DOVER – Secretary of State Jeffrey Bullock has suspended the Delaware medical license and controlled substance prescribing privileges of Ifeanyi Udezulu for repeatedly failing to adhere to state regulations for the safe prescribing of opioid medications.

In making this determination, Secretary Bullock considered a complaint filed by the Department of Justice, which alleged that Mr. Udezulu repeatedly prescribed opioid medications to patients without obtaining informed consent, discussing the risks associated with such medications, or conducting meaningful patient evaluations or examinations. The complaint further alleged that Mr. Udezulu ignored “red flags” that signaled misuse, abuse, or diversion of the medications he had prescribed.

The order suspending Mr. Udezulu’s medical license was signed by the secretary with the concurrence of the president of the Board of Medical Licensure and Discipline. The secretary had sole authority to suspend Mr. Udezulu’s Controlled Substance Registration.

Delaware Code Title 24 enables a temporary suspension pending a hearing to be issued upon the written order of the Secretary of State, if the activity of the licensee presents a clear and immediate danger to public health, safety or welfare.

The suspension of Mr. Udezulu will remain in effect for a period of 60 days, during which time disciplinary hearings will be held or the final disposition for this individual will take place. As the result of a hearing, the Board of Medical Licensure and has the authority to impose disciplinary sanctions up to and including revocation of a practitioner’s license. The secretary has the authority to impose disciplinary sanctions up to and including revocation of the Controlled Substance Registration.

The licensure status of Mr. Udezulu has been updated on the Division of Professional Regulation’s online license verification service. Documentation related to this suspension also may be viewed at this site.

DOVER, DE –The number of prescriptions written in Delaware for opioid pain medications has fallen since the enactment of new prescribing regulations by the Department of State earlier this year.

Statistics from the Division of Professional Regulation, which licenses controlled substance prescribers, show a 12-percent drop in opioid prescriptions statewide compared to the first quarter of 2017. The number of Delaware patients being treated with opioid medications has also declined by 8 percent over the same time period, the division reports.

“Limiting the availability of prescribed opioids that end up being diverted, sold and illegally abused is an important part our fight to stem the tide of opioid addiction in Delaware,” said Gov. John Carney. “Opioid prescription rates remain too high in Delaware, but this is an issue we will continue to address in a comprehensive way.”

The new regulations, which took effect April 1, were designed to help prescribers more closely monitor and control the use of opioids by their patients.

“A significant reduction in the number of pills being prescribed means a better chance that fewer end up on the street,” said Secretary of State Jeff Bullock. “Just as important, fewer people being prescribed opioids is a sign that medical professionals in Delaware may be changing their prescribing practices and relying less heavily on highly addictive opioids when better alternatives exist. Seven months into our new regulatory framework for opioids, we are seeing the results we had hoped for.”

Key elements of the new regulations are aimed at controlling the amount of opioids given to new patients and aggressively monitoring their treatment. First-time opioid prescriptions may not exceed a one week supply under the new rules. If further opioid prescriptions are deemed necessary, further action is required, including a physical exam with discussion of relevant patient history and the risks of opioids, and a check of the statewide Prescription Monitoring Program (PMP) database. In addition, the state’s new PMP Advisory Committee has begun the process of analyzing the practices of individual prescribers to ensure that they are following state laws and licensing standards.

“Although these are early results, they are encouraging,” said Attorney General Matt Denn. “The Secretary of State and the Division of Professional Regulation deserve a lot of credit for putting these new regulations into effect – they placed Delaware in the top tier of states nationally with respect to requiring the responsible prescription of opioids.”

The regulatory reforms complement efforts organized across state government and in cooperation with Delaware’s community of public health organizations and anti-addiction advocates.

“Each overdose death in our state represents a life lost. Gone are the hopes and dreams of someone’s child, brother or sister. We know that reducing the amount of opioids being prescribed is crucial toward saving lives and a key step in combatting the addiction epidemic,” said Lt. Gov. Bethany Hall-Long.

The newly established Behavioral Health Consortium, created this year by the General Assembly and chaired by Lt. Gov. Hall-Long, is working to develop an action plan that will prevent and treat substance use disorder, expand and improve mental health treatment and recovery and provide support for family members of loved ones who are battling addiction or coping with mental health issues.

The state’s Addiction Action Committee, also created by the General Assembly this year, is actively considering two other initiatives relating to the prescription of opioid drugs: possible legislation requiring health insurance coverage of alternatives to opioids for pain management, and possible state responses to the co-prescription of opioids and benzodiazapenes.

“We are grateful to the Division of Professional Regulation for enacting these new regulations,” said Dr. Karyl Rattay, director of the state’s Division of Public Health. “The bottom line is that precious lives will be saved by fewer people becoming addicted or having access to these dangerous drugs. We must continue our efforts to support safe opioid prescribing while ensuring individuals have access to alternative and more effective approaches to pain management.”

The Department of Health and Social Services also has boosted resources to help individuals struggling with addiction. Educational materials about identifying and fighting addiction can be found at HelpIsHereDE.com. Individuals who are suffering from addiction can also call DHSS’ 24/7 Crisis Hotline to be connected to treatment options. In New Castle County, call 800-652-2929, or Kent and Sussex Counties, call 800-345-6785.

DOVER – Continuing efforts to curb the abuse of opiate pain medication in Delaware, the state agency charged with regulating medical practice and drug prescription recently unveiled rules that will help doctors and pharmacists more closely monitor and control the use of opiates by patients under their care.

The new requirements contain expanded procedures related to prescribing opiates for acute episodes as well as for chronic, long-term pain management. Some components are at the discretion of the prescribing provider while other requirements are situation-based.

The result of an 18-month rulemaking process that included input from medical professionals, public health experts, the Attorney General, and other stakeholders, these regulations were published in the January issue of the Delaware Register of Regulations and will take effect on April 1.

“These regulations can save lives by helping to curb the abuse of opiates in our state. Delaware’s prescription rate for certain opiates is among the highest in the nation, according to the Centers for Disease Control, and we know what many users of heroin tell us: Their drug abuse can be traced back to a time when they were prescribed opiates for an injury or some other valid medical need,” said Secretary of State Jeff Bullock, whose department regulates and licenses prescribers of controlled substances in Delaware. “With these regulations, we are supporting the efforts of those seeking to break that cycle – including doctors, pharmacists, public health workers and our law enforcement agencies.”

Key elements of the new regulations are aimed at controlling the amount of opiates given to new patients and aggressively monitoring their treatment. First-time opiate prescriptions may not exceed a one week supply under the new rules. If further opiate prescriptions are deemed necessary, further action is required, including a physical exam with discussion of relevant patient history and the risks of opiates, and a check of the statewide Prescription Monitoring Program database.

Prescribers statewide will receive an overview of the new regulations and also be directed to HelpIsHereDE.com, which contains educational materials about identifying and fighting addiction, sample forms, and a link to access the Prescription Monitoring Program.

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FACT SHEET – New Opiate Regulations, Jan. 2016

Key elements related to prescribing for an acute episode (injury or procedure) include:

• A first-time prescription to an adult patient for an acute episode cannot exceed a 7-day supply
• No prescription to a minor can exceed a 7-day supply at any time If professional judgment dictates more than a 7-day supply is necessary
  o Document the condition triggering the prescription
  o Query the Prescription Monitoring Program to obtain a prescription history
  o Indicate that a non-opiate alternative was not appropriate
  o Obtain Informed Consent
  o Administer a fluid drug screen, at the discretion of the provider
  o Conduct a physical examination which must include a documented discussion to elicit relevant history, explain risks/benefits of opioid analgesics and possible alternatives, and establish other treatments tried or considered
  o Schedule periodic follow-up visits and evaluations to monitor progress, whether there is an available alternative to opiate use, and whether to refer the patient for a pain management or substance abuse consultation

Key elements related to prescribing for chronic, long-term treatment with an opiate include:

• Those listed above
• Query the PMP
  o At least every six months and more frequently if clinically indicated
  o Whenever the patient is also being prescribed a benzodiazepine
  o Whenever the patient is assessed to potentially be at risk for substance abuse or misuse
  o Whenever the patient demonstrates loss of prescriptions, requests for early refills, or similar behavior
• Administer fluid drug screens at least every six months
• Obtain a signed Treatment Agreement

Informed Consent elements must include at least:
• The drug’s potential for addiction, abuse, and misuse
• The risks of life-threatening respiratory depression associated with the drug
• Potential for fatal overdose as a result of accidental exposure, especially in children
• Neonatal opioid withdrawal symptoms
• Potential for fatal overdose when interacting with alcohol
• Other potentially fatal drug interactions, such as with benzodiazepines

Treatment Agreement elements must include:
• The patient’s agreement to take medications at the dose and frequency prescribed, with a specific protocol for lost prescriptions and early refills
• Reasons for which medication therapy may be re-evaluated, tapered or discontinued, including but not limited to violation of the Treatment Agreement or lack of effectiveness
• The requirement that all chronic pain management prescriptions are provided by a single practitioner or a limited, agreed-upon group of practitioners
• The patient’s agreement to not abuse alcohol or use other medically unauthorized substances or medications
• Acknowledgment that a violation of the agreement may result in action as deemed appropriate by the prescribing practitioner such as a change in the treatment plan, a referral to a pain specialist, or referral to an addiction treatment programs
• The requirement that fluid drug screens be performed at random intervals at the practitioner’s discretion, but no less than every six months.

More checks of prescription database, reviews of deaths, medical treatment of addiction and expanded police use of overdose drug proposed.

Building on Delaware’s efforts in recent years to combat prescription painkiller and heroin abuse, a plan released Thursday recommends that regulations governing prescription dispensing become more stringent, that deaths from opiates and heroin be reviewed to learn how they could have been prevented, that medical treatment of addiction be expanded and that more police be equipped with a drug that can counteract the effects on an overdose in an emergency, Attorney General Matt Denn was joined by Secretary of Health and Social Rita Landgraf, New Castle County Police Chief Col. Elmer Setting, Delaware Fraternal Order of Police president Fred Calhoun and atTAcK Addiction board members David Humes, Don Keister, and Rebecca King, to release the plan and begin discussions with those involved in the fight against opiate and heroin abuse.

“We are here today because, notwithstanding some extraordinary effort and hard work by many people in our state, far too many Delawareans are dying from prescription drug and heroin overdoses,” said Attorney General Denn. “The catalysts behind many of the state’s efforts in the last several years to deal with substance use disorder have been the family members of Delawareans who suffered from drug overdoses – some of whom did not survive. We owe it to them, and other families who have lost loved ones, to redouble our efforts.”

“When doctors prescribe opiates as pain medication, it is like giving patients a loaded gun that must be handled properly so that death by the disease of addiction does not occur,” Don Keister said, noting a need for doctors to limit the number of prescribed pills and also inquire into a patient’s family history and situation for signs of potential misuse.

“Sadly we are fighting a disease of epidemic proportion, and this disease is destroying, and is taking lives,” Secretary Landgraf said in talking about recovery options. “We know that treatment works and that recovery is possible.”

The plan addresses in four areas that should positively impact the prevalence of prescription opioid and heroin abuse:

• Strengthening the regulations that govern the amount of care that health care providers must exercise in prescribing opiate drugs. The state Controlled Substance Advisory Committee has drafted regulations to govern prescription by doctors and the plan includes ideas – already submitted in comment form – to make those regulations even strong before they are finalized.

• Conducting routine state reviews of deaths caused by prescription opiate and/or heroin overdoses to determine what could have been done differently, similar to reviews currently done in child death cases. Such a process would need to be created by the action of the legislature in 2016.

• Maximizing the responsible use of medically assisted treatment of substance abuse disorder. A group of medical professionals and advocates would convene to discuss best practices in the use of medications like Suboxone, methadone and naltrexone, which some doctors have advocated for wider use of to treat addiction.

• Encouraging our state’s law enforcement community to expand the number of officers who carry naxolene, a drug that is effective in reversing the effect of heroin overdoses. This drug has been successfully employed in nine cases by New Castle County Police (7), Middletown Police (1) and Ocean View (1) police to avert a potentially fatal overdose.

“The folks that are addicted to heroin aren’t necessarily criminals, they are certainly victims,” Col. Setting said. “These people need help and I am so glad that I am not the only person saying it any longer. This is not just a police problem.”

Speaking about police support for equipping officers with addiction-countering medication, FOP president Calhoun said “None of my officers want to be standing in the doorway when a family member or child walks up from the sidewalk, looking into their eyes, knowing that the next thing you’re going to tell them will impact them for the rest of their lives.”

Deaths from prescription opioid abuse and from illegal heroin remain as problems in Delaware. The Prescription Drug Monitoring Program, begun in 2012, is a significant advancement that should become more effective over time with improved utilization. Using various statistical measures from 2009 and 2010, the Prescription Drug Advisory Committee found in 2013 that Delaware had the nation’s ninth highest drug overdose rate, had a significantly higher percentage of its residents engaging in non-medical use of prescription opioids than the national average, and had the nation’s fifth highest overall rate for opioid sales. Regarding illegal heroin use, the number of deaths in Delaware from heroin overdoses increased from 8 deaths in 2009 to 23 in 2013.