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!
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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! |
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April 2023
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