The opioid overdose crisis continues to plague the United States with, on average, 130 Americans dying every day from opioid overdose.1 The Center for Disease Control and Prevention (CDC) has provided guidelines for providers prescribing opioids in an outpatient setting to patients with chronic pain. The guideline does not include patients with active cancer treatment, palliative care, or end of life care for which National Comprehensive Cancer Network (NCCN) guidelines or others can be referred.
CDC Guidelines Summary 2
The Food and Drug Administration (FDA) has continuously made safety updates to reduce opioid risk3:
- 2018 September – FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence to broaden access to medication assisted treatment of opioid use disorder.
- 2018 September – FDA approves Opioid Analgesic risk Evaluation and Mitigation Strategy (REMS), a program with measures that require education to patients and health care providers on the risk of opioid pain medications.
- 2018 January – All prescription cough and cold medicines containing codeine or hydrocodone are limited to adults 18 years of age and older due to risks outweighing the benefits of use.
- 2017 April – All prescription codeine and tramadol containing products become contraindicated in children less than 12 years old due to risk of respiratory sedation.
- 2016 August – To help inform patients and health care providers of the serious risks, FDA requires changes in drug labeling to warn that concomitant use of opioids with benzodiazepines or other central nervous system depressants may result in sedation, respiratory depression, coma, or death.
New Law Assembly Bill 27604 4
Effective 2019 January – In California, prescribers are now required to offer a prescription for naloxone or another FDA approved opioid-reversal agent as a rescue medication when:
- Patient is receiving ≥90 MME/day
- Patient is prescribed opioid concurrently with a benzodiazepine
- Patient has increased risk of overdose such as history of overdose, history of substance use disorder, or risk of returning to high dose of opioids for which patient is no longer tolerant
The bill also requires prescribers to provide education on overdose prevention and the use of naloxone or other similar FDA approved drug to the patient or patient’s caretaker.
HPSJ strives to keep up with new safety updates and guidelines and to apply them to our policies for our members:
- Initial fill of any opioid prescription is limited to a seven (7) day supply;
- Formulary short acting opioids are limited to a combined total of 120 units per month;
- Members are limited to 1 type of long-acting opioid with quantity limits per opioid;
- Morphine ER is limited to 90 tablets per month
- Fentanyl patches are limited to 10 patches per month with a PA required
- Oxycodone ER is limited to 60 tablets per month with a PA required
- HPSJ has also added age restrictions;
- Cough and cold medicines containing codeine or hydrocodone are limited to persons 18 years of age or older
- Tramadol and any non-cough and cold medicine containing codeine are limited to persons 12 years of age or older.
Links & Resources
- CDC Guideline for Prescribing Opioids for Chronic Pain: https://www.cdc.gov/drugoverdose/prescribing/guideline.html
- UCSF Substance Use Management Clinician Consultation:
- Substance Use Warmline: 855.300.3595
– Peer-to-peer consultation from physician, clinical pharmacists and nurses
– Monday -Friday, 9 a.m. – 8 p.m., EST
- SAMHSA Opioid Treatment Program Directory: http://dpt2.samhsa.gov/treatment/directory.aspx
- American Pain Society Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain: http://www.jpain.org/article/S1526-5900(08)00831-6/pdf
- Medical Board of California Guidelines for Prescribing Controlled Substances for Pain: http://www.mbc.ca.gov/licensees/prescribing/pain_guidelines.pdf
- CURES 2.0: https://cures.doj.ca.gov
- Opioid Risk Assessment Tool: https://www.drugabuse.gov/sites/default/files/files/OpioidRiskTool.pdf
- National Institute on Drug Abuse Opioid Prescribing Resources: https://www.drugabuse.gov/nidamed-medical-health-professionals/tool-resources-your-practice/opioid-prescribing-resources
- SMARTCARE California: https://www.chcf.org/project/smart-care-california/
- Curbing the Opioid Epidemic checklist: https://www.chcf.org/wp-content/uploads/2019/02/SmartCareHealthPlansOpioidChecklist.pdf
- Resources for Opioid Prescribers: https://www.cdph.ca.gov/Programs/CCDPHP/DCDIC/SACB/CDPH%20Document%20Library/OpioidPrescribersResources.pdf
- California Department of Public Health Opioid Overdose Surveillance Dashboard- https://pdop.shinyapps.io/ODdash_v1/
- Food and Drug Administration MedWatch Safety Alerts for Human Medical Products: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm
- Opioid Overdose. Centers for Disease Control and Prevention. https://www.cdc.gov/drugoverdose/epidemic/index.html. Published December 19, 2018.
- Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1
- Center for Drug Evaluation and Research. Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse. U S Food and Drug Administration Home Page. https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm338566.htm.
- Alert: New Naloxone Regulations Effective on January 1, 2019 -. Health Plan of San Joaquin. https://www.hpsj.com/alert-new-naloxone-regulations-effective-on-january-1-2019/. Published February 25, 2019.
- HSPJ Coverage Policy – Opioids. https://www.hpsj.com/wp-content/uploads/2018/07/Pain-Opioid-2018-05.pdf
Posted on October 26th, 2017 and last modified on May 1st, 2019.