FDA Fentanyl Reduction 12-7-25

The FDA combats the fentanyl crisis through a comprehensive approach focused on prevention, harm reduction, treatment development, and enforcement collaboration. Their actions address both the appropriate use of legal opioids and the challenges posed by illicit fentanyl.  

Prevention and Safe Prescribing

The FDA works to prevent new cases of opioid use disorder (OUD) by promoting appropriate prescribing of legal opioid medications. Key actions include: 

Strengthened Labeling: The FDA requires explicit warnings and safety information on immediate-release and extended-release opioid pain medications. This includes a warning that overdose risk increases with dosage and that these drugs should generally not be used for long periods.

Risk Evaluation and Mitigation Strategy (REMS): The agency mandates REMS programs for certain opioids, requiring prescribers and pharmacists to receive training on safe use and pain management.

Safe Disposal: The FDA requires manufacturers of opioid analgesics to provide prepaid mail-back envelopes as a convenient disposal option for unused medicines, reducing the risk of misuse by others. They also provide guidance on proper disposal of fentanyl patches.

Abuse-Deterrent Formulations (ADFs): The FDA encourages the development and wider availability of ADFs, which are designed to make abuse via crushing, snorting, or injection more difficult. 

Harm Reduction and Overdose Response 

The FDA supports harm reduction by expanding access to life-saving tools and technologies: 

Naloxone Access: The agency approved the first over-the-counter (OTC) naloxone nasal spray (Narcan) and a generic nonprescription naloxone nasal spray, making the overdose reversal medication more widely available in pharmacies, convenience stores, and online.

Innovative Devices: The FDA has authorized marketing for medical devices designed to monitor patients for signs of opioid-induced respiratory depression and alert personal contacts or emergency services.

Fentanyl Test Strips: FDA and NIH leaders encourage research and lower regulatory barriers for drug-checking tools like fentanyl test strips, which help users detect the presence of illicit fentanyl in drug samples. 

Advancing Treatment

The FDA facilitates the development and access to evidence-based treatments for OUD: 

Medication Approvals: The FDA has approved several medications to treat OUD, including methadone, buprenorphine (including an extended-release injectable product), and naltrexone (including a generic injectable version).

Research Support: The agency supports research into new treatments, including medications that may be more effective against potent synthetic opioids like fentanyl and xylazine. 

Enforcement and Collaboration

The FDA's Office of Criminal Investigations (OCI) works with domestic and international law enforcement partners like the DEA, Customs and Border Protection (CBP), and the U.S. Postal Inspection Service to disrupt the illicit supply chain: 

Combating Illicit Imports: The FDA places import alerts and conducts joint operations at international mail facilities to restrict the unlawful entry of unapproved drugs and controlled substances, including illicit xylazine.

Online Sales Investigations: OCI strategically targets online sales of illegal pharmaceutical drugs sourced from clandestine supply chains.

Addressing Xylazine Threat: In response to the growing threat of xylazine (an animal sedative) being mixed into illicit fentanyl, the FDA has alerted healthcare professionals and implemented import restrictions to ensure the chemical is used only for legitimate veterinary purposes. 

The FDA combats the fentanyl problem through a multi-pronged approach focused on reducing exposure to prescription opioids, promoting harm reduction, expanding access to treatment for opioid use disorder (OUD), and working with law enforcement to prevent illicit drugs from entering the U.S.. 

Key actions the FDA is taking include:

1. Supporting Primary Prevention and Safe Prescribing 

The FDA aims to prevent new cases of OUD by promoting the appropriate use of prescription opioids and ensuring safe disposal of unused medication. 

Labeling Changes: The agency requires strengthened warnings and safety information on immediate-release and extended-release/long-acting opioid packaging. These labels state that the risk of overdose increases with dosage and generally recommend short-term use for acute pain conditions.

Risk Evaluation and Mitigation Strategy (REMS): Opioid manufacturers must fund continuing medical education (CME) for prescribers to ensure appropriate pain management and safe prescribing of opioid drugs.

Safe Disposal Options: The FDA now requires manufacturers of opioid analgesics to make prepaid mail-back envelopes available to outpatient pharmacies and dispensers, offering a convenient way for patients to dispose of unused opioids securely. 

2. Encouraging Harm Reduction through Innovation 

To mitigate the risk of overdose deaths, the FDA facilitates the availability and development of life-saving harm reduction tools. 

Expanded Naloxone Access: The FDA has approved the first over-the-counter (OTC) naloxone nasal spray (Narcan) and generic versions, allowing this overdose reversal medication to be sold directly to consumers in pharmacies, convenience stores, and online without a prescription.

Innovative Monitoring Devices: The agency has granted marketing authorization for devices designed to monitor physiological markers and alert individuals or emergency services to signs of opioid-induced respiratory depression (OIRD).

Fentanyl Test Strips: The FDA has cleared laboratory-based tests to detect fentanyl in urine and hair specimens and supports the development of point-of-care devices (such as test strips for testing illicit drug samples) to help individuals identify the presence of fentanyl in illicit substances. 

3. Advancing Evidence-Based Treatments

The FDA supports the development and availability of medications and devices to treat OUD as a chronic, treatable medical condition. 

Approving New Treatments: The agency has approved generic versions of extended-release injectable naltrexone and buprenorphine products to treat OUD.

Facilitating Device Development: The FDA works with innovators on medical devices, including digital health technologies, intended to treat OUD or aid in risk prediction and management. 

4. Protecting the Public from Illicit Drugs

The FDA works with federal and international law enforcement agencies like the DEA and U.S. Customs and Border Protection to target the supply of illicit fentanyl. 

Combating Illicit Supply Chains: The FDA's Office of Criminal Investigations (OCI) conducts operations and works with foreign authorities to dismantle sources of supply and intercept unapproved or counterfeit drugs containing fentanyl, including those entering the U.S. via international mail facilities.

https://www.google.com/search?q=what+can+the+fda+do+to+stop+fentanyl+problem

Pill Testing

Pills are most commonly tested for illicitly manufactured fentanyl using fentanyl test strips (FTS), which are inexpensive, user-friendly, and provide rapid results within minutes. This method is a key harm reduction strategy.

In addition to fentanyl test strips, other methods for testing pills for fentanyl include:

Immunoassay tests: These tests use antibodies to detect the presence of fentanyl and related compounds.

Mass spectrometry: This is a more complex laboratory technique that can identify the specific chemical composition of a substance, including fentanyl.

High-performance liquid chromatography (HPLC): This method separates the components of a mixture and can be used to identify and quantify fentanyl. 

It is important to be aware of the limitations of all testing methods, including fentanyl test strips: 

No measurement of potency: Test strips and some other methods only indicate the presence of fentanyl, not the quantity or potency.

May not detect all analogs: Some testing methods may not detect all fentanyl-like drugs, such as carfentanil, which is even more potent.

False results: While test strips are unlikely to produce false negatives if used correctly, results are not 100% accurate. A negative result does not guarantee the drug is safe from fentanyl or other deadly additives. 

It is crucial to understand that no testing method can guarantee the complete safety of illicit drugs. The presence of fentanyl or other harmful substances can be unevenly distributed within a pill, leading to inaccurate test results. Health officials emphasize that the safest practice is to avoid using non-prescribed drugs altogether.

If someone chooses to use drugs, accessing harm reduction services, such as supervised consumption sites and naloxone distribution programs, can help reduce the risk of overdose. 

Pills are most commonly tested for the presence of fentanyl using fentanyl test strips (FTS), which are inexpensive, rapid screening tools for pre-consumption drug checking. For forensic or clinical purposes, more advanced laboratory techniques like mass spectrometry are used. 

Using Fentanyl Test Strips (FTS)

Fentanyl test strips were originally designed to test urine but are effective for checking illicit drug supplies. They are similar in function to a home pregnancy test, producing results within a few minutes. 

How to Test a Pill:

Prepare a sample: Crush the entire pill into a fine powder and mix it thoroughly. This is crucial due to the "chocolate chip cookie effect," where fentanyl may not be evenly distributed throughout a batch or even a single pill.

Add water: Put a small amount of the powder (about 10mg, or a few grains of salt) into a clean, dry container. Add about a half teaspoon of clean water for most drugs. For methamphetamine, MDMA, or ecstasy, use a full teaspoon of water.

Dip the strip: Hold the test strip by the solid or dark blue end and dip the wavy end into the liquid for 15 seconds. Do not dip past the maximum fill line.

Wait for results: Remove the strip and place it on a flat, non-absorbent surface for 2 to 5 minutes. Do not read the result after 10 minutes.

Read the result:

Two lines (even faint ones) mean a negative result (fentanyl was not detected).

One line means a positive result (fentanyl or a fentanyl analog was detected). 

Limitations and Safety Precautions

Not 100% accurate: No test is perfect. FTS may not detect all fentanyl analogs (variations), like carfentanil, or other dangerous adulterants like xylazine.

Cannot measure quantity: The strips only indicate presence, not how much fentanyl is in the sample. A tiny amount can be deadly.

Harm Reduction: A negative result does not guarantee safety. The safest practice is to avoid using illegally obtained drugs altogether. If you do use, always carry naloxone (Narcan), avoid using alone, start with a small amount, and go slowly. You can find test strips at local harm reduction centers or buy them online from sites like DanceSafe or CVS Pharmacy. 

https://www.google.com/search?q=how+are+pills+tested+for+fentanyl

Comments

Online Sales Investigations are included and should result in tracking the Fentanyl supply chain. There should be no online sales of drugs allowed. All drugs should be sold by Pharmacies.

Norb Leahy, Dunwoody GA Tea Party Leader