Tag Archives: pharmacy law
The Arkansas House of Representatives passed HB 2190, which amends the state’s medical marijuana guidelines and, amongst other things, requires medical marijuana dispensaries appoint a ‘pharmacist consultant‘ who, as a registered dispensary agent, would provide training to the dispensary at least once per year.
Under HB 2190, which is now headed to the Arkansas senate, a dispensary shall appoint a pharmacist consultant who is a pharmacist licensed with the Arkansas State Board of Pharmacy (Arkansas Board). Additionally, the pharmacist consultant is expected to register as a dispensary agent and follow all procedures, some which include the following:
- Developing and providing training to other dispensary agents at least one (1) time every twelve months from the initial date of the opening of the dispensary;
- Assist in the development and implementation of review and improvement processes for patient education and support provided by the dispensary;
- Provide oversight for the development and dissemination of educational materials for patients and their caregivers, information about side effects, potential drug-drug interactions, and policies and procedures for refusing to provide medical marijuana to individuals who appear to be impaired or abusing marijuana and;
- Be accessible by the dispensary or dispensary agent via telephone or video conference during business hours.
Under a new statewide protocol based on Senate Bill 16-135, only Colorado-licensed pharmacists that have completed an Accreditation Council for Pharmacy Education (ACPE) accredited educational training program related to the prescribing of contraceptives by a pharmacist, may dispense hormonal contraceptive patches and oral hormone contraceptives to patients who are at least 18 years of age.
Additionally, for new patients requesting contraceptive services, a participating pharmacist must:
- Obtain a completed Colorado Self-Screening Risk Assessment Questionnaire;
- Utilize and follow the Colorado Standard Procedures Algorithm to perform the patient assessment;
- Prescribe, if clinically appropriate, the hormonal contraceptive patch or self-administered oral hormonal contraceptive, or refer to a healthcare practitioner;
- Provide the patient with a Visit Summary;
- Advise the patient to consult with a primary care practitioner or women’s health care practitioner;
- Refer any patient that may be subject to abuse to an appropriate social services agency; and
- Ensure that the pharmacy provides appropriate space to prevent the spread of infection and ensure confidentiality.
Colorado Board of Pharmacy Approved Protocols include:
Hormonal Contraception Protocol A (includes Standard Procedures Algorithm and the Self-Screening Risk Assessment Questionnaire)
Smoking Cessation: currently being addressed the Colorado Board of Pharmacy (watch for updates)
With the passage of Colorado SB 16-135, which allows the Boards of Pharmacy, Nursing, and Medicine to collaborate on statewide protocols to address public health needs and improve patient outcomes, Colorado becomes the third state to authorize pharmacists to prescribe oral contraception.
Once trained, qualified pharmacists will screen all patients seeking pharmacist-prescribed contraception for potential contraindications and underlying health conditions in order to determine the most appropriate contraception for each individual patient.
Colorado is also considering a similar collaborative statewide protocol that would authorize pharmacists to furnish smoking cessation medications.
Last week, New Jersey Governor Chris Christie signed into law Assembly Bill 3, which, among other things:
1. Limits doctors’ ability to issue first-time opioid prescriptions for more than five days;
2. Mandates that doctors create a pain-management treatment plan regarding the use of opioids and review prescriptions every three months; and
3. Requires doctors to obtain a written record that the doctor and patient have discussed the risks of taking opioids.
The prescription drug limit would not apply to cancer and chronic pain patients or end-of-life care.
The Alabama Department of Public Health recently filed a “Notice of Intended Action” to amend Alabama’s current Controlled Substance List by rescheduling seven substances to a higher schedule due to the potentials of abuse as recommended by the Alabama Board of Medical Examiners.
The seven substances the Alabama Department of Public Health proposes to reclassify are:
1. Alprazolam – Reschedule from Schedule IV to Schedule II,
2. All other benzodiazepines (Clonazepam, Diazepam, Lorazepam, and Temazepam) from Schedule IV to Schedule III,
3. Pregabalin – Reschedule from Schedule V to Schedule IV,
4. Zolpidem – Reschedule from Schedule IV to Schedule III
The comment period ended on January 4, 2017, and Baer Law will keep you informed on when there is a final ruling as health care providers, pharmacists, pharmacies and wholesalers will have to change their practices to address such changes, especially if alprazolam is reclassified to Schedule II.
Ohio House Bill 188 (HB 188), which passed last year, greatly expands the role of the Ohio pharmacist by streamlining the collaborative practice agreement paperwork and allowing physicians to enter into an agreement with multiple pharmacists to manage drug therapy for their patients.
Under an Ohio collaborative practice agreement, pharmacists can order blood or urine tests, analyze the results and then, add, modify or discontinue a drug without requiring a qualified physician to cosign, provided the pharmacist’s work is done within the scope of the collaborative practice agreement.
Additionally, HB 188 allows pharmacists to order a 30-day supply of a prescription refill for patient if the prescription has expired and a physician cannot be reached.
With the passage of HB 188, Ohio joins other states such as California, North Carolina, Oregon and Washington, that have recently updated their collaborative practice agreements. Ultimately, the goal is to have pharmacists become more involved in nondispensing, hands-on patient care.
The State of Illinois is testing a new program where pharmacists visit elderly patients at their homes and counsel them on their prescriptions.
According to multiple studies, up to two-thirds of medications prescribed by doctors are taken incorrectly. In an effort to address this, the Illinois Department of Aging has partnered with suburban Chicago based APC Corp. to offer up to 2,000 qualifying elderly residents in-home pharmacist visits and counseling to manage their complex drug regimens. APC Corp. plans to fully fund the program.
After qualifying for this unique pilot program, patients will be contacted by an APC pharmacist. The pharmacist will visit the patient at their home, review their medications, counsel the patient as well as try to identify any problems or side effects. Then, once a routine has been established, the medications will be delivered directly to the patient’s home.
Ultimately, the goals of the program are to decrease costly hospital admissions and to let elderly patients maintain their way of life and keep them in their homes.
Find out more about the program here.
Baer Law will keep you posted on any updates.
Pharmacies that hold a permit in North Carolina and engage in any type of compounding are required to notify the North Carolina Board of Pharmacy (Board).
Pharmacies must report (both on their initial permit application and as part of each annual renewal) the following:
- Whether they compound;
- A good-faith estimate of the percentage of the pharmacy’s dispensing that involves compounded products;
- Whether the pharmacy engages in any non-sterile compounding;
- Whether the pharmacy engages in sterile compounding; and
- What risk level of sterile compounding, as defined by USP <797>, the pharmacy performs.
The Board published a guidance document to reduce any confusion about this reporting requirement.
On June 1, 2016, Colorado Governor John Hickenlooper signed Senate Bill 16-158: Concerning the Ability of a Physician Assistant to Perform Functions Delegated by a Physician that are within the Physician Assistant’s Scope of Practice. The bill, which went into effect on August 10, 2016, requires that a physician assistant prescription order meet the following three requirements:
1. The order must be within the scope of the physician assistant’s supervising physician;
2. If for a controlled substance, the order must contain the name of the supervising physician in addition to the other information required for a prescription; and
3. If for a controlled substance, the order must contain the physician assistant’s own DEA registration number.
Pharmacists filling prescription orders from physician assistants should ensure all three requirements are met prior to performing their final check. Failure to do so could result in disciplinary action.
Contact Baer Law with any questions.
Earlier this year, CVS paid $8 million for alleged violations of the Controlled Substance Act in its Maryland pharmacies.
Last week, the US Attorney’s Office for the District of Massachusetts announced that CVS has agreed to pay $3.5 million to settle allegations that its pharmacists filled forged prescriptions, mostly for addictive painkillers, between 2011 and 2014.
CVS also entered into a three-year agreement with the Drug Enforcement Agency (DEA) to make sure its pharmacies work more diligently to detect and prevent the diversion of controlled substances.
In a press release, US Attorney Carmen M. Ortiz stated, “Pharmacies have a legal responsibility to ensure that controlled substances are dispensed only pursuant to valid prescriptions. When pharmacies ignore red flags that a prescription is fraudulent, they miss a critical opportunity to prevent prescription drugs from entering the stream of illegal opiates on the black market.”
The CVS investigation started after the DEA began receiving a high volume of calls about forged oxycodone prescriptions in the Massachusetts CVS stores. Ultimately, the DEA found that 403 forged prescriptions were filled at 40 stores in Massachusetts and New Hampshire and that 120 forged prescriptions were filled at 10 CVS stores in the Boston area.
One of the major forgers, according to the DEA allegations, was a patient known as “PR,” who used a dentist’s name to fill 56 of 59 oxycodone prescriptions. CVS pharmacists continued to dispense the medications to “PR” despite having detailed computer warnings and notes regarding “PRs” history of trying to fill forged prescriptions.
“PR” allegedly was able to circumvent the CVS ban by creating a new patient profile with her Arizona driver’s license and using a different last name.
The attorney’s office press release stated, “The government alleged that CVS should have known that the new profile was really PR’s, and that the quantities and frequency of PR’s oxycodone prescriptions were excessive, especially coming from a dentist. Moreover, the government alleged, even if CVS had believed the prescriptions to be real, there were red flags that PR was doctor shopping, including the fact that PR presented oxycodone prescriptions from 2 different providers during a single week at 1 CVS store.”
Finally, the attorney’s office noted that pharmacists should continue to use diligence in identifying red flags to ensure that forged prescriptions are not filled.
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