Wednesday, December 18, 2019

HHS moves forward with prescription drug import plan

It could be years before patients would actually see imported drugs even if all steps of the plan proceed, but HHS Secretary Alex Azar said the administration is moving as quickly as possible to finalize the regulatory actions.

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Monday, December 16, 2019

Bordentown Doctor Pharmaceutical Representative Admit Healthcare Fraud in Compounding Pharmacy Case Submitted by RLS Staff on Dec 16 2019 - 5:39pm.

38 mins ago - Compounded medications are specialty medications mixed by a pharmacist to ... Oswari signed printed prescription forms from Compounding Pharmacies 1 and

Very Important Changes Regarding CDS Electronic Prescriptions in Oklahoma from Doctors and Veterinarians and opioid prescriptions

Regarding CDS Electronic Prescriptions:
  • Beginning January 1, 2020, unless a prescriber meets one of the exceptions listed in the Statute, all CDS prescriptions must either be electronic or on the prescription pads provided by the Oklahoma Bureau of Narcotics and Dangerous Drugs (OBNDD).
  • Prescriptions for Long Term Care Facility and Hospice patients must meet these same requirements unless the pharmacy is an on-site pharmacy in the Long Term Care or Hospice facility. 
  • Physicians are still authorized to issue oral emergency Schedule II prescriptions.  The oral emergency Schedule II prescriptions must be followed up with an electronic prescription or a written prescription on the OBNDD prescription pad.  [If written on the OBNDD prescription pad, it must qualify as one of the exceptions.] 
  • While Veterinarian prescriptions qualify as an exception from electronic prescriptions, they must be on the prescription pad from OBNDD. 
  • CDS prescriptions from out of state prescribers are not impacted by this law.
  • CDS prescriptions for a patient discharged from a hospital must be electronic or on the prescription pad from OBNDD.  [If they are written on the prescription pad from OBNDD, they must qualify as one of the exceptions.] 
  • Official prescription pads from OBNDD issued to a registered practitioner shall only be used by the prescriber to whom they are issued.  
OK State Board of Pharmacy
Regarding CDS Electronic Prescriptions:
  • Beginning January 1, 2020, unless a prescriber meets one of the exceptions listed in the Statute, all CDS prescriptions must either be electronic or on the prescription pads provided by the Oklahoma Bureau of Narcotics and Dangerous Drugs (OBNDD).
  • Prescriptions for Long Term Care Facility and Hospice patients must meet these same requirements unless the pharmacy is an on-site pharmacy in the Long Term Care or Hospice facility. 
  • Physicians are still authorized to issue oral emergency Schedule II prescriptions.  The oral emergency Schedule II prescriptions must be followed up with an electronic prescription or a written prescription on the OBNDD prescription pad.  [If written on the OBNDD prescription pad, it must qualify as one of the exceptions.] 
  • While Veterinarian prescriptions qualify as an exception from electronic prescriptions, they must be on the prescription pad from OBNDD. 
  • CDS prescriptions from out of state prescribers are not impacted by this law.
  • CDS prescriptions for a patient discharged from a hospital must be electronic or on the prescription pad from OBNDD.  [If they are written on the prescription pad from OBNDD, they must qualify as one of the exceptions.] 
  • Official prescription pads from OBNDD issued to a registered practitioner shall only be used by the prescriber to whom they are issued.  



Clarification on NEW OSBP Statute:
59 O.S. § 353.20.2(D): Upon receipt of a valid Schedule II opioid prescription issued pursuant to the provisions of Section 2-309I of Title 63 of the Oklahoma Statutes, a pharmacist shall fill the prescription to the specified dose, and shall not be permitted to fill a different dosage than what is prescribed.  However, the pharmacist maintains the right not to fill the valid opioid prescription.

  • This statute only applies to Schedule II Opioids.
  • After consultation with OBNDD, this statute is interpreted to mean that a Pharmacist cannot dispense any quantity other than what is designated on the prescription; OBNDD interprets this to include partial filling of any Schedule II Opioid prescription.
  •  In order to dispense a lesser than prescribed quantity, a new prescription must be obtained. 

If you have questions about the above information, please feel free to reach out to your Compliance Officer or call the Board Office. 

Saturday, December 14, 2019

Independent pharmacies struggle in shifting landscape December 13, 2019 by Kate Cough

https://www.ellsworthamerican.com/uncategorized/independent-pharmacies-struggle-in-shifting-landscape/

Pharmacy Raided After State Revokes Its License: Report No criminal charges have been filed against the pharmacy's owners, although it has been ordered to pay a $50,000 fine, according to reports. By Mark Hand, Patch Staff Dec 13, 2019 7:56 am ET | Updated Dec 13, 2019 11:28 pm ET

https://patch.com/virginia/leesburg/leesburg-pharmacy-raided-after-state-revokes-its-license-report

DEA, state and local authorities shut down Lansdowne Pharmacy after raid By John Battiston, jbattiston@loudountimes.com Dec 12, 2019 Updated Dec 13, 2019

https://www.loudountimes.com/news/dea-state-and-local-authorities-shut-down-lansdowne-pharmacy-after/article_d8072c6a-1cfe-11ea-a5b1-13ba89db81d3.html

Woman sues CVS, alleges she was denied 'morning after' pill

https://6abc.com/society/woman-sues-cvs-alleges-she-was-denied-morning-after-pill/5754991/
14 hours ago - Chuck Grassley (R-IA) and Ron Wyden (D-OR) have released a new drug pricing bill that includes language that would require price concessions to be inclu
13 hours ago - on ''Qualification Process for Drug. Development Tools.'' It does not ... guidances-drugs, https://www.fda.gov/ .... Although compounded drugs can serve an.
12 hours ago - Drug compounding is generally the practice of combining, mixing, or altering ingredients of a drug to create a medication tailored to the needs of an individual patient.

Wednesday, December 11, 2019

FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

The U.S. Food and Drug Administration today posted a warning letter to Alkermes, Inc. of Massachusetts, for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated with the drug from promotional materials. Vivitrol is approved for the prevention of relapse to opioid dependence, following opioid detoxification and should be part of a comprehensive management program that includes psychosocial support. Known as medication-assisted treatment, the use of medications like Vivitrol, in combination with counseling and behavioral therapies, is effective in the treatment of opioid use disorder (OUD) and can help some people to sustain recovery. The warning letter was issued in relation to a print advertisement about Vivitrol. While the print advertisement contains claims and representations about the drug’s benefits, it fails to ...