aid to governmentthe profession

the public1904 to 2010

Upcoming Events

September 25, 2010 DEA National Drug Take-Back Day

October 5-6, 2010 Task Force to Review and Recommend Revisions to the Controlled Substances Act NABP Headquarters

October 29-31, 2010 NABP/AACPDistrict 1 and 2 Meeting Cooperstown, NY

November 10-12, 2010 NABP/AACPDistrict 4 Meeting Cincinnati, OH

May 21-24, 2011 NABP 107th Annual MeetingSan Antonio, TX

In This Issue. . . .Legal Briefs:Where There’s Smoke, There’s Sales

180

Association News:NABP Seeks Nominations for 2011 Awards to be Presented at 107th Annual Meeting in San Antonio, TX

183

Association News:2010-2011 Committee, Task Force Appointments Announced

185

Association News:NABP Convenes Committee to Ensure Validity of MPJE Standards

186

Association News:DMEPOS Accreditation Deadline Extended; Pharmacies Seek Reaccreditation as New Laws Offer Limited Exemptions

187

Oc tobe r 2010 / Vo lume 39 Numbe r 9

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NABP Commissions Task Force to Review CSA Recommended Changes will Focus on Facilitating Provision of Patient Care and Protecting the Public Health

From policies guiding al-lowable Schedule II prescrip-tion changes by pharmacists, to regulations for secure dis-posal of unused medications, many of the Drug Enforce-ment Administration (DEA) regulations developed in the 1970s are in the process of being reviewed or studied by DEA and interested stake-holders, or amended through the legislative process. DEA regulations, promulgated to implement the federal Com-prehensive Drug Abuse Pre-vention and Control Act of 1970 – generally referred to as the Controlled Substances Act (CSA) – have impacted the practice and regulation of pharmacy as pharmacies and pharmacists comply with its provisions and boards of pharmacy ensure compli-ance with federal and state laws. Recognizing that the practice of pharmacy has changed significantly since the CSA was first imple-

mented and the CSA, therefore, could have the unintended ef-fect of restricting the provision of pharmacist care, NABP mem-bers approved a resolution at the NABP 106th Annual Meeting held May 22-25, 2010, to commis-sion a task force to review the CSA. The task force will meet October 5-6, 2010, and is charged with identify-ing provisions of the CSA that may require review and revision, and recommend-ing legislative and regulatory changes to amend the CSA and accompanying adminis-trative regulations.

Allowable Changes to C-II Prescriptions

One discrepancy in current guidelines, as DEA recognizes, is the confusion about federal regulations

pertaining to changes that a pharmacist may make to a Schedule II prescrip-tion after oral consultation with the prescriber. DEA published in the Federal Register on November 19, 2007, the Final Rule titled “Issuance of Multiple Pre-scriptions for Schedule II Controlled Substances,” which contained instruc-tions that conflict with prior DEA policy. Specifically, the more recent Final Rule states in its preamble that “the essential elements of the [Schedule II] prescrip-tion written by the practi-tioner (such as the name of

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newsletterNational Association of Boards of Pharmacy®

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The NABP Newsletter (ISSN 8756-4483) is published 10 times a year by the National

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and to communicate the objectives and programs of the Association and its 64 member boards

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Feature News

Controlled Substances Act(continued from page 177)

the controlled substance, strength, dosage form, and quantity prescribed) . . . may not be modi-fied orally,” while prior DEA policy permitted the same changes to a Sched-ule II prescription that a pharmacist may make to Schedules III-V controlled substance prescriptions after oral consultation with the prescriber. Currently, DEA advises that phar-macists should adhere to state regulations or policy regarding changes that a pharmacist may make to a Schedule II prescription after oral consultation with the prescriber. DEA plans to resolve the issue through future rulemaking.

Transmitting of Prescriptions in LTCF

Some confusion also exists related to certain DEA policies addressing the au-thority to transmit prescrip-tions in long-term care facil-ities (LTCF). Recently, DEA has stated that nurses at LTCF may not act as agents of prescribers for purposes of transmitting prescription orders. The confusion arises from the term “agent,” which means “an authorized person who acts on behalf of or at the direction of a manufacturer, distribu-tor, or dispenser,” (21 USC 802(3)) and it has been interpreted to mean that no legal agency relationship ex-ists between the LTCF nurse and the physician, therefore this widely-used system is not in compliance with

legal requirements. DEA solicited and is currently reviewing comments, which were due on August 30, 2010, from pharmacists and other stakeholders on issues related to the dispensing of controlled substances in LTCF.

Balancing Pain Management with Combating Abuse

Pharmacists and other health care providers have also been challenged with providing appropriate controlled substance pain medications to patients who need them, while maintaining compliance with DEA regulations enacted to prevent abuse and diversion. USC 21 1306.04(a) states “The re-sponsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a cor-responding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of pro-fessional treatment or in legitimate and authorized research is not a prescrip-tion within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relat-ing to controlled substanc-es.” Boards of pharmacy do not encourage pharmacists

to be inherently suspicious of all controlled substance prescriptions, as Jay Camp-bell, executive director, North Carolina Board of Pharmacy, noted in his continuing education presentation at the NABP 106th Annual Meeting, but pharmacists do have a re-sponsibility for reasonable diligence. As Campbell noted, many pharmacists have heightened vigilance due to certain circum-stances that fuel the rates of prescription drug addic-tion. These circumstances include the proliferation of pain clinics where il-legitimate prescriptions are issued, weight loss centers issuing massive numbers of the Schedule IV drug phentermine, and various Schedule III steroids, and the proliferation of Inter-net-based prescriptions.

To address requests for a guidance document on treating patients for pain, DEA issued a policy statement, “Dispensing Controlled Substances for the Treatment of Pain,” on September 6, 2006. The statement reiterates DEA policy to prevent abuse and diversion without adversely impacting the legitimate need of patients to have full access to pain relief pre-scribed by their physician.

As new rules are de-veloped and the CSA is further amended, stake-holders and government agencies will likely contin-ue to consider the balanc-ing act between ensuring that patients are treated appropriately for pain and

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Association News

Executive CommitteeGary A. SchnabelChairpersonOne-year term

William T. Winsley PresidentOne-year term

Malcolm J. BroussardPresident-electOne-year term

Michael A. BurlesonTreasurerOne-year term

James T. DeVitaMember, District 1Serving first year of a three-year term

Edward G. McGinleyMember, District 2Serving first year of a three-year term

Mark T. ConradiMember, District 3Serving first year of a one-year term

Gregory Braylock, SrMember, District 4Serving third year of a three-year term

Lloyd K. JessenMember, District 5Serving first year of a three-year term

Joseph L. “Joe” AdamsMember, District 6Serving second year of a three-year term

Cathryn J. LewMember, District 7Serving second year of a three-year term

Hal WandMember, District 8Serving third year of a three-year term

NABP Executive Committee elections are held each year at the Association’s Annual Meeting.

NABP Shares AWARxE Literature and Presentation at Expo BoothPictured above: NABP staff members Melissa A. Madigan, PharmD, JD, policy and communications director, and Brian Beaugureau, Internet drug outlet identification program coordinator, present information on the consumer protection program AWARxE to seniors during the 15th Annual Senior Lifestyle Expo. Attendees who stopped by the NABP booth received literature on AWARxE and safe alternatives for prescription drug discounts. In addition, approximately 1,300 AWARxE pill boxes were distributed and nearly 600 seniors spoke with staff at the booth.

AWARxE Alerts Seniors of Potential Risks when Purchasing Medications Online

On August 24-25, 2010, NABP introduced AWARxE, a consumer protection program pro-vided by the Association, to attendees of the 15th Annual Senior Lifestyle Expo, in Oakbrook Terrace, IL. The AWARxE booth provided seniors with information on the program as well as safe alternatives for pre-

scription drug discounts. According to research from AWARxE, as many as 96% of Web sites selling pre-scription drugs are out of compliance with pharmacy laws and practice standards established in the United States to protect patient health. By being aware of these dangers, consumers can protect themselves and

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their families from the risks posed by rogue Web sites. To get more facts on the potential dangers of prescription drugs visit www.AWARErx.org.

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Legal Briefs

Where There’s Smoke, There’s SalesBy Dale J. Atkinson, JD

Boards of pharmacy enforce the practice acts and other legislation

relevant to the licensure of pharmacies and pharmacists, among numerous other responsibilities. Occasionally, legislation outside the practice acts may affect and impose certain requirements or restrictions on licensees. While not always within the jurisdiction or enforcement responsibilities of the pharmacy board, federal, state, or local legislation is sometimes worthy of attention and analyses. Consider the following.

San Francisco City Ordinance No. 194-08 (ordinance) amended the local health code to provide that “No person shall sell tobacco products in a phar-macy except as provided in [citation to section of the health code].” The term “pharmacy” was subject to some confusion but ultimately was determined to refer to the entire retail establishment including that portion of the store referred to as a pharmacy. Of course, in addition to independent pharmacies, which predominantly sell prescription drugs, over-the-counter medications, and personal care products, there exist chain stores, supermarkets, and big box stores that sell a wide vari-ety of products in addition to prescriptions.

However, although such grocery or big box stores contain and qualify as

pharmacies as defined, the ordinance specifically ex-cludes such establishments from the prohibition on sales of tobacco products. As a result, the ordinance prohibits Walgreens stores that contain a licensed pharmacy from selling to-bacco products. Conversely, the ordinance imposes no such limitations on a Safe-way supermarket or Costco big box store that contains a licensed pharmacy.

The premise of the ordinance is based upon the principal conclusions that pharmacies convey tacit approval of the purchase and use of tobacco products through their availability and sale on the premises. Because patrons generally patronize pharmacies for health care products and services, the sale of tobacco products at these premises sends mixed messages. As further support for the or-

dinance, the city noted that pharmacies and drugstores are “among the most acces-sible and trusted sources of health information among the public” and that “clini-cians can have a significant effect on smokers’ probabil-ity of quitting smoking.” As a basis for distinguishing between drug stores and grocery stores that contain a pharmacy, the ordinance concludes that prescription drug sales for chain drug stores comprise a much larger portion of the busi-ness than grocery or big box store sales. Statistics found that in 2007 pre-scription sales for Rite Aid constituted 63.7% of total sales and for Walgreens, 65% of total sales. Phar-macy sales at Safeway were estimated at 7.5% and for Costco, 1.5% of total sales for 2002.

In September 2008, Wal-greens filed a complaint in state court seeking to inval-idate the ordinance, as well as moving for a preliminary injunction to prevent the ordinance from taking ef-fect. The trial court denied the motion for injunctive relief and the ordinance be-came effective on October 1, 2008. Walgreens then filed an amended complaint seeking to invalidate the ordinance.

In its complaint, Wal-greens alleged that the ordinance violated the equal protection clauses of the United States and California constitutions. It

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Legal Briefs

Attorney Dale J. Atkinson is a partner in the law firm of Atkinson & Atkinson, outside counsel for NABP.

stated that the ordinance arbitrarily prohibits some retail establishments from selling tobacco products while allowing others to engage in such sales in vio-lation of equal protection guarantees. Walgreens also argued that the city failed to undertake an economic impact study addressing the material impact the ordinance may have on the city as required under a voter adopted proposi-tion. Walgreens noted that it operates licensed phar-macies in 52 of its 54 full service stores in the city and, similar to the exempt grocery and big box stores, the pharmacies are located in the back of its stores and tobacco products are sold in the front of the stores. Wal-greens asserts that its stores are similar in all relevant respects to the 12 grocery and one big box store in the city, yet such stores are ex-empt from the prohibitions of the ordinance.

In defense, the city argued that the ordinance passes constitutional mus-ter as the exemption of the grocery and big box store is rationally related to the legitimate governmental interests at stake. The trial court agreed with the city and sustained the dismissal motions of the city without leave to amend the com-plaint. The city motions argued that there is no basis to endure a trial on the merits regarding the ordi-nance. Walgreens appealed

the lower court rulings to the appellate court.

On appeal, Walgreens argued that the challenged ordinance violates the equal protection clauses of the state and federal constitu-tions. Under both consti-tutions, equal protection provides that persons shall not be denied equal protec-tion under the law and stands for the principal that similarly situated persons shall receive like treatment. It should be noted that a corporation is considered a person and subject to constitutional guarantees of equal protection.

To successfully argue an equal protection claim, Walgreens must first show that the ordinance affects two or more similarly situ-ated groups in an unequal manner. The city concedes that all retail pharmacy establishments are similarly situated. The court next determined what level of scrutiny must be applied to the ordinance to assess its enforceability. There are three levels of scrutiny to potentially be applied based upon the class of impacted individuals. Laws that impact a suspect clas-sification or fundamental interests are subject to strict scrutiny and can be upheld only if they are necessary to achieve a compelling state interest. Laws based upon gender are subject to inter-mediate level or scrutiny. Finally, most legislation is subject to scrutiny deter-

mining whether the law bears a rational relation-ship to a legitimate state purpose. Both Walgreens and the city agree that the rational relationship test is appropriate in this case.

The court noted a pre-sumption of constitutional-ity of the law (in this case the ordinance) and requires merely that “distinc-tions drawn . . . bear some rational relationship to a conceivable legitimate state purpose.” While a conceiv-able state purpose may provide leeway in interpret-ing the constitutionality of a law, “[s]tatutory distinc-tions resting on ‘speculative possibility’ do not satisfy the requirements of equal protection.”

The court turned its attention to whether there exists a rational basis for exempting general grocery and big box stores that contain licensed pharma-cies from the ban on sales of tobacco products that are applicable to all other retail establishments containing licensed pharmacies. The court recognized the legiti-mate municipal objectives of discouraging smoking and promoting the health concerns of the state.

The city defends the distinction by asserting that the adopters of the ordinance “rationally could have concluded that the sale of cigarettes by stores like Walgreens sends the message about cigarettes

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Legal Briefs(continued from page 181)

Association News

more strongly than does the sale of cigarettes by big box stores or grocery stores that contain pharmacies. In rejecting this argument, the court agreed with Walgreens that the implied message from the sale of tobacco products from either type of establishment is the same.

Further, the court agreed that the Walgreens stores met the four criteria defin-ing a grocery store which included: (1) exceed 5,000 gross square feet; (2) offer a diverse variety of unrelated products; (3) prepare no food for immediate con-sumption; and (4) market all merchandise at retail pro-cess. Comparing Walgreens and grocery stores to previ-ously litigated hotels and motels, the court held Wal-greens and grocery stores to be similarly situated.

The court also noted that the city based its distinction upon greater sales of prescription drugs by Walgreens-type stores as compared to grocery or big box stores. But the court questioned why the message concerning health factors and the safety of tobacco products would be subject to differing inter-pretations based upon the percentage of sales of pre-scription drugs. The court concluded that the “pur-ported implied message conveyed by a pharmacy that sells tobacco products does not justify the ordi-nance’s distinction among general grocery stores, big box stores, and all other stores containing licensed pharmacies.”

The court held that Walgreens’ complaint adequately states a cause of action for a violation of the equal protection provisions of the US and

California constitutions. Thus, the appellate court reversed the lower court dismissal of the complaint related to the constitution-al claims. Regarding the

The matter will eventu-ally be tried on the merits and, if the ordinance is upheld, boards of phar-macy must consider the impact of the law on the regulatory community. From the perspective of the boards of pharmacy, issues may arise as to the impact of the licensure of pharma-cies and/or pharmacists for entities and individuals found to violate the law. Of course, the ordinance is premised upon the exis-tence of and messages sent by the presence of a phar-macy in the establishment. An analysis of the practice act and regulations will determine whether activi-ties “outside” the pharma-cy (but within the store) give rise to administrative consequences for noncom-pliance.

Walgreen Co. v City and County of San Francisco, 2010 WL 2280818 (App. Ct. CA 2010)

NABP Seeking Individuals to Serve on Examinations Committee Individuals interested in serv-

ing on the NABP Advisory Com-mittee on Examinations (ACE) are encouraged to apply. ACE members will oversee the development and administration of all NABP exami-nation and certification programs. ACE typically convenes two to three times per year, and considers policy matters, evaluates long-range plan-ning strategies, and recommends appropriate action to the NABP Executive Committee.

ACE is composed of representa-tives from boards of pharmacy as

well as faculty and/or staff of schools and colleges of pharmacy, and prac-ticing pharmacists who exemplify the diversity in pharmacy practice. Pharmacists chosen to serve on ACE must hold an active, unrestricted license in any state or territory of the United States.

Each ACE appointment is for a three-year term beginning June 1, 2011. Current board of pharmacy members, past board of pharmacy members, and actively practicing pharmacists who meet the criteria above are encouraged to apply.

Interested individuals must submit a written statement of interest and a current resume or curriculum vitae to NABP Execu-tive Director/Secretary Carmen A. Catizone at NABP Headquarters, 1600 Feehanville Drive, Mount Prospect, IL 60056 or exec-office@nabp.net no later than December 31, 2010.

Please contact the NABP com-petency assessment department at NABP_comp_assess@nabp.net with any questions regarding ACE.

. . . if the ordinance is upheld, boards of pharmacy must consider the impact of the law on the regulatory community.

claims that the city failed to undertake an economic impact study addressing the material impact the ordinance may have on the city as required under a voter adopted proposi-tion, the court upheld the dismissal without leave to amend. As a consequence of this decision, the matter will be remanded back to the lower court for a trial on the merits.

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Association News

NABP Seeks Nominations for 2011 Awards to be Presented at 107th Annual Meeting in San Antonio, TX

NABP is currently ac-cepting nominations for the Association’s awards to be presented at the 107th

Annual Meeting, held May 21-24, 2011, at the San Anto-nio Marriott Rivercenter in San Antonio, TX. Individu-als may nominate exem-plary colleagues or boards of pharmacy that represent the NABP mission of protecting the pub lic health.

Nominations are cur-rently being accepted for the following awards: 2011 Les-ter E. Hosto Distinguished Service Award (DSA), 2011 NABP Honorary President, 2011 Fred T. Mahaffey Award, and 2011 John F. Atkinson Service Award.

Lester E. Hosto DSA This award is the highest

honor bestowed by the As-sociation. It was first simply known as the Distinguished Service Award, but was renamed by NABP to serve as a memorial to the 1990-1991 NABP President Lester E. Hosto, whose motivating presence in the practice of pharmacy was recognized by practitioners of his state, pharmacy leaders across the nation, and former United States President Bill Clinton.

The Lester E. Hosto DSA recognizes those individuals whose efforts to protect the public health greatly fur-thered the goals and objec-tives of NABP. Any individual who meets these criteria may be nominated for the DSA, re-gardless of his or her member affiliation with NABP.

Honorary President Nominees who will be

considered for the position of honorary president must meet the following criteria:

• service on one or more NABP committee or task force;

• participation in NABP/American Association of Colleges of Pharmacy District Meetings and NABP Annual Meetings;

• exemplary services for, or on behalf of, NABP;

• strong commitment to NABP, the mission of the Association to protect the public health, and the practice of pharmacy; and

• affiliation (either current or past) as a board mem-ber or as an administra-tive officer of an active or associate member board.

Fred T. Mahaffey Award

This award was named after the late NABP Ex-ecutive Director Emeritus Fred T. Mahaffey, who held the executive direc-tor position from 1962 to 1987. His leadership and contributions to NABP, state boards of pharmacy, and the protection of the public health were sig-nificant and established NABP as one of the lead-ing pharmacy organiza-tions. The award recog-nizes a member board of pharmacy that has made substantial contributions to the regulation of the practice of pharmacy over the past year.

Boards considered for this award must have con-tributed to protecting the public health and welfare through the enforcement of state and federal laws and regulations, and to the ad-vancement of NABP goals and objectives as specified in the Association’s Consti-tution and Bylaws.

John F. Atkinson Service Award

Named in honor of for-mer NABP general counsel John F. Atkinson, who recently retired after serv-ing as NABP legal counsel for more than 40 years, the John F. Atkinson Service Award replaced the Lester E. Hosto Inspector DSA and was first awarded at the 105th Annual Meeting. Recipients of this award are individuals who have pro-vided NABP with exem-plary service in protecting the public health and have shown significant involve-ment with the Association related to pharmacy law and compliance.

Nominations for these awards must be received at NABP Headquarters no later than December 31, 2010. To submit a nomina-tion, individuals may send a letter explaining why the nominee should be con-sidered for the award, as well as a brief biography. A current resume or curricu-lum vitae of the nominee is also required. Please submit your nomination to NABP Executive Direc-

tor/Secretary Carmen A. Catizone at NABP Head-quarters, 1600 Feehanville Dr, Mount Prospect, IL 60056. The NABP Execu-tive Committee will review the nominations and select the honorary president and award recipients.

For more information, please contact Dana Ober-man, executive meeting planner supervising coordi-nator, via e-mail at doberman@nabp.net.

Henry Cade Memorial Award

In addition to the aforementioned awards, the Henry Cade Memo-rial Award will also be presented during the An-nual Meeting. The NABP Executive Committee selects a recipient(s) for the Henry Cade Memorial Award who has supported the goals and objectives of the Association and the state boards of pharmacy to protect the public health and advanced and main-tained the safety and in-tegrity of the distribution and dispensing of medica-tions. Nominations are not accepted for this award.

The Henry Cade Me-morial Award is named in honor of the late Henry Cade, who served as NABP president from 1987 to 1988. Tireless in his efforts on behalf of NABP and the Illinois State Board of Pharmacy, Cade was also a long time pharmacy practi-tioner.

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Feature News

helping to prevent activi-ties that fuel prescription drug abuse.

Multiple C-II Prescriptions

Though action on the aforementioned issues is still pending, in recent years DEA rules and de-veloping federal legislation have begun to address other issues related to the CSA.

Effective December 19, 2007, a DEA rule amended regulations to permit prac-titioners to issue multiple prescriptions for Schedule II controlled substances. In effect, the new rule allows practitioners to prescribe up to a 90-day supply of a controlled substance. Each prescription must be issued for a legitimate medical purpose with specific written instruc-tions by the practitioner indicating the earliest date on which a pharmacy may dispense each prescrip-tion. This rule is intended to “address patients’ needs for schedule II controlled substances while prevent-ing the diversion of those substances,” as explained in the Final Rule published in the November 19, 2007, Federal Register.

e-Prescribing RuleThe interim final rule

on electronic prescriptions for controlled substances went into effect June 1, 2010, and allows prescrib-ers the option to write prescriptions for con-trolled substances elec-

Controlled Substances Act(continued from page 178)

tronically, and pharmacies to receive, dispense, and archive these electronic prescriptions. The regula-tions are an addition to existing rules and will maintain a closed system of controls on controlled substance dispensing. The regulations will reduce paperwork for pharma-cies registered by DEA and have the potential to re-duce prescription forgery. Additionally, the regula-tions have the potential to reduce the number of pre-scription errors and will help integrate prescription records into other medi-cal records. The process of implementing this rule re-quires that prescribers and pharmacies utilize systems that have been certified as meeting the requirements of the rule and thus the implementation process will take time.

Secure Drug Disposal

As boards of pharmacy and pharmacists are well aware, current DEA regu-lations effectively make it unlawful for ultimate us-ers, ie, patients, to return unused controlled sub-stances to pharmacies or other entities for destruc-tion. Regulations stipulate that entities or individuals distributing or dispensing drugs be registered with DEA. The law does state, in USC 21 1307.21(a), that “Any person in possession of any controlled substance and desiring or required to dispose of such substance may request assistance from the Special Agent in Charge

of the Administration in the area in which the person is located for authority and instructions to dispose of such substance.” The code also states, in section 21 CFR 1307.21(d), “This section shall not be construed as affecting or altering in any way the disposal of con-trolled substances through procedures provided in laws and regulations adopted by any State.” Drug take-back programs have been care-ful to follow the federal law by ensuring that a DEA agent or other authorized law enforcement officer is present if accepting unused controlled substances. Many programs, however, opt to not accept unused controlled substances for disposal.

Various legislation has been introduced to the United States Congress to address the need for patients to securely dispose of unused medications. The Secure and Responsible Drug Disposal Act of 2010, (S 3397) passed in the Sen-ate on August 3, 2010. This act would amend the CSA to give the attorney general authority to promulgate regulations to allow patients to deliver unused controlled substances “to appropriate entities for disposal in a safe and effective manner con-sistent with effective con-trols against diversion.” The law would also allow for the authorization of controlled substance disposal by long-term health care facilities on behalf of patients. A similar bill, the Safe Drug Disposal Act of 2010 (HR 5809), has been introduced in the House, and referred to a

house subcommittee. This act would similarly amend the CSA and also would require the implementation of a public education cam-paign, government studies to assess the effectiveness of take-back programs, and an Environmental Protection Agency study on the envi-ronmental impact of exist-ing drug disposal systems.

Rescheduling DrugsProposals for schedul-

ing or rescheduling certain drugs with a high potential for abuse are also currently being considered. For example, DEA held a hear-ing in May 2010 regarding the proposed placement of carisoprodol into Sched-ule IV based on recom-mendations from the US Department of Health and Human Services and an evaluation by DEA.

NABP ActionsTo address such issues, as

previously mentioned, NABP members passed Resolution No. 106-6-10 at the NABP 106th Annual Meeting held in May 2010, which states that NABP should “commis-sion a task force of interested stakeholders to review the provisions of the CSA and ac-companying administrative regulations, identify those provisions that may require review and revision, and recommend legislative and regulatory changes to amend the CSA and accompanying administrative regulations.” See page 185 of this Newslet-ter for more details on this task force. The report of the task force will be available by Spring 2011.

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Association News

2010-2011 Committee, Task Force Appointments AnnouncedNABP provides guidance

on current topics of interest to the state boards of pharmacy through the commissioning of single-issue task forces. When an issue arises that requires special expertise or a commitment of time and funds, a task force is ap-pointed to address an explicit charge and to report its find-ings to the Executive Com-mittee. Copies of the task force reports are posted on the NABP Web site. This year, NABP has commissioned one single-issue task force to review and recommend revisions to the Controlled Substances Act (CSA). NABP President William T. Winsley, MS, RPh, has finalized his ap-pointments for this task force and for the standing commit-tees for the 2010-2011 year.

2010-2011 Task ForceThe Task Force to Review

and Recommend Revisions to the Controlled Substances Act is scheduled to meet October 5-6, 2010, at NABP Headquarters. The task force came about in response to Resolution No. 106-6-10, passed at the NABP 106th An-nual Meeting, calling for its development. The resolution acknowledges that “the prac-tice of pharmacy has changed significantly since the initial implementation” of the CSA which was adopted in 1970. Further, the resolution notes that “current provisions of the CSA could have the unin-tended effect of restricting and inhibiting the provision of pharmacist care.” The task force is charged with the fol-lowing objectives:

1. reviewing selected provi-sions of the CSA and accompanying adminis-trative regulations;

2. identifying those provi-sions that may require review and revision; and

3. recommending legislative and regulatory changes to amend the CSA and accompanying adminis-trative regulations.Chairperson of this task

force is Jay Campbell, RPh, JD, executive director of the North Carolina Board of Pharmacy. Individuals ap-pointed to serve as members include:

• Ross Brickley, RPh, MBA, CGP, North Carolina

• Kristi Dover, PharmD, Texas

• Danna Droz, RPh, JD, Ohio

• Kay Hanson, RPh, Minnesota

• Virginia Herold, MS, California

• Suzan Kedron, JD, Texas

• Lawrence Mokhiber, MS, RPh, New York

• Suzanne Neuber, RPh, Ohio

• Karen Ryle, MS, RPh, Massachusetts

• Jeanne Waggener, RPh, Texas

• Brenda Warren, DPH, Tennessee Serving as alternate

members are Michele Lynch, RPhT, of Florida; Amy Mattila, RPh, of Wisconsin; and J’aime Sirgany, RPh, of California. The Executive Committee liaison is Lloyd K. Jessen, RPh, JD, executive director and drug control program administrator of the Iowa Board of Pharmacy.

Due to the scope of the CSA, subgroups of the task force will also discuss issues via conference call. These subgroups will be composed of four expert panels that will focus on reviewing the CSA from the perspective of a specific pharmacy practice environment: community pharmacy, hospital pharma-cy, long-term care pharmacy, and other pharmacy environ-ments.

The following individuals were appointed to serve on each subgroup.

Community PharmacyChairperson of this

panel is W. Benjamin Fry, RPh, FIACP, FACA, mem-ber of the Texas State Board of Pharmacy. Members include:

• Donald Casar, RPh, Ohio

• Lenna Israbian-Jamgochian, PharmD, Maryland

• Heather Pasquale, RPh, Ohio

• William Prather, RPh, Georgia

• Joanne Trifone, RPh, Massachusetts

• Dennis Wiesner, RPh, TexasThe Executive Commit-

tee liaison is James T. DeVita, RPh, member, Massachusetts Board of Registration in Pharmacy.

Hospital PharmacyChairperson of this panel

is Susan Ksiazek, RPh, mem-ber of the New York State Board of Pharmacy. Members include:

• Kevin Borcher, PharmD, Nebraska

• Rebecca Deschamps, RPh, Montana

• Paul Limberis, RPh, Colorado

• Alice Mendoza, RPh, Texas

• Anne Policastri, PharmD, MBA, FKSHP, Kentucky

• Michael Romano, RPh, PennsylvaniaThe Executive Commit-

tee liaison is Cathryn J. Lew, RPh, of Oregon.

Long-Term Care PharmacyChairperson of this panel

is Patricia D’Antonio, RPh, MS, MBA, CGP, executive director of the District of Co-lumbia Board of Pharmacy. Members include:

• William Fitzpatrick, RPh, Missouri

• Elizabeth Gregg, RPh, Ohio

• Stanley Weisser, RPh, CaliforniaThe Executive Committee

liaison is Gary A. Schnabel, RN, RPh, executive direc-tor, Oregon State Board of Pharmacy.

Other Pharmacy Environments

Chairperson of this panel is Gay Dodson, RPh, execu-tive director/secretary of the Texas State Board of Phar-macy. Members include:

• Robert Giacalone, RPh, JD, Ohio

• William Harvey, RPh, New Mexico

• Randall Knutsen, RPh, Colorado

• Kendall Lynch, RPh, Tennessee

• Rich Palombo, RPh, New Jersey

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Association News

NABP Convenes Committee to Ensure Validity of MPJE StandardsBased on Multistate

Pharmacy Jurisprudence Examination® (MPJE®) validation study survey results garnered earlier this year, the application of pharmacy law appears to be shifting within the practice of pharmacy. Boards of pharmacy are placing more emphasis on the impor-tance of pharmacy juris-prudence as it applies to the practice of pharmacy and less on regulatory structure. It is imperative that the MPJE and all pharmacy-related examinations con-tinue to evolve and remain consistent with the scope of pharmacy practice as it undergoes these changes.

As a result of this shift and subsequent revisions to the MPJE competency statements set to take effect in January 2011, NABP recently held a standard setting meeting to evaluate

the current passing score for the MPJE. Standard setting is a critical compo-nent of test development, particularly in high-stake, criterion-reference tests such as the MPJE.

With representation from all NABP member districts, the standard set-ting committee consisted of both board of pharmacy members and MPJE Review Committee members. In addition, many of the panelists had participated in either an MPJE item-writing workshop or MPJE state-specific pool review workshop prior to serving on the standard setting committee.

NABP carefully selected each panelist to ensure that a demographically diverse group of individuals with expertise in pharmacy law served on the commit-tee. It was critical to have

representation from all of the NABP member districts during this meeting as the approved passing score will ultimately be applied to all current and future jurisdic-tions participating in the MPJE program.

The Standard Setting Process

After undergoing exten-sive training, the standard setting committee was asked to rate MPJE items by focusing on what they felt a sufficiently knowledgeable pharmacist should know in terms of the application of pharmacy law in practice. They did so utilizing a stan-dard setting analysis model and adhering strictly to test-ing industry standards.

Upon completion and thorough review, the standard setting committee established what they be-lieved to be an appropriate

passing score, which they then recommended to the MPJE Review Committee and NABP Advisory Com-mittee on Examinations.

The recommended passing score will be presented to the Execu-tive Committee and, after careful analysis of the outcomes and impact data, the Executive Com-mittee will make a final policy decision on wheth-er to approve the passing score. If approved, the passing score will go into effect concurrently with the MPJE revised compe-tency statements and blue-print in January 2011.

FPGEE Review Committee Meets to Discuss Test ItemsThe Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®) Review Committee convened at NABP Headquarters to discuss and evaluate items for the examination. Pictured from left to right: Timothy J. Smith, RPh, PhD, professor, physiology and pharmacology, and chairman, Department of Physiology and Pharmacology, University of the Pacific Thomas J. Long School of Pharmacy and Health Sciences; and Ronald Worthington, AB, PhD, assistant professor of pharmaceutical sciences, Southern Illinois University Edwardsville, School of Pharmacy.

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Association News

DMEPOS Accreditation Deadline Extended; Pharmacies Seek Reaccreditation as New Laws Offer Limited Exemptions to Some

The deadline for durable medical equipment pharma-cies to obtain durable medi-cal equipment, prosthetics, orthotics, and supplies (DMEPOS) accredita-tion has been extended to January 1, 2011. This change, along with provisions that exempt some pharmacies from having to seek accredi-tation, is a direct result of the health care reform legisla-tion, HR 3590, The Patient Protection and Affordable Care Act (PPACA), that was signed into law earlier this year. Section 3109(a) of the PPACA, amends sub-paragraph (F)(i) of section 154(b)(1)(A) of the Medicare Improvements for Patients and Providers Act of 2008 to indicate these modifications to DMEPOS accreditation requirements.

Suppliers wishing to ob-tain Medicare Part B billing privileges for products and services that are subject to the Centers for Medicare & Med-icaid Services (CMS) quality standards are still required to obtain DMEPOS accredita-tion; however, the PPACA exempts pharmacies that already have such privileges if they meet certain criteria. According to the PPACA, to qualify for exemption by January 1, 2011, a pharmacy must meet all of the follow-ing criteria:1. the total billings by the

pharmacy for DMEPOS are less than 5% of total pharmacy sales for the previous three calendar years;

2. the pharmacy has been enrolled as a supplier of DMEPOS and has been issued a National Supplier Clearinghouse (NSC) provider number for at least five years;

3. no final adverse action has been imposed on the pharmacy in the past five years;

(continued on page 188)

Of the 25 suppliers who obtained accreditation from [NABP] in 2007 when the program first began, nearly 70% have opted for reaccreditation.

4. the pharmacy submits an attestation, in the manner and at the time frame to be determined, that the pharmacy meets the criteria listed in 1-3; and

5. the pharmacy agrees to submit materials as requested during the course of an audit conducted on a random sample of pharmacies selected annually. CMS further discusses

these criteria in its fact sheet, stressing that crite-rion No. 1 pertains spe-cifically to total pharmacy revenue. If a pharmacy is part of a larger facility, such as a grocery store, the total DMEPOS sales would have to be less than 5% of

the total pharmacy sales, not of the total grocery store sales, in order for the pharmacy to be exempt from accreditation. Newly opened pharmacy locations are automatically required to be accredited by the January 1, 2011 deadline as they do not meet the five-year requirement stated in exemption criterion No. 2.

Status of DMEPOS Accreditations

Despite the enactment of the PPACA, NABP continues to receive new DMEPOS accreditation applications as well as requests for reaccredi-tation. Of the 25 suppliers who obtained accreditation from the Association in 2007 when the program first be-gan, nearly 70% have opted for reaccreditation. These suppliers are composed of both independent and chain pharmacies.

Requirements that may be driving suppliers to seek reaccreditation may include:

• Those set by CMS in order to participate in the competitive bidding process

• Those set by third-party insurance providers

• Those necessary to obtain an NSC number in order to bill for MedicareTim Cady, president of

Advanced Diabetes Supply, says he never really thought about not obtaining reac-creditation. He explains that Advance Diabetes Supply deals with a lot of Medicare Part B services and in order

to bill for these services they must be accredited. Advanced Diabetes Supply was first awarded DMEPOS accreditation by NABP in 2007 and obtained reac-creditation earlier this year. “Accreditation holds us to a higher standard,” Cady states.

According to Cady, another motive for seeking accreditation was for man-aged care reasons. “We are finding that more and more managed care organizations are asking for accredited suppliers,” he says. Cady explains that accreditation is becoming a standard of care for pharmacies and others who provide durable medi-cal equipment.

Like Advanced Diabetes Supply, CVS/pharmacy and Walgreen Co first received DMEPOS accreditation from NABP in 2007 and are both currently undergoing the DMEPOS reaccreditation process. Gregory Sciarra, RPh, director of pharmacy operations at CVS/pharmacy, explains that DMEPOS ac-creditation “adds credibility to our services while pro-viding us latitude to pursue different opportunities with Medicare.” Sciarra continues, “accreditation provides an additional level of comfort to our Medicare beneficiaries.”

According to Ric Leon-ardi, RPh, director of Medicare Part B at Walgreen Co, based on the rules writ-ten, he felt that as a large chain, Walgreens needed to

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Association News

DMEPOS Accreditation(continued from page 187)

obtain accreditation. Similar to Cady’s earlier statement, Leonardi also explains, “cer-tain state Medicaid programs have tacked on to the Medi-

care accreditation movement and have begun requiring that pharmacies be accredited in order to bill.”

Suppliers that are ob-taining and maintaining DMEPOS accreditation are doing their part to ensure

that Medicare beneficiaries receive the products, ser-vices, and patient care they deserve. With more than 100 years of experience in pharmacy, NABP shares this ultimate goal and remains committed to protecting

the public health through its DMEPOS accreditation program. More information on the DMEPOS accredita-tion program is available on the NABP Web site at www.nabp.net/programs/accreditation/dmepos.

Newly Accredited DMEPOS FacilitiesThe following facilities were accredited through the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) program:

A full listing of the nearly 1,000 accredited DMEPOS companies representing close to 30,000 facilities is available on the NABP Web site at www.nabp.net.

Caring PharmacyChamblee, GA

CityRx PharmacyPaterson, NJ

Seventh Avenue PharmacyNew York, NY

The Medicine ShoppeFresno, CA

Committee and Task Force Appointments(continued from page 185)

• Michael Podgurski, RPh, Pennsylvania

• Walt Slijepcevich, RPh, California

• Frank Whitchurch, RPh, KansasThe Executive Committee

liaison is Michael A. Burleson, RPh, executive director, Ken-tucky Board of Pharmacy.

2010-2011 Standing Committees

As authorized by the NABP Constitution and Bylaws, the Association’s standing com-mittees annually perform spe-cific responsibilities that are es-sential to the success of NABP’s programs. Once a committee has explored its assigned issues, the members submit recom-mendations or resolutions to the NABP Executive Commit-tee for consideration.

The Committee on Law Enforcement/Legislation will meet during the first quarter 2011 at NABP Headquarters. The committee is charged with the following tasks:1. reviewing and comment-

ing on existing legislation and rules for the prac-tice of pharmacy, legal distribution of drugs, and related areas within phar-macy, including impaired pharmacists;

2. developing model regula-tions for pharmacy as assigned by the Execu-tive Committee, or from resolutions adopted by the members of the Associa-tion, or from reports of the other committees of the Association; and

3. recommending to the Ex-ecutive Committee areas where model regulations are needed in pharmacy for improving the protec-tion of the public health.

Chairperson of the com-mittee is Patricia Donato, RPh, a member of the New York State Board of Phar-macy. Committee members include:

• Buford Abeldt, Sr, RPh, Texas

• Lee Ann Bundrick, RPh, South Carolina

• William Cover, RPh, Indiana

• Susan DelMonico, JD, RPh, Rhode Island

• Charles Wetherbee, Texas

• Philip Burgess, RPh, Illinois

• Wendy Anderson, RPh, ColoradoThe Executive Committee

liaison is Hal Wand, MBA, RPh, executive director of the Arizona State Board of Pharmacy.

The Committee on Constitution and Bylaws will meet in April 2011, via conference call. The charge of this committee, as defined by

the NABP Constitution and Bylaws, is to review proposed amendments to the Consti-tution and Bylaws, suggests changes where appropriate, and issue a recommendation for each proposed amend-ment.

Chairperson for the com-mittee is Edith Goodmaster, a member of the Connecticut Commission of Pharmacy. Committee members in-clude:

• Patrick Adams, RPh, Hawaii

• Troy Gahm, RPh, Ohio

• Joyce Tipton, RPh, MBA, Texas

• Vernon Benjamin, RPh, IowaServing as alternate mem-

bers are Karen Braman, RPh, MS, of Kansas, and Randy Kajioka, PharmD, of Califor-nia. The Executive Commit-tee liaison to the committee is Gregory Braylock, Sr, RPh, of Ohio.

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Professional Affairs Update

Around the Association

(continued on page 190)

Board Member Appointments

• Beth Foster, RPh, has been appointed a member of the Nevada State Board of Pharmacy. Foster’s appointment will expire on October 31, 2012.

• Kirk Wentworth, RPh, has been appointed a member of the Nevada State Board of Pharmacy. Wentworth’s appointment will expire on November 30, 2012.

Board Member Reappointments

• Lee Ann Bradley, RPh, has been reap-pointed as a member of the Montana Board of Pharmacy. Bradley’s appointment will ex-pire on July 1, 2015.

• Joseph Bushardt, RPh, has been reappointed as a member of the South Carolina Department of Labor, Licensing, and Regulation – Board of Pharmacy. Bush-ardt’s appointment will expire on June 30, 2012.

Board Officer Changes The Alabama State Board of Pharmacy has elected the following officers to the Board:

• Mike Mikell, RPh, President

Rise in Prescription Pain Pill Abuse Documented in Latest SAMHSA Data

Abuse of prescription pain medications continues to rise, according to the lat-est data from the Substance Abuse and Mental Health Services Administration (SAMHSA). The agency’s Treatment Episode Data Set showed that the pro-portion of substance abuse treatment admissions for individuals aged 12 and older rose 400% from 1998 to 2008. SAMHSA data also showed an increase in emergency room visits involving the non-medical use of a prescription nar-cotic pain reliever, which have tripled in propor-tion since 1998. SAMHSA Administrator Pamela S. Hyde, JD, stressed that the non-medical use of prescription pain reliev-ers is now the second most prevalent form of illicit drug use. Hyde emphasized the importance of rais-ing awareness about this public health threat and educating the public on the “critical importance of properly using, stor-ing, and disposing of these powerful drugs” as re-ported in a SAMHSA press release available at www .samhsa.gov/newsroom/advisories/1007140544.aspx.

Hearing Addresses Need for Single Federal Drug Disposal Guideline

At a hearing on drug waste and disposal, United

States Senator Herb Kohl, chairman of the Special Committee on Aging, emphasized the need for consistent federal guide-lines for proper and safe disposal of unused medica-tions. Kohl also called on Drug Enforcement Admin-istration (DEA) to update regulations to allow for the safe disposal of controlled substances through medi-cation disposal programs. Strategies such as improv-ing patient medication ad-herence, expanding medi-cation therapy management programs, and limiting initial dispensing for cer-tain medications with high noncompliance rates, were discussed as means to lower the amount of unused drugs at the prescribing and dispensing stages. DEA, Office of National Drug Control Policy, and repre-sentatives from successful take-back programs took part in the discussion. More information is available in a hearing summary available on the United States Senate Special Committee on Ag-ing Web site at http://aging .senate.gov/hearing_detail .cfm?id=326106&.

Internet Outlet Operator Convicted, Faces Prison Time

Convicted of conspiracy to distribute a controlled substance and other charges related to an Internet drug outlet scheme, David Allen Vogel forfeited over $29 million and could face more than 20 years in federal prison. According to the Department of Justice, from

August 2000 to November 2007, Vogel, the owner and operator of Madison Pain Clinic, and his co-conspir-ators operated an Internet-based pharmacy through which they distributed millions of hydrocodone tablets and other controlled substances without requir-ing valid prescriptions. A su-perseding indictment, filed on August 13, 2009, charged Vogel and three others with federal drug and money laundering violations. On June 30, 2010, Vogel was found guilty by a jury fol-lowing an eight-day trial and faces up to five years in federal prison on the drug conspiracy charge, up to 20 years in federal prison on the money laundering con-spiracy charge, and up to 10 years for each of the money laundering charges. More information is available in a press release on the Depart-ment of Justice Web site at www.justice.gov/usao/txe/news_release/news/EDTX_VOGEL063010.html.

Pharmacist Pleaded Guilty to Fraud and Other Charges, Sentenced to Prison

Pamela Arrey, a licensed pharmacist who owned and operated two pharmacies in Baltimore, MD, pleaded guilty to charges of health care fraud, aggravated iden-tity theft, and conspiracy to misbrand pharmaceu-ticals. According to the Department of Justice, from January 2003 to January 2008, Arrey claimed reim-bursements from health

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Professional Affairs Update

Around the Association(continued from page 189)

• Robert Nelson, PharmD, Vice President

• Donnie Calhoun, RPh, Treasurer

The Georgia State Board of Pharmacy has elected the following officers to the Board:

• Malcolm Tatum, RPh, President

Professional Affairs Update(continued from page 189)

care benefit programs for prescriptions for which physicians had authorized refills that were not request-ed by the patients. Arrey used patients’ personal identifying information to make these claims for drugs that were never dispensed, and obtained approximately

$505,745 through this fraudulent scheme. Fur-ther, as discovered in a July 2008 surprise inspection of one of Arrey’s pharmacies by the Maryland Board of Pharmacy, she had acquired large drums of misbranded pharmaceuticals that were purchased from an unli-censed supplier. The Mary-land Board of Pharmacy re-covered from one pharmacy 11 drums containing over

200,000 misbranded pills, and a subsequent search of Arrey’s home and pharma-cies by federal agents uncov-ered additional drugs with expiration dates removed and altered labels. Evidence of fraudulent claims and relabeled prescription drugs prompted Food and Drug Administration, in 2008, to issue an alert to customers not to use drugs distrib-uted by Arrey’s pharmacy.

Arrey was sentenced by a US District Judge to 57 months in prison followed by three years of supervised release. More information is provided in a Depart-ment of Justice press release available at www.justice .gov/usao/md/Public-Affairs/press_releases/press08/PharmacyOwnerSentencedtoover4YearsforHealthCareFraud AggravatedIdentityTheftandConspiracy.html.

ClarificationIn the Special Annual Meeting Issue 2010 NABP

Newsletter article “Examining the Harmonization of PharmD Program Standards for Foreign-Educated Students,” the NAPLEX pass rates were reported in error for Western University of Health Sciences College of Pharmacy’s International Post Baccalaureate PharmD (IPBP) Program. Both the IPBP graduates and the total graduating class had 100% pass rates for the 2007 and 2008 May-August testing window. The reported rates referred to measures of didactic perfor-mance in the PharmD curriculum. NABP regrets any confusion this may have caused.

• Steve Wilson, RPh, Vice President

The Massachusetts Board of Regis-tration in Pharmacy has elected the following officers to the Board:

• Joanne Trifone, RPh, President

• Sophia Pasedis, RPh, PharmD, Secretary

The Montana Board of Pharmacy has elected the following officers to the Board:

• Lee Ann Bradley, RPh, President

• Frances Carlson, Secretary

The South Carolina Department of Labor, Licensing, and Regulation – Board of Pharmacy has elected the following officers to the Board:

• James Bradham, RPh, Chairperson

• Joseph Bushardt, RPh, Vice Chairperson

The following entities were accredited through the NABP e-Advertiser ApprovalCM Program:

Foundation Care, LLCwww.foundcare.com

F & N Pharma, Inc dba West Drugwww.westdrug.com

A full listing of NABP approved e-Advertisers is available on the NABP Web site at www.nabp.net.

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191

State Board News

South Dakota Establishes PDMP

In South Dakota, a new law was passed establishing a prescription drug moni-toring program (PDMP), and placing the respon-sibility for implementing and operating the program with the South Dakota State Board of Pharmacy. The new law provides for an advisory committee made up of prescribers, dispensers, and other stakeholders to provide advice and make recom-mendations to the Board regarding how to best use the program to improve patient care and foster the goal of reducing misuse, abuse, and diversion of controlled substances. Board staff will be drafting administrative rules to de-fine the details of the pro-gram within the authority and mandate of the law. As the rules are developed they will be available on the Board’s Web site. The Board encourages pharma-cists to comment on the rules prior to the public hearing.

Submitting prescrip-tion drug utilization data to the program will be mandatory for all phar-macies and dispensers who provide controlled substances to South Da-kota patients. Data will be collected online via an interface data dump (like online insurance adjudi-cation). The information will be transferred to the secure database.

Prescribers and phar-macists will access this

information for the care of their patients. The pro-gram is not intended to be used to target subjects for investigation, but rather to identify illegal activ-ity such as prescription forgery, indiscriminate prescribing, and to deter “doctor shoppers.” Health care providers will have access to review the data online through a secure server once the data has been collected, but are not required to access the da-tabase prior to writing or dispensing a prescription.

The Board anticipates that the program will be operational by July 1, 2011.

Louisiana Board Adds Drugs of Concern to PMP Reporting Requirements

Effective September 1, 2010, the Louisiana Board of Pharmacy requires that eligible transactions of drugs of concern – defined by law to mean drugs other than controlled substances that demonstrate a potential for abuse – are reported to its prescription moni-toring program (PMP) database.

When the Louisiana Legislature enacted the Prescription Monitor-ing Program Act, the law directed dispensers of controlled substances and drugs of concern to report their eligible transactions to the program’s database for inquiry and analysis by prescribers and dis-pensers. When the Loui-siana Board of Pharmacy

implemented the program in 2009, the Board began with the collection of information for controlled substances in Schedules II through V. The Board is now prepared to add drugs of concern to the database. The Board has concluded the required rulemaking process to formally identify drugs of concern, and they include any material, compound, mixture, or preparation containing any quantity of the following substances, including its salts, esters, ethers, isomers, and salts of isomers (whenever the existence of such salts, esters, ethers, isomers, and salts of isomers are pos-sible within the specific chemical designation): (1) butalbital when in com-bination with at least 325 milligrams of acetamino-phen per dosage unit, and (2) tramadol.

Minnesota Enacts Laws Regarding Pharmaceutical Waste

The final version of the Minnesota Safe Drug Disposal Act that was en-acted into law clarifies that law enforcement agencies, hazardous waste haulers, and facilities regulated by the Minnesota Pollution Control Agency can pos-sess pharmaceuticals for the purpose of disposing of them. It also formally allows members of the public to transfer non-controlled legend drugs to these entities. The Min-nesota Board of Pharmacy

reminds pharmacists that they cannot accept pharma-ceuticals from patients or long-term care facilities, for the purpose of disposing of them, unless all applicable state and federal laws and rules are followed. This applies to both scheduled and non-scheduled drugs – although the restrictions are greater for scheduled drugs. In addition, a separate law was enacted that requires the Board to “study prescription drug waste reduction techniques and technologies applicable to long-term care facilities, veterans nursing homes, and correctional facilities.” The Board must present recommendations on the adoption of new prescrip-tion drug waste reduction techniques and technolo-gies to the Legislature by December 15, 2011.

Washington Requires Electronic Tracking of PSE, Ephedrine, and Phenylpropanolamine

The 2010 Washington State Legislature passed a bill to implement state-wide electronic tracking of pseudoephedrine (PSE), ephedrine, and phenyl-propanolamine (metham-phetamine precursors). The electronic tracking system will replace paper logs that are currently required. Over the next year, the Washington State Board of Pharmacy will write regulations and implement pharmacy training to use the Web-based software.

National Association of Boards of Pharmacy1600 Feehanville DriveMount Prospect, IL 60056

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