Controlled substances and EMS
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 they get used for the wrong reasons, there can be dangerous outcomes to one’s well-being. That’s why we need to screen, diagnose, and do proper patient assessment to assure that those who call us do not have a drug addiction, and just need a “quick fix” knowing that EMS carries narcotics and substances that can satisfy their addiction.
Administering controlled substances
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 reading. If not, and the patient is hypotensive to begin with, they will “bottom out” and become more hypotensive. 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 include:
- Is the patient an addict?
- Is the patient allergic to the controlled substance?
- Is the patient able to process the substance?
Failure to comply with regulations
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,
- Village
- Etc.
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 possible consequences of poor management of controlled substances, and how it can relate to EMS personnel and their agencies:
- Disciplinary 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.
Complying with controlled substance regulations
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.
- Issues with broken vials, preloaded syringes, etc.
- Verification 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
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 not 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 fire software and EMS software, or contact us for a free demo today!
Related Questions and FAQs
What is controlled substance tracking, and why is it important for first responders?
Controlled substance tracking is the monitoring of the distribution and usage of medications classified as controlled substances. It’s crucial for first responders to ensure the secure and accountable administration of these substances during emergencies.
What is controlled substance diversion, and how can it be prevented through tracking?
Controlled substance diversion refers to the illegal distribution or theft of medications from their intended use. Tracking helps prevent diversion by creating a transparent record of every transaction, making it easier to detect discrepancies.
What role does controlled substance management play in healthcare facilities?
Controlled substance management encompasses the entire lifecycle of these medications, from procurement to disposal. Effective management ensures compliance with regulations, reduces the risk of diversion, and promotes patient safety.
What are some best practices for implementing controlled substance tracking in healthcare settings?
Implementing controlled substance tracking in healthcare settings requires careful planning and execution. Best practices include regular audits, staff training, and utilizing technology like PSTrax to streamline the process.
How does PSTrax help healthcare professionals stay compliant with controlled substance regulations?
PSTrax provides tools for real-time tracking, reporting, and auditing of controlled substances. This helps healthcare professionals maintain compliance with regulatory requirements and reduce the risk of non-compliance penalties.
Can PSTrax be customized to fit the specific needs of different healthcare facilities?
Yes, pstrax.com is designed to be flexible and customizable to meet the unique needs of different healthcare facilities, ensuring a tailored solution for controlled substance tracking.
What are the consequences of failing to track controlled substances effectively?
Failing to track controlled substances effectively can result in regulatory violations, legal repercussions, and compromised patient safety. It can also lead to the diversion of these substances, contributing to serious and sweeping health crises.
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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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