Pharmacies in West Virginia will be able to dispense naloxone, the opioid overdose reversal drug, pursuant to a protocol beginning June 10, 2016. Under the new law, a pharmacist or pharmacy intern is authorized to dispense an opioid antagonist pursuant to a protocol.
The law states the West Virginia Board of Pharmacy is required to develop a protocol requiring patient counseling, educational materials, and documentation of distribution in the West Virginia Controlled Substances Monitoring Program database. In addition, the Board is required to revise existing reporting requirements, provide limited liability to pharmacists and pharmacy interns, and reorganize existing code language.
West Virginia codes to be amended and reenacted include Chapter 16, Article 46, Section 3; Chapter 16, Article 46, Section 5; and Chapter 16, Article 46, Section 6. The law also adds a new section: Chapter 16, Article 46, Section 3a. Senate Bill 431 was signed into law by Governor Earl Ray Tomblin in March 2016 and takes effect June 10, 2016.
Pharmacists in New Jersey would be able to dispense self-administered hormonal contraceptives pursuant to a standing order under a proposed New Jersey bill. Senate Bill 1073/2060 would require the New Jersey State Board of Pharmacy and Board of Medical Examiners to jointly develop procedures and protocols.
Under the proposed law, the standardized procedures and protocols would require a patient to use a self-screening tool to identify patient risk factors for the use of self-administered hormonal contraceptives, based on the current US Medical Eligibility Criteria for Contraceptive Use developed by the Centers for Disease Control and Prevention.
The standardized procedures and protocols would also require a pharmacist, upon furnishing a contraceptive to a patient or upon determining that a contraceptive is not recommended, to refer the patient to the patient’s primary care provider or to an appropriate and nearby medical clinic.
To date, the bill, sponsored by Senators Shirley K. Turner and Joseph F. Vitale, has been referred to the Senate Budget and Appropriations Committee.
Maine to Require Providers Use E-Prescribing and Check Prescription Monitoring Data for Opioids, Benzodiazepine; Law Includes New Limits for Opioid Prescribing.
Prescribers and dispensers in Maine will be required to check prescription monitoring information when prescribing and dispensing a benzodiazepine or an opioid medication under “An Act To Prevent Opiate Abuse by Strengthening the Controlled Substances Prescription Monitoring Program” signed into law by Governor Paul LePage on April 19, 2016.
Under the law, a person who violates this rule commits a civil violation for which a $250 fine per incident may be adjudged.
Specifically, a dispenser must check prescription monitoring information prior to dispensing a benzodiazepine or an opioid medication to a person under any of the following circumstances:
a. the person is not a resident of Maine;
b. the prescription is from a prescriber with an address outside of Maine;
c. the person is paying cash when the person has prescription insurance on file; or
d. the person has not had a prescription for a benzodiazepine or an opioid medication in the previous 12-month period according to the pharmacy prescription record.
Further, the law (SP 671-LD 1646) establishes opioid medication prescribing limits. Prescribers may not prescribe to a patient any combination of opioid medication in an aggregate amount in excess of 100 morphine milligram equivalents of opioid medication per day.
In addition, prescribers may not prescribe within a seven-day period more than a seven-day supply of an opioid medication to a patient under treatment for acute pain, and prescribers may not prescribe within a 30-day period more than a 30-day supply of an opioid medication to a patient under treatment for chronic pain.
Prescribers will also need to complete three hours of continuing education every two years on the prescription of opioid medication as a condition of prescribing opioid medication. The law also requires all opioid medication to be prescribed electronically by July 1, 2017. Certain sections of the law are effective January 1, 2017.
Section 1 Question 5 Explanation
(1). A pharmacy shall report in writing to the division not later than ten business days
after before the date of:
Section 1 Question 18
(1). A pharmacy shall report in writing to the division not later than ten business days
after before the date of:
I. The duration of a pharmacy intern license may be no longer than
one five years for a license issued if the applicant is a current pharmacy student, a resident, or fellow in a program approved by division in collaboration with the board.
II. The duration of a pharmacy intern license may be no longer than one
five year for a license issued if the applicant is graduated from a foreign pharmacy school and received certification of equivalency from a credentialing agency approved by division in collaboration with the board.
Section 2 Question 12 - Question and Explanation Are Changed.
A pharmacist or pharmacy intern who substitutes an interchangeable biosimilar product for a prescribed biological product shall notify the prescriber in writing, by fax, telephone, or electronic transmission of the substitution, as soon as practicable, but not later than 3 business days after dispensing the interchangeable biosimilar product in place of the prescribed biological product; and include the name and manufacturer of the interchangeable biosimilar product substituted.
Answer: False, [Utah Pharmacy Practice Act 58-17b-605.5(8)].
Within five business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer.
The communication shall be conveyed by making an entry into an interoperable electronic medical records system, through an electronic prescribing technology, a pharmacy benefit management system, or a pharmacy record that is electronically accessible by the prescriber.
Entry into an electronic records system is presumed to provide notice to the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication shall not be required where:
(a). there is no FDA-approved interchangeable biological product for the product prescribed;
(b). a refill prescription is not changed from the product dispensed on the prior filling of the prescription; or
(c). the product is paid for using cash or cash equivalent.
Section 2 Question 15 - Question and Explanation Are Changed.
Which of the following statements are TRUE about internship requirements of pharmacist interns under Utah State Pharmacy Law?
I. At least 1740 hours of practice supervised by a pharmacy preceptor shall be obtained.
II. A minimum of 150 hours shall be balanced between community pharmacy and institutional health system settings.
III. Pharmacy interns participating in internships may be credited no more than 50 hours per week of internship experience.
a. I only
b. I and II only
c. II and III only
Answer: All, [Utah Pharmacy Practice Act Rule R156-17b-303(b)].
(a). For graduates of all U.S. pharmacy schools:
(i). At least 1,740 hours of practice supervised by a pharmacy preceptor shall be obtained in Utah or another state or territory of the United States, or a combination of both.
(ii). Introductory pharmacy practice experiences (IPPE) shall account for not less than 300 hours over the first three professional years.
(iii). A minimum of 150 hours shall be balanced between community pharmacy and institutional health system settings.
(iv). Advanced pharmacy practice experiences (APPE) shall include at least 1,440 hours (i.e., 36 weeks) during the last academic year and after all IPPE requirements are completed.
(v). Required experiences shall:
(A). include primary, acute, chronic, and preventive care among patients of all ages; and
(B). develop pharmacist-delivered patient care competencies in the community pharmacy, hospital or health-system pharmacy, ambulatory care, inpatient/acute care, and general medicine settings.
(vi). Internship hours completed in another state or territory of the United States shall be accepted based on the approval of the hours by the pharmacy board in the jurisdiction where the hours were obtained.
(vii). Evidence of completed internship hours shall be documented to the Division by the pharmacy intern at the time application is made for a Utah pharmacist license.
(viii). Pharmacy interns participating in internships may be credited no more than 50 hours per week of internship experience.
(ix). No credit will be awarded for didactic experience.
(x). If a pharmacy intern is suspended or dismissed from an approved College of Pharmacy, the intern shall notify the Division within 15 days of the suspension or dismissal.
(xi). If a pharmacy intern ceases to meet all requirements for intern licensure, the pharmacy intern shall surrender the pharmacy intern license to the Division within 60 days unless an extension is requested and granted by the Division in collaboration with the Board.
(b). For graduates of all foreign pharmacy schools, at least 1,440 hours of supervised pharmacy practice in the United States.
Section 3 Question 5 - Question and Explanation Are Changed.
An applicant applying for licensure as a pharmacy technician shall complete which of the following exams?
I. Utah Pharmacy Technician Law and Rule Examination.
a. I only
b. I or III only
c. II or III only
d. I or II only
I and II or I and III, II or III only [Utah Pharmacy Practice Act Rule R156-17b-303(c)(4)].
An applicant applying for licensure as a pharmacy technician shall complete the following exams:
(a). the Utah Pharmacy Technician Law and Rule Examination, taken as part of the application for licensure, with a minimum passing score of 88 percent; and
(b). the PTCB or ExCPT with a passing score as established by the certifying body. The certificate shall exhibit a valid date and that the certification is active.
(a). the PTCB or ExCPT with a passing score as established by the certifying body. The certificate shall exhibit a valid date and that the certification is active.
Section 4 Question 3 - Question and Explanation Are Changed.
I and IIAll, [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf].
Od are now allowed to prescribe Hydrocodone containing CII prescriptions.
Section 4 Question 26 - Explanation is Changed. Reporting Requirement To Controlled Substance Database Is Changed.
Each pharmacy or pharmacy group shall submit all data collected at least once every SEVEN days on a weekly reporting cycle established by the pharmacy.
False, [Utah Controlled Substances Act Rules R156-37f-203(5a)].
(a). Effective January 1, 2016, each pharmacy or pharmacy group shall submit data collected on a daily basis (NOT 21 days) either in real time or daily batch file reporting. The submitted data shall be from the point of sale (POS) date.
(i). If the data is submitted by a single pharmacy entity, the data shall be submitted in chronological order according to the date each prescription was filled.
(ii). If the data is submitted by a pharmacy group, the data is required to be sorted by individual pharmacy within the group, and the data of each individual pharmacy within the group is required to be submitted in chronological order according to the date each prescription was filled.
Section 5 Question 16 - Explanation And Answer are Changed. Access To Controlled Substance Database by employee are Changed.
3 pharmacy tehnicians, [Utah April 2014 NewsLetter Rule SB178].
Effective May 2014, A pharmacist-in-charge (PIC) may designate up to three pharmacy technicians to have access to the Utah Controlled Substance Database Program (CSD) on behalf of the PIC.
5 pharmacy tehnicians, [Utah Controlled Substance Database Act 58-37f-301(3)(a)(i)(ii)].
(3).(a)(i). A practitioner may designate up to three employees to access information from the controlled substance database.
(ii). A pharmacist who is a pharmacist-in-charge may designate up to five employees (a licensed pharmacy technician and/or pharmacy intern) to access information from the controlled substance database.
Minnesota Pharmacies Could Take Back Prescription Medicines Under Proposed Legislation.
Pharmacies in Minnesota would be able to collect and dispose of controlled substances (CS) and non-CS under a proposed bill (Senate File (SF) 1425). Currently, it is unlawful for Minnesota pharmacies to take back prescription drugs, reports American Pharmacists Association. The companion bill to SF 1425 is House File 1503. To date, the proposed bill was referred to the Committee on Health, Human Services and Housing for a second reading.
Sign or Sticker to Be Developed for Washington Pharmacies That Prescribe and Dispense Contraceptives.
Once available from the Washington Pharmacy Quality Assurance Commission, a sticker or sign may be displayed at Washington pharmacies if their pharmacists are authorized to prescribe and dispense contraceptives under a collaborative drug therapy agreement. The plan aims to increase awareness of the availability of contraceptives in pharmacies. Under House Bill 2681, which was signed into law by Washington Governor Jay Inslee, the Pharmacy Quality Assurance Commission will develop a sticker or sign to be displayed at a pharmacy that initiates or modifies drug therapy related to self-administered contraception. The law goes into effect on June 9, 2016.
Florida Law Restricts Sale of Dextromethorphan to Adults.
A bill that prohibits a manufacturer, distributor, or retailer from selling a dextromethorphan product to a person younger than 18 years of age was signed into law by Florida Governor Rick Scott. An employee who sells a dextromethorphan product to a person younger than 18 years of age without a prescription is subject to a written warning for an initial violation, and civil fines may be imposed for subsequent violations. Under the law (Senate Bill 938), proof of age is required from the purchaser if the individual is presumed to be under 25 years of age. The law takes effect January 1, 2017.
Illinois Pharmacists Who Complete Training Program Can Dispense Naloxone.
Pharmacists in Illinois who seek to dispense naloxone, the opioid overdose reversal drug, must complete the Illinois State Opioid Antagonist Training Program. A trained pharmacist can dispense naloxone following standardized procedures or protocols developed by the Illinois Department of Financial and Professional Regulation with the Department of Public Health and the Department of Human Services under the law (Public Act 99-0480) passed in September 2015. Standardized procedures for pharmacists certified in naloxone antagonist training can be obtained by contacting the Illinois Prescription Monitoring Program.
HHS Proposes Increasing Buprenorphine Patient Limit for Medication-Assisted Treatment.
With the goal of expanding access to medication-assisted treatment (MAT), United States Department of Health and Human Services (HHS) has proposed a rule that would permit qualified physicians to prescribe buprenorphine, the opioid use disorder treatment medication, to as many as 200 patients. Under current regulations, physicians who are certified to prescribe buprenorphine for MAT can only prescribe up to 30 patients initially and after one year can request authorization to prescribe up to a maximum of 100 patients. Substance Abuse and Mental Health Services Administration Principal Deputy Administrator Kana Enomoto states “there are long patient waiting lists for prescribers who have reached the 100 patient limit.”
Buprenorphine is a Food and Drug Administration (FDA)-approved drug used as part of MAT, a comprehensive way to address the recovery needs of individuals that combines the use of medication with counseling and behavioral therapies to treat substance use disorders, indicates the HHS press release. HHS Secretary Sylvia Burwell said the proposal “is critical in our comprehensive approach to addressing the serious opioid epidemic facing our nation.” More information about MAT and increasing the patient limit is available in the HHS fact sheet.
Written or electronic comments on the proposed rule must be submitted by May 31, 2016. The Federal Register notice contains instructions and additional information for submitting public comment.
Certain Utah Pharmacies to Offer Naloxone Under Collaborative Practice Agreement.
Naloxone, the opioid overdose reversal drug, is available at Associated Food Stores retailer’s pharmacies in Utah under a collaborative pharmacy practice agreement with prescribers. Further, each pharmacist has been trained to provide patient counseling on the drug, indicates the company. A list of participating pharmacies is available in the Associated Food Stores press release. Patients under the age of 18 are required to bring an adult family member, notes Deseret News. The price of a kit ranges from $50 to $70, but patients who have insurance can get some of the cost covered, indicates Deseret News.
The state’s collaborative pharmacy practice agreement is defined under Senate Bill 158. Further information about dispensing naloxone in Utah is available in House Bill 119.