Pharmaceuticals in EMS: Are You Compliant?
Dean Meenach // April 28, 2016
Today's EMS agencies purchase pharmaceuticals from a variety of sources1. 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 requirements2,3. 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 include4,5,6,7:
- State-driven Medicaid requirements
- Increased monitoring of ambulance billing suggested by the Office of the Inspector General at the U.S. Department of Health and Human Services
- Ambulance claims processing changes from the Centers for Medicare Services
- Requirements of Drug Quality and Security Act and the Drug Supply Chain Security Act
- Requirements of the International Statistical Classification of Diseases and Related Health Problems or ICD-10 diagnosis codes
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?
On November 27, 2013, the Drug Quality and Security Act became law. Title II of the DQSA, the Drug Supply Chain Security Act mandates new definitions and requirements related to pharmaceutical product tracking and tracing5,8,9. Product tracing includes identifying transaction information for each drug while tracking includes keeping records for six years of those entities that have been in possession of the drug starting with the manufacturer to wholesale distributors to dispensers including EMS services5,8,9.
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 period5. 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?
EMS agencies can only accept ownership of a prescription drug if the previous owner — wholesale supplier or distributor — provides an official transaction report. These transaction reports must be maintained for six years. In most cases when an EMS entity purchases a medication, the wholesale supplier will provide the transaction report in the shipment. Since the supplier must also keep copies of the report, if an EMS agency misplaces a report they should be able to contact the supplier for another copy. This mandate may be problematic for EMS agencies with limited administrative capacities or financial resources.
Details required to be provided on a transaction report include the:
- Proprietary or established name or names of the
- Strength and dosage form of the product
- National Drug Code number of the product
- Container size
- Number of containers
- Lot number of the product
- Date of the transaction
- Date of the shipment, if more than 24 hours after
- Date of the transaction
- Business name and address of the person from whom ownership is being transferred
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:
- Is authorized as required under the Drug Supply Chain
- Received the product from a person that is authorized as required under the Drug Supply Chain Security Act
- Received transaction information and a transaction statement from the prior owner of the product, as required under section 582
- Did not knowingly ship a suspect or illegitimate product;
- Had systems and processes in place to comply with verification requirements under section 582
- Did not knowingly provide false transaction information; and
- Did not knowingly alter the transaction history.
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 drugs8. 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
EMS field providers can assist with drug tracking-and-tracing by implementing medication documentation standards and by strictly adhering to their established EMS agency restocking, storing, and administration policies. As previously mentioned some components of the required DSCSA provider-level documentation correlates with the recent ICD-10 diagnostic code documentation recommendations. Therefore, adhering to medication documentation and administration standards will improve compliance with both DSCSA and ICD-10 code requirements while improving your service's opportunity to maximize reimbursement10.
Document with DSCSA and ICD-10 codes in mind
Field care is rarely mentioned when national clinical practice guidelines and professional standards are developed. However, when it comes to DSCSA and ICD-10 code requirements, EMS is held to the same standards as other health care providers10,11. Here are some important documentation considerations.
1. Document medication orders and administration in the following format: Drug, dose, route, frequency12,13,14,15.
For example, contacting Medical Command might be necessary for analgesia when caring for a patient with acute abdominal pain. The order should be documented as "Contacted Dr. Langenkamp who ordered Morphine Sulfate 5 mg intravenous push every 30 minutes". If offline medical direction permits analgesia without direct medical control, simply documenting the procedure as "Morphine Sulfate 5 mg administered intravenous push" is sufficient.
2. Avoid nonmedical or slang terms when documenting medication administration.
For example, while the phrase "Hung bag of NS KVO" is understandable to most field providers, this type of documentation does not meet any documentation standards.
3. Avoid confusing and vague terms of fluid administration such as keep vein open (KVO), to keep open (TKO), and wide open (WO).
Since 1998, professional standards have called for all intravenous therapy fluid orders to contain a specific infusion rate15,16,17,18,19. A common infusion rate for KVO is 25 mL/hour, but this may vary. An example of a properly documented IV infusion would be "Intravenous 0.9% normal saline infusion at 25 mL/hour " or "IV 1 liter bolus 0.9% normal saline infusion at 1000mL/hour initiated".
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.
For example, not all patients with ischemic chest pain symptoms can receive nitroglycerin. Perhaps the patient took tadalafil (Cialis®), vardenafil (Levitra®), sildenafil (Viagra®), or another medication for erectile dysfunction in the past 48 hours. Document why the medication was not given because of the patient meeting exclusion criteria in the chest pain treatment protocol.
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.
Reassessment after medication administration should always include objective and subjective findings. This is important because it measures and evaluates the therapeutic value of the medication. For example, after administering albuterol 5 mg by nebulizer, objective findings would include post treatment work of breathing, respiratory rate, pulse, blood pressure, lung sounds, pulse oximetry, and waveform capnography. The patient reports the subjective data by describing his interpretation of the therapy, such as "breathing easier now".
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.
For example, the patient who received the albuterol treatment would most likely need several lung sound assessments. The patient who received sublingual nitroglycerin for chest pain would most likely receive another 12-lead ECG when his chest pain resolves or becomes worse. Performing and documenting all appropriate reassessments assists EMS agencies in satisfying DSCSA and ICD-10 code requirements.
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
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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
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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