Iowa Board of Pharmacy Rules Regarding Pharmacy Benefit Managers

Pharmacy Benefit Managers
Today, more than 210 million Americans nationwide receive drug benefits administered by pharmacy benefit managers (PBMs). It is estimated that there are fewer than 100 major
IA Vol. 27, No. 2

PBM companies in the United States. The Iowa Board of Pharmacy office routinely receives numerous questions about the activities of PBMs. In Iowa, PBMs are regulated by the Iowa Department of Commerce, Insurance Division. Current law resides in Iowa Code, Chapter 510B and administrative rules are located in 191 Iowa Administrative Code, Chapter 59. The law and rules have been in effect since 2007-2008. A copy of Iowa law and rules for PBMs is included as an insert to this issue of the Newsletter. PBMs are required to obtain the approval of the prescribing practitioner prior to request- ing any drug substitution under Iowa Code §510B.6. A PBM may not substitute an equivalent prescription drug contrary to a prescription drug order that prohibits a substitution. PBMs are required to develop an internal system to record and report complaints. These requirements are contained in 191 I.A.C. 59.5(1). The Iowa Insurance Division has drafted some specific instructions for pharmacists who wish to file a complaint against a PBM, which are available online at www .iid.state.ia.us/file_a_complaint. PBMs are required to submit a summary of all complaints filed against them with the Iowa commissioner of insurance on a quarterly basis. Forty-eight PBMs are listed in the online directory of the Pharmacy Benefit Management Institute at www.pbmi.com/pbmdir.asp. None of these companies are located in Iowa. In 2012, the five largest PBMs in the US were Express Scripts of St Louis, MO; CVS Caremark of Scottsdale, AZ; Prime Therapeutics of Eagan, MN; OptumRx of Irvine, CA; and Catamaran of Lisle, IL.

quoted from Iowa Board of Pharmacy September 2013 Newsletter

Kudos!! New Mexico Board of Pharmacy Law Updates Provided from now until End of Year

Law Update Reminder
In 2013, the Board has been offering two law updates each month in the Albuquerque, NM, area. Both updates are avail- able on the same Friday. One update is offered from 9 am to 11 am. The other update is offered from 2 pm to 4 pm. To reserve a space, contact Jessica Chavez-Lance at 505/222-9830 or Jessica .Chavez-Lanc@state.nm.us.
♦ Law Update Schedule (Albuquerque) ◊ September 13, 2013
◊ October 25, 2013
◊ November 15, 2013
◊ December 20, 2013
♦ Law Update Schedule (around state)
These law updates are scheduled for 7 pm to 9 pm. ◊ September 10, 2013 – Clovis, NM
◊ September 17, 2013 – Farmington, NM
◊ September 24, 2013 – Taos, NM
◊ October 29, 2013 – Hobbs, NM
◊ November 19, 2013 – Las Cruces, NM
The New Mexico Society of Health-System Pharmacists (NMSHP) will host a law update on Sunday, October 6, 2013. Please contact NMSHP for information and to reserve a spot. 

New Mexico Pharmacy Statute Change Relating to dangerous drugs

Statutory Change
During the 2013 legislative session, the statute 26-1-16.J. NMSA was revised. The revised statute says that a pharmacist may dispense a quantity not to exceed a 90-day supply of a dangerous drug by combining valid fills. The prescription must not state an indication specifically prohibiting a combined fill. And also, the medication cannot be a CS.

quoted from New Mexico Board of Pharmacy September 2013 Newsletter 

New Mexico Board of Pharmacy Disciplinary Action 2013

Disciplinary Actions
Anastacia Barka, PT – License PT-1727. Respondent voluntarily surrendered her registration as a pharmacy technician (PT). Must pay investigative costs in the amount of $500.
James Gaynor, RPh – License RP-4407. Respondent entered into a stipulated agreement with the New Mexico Board of Pharmacy. Respondent pled no contest to Board allegations that he filled a personal prescription for alprazolam. Must pay investigative and fine costs in the amount of $750.
Daniel Hall, RPh – License RP-6813. Respondent voluntarily surrendered his registration as a pharmacist. Must pay inves- tigative and fine costs in the amount of $1,362.
Madana Harvey, DDS – License CS-216894. Respondent volun- tarily surrendered her controlled substance (CS) registration. Must pay investigative costs of $100.
Kelly Kemper, RPh – License RP-5290. The Board found by a preponderance of the evidence that respondent Kelly Kemper unlawfully obtained a CS. Pharmacist license was revoked for a period of three years. May reapply after three years. Within 90 days, must pay investigation and Board costs of $1,121.17.
Lillian Lovato, RPh – License RP-6262. New Mexico Monitored Treatment Program (MTP) reported to the Board that respon- dent had violated terms of her contract. The Board suspended respondent from the practice of pharmacy until her successful completion of MTP contract.

North Dakota Board of Pharmacy Quality-Related Events – Errors and Continuous Quality Improvement

By Howard C. Anderson, Jr, RPh
The Board, at its July 18, 2013 meeting, voted to move ahead with a rule to require a continuous quality improvement (CQI) program in all North Dakota pharmacies.
The Board already has a requirement in all of its telepharma- cies, central sites, its hospitals, and for sterile product preparation.
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Many states have mandated reporting of errors that cause mortality or significant morbidity. The North Dakota Board feels this is too late in the process, as harm has already occurred.
It is the intent of the new requirement to focus on quality- related events (QREs), which are the precursors of errors (those that get out of the pharmacy’s hands and put the patient at risk).
The rule will require recording of QREs and analysis of them to identify places where changes can be made to prevent errors from occurring. Errors are also reported and serious analysis (gap analysis) is conducted to determine why we have a gap between our expected outcome (a perfect prescription or more importantly, a good patient outcome) and what actually occurred (an error of some kind resulting in a poor patient outcome).
The rule will include discovery protection (a lawyer cannot ask for your CQI report so he or she can find potential clients or reveal that you had six near misses to bolster his or her case before the judge or jury).
The rule will include a reference to reporting to a patient safety organization (PSO) to provide federal protection under the 2005 Patient Safety and Quality Improvement Act.
The North Dakota Pharmacists Association has a co-marketing agreement with a PSO and an excellent online CQI program. The Board will also have manual QRE recording forms on its Web site should you not choose to utilize an online CQI program. The Board will ask you to analyze your internally recorded QREs in lieu of the computer-assisted analysis.
Look for the rule hearing announcement, and of course the proposed rule will be published. 

quoted from the North Dakota Board of Pharmacy September 2013 Newsletter

Vermont Board of Pharmacy Public Hearing Scheduled for October 2, 2013 Regarding Rule Changes

Board Public Hearing
The Board has recently completed a review of the Rules Governing the Practice of Pharmacy. The Board will hold a public hearing on the proposed rule amendments, additions, deletions, and corrections on October 2, 2013, as part of its regularly scheduled meeting. The meeting is open to all and the Board will take testimony – positive, neutral, or negative – on the proposed changes. All individuals working in the profes- sion as well as any other interested individuals are encouraged to review the proposed changes and comment accordingly.
For more information or if you have questions, please contact the Board office.

quoted from Vermont Board of Pharmacy September 2013 Newsletter 

New Law in Vermont Relating to Pharmacy-Act 75

New Laws for Vermont
In response to seemingly increased opioid addiction and methamphetamine abuse in the state, the 2013 Vermont Gen- eral Assembly passed and Governor Peter Shumlin signed Act 75. The act was formerly known as H.522 (House Bill 522).
There are several provisions that affect the practice of pharmacy and pharmacists in the state of Vermont. It is the responsibility of all pharmacists to be familiar with the law, conversant with it, and to abide by its provisions in the course of their practice of the profession.
All prescriptions for regulated drugs shall be made to the order of an individual patient, dated as of the day of issue, and signed by the prescriber. The prescription shall bear the full name, address, and date of birth of the patient. In the event the prescription is for an animal, the name and address of the owner of the animal and the species of the animal.
All prescriptions shall also bear the full name, address, and registry number of the prescriber. If the prescription is written, it shall be in ink, indelible pencil, or typewritten and shall be signed by the prescriber. A written prescription for a controlled substance (CS) shall contain the quantity of the drug written both in numeric and word form.
Only a patient for whom a prescription was written, the owner of an animal for which a prescription was written, or a bona fide representative of the patient or animal owner may pick up a prescription for a Schedule II, III, or IV CS. Prior to dispensing a Schedule II, III, or IV CS, a pharmacist shall require the individual receiving the drug to provide a signature and show valid and current government-issued photographic identification as evidence that the individual is the patient for whom the prescription was written, the owner of the ani- mal for which the prescription was written, or the bona fide representative of the patient or animal owner. If the patient does not have valid, current government-issued photographic identification, the pharmacist may request alternative evidence of the individual’s identity, as appropriate.
The legislation requires the Vermont Board of Pharmacy to adopt rules to define which persons shall be considered bona fide representatives of a patient. To that end, the Board has proposed the following rule definitions.

“Bona fide representative of a patient” as referred to in 18 V.S.A. §4201(26) means an individual who is authorized by law or known to the patient and authorized by the patient to receive drugs dispensed by prescription for the patient.
“Bona fide representative of an animal owner” as referred to in 18 V.S.A. §4201(26) means the owner of an animal or a person authorized by the owner to receive drugs dispensed by prescription for the animal.
“Alternative evidence of the individual’s identity” as referred to in 18 V.S.A. §4201(26) means documents that reasonably permit a pharmacist to conclude that the individual is who he or she purports to be.
The adoption of the aforementioned proposed definitions will be part of a public hearing the Board will hold on Wednes- day, October 2, 2013.
quoted from the Vermont Board of Pharmacy September 2013 Newsletter 

West Virginia Board of Pharmacy Sets Deadline for Out-Of-State Board Sets Deadline for Mail-Order Pharmacy PIC Licensure

As mentioned in the last issue, the legislature passed “The Larry W. Border Pharmacy Practice Act,” House Bill 2577, on April 13, 2013, setting an effective date of July 1, 2013. As it was going through toward passage, some noticed that the language would require every pharmacist practicing “pharma- cist care” in West Virginia to have a West Virginia pharmacist license. This is not a surprising concept, of course; that is, until people noticed that the language would require all out- of-state pharmacists dispensing from mail-order pharmacies into West Virginia to be licensed in this state, which would be a new burden if implemented. There are approximately 360 active mail-order permits issued by the West Virginia Board of Pharmacy, with the vast majority of those being out-of-state permits. So, the act was amended to provide that only the pharmacist-in-charge (PIC) of the out-of-state mail-order pharmacy would have to be licensed as a West Virginia pharmacist; the other pharmacists working under the PIC would simply need a valid pharmacist license in the state where the pharmacy is located. The Board noted that the PICs around the country would need some time to reciprocate their licenses to West Virginia. So, the Board voted to allow until July 1, 2014, for the out-of-state mail-order pharmacies and their PICs to become compliant. If you are one of those PICs, the Board looks forward to working with you through the licensing and reciprocation process in the coming weeks. 

quoted from the West Virginia Board of Pharmacy September 2013 Newsletter

NABP Model Act Amended to Address Shared Service Concept, Medication Reuse Programs, and Internet Pharmacy Safety

NABP recently amended the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) in its effort to assist the state boards of pharmacy
as they work to protect the public health. Changes made to the Model Act were incorporated as a result of the Executive Committee- approved recommendations of the Task Force on Phar- macy Practice Technology Systems, the Task Force on Internet Pharmacy Practice, the Task Force on Drug Re- turn and Reuse Programs, and the 2012-2013 Commit- tee on Law Enforcement/ Legislation.

continue to read at NABP September 2013 Newletter 

From NABP Association Supports Member Boards With Development of Electronic Resource for Verifying Pharmacy Licensure State Compounding Pharmacy Inspection Programs Continue and Iowa Inspection Program Update

NABP member boards continue efforts to ensure the safety of compounded drug products, including a new initiative undertaken by the Association.
At the request of member state boards of pharmacy, NABP has begun develop- ing an electronic resource
to facilitate the sharing of pharmacy licensure and related information among the states. The Verified Pharmacy ProgramTM (VPPTM), scheduled to launch by the end of 2013, will store licensee data and inspection report compo- nents in a uniform format. Data will be available to boards of pharmacy with the aim of supporting licensing decisions, of par- ticular interest when boards are considering applications for nonresident licensure.
In addition to developing VPP, NABP continues to conduct pharmacy inspec- tions, including surveys of compounding pharmacies, on behalf of the Iowa Board of Pharmacy and in partner- ship with state agencies in New Jersey.
Verified Pharmacy Program
Relevant data on li- censed pharmacies will be stored in VPP in the form of a pharmacy e-Profile. Pharmacy e-Profiles will allow NABP to collect and verify the following infor-

mation for reporting to the boards of pharmacy:
• Pharmacy licenses (resi- • dent and nonresident).
Pharmacist-in-charge
(PIC) licenses (resident • and nonresident).
Disciplinary information.
The pharmacy e-Profile will also indicate whether
a qualified inspection has been performed by the resi- dent state or a designated agent.
Information in the pharmacy e-Profiles will be accessible to boards through the Board e-Profile Connect interface. The informa-
tion will also be proactively reported to boards.
In requesting that the Association initiate the de- velopment of VPP, member boards noted that the sys- tem would be particularly beneficial when considering applications for licensure from nonresident pharma- cies. Under the current system, boards may be asked to make licensing decisions about nonresident phar- macies with incomplete or outdated information. Chal- lenges creating this situa- tion include differing laws and regulations, as well as differing levels of resources from board to board. For example, some boards may not have the fiscal or human resources to conduct the same frequency and type
of pharmacy inspections as others with more robust budgets.

To help address the differences in regulatory structure and operations among the boards, VPP
will facilitate the sharing
of licensure information about pharmacies across
the country. Several exist- ing NABP programs and services are the foundation for the development of VPP, including the Electronic Li- censure Transfer Program® (e-LTP®); NABP Clear- inghouse, which includes disciplinary information; accreditation programs; and inspection services.
In fact, VPP is a natu-
ral extension of e-LTP, on which the Association was founded. In developing VPP, the Association is building on the success of e-LTP to create a means for boards to share information pertinent to the licensure of pharma- cies. Pharmacy e-Profiles will allow boards to verify that a qualified inspection of the facility has been conducted and its licensure status
in other states. A future planned capability is for the pharmacy e-Profiles to be in- terconnected with e-Profiles for pharmacists and pharma- cy technicians. This capabil- ity would assist boards in tracking PICs to ensure they meet state requirements, including verifying licensure and reviewing disciplinary information of both resident and nonresident PICs.
The primary impetus for the VPP was the linking

of the November 2012 mul- tistate fungal meningitis outbreak to contaminated injectable drugs com- pounded by the New Eng- land Compounding Center (NECC), a tragedy that brought to the forefront the need for boards to be able to verify inspection and other data when licensing nonresident pharmacies. More information about VPP and an application will be available on the NABP Web site by the end of Sep- tember 2013. In addition to initiating the development of VPP following the NECC compounding tragedy, some member state boards of pharmacy requested NABP’s assistance in conducting compounding pharmacy inspections.
Iowa Inspection Program
NABP began conduct- ing pharmacy inspections on behalf of the Iowa Board of Pharmacy in December 2012. As of press time, NABP surveyors have conducted inspections of 384 nonresident pharma- cies dispensing drugs to patients in Iowa. Inspec- tions are ongoing across the nation and as such are not consigned to any one state. Aggregate data reports with relevant survey findings are submitted directly to the Iowa Board. Trends from