Policy and Issuance Patient Age Group: ( ) N/A ( ) All Ages ( ) Newborns ( X) Pediatric ( X) Adult

Transcription

1 Applies To: Ambulatory Services Responsible Department: Ambulatory Admin Revised: 02/2018 Title: Controlled Substance Prescription Processing, Security Policy and Issuance Patient Age Group: ( ) N/A ( ) All Ages ( ) Newborns ( X) Pediatric ( X) Adult POLICY STATEMENT The purpose of this policy is to set forth standards for the processing, security and issuance of schedule I through V controlled substance prescriptions in the ambulatory setting. UNMH ensures secure handling and storage of all controlled substance prescriptions. All controlled substance prescriptions written in the ambulatory setting and not given directly to the patient at the time of visit shall be secured. Said prescriptions shall be issued only by authorized personnel and with proper authorization and identification of the person picking up the prescription. APPLICABILITY All UNM Hospital Clinics POLICY AUTHORITY Hospitals CEO s, Administrator, Ambulatory Services REFERENCES New Mexico Board of Pharmacy (BOP), (2014) [ NMAC - Rp 16 NMAC 19.20(1), ; A, ] New Mexico Medical Board, NMAC-N,1120/03;A,4/3/05, A,11/30/16. AREAS OF RESPONSIBILITY 1. The Medical Director and Unit Director are responsible for oversight of the adherence to the policy by all parties involved. 2. For patients age 14 years and older receiving controlled substances for pain management greater than 4 days the process shall be the same as for adults. a. PMP's will be reviewed every 3 months for patients 14 years of age and older on stimulant therapy for ADHD. Controlled substance agreements and urine drug screens are not required. b. Pediatric patients, regardless of age, on controlled substances for chronic conditions such as spasticity or seizures will have PMP reviewed every 3 months. Controlled substance agreements and urine drug screens are not required. 3. The prescribing provider is responsible for completing the Controlled Medicine Agreement on all patients receiving opioids for chronic pain for a period of 3 months or longer. The Controlled Medicine Agreement should be updated if medication is changed, additional medications are added, initiating provider changes or as deemed necessary by the clinician. Clinicians are encouraged to use the Controlled Medicine Agreement for other high risk medications such as benzodiazepines and stimulants. 4. The clinician will enter in the medication profile and in the problem list that the patient is on a Controlled Medicine Agreement. Page 1 of 9

2 5. The Controlled Medicine Agreement will be copied for the controlled substance folder and the original sent to scanning under Urgent Clinical documents utilizing the appropriate HIM cover sheet. 6. Patients on Controlled Medicine Agreements will have a Prescription Monitoring Program (PMP) checked at least every 3 months. 7. Clinicians are solely responsible for reviewing the PMP and must document their review of the report in the patient s Health Maintenance Module. 8. The clinician may designate printing of PMP to another staff person, according to the rules set forth by the Board of Pharmacy for assignment of proxy. 9. Clinicians shall review the PMP for the preceding 12 months before prescribing controlled substances for a period of greater than 4 days, or if there is a gap in prescribing for 30 days or more. 10. When available, clinicians shall review PMP reports for other states. 11. Upon review of a PMP report for a patient, the clinician shall identify, document and be aware of a patient currently receiving: a. opioids from multiple prescribers; b. opioids and benzodiazepines concurrently; c. opioids for more than 12 consecutive weeks; d. more than one controlled substance analgesic; e. opioids totaling more than 90 morphine milligram equivalents per day; or f. exhibiting potential for abuse or misuse of opioids and other controlled substances, such as overutilization, requests to fill early, requests for specific opioids, requests to pay cash when insurance is available, receiving opioids from multiple pharmacies. 12. A clinician does not have to obtain and review a PMP report before prescribing, ordering, or dispensing a controlled substance in schedule II, III, IV or V: a. for a period of four days or less; or b. to a patient in a nursing facility; or c. to a patient in hospice care; or d. when prescribing, dispensing or administering of: I. testosterone; or II. pregabalin; or lacosamide; or ezogabine; or III. stimulant therapy for pediatric patients less than age 14. (DO and Advanced RN practitioners cannot exclude these medications per their Title 16 Regulations) 13. A urine drug screen (UDM) will be obtained and reviewed by the prescribing clinician at the time of the initiation of an opioid and at least every 6 months while on therapy or sooner as deemed appropriate by the clinical circumstances and by the prescribing clinician. Clinicians are encouraged to utilize urine drug screens for other high risk medications such as benzodiazepines and stimulants at least every 6 months. Staff should obtain a urine drug screen a minimum of 6 months for all patients on a Controlled Medicine Agreement. 14. A patient who cannot void due to a medical condition or refuse to void, consider serum toxicology as an option. Page 2 of 9

3 15. If clinic utilizes the Controlled Substance Folder, it will contain at a minimum the current Controlled Medicine Agreement, Controlled Substance Prescription sign-out log, and a copy of patient s identification. Include proxy designee authorization form and identification of proxy (if applicable). 16. Retain controlled substance patient sign out log in for current and prior year, all other logs may be disposed of per current Records Management Retention and Disposal Policy. 17. The Unit Director or his/her designee is responsible for assisting in the resolution of problems which occur in the enforcement of the policy and for any needed exceptions, in conjunction with the attending physician. Attending physicians are responsible for education and oversight of the residents and fellows in completion of their responsibilities regarding controlled substance prescriptions. 18. If controlled substances are discontinued, the clinician is responsible for documenting rationale for this decision in the EHR and communicating the plan with the patient. Discontinuation of controlled substance agreement signed notation removed from Problem List, Controlled Substance Agreement removed from Medication List, and communication to staff for breakdown of folder. An additional option, Controlled Substance Agreement Terminated can be added to the Problem List. 19. Designated clinic staff is responsible for ensuring the patient or designee is given the controlled substance prescriptions according to the distribution schedule. When writing more than one prescription for future fill dates each prescription shall indicate a specific start date. 20. Designated clinic staff is responsible for establishing a working system to assure the patient s prescription needs are communicated to the clinicians and teams in a timely manner. 21. Clinicians are responsible for refilling controlled prescriptions at least 5 business days prior to next start date, unless the patient has an upcoming appointment and can get the prescription at the visit. 22. Clinicians can write for and/or release to patient up to 3 months of prescriptions with appropriate start date if medically indicated. 23. Patients on a Controlled Medication Agreement should be scheduled for reevaluation of pain and course of treatment at least every 6 months. Advanced RN practitioners should see the patient for reevaluation every 3 months per their Title 16 regulations. 24. The clinic staff is responsible for assisting in the management of the controlled substance prescriptions system. This activity includes: a. Reviewing of Controlled Substance Folders; b. Verifying accuracy of controlled substance prescriptions; c. Assisting in the maintenance of controlled substance records. d. Noting next PCP appointment on sign out log and assisting with scheduling if not seen at least every 6 months e. Securing of the Controlled Substance Folder in a locked cabinet until the prescription is picked up by the patient or authorized designee. 25. The designated staff member issuing the prescription to the patient or designee is responsible for: a. Assuring the patient or designee has the correct identification, documenting verification ; b. Issuing the prescription to patient or authorized designee; Page 3 of 9

4 c. Documenting sign out date and patient or designee signature on the sign out log. IMPLEMENTATION PROCEDURES 1. Who may pick up controlled substance prescriptions? a. Patients receiving controlled substance prescriptions are encouraged to pick up the prescriptions themselves however, the patient may designate up to 3 separate persons who may also pick up the prescriptions, using the Controlled Medicine Prescription Pick-up Designee Form (attachment A). The designee must be prearranged in writing by the patient. The form will be offered to the patient at the time the Controlled Medicine Agreement is signed and/or prescription written. The patient and/or designee must present a government issued or other photo ID in order to pick up the prescription. b. Patients who are in the post-operative period often need assistance picking up their prescriptions. If this is the case, both the patient s ID as well as the designee s will be required for issuance. c. Patients with extenuating circumstances who present without an ID will be evaluated on an individual basis by the Unit Director or designee to determine whether a controlled substance prescription will be issued. 2. Pick-up procedure: a. Patient or designee presents ID to the designated staff member. b. Designated staff member will verify the ID, collect the recipient s signature, initial the log and issue the prescription. 3. Security of controlled substance prescriptions: a. Controlled substance prescriptions MUST be secured in a locked area at all times. b. Each clinic shall have a defined process for staff to manage access to the locked area. 4. All controlled substance prescriptions that are not given to the patient by clinician will be logged in and out of the locked area using the approved log. Logs are patient specific. All clinics will utilize the approved log to document the following elements: a. prescription written b. prescription signed in. Requires initials of one licensed staff member c. of next appointment with PCP (every 6 months) d. patient may pick up prescription e. Number of prescriptions to release to patient (prescriptions with consecutive start dates) f. Rx paper control number g. Patient name and label h. Drug prescribed (including drug, dose and quantity) i. UDM (Urine Drug Screen) is required at least every 6 months or more frequently as determined by the clinician j. ID verified k. Signature of person picking up prescription l. prescription sign out m. Issuer s initials 5. Any controlled substance prescription not associated with a Controlled Medicine Agreement and not picked up within 7 days of being written must be destroyed by shredding in the presence of two witnesses. Both witnesses must be licensed and sign the accompanying log and attest to the prescription s destruction. 6. Any prescription associated with a Controlled Medicine Agreement and not picked up within 30 days past the fill date must be destroyed by shredding in the presence of two witnesses. Both witnesses must be licensed and sign the accompanying log and attest to the prescription s destruction. Page 4 of 9

5 7. After normal clinic business hours, a lock box will be used by providers to secure controlled substance prescriptions pending issuance. Printed controlled substance prescriptions must not be left unsecured anywhere. MAIL ORDER PROCESS 1. Schedule III, IV, and V controlled substance prescriptions can be mailed to patients via registered mail with signature upon receipt. 2. Schedule II controlled substance prescriptions cannot be mailed. DEFINITIONS Chronic Pain means pain that persists for longer than three consecutive months. This does not include pain associated with a terminal condition. Controlled Substance - a drug or substance listed in Schedules I through V of the Controlled Substances Act or rules adopted. There are five established schedules of controlled substances to be known as Schedules I, II, III, IV and V. Schedule placement is dependent on potential for abuse, medical uses (none, restricted or acceptable), and/or severity of psychological and physical dependence. Benzodiazepines: alprazolam, clobazam, clonazepam, chlorazepate, chlordiazepoxide, diazepam, lorazepam, oxazepam, temazepam Opioids: codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, tramadol Stimulants: Amphetamines (Adderall, Dexedrine, Vyvanse), Methylphenidate (Ritalin, Concerta, Methylin) Any Government issued or other photo ID including but not limited to: Driver s licenses Photo ID issued by the Dept. of Transportation or privately owned affiliates Military photo ID School ID SUMMARY OF CHANGES Added Changes related to BOP Management of pain and other conditions with controlled substances NMAC updated 11/30/16. Added pediatric management with controlled substances. Added Changes related to BOP Control Substance laws NMAC Areas of Responsibility: added prescriber responsibilities, medical director for oversight, urine drug screens every 6 months, PMP review every 6 months. Deleted specialty care record maintenance. Under #4: Removed Brief Pain Index (BPI) requirement. Added BOP definition of chronic pain. Removed requirement to record patient/designee driver s license or ID number. Added mail order process. Added PMP, UDM checked columns and reformatted attachment C: Controlled Substance Prescription Sign-out log Replaces Controlled Substance Prescription Processing Security & Issuance, 8/10/2010. Replaced medication with substance except on patient documents to have language agreement with regulatory bodies. Removed key sign out log and requirements for key sign out. Page 5 of 9

6 RESOURCES/TRAINING Training will occur by clinic Unit Director, RN Supervisors, and Office Supervisors. Ongoing staff training and new hires will be addressed by staff in the orientation process. Attending physicians will train advanced practice providers and resident staff. DOCUMENT APPROVAL & TRACKING Item Contact Approval Owner ED, Primary Care & ED, Specialty Care Louis Achusim, ED Pharmacy, Cynthia Lujan, Ambulatory Pharmacy, Consultant(s) Richard D Angio, Pharm D, BCPS, Director of Clinical Pharmacy, Alisha Parada, FACP, MD Internal Medicine, George Comerci MD Committee(s) Ambulatory Management Council, Medical Executive Committee, UNMH PPG Committee Y Nursing Officer Sheena Ferguson, Chief Nursing Officer Y Medical Officer Associate Dean for Clinical Affairs Y Official Approver Kori Beech, Administrator Ambulatory Services Y Official Signature Kori Beech (on Sharepoint) : 3/20/2018 Effective 3/20/2018 ATTACHMENTS A. Controlled Medicine Prescription Pick-up Designee Form B. Controlled Substance Prescription Sign-out log Page 6 of 9

7 Attachment A CONTROLLED MEDICINE AGREEMENT PRESCRIPTION PICK-UP DESIGNEE FORM I,, hereby identify the following individuals to act as my designee for the purpose of picking up my controlled medicine prescriptions. I understand that I may designate up to 3 people, 18 years of age or older. I also understand and agree that if anyone other than the 3 documented designees comes to the clinic for picking up controlled medicine prescriptions, they will not be given the prescriptions and will be asked to leave the clinic. I may withdraw permission at any time during clinic hours in person. The form will be marked as withdrawn and this person will no longer be allowed to pick-up controlled medicine prescriptions. A new form will be initiated at this time, to ensure accuracy of authorized persons. I agree to follow the terms of the Controlled Medicine Agreement (if applicable) and come into the clinic to pick up my prescriptions when a random urine specimen has been ordered. I also understand that my prescriptions will not be given to the designee when a urine specimen is required. Authorized Persons: Name Relationship Name Relationship Name Patient / Witness Signature: Relationship Patient Signature Witness Signature Patient Sticker Page 7 of 9

8 Attachment C: Controlled Substance RX Sign Out Log Log-in Procedure: 1. Enter date and initials of licensed personnel verifying log in of prescription. 2. Check last UDM, PMP date (due Q6 mo.). 4. Enter drug information. Sign out procedure: 1. Enter date of pick up. 2. Verify ID 3. Obtain signature of person picking up RX. 4. log. Destruction of RX Procedure: 1. Prescriptions should be destroyed if not picked up 30 days after fill date. 2. Enter date in sign out columns & write destroyed in name/sig column. 3. Enter initials of two licensed personnel verifying destruction of RX. Keep last and current year logs in folder Written Log In s UDM Q PCP 6 Months Appoint Circle one and initial when (Q 6mo) completed MAY Pick Up Number of months RX to release RX Control Number Drug (drug, dose & quantity) ID Verified Signature of person picking up RX Signed Out Staff s s Signature s Signature s Signature Page 8 of 9 PATIENT LABEL

9 s Signature s Signature s Signature Effective : 3/23/2017 Page 9 of 9 PATIENT LABEL