ALABAMA
ACT EXPANDS PA PRESCRIBING
At the request of the Alabama Board of Medical Examiners and the Alabama Physician Assistants' Association, Representative Ronald Johnson, a practicing pharmacist who serves in the State House of Representatives, introduced and passed House Bill 484, enacted as Act No. 09-489, which for the first time allows the prescribing of drugs listed in Schedules III, IV and V by a physician assistant (PA). The Act provides for a Qualified Alabama Controlled Substances Certificate (QACSC) to be issued by the Alabama Board of Medical Examiners to qualified PAs with approved registration agreements with Alabama physicians. The bill does not restrict the number of registrations to a physician in which a PA may be actively involved. In addition to a QACSC, PAs who prescribe controlled substances will have to obtain certain registrations from the U.S. Drug Enforcement Administration, and interested persons are encouraged to visit the DEA's website at www.deadiversion.usdoj.gov/drugreg/index.html to review their regulations and procedures.
The new legislation also establishes the qualifications required for a PA to apply for a QACSC and requires that applications be approved by the Alabama Board of Medical Examiners, which is responsible for the licensing and registration of PAs. The qualifications are completion of a course or courses approved by the board in the areas of advanced pharmacology and controlled substances prescribing trends and a minimum of 12 months of active clinical employment with a supervising physician. The new law allows the Alabama Board of Medical Examiners to establish rules concerning the application procedures, fees, fines, punishments and the conduct of any disciplinary hearings held relative to the alleged improper use of a QACSC. The board also will promulgate rules providing for grounds for the denial of an application and grounds for disciplinary action against a QACSC.
Under the Act, a PA registered to an approved Alabama physician may be authorized to prescribe medications in Schedules III, IV and V, and formularies and medical regimens may be approved by the board. It will require much thought on the part of those in existing PA/supervising physician relationships and those in the process of establishing new relationships to make certain that both the physician and the PA are in agreement on prescribing authority. PA prescribing authority will provide for the call-in or written prescription of any of the drugs in the approved formulary.
The board is in the process of formulating its rules under this new law, which becomes effective Oct. 1, 2009. Proposed rules will be posted at the board's website: www.albme.org.
PDMP ZERO BASED REPORTING
The Alabama Department of Public Health's Prescription Drug Monitoring Program (PDMP) has added a feature for dispensing physicians to submit a “zero report” when no controlled substances have been dispensed within a seven day period. PDMP rules require weekly reporting, whether or not any controlled substances have been dispensed. The zero based reporting will assist registered dispensers with complying with the rules. Detailed instructions on how to submit a zero based report are available on the PDMP website listed below. The instructions can be located by clicking on the Dispenser Packet link located on the left hand column of the website. If further clarification is needed, licensed dispensers can contact the PDMP technical support desk at (800) 225-6998 (option 8).
This information pertains to physicians who dispense controlled substances from their offices. Dispensing refers to ordering for and delivering to a patient a controlled substance for the patient's use. Physicians who dispense controlled substances are required to register with the board and report to the PDMP. Dispensing rules do not apply to writing a prescription, distributing pre-packaged samples and starter packs, or administration in the office. For more information on this topic, please see the board's website concerning dispensing physicians.
The PDMP is not only for physicians to report medications they dispense. Any licensed physician can use the PDMP to look up individual patients and access information about controlled substances that have been prescribed or dispensed to the patient, including the prescriber/dispenser, date, medication and quantity dispensed. Instructions on registering to query the PDMP can be found at the PDMP website.
Reprinted from Volume 24 Number 2 of Newsletter and Report, published by the Alabama Board of Medical Examiners.
ARIZONA
MULTIPLE SEQUENTIAL PRESCRIPTIONS FOR SCHEDULE II CONTROLLED SUBSTANCES
At its February 2009 meeting, the Arizona Medical Board unanimously approved a new interpretation of the Arizona Revised Statutes regarding multiple, sequential prescriptions for the same Schedule II Controlled Substance.
This action means the board will allow such prescriptions for up to 90 days. William R. Martin III, M.D., of Phoenix, the board chair, stated that the board should remain consistent with federal law, policies and guidelines.
Robert P. Goldfarb, M.D., F.A.C.S., of Tucson moved to conform the board's interpretation with 21 C.F.R. 1306.12(b), regarding prescription writing and dating. This interpretation aligns the board's guidelines with a practice that is currently permitted by the Arizona State Board of Pharmacy and the federal Drug Enforcement Administration (DEA).
If a physician provides multiple, sequential prescriptions to a patient that cannot be filled until a certain date, and yet are all accurately dated, the board will not consider this “predating” or “post-dating.” For further information, contact Lisa Wynn, executive director of the Arizona Medical Board.
A REVIEW OF PRESCRIBING LAWS FOR DOCTORS AND PAs
Both the Arizona Medical Board (board) and the Arizona Regulatory Board of Physician Assistants (ARBoPA) have seen a number of recent, unrelated cases involving prescribing violations and have cited the physicians and PAs involved. In light of that, it may be worthwhile to review the statutes regarding certain areas of prescribing. This information can be found in the Arizona Revised Statutes under “Definitions” in the Medical Practice Act and the Physician Assistant Practice Act.
In order to write prescriptions for patients, a physician assistant must first have the approval of that delegated task from the PA Board. Before prescribing prescription medication, a physician or a PA must first establish a professional relationship with the patient. This is done by conducting a physical examination of the patient and – if it hasn't been done before – taking a complete medical history. A.R.S. § 32-1401 (27)(ss) which applies to physicians states that unprofessional conduct is “prescribing, dispensing or furnishing a prescription medication or a prescription-only device … to a person unless the licensee first conducts a physical examination of that person or has previously established a doctor-patient relationship.” A.R.S. § 32-2501(21)(kk) for physician assistants is almost identical. It describes unprofessional conduct for PAs as being “prescribing, dispensing or furnishing a prescription medication or prescription-only device … to a person unless the licensee first conducts a physical examination of that person or has previously established a professional relationship with the person.
Physician assistants must have additional approval of their board to write or dispense 14-day prescriptions for controlled substances. State law prohibits a doctor or a PA from prescribing controlled substances to close relatives. This means that neither health care provider may write such prescriptions for a spouse, natural or adopted children, father, mother, brothers and sisters or the same relatives of the spouse. In most of the cases where a violation has occurred, the licensee has also failed to keep adequate medical records on the family member/patient, compounding the offense. The citation for this in the Medical Practice Act is A.R.S. § 32-1401(27)(h) and for the PA Practice Act, A.R.S. § 32-2501(21)(r).
Reprinted from Volume 4, Issue 1 of Primum, published by the Arizona Medical Board and Arizona Regulatory Board of Physician Assistants.
CALIFORNIA
OPERATION SAFE MEDICINE RETURNS JULY 2009
Effective July 1, 2009, the Medical Board of California reestablished its Operation Safe Medicine (OSM) unit in southern California to target unlicensed activity, corporate practice of medicine, and lack of supervision violations.
Some history: In 2000, there was a growth in unlicensed individuals and unregulated clinics, predominately in southern California. These unlicensed individuals operated from residences or the back of legitimate business locations, and targeted California immigrant health care consumers who were seeking familiar, discreet, and affordable services. These unlicensed individuals usually provided services and dispensed dangerous drugs not manufactured under the Food and Drug Administration guidelines or even approved for use in the United States. These unlicensed individuals lacked qualifications and training, which meant that the health care resulted in the increase of dangerous reactions and infections from faulty diagnosis, untreated disease, health complications, and even deaths.
In July 2000, the board was authorized four investigator positions to establish an unlicensed activity investigative team called Operation Safe Medicine, whose sole purpose was to investigate complaints of unlicensed activity received from health care consumers, and also to work with other regulatory and law enforcement agencies to find unlicensed facilities. In its 2001–2002 Annual Report, the board reported that the number of cases referred by board investigators for criminal action had increased.
The board's OSM was responsible for much of the increase in criminal filings from 58 in Fiscal Year (FY) 2000–2001 to 82 in FY 2001–2002. They reported that OSM had become an effective mechanism for dealing with unlicensed activity and the so-called backroom clinics in the Los Angeles and Orange County areas. Several criminal investigations conducted by OSM investigators had resulted in the filing of felony and misdemeanor charges against unlicensed individuals treating various medical conditions.
Shortly after, due to budget shortfalls that resulted in vacancy reductions and vacancy sweeps in FY 2002–2003, the established OSM positions were transferred to the board's enforcement units to maintain minimum staffing levels in other units. This unfortunately resulted in the closure of OSM.
As a consumer protection agency, the board's mission is to protect health care consumers through proper licensing and regulation of physicians, surgeons, and certain allied health care professionals through the vigorous, objective enforcement of the Medical Practice Act. It is also responsible for enforcing the disciplinary decisions it renders. Board decisions are varied and complex, and require specialized medical-legal expertise to ensure physicians comply with the terms and conditions ordered. Federal, local, and private organizations do not possess the medical-legal expertise required to ensure compliance with provisions of the Medical Practice Act.
Ultimately, at the November 2007 board meeting, the members approved the re-establishment of OSM, and the dedication of staff to the enforcement of laws relating to the unsafe practice of medicine in California, including, but not limited to, the various use of lasers for cosmetic procedures.
The following are some examples of the more egregious types of unlicensed cases that the new OSM will target:
An unlicensed female operating a booth at an indoor swap meet was dispensing and administering various prescription drugs, non-prescription drugs, and herbal remedies from another country. She injected a female with a substance labeled as eucalyptus oil in the bathroom of the swap meet and the victim died the following day at her residence.
An unlicensed male was performing breast augmentation surgery on females in an unlicensed facility; the victims suffered severe infections and disfigurement of their breasts.
An unlicensed female injected corn oil into the victims' buttocks as a means of cosmetic enhancement; one female victim almost died from a fat embolism.
An unlicensed individual was using unapproved Botox and industrial grade silicone on health care consumers.
An unlicensed female was injecting victims with household silicone, resulting in infections and disfigurement.
An unlicensed female operated a “medical clinic” where she performed intense pulsed light laser therapy for removal of excess fat and stretch marks, and treatment of skin conditions and broken capillaries; victims were injured.
An unlicensed male was conducting physicals and administering vaccinations as part of the immigration process; the physicals were not properly conducted and the vaccines were saline injections, thereby potentially exposing the California population to previously controlled and/or eradicated diseases.
An unlicensed individual burned a victim with a laser treatment at a laser clinic that had insufficient supervision.
An unlicensed individual permanently branded a victim using the wrong device, instead of removing a tattoo.
An unlicensed individual permanently scarred a victim who received laser treatment on a red vein, with a device designed to treat blue veins.
An unlicensed individual permanently de-pigmented the skin of a victim who was treated with an incorrect device.
With the re-establishment of the board's Operation Safe Medicine, California health care consumers will be better protected from various unsafe and unlicensed practices of medicine.
Reprinted from Volume 111 of the Medical Board of California Newsletter, published by the Medical Board of California.
COLORADO
MEDICAL BOARD IMPLEMENTS PHYSICIAN PROfiLE REQUIREMENTS
The Colorado Board of Medical Examiners has implemented the requirements of the Michael Skolnik Medical Transparency Act, which was enacted into law by the Colorado General Assembly in 2007. The Act requires all physicians who submit an application for an initial license, license reinstatement or reactivation, on or after January 1, 2008, to disclose specific information that can be accessed by the public. The Act requires that the following information be disclosed to the public:
Name
Aliases
Current Address
Telephone number
Information regarding all medical licenses ever held
Current Board Certifications
Practice Specialties
Affiliations with hospitals and health care facilities
Current ownership interests in businesses
Current employment contracts
Public disciplinary actions against a medical license
Agreements and Stipulations to temporarily cease medical practice
Involuntary hospital or health care facility privileging actions
Involuntary surrender of a DEA registration
Criminal convictions or plea arrangements for felonies and crimes of moral turpitude
Judgments, settlements and arbitration awards for medical malpractice claims
Refusal by an insurance carrier to issue medical liability insurance
Physicians will create their profiles using an online system and the information will be made available to the public through the board's website. Affirmative responses to the questions regarding disciplinary actions, temporary cessations of practice, surrender of DEA registration, criminal convictions and insurance refusals will require the physician to submit specific documents to the board.
Those documents will then be scanned and made available to the public as part of the physician profile. The board encourages physicians who will need to submit such documents to begin gathering them now so they are easily available for submission at the time of license renewal.
The Act as well as the rules, policies and updates are available on the board's website or copies can be requested from the board office. It is strongly recommended that physicians read the rules and policies carefully and retain them as a reference to be used at the time of license renewal. Also, note that your profile must be updated within 30 days of the effective date of any reportable action and not just during the renewal period. Physicians are also encouraged to periodically check the board's website for new information regarding the implementation of this legislation. Any questions regarding these requirements should be directed to [email protected] or (303) 894-5942.
ELECTRONIC PRESCRIPTION DRUG MONITORING PROGRAM (PDMP)
The Colorado State Board of Pharmacy is pleased to announce the availability of its Electronic Prescription Drug Monitoring Program (PDMP) at www.coloradopdmp.org.
This program provides a database of controlled substance prescriptions that have been dispensed by Colorado pharmacies and from nonresident pharmacies that ship prescriptions into Colorado. The purpose of the database is to provide objective information to assist practitioners and pharmacists in providing appropriate treatment for their patients.
The program allows prescribers and pharmacists to gather information about the patients they serve and to ensure that their prescribing and dispensing is appropriate for the circumstances presented. For instance, if a patient is taking OxyContin, the prescriber would be able to review when the patient was first prescribed the drug, how many providers prescribe for the patient, how often, and from what pharmacies the patient is receiving controlled drugs. The prescriber would also be able to determine the dosages the patient is receiving, and with that information try to determine whether the patient is taking the medication appropriately. The information collected by the PDMP is only accessible to prescribers of controlled substances and pharmacists. While patients may access their own personal data by contacting the program, law enforcement officials may only obtain information specific to an individual by the presentation of a subpoena or court order. The state has contracted with GHS Data Management to administer the database and manage the collection of the data. All information is transferred to and from the database via a secure Web portal or secure file transfer.
To learn more about the program, please visit www.colora-dopdmp.org.
Reprinted from the April 2009 issue of The Examiner Newsletter, published by the Colorado Board of Medical Examiners.
DISTRICT OF COLUMBIA
ACADEMIC DETAILING: DISTRICT TO OFFER PROGRAM FOR PHYSICIANS
The District of Columbia Health Professional Licensing Administration (HPLA) announces it will be coordinating an effort, on behalf of the D.C. Department of Health, to offer an academic detailing program to physicians practicing in the District. The Independent Drug Information Service (iDiS) will focus on providing optimal patient care and disease management resources. iDiS will offer helpful resources and tools so physicians can make the best decisions for their patients about therapeutic benefits, risks and costs.
iDiS develops health resources for patients, so physicians and other health care professionals can help educate patients about the medical and therapeutic decisions they've made, and to help improve adherence to treatment regimens. iDiS is a program provided by the nonprofit Alosa Foundation, which is comprised of physicians and researchers on the faculty at Harvard Medical School. The program will offer evidence-based, non-commercial information about medications and other therapeutic options commonly used in primary care.
The program is wholly financed by the District of Columbia through the Department of Health as mandated by SafeRx (D.C. Law 17-0364, the SafeRx Amendment Act of 2008, Title IV Pharmaceutical Education Sec. 401 “Pharmaceutical Education Program Establishment Act of 2008”), which was passed by the District Council to: address pharmaceutical detailing; require detailers to abide by a code of ethics; and establish a pharmaceutical education program for physicians and other health care providers in the District.
The iDiS team of Harvard-affiliated faculty, physicians and researchers comprehensively evaluate biomedical journals and other data sources to pull together the best available evidence about drug safety, efficacy, and cost effectiveness. They then synthesize this material into convenient, clinically relevant summaries. These materials are presented to physicians in their offices by a team of specially-trained physicians, nurses and pharmacists.
No pharmaceutical companies are associated with this program. Program facilitators will present evidence-based data from the most current medical literature. The materials are written by faculty who accept no personal compensation from any pharmaceutical manufacturer for any purpose.
Each D.C. physician's participation is significant and appreciated. Continuing medical education (CME) credits shall be provided to participating District physicians. The program is free and voluntary. Physicians who are interested in participating in this program should contact iDiS.
Through this, and other efforts, HPLA and the physicians of the District can join together to work collectively to ensure quality care for the citizens of the District of Columbia, and for all of the visitors who come to the nation's capital as well.
Reprinted from the May 2009 issue of D.C. Board of Medicine, published by the District of Columbia Board of Medicine.
GEORGIA
LEGISLATIVE UPDATES ON REWRITE OF THE MEDICAL PRACTICE ACT
The Medical Board updated the Medical Practice Act (Title 43, Ch. 34) this legislative session. The bill was signed by Governor Perdue and is effective July 1, 2009. Changes include the following:
Increases the number of board member from 13 to 15 to help with ever increasing workloads
Changes the Board's name from “Georgia Composite State Board of Medical Examiners” to “Georgia Composite Medical Board”
Gives the Board authority to order mental and physical examinations for all license groups
Changes the title of the board president to board chair-person
Requires individuals to notify the Board within ten days of conviction of a felony
Adds language to allow medical assistants to give injections under supervision
Eliminates provisional licenses for physicians
Eliminates the requirement to register medical licenses with the county clerk, and for the county clerk to report registrations to the board
Removes the apostrophe from the word “physician's” in the new title “physician assistant”
Updates the definition of job description, physician assistant, and supervising physician
Increases the fine from $1,000 to $5,000 for failure to obtain a license prior to practice
Authorizes PAs and APRNs to pronounce death if so delegated by a physician and identified in job description (PA) and protocol agreement (APRN)
Makes it unlawful for a physician to be an employee of the physician assistant whom he supervises. (Will grandfather existing relationships as approved by the Board)
Eliminates the 18-month temporary permit for respiratory care professionals
Shortens the late renewal period from two years to three months for Clinical Perfusionist licenses
Moves disciplinary authority for all professions to Article One
Provides for the delegation of tasks to polysomnographic technologists under physician supervision
Reprinted from the June 2009 issue of the Georgia Composite Medical Board Newsletter, published by the Georgia Composite Medical Board.
