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April 28, 2016
Pharmaceuticals in EMS: Are you compliant?
Today's EMS agencies purchase pharmaceuticals from a variety of sources . Whether you purchase/ obtain your pharmaceuticals through a hospital, wholesaler/ distributor or other entity, it’s important to know your responsibilities in ensuring the integrity of the pharmaceutical supply chain as well as ensuring you are in compliance with State and Federal Regulations.
Before 2013, EMS services were not considered part of the pharmaceutical supply chain and were generally beyond the radar of the U.S. Food and Drug Administration. However, due to the Drug Supply Chain Security Act requirements, EMS entities are now considered an accountable part of "dispenser-to-first-responder transactions" and subject to DSCSA requirements [2,3]. Although EMS can continue to purchase drugs and supplies from most of their previous vendors, certain track-and-trace documents need to be maintained.
The Affordable Care Act has mandated numerous pharmaceutical-related regulatory changes that affect EMS and the Medicare ambulance community. These changes include [4,5,6,7]:
Implementing the DSCSA requirements likely remains a challenge for many EMS agencies. Conveniently, some components of the required DSCSA provider-level documentation correlate with the recent ICD-10 diagnostic code documentation recommendations, which also affect EMS reimbursement.
What is the DSCSA?
The intent of the law is to enhance the FDA's ability to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful by improving detection and removal of potentially dangerous drugs from the drug supply chain to protect patients. The development of the system will be phased in with new requirements over a 10-year period . The market has responded by offering many software programs to help all parties in the pharmaceutical chain achieve compliance.
How can EMS agencies maintain DSCSA compliance?
Details required to be provided on a transaction report include the:
In addition to the transaction report a transaction statement is a paper or electronic form which documents that that the entity transferring ownership in a transaction:
EMS services can only purchase prescription drugs from a supplier that has a federal and state license. Drug suppliers must be licensed in the states that they ship into. A supplier holding a license in their home or headquarters state doesn’t necessarily mean the supplier can ship drugs into other states.
Before purchasing medications from a supplier verify the supplier's licenses. License verification, by state, is available on the FDA Verify Wholesale Drug Distributor Licenses website.
Also, each EMS agency must also have on file a copy of their medical director's Drug Enforcement Administration license to purchase drugs and a vast array of other drug administration related supplies from the licensed vendor. This requirement affects all training entities. If a training entity, such as a college, university, or private school, wishes to purchase intravenous supplies, simulated medications, or even normal saline for the sole purpose of education, they must produce for the vendor the same required documentation.
EMS agencies should carefully order only the pharmaceuticals they need. Although it is near impossible to use all stored medications before they expire, ordering more than is needed is costly. Due to the DSCSA requirements, most suppliers are expected to not allow returns of prescription drugs . Returning unused medications may be allowable for hospital-based EMS systems in which drugs are obtained from the hospital's own pharmacy service.
However, regardless of the EMS system, a tracking system must be in place to trace where the drug went once it was received from the distributor. In most cases the drugs will either be in a storage room, on an ambulance, or in another vehicle such as a supervisor's vehicle. Although some of the DSCSA requirements remain unclear, many EMS agencies are also preparing to track the administration data of each drug, such as who administered the drug, when — date and time and to whom it was administered, and from what ambulance it was dispensed.
The role of the field care provider
Document with DSCSA and ICD-10 codes in mind
1. Document medication orders and administration in the following format: Drug, dose, route, frequency [12,13,14,15].
2. Avoid nonmedical or slang terms when documenting medication administration.
3. Avoid confusing and vague terms of fluid administration such as keep vein open (KVO), to keep open (TKO), and wide open (WO).
In addition, your administration practice should also represent sound medication safety by using an IV pump or a simple rate flow device. There are many safe low cost products on the market.
5. Document why certain medications were not given.
Certain states have implemented time critical diagnosis programs that require EMS documentation to be more specific for conditions such as stroke, STEMI, and trauma. For example, if a TCD process for the treatment of Non ST elevation myocardial infarctions (NSTEMI) includes heparin and clopidogrel (Plavix®), carefully document why these medications were given, the inclusion criteria, or not given.
6. Document reassessment findings after treatments.
Both components of your reassessment are important findings to support DSCSA requirements, ICD-10 codes and CMS reimbursement. If there was no change in the patient's condition, or if the condition worsens, these too must be reported.
7. Perform serial physical exams and diagnostic tests as applicable.
Implementing the DSCSA requirements will no doubt remain a daunting task for EMS administrators, medical directors, and field professionals. Although some of the requirements are clear, they may elicit more questions than answers. Successful compliance with the requirements, as well as billing for services, likely requires an open and frequent dialogue with reliable legal counsel with specific knowledge of your EMS agency and its protocols. You can also submit questions to the FDA through the FDA's DSCSA website.
1. The Kaiser Family Foundation. (2005, March). Follow the pill: Understanding the U.S. pharmaceutical supply chain. Retrieved from http://kff.org/other/report/follow-the-pill-understanding-the-u-s/
2. Barlas, S. (2011). Track-and-trace drug verification: FDA plans new national standards, pharmacies tread with trepidation. Pharmacy and Therapeutics, 36(4), 51-68. doi:10.1201/b18697-5
3. Ducca A. (2012, October). Re: Determination of system attributes for the tracking and tracing of prescription drugs. (docket no. FDA-2010-n-0633). Fed. Reg. 2011 January 7;1182:76. Retrieved from http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0633-0012.
4. Centers for Disease Control and Prevention (CDC). (2016). International Classification of Diseases, tenth revision, clinical modification (ICD-10-CM). Retrieved from http://www.cdc.gov/nchs/icd/icd10cm.htm
5. U.S. Food and Drug Administration (FDA). (February 2016). Requirements for transactions with first responders under section 582 of the Federal, Food, Drug, and Cosmetic Act—Compliance policy guidance for industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM488240.pdf
6. Government Health Administrators. (2016). Ambulance providers ICD-10 CM planning and preparation. http://www.wpsmedicare.com/j5macpartb/claims/icd-10/ambulance-providers-icd10-planning-prep.shtml
7. Centers for Medicare & Medicaid Services (CMS). (2015, October). Medicare claims processing manual: Chapter 15—Ambulance. Retrieved from https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c15.pdf
8. Brennan, Zachary. (2016, February 29). New FDA guidance for first responders as track-and-trace requirements take effect. Retrieved from http://raps.org/Regulatory-Focus/News/2016/02/29/24429/New-FDA-Guidance-for-First-Responders-as-Track-and-Trace-Requirements-Take-Effect/
9. U.S. Food and Drug Administration (FDA). (2013). Drug Supply Chain Security Act (DSCSA). Retrieved from http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/
10. American Pharmacists Association (Apha). (2015). Apha Policy Manual. Retrieved from http://www.pharmacist.com/policy-manual?ids=p-929421&tids=t-929417
11. American Medical Association (AMA). (2017). CPT 2017 Professional Edition. Washington, DC: AMA.
12. Institute for Safe Medication Practices (ISMP). (2011). ISMP acute care guidelines for timely administration of scheduled medications. Retrieved from http://www.ismp.org/tools/guidelines/acutecare/tasm.pdf
13. Institute for Safe Medication Practices (ISMP). (2011, February). Preventing medication errors during codes. Retrieved from https://www.ismp.org/newsletters/acutecare/articles/20110210.asp
14. Institute for Safe Medication Practices (ISMP). (2015). ISMP safe practice guidelines for adult IV push medications. Retrieved from http://www.ismp.org/Tools/guidelines/ivsummitpush/ivpushmedguidelines.pdf
15. Institute for Safe Medication Practices (ISMP). (2016). 2016-2017 medication safety best practices for hospitals. Retrieved from http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf
16. Infusion Nurses Society. (2006). Infusion nursing specialty practice. Journal of Infusion Nursing, 29(Supplement), 1s, S18. doi:10.1097/00129804-200601001-00005
17. Infusion Nurses Society. (2006). Infusion nursing specialty practice. Journal of Infusion Nursing, 29(Supplement), 1s, S35-36. doi:10.1097/00129804-200601001-00005
18. Hadaway, L. C. (2004). Closing the case on the keep-vein-open rate. Nursing, 34(8), 18. doi:10.1097/00152193-200408000-00015
19. Infusion Nurses Society. (1998). An infusion of independence. Journal of Infusion Nursing, 21(1), 1st ser., S1-S91. doi:10.1097/00000446-199804000-00015