Form 222 is the equivalent of a prescription pad for ordering and transferring controlled substances. It calls for vigilance and judicious usage to avoid any possibility of abuse or violation of the DEA rules. The Drug Enforcement Administration (DEA) takes its responsibility of enforcing the Controlled Substances Act seriously and prescribes a series of rules and regulations towards this end. DEA registrants have to follow specific procedures and paperwork while prescribing, administering and dispensing the scheduled drugs. For instance, DEA form 222 is mandatory for ordering or transferring Schedule II drugs. Copies of the forms are sent to the physicians at the time of registration and they can later be ordered from the DEA headquarters or field offices. Online ordering facility is also available. The forms are usually mailed within 10 days of receiving the request. The form used to be in triplicate and the top copy had to be filled in indelible ink or through a typewriter. The registered healthcare practitioner has to fill the complete name and address information at the top (corresponding with the details on the DEA certificate) followed by the name, size and quantity of controlled substances. The date and signature of the registrant comes at the bottom of the form. The top copy had to be sent to the pharmacist, middle one to the local DEA office and the bottom retained in the physician’s records. A similar procedure is followed for transferring Schedule II controlled substances, like sodium pentobarbital, between laboratories, pharmacies or clinics. The lab or clinic sending the drugs serves as the ‘pharmacy’ while the receiving party is the one who has to fill and send the forms. Change in Procedures From the end of October last year, the DEA has overhauled this system by moving to a single copy form. According to the Code of Federal Regulations, the triplicate DEA 222 forms are no longer available or allowed to be used. The new single sheet forms can be ordered from the DEA office like earlier. Responsible usage The guidelines for using the DEA form 222 remain the same. The DEA registrant is charged with carefully securing the forms and retaining both the executed and unexecuted ones. The proper procedure is to make a list of the unique form numbers and record the date when each is used. The form should never ever be signed before it has been completed. Prudent and judicious usage is mandatory as any kind of laxity opens the door to misuse and abuse of these dangerous drugs. Therefore, the physicians should always be alert and follow the rules while maintaining utmost security for the forms. The best approach is to engage the services of compliance professionals. They will ensure that the DEA registered facility operates within the norms of the law at all times by meeting all the requirements and responsibilities of dealing with controlled substances. What sets the Titan Group (https://titangroupdea.com) apart is that they know the DEA because they have been the DEA!
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The pharmacist plays a crucial role in preventing drug diversion and has to be on the watch out for doubtful, questionable or suspicious activities when dispensing controlled substances. Drug abuse and misuse is rampant in the United States, making it a thorn in the side of the government. Stringent regulatory requirements have been instituted by the Controlled Substances Act and the Drug Enforcement Administration (DEA) strictly administers the policies to identify illegal activities and ensnare the perpetrators. Constant monitoring and inspections are underway and the penalties for even the slightest mistake or violation can be hefty with far-reaching repercussions. The DEA controlled substance regulations govern every link of the supply chain from manufacturers and distributors to practitioners and pharmacies. In fact, the pharmacy forms the last link in the chain before the scheduled drugs reach the hands of the patient. Therefore, pharmacists are considered the last line of defense for preventing diversion! Accordingly, there is a corresponding responsibility on the pharmacist that fills the prescription for a controlled substance. Given all that is riding on the dispensing of scheduled drugs, the pharmacist is duty bound to:
Therefore, he or she should pay due attention to the following red flags and can even refuse to fill the prescription until the suspicion is cleared:
In such cases, the pharmacist should proactively practice due diligence by taking the following precautionary measures:
In case of concern, taking the appropriate action – like reporting to the DEA, law enforcement or other entity –is mandatory. So much so that, if it comes to light that a pharmacist ignored a dubious prescription that could have been for an illegitimate purpose, he/she can face prosecution for knowingly distributing controlled substances! Simple professional judgment will not suffice here. It is better to seek specialized assistance along with DEA compliance training for handling such extenuating situations. A compliance consultant can help in staying on the right side of the law in regular circumstances as well – be it for matters related to registration and renewal or maintaining proper documentation, reporting, security, monitoring and disposal. This will bring proficiency in handling the audits and inspections too. |
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April 2023
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