Tag Archives: prescriptions

Colorado Pharmacists Can Prescribe Contraception

by admin on February 22nd, 2017 at 6:47 am

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.

 

 

 

 

 

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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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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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CVS Agrees to Pay Millions to Settle Allegations of Filling Forged Prescriptions

by admin on July 11th, 2016 at 8:09 am

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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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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Colorado Pharmacy Law: Telehealth and Identifying Valid Preexisting Patient-Practitioner Relationships

by admin on July 31st, 2015 at 11:49 am

The Colorado Medical Board recently published a new draft policy, No. 40-27, on “Guidelines for Appropriate Use of Telehealth Technologies in the Practice of Medicine.” The projected effective date is August 20, 2015.

The new guidelines, however, appear to be at odds with the existing Colorado Board of Pharmacy rules that state, in part, the following:

3.00.21. 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. 

Based on Colorado pharmacy case law, pharmacists that violated the Rule 3.00.21 have been disciplined by the Colorado Board of Pharmacy. In many cases, the pharmacists were issued letters of admonition, which is public reprimand issued to a pharmacist.

Ultimately, Colorado pharmacists should continue to use extreme caution when they identify prescriptions issued to patients based on telehealth consultations. Right now, the best course of action may be to contact the Colorado Medical Board directly to determine if (1) a patient-practitioner relationship was established under the new policy and (2) obtain guidance on whether that relationship was sufficient enough to satisfy the “preexisting” relationship requirement under current Colorado pharmacy rules that would then allow the pharmacist to lawfully dispense the prescription medication.

Follow the Baer Law Blog, for updates on both the Colorado Medical Board guidelines and any Colorado Board of Pharmacy rule updates.

 

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California and Oregon To Allow Hormonal Contraceptives Without A Doctor’s Prescription

by admin on July 15th, 2015 at 7:16 am

California and Oregon will become the first states to allow women to get birth control pills and hormonal contraceptives directly from their pharmacists, without a doctor’s prescription.

California’s rules are expected to take effect after October 1, 2015, while Oregon’s is expected to take effect after January 1, 2016.

The contraceptives, however, will not be readily available like most over-the-counter products. In California, pharmacists can only dispense the contraceptives after providing a health screening to women and taking their blood pressure. Oregon will also have a similar health screening requirement and is currently developing other specific rules and requirements.

The California law has no age restrictions on patients. Minors in California will have the same access as adults. In Oregon, pharmacists can only provide new birth control prescriptions to women 18 and older. Women under 18 must show proof of prior birth control prescriptions from a physician. In addition, the Oregon State Board of Pharmacy states that it will likely require all of its licensed pharmacists to undergo more training than the one hour of education currently required of all licensed California pharmacists.

While pharmacists in both California and Oregon are preparing for the new regulations, the issues related to insurance reimbursement remain.

Stay tuned to the Baer Law Blog for updates.

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