Informed Consent for Bisphosphonates
Your patients are taking bisphosphonate drugs. Ads for Boniva® ,Fosamax® and Actonel® are shown on TV all the time. What are these drugs and why are so many people taking them? Are there particular concerns for patients when it comes to dental treatment? What should staff do concerning the informed consent process and bisphosphonate usage?
What are bisphosphonates and why are so many people taking them?
Bisphosphonates include, but may not be limited to: Aredia®, Zometa®, Boniva®, Actonel® and Fosamax®. They are prescribed to treat osteoporosis and osteopenia. Osteoporosis is a progressive disease of the bone which can lead to bone fractures. Osteopenia is a less advanced condition that may be described as preliminary demineralization of the bone. Both conditions are caused by a deficiency in the mineral density of the bone architecture.
The World Health Organization defines osteoporosis as bone mineral density 2.5 standard deviations below peak bone mass as observed in a 20 year old person of the same sex. Osteoporosis has no specific symptoms but is typically diagnosed by a bone-mass screening or after a fracture has already occurred.
Individuals who are suffering from some cancers, such as myeloma or breast, lung, and prostate cancer, may develop osteoporosis. Endocrine disorders such as diabetes and thyroid problems can also cause osteopenia or osteoporosis. It is very common in women after menopause. While the condition is common, it can also be painful and crippling. It can cause a collapse of the vertebrae, as well as hip and other fractures. Impaired mobility and other serious general health complications can occur.
Prevention is preferable; with a diet high in calcium, calcium supplements, exercise, no smoking, and vitamin D; however, for those already suffering from the condition, bisphosphonates can be beneficial. The drugs are useful in “strengthening” bones to prevent fractures and pain. Osteoporosis itself has no specific symptoms but is typically diagnosed by a bone-mass screening or after a fracture has occurred. Bisphosphonates are useful in “strengthening” the bones and preventing fractures and pain.
Are there any particular concerns for patients who take bisphosphonates and also receive dental treatment?
Yes! It is possible for a serious jaw condition called bisphosphonate osteonecrosis or osteonecrosis of the jaw (ONJ) to develop subsequent to dental treatment. Symptoms can include:
These problems may occur along with or after dental treatment, or they may occur spontaneously on their own, bringing the patient into the office for care. ONJ may be associated with tooth extractions or localized infections which present with much delayed healing. According to the Journal of the Academy of General Dentistry, Jan.-Feb. 2007, certain treatments should be avoided for persons receiving bisphosphonates. These include extractions, implants, and some types of oral surgery. However, even a standard “cleaning” (D1110-Adult Prophylaxis) might set up a situation where an infection ensues in a bisphosphonate patient. Of further concern is the fact that the effects of bisphosphonates last for many years and that stopping the drugs does not necessarily result in a “safe” time period for dental treatment.
In fact, right now scientific evidence does not support the discontinuation of bisphosphonates for any length of time in order to promote osseous healing. According to the June 2006 issue of Dimensions of Dental Hygiene, the half-life of I.V, bisphosphonates is years in duration, with the medication being deeply deposited in the bone matrix. The half-life of oral bisphosphonates is thought to be similarly lengthy. (More information can be seen at the American Academy of Periodontology website as well as the American Association of Oral Maxillofacial Surgeons)
What should staff do concerning the informed consent process, treatment, and bisphosphonate usage?
Patients taking bisphosphonates should avoid extractions and implants. Endodontic treatment and the least traumatic methods possible for prophies, periodontal scaling, and other treatments should be used. It is thought that systemic antibiotic premedication might be beneficial prior to dental treatment, but dosages and drugs are not agreed upon by the dental and/or medical community. However, chlorhexidine mouthrinses are recommended before, during, and after dental treatment.
Staff must be sure that bisphosphonate patients understand the complications that may occur with dental treatment. Therefore, the office medical history form should include questions related to these drugs. In addition, a detailed, topic specific informed consent form should be presented and signed by the patient prior to dental treatment. Progress notes, or general consent forms, while better than nothing, are currently not considered to be as useful as topic and treatment specific consent forms. Conditions and/or treatments should be explained in as simple terms possible so that patients can actually understand what they are consenting to. One page forms with a section for the patient and a witness to sign are advisable.
A signed consent form does not ensure that a patient will not later sue a dentist, however having the form puts the “ball in the patient’s court”. The patient has to explain why he/she did not understand what was being presented, rather than the dentist having to defend his/her treatment. My Informed Consent Form booklet contains a consent form for 31 different topics and/or procedures, including treatment occurring for a patient who takes bisphosphonates. You do have patients that are taking these drugs. Informed consent is a must.
With 33 years in the dental field, Ms. Tekavec is the president and owner of Stepping Stones to Success. She is a well known author and lecturer. She has appeared at all of the nation’s top dental meetings, as well as providing programs for local dental societies and study clubs. Still practicing clinically, she is a consultant with the ADA Council on Dental Practice and was the columnist on insurance for Dental Economics magazine for 11 years. She has written over 200 magazine and journal articles as well as designing a “Patient Brochure” series.
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