Opioids are characterized as narcotic pain medications, such as the prescription drugs oxycodone, hydrocodone, and morphine, and also the illegal drugs heroin and fentanyl. Deaths from an overdose of these drugs have now become a leading cause of injury death in the US, even exceeding the fatalities caused from motor vehicle accidents.
Since the 1990s, the number of deaths attributed to prescription opioids and heroin has soared in the US, reaching a startling 28,648 in 2014. US Health and Human Services (HHS) Secretary Sylvia M Burwell assured that various agencies across the department, in collaboration with the federal government are striving to address this public health epidemic. The FDA is making vital contributions in this regard, innovating and modernizing the overall efforts at HHS.
FDA Calls For Extensive Review Of Agency Opioid Policies To Combat Opioid Addiction
In response to the rising abuse of prescription opioids, Dr Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders declared that a wide-reaching action plan must be established to assess the current approach towards opioid medication. This effort is in line with the wide national campaign and initiative taken by the HHS, and also supports the work of the Centers for Disease Control and Prevention (CDC) regarding guidelines for prescribing opioids for chronic pain and end of life care.
According to the devised plan, the FDA will have the following responsibilities:
Re-evaluate the risk-benefit model for opioids and guarantee the consideration of their numerous health effects, with the formal incorporation of the respective public health crisis.
Organize an expert advisory committee consisting of physicians and other experts overlooking the approval of any new drug application for an opioid that lacks abuse-deterrent properties. Opportunity for public input will also be granted.
Convene and collaborate with experts from the Pediatric Advisory Committee to establish a framework for pediatric opioid labeling prior to the approval of any new label.
Draft changes in the immediate-release (IR) opioid labeling – include additional warnings and safety precautions similar to those incorporated in the current extended-release/long-acting (ER/LA) opioid analgesics labeling. This aims to help the doctors decide safe doses and assess prospective risks.
Revise and update the Risk Evaluation and Mitigation Strategy (REMS) requirements for opioids after reviewing the existing needs and suggestions of the advisory committee. This intends to increase the number of prescribers trained in pain management and safety so that inappropriate opioid prescribing is reduced.
Encourage the development of abuse-deterrent formulations (ADFs) for opioids to enhance innovative generic products, and provide a means for their easy accessibility.
Improve access to medication-assisted treatment options, such as naloxone.
Fund superior pain management options and alternative treatment strategies.
Seek help from experts in the field of pain management and drug abuse, such as those at the National Academies of Sciences, Engineering, and Medicine, to provide wider access to overdose treatment, safer prescription and ultimately introduce new classes of analgesics without health risks.
Strengthen the requirements for drug companies to produce post-market data on the long-term influences of opioids that will further help understand risks of abuse, misuse and fatal overdose.
President Barack Obama Proposes $1.1bn To Treat Opioid Addiction
On 2 February, President Barack Obama proposed $1.1 billion in new funding to facilitate access to treatment related to prescription opioids and misuse of heroine. These will be included in the president’s fiscal year 2017 budget. The breakdown of the funds would be as follows:
$920m to assist in the expansion of affordable and accessible medication-assisted treatment programs for opioid disorders. These programs combine behavioral and pharmaceutical therapies. The White House stated that funds allocated would be based on the severity of the drug epidemic in every state respectively, along with its strength to deal with it.
$50m would be given to the National Health Service Corps (federal program providing primary care services to underserved communities) to expand access to providers of substance abuse.
$30m for the evaluation and improvement of the efficacy of medication-assisted treatment plans for opioid disorders.
New Guidelines From American Society of Addiction Medicine (ASAM)
Despite playing a vital role in the health management of patients, not all physicians are knowledgeable about prescribing complex medications for treating opioid use disorders. ASAM has published new evidence-based guidelines regarding the prescription medications for the treatment of opioid addiction, which were developed by a multidisciplinary Guideline Committee consisting of specialists in addiction medicine and other relevant fields.
“Suboptimal treatment has most likely contributed to the expansion of the opioid epidemic, along with concerns regarding unethical practices”, the researchers stated. “Simultaneously, access to competent treatment is significantly restricted since few physicians are willing and skilled enough to provide it. The expertise and time needed for effective use of medications for opioid use disorders are not generally available to primary care doctors”.
Keeping in mind this aspect, ASAM combined scientific evidence with clinical expertise and established guidelines for the assessment, diagnosis, treatment and management of opioid addiction and withdrawal.
Pharmacological Options – using opioid agonist (similar action) medication methadone, the partial agonist buprenorphine, and the antagonist naltrexone. Appropriate use and patient follow-up and monitoring is advised in the guidelines.
Rapid-acting Opioid Blocker Naloxone – vital role in reversing opioid overdose. Training of primary healthcare staff with the use of this drug has been emphasized.
Patient Populations With Special Needs And Concerns – pregnant women, patients with psychiatric disorders, chronic pain, young adults, and those involved in criminal justice system. The need for further research in these areas has been highlighted.
Future Prospects — New Medications For Treating Opioid Addiction
A novel method of delivering medication to treat opioid addiction was recently approved by the FDA after a careful analysis of its efficacy, safety, and risk-benefit profile. Certain physicians claim the matchstick-like implant will be a significant addition to the limited medication-assisted treatment options currently available.
The rod-like implant called Probuphine was developed by Braeburn Pharmaceuticals and Titan Pharmaceuticals. It contains the drug buprenorphine, an FDA approved drug for treating opioid addiction. This molecule binds to opioid receptors but does not elicit a profound reaction like heroin or morphine, hence reducing the cravings of the body for more. Taken in combination with naloxone, any effects of opioid overdoses will be potentially negated.
Once the implant has been inserted underneath the skin, its effects can last up to six months. This is the first long-acting, subdermal maintenance treatment for opioid addiction for stable patients receiving 8mg or less of oral buprenorphine per day.
“It’s really useful for those doing well on buprenorphine and who don’t need a high dose”, stated Dr Adam Gordon, a Professor of Medicine at the University of Pittsburgh and member of the advisory panel who voted in favor of approving Probuphine.
Another medication recently approved by the FDA was a nasal spray version of naloxone hydrochloride, which proved to be a highly effective method of drug delivery. The National Institute on Drug Abuse assisted in the approval of the product via a partnership to include new technologies with interventions for opioid overdose.
Conclusion – Analysis Of Situation
Prescription drug abuse, including opioids and heroin, has taken a tremendous toll on the social, economic, law enforcing and healthcare sectors of the US. The banning of such illicit and addictive drugs has been an issue for quite some time, with heroin, morphine, vicodin and medical marijuana being the highlights of the debate.
The present epidemic requires coherent government policies, along with a central collaborative role of the FDA and relevant organizations. The role of the media in educating and spreading awareness regarding this healthcare dilemma must also be emphasized and focused upon. Young adults must be warned against the inclination towards the ‘addiction culture’ that is prevalent in today’s society with proper references to the detrimental health effects and consequences such a lifestyle may have.
Listed below are some of the vital measures that have been made with regard to defeating the opioid epidemic:
In 2010, President Obama released his first National Drug Control Strategy, emphasizing the immediate need for action against opioid use disorders and overdose, along with the facilitation of individuals with complaints of pain to receive safe and effective treatment.
In 2011, the White House released its national Prescription Drug Abuse Prevention Plan, outlining goals for dealing with prescription drug abuse and overdose.
A Presidential Memorandum on prescriber training and opioid use disorder treatment was issued in October 2015. More than 66,000 providers have completed prescriber training till now.
In December, the president signed a bipartisan budget agreement with more than $400m in funding particularly addressed to the opioid epidemic – an increase of more than $100m over the previous year.
In November 2015, the president signed a bipartisan legislation ‘Protecting Our Infants Act’, to identify evidence-based tactics to care for mothers and their newborns affected by the opioid epidemic.
The President’s Budget (2017) that included a funding of $1.1bn to address the opioid overdose epidemic in the US, facilitate evidence-based prevention programs, improve prescription drug monitoring and take-back events and enhancing accessibility to medication-assisted treatment programs.
The Office of National Drug Control Policy (ONDCP), along with the Substance Abuse and Mental Health Services Administration (SAMHSA) facilitates local Drug-Free Communities coalition to decrease youth substance use via evidence-based prevention.
Prescriber education programs have been established which teach medical professionals how to start a conversation with patients dealing with substance use, how to help them manage pain appropriately, and how to effectively and safely treat patients using opioids.
The Department of Defense’s (DoD) Pharmacy Data Transaction Service now automatically screens all new medication orders against patient’s computerized medication history, allowing DoD physicians to monitor individualized drug usage patterns.
The Department of Veteran Affairs (VA) works in collaboration with the Opioid Overdose Education and Naloxone distribution program to help the veterans at risk of an opioid overdose.
In September 2015, the CDC launched a $20m Prescription Drug Overdose in 16 states entitled ‘Prevention for States Initiative’ to enlarge their capacity to prevent the opioid epidemic in communities and encourage prescriber and patient education about the risks of prescription drug overdose. In 2016, their initiative received an increase of $50m to expand their activities to the national level.
In December 2015, the Indian Health Service (IHS), along with the Bureau of Indian Affairs declared a new partnership to reduce opioid-related overdoses among American Indians and Alaska Natives.
Although these may take months and even years to come into action and create a significant impact, the following stepping stones provide hope and optimism.
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