Summer01.qxd

DEA Describes Policy On
he is able to provide himself with the medicine in question in Importing Controlled Drugs
the country of destination. In view of the express provisionthat each Party (i.e. the countries of transit and destination)is entitled to satisfy itself that the preparations have been The following is a portion of a policy statement made by lawfully obtained, it would be useful to require the traveller Laura M. Nagel, Deputy Assistant Administrator, Office of to carry a medical prescription or in cases in which the pre- Diversion Control, Drug Enforcement Agency in testimony to scription is withheld by the pharmacist, a duplicate or satis- factory copy of the prescription showing that the prepara- The US law pertaining to illicit controlled substances is contained in the Controlled Substances Act of 1970 (CSA).
Clearly, the treaty seeks to provide a means to allow Enforcement of the CSA is the responsibility of the DEA.
international travelers to carry personal use quantities of con- The Food and Drug Administration (FDA) also plays a criti- trolled substance medications while visiting foreign coun- cal role with regard to controlled substances. As the Federal tries. The CSA exemption does the same; however, neither authority for regulating all controlled and non-controlled pre- the treaty nor US statutes permit controlled substances to be scription drugs from a health and safety perspective, the imported under the personal medical use provision via FDA’s authority is contained in the Food, Drug and Cosmetic overnight courier, unaccompanied baggage, parcel service, Act (FDCA). Thus, controlled substances are subject to regu- US or international mail. Nor does the exemption permit one lation by both the FDA and the DEA. Together, the FDCA person to enter or depart the US with controlled substances and the CSA provide a framework to protect the health and intended for the personal medical use of another person. safety of the American public, and collaboratively, DEA and As set forth in the DEA regulation on this issue, 21 CFR FDA strive for consistent application of Federal laws.
Section 1301.26, anyone who seeks to import a controlled Additionally, the United States Customs Service is responsi- substance for personal medical use must satisfy all of the fol- ble for enforcing the import and export provisions of the (a) The controlled substance is in the original con- The CSA contains a personal medical use exemption to tainer in which it was dispensed to the individual; and allow international travelers, both US citizens and others, to (b) The individual makes a declaration to an appro- enter and leave the US with controlled substances for their priate official of the US Customs Service stating: legitimate personal medical use. Specifically, Section 956(a) 1) The controlled substance is possessed for his/her per- of the CSA, entitled “Exemption Authority, Individual sonal use, or for an animal accompanying him/her; Possessing Controlled Substance,” states that the “Attorney 2) The trade or chemical name and the symbol designat- General may by regulation exempt from sections 952(a) and ing the schedule of the controlled substance if it appears on (b), 953, 954 and 955 of this title any individual who has a the container label, or if such does not appear on the label, controlled substance (except substances in Schedule I) in his the name and address of the pharmacy or practitioner who possession for his personal medical use, or for administration dispensed the substance and the prescription number, if any; to an animal accompanying him, if he lawfully obtained such substance and he makes a declaration (or gives such other (c) The importation of the controlled substance for notification) as the Attorney General may by regulation personal medical use is authorized or permitted under other This exemption is consistent with the 1971 Convention The “Controlled Substances Trafficking Prohibition Act” on Psychotropic Substances. Article 4 (a) of the Convention (“the Act”) (Pub. L. 105-357), was introduced in the US states, with respect to psychotropic substances other than House of Representatives on April 1, 1998, to amend the those in Schedule I, parties may permit: “The carrying by Personal Medical Use Exemption. It was signed into law by international travellers of small quantities of preparations for the President on November 10, 1998. The Act addressed the personal use; each Party shall be entitled, however, to satisfy fact that large quantities of controlled substances were being itself that these preparations have been lawfully obtained[.]” brought into the US from Mexico by individuals misusing The official commentary to the treaty explains the purpose of the exemption in order to divert pharmaceutical controlled this provision: “[This provision] applies only to small quanti- substances into illicit channels. The bill amended the CSA to ties needed for personal use, i.e. to such quantities as the prohibit any US resident from entering the US with more traveller may require during his journey or voyage and until see DEA page two
DEA Describes Policy
in the top 50 most prescribed drugs1 and it has been heavilydetailed and marketed to physician’s offices. It is a centrally than 50 dosage units of a controlled substance through a land acting oral analgesic that has both opioid activity and border crossing with Mexico or Canada unless they demon- monoamine reuptake inhibition. While the mode of action of strate that they posses a valid prescription for the substance, Tramadol is not completely understood, animal studies sug- issued by a properly licensed US physician. This does not
gest that these two complementary mechanisms appear appli- mean that any US resident may enter the United States with cable: binding of parent and M1 metabolite to mu opioid up to 50 dosage units of a particular controlled substance “no receptors and weak inhibition of the reuptake of questions asked.” Rather, the resident must satisfy all the norephinephrine and serotonin. This mu opioid receptor that requirements set forth in 21 CFR 1301.26. States may is bound by Tramadol is the euphorogenic receptor associat- impose additional requirements as well.
ed with addictive potential. Tramadol appears to be a full For example, if there is evidence that the drugs are not agonist (i.e., it has no antagonist properties). for legitimate personal medical use (e.g., the same person Prior to the release of Tramadol, the Food and Drug has made repeated attempts over a short time period to Administration, FDA, and its Drug Abuse Advisory import new packages of controlled substances for claimed Committee, DAAC, considered at length its abuse potential personal medical use; or the person has a variety of different in order to comply with the Controlled Substances Act controlled substances under circumstances that are indicative regarding whether to recommend that it be scheduled as a of diversion), the importation does not comply either with controlled substance. Tramadol had an acknowledged poten- §956(a)(1) nor the DEA regulations and must, therefore, be tial for abuse based upon: (1) reports from Europe of abuse, where Tramadol had been available for years2, (2) its mode Furthermore, the requirement specified in 21 CFR of analgesic action involving the stimulation of opiate mu 1301.26(c) - that the importation for personal medical use is receptors, and (3) a concern regarding the history of other authorized or permitted under other Federal laws and state similar opiate analgesics being initially introduced in the law - must be satisfied regardless whether the person import- United States as “non-addictive” and later being found to ing is a US resident with no more than 50 dosage units of a have serious abuse problems requiring subsequent scheduling controlled substance. For example, if a person were seeking (e.g., Darvon, Stadol, Talwin, and others). However, despite to import a particular controlled substance for personal med- these concerns, because the abuse potential appeared rela- ical use, and the Food and Drug Administration advised the tively low, based upon available information at that time, United States Customs Service that importation of the drug Tramadol was not scheduled, and a “wait and see” policy should be disallowed under the Food, Drug, and Cosmetic Act, the importation would not comply with 21 CFR Twenty-seven physicians referred to the Alabama 1301.26(c) and would have to be denied.
Physician Health Program for substance related disorders In the same way, if a person sought to import a con- since 1996 have given histories that included abuse of trolled substance for purported personal medical use when Tramadol. Several patterns of abuse are noted among physi- entering the United States in a border state that prohibits cians: primary Tramadol dependence, Tramadol relapse, and either the importation or possession of the controlled sub- Tramadol substitution. Primary Tramadol dependence stance, such importation must be disallowed under 21 CFR includes cases where Tramadol was the initial drug of choice, the sole drug of use, or was a significant part of an Since the passage of the Act, DEA has received informa- initial episode of a drug dependence syndrome. Tramadol tion from the United States Customs Service that indicates relapse includes cases where an individual was in recovery that individuals are circumventing provisions of the Personal from previous addiction but relapsed to addictive use involv- Medical Use Exemption by making repeated trips across the ing Tramadol. Tramadol substitution involves individuals border to obtain controlled substances. DEA is currently who switch to Tramadol in an effort to change from a more considering ways of addressing this problem, such as amend- addictive and potent drug to Tramadol. If Tramadol is substi- ing DEA’s regulations to provide the clarity and guidance tuted for a more potent opiate analgesic, there is a tendency that the Customs Service needs to develop a clear, concise to increase the dose until an equivalent therapeutic effect is and enforceable policy for its inspectors at the Nation’s land attained. This is hazardous, as there is significant potential for seizures with Tramadol when the dose is increased. When the incidence of abuse and dependence of Ultram® Abuse and Dependence
Tramadol among health professionals is examined there Among Health Professionals
appears to be a much higher rate among this group thanamong the general population. It has been suggested that Gregory E. Skipper, M.D., FASAM, Medical Director health professionals are the “point men” who demonstrate abuse and dependence with new prescription drugs prior to Tramadol, Ultram®, despite its low abuse potential, problems in the general public. According to physicians who poses some risk for health professionals. Because of numer- have developed dependence, availability and false reassur- ous case reports of abuse of this drug among physicians, the ance regarding risk may be factors that have increased the State of Alabama Medical Licensure Commission requested chance of inappropriate use and dependence.
in February 2001 that the State Board of Health consider According to the Drug Abuse Warning Network adding Ultram to the schedules of controlled substances. In (DAWN) study in 1999 there were 1113 estimated ER May of 2001 the Controlled Substances Advisory Committee episodes involving Tramadol as compared to 1313 for met to review this issue. It was the third time this committee Hydromorphone and 512 for Meperidine. In Cincinnati a has met to consider this drug since 1996.
study of Tramadol3 found that there were 362, 107, 515, and Tramadol has been available in the United States as an 326 Tramadol abuse calls in 1995, 1996, 1997, and 1998, uncontrolled prescription analgesic since 1995. Tramadol is respectively, to the Drug and Poison Information Center.
see Ultram Abuse on page 3
Ultram® Abuse
render of the certificate of qualification and license to prac-tice medicine in Alabama of Carl A. Hyman, M. D., license The Cincinnati police documented diversion of 7,258 doses number 16977, Mobile AL. Dr. Hyman is not authorized to of Tramadol from 9/97–12/97 and 11,385 doses in 1998.
Tramadol was listed in the top 10 diverted prescription On June 27, 2001, the Board accepted the voluntary sur- drugs. Their conclusion was that physicians need to consider render of the certificate of qualification and license to prac- the abuse potential and monitor patients for dependence and tice medicine in Alabama of Winston Ellis Bradley, Jr., M.
that tighter controls need to be considered. D., license number 10292, Jasper AL. Dr. Bradley is no The manufacturer has aggressively marketed this drug longer authorized to practice medicine in Alabama.
and many physician offices contain samples supplied by the On June 27, 2001, the Board accepted the voluntary sur- drug company. Because the drug is not scheduled, its supply render of the certificate of qualification and license to prac- and storage as a sample is not constrained as are scheduled tice medicine in Alabama of Glenn R. McDaniel, Jr., M. D., drugs. The low or absent abuse potential is mentioned fre- license number 15251, Birmingham AL. Dr. McDaniel is no quently by drug salespersons, and the drug is compared to longer authorized to practice medicine in Alabama.
nonsteroid antiinflammatory drugs with regards to its use On June 27, 2001, the Board accepted the voluntary sur- and risk. Tramadol is not a non-steroidal anti-inflammatory render of the Alabama Controlled Substances Certificate of drug (NSAID) and has no anti-inflammatory activity. Charles David Quarles, M. D., license number 11755, York The package insert has been upgraded three times AL. Dr. Quarles is no longer authorized to prescribe con- regarding the abuse potential of the drug since it was released. The current warning is: “Cases of abuse and On June 27, 2001, the Board accepted the voluntary dependence on TRAMADOL have been reported. TRA- restriction on the certificate of qualification and license to MADOL should not be used in opioid-dependent patients.
practice medicine in Alabama of Daryl A. Ellis, M. D., Since TRAMADOL can reinitiate physical dependence, it is license number 18084, Columbus GA, which provides for not recommended for patients with a tendency to drug abuse, monitoring by the Board of his health status.■ a history of drug dependence, or chronically using opioids.”The problem is that often we do not know who has “a ten- Medical Licensure Commission
Concluding its deliberation, the Alabama Controlled PUBLIC ACTION REPORT
Substances Advisory Committee decided not to recommend April – July 2001
scheduling Tramadol at this time. Instead, they decided tocontinue to study the issue of Tramadol abuse and requested On March 28, 2001, the Medical Licensure Commission that the drug company participate in educational efforts to entered an order which temporarily suspended the Alabama decrease risk of abuse of this drug in Alabama. Tramadol medical license of James Frederick Graves, Jr., M.D., license abuse and dependence is a risk for health professionals and they should be aware of this risk and use this drug with care.
On April 9, 2001, the Medical Licensure Commission entered an order which issued to Marcus Edward Ward, M.D., license number 11178, a reprimand, assessed an 2 Richter W, Barth H, Flohe L, Giertz H (1985) Clinical administrative fine in the amount of $1,000, and required Dr.
investigation on the development of dependence during oral Ward to obtain additional continuing medical education for therapy with Tramadol. Arzneimittelforschung 35:1742- On April 11, 2001, the Medical Licensure Commission 3 Krummen K. Nelson E. Tsipis G. Siegel E. Bottei E.
entered an order which revoked the Alabama medical license Cincinnati Drug and Poison Information Center, Children’s of Joseph Ayer Beckwin, M.D., license number 12480.
Hospital Medical Center, Cincinnati, OH■ On April 11, 2001, the Medical Licensure Commission entered an order which revoked the license to practice medi- Alabama Board of Medical Examiners
cine of John Elliot Polson Sams, D.O., license number DO- PUBLIC ACTIONS
April - June 2001
On April 25, 2001, the Medical Licensure Commission issued an order which temporarily suspended the Alabama On April 18, 2001, the Board accepted the voluntary sur- medical license of Ricky Joe Nelson, M.D., license number render of the certificate of qualification and license to prac- tice medicine in Alabama of Tad R. Connine, M. D., license On April 25, 2001, the Medical Licensure Commission number 22898, La Plata MD. Dr. Connine is no longer entered an order which temporarily suspended the Alabama authorized to practice medicine in Alabama.
medical license of Carl A. Hyman, M.D., license number On April 18, 2001, the Board accepted the voluntary sur- render of the certificate of qualification and license to prac- On April 25, 2001, the Medical Licensure Commission tice medicine in Alabama of Jerry H. Crump, M. D., license entered an order which dismissed the Administrative number 13179, Enterprise AL. Dr. Crump is not authorized Complaint filed by the Board of Medical Examiners against Jerry Henry Crump, M.D., based upon Dr. Crump’s volun- On May 16, 2001, the Board accepted the voluntary sur- tary surrender of his Alabama medical license, license num- render of the Alabama Controlled Substances Certificate of Morgan Jackson Moore, M. D., license number 1272, On April 25, 2001, the Medical Licensure Commission Andalusia AL. Dr. Moore is no longer authorized to pre- entered an order which dismissed the Administrative scribe controlled substances in Alabama.
Complaint filed by the Board of Medical Examiners regard- On May 16, 2001, the Board accepted the voluntary sur- see MLC Public Actions on page 4
MLC Public Actions continued
On July 25, 2001, the Medical Licensure Commission entered a Stipulation and Consent Order which issued a rep- ing the withdrawal of the application for reinstatement of rimand and assessed an administrative fine in the amount of the Alabama medical license of Philip Anderson Miller, $2,500.00 to Michael Jude Naughton, M.D., license number 12757, based upon his noncompliance in obtaining annual On April 25, 2001, the Medical Licensure Commission entered a Stipulation and Consent which issued a reprimand On July 25, 2001, the Medical Licensure Commission and assessed an administrative fine to Janet McBarron, entered a Stipulation and Consent Order which issued a rep- rimand and assessed an administrative fine in the amount of On April 25, 2001, the Medical Licensure Commission $2,500.00 to Chudy Nathaniel Okoye, M.D., license number entered an order which revoked the medical license of 7286, based upon his noncompliance in obtaining annual Pascual Herrera, Jr., M.D., license number 13663.
On May 7, 2001, the Medical Licensure Commission entered an order which issued to Steven Mark Hayden, Pain, Opioids & the Law
M.D., license number 13468, a reprimand and assessed anadministrative fine in the amount of $6,000.00.
On May 23, 2001, the Medical Licensure Commission entered a Stipulation and Consent Order which issued a rep-rimand and assessed an administrative fine in the amount of September 21 - Mobile Country Club
$5,000.00. to Sam C. West, Jr., M.D., license number 8923.
September 28 - Dothan Country Club
On July 6, 2001, the Medical Licensure Commission September 29 - Montgomery Museum of Fine Arts
entered an Order which placed on probation, in compliancewith Mississippi, the medical license of Steven Morris, III, October 27 - Huntsville, Location to be announced
On July 9, 200, the Medical Licensure Commission revoked the Alabama medical license of James Frederick Graves, Jr., M.D., license number 16215.
On July 25, 2001, the Medical Licensure Commission entered a Stipulation and Consent Order which issued a rep- rimand and assessed an administrative fine in the amount of $2,500.00 to Jay W. Ripka, M.D., license number 14557.
On July 25, 2001, the Medical Licensure Commission entered a Stipulation and Consent Order which issued a rep- Call 800-239-6441
rimand and assessed an administrative fine in the amount of $2,500.00 to Harold Walker Brown, M.D., license number2992, based upon his noncompliance in obtaining annual Alabama Board of Medical Examiners NEWSLETTER is published quarterly for physicians who hold a license to practice medicine or On July 25, 2001, the Medical Licensure Commission osteopathy in the state of Alabama. The newsletter is designed to keep entered a Stipulation and Consent Order which issued a rep- the licensed physicians of Alabama updated as to developments in theregulation of the practice of medicine in this state. The Board welcomes rimand and assessed an administrative fine in the amount of your comments, questions or other input.
$2,500.00 to Kendal Irwin Foster, M.D., license number12209, based upon his noncompliance in obtaining annual Larry Dixon, Executive Director, P.O. Box 946, Montgomery, AL36101-0946 or call (334) 242-4116 or fax (334) 242-4155. Please visit our web site: www.albme.org.

Source: http://albme.studio21design.com/Documents/Newsletters/Summer2001.pdf