Category Archives: Prescription Drug Abuse

Long-term Dental Study to Determine Whether OTC Meds as Effective as Opioids

Long-term Dental Study to Determine Whether OTC Meds as Effective as Opioids

Rutgers University School of Dentistry will be heading a long-term study looking at whether non-addictive pain medications (acetaminophen and ibuprofen – OTC meds) are as effective as opioids after dental work. The National Institute of Health will be spending close to $12 million to fund the research, which will take place over several years and involve approximately 1,800 of the dental school’s patients.

Potential for Abuse Present with Opioids

Dr. Joseph Wineman, the former president of the Southern Nevada Dental Association, said he hopes the study will lead to some useful results. He noted that “[O]pioids always present the potential for prescription abuse.”

Dr. Wineman used the example of a patient who will find that one tablet isn’t providing the expected level of pain relief. That patient will then take five tablets, thinking that if one isn’t working “properly,” then increasing the dose must be the right solution.

He also stated that even the most painful dental procedures shouldn’t open up the door to drug dependency. Dr. Wineman said that having wisdom teeth removed shouldn’t be the cause of drug addiction unless a patient “goes overboard” and takes all the medication they have.

Dentists Talk to Patients About Pain Management & OTC Meds

The University of Las Vegas School of Dentistry teaches students and residents how to communicate with patients about appropriate pain management following common procedures such as tooth extractions, root canals or oral surgery. Part of the dentist’s scope of practice includes interviewing the patient and evaluating their level of pain, according to Dr. John Gallob, the Director of Faculty Dental Practice. He says that when pain medication is used appropriately, the likelihood of a dental patient becoming addicted is “incredibly rare.”

Dr. Wineman pointed out that dentists can check the Pharmacy Management Program (PMP) to ensure that a patient isn’t abusing potentially addictive pain medications. The PMP will tell the dentist whether their patient already has a prescription for opioids and if he recently picked up one for a certain number of pills. The dentist can prescribe pain medication for the dental procedure accordingly.

ADA Policy Recommends Non-opioid Pain Medications

Since 2011, the American Dental Association (ADA) has worked with its members to raise awareness about the potential harm that opioids can cause to dental patients and their families. It states that a growing number of studies support its policy that dentists should consider prescribing non-steroidal anti-inflammatory drugs (NSAIDs), either on their own or in combination with acetaminophen, as opposed to opioids as the first choice for acute pain management.

OxyContin Maker Purdue Pharma Files for Chapter 11 Bankruptcy Protection

OxyContin Maker Purdue Pharma Files for Chapter 11 Bankruptcy Protection

Purdue Pharma, the manufacturer of the prescription pain reliever OxyContin, has a hearing scheduled in federal court in White Plains, New York, for the company’s Chapter 11 bankruptcy case. Along with filing for bankruptcy protection, the drugmaker has negotiated a settlement that may well cost several billion dollars to deal with thousands of outstanding lawsuits filed against it.

Multi-billion Dollar Proposed Settlement

Under the proposed plan, $10-$12 billion would be paid to local and state governments. The funds would be used to reimburse them for costs associated with OxyContin use and compensate them for damage caused by prescription pain medications and illegal drugs, such as heroin. These drugs have been blamed for more than 400,000 deaths in the United States over the past 20 years.

To date, two dozen states have agreed to be part of the settlement plan, along with attorneys who represent a number of the 2,000 local governments suing Purdue Pharma. Other states have refused to sign the proposed settlement.

Focus on Keeping Doors at Purdue Pharma Open for Now

The initial court appearance will focus on making sure that the company has the means to keep its bills paid during its Chapter 11 bankruptcy. Judge Robert Drain will hear motions from the parties to authorize payments for employees’ wages, vendors, utilities and other important entities.

The judge will also hear from lawyers who object to the Chapter 11 filing. These attorneys will describe it as a “bad faith claim.” The judge may choose not to hear those arguments at the same time as the motions about wage and accounts payable matters.

The court will have to make a decision between the following options:

1. Approve the proposed settlement in its current form
2. Reject the settlement
3. Order the parties to make modifications to the proposed settlement.

Several states have already indicated they have objections to the proposed settlement, which the judge may consider when making his decision. At the same time, the Sackler family, which owns the company, would like to see more states agree to the proposed settlement.

Judge Drain will also decide when the lawsuits against the Sackler family in state court will be allowed to proceed as well as what happens to the company proper. Under the provisions of the proposed settlement, Purdue Pharma would continue to operate. The company’s profits would be used to pay for the settlement. The judge could also order that the company be sold outright.

One Settlement May be Best Way to Resolve Multiple Lawsuits

According to bankruptcy expert Jerry Reisman, settling multiple claims with one settlement is often considered the best way to resolve these types of cases. He said that the money would be placed into one pool to be divided among the claimants. The advantage of this option is that it would reduce the costs associated with bringing separate lawsuits through different courts. If each lawsuit is being heard separately, there is a race to have each one heard before the company runs out of money.

Oklahoma Judge Orders Johnson & Johnson to Pay $572M for Opioid Crisis

Oklahoma Judge Orders Johnson & Johnson to Pay $572M for Opioid Crisis

Pharmaceutical firm Johnson & Johnson has been ordered to pay $572 million in damages to the state of Oklahoma after losing a lawsuit. The State claimed that the company had participated in a sales campaign that was described at trial as “false and dangerous” and that it was responsible for the opioid epidemic currently plaguing the US.

Lengthy Decision Blames Company for Drug Epidemic

Judge Thad Balkman wrote a 42-page decision in which he determined that the company was responsible for creating what has been described as “the worst drug epidemic in US history.” The judge said that the company was aggressive in its marketing practices, pushing false claims that narcotic pain medications weren’t addictive to physicians. It also used its own resources to provide funding for organizations and research that would actively promote narcotic use.

Johnson & Johnson to Pay for Treatment, Overdose Prevention Costs

The $572 million isn’t the entire amount of the judgment that Johnson & Johnson has been ordered to pay. In his decision, Judge Balkman made a provision for the $572 million as an initial payment. Other payments from the company to the state of Oklahoma will need to be negotiated to pay for the following:

• Treatment costs
• Overdose prevention
• Cost of combatting the Oklahoma epidemic in future years

The State has requested $17 billion in compensation from Johnson & Johnson. The company has announced it will appeal the judgment.

Opioid Manufacturers Face Hundreds of Lawsuits

This decision is a disappointment to other drug manufacturers, as well as medication distributors and pharmacies that have been named in over 2,000 legal actions by districts nationwide. They will find it much more difficult to argue that the blame for the opioid crisis, which has been responsible for more than 400,000 deaths in the past 20 years, solely on the physicians who prescribed the medications or the people who took them (whether they had a prescription or not).

Oklahoma Attorney General Mike Hunter also filed a lawsuit against Purdue Pharma, the company which produced OxyContin. This opioid pain medication is considered to have had a major role in starting the opioid epidemic in the 1990s. Purdue and Oklahoma reached a settlement for $270 million without having to go to trial; however, the company has to defend itself against several hundred other legal actions.

Employers Face Uncertainty When Dealing with Opioid-Addicted Workers

Employers Face Uncertainty When Dealing with Opioid-Addicted Workers

The national opioid epidemic is creating a legal wrinkle in the nation’s workplaces. Workers who are living with addiction are protected under federal law — the Americans with Disabilities Act (ADA) — unless they happen to be currently using drugs illegally.

Defining “Current Use” Proving Challenging

The legal wrinkle comes from trying to determine what “current use” means. Some federal judges have ruled that current use for illegal drugs means up to a few weeks or a few months ago. The US Court of Appeals for the Tenth Circuit said in a decision (2011) that completing a drug and alcohol treatment program doesn’t necessarily give an employee disability protection. The court also said that it wasn’t going to bring in a “bright-line rule” that would set a standard for the number of drug-free days or months would be needed for someone to qualify for ADA protection.

“Bright-line Rule” Definition

A “bright-line rule” is used to clarify a law or regulations that could be read in more than one way. It may be established by a court where the judge determines that the need to make a simple decision is more important than weighing each side of an issue before making a ruling on it.

Opioid-Addicted Workers a Problem for Employers

People who have issues with opioid addiction (which includes prescription pain medications and illegal drugs) and are at risk for overdose are often employed. Workers in this category also present an issue for employers who often want to be fair to their team members, but who also need to ensure that the workplace is safe for everyone.

Medication-assisted treatment is an effective treatment option for opioid addiction. It involves addressing drug cravings and other physical symptoms, which can last for several months, with medication while the client participates in group therapy and individual therapy sessions.

This type of addiction treatment is sometimes frowned upon by employers, who see it as “replacing one type of addiction for another.“ This is a myth since the medications used to treat addiction don’t create a sense of euphoria (a “high”) in the user. They are used only to deal with cravings and reduce the urge to use opioids.

If an employer dismisses an employee who is undergoing treatment or refuses to give them reasonable time off from work to go to a methadone clinic daily, it could be considered discrimination due to disability under the ADA. Medically assisted treatment for opioid addiction can be safely followed under a doctor’s orders for months or years, depending on a client’s needs. The medications used would likely appear on an employer-administered drug test; however, using them doesn’t void the employee’s protection under ADA in the same way that using street drugs would.

 

FDA Proposes New Rules for Opioid Manufacturers, New Drugs to be Less Addictive

FDA Proposes New Rules for Opioid Manufacturers, New Drugs to be Less Addictive

The US Food and Drug Administration (FDA) is proposing that rules for opioid manufacturers be tightened to make new drugs less addictive. The Agency’s Acting Commissioner Ned Sharpless withdrew the previous guidelines and introduced a new framework for evaluating new opioids coming onto the US market.

Under the new proposal, drug manufacturers would have to state directly whether their medication has “any characteristics that would mitigate the risks of overdose, abuse or the development of addiction.”

Drug Companies Would Have to be More Transparent About Risks

The FDA has also stated that companies should state clearly whether their product has new or greater risks compared to other opioid pain medications on the market. The companies should also record whether their product presents any public health implications to non-patients, including members of the patient’s household and visitors to the home.

The Trump administration has vowed to crack down on illicit opioid use. More than 130 people lose their lives each day from an opioid overdose. In 2017, approximately 47,000 people died due to opioid misuse, according to the Centers for Disease Control and Prevention.

Opioid Crisis Priority for FDA

In a statement, Mr. Sharpless said that addressing the opioid crisis is an important issue for the US and that it remains a “top public health priority” for the FDA. He went on to say that the agency is taking new measures to take on the crisis, while also paying attention to the needs of patients who need access to pain management.

About 1,600 civil cases brought against opioid manufacturers are being consolidated and transferred to a judge in Ohio’s Northern District. The cases include one involving Purdue Pharma, the maker of OxyContin. In April, a former CEO of Rochester Cooperative was indicted. Prosecutors say this is the first time an executive of a drug company has faced criminal charges related to the opioid epidemic.

The FDA has admitted that this class of drugs “presents unique challenges” because they help relieve patients’ pain but they also have the potential for considerable harm if they are abused.

genetic test for opioid addiction

Genetic Test for Opioid Addiction Could Soon be a Reality

If you could order a genetic test that could tell you whether you were at risk for opioid abuse later in life, would you take it? What factors are considered in this genetic test for opioid addiction? The test would be something like the one available from companies currently offering health predisposition information along with DNA testing. Instead of indicating whether someone has a higher-than-average risk of developing heart disease, the proposed test would tell who is at risk for opioid addiction.

A New Jersey research institute is working with leaders in the medical community, scientists and academics to unravel the genetic code as it pertains to opioid dependency. 
genetic test for opioid addiction

Team Investigates Factors Contributing to Opioid Abuse

The Coriell Institute for Medical Research, Rowan University’s Cooper Medical School and Cooper University Health Care have come together to launch the Camden Opioid Research Initiative (CORI). This team will investigate “genetic and biological factors that contribute to opioid abuse.”

One key part of the study will involve collecting and testing tissue samples from people who have lost their lives from an opioid overdose. The researchers will also be studying people currently in treatment for opioid addiction, along with patients who are receiving prescription opioids for chronic pain treatment but have not become addicted. The findings from the two groups will be compared.

Stefan Zajic, the principal scientist and scientific lead for CORI, explained that the dream for scientists would be to have access to a profile or algorithm that would provide doctors and patients with information about genetic factors that may influence their susceptibility to opioid addiction.

Genetic Test Could Influence Future Prescribing Habits

If a genetic test for opioid addiction were available to indicate to healthcare providers which patients are at higher risk for opioid addiction, a doctor could take that factor into consideration when making decisions about which medications to prescribe. The doctor may choose to prescribe a non-opioid, adjust the dose if he or she decides to prescribe an opioid medication or prescribe a smaller number of pills so that the patient can be monitored more closely for follow-up.

The research team will work with the medical examiner’s office to establish a biobank of the tissue samples (with the respective families’ permission). Zajic believes it will be the first one of its kind in the country. The tissue samples will be made available to researchers in the field of opioid abuse going forward.

Long-acting Buprenorphine Injections Effective Opioid Addiction Treatment

Long-acting Buprenorphine Injections Effective Opioid Addiction Treatment

A monthly injection of buprenorphine BUP-XR is more effective than a placebo for treating opioid addiction, according to the results of a new study. This formulation is the extended release version.

A daily dose version of buprenorphine was approved by the FDA (US Food and Drug Administration) in 2002. It has been an effective treatment for opioid use disorder. Daily doses mean patients must commit to taking it each day; they may start to experience cravings for opioids once they get close to the end of the 24-hour cycle when they can take more medication.

Medication Assisted Therapy and Treatment for Opioid Addiction

Buprenorphine and methadone are both used in MAT (Medication Assisted Therapy) to treat opioid addiction. These medications are used in combination with behavioral counseling as part of a “whole patient” approach. The medications are used to control cravings and clients work with a counselor to develop new ways of thinking and responding to life stresses.

Extended Release Buprenorphine Called Sublocade

The extended-release version of buprenorphine was approved by the FDA in November 2017, which is being marketed under the brand name Sublocade. Approval was based on positive results in a Phase III human subjects study. The study has been published in The Lancet to make it available to the wider scientific community.

Double-Blind Study Conducted

Researchers divided 200 participants in the randomized, double-blind study into three groups. All of them had a mean duration of opioid use of between 11 and 12 years. Two of the groups were given different monthly doses of BUP-XR and one was given a placebo.

Both groups who were given BUP-XR reported “substantial portions of participants” abstaining from opioids. They also experienced relief from opioid withdrawal symptoms and control from cravings for opioids without having to take medication on a daily basis.

breakthrough in measuring pain may help to reduce opioid crisis

Breakthrough in Measuring Pain May Help Reduce Opioid Crisis

Breakthrough in Measuring Pain May Help Reduce Opioid CrisisResearchers at Indiana University’s School of Medicine have developed a blood test that identifies biomarkers in the blood which can help to determine the severity of a patient’s pain. The results could potentially help doctors to accurately measure pain on a scale. Some people believe this breakthrough in measuring pain may help reduce opioid addiction and ultimately the opioid crisis.

Currently, doctors must rely on their patients’ accounts of the amount of pain they are experiencing and suggest a treatment plan accordingly. A more accurate way to measure pain could lead to better treatment options for patients.

Breakthrough in Measuring Pain: Researchers Developed Prototype for Blood Test for Pain

The study was led by Alexander Niculescu, MD, Ph.D., a psychiatry professor, and was published in the Nature journal Molecular Psychiatry. Hundreds of participants were tracked to find biomarkers in the blood to that can help doctors to objectively determine how much pain a patient is experiencing. This blood test, which is the first of its kind, would also help doctors to understand a patient’s long-term prognosis.

The blood test can objectively tell doctors whether a patient is experiencing pain and how severe the pain is. It’s important to have an objective way to measure this symptom since until now the feeling of pain has been subjective. Physicians have to rely on what patients tell them about their pain or whatever clinical observations they can make to determine their patients’ pain levels. This blood test promises to give doctors a tool to treat and prescribe medications more appropriately for people experiencing pain.

Biomarkers in Blood Help Doctors Assess Pain Levels

The researchers looked at biomarkers in the blood. These biomarkers work in a similar manner to the way glucose is a biomarker to diabetes; they let doctors assess the severity of their patient’s pain and then provide appropriate treatment. It’s hoped this prototype may alleviate the problems that have contributed to the current opioid crisis.

The goal of pain management is to match the patient with the medication that is going to provide the best level of relief with the fewest side effects. Dr. Niculescu points out that through precision health, by having “lots of options geared toward the needs of specific patients, you prevent larger problems, like the opioid epidemic, from occurring.”

The study experts on the team found biomarkers that match with non-addictive drugs for treating pain and can also help to predict when patients may experience pain going forward. They will assist doctors in determining if a patient is experiencing chronic pain which may result in future Emergency Room visits.

Further research will focus on establishing whether there are some markers for specific conditions, such as headaches or fibromyalgia, or for ones that work better for men or women.

Number of Donor Organs Carrying Hepatitis C Rising Due to Opioid Crisis

Number of Donor Organs Carrying Hepatitis C Rising Due to Opioid Crisis

The opioid epidemic has triggered a hardship that most people likely haven’t thought of: A higher number of donated organs are infected with the hepatitis C virus.

Dr. Winston Abara, a hepatitis researcher at the Centers for Disease Control and Prevention (CDC), explains that as the number of drug overdose deaths and acute hepatitis infections increases, young people are most affected. These are the people who are most likely to be eligible organ donors.

Opioid Users Considered Increased Risk Donors

In the years 2010-2017, the number of organs obtained for transplant obtained from “increased risk” donors (people at risk of hepatitis due to drug abuse) tripled, according to the results of a new study published in the January 25 edition of CDC’s Morbidity and Mortality Weekly Report.

In 2010, approximately nine percent of donor organs came from people in this category. By 2017, that number had jumped to over 26 percent, according to Dr. Abara’s team.

The number of organs obtained from people who died as the result of “drug intoxication” tripled as well. They climbed from just over four percent in 2010 to over 13 percent by 2017, according to CDC researchers. Organ donor deaths linked to injected drugs like heroin increased fivefold during the same period.

This is concerning, since tainted needles are a prime source of infection with hepatitis C, which can lead to liver disease, a potentially fatal condition, over time. Due to advances in medical care, donor kidneys, along with livers and other organs can now be used for transplant and may save potentially save the lives of thousands of people on waiting lists.

Medications Available to Treat Hep C in Transplant Recipients

Powerful new medications exist to rid the body of hepatitis C and render the transplant viable. The transplant recipient would be screened after receiving the donor organ. If a hepatitis C infection is diagnosed, the donor organ recipient is offered antiviral treatment.

Dr. David Bernstein, a liver specialist, stated that understanding whether an organ donor has a history of addiction is essential. He said that when that knowledge is available, organ recipients and their doctors can be notified and screened after transplant surgery.

Survey on Opioids in the Workplace Shows Impact on Employers

Survey on Opioids in the Workplace Shows Impact on Employers

Survey on Opioids in the Workplace Shows Impact on EmployersThe results of a survey conducted by The Hartford, a leading property and casualty insurance company, have found the current opioid epidemic is having a “tangible and growing impact” on employers across the US. The survey also found that a majority of Human Resources (HR) professionals and workers feel they don’t have the knowledge or resources necessary to deal with addiction.

Companies of All Sizes Participated in Opioid Survey

Two thousand workers and 500 HR leaders participated in the national survey, which collected responses from companies of all sizes.

• Two-thirds of HR professionals (67 percent) said their company is being impacted by opioid use today or will be in the future.
• Just under two-thirds of the HR professionals (65 percent) revealed that opioid addiction is impacting their company financially.

Employees, HR Staff Feel Unprepared for Substance Use Problems

The Hartford survey is an opportunity for employers to provide addiction education materials to workers, as well as develop and implement consistent policies and procedures regarding drug misuse.

• Many employees (76 percent), as well as HR professionals (64 percent), don’t feel they are well trained when it comes to helping co-workers who have an opioid addiction issue.
• When asked if they could spot the signs of opioid addiction, 24 percent of HR professionals and 18 percent of employees felt extremely or very confident they could.
• Nineteen percent of HR professionals and employees feel they are extremely or very knowledgeable about how to reduce the risk of opioid addiction.

Survey Methodology

The Opioids in the Workplace survey was conducted with an online research panel on August 9-15, 2018. A representative sample of 2,500 US adults from across the nation was divided into two groups. Two thousand full and part-time workers and 500 participants with an HR role answered questions.

The margin of error for the first group is +/-2.2 percent at the 95 percent confidence level. For the second group, the margin of error is +/-4.4 percent at the 95 percent confidence level.