An estimated 36 million Americans, or one in six people, have ordered prescription drugs from Internet Web sites without a prescription, according to a Partnership at Drugfree.org survey. Consistent with this finding, NABP has found that approximately 80% of the sites on the Association’s Not Recommended list do not require a valid prescription. Consumers using rogue sites continue to be at risk as regulators look for new ways to combat this issue.
As stressed in the October 2011 NABP Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators, the operators of rogue sites, “take advantage of patient confidence in trusted brands to sell pills that may contain too much or too little, if any, of the approved drug’s active ingredient, an entirely different active ingredient, or contaminants ranging from talcum powder to printer ink.” Indeed, cases of consumers, both in the United States and abroad, harmed by counterfeit drugs ordered from such rogue sites have been documented. Further, rogue Internet drug outlets put patients at risk by distributing controlled substance (CS) drugs without requiring prescriptions, raising the potential for drug-drug interactions, overdose, and drug abuse or addiction. In fact, Drug Enforcement Administration (DEA) has indicated that rogue sites contribute to the prescription drug addiction epidemic.
Federal regulators have had some success, at times in collaboration with their international regulatory counterparts, in shutting down rogue Internet drug outlets. Congress is considering bills to address the problem, one by way of protecting intellectual property, and another by adopting tougher penalties for counterfeit trafficking.
On the state level, boards of pharmacy have had an impact by disciplining licensees engaged in dispensing drugs based on invalid prescriptions associated with Internet drug outlets. Boards have also partnered with DEA in cases where licensees are involved in larger scale Internet drug distribution schemes. In some states, laws requiring board of pharmacy oversight for the registration of Internet pharmacies, and laws or rules that recognize VIPPS® (Verified Internet Pharmacy Practice SitesCM) as fulfilling certain state requirements also help to protect patients.
Through establishing programs such as VIPPS, Vet-VIPPS® (Veterinary-Verified Internet Pharmacy Practice SitesCM), and the NABP e-Advertiser ApprovalCM Program, providing research on rogue sites to federal and state regulators, and through consumer education initiatives, NABP has taken several steps to protect patients from the harmful products peddled by rogue Internet drug outlets. And to determine whether additional action should be taken by boards of pharmacy and the Association to address the illegal distribution of drugs via Internet sites, the NABP Task Force on Internet Pharmacy Practice will convene March 6-7, 2012.
State legislatures and state boards of pharmacy continue to take steps to protect their residents from rogue drug outlets operating via the Internet.
In Iowa, legislation adopted in 2009 required that the Iowa Board of Pharmacy develop rules for the registration of Internet pharmacies, including rules to define “Internet pharmacies” and “Internet pharmacy sites,” and to establish requirements for site registration, site content, and other relevant matters. The rules must also cover the requirement that Internet pharmacies doing business in Iowa must be accredited through the VIPPS program. The Board is currently developing the rules.
As reported in the 2012 NABP Survey of Pharmacy Law, at least 14 states, in addition to Iowa, recognize VIPPS accreditation as fulfilling certain requirements of Internet pharmacies dispensing to patients in their state. And at least four states, Florida, Hawaii, Missouri, and Utah, have a separate category for licensing Internet pharmacies. At least one state, Indiana, requires that in-state Internet pharmacies are licensed as mail order pharmacies.
Boards are also able to have an impact on illegal Internet drug outlets by disciplining licensees, both pharmacies and pharmacists, who facilitate their business by dispensing invalid prescriptions. Boards of pharmacy in California, Minnesota, and Ohio have issued fines and put pharmacist licenses on probation for such violations, as reported in the December 2010 NABP Newsletter article “State Boards of Pharmacy Take Action to Stop Licensees Involved in Unlawful Internet Drug Outlet Schemes.” As detailed in the same article, the boards in Iowa and Kansas also took emergency actions against pharmacies involved in larger scale Internet drug distribution schemes.
NABP continues to keep federal and state regulators and other stakeholders informed via the quarterly reports of the Internet Drug Outlet Identification program. As of October 2011, the program had reviewed almost 8,500 Internet drug outlets, finding that over 96% of the sites are operating out of compliance with state and federal laws and/or NABP patient safety and pharmacy practice standards.
NABP shared such information at a White House meeting on rogue Internet drug outlets November 9, 2010, and also presented information about the VIPPS accreditation program. The US Office of the Intellectual Property Enforcement Coordinator (IPEC) that coordinated the meeting, as well as meeting participants, were supportive of developing a “White List” of legitimately operating online pharmacies based on expanding the VIPPS list. Subsequently, NABP participated in a panel discussion, “Dangers of Counterfeit Pharmaceuticals,” coordinated by the IPEC office December 14, 2010.
NABP also participated in a Congressional Briefing coordinated by the Partnership for Safe Medicines (PSM) and Senator Chris Coons on June 23, 2011, to discuss the problem of rogue Internet drug outlets. Participants at the meeting discussed challenges regulators face and strategies to solve the problem.
To raise awareness among consumers, NABP issued a public health alert warning Americans about the dangers associated with medications purchased through fake online pharmacies, and presented some of the Association’s research statistics. NABP also continues to educate the public via e-News announcements and via the AWARxE™ consumer protection program Web site, www.AWARErx.org, and outreach events.
The Ryan Haight Online Pharmacy Consumer Protection Act, by amending the Controlled Substances Act (CSA) with a definition of “valid prescription,” allowed for the prosecution of individuals distributing CS via the Internet without requiring a valid prescription. The law went into effect April 13, 2009, and DEA announced the first charges in violation of the law in May 2010.
In addition, federal law enforcement and regulators, often in partnership with international regulators and with private US entities, have been able to shut down thousands of such Web sites.
However, new challenges in both arenas continue to arise. IPEC explains, in a report released in March 2011, that the definition applied to the CSA “was designed to address the practice of online pharmacies that dispensed controlled substances without a prior prescription or on the basis of a purported review by a physician who reviewed a questionnaire.” However, many online sellers market prescription drugs other than CS. Thus, IPEC recommends, that the Federal Food, Drug, and Cosmetic Act (FD&C Act) be amended to use the Ryan Haight definition of valid prescription so that non-CS prescription drugs sold online may be regulated. IPEC indicates that a similar amendment to the FD&C Act can “help reduce the number of online pharmacies evading prescription requirements and, in turn, selling counterfeit drugs.”
Bryan Liang, PhD, MD, JD, vice president of the PSM, agrees with IPEC’s recommendation and stressed at the Congressional Briefing in June 2011 that current federal regulations address only online pharmacies that are based in the US and that distribute CS.
Liang and other industry experts point out another challenge; specifically, while thousands of rogue Internet drug outlets have been shut down, the operators of such sites can easily set up shop again. Further, if investigations result in arrests and convictions on charges related to distributing counterfeit drugs via the Internet, the penalties are not tough enough to deter others from engaging in counterfeit manufacture or distribution. Liang has also noted that it is “difficult to attribute patient death or injury to online drug consumption or purchase.” Meanwhile, counterfeiters and rogue site operators are motivated by hefty profits. For example, “When sold at market price, counterfeit ED [erectile dysfunction] drugs reportedly can generate 2,000% profit margins – approximately 10 times the profitability of heroin,” as indicated in the October 2011 NABP Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators. Industry experts, both represented by the Alliance for Safe Online Pharmacies (ASOP) and by IPEC have stressed that increasing penalties for convictions related to the manufacture and distribution of counterfeit drugs can help to prevent this crime.
Liang indicates another challenge for customs and law enforcement – with the millions of illegal imports being shipped into the US, it is impossible for every package to be screened for the presence of counterfeit drugs. And, as highlighted in a March 2011 60 Minutes report, even with the thousands of packages seized, under current law, many packages must be shipped back to overseas senders, giving another chance for the package to be reshipped and possibly evade detection. Customs and Border Protection told PSM that many such packages are the result of Internet orders with the counterfeits being shipped directly to patients.
Consistent with the IPEC recommendation, the Online Pharmacy Safety Act of 2011 (S 2002), introduced to the Senate on December 15, 2011, would amend the FD&C Act to use the Ryan Haight definition of valid prescription so that non-CS prescription drugs may only be ordered and dispensed from an Internet pharmacy pursuant to a valid prescription. The bill is also intended to protect Americans from counterfeit drugs sold over the Internet by requiring the establishment of a registry of legitimate online pharmacy Web sites, which would include Internet pharmacies accredited by the NABP VIPPS program. In addition, the legislation would allow Internet service providers – such as domain name registrars, financial transaction providers, and Internet advertising services – to cease or refuse to provide services to Internet drug outlets not included on the registry.
Other legislation has been drafted to specifically target the trafficking of counterfeit drugs and was introduced by Senator Patrick Leahy (D-VT) to the Senate on November 17, 2011. The Counterfeit Drug Penalty Enhancement Act of 2011 would increase penalties for trafficking counterfeit drugs, with convicted individuals facing penalties of up to $4 million and 20 years imprisonment, and up to $8 million for multiple offenses. Entities convicted of trafficking counterfeit drugs could face fines as high as $10 million for a single offense or as much as $20 million if convicted of multiple offenses. One supporter of the bill stated that under current US law, individuals convicted of trafficking counterfeit drugs typically face prison sentences of three years, while the products they peddle can cause serious health issues for unsuspecting purchasers.
Attempts to fight counterfeits with legislation protecting intellectual property have been met with much debate. In May 2011, the “Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011” was introduced to the US Senate. This legislation was developed with the intention of targeting the worst-of-the-worst Internet intellectual property infringers by eliminating financial viability of a site, rather than blocking access. While the bill was developed to respond to concerns voiced by various parties over 2010 intellectual property legislation, it also faced much criticism.
In addition, another bill, the Stop Online Piracy Act (SOPA), which was introduced to the House in October 2011, as of press time has been deferred to a House committee. SOPA builds upon the two previous pieces of legislation and includes provisions intended to fight rogue Internet drug outlets by encouraging private companies to stop doing business with them, as summarized by ASOP. The bill also includes provisions that would increase penalties for convictions related to trafficking counterfeit drugs.
Along with federal and state legislation, industry experts and government agencies have recognized the need for a global perspective and for international partnerships to make headway in regulating rogue Internet drug sites.
Food and Drug Administration (FDA) joined regulatory agencies from 81 countries for the International Internet Week of Action, September 20-27, 2011. The collaborative effort aims to curb online distribution of counterfeit medications, and in 2011 INTERPOL reports that “almost 13,500 websites engaged in illegal activity were shut down.” FDA reports that at least 578 sites selling unapproved drug products to US citizens were shut down as a result of the global action.
The World Health Organization and other international health groups have taken serious steps to fight counterfeits and protect the quality of drugs. At a November 21, 2011 meeting called by the World Health Professions Alliance (WHPA), participants focused on reducing the impact of counterfeit drugs on patients and the public in central Europe and acknowledged the role of the Internet in disseminating counterfeit drugs. The resulting WHPA Prague Call to Action, among its four objectives for action, called for fostering regional collaborative initiatives, including attention to the illegal Internet distribution of counterfeit drugs.
Closer to home, the Canadian regulatory agency, Health Canada, has taken steps to protect its citizens from the dangers of counterfeit drugs sold on the Internet. In November 2010, Health Canada issued a warning to consumers about three specific sites found to be peddling counterfeit drugs. As explained in the warning, the sites had been reviewed by the Ontario College of Pharmacists and it was determined that they were not associated with pharmacies licensed in Ontario. Health Canada has also provided a section of its Web site devoted to raising awareness among Canadians about the risks of ordering drugs online.
The NABP task force is committed to taking a global view, as it also considers the future steps of state boards of pharmacy and the Association. The charge of the task force will be to:
At least one representative from a Canadian pharmacy regulatory body will participate on the task force, and recommendations from the task force may help bring about global cooperation. The report of the task force will be the topic of a future NABP Newsletter article.
With claims of offering users a means of altering consciousness without running afoul of the law, two relatively new classes of synthetic drugs are sweeping through the country. Despite its comparatively recent arrival in the United States, cannabinoid-laced “incense” alone is estimated to be a $5 billion industry. Synthetic cannabinoids supposedly mimic the effects of marijuana use, while synthetic cathinones have been touted as a “legal” alternative to such drugs as cocaine or methamphetamine. As evidence of the increasingly widespread use and harm caused by these substances has mounted, local, state, and federal governments have taken swift action to legally constrain their manufacture, possession, and use. At the same time, manufacturers and sellers of the synthetic drugs are taking steps to circumvent new regulations and continue to grow a lucrative new industry.
The histories of synthetic cannabinoids and synthetic cathinones are similar. Both drug types became widespread in Europe before being documented in the US around 2008 (cannabinoids) or 2009 (cathinones). Both are marketed as small packets of “not for human consumption” items – usually “herbal incense” for cannabinoids and “bath salts” for cathinones – but are clearly understood by both buyer and seller to be intended for ingestion by those seeking a psychoactive result. Both are widely available over the Internet and from brick-and-mortar stores ranging from head shops to gas stations. Both have triggered a dramatic upsurge in related visits to emergency rooms and calls to poison control centers. US poison control centers received 2,915 calls related to synthetic cannabinoids in 2010; for 2011, the number had risen to 5,741 for the first 10 months of the year. As for synthetic cathinones, related calls to poison centers shot up from 303 in 2010 to 5,625 in 2011 through the end of October alone.
Synthetic cannabinoids are chemically engineered substances functionally similar to delta-9-tetrahydrocannabinol (THC), the principal psychoactive component in marijuana. Originally developed for research purposes, they have never been approved by Food and Drug Administration for therapeutic purposes, and according to Drug Enforcement Administration (DEA), “there is little information regarding the pharmacology, toxicology, and safety of these substances in humans.” Producers of herbal incense products often dissolve the substance in solvents and spray it in liquid form onto a mixture of dried, chopped, or crushed herbs and other botanical materials; users primarily smoke the “incense” to achieve the psychotropic effects. Analysis has found extensive variation across different samples, including those from the same supplier: different chemical variations, differing potency varying from two to more than 500 times stronger than THC, and even difference in the brain receptors targeted.
While synthetic cannabinoids reportedly often trigger the same physiological responses as marijuana, this is not always the case. Adverse health effects associated with synthetic cannabinoids include agitation, anxiety, nausea, vomiting, tachycardia, hypertension, tremors, seizures, hallucinations, paranoid behavior, and loss of consciousness. News reports and researchers have linked a number of psychotic episodes and deaths to the ingestion of “herbal incense,” including a teenager in Illinois who drove his vehicle into a house and a Nebraska student who killed an assistant principal at his school and himself.
Synthetic cathinones, meanwhile, are central nervous system stimulants structurally and pharmacologically similar to substances such as amphetamine, 3,4-methylenedioxymethamphetamine, and cathinone (which occurs naturally in the khat plant). At least two synthetic cathinones, methylenedioxpyrovalerone (MDPV) and methylone, were originally derived from products developed in pharmaceutical research; however, as DEA points out, there are currently no accepted medical uses for these products in the US. Most users reportedly ingest “bath salts” (which are often sold in granular form reminiscent in appearance to real bath salts) by snorting them in powder form or swallowing them, usually in capsule or tablet form.
Synthetic cathinones reportedly trigger physical and psychological responses similar to cocaine or meth; some of the many adverse health effects include extreme agitation or anxiety, hallucinations, paranoia, aggression or disturbed behavior, palpitations, seizures, vomiting, headaches, and hypertension. A number of atrocities and deaths have been attributed to ingestion of synthetic cathinones, including a 21-year-old in Louisiana who shot himself, deaths attributed to driving under the influence of the substances, and users’ violent behavior toward themselves or others.
Lawmakers and regulators have acted quickly in response to the situation. On the federal level, in March 2011, DEA issued a final order temporarily designating five chemicals used in synthetic cannabinoid products – referred to as JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol – as Schedule I substances. Their placement into the Controlled Substances Act (CSA) makes illegal their manufacture, distribution, possession, importation, and exportation. The designation lasts for one year, and may be extended for an additional six months during “pendency of proceedings” for a more permanent placement. Likewise, on October 21, 2011, DEA issued a final order temporarily placing three synthetic cathinones – mephedrone, methylone, and MDPV “and their salts, isomers, and salts of isomers” – in Schedule I of the CSA.
Meanwhile, US legislators in early 2011 introduced two bills in each the House of Representatives and the Senate dealing with synthetic cannabinoids and synthetic cathinones. Senate Bill 409, the “Combating Dangerous Synthetic Stimulants Act of 2011,” proposed to amend the CSA to include mephedrone and MDPV as Schedule I controlled substances. At press time, it had passed through committee and had been placed on the Senate Legislative Calendar; an identical bill remained in committee in the House. Senate Bill 605, the “Dangerous Synthetic Drug Control Act of 2011,” addressed synthetic cannabinoids; it would put a broad list of “any material, compound, mixture or preparation which contains cannabimemetic agents (or the salts, isomers, or salts of isomers thereof)” into Schedule I of the CSA, and would also extend temporary listing of substances in CSA Schedule I to up to two years, with a one-year extension. At press time, the bill had also been placed on the Senate Legislative Calendar; the House version, which would also ban a number of synthetic cathinones, passed in the House on December 8, 2011, and has been referred to the Senate Committee on the Judiciary.
Local and state legislators and regulators have acted even faster. Kansas outlawed the use, possession, and sale of synthetic cannabinoids in 2010 – the first state to pass legislation doing so. By the end of October 2011, at least 40 states had adopted laws or departmental rules banning chemical substances related to synthetic cannabinoids. At least three additional states had similar legislation pending. The drugs have been addressed throughout the country on a more local level, as well. In November 2011, for example, Chicago prohibited the sale of “synthetic marijuana.” States have also taken action against bath salts: by the end of October 2011, at least 33 states had adopted laws or departmental rules outlawing substances related to synthetic cathinones.
The complex nature of the synthetic drugs, however, makes regulation difficult. The manufacturers of the products subtly change the compounds to sidestep laws. In Kansas, for example, the original 2010 law banned three compounds; almost immediately, new compounds began appearing. The state more recently passed legislation taking a broader approach, banning the general chemical classes associated with synthetic cannabinoids. The state’s laws related to synthetic cathinones are likewise broad and attempt to include substitutions or variations the producers might come up with. Other states’ laws vary widely in their specificity, but a number of states are considering legislation adding additional compounds to their original bans, or broadening language to encompass more potential formulations.
Most of the legislation, particularly the more recent broad designations of chemical classes, has been enacted too recently to judge its impact. With large profits, manufacturers and retailers of the substances, meanwhile, have a significant incentive to continue their activities. Enough incentive, no doubt, to keep the cat-and-mouse game between regulators and illicit drug manufacturers going for some time to come.
]]>NABP is partnering with the American Pharmacists Association (APhA) to develop the voluntary community pharmacy accreditation program. The associations are working together to develop, test, and implement standards and the accreditation process, and the program is expected to launch this year. The program standards will be focused on assisting pharmacies in the ongoing patient safety and quality initiatives that support the best interest of patients.
Further, both APhA and NABP see the developing community pharmacy accreditation program as supporting the realization of the Joint Commission of Pharmacy Practitioners’ (JCPP) 2015 Future Vision of Pharmacy Practice, which envisions that “Pharmacists will be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes.” The NABP 2011 Report of the Executive Committee, presented by 2010-2011 NABP Executive Committee Chairperson Gary A. Schnabel, RN, RPh, at the Association’s 107th Annual Meeting, stressed that the change in pharmacy practice envisioned in the JCPP statement “can be realized with the community pharmacy accreditation program.”
]]>The Partnership for Safe Medicines (PSM) presented NABP with the inaugural Guardian award, recognizing the Association’s efforts in raising awareness of and combating unlicensed online pharmacies. The award was presented at the PSM Interchange, October 27, 2011, an annual conference bringing together investigators, regulators, patient advocates, counterfeit drug victims, and law enforcement to address issues related to fighting counterfeit drugs.
Over 120 stakeholders participated in the 2011 PSM Interchange “to discuss ways to stem the rising tide of counterfeit and unsafe medicines not only in the United States, but around the globe,” as noted in a PSM press release. Speakers included United States Under Secretary of State Robert D. Hormats, who stressed the importance of collaboration among US government agencies, international governments, and private sector and stakeholder groups, in making progress in the fight against counterfeit and substandard medicines. Dr Marv Shepherd, president of PSM and director of the Center for Pharmacoeconomic Studies at the University of Texas-Austin, stated that the goal of the Interchange conference was to “send a message of empowerment – empowering consumers and medical professionals to identify and avoid unsafe medicines, empowering lawmakers and regulators to develop policies to keep our drug supply safe, and empowering global stakeholders to join together to develop a unified, collaborative effort to fight the growing counterfeit drug risk.” Other PSM Interchange speakers included Senator Michael Bennet (D-CO), Congressman Jim Matheson (D-UT), Deputy Director of Immigration and Customs Enforcement Kumar C. Kibble, Maryland Attorney General Douglas Gansler, and representatives from Food and Drug Administration, the White House Office of the US Intellectual Property Enforcement Coordinator, and a variety of domestic and international patient and health advocacy organizations.
The Guardian will be an annual award presented by PSM to an individual or organization that has demonstrated outstanding leadership in the fight to stop counterfeit medicines.
]]>The full text of the notice is available on the DEA Web site.
]]>These areas encompass the patient-centered research that PCORI intends to fund and are inclusive of all diseases and health conditions. PCORI’s draft Research Agenda outlines more specific areas of research for each of the five priorities, as noted in a news release.
PCORI Executive Director Joe Selby, MD, MPH, stated that the initial agenda “does not limit which conditions or treatments will be studied.” He added that PCORI hopes patients and other stakeholders will partner with the organization as the framework is applied “to identify the specific questions that are most important for PCORI to address.” Comments can be submitted to PCORI through March 15, 2012, by following the instructions on the PCORI Web site.
Additional information and links to related resources are available on the CDC Web site.
]]>The proliferation of technological advancements enables boards of pharmacy to provide the public with virtually immediate access to information about applicants and licensees, including persons subject to administrative discipline. This ease of availability of public information enhances opportunity for an informed public and allows consumers not only to verify a professional’s credentials, but also to assess such practitioner’s administrative background.
On the other hand, licensees may not appreciate the public nature of certain adverse information and, based upon the ease of public access, may seek to have such information removed from public availability. Requests to delete administrative discipline from public access may be justified based upon the completion of the sanctions set forth in the order, the mere passage of time, as well as other legal or equitable grounds. One such mechanism is to have a record “expunged.” Expunction effectively destroys the records and treats the impacted person, for purposes of the official records, as if the event (generally a crime) had never occurred. The authority and criteria for having one’s records expunged is addressed in state law and most often applies to criminal convictions.
Based upon the public’s access to administrative information, boards of pharmacy are likely to experience an increase in requests to expunge adverse administrative records. Boards are encouraged to proceed cautiously and to check with counsel regarding the authority, if any, to expunge an administrative record.
The admissibility of information that led to criminal action of a now expunged record may, however, remain relevant. As mentioned, most likely the expunged record addresses a criminal matter. But, to what degree is information related to the events of an expunged criminal conviction relevant and admissible in an administrative proceeding? Or perhaps more difficult, what about an expunged record related to a criminal arrest that did not result in a conviction? Consider the following.
An officer of the Texas Alcoholic Beverage Commission was conducting an inspection of a bar. While on the premises he was approached by a patron who reported a male alone near the dance floor was engaged in lewd acts. The inspector observed the lewd acts and immediately removed the patron from the establishment. As a result of the incident, the patron was arrested and charged with indecent exposure. Sometime later, the charges were dismissed and eventually his arrest records were expunged. He was never convicted of a crime.
The patron (Licensee) was a teacher who held an active Texas Educator Certification at the time of the incident and was employed by a public school district. Eventually, the State Board for Educator Certification (Board) filed a petition against the Licensee with the State Office of Administrative Hearings. The petition alleged that the actions of the Licensee at the bar indicated that he was a person “unworthy to instruct or supervise the youth of the State of Texas.” The Board sought to have his educator certification permanently revoked.
Prior to the administrative hearing, the Licensee filed a motion arguing that because his arrest record had been expunged the Board could not produce any evidence to support its claim. An expunction order under the Code of Criminal Procedure prohibits the use of any records or files concerning the Licensee’s arrest. The Board responded that it intended to use the testimony of the inspector who was an eyewitness to the events and it would not use nor rely upon the arrest records.
At the hearing, the administrative law judge allowed the inspector to testify but did not admit such testimony into the record until the conclusion of the proceedings. In overruling the Licensee’s objections to the testimony of the inspector and allowing such to be made of record, the administrative law judge noted that the inspector did not refresh his memory from the arrest record or any other record subject to the expunction order. The Licensee testified and admitted he was escorted out of the nightclub but denied engaging in lewd acts. Two additional character witnesses testified on behalf of the Licensee.
The administrative law judge found that the Licensee engaged in the lewd acts at the nightclub and concluded that such conduct was an act of moral turpitude and that an act of moral turpitude can preclude a finding of good moral character. However, the administrative law judge concluded that the Board did not have the basis for discipline because the Board’s definition of “unworthy to instruct or supervise the youth of the state of Texas” basically required the educator to have been convicted of one of the enumerated crimes set forth in that section of the cited law.
The Board adopted the findings of the administrative law judge with the exception of the two conclusions of law related to the interpretation of what constitutes unworthy to instruct or supervise. The Board found the administrative law judge’s interpretation to be inconsistent with applicable law, agency rules, and prior administrative decisions. The Board concluded that the conduct of the Licensee established that he was unworthy to instruct or supervise the youth of the state of Texas and revoked his license. The Licensee appealed.
On appeal, the Licensee argued that the Board exceeded its statutory authority by rejecting the administrative law judge conclusions; that the testimony of the inspector was inadmissible as it was subject to the expunction order; and that the Board erred by denying his request to present additional evidence to the Board.
After summarizing the standard of review, the court turned its attention to the arguments of the Licensee. First, addressing the authority of the Board to reject the administrative law judge conclusion regarding her interpretation of the phrase “unworthy to instruct,” the court held that the Administrative Procedure Act (APA) specifically allows for the Board to change a finding of fact or conclusion of law. It held that the Board complied with the APA requirement of explaining the reasons and legal basis for its rejection of the administrative law judge conclusions. The court also reiterated its role under the standard of review as assessing whether the Board’s interpretation was reasonable and did not contradict the plain language of the statute or rule.
The court held that requiring a criminal conviction of one of the two cited criminal sections in order to find one unworthy to instruct was inconsistent with the public protection intent of the statute. In deferring to the Board’s authority, the court held that the Board’s interpretation was reasonable, consistent with the statute, and was delineated in its order. Thus, the Board acted within its statutory authority.
Addressing the admission of the eyewitness testimony, the Licensee argued that the expunction statute “precludes a person who acquires knowledge of an arrest while a state employee and who knows of an order expunging the records and files relating to that arrest from disseminating or using the records or files.” In rejecting this argument and upholding the allowance of the inspector’s testimony, the court held that such testimony relied upon personal observation, not on an expunged record or file. Indeed, the inspector testified to the fact that his recollection of the events of that evening were based upon his direct knowledge and that he did not refresh his memory using the expunged records or files. In interpreting the statute, the court noted “the legislature’s intent in enacting the expunction statute was not to eradicate all evidence of the conduct underlying the expunged arrest.” Thus, the allowance of the inspector’s testimony was affirmed and this argument of the Licensee was rejected.
Finally, the court addressed the Licensee’s argument that the Board erred in denying his request to supplement the record with additional evidence not presented to the administrative law judge. The Licensee had sought to have an additional order entered by the expunging court made of record in the administrative proceedings. This additional court order called for the Texas Education Agency to return to the court all files related to the Licensee and was based upon allegations of noncompliance by such agency. The court noted that to allow on appeal the submission of additional evidence outside the administrative record, the requesting party must show the evidence is material and that there were good reasons for its failure to be presented in the proceedings before the administrative law judge. In this case, the court held that the Licensee failed to argue that the agency was not complying with the expunction order but, instead, merely argued that the admission of the testimony of the inspector was improper. Accordingly, this argument by the Licensee was rejected.
Rejecting all arguments of the Licensee, the court affirmed the findings of the Board and the revocation of the license. Due to the implication of criminal laws related to pharmacists accused of wrongdoing and the potential for criminal arrests, boards of pharmacy may be confronted with the admissibility of information related to an expunged criminal record. This can be a complicated legal arena and advice from counsel is essential.
Gomez v. Texas Education Agency, 2011 Tex. App. LEXIS 9277 (App. Ct. TX 2011).
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