Legal Prescription

ALRT's Exploration of Addiction, Law, and Medicine

Category: Naloxone

Affordability of Naloxone in Pennsylvania

[The Addiction Legal Resource Team is proud to unveil a three-part series on Naloxone, a drug that reverses the effects of an overdose. While the role of Naloxone as a tool to combat the opioid crisis is undisputed, this series does not intend to address every aspect of the drug. Instead, the ALRT is releasing three different pieces that will explore how this drug may be used as a tool to fight the opioid crisis. This is the final post in that series.]

By Travis Murray

In response to the opioid epidemic in the Commonwealth, the Physician General of Pennsylvania issued a standing order for people to purchase naloxone from pharmacies in 2014 that was laid out in a Dear Pharmacist Letter.  Naloxone is a prescription medication indicated for the reversal of opioid toxicity. Naloxone works quickly to reverse overdose symptoms, but repeated doses of naloxone are often necessary. The standing order’s goal was to decrease opioid-related deaths by increasing naloxone accessibility. However, in the years since the standing order has been in effect, the price has risen sharply. Those without medical assistance or private insurance may have to pay out-of-pocket drug costs or rely on emergency services or limited free naloxone distribution days. 

Drug Cost

Narcan® and Evzio® are the only two branded naloxone agents on the market for the reversal of fatal opioid toxicity.  Narcan® is available in an easy-to-use intranasal spray, and Evzio® is an auto-injector, making both easy to administer by an individual to unconscious overdose victims. By mandate, both the naloxone nasal spray and the injection are covered without a prior authorization for recipients of Pennsylvania medical assistance (MA). However, people who are not policy-holders are not covered. Therefore, if an MA patient indicates at any time in the pharmacy that the naloxone is for someone else, the pharmacist may be unable to bill the insurance for the medication. Then, if the person wishes to purchase naloxone, he or she must pay out-of-pocket, and prices can range from hundreds to thousands of dollars per dose. For some patients, this may not be enough naloxone to keep the patient alive until emergency services arrive. While chemical dependence and addiction can affect any person, especially those with environmental and genetic risk factors, opioid deaths affects those with lower socioeconomic status disproportionately. Without insurance, a major population that would require access to naloxone may be unable to purchase the medication. 

This standing order has seen an increase in naloxone purchases in Pennsylvania, both by private citizens and municipalities, but has unintended consequences of payers insuring non-policy holders and the state is likely trying to limit paying for people who are not covered. For pharmacists, it raises an ethical question of knowingly dispensing and billing a medication to a person who will use the medication on another person. Regarding the high prices of branded naloxone, pharmacy benefit managers (PBMs) have contributed to increased prices for naloxone and many other prescription drugs. PBMs, in theory, are a middleman between drug manufacturers and Medicaid plans and other payers to negotiate and create health formularies, often via rebates. Most PBMs charge administrative fees that get passed on to the insurers and pharmacies that fill the prescription. Pharmacies do not independently contract with insurance plans and often accept these plans or risk forfeiting patients. High drug prices are essential for drug companies to be able to generate a profit from its investment in creating the product. In the end, individuals who wish to purchase the medication and do not have insurance or medical assistance could be unable to afford it.

Solutions to Accessibility Issues

Community pharmacies are trying to make the medication more accessible to patients by dispensing the significantly cheaper generic naloxone solution for injection. The naloxone solution in the syringe is actually safe for intranasal use, and pharmacies have been dispensing them without needles for this route. Some states have taken approaches with other life-saving medications to control costs that may have some applicability. Recently, Colorado limited the maximum price for vials of insulin. Other states have taken PBMs head-on and pushed for their abolition for their responsibility in soaring prescription drug costs. Ohio’s Attorney General has sued OptumRx and CVS Caremark. Pennsylvania has a bill currently in the works to bring payment transparency among PBMs, managed care organizations, and pharmacies in PA General Assembly HB-569. Sometimes even the best intentions can have unintended consequences, and naloxone is not immune to the plague of rising drug costs. Years out from generic formulations of Narcan® and Evzio®, there is much to be done to make naloxone more readily accessible and to protect pharmacists from difficult ethical situations. 

Opportunity Knocks and Communities Answer: Naloxone Co-Prescription and Its Effect on Overdose Deaths

 

By Evan Marmie

[The Addiction Legal Resource Team is proud to unveil a three-part series on Naloxone, a drug that reverses the effects of an overdose. While the role of Naloxone as a tool to combat the opioid crisis is undisputed, this series does not intend to address every aspect of the drug. Instead, the ALRT is releasing three different pieces that will explore how this drug may be used as a tool to fight the opioid crisis. This is the second post in that series.]

Across the country, states have begun to look towards individual and doctor responsibility for a solution to opioid related overdose deaths. Naloxone is a drug used to immediately treat overdoses in emergency situations. Naloxone, despite being one of the most accessible and affordable options for immediate treatment in an overdose crisis, requires some training to use effectively. 

States have responded by passing laws to make naloxone prescriptions more available and accessible at the most crucial point: the prescription of an opiate or opioid analgesic in a practice known as “co-prescription”. Co-prescription is the policy and practice of prescribing naloxone at the same time as prescribing and opioid medication if the doctor believes the patient is at risk of developing an addiction or dependency. In order to determine the efficacy of co-prescription, it is important to discuss: the theory behind the laws, the kind of naloxone dispensers available, the costs of treatment, both doctor and community concerns, and the solutions to those concerns alongside the results of the laws in discussion.

To begin, the theory behind the co-prescription laws is not only one of treatment, but of messaging and deterrence. By providing overdose medication at the beginning of an opioid regiment, the doctor and pharmacist send a powerful reminder that the drug’s effectiveness at treating pain is coupled with the potential for crippling addiction. Co-prescription was signed into law in California, Ohio, Virginia, Rhode Island, Massachusetts, Vermont and Washington. Recently, Tennessee’s legislature has also passed a co-prescription bill, but the governor has not yet signed the bill.

The most important factor when thinking about co-prescription, beyond the law, is Naloxone and the issues surrounding it. The most common means of dispensing naloxone is “Narcan ®,” a nasal spray that requires some assembly and impractical for a person to use on their own. There are other kinds of dispensers, such as self-injectors. The self-injector “pen” like dispensers are much more expensive, however.

Expense for self-injectors has been a notable concern. The most recognizable brand of self-injector, “Evzio ®,” has come under fire for taking advantage of the opioid epidemic to steeply raise prices after many became accustomed to using the new delivery method for naloxone. The company has since taken steps to walk back the predatory tactic, but communities remain distrustful in the wake of the price hike. The cost hike on self-injectors and the impracticality of nasal sprays for self-use leaves individuals suffering from Substance Use disorder disillusioned with co-prescription policies. 

Beyond injectors, expense is thought of generally when it comes to prescription-based policy. Naloxone dispensers are costly, with some running well over 100 dollars per unit and the cheapest generic still running a hefty 40 dollars per unit. The cost is incurred by states in some cases and individuals in others. It is important to note that, while Naloxone can be expensive, the overall cost to communities and individuals is lower than emergency care and loss of life. 

Other concerns come from doctors who must make decisions when prescribing opioids to patients for pain. Doctors fear that with the growing responsibility in decision making, there is an increase to their liability of malpractice. However, naloxone has been shown to have lower liability for doctors than most other drugs because of its abuse-deterrent design and inability to produce harmful effects.  Despite the lack of any harmful effects, doctors are concerned that prescribing naloxone will result in higher drug use generally. 

While naloxone administration is best handled by medical professionals in a hospital setting, it is more commonly administered by a layperson in the field. The major concern with untrained administration is that withdrawal symptoms occur upon revival and a layperson is ill-equipped to handle such a situation. The withdrawal symptoms combined with a lack of readily available training on naloxone administration can lead to dangerous outcomes to the civilians attempting to save someone’s life in an emergency. The best answer to the issue is simple: training to be made available to civilians, as is the case in Virgina and several other states.  

Fear of legal repercussion has been a concern among communities.  Bystanders and other individuals are often concerned with prosecution for naloxone injection, especially when the prescription is not theirs, the overdose victim cannot consent to treatment, or they are in possession of opiates themselves. Individuals in a position to administer life-saving aid to an overdose victim may be reluctant to do so when facing criminal consequence. To address the concerns of affected communities, 46 states and the District of Columbia states passed Good Samaritan laws designed to protect helping individuals in any situation when providing life-saving assistance.

Even with the cost and issues surrounding naloxone co-prescription and use, the effects of the laws are substantial for communities struggling with substance use disorder. In a non-randomized study, patients prescribed naloxone alongside opioid analogues were found to have fewer emergency situations resulting from opioid related causes. When availability is combined with community efforts on training, the mortality from overdose continues to decline. Despite the effects that layperson administration may have, Naloxone is still 75-100% effective in emergency conditions when administered generally. However, the exact impact of the laws is difficult to measure due to a lack of hard data. The lack of data is likely due to the short amount of time since the passage of co-prescription laws. 

To conclude, substance use disorder and overdoses deaths continue to rise. Naloxone co-prescription acts as a medication-focused attempt at a solution. Co-prescription acts as both a notice of potential abuse and an attempt to prevent another unfortunate death in the case of such abuse. Combined with community efforts to train people and inform them of their rights in assisting others, the number of opioid related overdose incidents would likely decrease. While results are inconclusive, what data exists shows promise and, hopefully, a way forward for struggling communities. 

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