It is not dangerous. It has no potential for abuse or dependency. And, if administered to someone who is not at risk of overdose, they will generally experience no side effects.
Worst case scenario it does nothing. Best case scenario it saves a life. So, why has this 'overdose antidote' not been made more widely available and accessible?
One of the most common misconceptions is that these types of initiatives actually encourage use and do more harm than good. Of course, these misconceptions are no different when it comes to naloxone distribution and over-the-counter use. So, let’s get down to the facts.
First, naloxone is much safer and doesn't hold the potential for abuse and drug interactions like many drugs you can currently pick up over the counter. Tylenol and medications containing pseudoephedrine and even things like NSAIDs carry more potential danger than naloxone.
Many people believe having access to naloxone would only encourage and increase drug use, as there is no longer any risk or reason to stop the user from injecting larger and larger amounts knowing that the naloxone is there to save them. This is simply not true. Any opiate user who has had the experience of being given naloxone will tell you otherwise and explain it is not an experience they care to have again.
Naloxone is in a class of medications known as antagonists, which work by rapidly attaching to the same parts of the brain that receive other opiates, blocking their effects. This results in the user rapidly being thrown into withdrawal since it so quickly stops and reverses the effects of the opiate taken. As uncomfortable of an experience as this aspect of naloxone can be, it allows the medication to also reverse the respiratory depression that is often deadly in cases of opiate overdose.
However, when no opiates are present in the body, nothing happens, making it reportedly safe in the case of dosing a person who is not experiencing an overdose.
Methods of Administration
Intramuscular injections via syringe are no longer the only way to administer naloxone. However, it is still the most commonly prescribed and used form. Some of the most prominent new formulations include the Evzio, a handheld take-home version of a naloxone injection; a nasal spray version of naloxone; and even a wearable armband naloxone auto-injector. Training is of course provided for the type of formulation being administered in order to ensure safe use, as well as proper medical care.
In order to have naloxone available to the public over the counter and without a prescription, certain changes must be made. Currently, the U.S. Food and Drug Administration policies and regulations state that naloxone must be prescribed by a physician. Maia Szalavitz article in Health & Time explains the process, as well as the roadblocks involved in changing the drugs status.
"Despite the widespread support for naloxone, however, there are significant barriers to change. For one thing, a drug company would need to submit an application to the FDA to change the status of the drug, which would require presenting a great deal of data. Alternatively, a citizen could petition the agency to make the drug available over-the-counter, but that procedure would take years longer than it would with a drug company involved,” an FDA official said.
“Since naloxone is off-patent, any company seeking over-the-counter approval would be able to market it exclusively for only three years. If it wanted to seek a longer period of exclusivity by patenting a new method of delivering the drug, that would require more data and more expense.
The CEO of a start-up pharmaceutical company called Anti-Op, which would like to sell naloxone over-the-counter, estimated that the approval process would cost $10 to $20 million, an amount that could exceed the current market for the drug. With insurers and Medicaid unwilling to cover over-the-counter medications and funding for naloxone programs currently extremely limited, how the drug would be paid for is also unclear.
Right now, only one manufacturer produces naloxone in the U.S. And, not only is there currently a national shortage of the drug, its price has also risen dramatically,” according to TIME.
While there are many hurdles and steps to overcome, in April 2012 the FDA did hold a meeting to take testimony from parents, families, medical professionals and harm reduction advocates as to why this policy change is so vitally important. However, as it stands currently, the prescription-only status of naloxone remains, along with the seemingly endless amount of expensive FDA trials, policy and approvals to overcome.
Reaching Those In Need
Even though naloxone is available via prescription to those who wish to obtain it, many drug users and addicts do not feel safe or comfortable obtaining it in this manner. Often times, those at highest risk for overdose are those users who do not regularly visit healthcare providers or access treatments and care through regular means due to stigma and discrimination.
By providing over the counter naloxone access, even people who are not as likely to seek out help would be able to access the drug.
If the situation arises where the drug is administered, emergency services still need to be called to provide further treatment, as naloxone only provides a temporary window of help. Someone who is overdosing is not likely to seek out medical attention, and this point of contact with healthcare providers can help lead them to proper treatment and resources they otherwise would not have sought out.
Finally, over-the-counter accessibility of naloxone is not some ploy by addicts to use with no care or responsibility. It’s seen as a way to address the very real and growing epidemic of opiate addiction and overdose, stemming from other issues such as the overprescribing of prescription narcotics and the massive failure that is the 'war on drugs.’
Addiction is not a moral failure or weakness. It is an illness that affects millions of people all over the country and every last one of them deserves to be treated with dignity, respect and value. Widely accessible naloxone can help keep addicts safe and alive until they are ready and able to seek treatment.
K. Lanktree is a NewsOK contributor, Freelance Writer, Former IV Drug User, Methadone Patient and Harm Reduction Advocate. For more information, check out her blog.
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