Rocky Mountain EMS. Medications and Controlled Substances. Policies and Procedures for the handling of. Page 1 Revised 04/02/04

Transcription

1 Rocky Mountain EMS Policies and Procedures for the handling of Medications and Controlled Substances Page 1

2 I. Table of Contents I. Table of Contents...2 II. III. IV. General Statements...4 A. EMS Clinic Objectives B. Multiple Clinics C. Use of Consultant Pharmacist D. Responsibilities of Rocky Mountain EMS Employees E. Regulatory Precedent and Policy Severability F. Definitions Duties of Consultant Pharmacist...5 A. Code of Ethics B. Qualifications and Knowledge C. Establishing Policies and Procedures D. Patient Safety E. EMS Clinic Visitations F. Drug Handling G. Documentation Review and Reporting of Exceptions H. Annual Reporting Consulting Pharmacist Agreement...10 A. Scope of Work B. Compensation & Term C. Termination D. Status of Contractor E. Assignment F. Subcontracting G. Liability & Insurance H. Records and Audit I. Release J. Confidentiality K. Work Products L. Conflict of Interest M. Amendment N. Additional Services O. Scope of Agreement P. Applicable Law V. EMS Clinic Formulary...13 A. Medications - Irrigating Solutions B. Medications - IV Solutions C. Medications - Condition Specific D. Controlled Substances - Scheduled E. Controlled Substances - Unscheduled VI. Drug Acquisition and Disposal...14 A. Drug Procurement B. Packaging and Repackaging of Drugs C. Sample Medications D. Dispensing/Distribution of Medications E. Drug Recall Procedure F. Expired (Outdated) Drugs G. Expired Medications Used for Training Page 2

3 VII. Drug Storage...15 A. Approved Storage Locations B. Environmental Conditions C. Security VIII. IX. Drug Handling and Administration...16 A. Medications B. Controlled Substances Record Keeping...18 A. Invoices for Purchases of Controlled Substances B. Medication Transfer C. DEA 222 (requisition) Forms D. Expired Medications Disposal E. Expired Medications Used for Training F. Run Report G. Proof of Use H. EMS Clinic Controlled Substances I. Controlled Substances Inventory J. Expired Controlled Substance Disposal K. Consultant Pharmacist Visitation X. Appendix A. Sample Record Keeping Forms...21 A. Expired Medications Disposal B. Expired Medications Used for Training C. Proof of Use D. EMS Clinic Controlled Substances E. Controlled Substances Inventory F. Expired Controlled Substance Disposal G. Consultant Pharmacist Visitation H. Significant Adverse Drug Event Reporting XI. XII. XIII. Appendix B. 7 NMAC Scopes of Practice for EMS Personnel...30 Appendix C. Approved Special Skill Medications and Controlled Substances...36 Appendix D. 16 NMAC 19 Pharmacists...37 A. 16 NMAC 19.4 Pharmacist B. 16 NMAC Fees C. 16 NMAC Temporary Business Licenses D. 16 NMAC Controlled Substances E. 16 NMAC Emergency Medical Services Dangerous Drugs F. 16 NMAC Adverse Drug Event G. 16 NMAC Dishonorable Conduct XIV. Appendix E. Practitioner s Manual...73 XV. Appendix F. Controlled (Schedules) Criteria...81 XVI. Appendix G. Narcotics Officer Guidelines (To be published at a later date)...82 Page 3

4 II. General Statements A. EMS Clinic Objectives The objectives of Rocky Mountain EMS Clinics are to: 1. Provide the highest level of pre-, inter-, and post-hospital care possible. 2. Provide the care in the safest and most cost efficient manner possible. 3. Operate our EMS Clinics so that all of our employees, peers and customers are served with integrity. B. Multiple Clinics Rocky Mountain EMS will license multiple EMS clinics in accordance with current NM Board of Pharmacy Regulations. C. Use of Consultant Pharmacist Rocky Mountain EMS will contract with a licensed pharmacist to serve as consultant. This pharmacist will provide services in accordance with Federal and State Board of Pharmacy regulations, the Consultant Pharmacist Agreement and the Rocky Mountain EMS Medications and Controlled Substances policies and procedures. D. Responsibilities of Rocky Mountain EMS Employees Rocky Mountain EMS personnel will be engaged in administration of medications and/or controlled substances, limited to those listed in the EMS Clinic Formulary, to patient(s) under care at the EMS Clinic. Any inadvertent, incorrect or accidental administration, or any suspected mishandling of any medication(s) will be immediately reported to their Supervisor and the EMS Service Medical Director. All requested documentation will be completed as soon as possible and forwarded to the Director of Operations, Medical Director and Consultant Pharmacist. E. Regulatory Precedent and Policy Severability In the event any portion(s) of the Medications and Controlled Substances policies and procedures is/are in disagreement with Federal or State regulations, the regulations will take precedent. Changes will be made as soon as possible to bring the Medications and Controlled Substances policies and procedures into compliance with regulation. Severance of any portion of these policies and procedures shall not nullify the balance of the document. Page 4

5 F. Definitions For the purposes of these Medications and Controlled Substances policies and procedures, the following definitions apply: 1. Drug: An umbrella term for any protocol-authorized substance introduced into the body of a patient, by ingestion, injection, intra-venously, or topically, for the purposes of improving the patient s health. Section V., the EMS Clinic Formulary, lists all approved drugs for use by Rocky Mountain EMS employees. "Dangerous Drug" means a drug that, because of any potentiality for harmful effect or the methods of its use or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such drug and the drug prior to dispensing is required by federal law and state law to bear the manufacturer's legend "Caution: Federal law prohibits dispensing without a prescription". 2. Medication: Any drug not designated as a controlled substance. 3. Controlled Substance: Class (Schedule) II - Class (Schedule) V drugs, plus Paralytics. 4. Consultant Pharmacist: See sections IIIA. & IV. of these policies and procedures. 5. Director of Operations: The Rocky Mountain EMS employee responsible for corporate over-site of operations, activities and planning. The Director of Operations is the primary point of contact between Rocky Mountain EMS, it s employees and it s consultants. 6. Jump Kit: A portable carrying devices that contain emergency medical supplies and drugs. 7. Medical Director: The New Mexico licensed Physician contracted with Rocky Mountain EMS to provide medical over-site and consulting services consistent with 7 NMAC EMS Medical Director means a physician who is responsible for all aspects of patient care for an EMS system or EMS provider service, including providing for or ensuring the medical control of EMS providers; the development, implementation, evaluation of medical protocols; and oversight of quality assurance activities. 8. Narcotics Officer: The individual responsible for the purchasing, recording and disbursement of controlled substances to the EMS Clinics. This individual is also responsible for the proper care and recording of expired controlled substances and their proper disposal, in conjunction with the Consultant Pharmacist. See Section IIIB. 9. Pharmacy Purchasing Agent: The individual responsible for the purchasing, recording and disbursement of medications to the EMS Clinics. This individual is also responsible for the proper care and recording of expired medications and their proper disposal, in conjunction with the Consultant Pharmacist. See Section IIIC. Page 5

6 III. Duties - Consultant Pharmacist The following are the general duties of the Consultant Pharmacist contracted to Rocky Mountain EMS. A. Code of Ethics Abide by the code of ethics of the American Society of Consultant Pharmacists: ARTICLE I The Consultant Pharmacist shall provide a high quality of pharmaceutical care and service which not only meets the minimum standards of existing law and regulation, but surpasses them. ARTICLE II The Consultant Pharmacist's primary goal and objective shall be the health and safety of the patient, in whose behalf every effort shall be exerted to assure the maximum level of safety and efficacy in the provision of pharmaceutical service. ARTICLE III The Consultant Pharmacist shall pursue the practice of pharmacy in an ethical manner, and in such a way as to reflect credit on the specialty of consultant pharmacy; and shall be obligated to expose any illegal or unethical conduct or practice among his peers of which he may have knowledge. ARTICLE IV The Consultant Pharmacist shall agree to practice pharmacy under terms and conditions which clearly provide for the proper exercise of professional judgment and skill, and which do not tend in any manner whatsoever to subvert the quality of professional services of the ethical conduct of the practice of pharmacy. ARTICLE V The Consultant Pharmacist shall determine that only those drugs, drug products or medical devices which meet standards of quality required by law and by sound and responsible professional judgment, and which are determined to have therapeutic value for the patient, are dispensed and distributed. ARTICLE VI The Consultant Pharmacist shall respect the confidentiality of all clinical records, professional notes, memoranda, reports and other records relating to any patient's medical condition or medication therapy; and shall in no case disclose such information without proper legal authorization. ARTICLE VII The Consultant Pharmacist shall not condone or participate in any transaction with any practitioner of another health profession or any other person whatsoever under which fees are divided, or rebates or kickbacks paid or caused to be paid, or which may result in financial exploitation of patients or their families in connection with the provision of medications and supplies or pharmaceutical services. ARTICLE VIII The Consultant Pharmacist shall seek continuously to refine and enlarge upon his professional knowledge, abilities and skills, through the pursuit of continuing educational experience in a variety of settings. ARTICLE IX The Consultant Pharmacist shall, to the best of his ability, associate and affiliate with organizations insofar as they are directed toward the improvement of patient care and safety. Page 6

7 B. Qualifications and Knowledge Must be qualified to practice as a consultant pharmacists and aware of all federal and state drug laws, rules and regulations related to pharmacy services, and to provide the facility with current information pertaining to drug service. C. Establishing Policies and Procedures Participate in the setting of the policies and procedures in the EMS Clinic as related to all facets of drug handling and distribution: these policies and procedures to be reviewed and updated on an annual basis. D. Patient Safety Make every effort to assure the maximum level of safety and efficacy in the provision of pharmaceutical services, with the understanding that the primary goal and objective shall be the health and safety of the patient. E. EMS Clinic Visitations Visit the EMS Clinics as specified by Pharmacy Board regulations relative to the facility or by written contact with the administration of the facility not inconsistent with Pharmacy Board regulations. F. Drug Handling Ensure that drugs are handled in the EMS Clinic facilities in which he/she is the consultant pharmacist in a manner that protects the safety and welfare of the patients we serve. G. Documentation Review and Reporting of Exceptions Visit the principal place of business and review all instances in which controlled substances were used, and review all or a sample of at least 5% of instances in which other drugs were used, at least every 90 days and report in writing any exceptions to the Medical Director and the Director of Operations within 24 hours upon learning of the same. H. Annual Reporting Make a written report to the Medical Director and Director of Operations at least annually on the EMS s drug handling practices, including corrective action taken on exception(s). Page 7

8 Duties - Narcotics Officer A. Ethics Must exhibit and abide by the highest degree of accountability and reliability. This individual shall at no time be subject to civil or criminal proceedings which relate to their trustworthiness, morals, or drug or alcohol misuse or abuse. B. Qualifications and Knowledge Must be aware of all federal and state drug laws, rules and regulations related to drugs and drug handling in an EMS environment, and to provide the Director of Operations and EMT s with current information pertaining to drug issues. C. Establishing Policies and Procedures Participate in the setting of the policies and procedures in the EMS Clinic(s) as related to all facets of drug handling and distribution: these policies and procedures to be reviewed and updated on an annual basis, in conjunction with the Consulting Pharmacist, Pharmacy Purchasing Agent and the Director of Operations. D. Patient Safety Make every effort to assure the maximum level of safety and efficacy in the handling and administration of drugs, with the understanding that the primary goal and objective shall be the health and safety of the patient. E. EMS Clinic Visitations Visit the EMS Clinics as required to oversee, inventory, restock or remove drugs as necessary. F. Drug Handling Ensure that drugs are handled in the EMS Clinic facilities in a manner that protects the safety and welfare of the patients we serve, as well as protects the interests of Rocky Mountain EMS, it s employees and consultants. The Narcotics Officer should not handle any controlled substances or records without a second party present to verify actions and accounting. G. Documentation Review and Reporting of Exceptions Review all instances in which controlled substances were used and maintain the records related to controlled substance purchase, storage, handling and disposal at the company level. In addition, oversee the EMS Clinics to assure that their record keeping is compliant with all pertinent policies, procedures and regulations. Report in writing any exceptions to the Director of Operations and Consulting Pharmacist within 24 hours upon learning of any egregious activities or any errors which are not corrected in a reasonable period of time after having been identified. H. Quarterly Reporting Make a written report to the Director of Operations at least quarterly on the drug handling practices, including identifying exceptions and the corrective actions taken. I. Orderly Operations The Narcotics Officer will maintain orderly operations which can easily be reviewed by the Consultant Pharmacist and the Director of Operations. A suggested system is: 1. The Rocky Mountain EMS Narcotics Officer shall purchase all controlled substances 2. Receive controlled substances and log immediately on the Controlled Substances Inventory 3. Methodically make additions and subtractions to any log page 4. Maintain all Proof of Use and Run Reports as required by regulation and policy 5. Keep expired controlled substances at the lowest possible level, sending them for proper disposal no less than quarterly and logging transactions in the Expired Controlled Substances Disposal log 6. Involve the Consultant Pharmacist in the disposal process, resolving issues or questions, and making changes to policies 7. Order replacement controlled substances in a fashion so that the new stock arrives prior to any stock expiring. This will permit time to develop an acceptable alternative should the replacement stock be unavailable. Page 8

9 Duties - Pharmacy Purchasing Agent A. Ethics Must exhibit and abide by the highest degree of accountability and reliability. This individual shall at no time be subject to civil or criminal proceedings which relate to their trustworthiness, morals, or drug or alcohol misuse or abuse. B. Qualifications and Knowledge Must be aware of all federal and state drug laws, rules and regulations related to drugs and drug handling in an EMS environment, and to provide the Director of Operations and EMT s with current information pertaining to drug issues. C. Establishing Policies and Procedures Participate in the setting of the policies and procedures in the EMS Clinic(s) as related to all facets of drug handling and distribution: these policies and procedures to be reviewed and updated on an annual basis, in conjunction with the Consulting Pharmacist, Narcotics Officer and the Director of Operations. D. Patient Safety Make every effort to assure the maximum level of safety and efficacy in the handling and administration of drugs, with the understanding that the primary goal and objective shall be the health and safety of the patient. E. EMS Clinic Visitations Visit the EMS Clinics as required to oversee, inventory, restock or remove drugs as necessary. F. Drug Handling Ensure that drugs are handled in the EMS Clinic facilities in a manner that protects the safety and welfare of the patients we serve, as well as protects the interests of Rocky Mountain EMS, it s employees and consultants. G. Documentation Review and Reporting of Exceptions Review all instances in which controlled substances were used and maintain the records related to Medication purchase, storage, handling and disposal at the company level. In addition, oversee the EMS Clinics to assure that their record keeping is compliant with all pertinent policies, procedures and regulations. Report in writing any exceptions to the Director of Operations and Consulting Pharmacist within 24 hours upon learning of any egregious activities or any errors which are not corrected in a reasonable period of time after having been identified. H. Quarterly Reporting Make a written report to the Director of Operations at least quarterly on the drug handling practices, including identifying exceptions and the corrective actions taken. I. Orderly Operations The Pharmacy Purchasing Agent will maintain orderly operations which can easily be reviewed by the Consultant Pharmacist and the Director of Operations. A suggested system is: 1. The Rocky Mountain EMS Pharmacy Purchasing Agent shall purchase all medications 2. Maintain complete records and invoices for medication purchases 3. Methodically make additions and subtractions to any log page 4. Maintain all documentation as required by regulation and policy 5. Keep expired medications at the lowest possible level, disposing of them no less than quarterly and preferably as soon as they are removed from service and properly logged 6. Involve the Consultant Pharmacist in the disposal process, resolving issues or questions, or making changes to policies 7. Order replacement medications in a fashion so that the new stock arrives prior to any stock expiring. This will permit time to develop an acceptable alternative should the replacement stock be unavailable. Page 9

10 IV. Consulting Pharmacist Agreement This AGREEMENT is made and entered into by and between Rocky Mountain EMS Christine Atwell, RPh, hereinafter referred to as the Contractor. It is mutually agreed between the parties: A. Scope of Work The Contractor shall render the following services at a minimum: 1. Report in writing to the Board of Pharmacy any termination of this agreement within ten days. 2. Quarterly visit to each EMS Clinic. Develop and maintain log books demonstrating dates of all visits, activities, findings and any other pertinent information. A log will be maintained at each EMS Clinic and will be available to appropriate inspectors upon request. 3. Assist in writing the Medications and Controlled Substances policies and procedures outlining the system of drug control and accountability in the EMS clinics. 4. Assume the over-site responsibility for implementation of and adherence to the Medications and Controlled Substances policies and procedures. 5. Assume over-site responsibility for the destruction or removal of unwanted or outdated medications and the proper disposition of unwanted or outdated controlled substances as required by applicable laws and regulations. 6. Provide annual in-service training at each EMS Clinic on the Medications and Controlled Substances policies and procedures. 7. Provide in-service training, if requested by the Director of Operations or the Medical Director, either personally or in written form, on any drugs added to the EMS Clinic Formulary. B. Compensation & Term Rocky Mountain EMS shall pay to the Contractor, for services rendered in full compliance with this agreement, an amount not to exceed $2,000 per fiscal year, including gross receipts taxes, if applicable. This Agreement shall become effective on the date of execution of this Agreement by all parties. C. Termination Either party hereto upon may terminate this Agreement by written notice, delivered to and receipt acknowledged by the other party, at least thirty (30) days prior to the intended date of termination. By such termination, neither party may nullify obligations already incurred for performance or failure to perform prior to the date of termination. D. Status of Contractor The Contractor and Contractor s agents and employees are independent contractors performing professional services for Rocky Mountain EMS, and are not employees of Rocky Mountain EMS. Notwithstanding the agreed upon compensation, the Contractor and the Contractor s agents and employees shall not accrue leave; participate in retirement plans; be insured under any Rocky Mountain EMS insurance plans or liability bonding; drive Rocky Mountain EMS vehicles; or, participate in any other benefits afforded to employees of Rocky Mountain EMS. E. Assignment The Contractor shall not assign or transfer any interest in this Agreement or assign any claims for money due or to become due under this Agreement without the prior written approval of Rocky Mountain EMS. F. Subcontracting The Contractor shall not subcontract any portion of the services to be performed under this Agreement without the prior written approval of Rocky Mountain EMS. Page 10

11 G. Liability & Insurance It is expressly understood and agreed by and between the parties hereto that the Contractor shall hold Rocky Mountain EMS harmless for all losses, damages, claims, or judgements on account of any suit, judgement, execution, claim, action or demand whatsoever resulting from Contractor s actions or inactions under this Agreement. H. Records and Audit The Contractor shall maintain detailed records of all services identified previously in the Scope of Work. Said records are to be maintained at each EMS Clinic. Rocky Mountain EMS shall have the right to inspect all records and to audit billings both before and after payment. Payment under this Agreement shall not foreclose the right of Rocky Mountain EMS to recover excessive or illegal payments. I. Release The Contractor, upon final payment of the amount due under this Agreement, releases Rocky Mountain EMS, its officers, agents and employees from all liabilities, claims and obligations whatsoever arising from or under this Agreement. The Contractor agrees not to purport to bind Rocky Mountain EMS to any obligation not agreed to herein unless the Contractor has express written authority from Rocky Mountain EMS to do so, and then only within the strict limitations of that authority. J. Confidentiality Any confidential information provided to or developed by the Contractor in the performance of this Agreement shall be kept confidential and shall not be made available to any individual or organization by the Contractor without the prior written approval of Rocky Mountain EMS. Contractor agrees to be bound by and compliant with Federal HIPAA regulations. K. Work Products All materials developed or acquired by the Contractor (Work Products) under this Agreement shall immediately become the property of Rocky Mountain EMS. Both tangible copies and, if possible, electronic copies (compatible with Microsoft Office 2000 software) of each Work Product shall be delivered to Rocky Mountain EMS no later than the termination date of this Agreement. Nothing produced, in whole or in part, by the Contractor under this Agreement shall be the subject of an application for copyright by or on behalf of the Contractor. L. Conflict of Interest The Contractor and Contractor s agents and employees warrants there is presently no interest and Contractor and Contractor s agents and employees shall not acquire any interest, direct or indirect, which would conflict in any manner or degree with the performance of services required under this Agreement. M. Amendment This Agreement shall not be altered, changed or amended except by instrument in writing executed by the parties hereto. N. Additional Services The parties agree that all tasks set forth in the Section IV.A. of this Agreement, shall be completed in full, to the satisfaction of Rocky Mountain EMS, for the amount set forth in Section IV.B. of this Agreement, and for no other cost, amount, fee, or expense. O. Scope of Agreement This Agreement incorporates all the agreements, covenants, and understandings between the parties hereto concerning the subject matter hereof, and all such agreements, covenants and understandings have been merged into this written Agreement. No prior agreement, covenant or understanding, verbal or otherwise, of the parties of their agents shall be valid or enforceable unless embodied in this Agreement. P. Applicable Law The Ordinances of Rocky Mountain EMS and the laws of the State of New Mexico shall govern this Agreement. Page 11

12 IN WITNESS WHEREOF, the parties have executed this Agreement this day of, 200. Contractor Contractor Federal Tax Identification No. Director of Operations President Approved as to legal form:, Rocky Mountain EMS Attorney Page 12

13 V. EMS Clinic Formulary Modifications may be made to this formulary based on updates of medical protocols. The Rocky Mountain EMS Medical Director will determine the formulary list consistent with treatment protocols, scope of practice and regulations. The drugs to be procured and stored at the EMS Clinics, and administered to the patients under the care of Rocky Mountain EMS, will be limited to the following formulary: A. Medications - Irrigating Solutions 1. Sterile water for irrigation 2. NaCl 0.9% for irrigation B. Medications - IV Solutions 1. NaCl 0.9% 2. Lactated Ringers 3. Dextrose 5% in Water % Lidocaine C. Medications - Condition Specific 1. Adenosine 2. Albuterol 3. Acetylsalicylic Acid 4. Amioderone 5. Atropine Sulfate 6. Calcium Preparations 7. Diphenhydramine 8. Bretylium Tosylate 9. Dextrose 50% 10. Dopamine 11. Epinephrine 12. Furosemide 13. Glucagon 14. Glucose (Oral) 15. Haloperidol 16. Lidocaine 17. Magnesium Sulfate 18. Naloxone 19. Nitroglycerin 20. Oxytocin 21. Phenylephrine nasal spray 22. Promethazine 23. Proparacaine opathalmic solution 24. Sodium Bicarbonate 25. Vasopressin D. Controlled Substances - Scheduled 1. Diazepam 2. Midazolam 3. Morphine Sulfate E. Controlled Substances - Unscheduled 1. Succinylcholine* (where approved by EMS Medical Director) See Appendix B. for the current list of medications and controlled substances which are approved in the NM SOP. See Appendix C. for the current list of approved Special Skill medications and controlled substances. Page 13

14 VI. Drug Acquisition and Disposal A. Drug Procurement Rocky Mountain EMS will purchase drugs from an appropriate supplier in accordance with Federal and State regulations. Medications listed on the EMS Clinic Formulary may only be purchased by the Pharmacy Purchasing Agent or designee. Controlled substances listed on the EMS Clinic Formulary may only be purchased by the Narcotics Officer. At the time of receipt of a drug order, the Pharmacy Purchasing Agent or Narcotics Officer, as appropriate, must confirm that the shipment is correct and complete. They must then store the invoices per section IX.A.. B. Packaging and Repackaging of Drugs Rocky Mountain EMS will not package or repackage drugs. C. Sample Medications There will be no sample medications kept on the premises or used for the patients we serve. D. Dispensing/Distribution of Medications There will be no dispensing or distributing of medications to the patients we serve. Medications may only be administered to our patients per protocol. E. Drug Recall Procedure All recalled drugs will be removed from stock as soon as possible following notification. Upon notification of a recall, all effected lots shall be removed from stock and placed in the appropriate Expired drug box. The consultant pharmacist or designee will dispose of the recalled drugs in an appropriate manner, and document that action in the relevant log. F. Expired (Outdated) Drugs All drugs in stock must be rotated when new stock arrives to assure that the older drugs are used first. Drugs which are dated with only the expiration month and year will be considered expired on the last day of the month. Expired drugs may not be used on a patient or be stored in a patient care area. Expired medications may not be stored in a location that could be confused with usable medications, and so may not, at any time, be stored in an area that contains in-date drugs. In the event of an emergency situation where current-dated drugs are unavailable, the Director of Operations will consult with the Medical Director for guidance. When a drug expires, the drug must be pulled from stock and logged on the Expired Medications Disposal or Expired Controlled Substances Disposal log. Logged medications, once logged, may either be immediately disposed of in an appropriate manner, or must be placed in a box clearly labeled Expired Medications for future disposal. Expired controlled substances must be returned to the Narcotics Officer for proper disposal. They may not be disposed of by any other personnel. G. Expired Medications Used for Training Only expired medications may be used for training purposes. All expired medications used for training must be labeled Expired. All expired medications used for training must be recorded in the Expired Medications Used for Training log book and must be signed out from the log as used for training and be signed and dated by licensed EMS personnel. Page 14

15 VII. Drug Storage A. Approved Storage Locations All medications used by Rocky Mountain EMS will be stored in one of the following locations: 1. Storage facility at the EMS Clinic 2. Ambulance or supervisor vehicle. 3. Jumpkit assigned to the ambulance or supervisor vehicle. Controlled substances may not be stored at the EMS Clinic unless the EMS Clinic has a controlled substance license. Storage is otherwise limited to: 1. Ambulance or supervisor vehicle. 2. Jumpkit assigned to the ambulance or supervisor vehicle. Any drug which is part of the inventory of a jumpkit may be temporarily removed from the ambulance or supervisor vehicle, so long as: 1. The removal is for the performance of duty 2. Positive control of the drugs by the individual responsible for the jumpkit is not broken 3. Drug inventory is replaced or restocked as soon as possible. B. Environmental Conditions Drugs must be stored in a clean, well lighted and clutter free area. EMS Clinic locations are required to assure appropriate temperature controls for all storage locations and will take appropriate steps to store all drugs, regardless of storage location, in a manner as to avoid temperature extremes. Drugs may not be subject to extreme heat or cold for lengthy periods. Thermometers capable of recording minimum and maximum temperature recordings shall be mounted in the patient compartment area of all ambulances or supervisor vehicles. During cold weather operations, a heater must be kept on in the patient compartment to keep all drugs above 50 degrees Fahrenheit. During hot weather operations, drugs should not be kept inside a vehicle which is allowed to exceed 80 degrees Fahrenheit for extended periods. C. Security All drugs must be stored in such a manner that when they are not on an authorized EMT s person or in use during patient care, they will be behind at least one locked door. Controlled substances must be stored in such a manner that when they are not on an authorized EMT s person or in use during patient care, they will be behind at least two locks. The two locks may not have the same key or combination. At least one of the two locks must have a key or combination which must be changed each time a previously authorized EMT leaves the employment of Rocky Mountain EMS. Keys or combinations to storage locations are restricted to authorized personnel only. Any time a key or combination is changed, a copy of the new key or combination will be forwarded immediately to the Director of Operations in order to facilitate random inspections by the Consulting Pharmacist, EMS Medical Director, Board of Pharmacy and/or Drug Enforcement Agency. Page 15

16 VIII. Drug Handling and Administration At all times, any employee of Rocky Mountain EMS found to be in unauthorized possession of drugs from Rocky Mountain EMS resupply, in-use or expired stock, while off duty, will face disciplinary action, up to being terminated. The Consulting Pharmacist, EMS Medical Director and Board of Pharmacy has a right to review any and all patient documentation, forms, logs, or records reports at any time, consistent with operational and quality control needs. Failure by any employee to fully cooperate with an inspection is grounds for immediate dismissal. Every employee has the right to contact the Consulting Pharmacist, Medical Director or appropriate Federal or State agencies if they believe an investigation related to drugs is warranted. Employees are encouraged to try resolving questions or problems at the lowest possible level first, meaning their supervisor, the Narcotics Officer or Pharmacy Purchasing Agent, or the Director of Operations. The Consulting Pharmacist and Medical Director will ask the employee if they have notified their supervisor(s) of their concerns, and the Consulting Pharmacist and Medical Director may notify management of the issues raised by an employee. EMTs should note that all drugs for restocking are issued from Rocky Mountain EMS medical supply. No Rocky Mountain EMS provider should receive these items from any other source nor should they solicit a prescription to replace controlled substances. Authorized EMT s may, on an as needed basis, administer drugs issued by a transferring facility for a specific patient s care. This must be: 1. Documented 2. Within protocol, Scope of Practice, and the EMT s licensure level 3. Disposal of the drug(s) must be done in a witnessed manner. Employees will only use approved drug administration equipment, obtained either from Rocky Mountain EMS supplies or, in the case of inter-facility transfers, the sending facility. Employees are responsible to use only equipment and drugs which they are licensed and trained to use and which they are comfortable using. Employees are responsible to ensure their ambulance or supervisor vehicle has the company issued drug reference manual on board at all times, as well as the phone number for New Mexico Poison Control. A. Medications All medications will be purchased by the Pharmacy Purchasing Agent, or designee, with the approval of the Director of Operations. Bulk supplies will be kept in a medical supply cabinet which is located in an environmentally controlled area. Access to this cabinet will be restricted to EMS personnel only. Each ambulance will have a stock of medications as necessary for the function of that unit. This supply will be secure from access by non-rocky Mountain EMS personnel as much as is practical. It is acknowledged that field operations of an emergency nature may impact this. Any Rocky Mountain EMS EMT who is licensed by the State of New Mexico Injury Prevention & EMS Bureau, and in Good Standing with same, may use these supplies, via protocol or direct order of a physician, as allowed by their Scope of Practice as set forth in regulations. See Appendix C. The guidelines for use, handling and documentation are as follows: 1. Use shall be documented on the Run Report form upon completion of the call. 2. Replacement of supplies expended shall be accomplished immediately upon return to base. 3. Any expired, broken or otherwise unusable medications removed from an ambulance, supervisor vehicle or supply cabinet will be so indicated on the Expired Medications Disposal log. 4. Each licensed EMT with access to these items will be responsible for ensuring that all items are current, environmentally protected as practical, used properly, and said use is documented properly. 5. Rocky Mountain will be responsible for copies of Run Reports showing use of medications. These reports must be kept for three years. 6. The Rocky Mountain EMS officers, the EMS Medical Director, the Consulting Pharmacist, and any representative of the Pharmacy Board or Drug Enforcement Agency shall have unlimited access to all supplies and documents covered by this policy. This is to include but is not limited to periodic inspections by the above mentioned personnel. Page 16

17 B. Controlled Substances Only licensed personnel approved by the EMS Medical Director to administer controlled substances may handle or restock controlled substances. EMTs shall be responsible for ensuring that all controlled substances are current, stored and used properly and that said use is documented properly. Because of the serious nature of properly handling and accounting for controlled substances, failure to properly handle them or complete the daily inventories will result in disciplinary action for every EMT who violates the proper procedures. Controlled substances will be secured by exterior vehicle door locks and a locked cabinet which is in the ambulance or supervisor vehicle body interior. Unless otherwise approved by the EMS Clinic Supervisor and Director of Operations, controlled substances should only be assigned to and stored on ambulances which are in active use plus one designated backup ambulance. These controlled substances and amounts are the standard issue per ambulance (supervisors may be issued less): Controlled Substance Ambulance Quantity Jumpkit Quantity Total Issued Stock Replacement Level 1. Diazepam 60 mg 40 mg 100 mg 40 mg 2. Midazolam 40 mg 20 mg 60 mg 20 mg 3. Morphine Sulfate 60 mg 40 mg 100 mg 40 mg 4. Succinylcholine 200 mg 200 mg 400 mg 200 mg (If approved by Medical Director) An EMS Clinic Controlled Substances log will remain locked inside every ambulance or supervisor vehicle controlled substances cabinet. This log will be completed every day for every vehicle carrying controlled substances. The sum of the controlled substances on-hand plus the amounts recorded on the Proof of Use forms should equal total issued stock. Then the minimum and maximum temperature should be recorded. Finally, both EMT s assigned to the unit (or the supervisor) should initial the log. It is the responsibility of the senior EMT (as defined by the lowest personnel number) to notify the EMS Clinic Supervisor, or if unavailable, the Narcotics Officer or Director of Operations, that the replacement level of one or more controlled substances has been reached. This should be done as soon as the inventory is completed. Blank Proof of Use forms will be locked in the controlled substance cabinet. Completed Proof of Use forms and photocopies of any associated Run Reports will be placed in the controlled substance cabinet and inventoried daily with the controlled substances until the Narcotics Officer restocks the vehicle and initials the EMS Clinic Controlled Substances log, accepting possession of and responsibility for the documents. Any ambulance or supervisor vehicle removed from service or otherwise not secured under routine policy shall have the EMS Clinic Controlled Substances log, Proof of Use and Run Reports, and controlled substances removed from that vehicle and transferred to another ambulance or supervisor vehicle. If the transfer extends into subsequent shifts, the EMT s responsible for the storage of the additional controlled substances and related documentation will inventory the additional controlled substances as well. Efforts should be made to segregate the two (or more) inventories and sets of records in order to facilitate returning them to their assigned vehicle when it returns to use. If an ambulance is placed in service for a short period, e.g. for a stand-by, a limited amount (such as a jumpkit quantity) of controlled substances may be transferred from an active ambulance and the controlled substances and documentation returned after the event. Both transactions should be recorded in the EMS Clinic Controlled Substances log of each ambulance. Any remaining controlled substance in a syringe, vial or ampule must be wasted as soon as possible after the completion of a call. The wasting must be witnessed, preferably by another person authorized to administer controlled substances. Any broken / damaged controlled substance container or dispensing unit must be immediately placed in a plastic bag and sealed by date, time and EMTs. The bag will be turned in to the Rocky Mountain EMS Narcotics Officer along with a written explanation as to how the damage occurred. The Narcotics Officer or the Director of Operations may change the keys or combinations to secured areas periodically, even if they have not been breached or compromised. Should any employee, including the Narcotics Officer or Director of Operations, leave Rocky Mountain EMS or loose their New Mexico or company Good Standing, at least one lock protecting each controlled substance storage area should be changed as soon as possible. Page 17

18 IX. Record Keeping The following records will be maintained at Rocky Mountain EMS: A. Invoices for Purchases of Drugs Copies of all invoices for purchases of drugs will be filed separately and maintained chronologically for a period of three years from the invoice date. Invoices for medication purchases will be stored in a locked location. Invoices for all Controlled Substance purchases will be retained in the Narcotics Officer s locked box. B. Medication Transfer Written documentation of all medication transfers to EMS Clinics will be kept by the Pharmacy Purchasing Agent in the same manner and location as the invoices. C. DEA 222 (requisition) Forms All DEA 222 (requisition) forms will be accounted for and retained in a double-locked box requiring two keys, within Rocky Mountain EMS Narcotics Office. D. Expired Medications Disposal The Expired Medications Disposal log is used to track the expired medication inventory until it is properly disposed of. The Expired Medications Disposal log will require as a minimum the following information: 1. Date expired medication added to expired inventory 2. EMT s initials 3. Medication name 4. Date expired 5. Total milligrams added to the expired inventory 6. Date expired medications sent for proper disposal 7. Facility expired medications sent to. E. Expired Medications Used for Training Any expired medications removed from the premises by any person, other than for performance of their scheduled and approved duties, must be signed out with their supervisor in the Expired Medications Used for Training log at each EMS Clinic. Failure to sign out the expired medications will be viewed as both a policy violation and theft. The log book will be used to record: 1. Name of EMT taking expired medications for training 2. Signature of authorizing supervisor 3. Type of medication(s) 4. Date of expiration 5. Lot number 6. Quantity of each medication, in milligrams (or liters for IV solutions) 7. Purpose of training (e.g. Refresher, Class, Public Relations, etc.) 8. Location of training. F. Run Report Run Reports will serve as the documentation for all drug administrations and must be maintained on file for a period of three years. When a Controlled Substance is administered, a copy of the completed Run Report must be attached to the Proof of Use form and retained in the controlled substances locker for inspection, record keeping and restocking. The Run Report shall include at a minimum: 1. Patient Name 2. Date of Administration 3. Run Report # 4. Drug Name(s) 5. Individual Doses and Routes of Drug(s) Administered 6. Signature of Administering EMT. Page 18

19 G. Proof of Use The completed Proof of Use form must accompany a copy of a completed Run Report for every controlled substance administration. Only one controlled substance may be recorded on each Proof of Use form. Therefore, if two or more controlled substances are administered to a patient, two or more Proof of Use forms must be completed and attached to two or more copies of the Run Report. The Proof of Use form will be the basis for obtaining replacement medications. Blank Proof of Use forms will be issued with the replacement controlled substances. Proof of Use forms should receive the same security as controlled substances, so the blank Proof of Use forms will be kept in a locked cabinet with the controlled substances. The Proof of Use form shall be kept in a file chronologically for three years, with a copy of the associated Run Report attached, by the Narcotics Officer. The Proof of Use form and associated Run Report must be segregated into one of two folders. All records of the use of Class (Schedule) II Controlled Substances must be kept in one file, while the records of the use of Class (Schedule) III-V Controlled Substances may be kept together in another file. Both files must be kept locked by the Narcotics Officer. These forms will require as a minimum the following information: 1. Patient Name 2. Date of Administration 3. Run Report # 4. Controlled Substance Name 5. Total Dose of Controlled Substance Administered 6. Total Wasted 7. Printed Name and Signature of Waste Witness, if applicable 8. Printed Name and Signature of Administering EMT H. EMS Clinic Controlled Substances The EMS Clinic Controlled Substances log is to track controlled substances in an approved storage location. It is to be updated no less than daily and each time an EMT assumes responsibility for the controlled substances. In addition, the log should also contain a copy of these policies and procedures. Each approved storage location should have an EMS Clinic Controlled Substances log. The EMS Clinic Controlled Substances logs must be kept in the double-locked ambulance or supervisor vehicle cabinets. The EMS Clinic Controlled Substances log will require as a minimum the following information: 1. Storage Location Identifier (e.g. Ambulance Number) 2. The Inventory or Transaction Date 3. The Responsible EMT Personnel Number and Initials 4. Narcotics Officer Initials 5. Run Report Number 6. For Each Controlled Substance: a) Name of Controlled Substance b) Amount Used (Administered + Wasted) per Proof of Use Form (-) c) Amount Transferred to Another Storage Location (Identify Where) (-) d) Expired Amount Removed (-) e) Amount Issued (or Returned) to Inventory (+) e) Total Controlled Substance Inventory (=) Page 19

20 I. Controlled Substances Inventory The Controlled Substances Inventory log is used by the Narcotics Officer and the Consultant Pharmacist to track the receipt of new inventory, the disbursement of inventory, and the removal of damaged or expired inventory from the controlled substance containers. The Controlled Substances Inventory log will require as a minimum the following information: 1. Storage Location Identifier (e.g. Resupply Locked Container) 2. The Inventory or Transaction Date 3. The Assisting EMT Personnel Number and Initials 4. Narcotics Officer Initials 5. For Each Controlled Substance: a) Name of Controlled Substance b) Amount Transferred to Another Storage Location (Identify Where) (-) c) Expired Amount Removed from Resupply Inventory (-) d) Amount Added (from Pharmacy) or Returned (from Clinic) (+) e) Total Controlled Substance Inventory (=) J. Expired Controlled Substance Disposal The Expired Controlled Substances Disposal log is used to track the expired drug inventory until it can be properly disposed of. The Expired Controlled Substances Disposal log will require as a minimum the following information: 1. Date expired drug added to expired inventory 2. Narcotics Officer s initials 3. Drug name 4. Date expired 5. Total milligrams added to the expired inventory 6. Date expired drugs sent for proper disposal 7. Facility expired drugs sent to. K. Consultant Pharmacist Visitation The Consultant Pharmacist Visitation log is for documenting the visits from the Consultant Pharmacist to each EMS Clinic. The Consultant Pharmacist Visitation log will require as a minimum the following information: 1. Date of visit 2. Consultant Pharmacist s initials 3. EMS Clinic representative s initials 4. Positive Findings 5. Exceptions 6. Activities or Actions required and when. Page 20

21 X. Appendix A. - Sample Record Keeping Forms Page 21

22 A. Expired Medications Disposal See for FORM.Drugs.ExpiredMedicationsDisposal.pdf. Page 22

23 B. Expired Medications Used for Training See for FORM.Drugs.ExpiredMedicationsUsedForTraining.pdf. Page 23

24 C. Proof of Use See for FORM.Drugs.ProofOfUse.pdf. Page 24

25 D. EMS Clinic Controlled Substances See for FORM.Drugs.EMSClinicControlledSubstances.pdf. Page 25

26 E. Controlled Substances Inventory See for FORM.Drugs.ControlledSubstancesInventory.pdf. Page 26

27 F. Expired Controlled Substance Disposal See for FORM.Drugs.ExpiredControlledSubstanceDisposal.pdf. Page 27

28 G. Consultant Pharmacist Visitation See for FORM.Drugs.ConsuntantPharmacistVisitation.pdf. Page 28

29 H. Significant Adverse Drug Event Reporting See for FORM.Drugs.SignificantAdverseDrugEventReporting.pdf. Page 29