January 2019
L.A. Care is sharing several updates and reminders related to prescription drugs for your information.
Drug Safety Communications Update
The U.S. Food and Drug Administration (FDA) requires updates on a manufacture drug label when new information becomes available regarding: safety warnings, efficacy, dosing restrictions, side effects and indication for use.
In July 2018, the FDA announced it is strengthening the current warnings in prescribing information for Fluoroquinolone Antibiotics.
The new label warnings include:
- Language stating hypoglycemia can lead to coma
- Mental health side effects updates across all fluoroquinolones
- Recommendations to minimize risks in treatment
In January 2018, the FDA also announced manufacture safety labeling changes for cough and cold prescriptions containing Codeine or Hydrocodone.
The new label safety warnings include:
- Use limited to adults 18 years or older
- No longer indicated for use in children
- Alternative treatment for cough due to cold in children
Regulatory Updates Regarding Controlled Medications
Senate Bill 1109 was signed into law on September 22, 2018, and requires the following key points:
- Nurses, nurse practitioners, physician assistants, dentists, optometrists - mandatory continuing education (CE) requirements in the risks of addiction associated with the use of Schedule II controlled substances
- Physicians and surgeons - for those licensed on or after January 1, 2019, mandatory CE course on pain management to include the risks of addiction associated with the use of Schedule II drugs (existing law only requires a CE in pain management for physicians)
- Nurse-midwives - the required pharmacology course to now include the risks of addiction and neonatal abstinence syndrome associated with the use of opioids
- Pharmacists or practitioner - dispensing outpatient CII opioids to prominently display on the label a warning of overdose and addiction risks
View the full SB-1109 text.
New Medicare Part D Opioid Overutilization Policies for 2019
The Centers for Medicare and Medicaid Services (CMS) finalized new policies for Medicare drug plans starting January 1, 2019. These include policies for physicians and other prescribers who prescribe opioid medications to patients with a Medicare Part D prescription drug benefit.
CMS has published a Medicare Learning Network article on this topic called A Prescriber’s Guide to the New Medicare Part D Opioid Overutilization Policies for 2019.
Controlled Drug Prescription Form Requirements
Effective January 1, 2019, Assembly Bill 1753 requires controlled substance security prescription forms to include a unique serialized number in a format approved by the Department of Justice.
The Medical Board of California published a notice to prescribing physicians on AB 1753.