On 23-Jul-2020, United States Food and Drug Administration (USFDA) has released a recommendation for the use of Naloxone in the treatment of opioid use disorder and for patients who are at increased risk of opioid overdose.

Opioids are a class of drugs which are used to reduce moderate to severe pain in patients who are not responding to the other pain-relieving medications.

Some of the drugs coming under this ‘therapeutic class of opioids’ are oxycodone (OxyContin), hydrocodone (Vicodin), codeine, morphine, and methadone which are referred as prescription opioids. Fentanyl is a synthetic opioid pain reliever which is much more powerful than other opioids and is approved for treating severe pain, typically advanced cancer pain. Heroin, which is considered as an illicit drug also comes under the category of opioid class. The drugs of these therapeutic class act centrally on the opioid receptors present in nerve cells in the body and brain and produce pain-relieving effect.

Opioid Overdose Epidemic: A major risk to Patient Safety & Public Health

Opioid medications are generally safe when they are used as per prescription taken for a short period of time exclusively for pain relief. However, these types of drugs have potential to produce the euphoretic effect in addition to pain relief. Due to euphoria (a temporary state of intense joy and excitement), these medications have potential for the risk of drug misuse and drug abuse by the following ways:

• Administering larger quantities than the prescribed amount
• Using without a physician’s prescription for pain relief
• Using for euphoretic purpose illicitly

Sometimes, a physician prescription could lead to drug dependence which in turn causes misuse, addiction, overdose incidents and finally death.

As per CDC-Centers for Disease Control and Prevention, there were approximately 450,000 people died due to opioid overdose, including prescription and illicit opioids during the period of 1999 to 2018.

Opioid Use Disorder:

This disorder consists of an overpowering desire to use opioids, increased opioid tolerance, and withdrawal syndrome when discontinued. It is the chronic use of opioids that causes clinically significant distress or impairment. This disorder has affected over 16 million people worldwide. This disorder includes dependence and addiction to opioids which can be treated with opioid replacement therapy buprenorphine or methadone, which reduces the risk of morbidity and mortality

Naloxone:

Naloxone is an a “mu-opioid receptor antagonist” which acts by blocking the effects of opioid class of drugs on opioid receptors present in the central nervous system. It is used as the standard treatment for opioid overdose and for suspected opioid overdose. Naloxone rapidly reverses the effects of opioid overdose; it also temporarily reverses the breathing problems caused by opioid overdose which can help in preventing death of patient.  it can be a life-saving treatment for patients on chronic use of opioid class of drugs. The expanded availability of naloxone through diverse mechanisms is considered an important component of preventing the opioid overdose, with primary care access a potentially valuable intervention. Naloxone is safe to use for people of all age groups-from infants to elderly adults. This includes a child who might have accidentally taken an opioid pain reliever or medicine to treat opioid use disorder. Three FDA-approved forms of naloxone are available in the market which included- a nasal spray, an injectable, and an auto-injector. This drug is available in generic version and also sold under the brand names Narcan and Evzio.

US-FDA Drug Safety Recommendations:

In order to reduce the risk of death from opioid overdose, US-FDA has provided following recommendations about the safe use of naloxone-“an opioid-effect reversal medicine”:

Health care professionals should discuss the availability of naloxone to all the patients who are prescribed with opioid pain relievers.

Health care professionals who prescribed opioid pain relievers for patients with the below conditions should consider prescribing the naloxone as a risk minimizing measure for opioid overdose.

1. Patients with concomitant use of benzodiazepine class of drugs
2. Patients with concurrent use of antidepressant medicines (drugs that depress CNS system)
3. Patients with a past/recent history of opioid use disorder and experienced previous opioid overdose

Health care professionals should also consider prescribing naloxone if the patient has household members, including children, and other possible close contacts with the potential risk for accidental ingestion or opioid overdose.

Health care professionals should also consider prescribing naloxone to patients who are at increased risk of opioid overdose, regardless of whether they are receiving a prescription for an opioid pain relievers or medicine to treat opioid use disorder. These may include people with a current or past diagnosis of opioid use disorder or who have experienced a previous opioid overdose.

Health care professionals are advised to educate patients and patient’s care givers to recognize the symptoms of respiratory depression and knowledge on naloxone administration during emergency.

Health care professionals are advised to encourage patients and patient caregivers to read the patient information leaflet or other educational material and instructions for use related to naloxone product use before an emergency of opioid overdose happens.

Health care professionals are advised to educate patients and caregivers on proper storage and disposal of opioid pain-relieving medicines.

Patients and patient’s care providers are advised to be aware and recognize the following signs and symptoms of a possible opioid overdose during usage of opioid pain-relieving medicines-

Sings & Symptoms of a potential opioid overdose:

• Decreased or slow breathing rate
• Shallow or difficulty in breathing
• Severe sleepiness
• Not being able to respond
• Not being able to wake up

Patients and patient’s care providers are suggested to carry out naloxone for use during emergency or while observance of above suspected symptoms of opioid overdose. A single dose usage of naloxone is temporary for opioid overdose reversal. Further, it might require repeated doses and medical emergency visit to nearby hospitals.

USFDA has increased the access of this “opioid-effect reversal medicine” by recommending manufacturers of naloxone drug to update the prescribing information leaflet and documentation by including this drug as recommendation for opioid use disorder to ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription.

Naloxone safety profile:

Use of naloxone might cause symptoms of opioid withdrawal which included feeling nervous, restless, or irritable; body aches; dizziness or weakness; diarrhea, stomach pain, or nausea; fever, chills, or goose bumps; or sneezing or runny nose.

Voluntary ADR reporting:

Health care professionals and patients are advised to report any adverse experiences or adverse drug reactions or quality problems experienced with the use of naloxone, opioid pain relieving medicines, or other medicinal products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report via MedWatch Online Voluntary Reporting
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178