These rules and regulations apply to all persons possessing, applying for or required to have a license or certificate or other authorization or approval which the Board of Medical Licensure and Discipline is empowered to issue or grant.
“Accredited Hospital” means a medical facility accredited by the Joint Commission on Accreditation of Healthcare Organizations or the American Osteopathic Hospital Association.
"Board" means the Board of Medical Licensure and Discipline.
"ECFMG" means the Educational Council for Foreign Medical Graduates.
"Emergency Care" means an unplanned and unstructured medical intervention by any individual, whether or not licensed to practice medicine and surgery in the State of Delaware, which, if not immediately provided, would likely result in either loss of life or subsequent permanent impairment.
"FLEX Examination" means the Federation Licensing Examination as promulgated by the Federation of State Medical Boards of the United States, Inc.
"Foreign Medical School" means any medical school located outside of the United States or Canada.
"Institutional License" means a certificate to practice medicine as outlined under 24 Del.C. §1722(a)(2).
“LCME” means the examination given by the Medical Council of Canada.
“National Boards” means the examination administered by the National Board of Medical Examiners.
"NBME" means National Board of Medical Examiners.
"NBOME" means National Board of Osteopathic Medical Examiners.
"SPEX" is the Special Proficiency Examination.
“United States” means the 50 States and its territories or possessions.
"USMLE" means United States Medical Licensing Examination.
"VQE" means Visa Qualifying Examination as mandated by Public Law 94-484.
3.1.1 If FLEX was taken before June, 1985 applicant must have successfully passed a FLEX examination (Component 1 and Component 2) and have attained a passing score of a weighted average of seventy-five (75). After June, 1985 a passing score of 75 must have been obtained on Component 1 and Component 2.
3.2.2 Passing Step 1, Step 2, and Step 3 of the examination must occur within 7 years. There shall be no more than six attempts to pass each Step without demonstration of additional experience acceptable to the Board.
3.3 Certain persons licensed in other states: Doctors with valid state licenses by examination from other jurisdictions may be licensed at the discretion of the Board if this examination took place before January, 1973.
The Board may issue institutional certificates to qualified persons who may be employed as post graduate trainees (interns, residents, or fellows) or house physicians by an accredited hospital operated within this State. The Board will also issue institutional certificates to qualified persons who will be employed as staff physicians in a medical institution operated in this State by any governmental institution.
220.127.116.11.1 He or she meets all the requirements for licensure specified in 24 Del.C. §1720(b)(1) through (b)(6) excluding (b)(3); and
18.104.22.168.2 He or she intends to limit him or her selves solely to practice within the hospital, or the performance of such medical duties outside the hospital which may be assigned to them as part of a post graduate training program.
22.214.171.124 An affidavit of the chief administrative officer of said hospital certifying that the individual will be employed by the hospital and meets all requirements for licensure specified in 24 Del.C. §1720(b)(1) through (b)(6), excluding (b)(3).
4.1.2 A person who is to be employed by an accredited hospital as a post graduate trainee who was not a citizen of the United States at the time he or she enrolled in medical school outside of the United States must present a photocopy of his or her permanent ECFMG Certificate or VQE results.
4.1.3 Post graduate trainees employed by accredited hospitals who have been granted institutional certificates shall be specifically limited to the practice of medicine within the hospital where they are employed, except that they may perform such medical duties outside the hospital which may be assigned to them as part of their postgraduate training program, provided such outside duties are performed under the supervision of a physician with a Certificate to Practice Medicine in the State of Delaware.
4.1.4 Postgraduate trainees who are registered in training programs outside of Delaware and who rotate through programs in institutions in Delaware for over one month are required to obtain an institutional certificate.
4.1.5 Institutional certificates issued pursuant to these rules shall expire on the day on which the holder ceases to be employed by the employer hospital. If the employment relationship is prematurely terminated, both the holder and the Chief Administrative Officer of the employer hospital shall notify the Executive Director of the Board in writing not later than three days after the employment relationship is terminated.
4.1.7 No institutional certificate issued to a post graduate trainee will be renewed at the end of the first year of issuance unless the trainee has passed at least one component of the FLEX examination or at least one part of the National Board Examination or the USMLE Step 1.
126.96.36.199 An affidavit of the chief administrative officer of said institution certifying that the individual will be employed by the institution and meets all the requirements for license specified in 24 Del.C. §1720(a)(1) through (a)(6).
188.8.131.52 An affidavit of the physician seeking licensure certifying that he meets all the requirements for licensure specified in 24 Del.C. §1720(a)(1) through (a)(6).
4.2.2 Physicians applying for an institutional license who are to be employed by a governmental institution and who were not citizens of the United States at the time they enrolled in medical school outside the United States must present a photostatic copy of his/her permanent ECFMG or VQE certificate.
4.2.3 Physicians granted institutional licenses to practice medicine in governmental institutions shall be specifically limited to the practice of medicine within the governmental institution wherein the holder is employed.
4.2.4 Institutional licenses shall expire on the day on which the holder ceases to be employed by the employer institution. Both the holder and the employer institution shall notify the Executive Director of the Board in writing not later than three days after the employment relationship is terminated.
5.1 As part of the application process for certification, a personal interview is required and will not be conducted until the completed application of the candidate has been received in the Board's Office.
5.2 Electronic Interviews via video-conferencing means satisfy the requirement for a personal interview provided the interviewer is able to view the applicant and the applicant’s photo identification.
Consultation may be done telephonically, electronically or in person. Consultation shall ordinarily consist of a history and physical examination, review of records and imaging pathology or similar studies. Consultation includes providing opinions and recommendations. An active Delaware certificate is required of any out of state physician who comes into Delaware to perform a consultation more than twelve (12) times per year. A physician who comes into Delaware to perform consultations must be actively licensed in another State or country on a full and unrestricted basis. Any consultations done for teaching and/or training purposes may include active participation in procedures and treatment, whether surgical or otherwise, provided a Delaware licensed physician remains responsible as the physician of record, and provided the patient is not charged a fee by the consultant.
7.1 Each license shall be renewed biennially. The failure of the Board to notify a licensee of his/her expiration date and subsequent renewals does not, in any way, relieve the licensee of the requirement to renew his/her registration/license pursuant to the Board’s regulations and 24 Del.C. Ch. 17.
7.3 Failure of a licensee to renew his/her license shall cause his/her license to expire. A physician whose license has expired may renew his/her license within one year after the expiration date upon fulfilling items 8.2.1 – 8.2.4 above, certifying that he/she has not practiced medicine in Delaware while his/her license has expired, and paying any renewal fees and a late fees determined by the Division of Professional Regulation.
7.5 The former licensee may re-apply under the same conditions that govern applicants for new licensure under 24 Del.C. Ch. 17 and meeting any requirements for re-entry to practice established under Board Rule 8.7.
7.7 A physician seeking to obtain an initial license who has not been engaged in the clinical practice of medicine within the three (3) years immediately preceding the application shall be required to demonstrate clinical competency as follows:
7.7.1 completing an approved practice assessment program that is both clinical and didactic in nature. Approved physician re-entry programs are listed on the Board’s website. Programs not on the list must be submitted to the Board for approval. A physician who completes a program not on the list without first obtaining Board approval does so at his or her own risk that the program may not be approved by the Board; and
8.0 Dishonorable or Unethical Conduct (24 Del.C. §1731(b)(3))
8.1 The phrase "dishonorable or unethical conduct likely to deceive, defraud, or harm the public" as used in 24 Del.C. 1731(b)(3) shall include, but not be limited to, the following specific acts:
A physician or other healthcare provider regulated by the Board who has not been granted a certificate or license in the State of Delaware may render care or treatment to a patient in an emergency vehicle which is in transit in the State of Delaware provided such healthcare provider is certified or licensed in the state from which the emergency vehicle departed, or the state to which the emergency vehicle is destined.
11.1.1 Any physician who delegated medical responsibility to a non-physician is responsible for that individual's medical activities and must provide adequate supervision. No function may be delegated to a non-physician who by statute or professional regulation is prohibited from performing that function. Supervision may be direct or indirect depending upon the type of medical responsibility delegated. The delegating physician cannot be involved in patient care in name only.
11.1.2 For the purpose of clarification, the terms "guidelines", "standing orders", "protocols", and "algorithms" are synonymous in their application under these regulations. Hereafter, the term "standing orders" will be used. Standing orders must not be used to make a medical diagnosis or to prescribe medication or other "therapeutics". Non-prescription medications, however, may be initiated by standing orders if these standing orders have been approved by the responsible delegating physician. Emergency care as defined in the Medical Practice Act is exempt from these regulations.
11.1.3 Direct supervision requires the delegating physician to be physically on the premises and to perform an evaluation or give a consultation. Direct supervision is required if a medical diagnosis is rendered or a treatment plan involving prescription medications is to be instituted.
11.1.4 Indirect supervision requires the physician to be either physically present on the premises or readily available by an electronic device. Readily available necessitates the ability to become physically present within thirty minutes of notification if the situation warrants such action. Indirect supervision is required whenever a non-physician evaluates a patient, initiates a non-prescription medication or therapeutic, or renews a previously prescribed medication or therapeutic. Direct supervision (as defined above) required whenever a controlled substance is renewed. A non-physician may follow a physician-initiated standing order under the indirect supervision of the physician, providing the standing order does not call for the initiation of a prescription drug or therapeutic.
11.1.5 The Board considers it to be appropriate and good medical procedure for all responsible physicians who choose to have their patients followed by non-physician associates to personally re-evaluate at least every three months any patient receiving controlled substances, or at least every six months any patient receiving other prescription medications or therapeutics.
11.1.6 Any exemptions from the requirements specified above previously issued under former Regulation 20.1.6 will continue in effect and must be renewed by the Board every two years. No exemption will be renewed by the Board until it reaches the determination that the training and experience of the non-physician associate involved is adequate. Procedural safeguards must be in place to ensure the safe dispensing of drugs and other therapeutics. All exemptions must be judged by the Board not to endanger the public health of the citizens of Delaware.
11.1.7 A supervising physician who fails to adhere to these regulations would be considered to be permitting the unauthorized practice of medicine (as defined under 24 Del.C. §1702(12) of the Medical Practice Act), and would be subject to disciplinary action by the Board.
12.1 Pursuant to the provisions of 24 Del.C. §1713(d) the Board adopts the following regulation regarding requirements for continuing medical education as a prerequisite for renewal of registrations to practice medicine in the State of Delaware. Prior to renewal of registrations to practice medicine in this State a physician must be prepared to supply the Board with proof that he has completed forty (40) hours per registration period of continuing medical education in Category I courses approved by the American Medical Association (AMA) or equivalent courses approved by the American Osteopathic Association (AOA) since the time of the physician's last renewal of his registration. Individuals enrolled in approved medical or osteopathic resident or fellowship training programs may be requested to submit proof of satisfactory participation in lieu of approved continuing medical education credits. Certification by the Medical Society of Delaware that a physician has completed such continuing medical education since the time of his last renewal of his registration shall be acceptable proof of completion of these requirements.
12.2 A physician who is renewing his registration for the first time and who has been licensed to practice medicine in Delaware for more than one year shall be prepared to supply the Board with proof that he has completed twenty hours of continuing medical education in Category I courses approved by the AMA or equivalent courses approved by the AOA. A physician who is renewing his registration for the first time and who has been licensed to practice medicine in Delaware for less than one year shall not be required to meet any continuing medical education requirements until the time of the next subsequent renewal of his registration.
12.3 The Board may, upon application from the physician, waive the requirements of the regulation for good cause shown. The Board will consider good cause to have been shown if the lack of compliance with this regulation was due to causes beyond the physician's control.
184.108.40.206.1 The supervising physician cannot be involved in patient care in name only and must provide adequate supervision. The supervising physician must be available for consultation, during the patient encounter, when necessary as defined under supervision in the 24 Del.C. §1770A(3).
220.127.116.11.2 No supervising physician may supervise more than 4 physician assistants at any given time unless granted an exemption by the Board. As provided in 24 Del.C. §1771(f) and (h) the Board may increase or decrease the number of physician assistants being supervised. The Board may issue an exemption to increase the number of physician assistants supervised by a physician upon written application filed by the supervising physician demonstrating good cause for the request. Requests for exemption will be considered on a case-by-case basis. The requesting physician has the burden of demonstrating that the granting of an exemption will not endanger the public health, safety, or welfare.
18.104.22.168.3 Any physician desiring to supervise an assistant who will perform acupuncture upon a patient shall make a medical evaluation of the patient and determine that acupuncture treatment is medically appropriate prior to the commencing of any acupuncture treatment by a physician assistant. Such evaluation will be made on the patient's initial contact with the physician without referral. A physician assistant employed by a physician for the purpose of administering an acupuncture treatment to patients shall not administer such treatment unless an initial evaluation by the physician has been made. In addition, no subsequent acupuncture treatments of a patient shall occur unless the physician has requested such treatment. No physician shall supervise a physician assistant who administers acupuncture treatment to patients unless the physician is proficient in the field of acupuncture and has assured himself that the physician assistant is also proficient in the administration of acupuncture treatment. A physician assistant who administers acupuncture treatment to patients at the direction of a physician shall administer such treatment only within the physical confines of the physician's office at such times when the physician is physically present on the premises and immediately available for consultation.
13.1.2 Legend - For the purpose of these rules and regulations the term "legend" is defined as any drug containing the statement "Caution: Federal law prohibits dispensing without prescription" required by section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act as part of the labeling of all prescription drugs (and only such drugs). A "legend" drug is thus a prescription drug, III.B.3 and 24 Del.C. §2502(22).
13.2.2 Completion of required renewal form, and submission of documentation of one hundred (100) hours of Continuing Medical Education (CME), 50 hours of Category 1 during every 2 year cycle. A licensee who submits proof of holding current certification from the NCCPA shall be deemed to have met this requirement.
22.214.171.124 PAs may prescribe legend medication including Schedule II-V controlled substances, (as defined in the Controlled Substance Act). parenteral medications, medical therapeutics, devices and diagnostics.
126.96.36.199 Prescriptions must include the printed or legibly handwritten name of the PA. Prescriptions shall be written in accordance with 17 Del.C. §1764A and shall contain the following information clearly typed or written:
188.8.131.52 As a delegated authority by the supervising physician PAs may request and issue professional samples of legend and over-the-counter medications. Professional samples must be labeled in compliance with 24 Del.C. §2522(c).
14.1.1 Upon notification of the receipt of an application signed by the applicant accompanied by a letter of recommendation from the Paramedic Administrator of the Office of Emergency Medical Services (OEMS), the Board of Medical Licensure and Discipline (Board) may grant initial certification pursuant to 16 Del.C. §9809(a) to a paramedic whose application establishes that the applicant has meet all of the following course requirements and standards.
14.1.4 Certification by the Paramedic Administrator that the applicant, upon a valid offer of employment and/or an affiliation with an OEMS approved advanced life support service, has satisfactory completed such written and practical examinations as determined by the State EMS Medical Director.
14.2.1 Such initial certification by the Board will be valid for a period of either one (1) or two (2) years depending upon the applicant’s position in the Delaware recertification cycle and may be renewed thereafter for two-year (2) periods upon application in writing to the Board accompanied by a certification from the paramedic administrator establishing that the applicant has met all of the following requirements:
184.108.40.206 Current registration as an Emergency Medical Technician-Paramedic with the National Registry of Emergency Medical Technicians (except for those paramedics who have been continuously employed as a Delaware Paramedic since before January 1, 1990).
220.127.116.11.3 Possession of current course completion cards or approval of an equivalent level of instruction by the State EMS Medical Director in each of the following disciplines. There cannot be a lapse in course completion cards in any of the referenced disciplines at any time during the re-certification/re-registration cycle.
18.104.22.168.8.1 That the applicant has demonstrated competency in the management of stable and unstable patients presenting with medical and/or traumatic emergencies by the State and respective agency Medical Director.
The Board finds that for purposes of licensing, renewal, reinstatement and discipline, the conviction of any of the following crimes, or of the attempt to commit or a conspiracy to commit or conceal the following crimes or substantially similar crimes in another state or jurisdiction, is deemed to be substantially related to the practice of Medicine, Respiratory Care, Acupuncture, Genetic Counseling and Physician Assistants in the State of Delaware without regard to the place of conviction:
“Conviction” means a verdict of guilty by whether entered by a judge or jury, or a plea of guilty or a plea of nolo contendere or other similar plea such as a “Robinson” or “Alford” plea unless the individual has been discharged under §4218 of Title 11 of the Delaware Code (probation before judgment) or under §1024 of Title 10 (domestic violence diversion program) or by §4764 of Title 16 (first offenders controlled substances diversion program).
“Jurisdiction” Substantially similar crimes in another State or Jurisdiction including all crimes prohibited by or punishable under Title 18 of the United Stated Code Annotated (U.S.C.A.) such as, but not limited to, Federal Health Care offenses.
15.2 Any crime which involves the use of physical force or violence toward or upon the person of another and shall include by way of example and not of limitation the following crimes set forth in Title 11 of the Delaware Code Annotated:
15.3 Any crime which involves dishonesty or false, fraudulent or aberrant behavior and shall include by way of example and not of limitation the following crimes listed in Title 11 of the Delaware Code Annotated:
15.5 Any crime which involves offenses against the public order the commission of which may tend to bring discredit upon the profession and which are thus substantially related to one’s fitness to practice such profession and shall include by way of example and not of limitation the following crimes listed in Title 11 of the Delaware Code Annotated:
15.6 Any crime which involves offenses against a public health order and decency which may tend to bring discredit upon the profession, specifically including the below listed crimes from Title 11 of the Delaware Code Annotated which evidence a lack of appropriate concern for the safety and well being of another person or persons in general or sufficiently flawed judgment to call into question the individual’s ability to make health care decisions or advise upon health care related matters for other individuals.
15.7 Any crime which involves the illegal possession or the misuse or abuse of narcotics, or other addictive substances and those non-addictive substances with a substantial capacity to impair reason or judgment and shall include by way of example and not of limitation the following crimes listed in Chapter 47 of Title 16 of the Delaware Code Annotated:
15.8 Any crime which involves the misuse or illegal possession or sale of a deadly weapon or dangerous instrument and shall include by way of example and not of limitation the following crimes listed in Title 11 of the Delaware Code Annotated:
15.9 Any crime which is a violation of Title 24, Chapter 17 (Delaware Medical Practices Act) as it may be amended from time to time or of any other statute which requires the reporting of a medical situation or condition to state, federal or local authorities or a crime which constitutes a violation of the Medical Practice Act of the state in which the conviction occurred or in which the physician is licensed.
15.10 The Board reserves the jurisdiction and authority to modify this regulation as and if it becomes necessary to either add or delete crimes including such additions as may be required on an emergency basis under 29 Del.C. §10119 to address imminent peril to the public health, safety or welfare. The Board also specifically reserves the jurisdiction to review any crime committed by an applicant for licensure as a physician and to determine whether to waive the disqualification under 24 Del.C. §1720(d).
16.1 A patient requesting of a copy of his or her own medical records to be transferred to another physician or to be obtained on their own behalf may be charged a reasonable fee not to exceed the fees set forth in the schedule below, excluding the actual cost of postage or shipping if the records are mailed:
17.0 Disciplinary Guidelines [Authority: 24 Del.C. §1713 (f)]
17.1 Purpose: The Legislature has created the Board of Medical Licensure and Discipline to assure the protection of the public from persons who do not meet the minimum requirements for safe practice or who pose a danger to the public. Pursuant to 24 Del.C. §1713(f), the Board provides the disciplinary guidelines it will apply to licensees regulated under 24 Delaware Code, Chapter 17, after a full investigation and at the conclusion of a hearing after finding violations of the Board’s statute and/or regulations. The purpose of this rule is to notify applicants of the ranges of penalties which may be imposed unless the Board finds grounds to deviate from the guidelines due to aggravating or mitigating circumstances (Rules 31.12 and 31.13). The practice of medicine is already subject to both civil and criminal penalties. Recognizing its role as protector of the public’s health, safety, and welfare, the Board offers these guidelines as a means to improve the quality of medical care and not to enforce the penal code, a responsibility left to law enforcement and to the courts. The purpose of imposing discipline is to sanction licensees for violation; deter them from future violations; to offer opportunities for rehabilitation when appropriate; and to dissuade other applicants and licensees from committing disciplinable offenses.
17.2 Violations and Range of Penalties: When imposing discipline, the Board shall act in accordance with the following disciplinary guidelines and shall impose a penalty within the range corresponding to the violations unless grounds to deviate are found. The following identification of categories of offenses and summary explanations are intended to be descriptive only; the full language of each statutory provision cited must be consulted in order to determine the conduct included.
17.5 Misconduct is that conduct which is recognized to be unsafe or improper by the ethical and competent members of the profession. The term also includes, but is not limited to, general conduct that is dishonorable or unprofessional and that is not addressed in other categories within these guidelines, and includes acts prohibited by policies expressed in legislation.
17.6 Criminal Conduct is conduct which violates rules and statutes that define conduct prohibited by the government. Such unprofessional conduct reflects upon the licensee’s fitness and qualifications to practice in the healthcare field and detracts from the trust of the public.
17.6.1 Crimes Substantially Related – a range from 90 days probation to suspension with reinstatement only after proof satisfactory to the board of practice improvement, not to be less than any court-ordered sanctions – §1731(b)(2)
17.7 Sexual Misconduct – These guidelines cannot define or foresee all the possible scenarios of sexual misconduct. The professional boundary required between physician and patient is based upon the fiduciary relationship in which the patient entrusts his or her welfare to the physician, reflects the physician’s respect for the patient. That boundary, once crossed, severely impacts the patient’s well-being on an individual basis, and causes distrust to other professional relationships in general. Sexual misconduct is a harmful example of a boundary violation, occurring in multiple contexts and involving a wide range of behaviors. Sexual misconduct includes but is not limited to, sexual impropriety towards a patient, sexual conduct towards patients, sexual harassment in the workplace facilitating a hostile work environment, sexual conduct between supervisors and subordinates, the commission of sexual assault and other sexual crimes.
17.7.1 Sexual involvement can occur in circumstances involving two consenting adults. However, sexual involvement with a current patient is considered misconduct. It is the responsibility of the physician to transfer the patient’s care to another health care provider if they foresee a romantic or sexual relationship developing.
17.7.2 Sexual involvement with former patients is misconduct when the licensee exploits knowledge or information obtained from the previous physician-patient relationship. Sexual or romantic relationships between physicians and their patients may exploit the vulnerability of the patient and may obscure the physician’s objective judgment concerning the patient’s health care. Sexual misconduct between a physician and a patient is never diagnostic or therapeutic. Romantic or intimate relationships may impede the physician’s ability to confront the patient about noncompliance with treatment or to bring up unpleasant medical information. Physicians must set aside their own needs or interests in the service of addressing the patient’s needs. The physician-patient relationship depends upon the ability of the patient to have absolute confidence and trust in the physician, and a patient has the right to believe that a physician is dedicated solely to the patient’s best interests. When considering action related to sexual involvement with a former patient the Board should consider the extent, if any, to which the (medical provider) exploited the previous patient-provider relationship.
17.7.3 Sexual impropriety may include, but is not limited to, sexually suggestive behavior, gestures, expressions, statements, and it may include failing to respect a patient’s privacy such as in the following examples:
17.8 Billing/Business Issues, includes but is not limited to, charging grossly exorbitant fees for services, failure to report laboratory costs and failure to disclose to the patient a financial interest.
17.10 Impairment is a condition which renders the licensee unable to practice medicine with reasonable skill or safety. Impaired licensees are not only at risk of causing patient harm but are also at risk of causing significant personal endangerment. Impairments include drug abuse, alcohol abuse, and mental or physical conditions that impede the licensee’s ability to practice with reasonable skill and safety.
17.11 Administrative Misconduct is conduct that fails to adhere to the standards required for the regulation of the profession. All licensees in their practice have not only professional medical requirements but administrative requirements that are integral to their performance as a licensed physician. Administrative misconduct includes, but is not limited to, disregard of continuing medical education requirements.
17.12 Inappropriate Prescribing is prescribing that fails to follow medically accepted standards to ensure the patients health and safety. It includes, but is not limited to, misconduct as the failure to follow required procedures that have been established to ensure prescriptions are legitimate, prescribing to family or friends who suffer from addiction or misuse, diversion for self use, and criminal trafficking in dangerous drugs.
17.12.3 Failure to follow the Board’s Regulations for the Use of Controlled Substances for the Treatment of Pain - education in pharmacology of pain management and a range from $1,000 fine and probation to revocation
17.13 Patient Records Violations – Patient records consist of documentation that reflects the physician-patient relationship and any misuse of the documentation constitutes a patient records violation. Failure to adequately maintain patient records includes, but is not limited to, misconduct such as the failure to adequately document evaluation and/or treatment of the patient, failure to adequately maintain or store the records, and failure to allow the patient or the patient’s authorized representative access to the records.
17.16 Applicability: These guidelines are applicable to all professions or occupations regulated under the Medical Practice Act. The guidelines will be construed to apply to any substantially similar violations or offenses under the specific statutory or regulatory provisions applicable to those professions or occupations regardless of whether the code section or regulation is specifically referenced herein.
The Board has adopted the Federation of State Medical Board's "Model Policy for the Use of Controlled Substances for the Treatment of Pain" ("Model Policy). These regulations have been developed to define specific requirements applicable to pain control, particularly related to the use of controlled substances, to alleviate licensed practitioners' uncertainty, to encourage better pain management, and to minimize practices that deviate from the appropriate standard of care and lead to abuse and diversion. Licensed practitioners should familiarize themselves with the Model Policy available online at www.dpr.delaware.gov. To the extent there are any inconsistencies between these regulations and the Model Policy, these regulations shall control.
The principles of quality medical practice dictate that citizens of Delaware have access to appropriate and effective pain relief. The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. The inappropriate treatment of pain includes a wide spectrum of issues that do not provide treatment appropriate to the patients' specific needs.
The diagnosis and treatment of pain is integral to the practice of medicine. Licensed practitioners view pain management as a part of quality medical practice for all patients with pain, acute or chronic, and it is especially urgent for patients who experience pain as a result of terminal illness. Licensed practitioners should become knowledgeable about assessing patients' pain and effective methods of pain treatment, as well as statutory requirements for prescribing controlled substances. These regulations are primarily directed to the treatment of chronic pain but may be applicable to prescribing controlled substances for the treatment of acute pain when clinically appropriate.
Inappropriate pain treatment may result from the practitioner's lack of knowledge about pain management. Fears of investigation or sanction by federal, state and local agencies may also result in inappropriate treatment of pain. Appropriate pain management is the treating practitioner's responsibility. As such, the Board will consider the inappropriate treatment of pain to be a departure from standards of practice and will investigate such allegations, recognizing that some types of pain cannot be completely relieved, and taking into account whether the treatment is appropriate for the diagnosis.
The Board recognizes that controlled substances including opioid analgesics may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. The Board may refer to current clinical practice guidelines and/or expert review in approaching cases involving the management of pain. The medical management of pain should consider current clinical knowledge and scientific research and the use of pharmacologic and non-pharmacologic modalities according to the judgment of the licensed practitioner. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity, duration of the pain, and treatment outcomes. Licensed practitioners should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and alone are not the same as addiction.
The Board recognizes that the use of opioid analgesics for other than legitimate medical purposes can pose a threat to the individual and society and that the inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Accordingly, these regulations mandate that licensed practitioners incorporate safeguards into their practices to minimize the potential for the abuse and diversion of controlled substances.
Licensed practitioners should not fear disciplinary action from the Board for ordering, prescribing, dispensing or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the course of professional practice. The Board will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. All such prescribing must be based on clear documentation of unrelieved pain. To be within the usual course of professional practice, a licensed practitioner-patient relationship must exist and the prescribing should be based on a diagnosis and documentation of unrelieved pain. Compliance with applicable state or federal law is required.
The Board will judge the validity of the licensed practitioner's treatment of the patient based on available documentation, rather than solely on the quantity and duration of medication administration. The goal is to control the patient's pain while effectively addressing other aspects of the patient's functioning, including physical, psychological, social and work-related factors.
Allegations of inappropriate pain management will be evaluated on an individual basis. The Board will take disciplinary action against a licensed practitioner for deviating from these regulations unless contemporaneous medical records document reasonable cause for deviation. The practitioner's conduct will be evaluated to a great extent by the outcome of pain treatment, recognizing that some types of pain cannot be completely relieved, and by taking into account whether the drug used is appropriate for the diagnosis, as well as improvement in patient functioning and/or quality of life.
18.1 The following criteria must be used when evaluating the treatment of chronic pain but may be applicable to prescribing controlled substances for the treatment of acute pain when clinically appropriate:
18.2 Treatment Plan- A written treatment plan is required and must state goals and objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. The treatment plan must address whether treatment modalities or a rehabilitation program are necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. After treatment begins, the practitioner must adjust drug therapy to the individual medical needs of each patient.
18.3 Informed Consent - The practitioner must discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient or with the patient's surrogate or guardian if the patient is without medical decision-making capacity.
18.4 Agreement for Treatment- If the patient is at high risk for medication abuse or has a history of substance abuse, the practitioner must use a written agreement between the practitioner and patient outlining patient responsibilities, including;
18.5 Periodic Review- The licensed practitioner shall periodically review the course of pain treatment and any new information about the etiology of the pain or the patient's state of health. Periodic review shall include, at a minimum, evaluation of the following:
18.5.2 satisfactory response to treatment as indicated by the patient's decreased pain, increased level of function, or improved quality of life. Objective evidence of improved or diminished function must be monitored and information from family members or other caregivers should be considered in determining the patient's response to treatment.
18.5.3 if the patient's progress is unsatisfactory, the practitioner shall assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.
18.6 Consultation- The practitioner shall refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention must be given to those patients with pain who are at risk for medication misuse, abuse or diversion. The management of pain in patients with a history of substance abuse or with a co-morbid psychiatric disorder requires extra care, monitoring, documentation and may require consultation with or referral to an expert in the management of such patients. At a minimum, practitioners who regularly treat patients for chronic pain must educate themselves about the current standards of care applicable to those patients,
18.8 Records should remain current and be maintained in an accessible manner and readily available for review. Each practitioner should include documentation appropriate for each visit's level of care and will include the:
18.9 Compliance with Controlled Substances Laws and Regulations- To prescribe, dispense or administer controlled substances, the practitioner must be licensed in the state and comply with all applicable federal and state regulations. Licensed practitioners are referred to the Practitioner's Manual of the U.S. Drug Enforcement Administration and specific rules governing controlled substances as well as applicable state regulations.
18.10.1 Acute Pain- Acute pain is the normal, predicted physiological response to a noxious chemical, thermal or mechanical stimulus and typically is associated with invasive procedures, trauma and disease. It is generally time-limited.
18.10.2 Addiction- Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm. Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and are not the same as addiction.
18.10.3 Chronic Pain- Chronic pain is a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.
18.10.4 Licensed Practitioner - Licensed practitioner means those licensed individuals with prescriptive authority regulated under the Medical Practice Act including, but not limited to, physicians, physician assistants and nurse practitioners, except as exempted by 16 Del.C. §4798(b)(9).
18.10.6 Physical Dependence- Physical dependence is a state of adaptation that is manifested by drug class-specific signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Physical dependence, by itself, does not equate with addiction.
18.10.7 Pseudo addiction- The iatrogenic syndrome resulting from the misinterpretation of relief seeking behaviors as though they are drug-seeking behaviors that are commonly seen with addiction. The relief seeking behaviors resolve upon institution of effective analgesic therapy.
18.10.9 Tolerance- Tolerance is a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.