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Winter 2015 Edition of the Script

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Winter 2015 Edition of the Script BE AWARE & TAKE CARE: Talk to your pharmacist! CALIFORNIA STATE BOARD OF P H A R M A C Y Winter 2015 Changes in Pharmacy Law The Senate and Assembly bills listed donation of medications to or transfer of prior to performing this procedure. The in this article were enacted in 2014 and medications between participating entities Board of Pharmacy is directed to adopt unless otherwise specified took effect on under the unused medication repository emergency regulations to establish the January 1, 2015. The new and amended and distribution program established in the standardized procedures or protocols Business and Professions Code (B&PC), Health and Safety Code. The law prohibits immediately (upon filing with the Office Health and Safety Code (H&SC), the intermediary from taking possession, of Administrative Law). and Civil Code laws are paraphrased custody, or control of dangerous drugs and or summarized below. For pertinent devices, but authorizes the intermediary Incarceration information that is not included in the to charge specified fees for the reasonable AB 1702 (Maienschein), Chapter 410, summaries you are strongly urged to costs of the support and services Statutes of 2014 review the changes to the laws at http:// provided. The law requires a surplus B&PC Adds section 480.5 to provide that www.pharmacy.ca.gov/laws_regs/new_ medication collection and distribution an individual who has satisfied any of the laws.pdf. intermediary to keep and maintain for requirements needed to obtain a license three years complete records for which the while incarcerated, who applies for that You can view the new law book for intermediary facilitated the donation of license upon release from incarceration, 2015 at http://www.pharmacy.ca.gov/ medications to or transfer of medications and who is otherwise eligible for the laws_regs/lawbook.pdf. between participating entities. The license shall not be subject to a delay in law also exempts a surplus medication processing the application or a denial Temporary Licensure For Military collection and distribution intermediary of the license solely on the basis that Spouses from criminal or civil liability for injury some or all of the licensure requirements AB 186 (Maienschein), Chapter 640, caused when facilitating the donation of were completed while the individual was Statutes of 2014 medications to or transfer of medications incarcerated. B&PC Adds section 115.6 to establish in compliance with these provisions. a temporary licensure process for an applicant who holds a current, active, and Naloxone See Changes in Pharmacy Law, Page 10 unrestricted license in another jurisdiction, AB 1535, (Bloom), Chapter 326, and who supplies satisfactory evidence Statutes of 2014 of being married to or in a domestic B&PC Adds section 4052.01 to authorize In This Issue partnership or other legal union with an a pharmacist to furnish naloxone Changes in Pharmacy Law for 2015 ........................Front Page active duty member of the Armed Forces hydrochloride in accordance with President’s Message ..........................................................Page 2 of the United States who is assigned to a standardized procedures or protocols New Licenses Required for 3PLs .....................................Page 3 duty station in California under official developed and approved by both the Private Pilots Killed in Crashes Using OTC and Rx .....Page 4 active duty military orders. The temporary Board of Pharmacy and the Medical Med Board of CA Revises Guidelines for Prescribing ....Page 5 Include Provider NPI for Medicare or Medi-Cal Claims .Page 5 license would expire 12 months after Board of California. The law requires Drug Diversion: A Growing Patient Safety Risk ..............Page 6 issuance, upon issuance of an expedited the pharmacist to provide a consultation Rite Aid Pays $500,000 for Failing to Consult .............Page 7 license, or upon denial of the application to ensure the education of the person Sign up for CURES ...........................................................Page 8 for expedited licensure by the board. to whom the drug is furnished, and to Clarifying What Constitutes an “Emergency” ..................Page 9 provide notification to the patient’s Standardized Milliliter Recommended for Liquid..........Page 12 Prescription Drug Collection and primary care provider of drugs or Board Recommends Eliminating Cigarette & Tobacco .Page 12 Distribution Program devices furnished to the patient. The New Regulations .............................................................Page 13 AB 467 (Stone), Chapter 10, Statutes of law prohibits a pharmacist furnishing NABP to Begin Sunrise Trademark Registration...........Page 13 2014 naloxone hydrochloride from allowing the CE Hours Awarded for Attending Day of Meeting .......Page 14 B&PC Adds section 4046 and Article person to whom the drug is furnished to Board Honors Pharmacists Registered for 50 Years ....Page 15 11.5 to permit the board to annually waive the consultation. The law requires Pharmacist Honored For Rescuing Patient ...................Page 16 Corresponding Responsibility .........................................Page 17 license a surplus medication collection a pharmacist to complete a training New Board Member .......................................................Page 17 and distribution intermediary for the program on the use of opioid antagonists Explanation of Disciplinary Terms ................................Page 18 Disciplinary Actions ........................................................Page 18 Winter2015 BOARD OF PHARMACY 2 After July 1, the board was licensing fee was approved. Board staff able to hire additional inspectors to will soon be noticing this language for handle ongoing, annual inspections of a 45-day public comment period to both in-state and out-of-state sterile initiate the rulemaking process needed compounding pharmacies. Support to adopt regulations. staff positions were also added. In January 2015, the Board of Many sterile compounding Pharmacy and Medical Board approved facilities required re-inspections or three protocols developed by the required the inspection of multiple committee for pharmacists furnishing locations within a facility prior to nicotine replacement products, for licensure or renewal. In all, the board pharmacists furnishing hormonal conducted approximately 1,394 sterile contraception and for pharmacists to compounding inspections in 2014 and provide naloxone. 851 sterile compounding licenses were issued or renewed. The first two protocols will soon be noticed for public comment as part The inspections resulted in 1,746 of the regulation adoption process. The violations found in 690 facilities. naloxone protocol will be adopted as President’s Message The top violations included lack an emergency regulation in accordance By Stanley C. Weisser, R.Ph. of completion of a compounding with provisions in the enacting President, Board of Pharmacy self-assessment, insufficient or legislation. The protocol is expected nonexistent policies and procedures, to go into effect in March 2015 upon Board Growth substandard equipment and inadequate filing with the Office of Administrative Will Benefit Patient Care compounding attire. There were Law and a subscriber alert will go out also issues with lack of training, to notify pharmacists. New legislation that was enacted quality assurance, facilities, general in 2013 and 2014 has spurred a period compounding quality assurance and The board will then take the of tremendous growth for the Board process validations. steps required to formally adopt the of Pharmacy. This growth will benefit regulation through the normal adoption patient care. SB 493 Implementation process. Emergency rulemaking allows for the immediate implementation of One of the new laws expands The SB 493 Implementation a regulation and provides a 180-day requirements for sterile compounding Committee met four times in 2014 and period to formally adopt the regulation. licensure. The other will bring again on February 25, 2015, in Los pharmacists to the forefront of serving Angeles. The SB 493 Implementation patients with the creation of regulations Committee plans to meet at least for advanced practice pharmacist The committee’s goal is to every other month until the remaining licensure and for pharmacists develop parameters for SB 493’s work projects are completed, which is performing other patient care functions. implementation. This included creating expected to be July 2015. the first requirements for licensure for Implementation of these new laws advanced practice pharmacists (APP) Prescription Drug Abuse Prevention has been a top priority for the board. and protocols for furnishing hormonal contraception and nicotine replacement Prescription drug abuse has risen Sterile Compounding products. The committee also to epidemic proportions and become developed a protocol to implement AB a public health crisis. The abuse of Changes to sterile compounding 1535 (Bloom, Chapter 326, Statutes prescription opioids has also fueled a licensure went into effect on July 1, of 2014) authorizing pharmacists to heroin epidemic as abusers turn to the 2014. The revised law requires board provide naloxone hydrochloride to much cheaper street drug. inspection for licensing or annual prevent opioid overdose deaths. renewal of sterile compounding In response, the California pharmacies. From January to June The first phase of APP registration Department of Public Health created 2014, these inspections
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