Drug diversion can hit a health care provider or pharmacy at any point of time. The best way to abet the issue and stay in compliance is to avail the services of compliance professions right from the outset. Drug diversion refers to the illegal obtaining or using of prescription drugs. Analgesics and psychoactive drugs like opioids and benzodiazepines are the common ones that are unlawfully channeled from legal sources like health care providers and pharmacies to the illicit marketplace. And the diverters are usually the physicians themselves or their staff, family and friends. The Drug Enforcement Administration (DEA) enforces the various provisions of the Controlled Substances Act pertaining to licensing and registration, veterinary controlled drug log and other documentation, storage and more. It also conducts regular inspections and audits to check whether the registrants are in compliance or not. Various other measures are also underway to check for drug diversion and other criminal activities. However, cases of drug diversion still keep rearing their ugly head now and again. And the headline cases usually involve settlements in thousands of dollars! The other end of the picture Indeed, drug diversion is a growing menace in the United States. So much so that, health care providers dealing with controlled substances are routinely advised that it is not a matter of if drug diversion will hit them but when it will happen! And once detected, it all boils down to the extent to which the DEA registrant is found to be in compliance with the DEA. This will directly impact the level of fine, penalty and even legal action initiated against the perpetrator of the drug diversion. Alas, non-compliance does play a starring role in most cases of drug diversion. Here, the blame is not limited to lapses in diversion monitoring alone. The fault more often lies in non-maintenance of proper records, failure to follow security protocols, not reporting theft/loss to the DEA, etc. The dirt can fly high and wide – from monetary fines and civil penalties to losing registration and even judicial action. Not to mention the disastrous effect on reputation and business potential! Locking the stable before the horses have bolted There is so much that can go wrong at the DEA registrant’s end – from the storage of the controlled substances to messing with the veterinary controlled drug log and so on. The most effective approach for staying on the right side of the law is to engage a professional compliance consultant. Take the Titan Group for instance. They thoroughly review and analyze the client’s procedures, workflow and compliance levels before providing an in-depth assessment of the facility’s risk for drug diversion or failing a DEA regulatory audit. They will meticulously scan for gaps in the controlled substance procedures and security protocols that can run afoul of the DEA. Ultimately, the focus will be on strengthening the policies, procedures and day-to-day operations to ensure that everything proceeds smoothly without any potential entanglements with any of the regulatory agencies.
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The COVID-19 pandemic is at the forefront of our minds, but the enduring opioid crisis appears to be raging right under our noses without any signs of giving up! Compliance with DEA is more crucial now. Opioids – derived from the opium poppy plant – are legally manufactured drugs that are subject to controlled substance regulations, and for good reason at that. While they should be primarily used to treat protracted pain conditions that are associated with surgery or cancer treatment, medical practitioners even prescribe these scheduled drugs for other chronic conditions like back and joint pains. Opioid medications like oxycodone, hydrocodone and morphine are actually pretty effective in muffling the perception of pain in the body. However, fact is that the same drugs also boost the feelings of pleasure in the body which makes users want to continue experiencing those feelings. At times, the brain even starts believing that the drug is necessary for survival. This obviously leads to addiction over time. While the initial low doses only make the users feel lazy and sleepy, as the body gets used to the dose, it demands more and more. This can prove to be life-threatening over time, as continued use of higher doses can slow the breathing and heart rate, even leading to death. Opioid abuse is not just limited to the prescription pain relievers. There are synthetic versions (fentanyl) and even heroin that are either illicitly manufactured or trafficked into the country. These are not only illegally used, but often combined with other drugs or alcohol which compounds the risks even further. The statistics are staggering. Nearly seventy thousand people in the United States died of opioid-related overdoses in 2020, the highest annual toll on record.Millions of other Americans suffer from the side effects of the addiction. The Centers for Disease Control and Prevention estimates that the total ‘economic burden’ of prescription opioid misuse alone in the United States is $78.5 billion a year. The ongoing COVID-19 pandemic is continuously exacerbating the crisis ever more! Efforts to control the raging epidemic Opioids are classified as Schedule II drugs under the Controlled Substances Act and federal regulators are doing everything possible to limit the domestic supply. Pharmaceutical companies are advised to reduce the production of certain opioids while limits have been instituted on the prescription of opioids as well. There are sustained crackdowns on foreign opioids and trafficking is being dealt with a heavy hand. The DEA (Drug Enforcement Authority) is also being extremely circumspect in its efforts to deter the growing abuse and keeping a watchful eye on physicians, veterinarians, pharmacies and hospitals that prescribe or handle such highly-addictive substances. Staying in compliance with the controlled substances regulations and veterinary DEA regulations has become all the more crucial in this high-risk scenario that has even been declared a public health emergency. Medical practitioners have to stay alert on their part, not only to comply with the regulations, but also in the interests of keeping the community safe and healthy! A DEA license is mandatory for prescribing or dispensing controlled substances and this covers veterinarians as well. Following is a look at how to get the license and what it entails in the future. Controlled substances are regulated by the Drug Enforcement Agency (DEA) under the Controlled Substances Act. These scheduled drugs can only be prescribed and administered by DEA registrants who hold an active DEA license along with a state medical license or controlled substance permit. This applies to all physicians, dentists, optometrists, physician assistants, scientific investigators, pharmacies and hospitals that prescribe or dispense controlled substances. Veterinarians also need a veterinary DEA license for this purpose. How to get the license? Getting a DEA license is a simple and straightforward process. Meeting the state licensing requirements is an essential pre-requisite here. DEA registration forms are available online on the U.S. Department of Justice website, https://www.deadiversion.usdoj.gov/. The applicant can also request a physical form from the DEA Registration Field Office which will be mailed within 10 working days. The form has to be filled with all the required details before submitting along with the application fee, which is non-refundable. Once the formalities have been completed and approved, the DEA will issue the license. A unique DEA number will also be assigned to the applicant which has to be specified on every prescription or order of a controlled substance medication. However, the license can be denied due to certain reasons. In such cases, the applicant can always appeal the decision. Applicants should keep in mind that they will need a separate license for every location of practice. And in case they shift to a new state, the said information should be duly updated to include the new location. Moreover, the license has to be renewed every three years. Conditions of use It is not just about using the veterinary DEA license to prescribe, administer or dispense controlled substances for animals. The license comes with a list of rules that have to be adhered to for ensuring safe and proper usage of the scheduled drugs. In fact, the DEA uses the license number to track the provider prescriptions and monitor potential fraud and abuse. The registrant will be prosecuted in case of negligence, malpractice, misuse or abuse in any manner – this can range from confiscating the license to initiating criminal action. Furthermore, the license may be suspended in case the state medical license is revoked/denied or if the licensee is convicted for any felony related to a controlled substance. However, keep in mind that healthcare professionals including veterinarians can always practice without a DEA license as long as they do not intend to prescribe opioids, sedatives or other controlled substance medications to their patients. When it comes to obtaining a DEA license veterinary and abiding by the myriad regulations, it is always better to seek professional assistance from a compliance provider. The Titan Group (https://titangroupdea.com/) offers a full suite of services for ensuring full compliance with the legal requirements and responsibilities of dealing with controlled substances. A compliance program makes it easy for those who deal with controlled substances to abide by the regulations. Engaging professional services spells safety and security in terms of potential compliance issues. The regulatory environment is tightening its hold on controlled substances. Federal agencies like the Drug Enforcement Administration (DEA) are focused on weeding out diversions and illicit use of scheduled drugs. Pharmacies, laboratories and other storage locations that handle controlled substances are constantly scrutinized and investigated in the form of inspections and audits. Apart from this, the DEA registrants have to comply with a range of regulations that govern everything from licensing to ordering, documentation and disposal. Even any theft or losses have to be reported through DEA Form 106. Here it is not just about having the right policies in place; instituting a proper enforcement mechanism on the ground is a must as well! It follows that those who stock scheduled drugs will be better off by engaging professional services to ensure that they stay in compliance with the laws. Following is a sample of the arenas where services providers like the Titan Group (https://titangroupdea.com/) can be of wholesome assistance:
In other words, the service provider will review and analyze the workflow and other procedures to assess both the compliance norms and risk exposure of the facility before designing a customized compliance program that will protect the business and personnel alike from any kind of federal liability or other persecution in the future. However, the functionality of this service is not just limited to ensuring full DEA compliance at all times. It will also set the right tone across the company as employees realize that the executives are focused on staying within the law and they themselves have to abide by the same. On the other hand, this will signal the company’s commitment to doing things right to the federal and law enforcement agencies as well. Peace of mind is guaranteed and the facility can focus on its core business without the worry of accidentally ending up on the wrong side of the law and paying a heavy price for the same! It is easy to find yourself in the crosshairs of the DEA for non-compliance of the provisions for dealing with controlled substances. And the potential consequences can prove to be quitegrave! Healthcare providers and pharmacies that prescribe, administer or dispense scheduled drugs are subject to a long list of regulations. To begin with, they have to comply with the Federal Controlled Substances Act (CSA). This requires them to register with the U.S. Drug Enforcement Administration (DEA) and obtain a license by filling the requisite DEA forms for controlled substances. Following this, they have to abide by the prescribed protocols for ordering, storing, handling, dispensing and recording the scheduled drugs. The DEA is responsible for controlling drug trafficking, diversion and other illegal use of prescription drugs in the country. Accordingly, the agency conducts regular investigations and audits of the facilities, storage locations and other parameters to check whether the rules are being followed or not. They are trained to keep an eye for any suspicious activities and take strict action at the slightest hint of unlawful dispensing or handling of controlled substances. However, given the myriad regulations on the one hand and the risks of illegal use on the other, it is easy to fall afoul of the law. Many DEA registrants find themselves paying a heavy price even for the most inadvertent non-compliance. The fallout can be:
Therefore, doctors, pharmacies, hospitals and other providers that handle controlled substance medications have no choice but to make DEA compliance a top priority. Professional experts in the field of compliance – like the Titan Group (https://titangroupdea.com/) – come to the rescue of the harried and worried DEA registrants with a suite of services designed to take care of everything from the DEA forms for controlled substances to ensuring that the operations stay within the laws and regulations. Opioids are harming health and claiming lives at a staggering rate. But does this mean that doctors should stop prescribing them completely. Why not use a more judicious approach here instead? One of the main challenges faced by primary healthcare providers is managing chronic pain. Prescription opioids – like oxycodone, hydrocodone and morphine - are powerful pain-reducing medications. However, the benefits come with a heavy dose of potential risks as well. These are controlled substance drugs as they entail heavy chances of addiction, overdose and death. In fact, opioid abuse and misuse is a huge crisis in the United States. However, does this mean that physicians should shy away from using these analgesics to treat chronic pain due to the fear of the drugs being abused, diverted or misused in another manner? A healthcare provider’s first duty is to help the patient to manage the pain in the best way possible. However, they should be extra careful when prescribing opioid medications as they are ripe for various forms of mistreatment. Following are some tips that will ensure more prudent prescriptions:
While healthcare providers should always be judicious when prescribing controlled substances, they also need to abide by the other DEA controlled substance regulations to ensure that there is no diversion or misuse. Teaming up with a professional service provider - like the Titan Group - can be a lifeline when it comes to conforming with the varied rules and regulations governing the procuring, handling, storage, prescribing, dispensing and disposing of prescription drugs. To add to this, they provide post-remediation training as well. Obtaining and using scheduled drugs in an illegal manner is known as drug diversion. This is very common and the DEA makes every effort to combat the incidence by maintaining checks and controls. Every drug is meant for a specific use and most often, fulfils its mission of treating, alleviating or managing a health condition. But what happens when the drug is diverted from its intended role and used for other purposes? It may sound absurd, but drug diversion is a common phenomenon, especially in the case of controlled substances. Indeed, prescription medicines are often acquired illegally and put to illegitimate use. While scheduled drugs are subject to intensive regulations and the handling even entails DEA compliance training, illicit diversions from legal sources happens all the time. Drug diversion can take place at any point in the supply chain, right from manufacturing site to the wholesale distributor, the physician's office, the retail pharmacy or the patient himself. It can be done by the drug manufacturing companies themselves, the healthcare providers or their staff, or the pharmacists and their employees. Then there are individuals who try to obtain the prescriptions under false pretences, forge or steal prescriptions or indulge in thefts at the hospital/pharmacy. Leftover medications following an illness or injury can also be misused by the patient himself or others who gain access to the drugs. The reasons for drug abuse are aplenty. People want to enjoy the pain relief, stay awake, induce sleep or just get ‘high’. What they don’t realise or prefer to overlook is that the controlled substances are strictly regulated for good reasons–they can lead to addiction, impair behaviour and emotions, turn toxic and even lead to death. The statistics are mind-boggling - Every year more than a million people end up in the emergency room for taking prescription drugs incorrectly. The misuse of prescription painkillers claims the lives of more than 40 people daily - more than the combined number of people dying from using heroin and cocaine. Efforts to combat drug diversion Drug diversion is a serious offence and violators can end up in jail. The Drug Enforcement Agency (DEA) is responsible for enforcing the Controlled Substances Act and goes all out to prevent drug diversion in the United States. The Diversion Control Division (DC) deploys Tactical Diversion Squads (TDSs) - composed of special agents, diversion investigators and intelligence research specialists located in all field divisions – that are solely dedicated to investigating, disrupting and dismantling individuals and organizations involved in diversion schemes. The onus is on the pharmacies, physicians, hospitals, suppliers, wholesalers, manufacturers and other entities that handle, prescribe or administer scheduled drugs to ensure that they are stored and used properly without leaving any scope for theft, ‘doctor shopping’ or other forms of diversion. The rules are varied and it proves difficult to abide by all of them at all times. Employing the services of an expert and established DEA compliance consultant – like the Titan Group – can ease matters and ensure complete compliance! Federal authorities are bringing in new regulations for controlled substances in a bid to control abuse, diversion and fraud. Staying in compliance can become easier through special service providers. Dealing with scheduled drugs is no easy task. There are various regulations and limitations under the Controlled Substances Act. The doctors, hospitals and pharmacies also have to stay in compliance with the Drug Enforcement Agency (DEA) requirements. The protocols range from registration with the DEA to abiding by the storage and record keeping rules to reporting any theft or loss through the DEA Form 106. There are specific regulations for prescribing of the controlled substances as well. In fact, these are updated periodically in an attempt to combat the nationwide challenges of opioid abuse, drug diversion and drug fraud. Physicians, dentists, veterinarians, physician assistants and nurse practitioners who prescribe or dispense these drugs have no choice but to stay updated with the changes and ensure compliance at all times. For instance, since January last year, all health facilities have been mandated to adopt electronic prescribing of controlled substances (EPCS). Accordingly, the prescriptions of controlled substances have to be transmitted via electronic prescribing software. Therefore, all health care entities had to integrate a compliant EPCS as noncompliance invokes penalties by the Centers for Medicare & Medicaid Services (CMS). This move is designed to improve the efficiency of the health system while clamping down on the use of illicit drugs in the country. The new system entailed adoption of certain specific techniques like:
The updates have their heart in the right place. Apart from eliminating wrong prescriptions and other medical malpractices, they also reduce the dangerous incidence of erroneous medication being dispensed due to spelling mistakes by the prescriber or illegible handwriting. The e-prescription eliminates assumptions by the pharmacists and ensures that the correct drugs are issued at all times. It also facilitates interoperability as patient history, drug use and other data can be seamlessly transferred and accessed when treating the patient. When a healthcare provider, facility or other center’s capability to keep updating in accordance with changing regulations seems challenging, it is better to seek professional assistance for professional service providers, like the Titan Group. They eliminate the heavy risks of non-compliance by keeping track of all the existing and new legal requirements of dealing with controlled substances! Controlled substances comprise of both prescription drugs and illicit drugs that are classified into five schedules and regulated based on their potential for abuse, misuse and addiction. There are many drugs like opioids, stimulants, anti-depressants, hallucinogens and anabolic steroids which do a world of good, but they can be misused, abused or even lead to addiction. They can easily fall victim to diversion and trafficking as well. This is why the government has to maintain strict control over how they are made, stored, distributed, handled and used. USA has instituted the Controlled Substances Act to promote the legitimate availability and use of such drugs for medical and scientific purposes while curbing any kind of illegitimate usage. The Act has established five schedules that classify the controlled substance drugs based on parameters like their medical value, risk of addiction and ability to cause harm.
All scheduled drugs are available only by prescription from a DEA-licensed medical professional. These practitioners also have to follow a slew of procedures and protocols for the safe and controlled handling of the controlled substances, like physical security, inventory control, maintaining a veterinary controlled drug log and so on. The Titan Group can ensure proper and complete DEA compliance by assessing the risk, providing remedial solutions, training the staff and so on. They provide end-to-end solutions with mock inspections and audits to keep the establishment prepared and in compliance at all times! The DEA expects tight control over the inventory of controlled substances and thefts/losses have to be reported immediately. This opens a minefield of regulation that is best left to the experts. Controlled substances are the prime targets for theft and diversion. It could be due to lax security or even a long-time employee or relative may be perpetrating the act. Whatever be the reason, any kind of irregularity, diversion or theft of DEA scheduled drugs has to be reported immediately. The Drug Enforcement Administration (DEA) expressly requires that any theft or significant loss of controlled substances should be reported in writing to the area DEA field office on DEA Form 106 either electronically or manually within one business day of the discovery. However, minor discrepancies in inventory that are not attributable to theft do not have to be reported or recorded on a DEA Form 106. This may sound simple at first. However, there are complications at every step - from what constitutes a significant loss to the ‘upon discovery’ rule. Quantifying of a significant loss will obviously vary based on the level of business activity and environment. What is significant for a small corner drugstore is minor for a large healthcare system…. Federal regulations provide the following factors to be considered for determining whether the loss of a controlled substance is significant or not:
However, this is not exclusive and other factors can also come into play in some cases. For instance, the DEA itself warrants that, “the repeated loss of small quantities of controlled substances over a period of time may indicate a significant aggregate problem triggering reporting even where the quantity lost in each occurrence, by itself, is not significant.” Again, the short reporting window of one business day from discovery can prove to be exceptionally taxing, especially when it is difficult to determine whether it is a theft or loss. While it is always better to err on the side of caution and alert the authorities in a timely manner, this will be followed by providing the DEA with updates for up to two months about the possible causes or source. And everything has to be in writing and submitted either electronically or manually. Therefore, it is better to leave the headache of reporting the DEA Form 106 to qualified experts like the Titan Group https://titangroupdea.com |
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