Tag Archives: pharmacist

Arkansas House Passes a Bill Requiring Pharmacist Consultants at Medical Marijuana Dispensaries

by admin on March 29th, 2017 at 11:22 am

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:

  1. 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;
  2. Assist in the development and implementation of review and improvement processes for patient education and support provided by the dispensary;
  3. 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;
  4. Be accessible by the dispensary or dispensary agent via telephone or video conference during business hours.
Finally, the bill also protects pharmacist consultants from arrest, prosecution or penalty from the Arkansas Board or any other business or professional licensing board solely for performing their duties as a pharmacist consultant for a registered dispensary.
Baer Law will keep you updated on the HB 2190 and the role of Arkansas Pharmacist Consultants.
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Alabama’s Proposed Action to Reschedule Seven Controlled Substances

by admin on January 11th, 2017 at 6:57 am

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. 

 

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Ohio Pharmacy Law: Expanding the Powers of the Pharmacist

by admin on January 9th, 2017 at 4:32 pm

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.

 

 

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In-Home Pharmacist Visits for the Elderly: An Illinois Test Program.

by admin on December 13th, 2016 at 1:09 pm

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.

 

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Colorado Senate Bill 16-158: Physician Assistant’s Performing Functions Delegated by a Physician

by admin on September 2nd, 2016 at 5:47 am

 

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.

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Two Pharmacists Sentenced to Prison for Adulteration of Drugs

by admin on July 6th, 2016 at 5:58 am

On June 21, 2016, the Department of Justice announced that two Alabama pharmacists were sentenced to prison terms of 12 and 10 months for their roles in the distribution of adulterated drugs. The drugs in question were compounded at the now-defunct compounding pharmacy Advanced Specialty Pharmacy (dba: Meds IV.)

Meds IV allegedly compounded numerous drugs for human use, including intravenous drugs known as Total Parenteral Nutrition (TPN) which is a liquid nutrition for patients who cannot or should not receive medications orally, without taking the legally required precautions to ensure the sterility of its products.

Allegedly, in early 2011, Meds IV began compounding its own amino acid solution which was then mixed with other intravenous medications to create patient specific TPNs. The amino acids used in compounding the TPNs were adulterated as  the amino acids were found to be contaminated with the highly resistant bacteria Serratia marcescens (S. marcescens) which can cause bloodstream infections if introduced into the bloodstream through contaminated medications.

According to documents, the amino acid was prepared by Meds IV outside a laminar airflow workbench and kept unrefrigerated in a non-sterile room in a large pot sitting on the floor before it was sterilized and used.

Nine patients, with other serious underlying medical conditions, who developed bloodstream infections caused by S. marcescens died while many others developed infections but survived.

David Allen of McCalla, Alabama, the former pharmacist-in-charge of Meds IV, was responsible for reviewing and approving TPN formulations, and William Timothy Rogers, of Hoover, Alabama, the former president of Meds IV, pleaded guilty in March 2016 to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA). Allen and Rogers received 12 month and 10 month prison terms, respectively, and also received a one year of supervised release following their imprisonment and a $5,000 fine.

The Department of Justice and the Food and Drug Administration continue to work aggressively to protect consumers from drugs compounded under insanitary conditions.

 

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New Colorado Law Expands Pharmacist Opportunities

by admin on June 14th, 2016 at 9:09 am

On June 6, 2016, Colorado Governor John Hickenlooper signed into law Senate Bill 16-135 which amends the Colorado Pharmacy Practice Act and the Colorado Insurance Code to expand practice opportunities for pharmacist and provide a pathway for reimbursement of pharmacy services.  The Bill is expected to go into effect in early August 2016.

The Bill includes the following:

  • Providers reimbursement opportunities for pharmacies that provide healthcare services otherwise provided by a physician or advanced practice nurse;
  • Calls on insurance plans to include pharmacists in their network of providers;
  • Expands collaborative practice agreements to one or more patients cared for by the collaborative physician or advanced practice nurse;
  • Expands collaborative practice agreements to treat a protocol rather than a single drug;
  • Provides for the development of Statewide Drug Therapy Protocols to be jointly developed by the Boards of Medicine, Pharmacy and Nursing in collaboration with the Colorado Department of Public Health and Environment.

Baer Law will continue to keep you updated.

 

 

 

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FDA Warning Letters Sent to California and Kentucky Compounders

by admin on January 26th, 2016 at 12:10 pm

 

The FDA recently issued two warning letters to compounders in California and Kentucky for violating current good manufacturing practices related to sterility.

Ionia Pharmacy, based in Tustin, California, and Spoonamore Drug Co., located in Louisville, Kentucky, were both issued warning letters for deficiencies in:

  1. Producing sterile drug products and putting patients at risk,
  2. Not receiving valid prescriptions for individually identified patients,
  3. Misbranded drug products; and
  4. Poorly written guidelines.
FDA inspectors sighted a lack of effectiveness in Ionia’s cleaning and sanitation program, specifically that non sterile wipes were being used for disinfection and that items brought into a cleanroom were not properly disinfected. Also, Ionia failed to establish or follow the required written procedures designed to prevent microbiological contamination of sterile products and did not have an adequate stability testing program to determine appropriate storage conditions and expiration dates. Finally, FDA inspectors found that Ionia workers were improperly dressed while working in the cleanrooms, leaving their skin and eyes exposed. 

Ionia, in response to the FDA’s noted deficiencies, stated that it would cease all operations and close. The FDA, however, has not received confirmation of Ionia closing.

Inspections at Spoonamore revealed that Spoonamore did not use a sporadical agent as part of its disinfection program in its cleanroom. Additionally, FDA inspectors found that Spoonamore produced domperidone, a medication commonly used to treat nausea and vomiting, that has not been approved by the FDA for use in the United States and therefore should not be used in compounding. Spoonamore reportedly has stopped producing domperidone.

Stay tuned to the Baer Law Blog for more compounding updates.

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Colorado Board of Pharmacy Considering Rule Amendments to Address Medical Board Telehealth Guidelines

by admin on December 9th, 2015 at 7:15 am

As previously discussed on the Baer Law Blog in August, the Colorado Medical Board (Medical Board) adopted Guidelines for the Appropriate Use of Telehealth Technologies in the Practice of Medicine (Guidelines).

The Medical Board defined telehealth as:

“‘a mode of delivery of health care services through telecommunications systems, including information, electronic, and communication technologies, to facilitate the assessment, diagnosis, consultation, treatment, education, care management, or self-management of a person’s health care while the person is located at an originating site and the provider is located at a distant site. The term includes synchronous and store-and-forward transfers.’

The Colorado Board of Pharmacy (Pharmacy Board) is considering amending some of its rules to improve the administration and enforcement of the Pharmacists, Pharmacy Business and Pharmaceuticals Act.

Presently, the Pharmacy Board Rule 3.00.21 states, in part the following:

  • A pharmacist shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner.
  • A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the order for such drug was issued on the basis of an internet-based questionnaire, an internet-based consultation, or a telephonic consultation, all without a valid preexisting patient-practitioner relationship.

The proposed 3.00.21 rule is as follows:

  • A pharmacist shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner.
  • A pharmacist shall not dispense a prescription drug if the pharmacist knows or should know that the order for such a drug was issued without a valid preexisting patient-practitioner relationship. Such relationship need not involve an in-person encounter between the patient and practitioner if otherwise permissible under Colorado law. 
The above changes are only proposed draft rules. After soliciting views from interested stakeholders, the Pharmacy Board will likely commence the formal rule making process to ensure Rule 3.00.21 is consistent with the telehealth provisions of HB 15-1029.
Baer Law will keep you updated on the final rule. 
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California & Oregon Pharmacy Update: Pharmacists and Birth Control

by admin on November 24th, 2015 at 9:03 am

In 2016, groundbreaking laws in California and Oregon will allow women to obtain hormonal contraceptive pills, patches and rings directly from pharmacists without a doctor’s prescription — a change many say is more convenient and likely a less expensive option than going to the doctor.

Presently, a doctor’s prescription for hormonal contraceptive products is required, but over the next few months, pharmacists in Oregon and California will be authorized to prescribe contraceptives after a quick screening process where women fill out a questionnaire about their health and medical histories.

As noted on the Baer Law Blog previously,  Oregon and California laws differ in that California’s law has no age restriction, whereas Oregon law requires teenagers under 18 obtain their first contraceptive prescription from a doctor. Also, California pharmacists will likely have to take a women’s blood pressure if filling a contraceptive containing estrogen.

Advocates of the new law, including some pharmacists’ organizations and reproductive health experts, plan to actively lobby for a nationwide change, provided they can be assured that pharmacists can safely dispense contraception without a doctor’s prescription and that women’s health risks can be can be safely and accurately assessed via questionnaires.

As the role of the pharmacist continues to expand and the strong push to recognize pharmacists as health care providers continues, a big unanswered question is whether insurers will pay for the time pharmacists spend reviewing the health questionnaires to ensure all patient safety issues are appropriately addressed.

Stay tuned to the Baer Law Blog for more updates.

 

 

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