Controlled substances mean just that! They need to have regulations and controls in place because of the effects they can have on people. For EMS, it is for therapeutic reasons and patient care. However, when used incorrectly or if it gets used for the wrong reasons, there can be dangerous outcomes to one’s well-being. We are not trying to say that the persons administering them are the users, what we are saying is that we need to screen, diagnose, and do proper patient assessment to assure that those that call us in need do not have a drug addiction, and just need a “quick fix” knowing that EMS carries Narcotics and substances that can satisfy their addiction.
Even though it is not a controlled substance, sub-lingual Nitro and/or Nitrostat spray, EMS/Medical providers must understand that we cannot automatically give these medications, regardless of signs or symptoms, until we get a Blood Pressure. If not, and the patient is hypotensive to begin with, they will “bottom out” and become more hypotensive. Then we are left with a patient who is deteriorating and becoming less stable than getting better or becoming stabilized. The point here is that we need to take these same precautions when using “controlled” medications and substances. We need to know our pharmacology, method of treatment based on our findings, and treat the patient using methods and techniques that are proven as a standard practice or driven by a medical director’s protocol. Things you need to consider includ:
- Is the patient and addict?
- Is the patient allergic to the controlled substance?
- Is the patient able to process the substance?
So, what are the consequences if we do not abide by the Laws, Rules, and Regulations? Well first, as we all know, there is a hierarchy. It starts with the FDA (Food & Drug Administration) of the federal government. Then you may have any other lesser regulators whether it is, Regional, State, County, Parrish, City, Township, or Village, etc. Regardless, Big Brother is watching, the FDA. Here is the link that applies to controlled substances, CFR 21 (Code of Federal Regulation), and the DEA (Drug Enforcement Agency) Controlled Substances Act.
Another good reference is the JEMS (Journal for Emergency Medical Services) article – Best Practices for Controlled Substance Monitoring.
Here are some of the consequences that were found, and how it can relate to EMS personnel and their agencies:
- Written Letters
- Seizure of the Product.
- Injunction.
- Criminal Prosecution.
The FDA field offices have primary responsibility for conducting inspections and/or collecting samples which may lead to recommendations for enforcement/regulatory action. The type of action recommended will depend upon the nature of the violation and the public health concern, Agency policy, previous history of violations by the firm, and other factors.
Criminal Fines for Food Drug and Cosmetic Act Violations
Misdemeanor fines under the Act may reach $500,000 under some circumstances. The Criminal Fine Enforcement Act of 1994 (Public Law 98-596) provides for fines for violations of Federal law. Although it is not part of the Act, the Criminal Fine Enforcement Act of 1994 applies to all fines levied under the Act, as well as other statutes that contain provisions enforced by FDA.
The following fines are applicable for each offense:
- Up to $100,000 for a misdemeanor by an individual that does not result in death.
- Up to $200,000 for a misdemeanor by a corporation that does not result in death.
- Up to $250,000 for a misdemeanor by an individual that results in death, or a felony.
- Up to $500,000 for a misdemeanor by a corporation that results in death, or a felony.
The maximum imprisonment for a misdemeanor under the Act remains a year for each offense.
This can be a career ending violation or can result in your organization and/or those responsible in fines and imprisonment.
We are not trying to present an atmosphere of gloom and doom here. We just need to be aware that we need to be responsible, follow the rules, and use good judgement.
Ok, so the good news. Assuring that we can meet all the necessary mandates we must abide by, there is a way that we can assure we are compliant. PSTrax Cloud based software will assure that you have a seamless operation when it comes to documentation, supplies on hand, and communication to and from each Emergency Response Unit to your departments supply person. A surprise visit can happen at any time from the authorities. You need to have the peace of mind and assurance that you are following the Rules & Regulations when the FDA shows up at your front door.
Some of the things you need to document are:
- Amount of substance used
- Amount wasted/disposed of
- Alarm or incident #
- Patient’s name
- Name(s) of the personnel that checked for proper amount in the medical Cache, both the station and apparatus
- Amount(s) coming on-duty and going off-duty. 6. Issues with broken vials, preloaded syringes, etc.
- Witnessing by other crew members that the stock is right
- Ability to sign (Digitally) or in person as a witness that events took place regarding inventories, wasted substances, faulty or broken containers, etc.
- Signatures when replaced by supply and response personnel
Get away from the paper and get into the digital realm. PSTrax offers scroll down documentation either via Excel® or PDF if needed for authorities requesting a “hard” copy. Remember as the adage goes – “If it was not documented, then it was no done!”
As always, we thank you for all you do for your community. Be safe out there!
If PSTrax can help you with operations checks and logistics management, we’d love to chat. Please check out our solutions and offerings or contact us for a free demo today!
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Frank R. Myers is a retired Lieutenant with the City of Miami (FL) Fire Rescue, where he served 32 years. Before his retirement, he served at the Training Center for six years as the Driver Engineer Instructor. He also served as a Logistics Manager for FEMA, USAR, FLTF2. Currently he works as an Industry Strategic Advisor for PSTrax.com, a technology service that helps fire departments across the country automate their apparatus, equipment, and inventory checks. On behalf of PSTrax, Frank has written over 150 articles in various public and trade magazines.
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