author’s identity may be forgotten if the individual who recorded the entry is needed in a legal proceeding. For instance, initialing the entry makes it easier to identify the particular clinician or auxiliary who, after the original recording, is now employed elsewhere. A separate log of clinician and staff initials should be created and stored for later comparison to identify the entrant’s initials (see Fig. 29-13 ).
Patient Record Request
Patient requests for record transfers or copies must be honored. It is unethical to refuse to transfer patient records, on the patient’s request, to another treating clinician. Moreover, refusing to provide patient records is illegal in some states, subjecting the clinician to discipline and fines should the records not be provided to the patient upon written request, even if the balance is outstanding.
Patient education pamphlets may be used in litigation as evidence that a patient was properly informed and given endodontic alternatives but instead chose extraction. Such pamphlets include the American Dental Association’s (ADA’ s) Your Teeth Can Be Saved by Endodontic Root Canal Treatment and the American Association of Endodontists’ (AAE’s) Your Guide to Endodontic Treatment, Your Guide to Endodontic Retreatment, and Your Guide to Endodontic Surgery . The clinician should indicate in the patient’s chart which particular pamphlets the patient was provided or which video was shown, because this may prove useful should the patient later deny being informed of endodontic alternatives.
Patient Education Materials
The use of educational materials may improve health behavior, enhance patient satisfaction, and facilitate the consultation processes. Consequently, the patient is better informed if patient questions are answered after prompting with informative educational materials.
It is unlikely a patient will remember oral postoperative instructions unless accompanied with written instructions. After endodontic procedures, the patient may be sedated or affected by analgesic drugs. Accordingly, written postoperative instructions are beneficial. Emergency phone numbers to contact the treating clinician should be included on the form. Written instructions reduce postoperative morbidity and pain and improve patient compliance. Document that both written and oral postoperative instructions were provided. If treating in close proximity to the IANC, place a precaution, such as seen in Figure 29-14 , in the postoperative instruction sheet.
Every clinician, including the endodontic specialist, has a duty to refer under appropriate circumstances. If consultations with additional experts or specialists become necessary, referrals should be recorded lest they be forgotten or refused. Carbonless, two-part referral cards allow the clinician to provide an original referral slip to the patient while retaining a copy for the patient’s chart. The clinician or staff member should document the fact that the original referral card was given or mailed to the patient and record the name of the person who provided the referral card and the date on which it was provided. A copy of the referral card should also be sent to the referred doctor. If the patient fails to keep the referral appointment, this copy will provide proof that a referral was made. The clinician should request that the patient and the referred clinician report back if the referral appointment is canceled. Staff should calendar to verify that the referral consultation occurred.
Dental Fees Related to Quality Care
The link between health care fees and the quality of health care remains unclear.
Records must be complete, accurate, legible, and dated. All diagnoses, treatments, and referrals should be recorded. Chart additions may expand, correct, define, modify, or clarify (as long as they are currently dated to indicate a belated entry).
To correct an entry, the clinician should draw a line through (but not erase or obscure) the erroneous entry. The correction should then be written on the next available line and dated. Handwriting and ink experts use ink chemical tags, age dating, and infrared technology to prove falsified additions, deletions, or substitutions. If records are proved to be falsified, the clinician may be subject to punitive damages in civil litigation. In addition, the clinician may be subject to license revocation for intentional misconduct. Professional liability insurance policies may defend but will usually not indemnify punitive damages if the clinician is found to have committed fraud or deceit. In addition, insurance carriers may deny renewal of professional liability coverage to a clinician who fraudulently alters dental records.
If an erroneous entry occurs, the clinician should add another entry dated as a late entry to demonstrate later corrected information. Figure 29-15 gives an example of the proper method of belated record correction.
When patient records have been requested or subpoenaed, it is wise to refrain from examining in detail prior to copying to avoid the temptation to clarify or belatedly add an entry. Alteration of clinical records is a cause of large settlements because the clinician’s credibility is suspect. Also the jury may be similarly instructed. For instance, California Jury Instruction 204 regarding “Willful Suppression of Evidence” states as follows:
You may consider whether one party intentionally concealed or destroyed evidence. If you decide that a party did so, you may decide that the evidence would have been unfavorable to that party.
Spoliation is the destruction or significant alteration of evidence, or the failure to preserve property for another’s use as evidence, in pending or reasonably foreseeable litigation under Fed. R. Civ. P. 37(b)(2)(C).
Spoliation occurs when the wrongdoer alters, changes, or substitutes dental records in an attempt to defeat a civil lawsuit. It is far easier to defend a dental negligence lawsuit with poor records compared to attempting to justifiably defend altered (falsified) records. A jury and/or a judge will likely conclude the clinician acted with consciousness of guilt for falsifying records compared with excusing staff clerical oversight if records are poorly maintained. Dental records, like all business records, deserve accuracy and completeness.
Questioned document experts utilize ink age dating, examine watermarks, or apply infrared techniques to ascertain substituted pages and additions or deletions in records, including prior erasures, entries underneath whiteouts, and indentations made when one page is overwritten on another page. Infrared technique analyzes these patterns of indentations underneath the altered pages that detect belated second entries. In one case, the defendant clinician claimed a written referral was made to a specialist in 1998, but the patient refused the referral. During litigation, the patient denied the referral and subpoenaed records of the print shop where the specialist’s referral forms were printed. These subpoenaed records proved the carbon copy of the form used for the purported 1998 referral was instead first printed in 2000, which was 2 years after the alleged specialist referral was made ( Fig. 29-16, A and B ).
In another example, altered records were detected in nine different entries in one medical negligence case involving an undiagnosed malignancy. The physician’s carrier subsequently settled for $1 million. Also, the defendant personally paid a separate fine to the court. As part of the settlement, the defendant authored an article for the Washington Medical Association detailing why records falsification is wrong.
Records are subjected to (1) audits by insurance carriers for documentation that treatment was performed, (2) review by peer review committees, and (3) subpoena by state licensing boards or agencies for disciplinary proceedings. Accordingly, falsified records expose the clinician not only to civil liability for professional negligence but also to criminal penalties for criminal offenses, such as insurance fraud.
Deliberate record alteration with intent to deceive may also subject the clinician to licensing and ethical discipline as well as punitive damages for deceitful misconduct. Insurance carriers may defend but not indemnify a verdict for intentional material alteration of dental records done with intent to deceive.
Digital radiography may have dental advantages, but because the digital images originally may be computer manipulated, they may be legally suspect as altered. Therefore, hard copies of the digital images may also be printed and dated in ink to show the informational baseline upon which the clinician based diagnostic or therapeutic decisions. This also protects against computer glitches, such as disk drive crashes, electrical power surges, computer viruses, and operator delete errors.
In one instance, a judgment of $641,541.65 was awarded for negligently designed and prepared veneers and crowns. The dentist claimed she spilled Diet Coke on her records, which entailed inspection with a questioned document expert. Also the claim that a flood of muddy water caused the dentist to discard her study models was refuted by showing that the models could have been easily washed and preserved.
Performing or billing for unnecessary endodontic therapy, such as prophylactic endodontic therapy with every crown preparation, subjects the clinician to fraud. In non–pulpal exposure crown preparation, the likely incidence of subsequent endodontic therapy is approximately 3%. Therefore, performing prophylactic endodontics on the other 97% of patients represents unnecessary and therefore fraudulent treatment. Excessive unnecessary treatment also ethically violates the Hippocratic oath of “primum non nocere” (“first, do no harm”).
The Federal False Claims Act carries both civil and general penalties of treble damages, fines, and attorneys’ fees for fraudulently billing government programs, such as the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) or Medicare. Fines between $5000 and $10,000 per claim form apply if the U.S. mail was used for a false-claim submission. If any portion of the claimed treatment was fraudulently misrepresented, even if a small minority, a violation results. Fraudulent intent need not be conclusively proved. Reckless disregard for the accuracy of submitted data is all that is necessary to obtain a federal criminal conviction or prove civil wrongdoing.
More than 42% of physicians have been sued over the course of their careers. Before reaching the age of 40, more than half of obstetricians/gynecologists have already been sued. About 90% of general surgeons age 55 and over have been sued.
Incidence of Negligence
Medical errors or adverse events are estimated to occur in almost one out of four patient visits to a family practitioner. A U.S. government study of the Institute of Medicine found that 152,000 avoidable deaths occur annually because of medical negligence. In this government study, injury from medical care occurred in 3.7% of hospital admissions. Some 58% of these injuries were concluded to be preventable, and 13.6% were fatal injuries. The actual fatality numbers may be underestimated, because calculations were based solely on hospital chart review.
Malpractice Prophylaxis: Importance of Records
Good clinicians keep good records. Records represent the single most critical evidence a clinician can present in court as confirmation that an accurate diagnosis, proper planned treatment, and informed consent were provided.
Prevention is the goal of modern dental care. Competent endodontic treatment performed within the requisite standard of care not only saves endodontically treated teeth but also helps prevent a lawsuit for professional negligence. Thus, sound and carefully applied endodontic principles protect both patient and clinician. Prudent practices reduce avoidable and unreasonable risks associated with imprudent or careless endodontic diagnosis or therapy.
Not all examples of negligent endodontic treatment are included in this chapter, because the myriad of malpractice incidents far exceeds its scope and length. Rather, only select examples are elucidated for educational purposes.
Standard of Care
Good endodontic practice, as defined by the courts, is the standard of reasonable care that reasonably careful clinicians legally are required to comply. The standard of care does not require perfection. Instead, the legal standard is the reasonable degree of skill, knowledge, and care ordinarily possessed and exercised by reasonably careful clinicians under similar circumstances.
Although the standard of care is flexible to accommodate individual variations in treatment, it is objectively tested based on what a reasonable clinician would do. Reasonable conduct represents a minimum standard required for legal due care. Reasonable care is care based on reasoning supported by sound science such as evidence-based peer-reviewed literature. Additional precautionary steps that rise above this minimal floor of reasonableness and ascend to achieve ideal care are laudable but not legally mandated. Again, the standard of care does not require perfection; nor does it require ideal endodontics. Nevertheless, prudent clinicians should always strive to achieve a higher level of care than barely or minimally adequate care. Excellent clinicians always strive to do their best and practice endodontics at the highest level. Some have criticized this concept by contending that average care is below average, because 49% of clinicians represent a minority compared to the majority of clinicians. Careful clinicians should strive to avoid the mediocrity of minimally acceptable care and instead zealously pursue a goal of endodontic excellence. Endodontists set the standard of care in endodontics. Accordingly, a general dentist and endodontist must each meet the same standard of care.
The written policies and procedures of a clinician, institution, or organization may be used as evidence of standard of care. An expert may consider these the appropriate standard of care in testifying about alleged breaches of standard of care on that issue. For instance, an expert may rely upon AAE’s 1998 position paper on paraformaldehyde-containing root canal filling materials as substandard practice, as well as the fact that all U.S. dental schools teach that toxic paraformaldehyde substances should not be used for adult patients as a root canal obturant.
Negligent errors are unintended acts, either of omission or commission. Some errors do not lead to patient injury if intercepted. Failure to mitigate factors that contribute to errors or near misses may combine with human fallibilities of mood, inattention, carelessness, and forgetfulness to cause error repetition or a future more serious injury.
In deep-sea oil exploration (e.g., Deepwater Horizon) and nuclear power (e.g., the Fukushima Daiichi Power Plant) obtained oil and nuclear power presumed safely but paid a great human and environmental cost because of inadequate safety precautions. (The difference in dental care is that dental disasters are usually episodes of patient suffering or a single death rather than a single episode with many injuries and multiple deaths.)
We all make mistakes. The biggest mistake we make is not to learn from these errors. Our responsibility is to recognize our error, discuss the adverse event with the injured patient and colleagues, and follow up with prevention strategies.
An example of error prevention through shared learning from the mistakes of others is Radiology Events and Discrepancies (READ). READ is structured as a confidential, educational resource to encourage learning from events and discrepancies with the goal of promoting improved patient safety.
Useful lessons are thus learned from incidents/discrepancies that result in adverse consequences. As clinicians, we learn from the mistakes of others. By encouraging a reflective approach to adverse events, radiologists are encouraged to become keenly critical self-observers. For example, a “miss” is noted when an abnormality is radiographically visible but not detected at the time of reporting.
The READ submission form is accessible online via the READ website. Radiologists are encouraged to submit reports and safety-related events that have occurred in their practice. Submitted reports must be anonymized to assure the reporter’s identity remains confidential. The READ panel reviews all reports and learning points identified. To ensure patient confidentiality, the event is “disidentified” by changing age and sex along with other alterations to preserve confidentiality. After publication, all material relating to the case is destroyed. A story is thus created based on a real event, which is published for shared learning. A “lessons learned” conclusion provides instructions to prevent future risks.
Standards of Care: Generalist versus Endodontist
A general practitioner performing treatment ordinarily performed exclusively by specialists—such as apical endodontic surgery, periodontal surgical grafting, or full bony impaction surgery—will be held to the specialist’s standard of care. To avoid performing treatment that is below the specialist’s standard, a generalist should refer to a specialist rather than perform procedures that are beyond the general practitioner’s training or competency. The three levels of clinical skill are (1) competency or beginning level, (2) proficiency, and (3) mastery. To err is human. Even specialists may not always know what they believe they know. Approximately 80% of general practitioners in the United States provide some endodontic therapy. Endodontic expansion into the realm of the generalist can be linked to (1) refinements in root canal preparation and improved obturation (i.e., packing) techniques currently taught in dental schools, (2) continuing education courses, and (3) significant improvements in the armamentarium of instruments, equipment, and materials available to all clinicians to optimize efficiencies in endodontics.
The AAE’s Guidelines Case Difficulty Assessment Form and Guidelines provide a road map for when a generalist should treat or refer to an endodontist. Levels of difficulty range from minimal to moderate and high difficulty ( Fig. 29-17 ). General dentists are competent to treat cases of minimal difficulty. Experienced general dentists may treat the moderate-difficulty cases but should refer high-difficulty patients.
The ADA’s Code of Ethics guides conduct that distinguishes the dental profession from a trade by placing patient service paramount and profit secondary. Section 5 of the ADA Code of Ethics regarding veracity (“truthfulness”) states, “Professionals have a duty to be honest and trustworthy in their dealings with people.” Accordingly, both ethically and legally, clinicians are obligated to communicate truthfully and without deception to patients. Announcements to the public must be truthful so that the average person is not materially misled. Truth in dentistry is the rule and not the exception.
Section 5.I of the ADA Code of Ethics provides the following:
General Practitioner Announcement … general clinicians who wish to announce the services available in their practices are permitted to announce the availability of those services so long as they avoid any communications that express or imply specialization.
Thus, clinicians should not misrepresent or overstate the facts of their training and competence in any way that would be false or misleading in any material or significant manner to the public or their peers. General clinicians should avoid false and misleading self-representation regarding endodontic “superiority.” Implying credentials that the generalist lacks misrepresents a general clinician’s endodontic skill and knowledge as equivalent to a board-eligible or board-certified endodontist. A generalist’s 30-year experience may be little more than 1 year’s experience repeated 30 times. Every state has specific laws governing advertising. Consult your state’s law, because each state deals differently with specialty announcements.
Telephone directory listings are organized into categories based on types of procedure, such as endodontics. Generalists must also state in such ads that endodontic services are being provided by general clinicians. The public is entitled to be informed of the distinction between an endodontist specialist and a generalist, although each provides endodontics. Only an ADA-recognized board-eligible or board-certified clinician is entitled to represent him or herself as an endodontist. With this distinction in mind, the ADA-recognized endodontic specialty organization is titled the American Association of Endodontists, not the American Association of Endodontics.
Standard of Care for Endodontics
Endodontists set the standard for routine endodontics. Therefore, if the endodontist’s standard of care cannot be met, such as the need for microscopy or apical surgery, the generalist should refer the patient to an endodontist.
Endodontists should not forget their general dentist training. Even though a patient may be referred for a specific procedure or undertaking, the endodontist should not overlook sound biologic principles inherent in the overall treatment. A specialist may also be held liable for relying solely on the information referral card or radiographs of the referring clinician if the diagnosis or therapeutic recommendations prove incorrect, unnecessary, or the referral card lists the wrong tooth for treatment. Therefore, conduct a “time-out” with patient and staff to verify which tooth is to be treated.
Figure 29-18 demonstrates a general clinician’s radiograph showing apparent complete endodontic fill within the canal space, whereas Figure 29-19 demonstrates an endodontist’s radiograph showing a transported canal. This difference is explained by radiographic quality and angulation. Taking radiographs at different angles improves radiographic accuracy.
Endodontists should not provide rubber-stamp treatment to whatever the clinician refers or recommends. Without performing an independent examination, the endodontist risks misdiagnosis and resulting incorrect treatment. Prevention of misdiagnosis or incorrect treatment requires an accurate medical and dental history preceding a clinical examination (not only of the specific tooth or teeth involved but also of the general oral condition). Obvious problems such as oral lesions, periodontitis, or gross decay should be noted in the chart and the patient advised regarding a referral for further examination, testing, or another specialist’s consultation.
Radiographs from the referring clinician should be reviewed for completeness, clarity, and diagnostic accuracy. An endodontist should expose a new radiograph to verify current status before treatment and only use the referring clinician’s radiograph for historical comparison. Unfortunately, the referring clinician may surreptitiously forward a pretreatment film with the referred patient, rather than the referring clinician’s own posttreatment film depicting a perforation or broken file that necessitated the referral. This may occur whenever an errant clinician attempts to fraudulently conceal negligently performed endodontic treatment in an attempt to shift blame for bungled treatment to the endodontist. In such cases, a valuable lesson is learned when the endodontist exposes independent pretreatment radiographs, rather than relying exclusively on the referring clinician’s radiographs to determine current status of endodontic treatment.
Poor oral hygiene may contribute to periodontal disease. In such cases, endodontic treatment may be compromised unless the associated periodontal condition, along with the tooth being treated endodontically, is brought under periodontal disease control, including any crown-lengthening needs (see Chapter 25 for more information). Referral to a periodontist may be necessary before or contemporaneous with completion of endodontic treatment.
In summary, it is necessary for the endodontist to do the following:
Be alert to any contributory medical or dental condition within the operative area of endodontic treatment that can affect treatment.
Undertake an independent diagnostic and radiographic examination of the treatment area and treatment plan rather than relying solely on the referring clinician.
Perform a general dental examination (at least a screening) to diagnose any hard- and soft-tissue pathosis.
Evaluate status and prognosis of adjacent and opposing teeth.
Advise the referring clinician and patient of pertinent findings.
Ordinary Care Equals Prudent Care
Ordinary is commonly understood (outside its legal context) to mean “lacking in excellence” or “being of poor or mediocre quality.” As expressed in the context of actions for negligence, however, ordinary care has assumed a technical legal definition that differs somewhat from its common meaning. The eighth edition of Black’s Law Dictionary describes ordinary care as “that degree which persons of ordinary care and prudence are accustomed to use or employ … that is, reasonable care.”
In adopting this distinction, the courts have defined ordinary care as “that degree of care which people ordinarily prudent could be reasonably expected to exercise under circumstances of a given case.” It has been equated with the reasonable care and prudence exercised by ordinarily prudent clinicians under similar circumstances. It is not extraordinary or ideal care. Thus, ordinary care is not average care but instead equates with prudently careful care. Stated otherwise, average care may be below the average of what all reasonable clinicians should practice.
Although the standard required of a professional cannot be only that of the most highly skilled practitioner, neither can it be limited to the arithmetic-average member of the profession, because those who possess somewhat less than median skill may still be competent and qualified to treat. By such an illogical definition of average care, half of all clinicians would automatically fall short of the mark and be negligent as a matter of law. As one court explained, “We are not permitted to aggregate into a common class the quacks, the young men who have not practiced, the old ones who have dropped out of practice, the good, and the very best, and then strike an average between them.” Thus, the standard of care equates with reasonable care and not average care.
Customary Practice versus Negligence
Customary practice may constitute evidence of the standard of care, but it is not the only determinant. Moreover, if the customary practice constitutes negligence, it is not considered reasonable (although or even if customarily practiced by a majority of clinicians). Rather, the reasonably careful clinician is the standard of care and not an average or mediocre practitioner. For instance, a majority of clinicians did not perform biologic testing of the dental unit water lines despite ADA recommendations to do so. However, careful clinicians did follow the ADA’s recommendation ( Box 29-2 and Fig. 29-20 ).
Failing to probe and record periodontal pockets
Failing to take diagnostic-quality radiographs
Failing to refer patients for complicated procedures
Failing to use aseptic practices such as gloves, facemasks, and sterile fluids for surgery
Failing to use rubber dams for root canal therapy
Failing to install or periodically check valves in dental units to prevent water retraction, suck-back, and cross-contamination
Failing to do thermal pulp testing as an aid to diagnosing pulpal disease (see Chapter 1 )
Failing to discontinue quaternary ammonium chloride–based products for precleaning or disinfection of environmental surfaces
Failing to use a microscope for fractured file retrieval and periradicular surgery
Failure to include CAMBRA in a comprehensive new patient exam
Failure to use CBCT technology to guide implant placement when placement is in close proximity to the IANC (see Fig. 29-21 for implant “harpooning” of IANC)
Not informing CT radiation risks to patient
CAMBRA, caries management by risk assessment; CBCT, cone-beam computed tomography; IANC, inferior alveolar nerve canal.
Merely because a majority of clinicians in a community practice a particular method does not establish it as the standard of care if the practice is unreasonable or imprudent. Ultimately, the courts determine what constitutes reasonable practice by considering available dental knowledge and evaluating the relative risks versus benefits of a particular procedure.
Again, the law does not require dental perfection. Instead, the legal yardstick by which prudent conduct is measured is what a reasonably prudent clinician should do under the same or similar circumstances, regardless of how many or how few clinicians conform to this standard.
In one case, it was not customary practice in the state of Washington for ophthalmologists to test patients under 40 years old for glaucoma, because the incidence was only 1 in 25,000 patients. Nevertheless, the Supreme Court of Washington state held that the defendant ophthalmologist was negligent as a matter of law, irrespective of customary medical practice, as a negligent customary practice is no defense.
Little excuse exists for failing to routinely probe and chart periodontal pockets before rendering endodontic therapy, no matter how many other clinicians in the community may fail to do so. The benefit of probing for periodontal disease substantially outweighs the virtually nonexistent risk of conducting this valuable diagnostic procedure. A legal defense likely to invoke a jury’s wrath is to claim that a necessary diagnostic or prophylactic procedure is “too time consuming,” when dental and medical patient health are placed at risk if not done. If the benefit outweighs the risk, a reasonable clinician complying with the standard of care should opt for the beneficial diagnostic test or treatment. For instance, the Accuitomo and Kodak 9000 CBCT may prove an invaluable benefit for diagnosing the etiology and source of endodontic pain when compared to the relatively low radiation risk. Thus, the CBCT diagnostic benefit outweighs the radiation risk if a differential diagnosis cannot accurately rule in or rule out a final diagnosis.
Another example of negligent customary practice includes a majority of general dentists not using a rubber dam for all root canal therapy despite virtually all endodontists who do so. The AAE’s 2010 Position Statement mandates that “tooth isolation using the dental dam is the standard of care; it is integral and essential for any nonsurgical endodontic treatment.”
A further instance of a customary but nevertheless negligent practice concerns the majority of dentists who did not adhere to CDC guidelines for infection control.
Health Maintenance Organization Care versus Standard of Care
Reasonably careful or prudent practitioners (not insurance carriers) set the standard of care. Third-party payers may limit reimbursement but should not limit access to quality care. Clinicians have an affirmative duty on behalf of patients to appeal insurance carrier care denial decisions and, in some states, are protected against retaliation. The clinician who complies (without protest) with restrictive limitations or denials imposed by a third-party payer when sound judgment dictates otherwise cannot avoid ultimate responsibility for the patient’s care.
Although dental insurance companies do not set the standard of care, insurance carriers may contractually limit dental benefits. Therefore, a clinician is obligated to inform patients of their dental needs, regardless of carrier reimbursement. Patients may then elect to pay out of pocket for noncovered treatment or decline uninsured services. Informed choice is uninformed if the clinician fails to provide patients with all reasonable options and alternatives. Follow the adage to not x-ray the patient’s pocket book or wallet to determine what options the patient should be presented. Instead offer the patient all reasonable treatment options.
Notwithstanding that an insurance carrier denies endodontic therapy or limits endodontics to only certain clinical conditions, a prudent clinician must nevertheless, both legally and ethically, provide an informed consent option to the patient that a tooth may be endodontically treated and retained rather than extracted. The California Dental Association’s Dental Patient Bill of Rights advises patients that “You have the right to ask your clinician to explain all treatment options regardless of coverage or cost.”
Clinicians may agree to a discounted fee with a health maintenance organization (HMO) carrier but must never discount the quality of care provided. Peer reviews and the courts recognize only one standard of care. A lower, double, or different standard of care for reduced-fee HMO plans is not legally recognized. Expediency should not be exercised at the expense of quality patient care. Section 3 of the ADA Code of Ethics affirms, “Managed care contract obligations do not excuse clinicians from their ethical duty to put the patient’s welfare first.”
An Illinois appellate court held that a clinician may be sued for injuries a patient experiences as a result of the clinician’s failure to disclose a contractual arrangement with the patient’s HMO that creates financial incentives to minimize diagnostic tests and referrals to specialists. The court recognized a distinct cause of action for breach of fiduciary duty for failure to disclose these types of financial incentives. In reaching its conclusion, the court cited an American Medical Association (AMA) ethics opinion that stated that a clinician must ensure that a patient is aware of financial incentives through which health insurers limit diagnostic tests and treatment options.
Managed care organizations use a variety of strategies to influence the practice styles of providers. One of the most controversial of these methods is the use of financial incentives designed to limit referrals to specialists. Such financial incentives usually take the form of bonus payments drawn from surpluses in risk pools funded by “withholds.” These funds are deducted from the primary care provider’s base payments or otherwise reserved under contracts in which the care provider bears financial risk. Such bonuses are based on referral limitations. Conversely, the federal Patient Protection and Affordable Care Act compensates based on the quality of care rather than the quantity.
Plans that delay treatment approval, resulting in endodontic complications or tooth nontreatability, may be subject to liability. HMO carriers have not always succeeded in arguing that the 1974 Employee Retirement Income Security Act (ERISA) preempts state law for dental negligence claims against entities who administrate health care benefits to an ERISA plan and shift blame to the clinician.
Capitation systems have a built-in incentive to undertreat, delay, or discourage treatment and access to care. For the HMO-paid clinician, the patient may be perceived as a threat to profits. Thus, capitation creates incentives that can transform clinicians from the patient’s advocate to the patient’s adversary.
Although clinicians seem like double agents serving two masters (i.e., managed care carriers and patients), the law is clear that the clinician must always act in the patient’s best interest, because the clinician owes a fiduciary obligation to the patient. Should the carrier deny requested care, the clinician is legally obligated to appeal the decision to protect the patient’s dental health. A patient’s best interest is always paramount, both legally and ethically, to a clinician’s financial interest.
Although profitable to insurance carriers, the success of denying or limiting benefits has created an era of rightfully indignant patients and frustrated clinicians. Consequently, the clinician must guard against patient disappointment with limited insurance benefits by explaining that although insurance carriers determine coverage under their patients’ insurance policy, carriers do not set the standard of care. Regardless of how much or how little is covered by the patient’s insurance carrier, prudent and reasonably careful clinicians set the standard of care. Providing less than necessary care because of insurance carriers’ dictates may explain resulting deficient endodontics but does not excuse such conduct. Moreover, the legal doctrine of informed consent mandates the patient be informed of alternative therapy choices that the patient may pay privately even though the HMO denies approval for alternative therapies. Follow the maxim: Do not x-ray a patient’s pocketbook. Reasonable informed consent is premised on patient choice and not cost alone.
An employer may fire an employee for a bad reason or no reason at all, as long as termination was not done for discriminatory reasons.
Dental Negligence Defined
Dental negligence is defined as a violation of the standard of care (i.e., an act or omission that a reasonably careful or prudent clinician under similar circumstances would not have done). Negligence is equated with carelessness or inattentiveness. Malpractice is a lay term for such professional negligence. Dental negligence occurs for two reasons:
A clinician does not possess a reasonable degree of education and training to act prudently.
Despite reasonable schooling, additional training, and continuing education, the clinician acts with unreasonable carelessness or imprudently fails to act as a reasonably careful clinician would act.
One simple test to determine if an adverse outcome results from negligence is to ask the following question: Was the treatment result reasonably avoidable? If the answer is yes, it is probably malpractice. If the answer is no, it is instead an unfortunate maloccurrence that resulted despite reasonable care attempts.
The locality rule, which provides for a different standard of care in different communities, is rapidly becoming outdated. Originating in the 19th century, the rule was designed to acknowledge differences in facilities, training, and equipment between rural and urban communities.
The trend across the United States is to move from a locally based standard to a statewide standard, at least for generalists. For endodontists, a national standard of care is applied, as the AAE Board is national in scope. Because of nationally published endodontic literature, advances in Internet communication, continuing education courses, and reasonably available transportation for patients, no disparity generally exists between rural and urban endodontic standards. A current exception may be the limited geographic availability of specific cone-beam CT technology such as the Accuitomo or Kodak 9000. Their higher resolution provides superior radiographic endodontic diagnosis compared with 2D imaging and even other CBCT devices. As CBCT machine pricing is lowered and availability increases, the locality rule may be broadened beyond a local community for CBCT technology. On the other hand, time is critical during the first 48 hours of symptomatic numbness if an endodontic overfill enters the IANC. In such instances, a referral to a distant CBCT facility may be required to assess the need for immediate microsurgical removal or instead obtain, at the very least, a medical CT in the local geographic area if a CBCT facility is unavailable. *
* References .
A clinician should provide reasonably careful endodontic care to a patient regardless of treatment locality. Rather than focusing on different standards for different communities, more important considerations include knowledge of endodontic advances in the field gained with continuing education to utilize improved diagnostics, instrumentation, and therapeutic interventions.
The locality rule has two major drawbacks. In areas with small populations, clinicians may be reluctant to testify as expert witnesses against other local clinicians. Also, the locality rule allows a small group of clinicians in an area to establish a local standard of care inferior to what the law requires of larger urban areas. Peer-reviewed publications are available to all clinicians in print and online. Clinicians can easily travel great distances to attend continuing education courses or attend webcasts in their own office. Blaming technologic ignorance on a clinician’s rural location is inexcusable with modern media, computer technology, continuing education courses, and travel ease.
Continuing education should not add new skills at the expense of compromising or eliminating core clinical values. A prudent practitioner should be cautious adding a new methodology that is counterintuitive to basic biomechanical principles. As a general maxim, don’t be the first or the last to adopt new technology.
A clinician is legally obligated to maintain current knowledge in the field of endodontics. If not, the clinician may have only 1 year of knowledge (repeated 30 times) during the span of a 30-year career. By not maintaining continuing education knowledge and updating clinical skills, a clinician may unreasonably condemn otherwise salvageable teeth because of inadequate diagnosis or treatment.
Scientific Research Evaluation
In evaluating scientific research, the clinician should remember that epidemiologic data of risk factors are not always equivalent to etiology. Thus, epidemiology is not a synonym for etiology . The scientific community has never exclusively relied on epidemiology as the accepted method of evaluating cause-and-effect relationships in an effort to make clinical decisions. Accordingly, clinicians should not consider only one class of data to supply ultimate proof when conducting an evaluation. Instead, clinicians should consider the strength of any study to be related to the presence and contributing cause of other cofactors. The unusual characteristics of a particular patient can place the patient at higher risk than the average patient.
New products and procedures are often introduced faster than epidemiologic and toxicologic studies are implemented to evaluate their potential risks. Academic medical/dental centers are facing severe pressure on their reimbursement for health care services and postgraduate education. This creates the need to examine additional sources of revenue to fund their tripartite mission of education, research, and patient-care delivery. Reduced government spending for research has resulted in proprietary interests (with proprietary goals) funding more research. Since 1984, the New England Journal of Medicine ‘s policy has been to refuse publication of research done by those with financial ties to drug makers. But in 1999, the journal admitted conflicts in nearly half of the drug studies published since 1997. The next year, the retiring editor of the New England Journal of Medicine concluded that despite tax-supported privileges and extraordinary pharmaceutical industry profits, the best interests of society were not always served. A public trust more accountable to science was needed.
Although much emphasis is currently placed on evidence-based medicine and dentistry, most clinical practices are not based on data derived from randomized clinical trials. It is virtually impossible to conduct a trial to test the validity of every possible patient-management option. Many therapeutic choices are so compelling that a test would be unethical; others are so trivial that a test might not be worth the time or effort. Clinicians do not always practice in conformity to evidence-based research, even when evidence is available from randomized clinical trials. This is because knowing the right answer is only the first step in the process of adopting a new treatment methodology. Many clinicians will not use a new drug simply because supporting research data suggest its efficacy. Instead, identification of the probable mechanism of action is often a prerequisite before adopting a new treatment. Moreover, the test of time may eventually reveal an adverse effect of a particular drug or device (e.g., defects that were not identified before marketing). Even if the new product’s research proves beneficial, comparative effectiveness studies with other time-proven and tested products are needed to determine a new product’s relative worthiness.
Clinicians should not avoid using certain drugs if the data supporting their use are overwhelming. When the results of a clinical trial conflict with a widely held mechanistic model, many clinicians doubt research-based evidence. However, when the results from well-researched clinical trials become so convincing that the evidence can no longer be ignored, a prudent clinician embraces the new paradigm and discards previously held concepts. Endodontic science advances as disproved older concepts retreat. For example, delaying extractions until after several days of antibiotic use to reduce infection is no longer the accepted practice. Rather, immediate extraction, along with any necessary antibiotics, is the preferred current therapy. Another example is one-visit endodontics, which has been proved to be as effective as two-visit endodontics.
New devices that lack definitive research studies should be used cautiously. For instance, high-intensity, wireless, fast-curing lights may generate heat at the wand tip and cause pulpal pathosis. First-generation halogen bulbs require longer composite curing time to achieve polymerization but generate only 400 to 800 mW/cm. Plasma arc bulbs reduce curing time but generate 2000 mW/cm.
Hydron was marketed without long-term clinical testing. Its purported biocompatibility and reduced inflammation portended an improved endodontic drug for obturation. Postmarketing failures resulted from inadequate premarket testing that lacked long-term research. Thus, Hydron’s inability to obturate canals with a durable filling material resulted in both clinicians and patients being harmed as postmarket guinea pigs. Hydron’s in vitro research did not match in vivo patients’ experiences.
Other examples include Endocal 10 (formerly Biocalex 6/9), which proved ineffective. Arsenic to promote devitalization of the pulp resulted in local osteonecrosis. Thermafil metal carriers proved difficult to remove and were replaced with plastic carriers. Advance cement was touted as an improved luting cement for retaining permanent restorations. The high incidence of marginal leakage with Advance resulted in its withdrawal from the market in 2000. A multimillion-dollar class action settlement resulted against the manufacturer on behalf of California clinicians with unsealed margins of crowns cemented with the Advance luting agent.
Older devices, over time and with sufficient patient experience, may manifest adverse events. Overheating with ultrasonic tips for post removal has resulted in teeth and tissue loss ( Fig. 29-21 ). Accordingly, despite insufficient label warnings on some ultrasonic devices, copious water coolant, rest periods, and avoidance of prolonged ultrasonic device use are needed for safe post removal.
Today’s clinician exploring ways to improve the quality and success of endodontic therapy is constantly presented with new dental products and techniques. For prescribing and using drugs or other agents, the ADA’s Principles of Ethics, Section 5D, provide this guideline :
Except for formal investigative studies, dentists shall be obliged to prescribe, dispense, or promote only those devices, drugs and other agents whose complete formulae are available to the dental profession. Dentists shall have the further obligation of not holding out as exclusive any device, agent, method or technique if that representation would be false or misleading in any material respect.
Ethical clinicians should not indiscriminately adopt every new product. Instead, the supporting research should be reviewed, rather than risk the patient’s welfare with inadequately tested products or researched products only tested in vitro. Again, don’t be the first or the last to adopt new technology.
Despite FDA approval, some drugs are marketed with fraudulent concealment of the number and nature of adverse event incidents.
FDA Drug Approval
Until 1962, drug companies were allowed to promote their products for any use so long as they were shown to be “safe” for one use. Manufacturers were marketing drugs with serious side effects for minor conditions and to vulnerable populations, resulting in many injuries and deaths. Ineffective drugs were the rule rather than the exception. When a retrospective review of all drugs was conducted after 1962, the National Academy of Sciences found that fully 80% of the uses for which drugs were being promoted could not be shown to be effective. Since 1962, the FDA has required prescription drug manufacturers to demonstrate safety and efficacy with animal and randomly controlled research trials conducted with FDA-approved protocols. FDA “approval” to market new drugs for specific uses is termed premarket approval (PMA).
In a new drug application (NDA) to the FDA, findings from many clinical studies are done to assess a new drug’s efficacy and safety and to gain the FDA’s PMA to market the drug. An NDA judges whether the proposed new drug (1) causes more good than harm (benefit outweighs the risk), (2) is comparatively more effective than already existing marketed drugs, or (3) has unreasonably frequent or severe side effects (risk outweighs the benefit).
In 2008, $58 billion in privately funded drug research was approximately twice the basic federal medical research budget and encompassed an estimated 50,000 clinical trials among 2.3 million patients. Medicare drug spending is forecast to grow from $2 billion in 2000 to $153 billion in 2016, a 7550% increase. In 2007, one in seven U.S. residents younger than age 65 skipped prescribed medications because of rising prescription cost.
The Pharmaceutical Research and Manufacturers Association of America has created an online database that summarizes clinical study results involving hundreds of prescription medicines. Notwithstanding, the sheer volume of clinical testing has overwhelmed the FDA’s ability to independently assess commercial trials and make all test results public. Deceptive marketing, unreported side effects, and hidden payments to medical/dental researchers highlight the gap between the number of clinical trials conducted and the number published. *
* References .
Comprehensive clinical data filed with the FDA for gaining market approval of a new drug (PMA) form the basis for safety information that accompanies every prescription label. For the first time, under a new federal law effective in 2009, researchers in PMA trials will have to post their basic research results publicly on a federal online registry maintained by the National Library of Medicine. However, new registry regulation will only cover new tests, not tests with poor results done prior to the effective date of the new law. Moreover, findings are not independently FDA verified. Instead, the FDA relies on the manufacturer’s submitted trial data research.
Until September 2007, researchers only had to report the start of a clinical trial and were under no federal legal obligation to report the outcome in the FDA’s registry or in a peer-reviewed journal. Consequently, clinical data on health risks could be downplayed or benefits extolled selectively in any one of 5200 peer-reviewed biomedical journals.
By January 31, 2009, as a voluntary patient guide, the federal registry ( www.clinicaltrials.gov ) logged 67,000 studies. The results of all drug trials that were ongoing on or after September 27, 2007, must be reported at ClinicalTrials.gov if the products under study have FDA approval. The results for drugs not yet receiving FDA approval do not have to be posted. A deficiency of the current law is that the results of older trials of drugs that were FDA approved before September 27, 2007, and that were no longer the subject of ongoing trials on or after September 27, 2007, do not need to be posted. Such drugs constitute the majority of current prescription drugs. The FDA considers much of the data on clinical trials it receives from sponsors—and its own analyses of these data—to be “confidential commercial information.” FDA drug-trial information released to the public is frequently heavily redacted. Redacted disclosure occurs in response to one or multiple requests made under the Freedom of Information Act, but usually only after a prolonged delay. The FDA Amendments Act of 2003, Section 916, institutionalizes this limitation by mandating that the FDA publish on its website key information related to approval of an application for a drug that contains a previously approved active ingredient only after it has received three Freedom of Information Act requests.
In a 2008 University of California, San Francisco (UCSF), study of 164 clinical trials testing 33 different drugs submitted for FDA approval, approximately one in four had yet to be published. Virtually all of the unpublished findings were negative. The UCSF study also reported that in 900 FDA filings involving 90 new drugs, more than half the clinical trials were still unpublished 5 years after the drug had FDA approval. UCSF researchers who reviewed the FDA’s regulatory paperwork for dozens of recently FDA-approved (PMA) drugs found that in some clinical trials previously reported to the FDA, when subsequently submitted for publication, conclusions were changed, statistics revised, and outcomes altered to make treatments appear more effective. Among 43 outcomes reported in the FDA filings that did not favor a drug, 20 were never published. In four out of five instances in which the statistical significance of findings were changed from the FDA filing, the published version was more favorable. Positive effects of a new drug were more likely to be submitted for publication than those reporting negative findings. Basic principles of evidence-based practice require the analysis of all data. Publishing only some results but not others undermines the ability to adequately assess a product’s safety and efficacy, which is FDA’s standard for FDA approval of drugs or devices.
Journals want to sell journals. Companies wish to increase profits. Researchers promote career advancements and seek research funding. Consequently, potential conflicts are pervasive. To offset these temptations, failure to timely report basic data about clinical test results in the federal public registry can subject researchers to fines of $10,000 a day and/or loss of their federal research funding (Public Health Service Act Section 302[J]).
In 2009, the Government Accounting Office (GAO) concluded in the GAO’s 2009 High-Risk Series, FDA Oversight of Medical Products :
New Laws, the complexity of items submitted to FDA for approval, and the globalization of the medical products industry are challenging FDA’s ability to guarantee the safety and effectiveness of drugs, biologic, and medical devices. As a result, the American consumer may not be adequately protected from unsafe and ineffective medical products. FDA needs to improve the data it uses to manage the foreign drug inspection program, do more inspections of foreign establishments that manufacture drugs or medical devices, more systemically review the claims made in drug advertising and promotional material, and ensure that drug sponsors accurately report clinical trial results.
Globalization of clinical research is a relatively recent phenomenon. The number of countries serving as trial sites outside the United States more than doubled in 10 years. Conversely, the proportion of trials conducted in the United States and Western Europe decreased. Clinical testing in developing countries sidesteps stringent FDA regulatory barriers for FDA drug approval.
Wide disparities in education, economic and social standing, and health care systems may jeopardize the rights of research participants in foreign countries. Foreign participants may lack understanding of the investigational nature of therapeutic products or the use of placebo research participant groups. In some places, financial compensation for research participation may exceed participants’ annual wages. Standards of health care in developing countries may also allow ethically problematic study designs or clinical research trials that would not be allowed in wealthier countries. In one study, only 56% of the 670 researchers surveyed in developing countries reported that their research had been reviewed by a local institutional review board or health ministry. In another study, 90% of published clinical trials conducted in China in 2004 did not report ethical review of the protocol, and only 18% adequately discussed informed consent.
Developing countries will also not realize the benefits of clinical research trials if the drugs being evaluated do not become readily available for host-country research participants after FDA approval is obtained. The Declaration of Helsinki includes an expectation that every patient enrolled in a clinical trial should, at the end of the trial, be assured access to the best proven therapy identified in the research study.
Geographically distinct populations can have different genetic profiles; these differences have been shown to be related to the safety and effectiveness of drugs and medical devices. For example, a study of 42 genetic variants associated with pharmacologic response in drug studies showed that more than two thirds had significant differences in frequency between persons of African ancestry and those of European ancestry. Genetic diversity is often not considered in study design and interpretation and in the reporting of trial results.
From fiscal 2002 through 2007, the FDA issued 15 warning letters to foreign companies with serious deficiencies, but the agency only reinspected four of the companies, and then only 2 to 5 years later. Decades ago, most pills consumed in the United States were made here. But like other manufacturing operations, drug plants have been moving to Asia where labor, construction, regulatory, and environmental costs are lower. The world’s growing dependency on Chinese drug manufacturers became apparent in the heparin scare. In 2007, Baxter International and APP Pharmaceuticals split the domestic market for heparin, an anticlotting drug needed for surgery and dialysis. When federal drug regulators discovered that Baxter’s product had been contaminated by Chinese suppliers, the FDA banned Baxter’s product and turned almost exclusively to the one from APP. However, APP also obtained its heparin product from China. Of the 1154 pharmaceutical plants with generic drug application to the FDA in 2007, only 13% were in the United States; 43% were in China, and 39% were in India. Drug labels often claim that the pills are manufactured in the United States, but the listed U.S. plants are often the sites where foreign-made drug powders are pounded into pills and packaged.
Under the Prescription Drug User Fee Act, known as PDUFA, pharmaceutical companies pay the FDA to facilitate their PMA applications. Congress provided PDUFA with added power to impose restrictions on the sale of drugs and enforce regulations requiring that postmarketing surveillance studies be completed in a timely manner rather than delayed or evaded. Notwithstanding PDUFA, in 2008 the FDA was still missing target dates to act on NDAs because the FDA lacks sufficiently adequate staffing to handle PMA applications.
The applicant must receive FDA approval of its PMA application prior to marketing the device as FDA approved. PMA approval is based on an FDA determination that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended uses.
The FDA lists certain products that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization act), which include the following endodontic products:
Root canal posts
Adverse Drug Events (ADEs)
Adverse drug events (ADEs) include “injury due to medications.” In 1999, the Institute of Medicine identified medication errors as a significant and preventable source of ADEs. Warning labels represent a quick reminder to highlight the most important instructions for the safe and effective use of prescribed medications. In one study, 50% of participants looked directly at the warning labels; 22% did not look at any. The recommendation was to move all of the warnings from the colored stickers to the main, white label. More than 30% of those 65 and older take 10 medications daily.
Primary Medication Nonadherence: Unfilled Prescriptions
Primary medication nonadherence occurs when a noncompliant patient fails to fill a prescription. Up to 25% of children discharged from a hospital with a prescription do not have those prescriptions filled. Other data from emergency departments suggest that the frequency of unfilled prescriptions is between 7% and 35%. Electronic prescriptions are more likely to be filled. When a prescription is electronically prescribed, the patient does not have an opportunity to lose or misplace it. Data suggest that clinicians should explore whether patients actually filled the medication prescribed or were taking it properly when a patient does not appear to be responding adequately to prescribed treatment.
Newly marketed drugs may not list all potential adverse drug reactions or events because of the limited number of patients in research trials before marketing. Therefore, the FDA’ s MedWatch program encourages clinicians to report known or suspected drug reactions. MedWatch encourages reporting of serious unexpected adverse drug reactions whose nature and severity are inconsistent with or absent from the drug’s labeled warnings. Clinician reporting to the FDA is confidential and voluntary. The patient’s identity need not be disclosed. Clinicians should contact the FDA by telephone at (800) FDA-1088 or fax at (800) FDA-0178 to obtain the FDA Medical Products Reporting Program (MedWatch) form (FDA form #3500). The back portion of the Physicians’ Desk Reference (PDR) contains a MedWatch form. Clinicians can also download the MedWatch reporting form at www.fda.gov/medwatch/getforms.htm ; request the form by mail via MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787; and report suspected drug interactions, reactions, or adverse product events at www.fda.gov/medwatch/report.htm . Other electronic drug databases are available to report and access important drug interaction information. For FDA-approved safety-related drug labeling online, see www.fda.gov/MedWatch .
Adverse drug reactions are injuries occurring when drugs are administered at usual doses. These reactions represent the primary focus of regulatory agencies and postmarketing surveillance. An adverse drug event suggests medication prescribing or dispensing errors that compromise patient safety. Unfortunately, clinicians report only between 1% and 5% of adverse drug incidents to the FDA, because clinician reporting is voluntary. On the other hand, drug manufacturers must report known adverse drug incidents to the FDA.
Clinicians should document adverse drug reactions not only in the progress notes but also in the allergy section of the chart in order to assess whether future use of the same drug is contraindicated and to prevent a harmful recurrence. Predictable adverse drug reactions that manifest should also be recorded as consideration for future disuse of the involved particular drug.
The Weber effect is a known phenomenon in the epidemiology literature in which the number of spontaneously reported adverse events for a drug tends to peak around the second year after a drug’s initial marketing. The influence of the Weber effect suggests that an increase in adverse events may be attributed to epidemiologic reporting bias, which may not reflect a true difference in adverse events.
More than 500 cases of fungal meningitis including 44 fatalities were attributed to injectable steroid solutions prepared by the New England Compounding Center (NECC), which subsequently filed for bankruptcy.
Contamination is only one of five categories of risk associated with compounding pharmacies. The other four are subpotency, superpotency, overmedication, and medication replacement.
Many patients received sterile injections for back and joint pain for procedures that lack high-quality evidence-based efficacy. FDA-approved methylprednisolone acetate is sold by Pfizer and two generics companies. NECC’s version did not contain preservatives, which avoided the FDA’s regulatory process.
Compounding involves the preparation of medications on prescription to meet unique patient health care needs that cannot be met with commercially manufactured and marketed drug products. Compounding includes providing different strengths of a drug with different nonactive excipients for allergy patients or creating dosage forms that are more palatable for a patient. Compounding pharmacies and pharmacists work directly with the prescribing dentist to create customized personalized medication solutions for patients in doses and formulations that the pharmaceutical industry does not manufacture.
The Food and Drug Administration Modernization Act (FDAMA), enacted November 21, 1997, amended the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biologic products. FDAMA exempted individualized compounded drug products from the rigid federal current goods manufacturing practices. Under federal law, drugs that are not manufactured in conformity with federal current goods manufacturing practices are deemed to be “adulterated” under 21 U.S.C. 351(a)(2)(B) and subject to federal sanction. FDAMA, 21 U.S.C. 351(a)(2)(B) does not apply to a drug product compounded by a licensed pharmacist in a state-licensed pharmacy for an identified individual patient with a valid prescription order—or in limited quantities before receipt of the valid prescription order.
Federal law prohibits compounding of drugs previously removed from the market because such drug products, or one or more of their components, have been found to be unsafe or ineffective. Compounding drugs that are copies of a commercially available drug product is also prohibited.
After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA), requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” in response to thalidomide’s fatal side effects causing impaired limb development.
Traditional compounding pharmacies are not registered with the FDA as drug manufacturers. The FDA does not approve compounding pharmacy prescriptions before marketing. Nor does the FDA require compounding pharmacies to report adverse events. Instead, state law generally controls recordkeeping, certifications, and licensing for compounding pharmacies.
The Dietary Supplements Health and Education (DSHE) Act allows dietary supplements to be sold directly to consumers without any oversight or FDA regulation. In response to intense lobbying by the multibillion-dollar dietary supplement industry, Congress in 1994 exempted these products from FDA regulation. Products may contain amounts claimed, but they need not, and nothing can prevent their sale if they do not. For example, an analysis of ginseng products showed no ginseng at all in some products. The DSHE Act places the burden of proof for dietary supplements’ safety on the FDA and not the manufacturer. As a result, consumers of herbal supplements must depend on self-regulation within the industry for assurance of product quality, consistency, potency, and purity. An understaffed and overworked FDA can hardly be expected to be a vigorous enforcer.
An herbal product label can state the way the product is intended to affect “the structure or function” of the body but cannot claim its use for a specific disease. Manufacturers thus use creative language that complies technically with the statute but generally is confusing or deceptive.
A current medication history form should include over-the-counter, herbal, and illicit drugs, many of which have the potential for synergistic or antagonistic interaction with clinician-prescribed drugs. Ma-huang, or ephedra, a major component of many weight loss supplements, has been associated with more than 800 adverse health effects, including the death of major league baseball player Steve Bechler. Ephedra is an amphetamine-like compound with the potential for overstimulating the central nervous system and heart. Ephedra/ma-huang has been associated with 54 deaths, primarily involving cranial hemorrhage or stroke. A Los Angeles police officer who experienced a crippling stroke after taking an ephedra-based energy supplement, Dymetradrine Xtreme, was awarded $4.1 million. The retail storeowner had read but disregarded 30 journal articles warning of strokes, heart attacks, seizures, and other ailments associated with the drug. The stroke occurred before the FDA banned ephedra from sale in April 2004. Nonetheless, Internet sales proliferated.
Echinacea increases potential for liver damage when used with steroids. Gingko biloba and feverfew interfere with anticoagulants such as warfarin (Coumadin). Dong quai root, willow bark, goldenseal, guarana, horse chestnut, and bilberry tablets/supplements also have antiplatelet properties. Ginseng may cause rapid heartbeat or high blood pressure in some individuals, as well as coagulation disruption. Vitamin E has antiplatelet properties and inhibits vital clot formation. Gingko and selenium are powerful anticoagulants, three times stronger than vitamin E. In 1998, California investigators found about one third of 260 imported Asian drugs were either spiked with unlisted drugs or contained mercury, lead, or arsenic. In 2009, the FDA warned of 70 weight-loss pills containing potentially harmful drugs unlisted on their labels.
The formulations for herbal supplements—or botanicals, as they are correctly called—such as St. John’s wort and Echinacea are often complex, highly variable, and impure. Many are toxic, carcinogenic, or otherwise dangerous. Side effects include blood-clotting abnormalities, high blood pressure, life-threatening allergic reactions, abnormal heart rhythms, exacerbation of autoimmune diseases, and interference with life-saving prescription drugs.
The American Society of Anesthesiologists has warned patients to stop taking herbal supplements at least 2 weeks before surgery to avoid dangerous interactions with anesthesia.
Congress exempted supplements from oversight under a 1994 law that prevents federal regulators from requiring manufacturer’s proof that botanicals are safe or effective, or even that dosage information on the label is correct. In 1999, the FDA allowed manufacturers to make dubious health claims, such as for products to treat conditions such as premenstrual syndrome and acne, although only a few botanicals have proved to be efficacious for anything.
Negligence Per Se
Violation of a health safety statute constitutes negligence per se if the patient was in the class of persons the statute was designed to protect. Compliance with a health safety statute does not conclusively establish due care, because regulations require only minimal care and not (necessarily) prudent care or what the law regards as due care.
Clinicians should exercise extreme caution when administering or prescribing dangerous drugs. For sedative or narcotic drugs, cautionary directions should be written on prescriptions, and the pharmacist should place these directions on the prescription container as a patient reminder. For example, for the appropriate drugs, the clinician should prepare a prescription rubber stamp or obtain preprinted prescriptions that state the following:
Do not drive or operate dangerous machinery after taking medication because drowsiness is likely to occur. Alcohol, sedative, or tranquilizing drugs will cause drowsiness if taken in combination with this prescribed drug.
The ADA and American Medical Association (AMA) provide prescription drug warning pads. Clinicians should document each drug information form provided with the prescription in the patient’s chart.
Overuse of antibiotics risks resistant-strain development and side effects. Studies demonstrate generally no increased therapeutic efficiency of endodontic therapy with antibiotics when performed in the absence of facial swelling. Unless persistent infections occur or compelling systemic reasons exist (e.g., uncontrolled diabetes, antibiotic prophylaxis necessary because of mitral valve regurgitation), antibiotics should not be prescribed prophylactically. Neither pain nor localized swelling alone justifies antibiotics. However, extraoral swelling, cellulitis, or lymphadenopathy may require surgical drainage, antibiotics, or both. The U.S. Centers for Disease Control and Prevention (CDC) estimates about one third of all antibiotic outpatient prescriptions are unnecessary.
Product liability may result when the manufacturer provides inadequate hazard warnings for safe use of its product. Product contraindications should be identified ( Fig. 29-22 ).