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The number of drug overdose deaths in the United States (US) has exceeded 750,000 since 1999. The yearly fatality rates from opioid-related overdoses (OROs) climbed by more than six times throughout that period. The US Department of Health and Human Services issued a public health emergency declaration in 2017, listing five crucial steps to address the situation.
There is a limited amount of time in which naloxone can be given in the case of a potentially fatal overdose to reverse the overdose and avoid long-term morbidity and mortality successfully. Thus, expanding community access to naloxone, especially for people living near those who are at high risk of overdose, is essential to lowering ORO mortality because it increases the possibility that naloxone will be administered promptly. The US Surgeon General issued formal advice in 2018 stressing the need to take this precaution and advising that everyone at high risk of ORO and anyone likely to come into contact with them get naloxone.
Since the US Food and Drug Administration (FDA) originally authorised naloxone in 1971, it has been extensively utilised in acute care environments. More recently, intranasal and intramuscular dose formulations that are simpler to administer have been introduced to the market to enable layperson usage in a community context. Although naloxone has a reasonably mild side effect profile, is not classified as a prohibited drug, and can be abused, it has only historically been available with a prescription. Prescription-only status, however, raises several possible access issues. First, despite guidelines, co-prescribing naloxone to patients at elevated risk of overdose is still uncommon, and the present level of naloxone prescribing is far from appropriate considering the number of patients in the country at risk.
People Who Use Drugs (PWUD) could encounter further difficulties. PWUDs are more likely to come from lower socioeconomic backgrounds and have lesser health insurance, which may make it more difficult for them to pay for prescription drugs or copays for doctor appointments. PWUD may also put off or avoid interacting with the traditional healthcare system for several reasons, including unfavourable personal experiences and a fear of being stigmatised by their providers. These worries could keep individuals from asking for a prescription for naloxone, talking about their drug use, or coming back to ask for more supplies if they use naloxone. Establishing care may also take longer for people without a primary care physician. For similar reasons, stigma at pharmacies may hinder patients from filling naloxone prescriptions. Research demonstrates that some PWUD decline naloxone when it is provided to them because they feel stigmatised or believe they are not in danger while they are sober. Evidence that some pharmacists have unfavourable attitudes about giving out naloxone because they worry about "clientele who would frequent the store" or "providing the person with a 'free pass' when they should instead seek professional treatment" is especially problematic.
Naloxone access laws (NALs), which aim to increase community access to naloxone, have been extensively introduced by state lawmakers in recent years to address these impediments. State-by-state variations in these laws notwithstanding, the majority share some or all of the following essential characteristics:
Protection from criminal or civil liability for naloxone prescribers, dispensers, or those administering the medication in good faith if something goes wrong;
Permission to prescribe to third parties or people who are unlikely to be the ones to receive the medication in the end;
Permission for laypeople to possess and distribute naloxone without a prescription and
Provide means by which pharmacists can dispense naloxone without a patient-specific prescription (e.g., through standing orders with prescribers or state-level protocols directly).
While links between NAL adoption, greater naloxone access, and reduced ORO morbidity and death have been established, overall rates of ORO mortality have tragically continued to grow. A record 50,042 ORO deaths occurred in the US in 2019, partly as a result of the ongoing rise in the availability of potent synthetic opioids on the black market. These alarming figures suggest that much more is needed to reduce ORO mortality. Raising naloxone's accessibility even further, some physicians and legislators are pushing for it to be reclassified as an over-the-counter (OTC) drug. This blog's objectives are to outline the advantages and disadvantages of the existing NAL strategy and go over the possible benefits and drawbacks of reclassifying naloxone as an over-the-counter drug.
Access: Until 2010, only four states had approved NALs; now, all fifty states and the District of Columbia have done so. There's proof that these laws have led to more pharmacies providing naloxone. Naloxone dispensing from US pharmacies surged eight-fold between the fourth quarter of 2015 and the second quarter of 2017, per research that used IQVIA's National Prescription Audit. Examining the effects of individual NAL components more closely among US Medicaid patients, introducing NALs with provisions allowing pharmacists to distribute medication by standing order from a doctor led to an extra 33 naloxone prescriptions per state per quarter. Similarly, two other studies found that independent of the payer, standing order or third-party prescribing policies were associated with higher naloxone dispensing from community pharmacies. Lastly, although naloxone co-prescribing for patients with ORO risk factors is only required in a few jurisdictions, this practice has been linked to even higher increases in naloxone dispensing.
In addition to providing significant government cash to address the opioid epidemic, NALs have enabled the expansion of overdose education and naloxone distribution (OEND) programmes in the community. These initiatives offer free naloxone to at-risk individuals and other laypeople who might be able to deliver a prompt overdose reaction, together with education aimed at lowering ORO mortality. In 2019 alone, such initiatives supplied more than 1 million doses of naloxone, which is roughly twice as many doses as dispensed from US community pharmacies. The number of law enforcement officers and other first responders who are naloxone-equipped and prepared to respond to an ORO has significantly increased as a result of OEND and related training initiatives. But despite their achievements, these programmes have never been adequately supported and aren't now.
Moreover, suppose a person uses the naloxone they receive from one of these programmes. In that case, they might be unable to quickly restock from another OEND programme due to logistical obstacles like figuring out where, how, and to whom the supply of naloxone should be distributed to provide the most significant impact. Naloxone must thus continue to be easily accessible from community pharmacies to guarantee that it is available in the case of an overdose.
Outcome: Naloxone users in opioid treatment programmes reported using it to reverse an overdose in 18% of cases. It has also been discovered that granting law enforcement and other first responders greater access to naloxone lowers the death rate from opioid overdoses.
Barriers: There are numerous reasons why PWUD access to naloxone can be hampered, such as the naloxone being inconsistently stocked in community pharmacies (which may be partly explained by low customer demand at some pharmacies), the medication being less readily available in independent pharmacies than chain pharmacies; the pharmacist or pharmacy staff not understanding standing order legislation and company procedures regarding their implementation or the age requirements for using standing orders; the PWUD population being less accessible than third parties; stigma or negative beliefs regarding the dispensing of naloxone; and the pharmacist's time constraints. Although naloxone may be included on many insurance formularies, the cost is still a significant barrier for patients without insurance or with inadequate coverage, and community pharmacists are unsure whether naloxone can be billed to insurance plans when dispensed via standing order.
Although these audit studies have revealed essential obstacles to community pharmacists' provision of naloxone, they have also shown several promising approaches to enhance the influence of NALs on community pharmacy access. After the Board of Pharmacy in Massachusetts ordered that pharmacists have enough naloxone to fulfil community needs, more than 80% of Massachusetts pharmacies had naloxone available, according to two different audit investigations. In addition to requiring pharmacies to carry naloxone, more training for pharmacists seems to help make naloxone more accessible. Pharmacist educational interventions have been demonstrated to raise patient perceptions of the importance of ORO prevention counselling while also improving the chance of standing order dispensing, keeping naloxone stocked at the pharmacy, and offering SUD counselling.
Moreover, as time passes after the NAL's original deployment, naloxone accessibility could improve. If naloxone use grows more widespread, more public access to the drug may help lower the stigma attached to both getting it and using opioids. Increasing the number of naloxone prescriptions filled by pharmacists may also increase their comfort level and awareness of the significance of initiatives to lessen stigma and increase anonymity.
Naloxone's eligibility for over-the-counter status is based on its compliance with four FDA requirements:
The drug's benefits must exceed its risks.
It must treat a condition that can be identified without a doctor's help.
It must have a low potential for misuse.
Its label must make it clear how to use it.
Specifically, compared to earlier intramuscular formulations created for use in healthcare settings, the discovery of an easy-to-use intranasal naloxone formulation, Narcan®, has dramatically improved overall simplicity of use and should promote its safe and effective usage as an OTC medicine. The FDA Centre for Drug Evaluation and Research has also created and evaluated a sample drug information label for over-the-counter medications.
To your health,
Nwabekee.
Reference
Evoy, K.E., Hill, L.G. and Davis, C.S. (2021) ‘Considering the potential benefits of over-the-counter naloxone’, Integrated Pharmacy Research and Practice, Volume 10, pp. 13–21. doi:10.2147/iprp.s244709.
Good work. As drug overdose is a public health issue, naloxone should be available.