EFTA00039312.pdf

O.S. Department of Justice Federal Bureau of Prisons Program &atement OPI: HSD/HPB NUMBER: P6360.01 DATE: 1/15/2005 SUBJECT: Pharmacy Services 1. PURPOSE AND SCOPE. To guide a broad spectrum of operations in the Bureau pharmacy program. 2. PROGRAM OBJECTIVES. The expected results of this program are: An inmate's access to quality, necessary, cost-effective pharmaceutical care will be provided. 3. DIRECTIVES REFERENCED P4100.04 BOP Acquisitions Manual (5/19/04) P4500.04 Trust Fund/Warehouse/Laundry Manual (12/15/95) P6010.02 Health Services Administration (1/15/05) P6013.01 Health Services Quality Improvement Program (1/15/05) P6027.01 Health Care Provider Credential Verification, Privileges, and Practice Agreement Program (1/15/05) P6031.01 Patient Care (1/15/05) P6090.01 Health Information Management (1/15/05) P6340.04 Psychiatric Services (1/15/05) P6541.02 Over-the-Counter Medications (11/17/04) 21 CFR Chapter II, Part 1300 4. STANDARDS REFERENCED a. American Correctional Association 4ah Edition Standards for Adult Correctional Institutions: 4-4378(M), 4-4379(M), 4-4397(M), 4-4401(M), and 4-4402 EFTA00039312

P6360.01 1/15/2005 Page 2 b. American Correctional Association 3rd Edition Standards for Adult Local Detention Facilities: 3-ALDF-4E-17(M), 3-ALDF-4E-12-1(M), 3-ALDF-4E-18, 3-ALDF-4E-39, 3-ALDF-4E-42, and 3-ALDF-4E-43 5. STAFFING. Each institution will maintain a pharmacy directed by a professionally and legally qualified pharmacist and staffed by a sufficient number of trained personnel, in keeping with the size of the institution and the scope of medical services provided. Consultant/contract pharmacists, if used, will provide the Health Services Administrator (HSA) with a written monthly report of pharmacy activities. The HSA will maintain this report on file. 6. STANDARDS OF OPERATION. Each institution will provide space, equipment, and supplies for the professional and administrative functions of the pharmacy to promote patient safety through the proper storage, preparation, dispensing, and administration of drugs. a. The Chief Pharmacist will maintain up-to-date reference materials (computer-accessible or print), specifically: (1) Drug Information reference (e.g. Facts and Comparisons, American Hospital Formulary Service, MicroMedex, etc.); (2) Pharmacology/Pharmacotherapeutics reference (e.g. Goodman/Gilman's, Applied Therapeutics, Harrison's Internal Medicine, Dipiro); (3) Drug Interactions; (4) Drug Information for Patients; and (5) Internet access in the pharmacy. b. Equipment in the pharmacy will include at least: (1) Adequate computer equipment including GroupWise access; • The Chief Pharmacist will be the owner of the institution pharmacy mailbox with proxy rights to a designee for leave purposes. (2) A refrigerator dedicated to and appropriately labeled, for the storage of medications and biologicals; (3) Adequate lighting and ventilation; (4) A sink with running water; EFTA00039313

P6360.01 1/15/2005 Page 3 (5) A system to monitor temperature control that meets compendia/Food and Drug Administration (FDA) standards. Medications are considered distressed and must be discarded if temperature controls are not maintained over a 48 hour time frame. • There must be either daily temperature control documentation or an electronic temperature control system that alerts staff to values outside standards. (6) The Bureau Correctional Institution Pharmacy System (CIPS) computer software system. c. Key Control And Accountability. Only pharmacy staff (pharmacists and pharmacy technicians) and the off-shift duty provider will have keys to the pharmacy. Only the Chief Pharmacist and/or pharmacist-designee(s) will have access to the main stock of controlled substances. • The key ring for the off-shift duty provider will have a key to the pharmacy, but not to the pharmacy storeroom or any key which would allow them access to main stock medications. • Access to the controlled substances sub-stock is limited to the staff member who is responsible for the shift inventory of sub-stock. This staff member will sign the "sub-stock inventory certification sheet" for each shift. • Each institution will develop local procedures for conducting the sub-stock shift inventory. • The use of automated medication administration cabinets (e.g. SureMed, Pyxis) negates the need for shift inventories and proof of use (disposition) sheets for controlled substances, needles, and syringes. 7. PROCEDURES AND OPERATIONAL PRACTICES. The Chief Pharmacist will develop and maintain written procedures and operational practices pertaining to pharmaceutical services, in concert with the medical staff and, as appropriate, with representatives of other disciplines. a. Pharmacy and Therapeutics (P&T) Committee. The Clinical Director (CD) will establish a Pharmacy and Therapeutics (P&T) Committee that will meet at least quarterly. Membership of the P&T Committee will be defined in institution policy and will EFTA00039314

P6360.01 1/15/2005 Page 4 include, at a minimum, representatives from the medical (physician), psychiatric (if available), pharmacy, dental, and nursing staff, as well as Health Services Administration. (1) Meetings. The required minimum agenda for this committee meeting includes: • Determine what drugs on the National Formulary will be available locally; • Determine what strengths and dosage forms will be available locally; • Determine if any drugs on the National Formulary should be restricted further (i.e. designated as "Pill Line"); • Discuss and evaluate errors in prescribing, dispensing, and administering medications in the institution; • Discuss and evaluate Adverse Drug Reactions that occur in the institution; • Approve Drug Use Evaluations (DUEs) used in the institution; • Review DUE data and track problems over time; • Review changes in the National Formulary; • Present drug information; • Recommend that a "Request for Addition to Formulary" be completed for a specific drug; and • Discuss Quality Improvement measures. (2) Minutes. Local P&T Meeting minutes will be made available to all institution health services staff. An electronic copy of the minutes will be sent to the BOP Chief Pharmacist within 30 days of the end of the quarter. Institution P&T Committee Meeting minutes will contain: • Date of meeting; • List of attendees; • Reading and acceptance of previous minutes; • Policy and Procedure Review; • Review of past issues; • Formulary issues; • Investigational drugs; • Drug related research projects; • Monitoring and enforcement activities; • Medication recalls; • Medication errors; • Adverse drug reactions and monitoring; • Quality Improvement activities; • Pharmacy interventions; • Floor stock medications; EFTA00039315

P6360.01 1/15/2005 Page 5 • Drug Utilization Review; • Completed DUES; • DUE proposals; and • Overall and specific pharmaceutical cost trends. b. National Drug Formulary. Each institution will use the Bureau's National Drug Formulary. The National Formulary will be issued following the publication of the National Pharmacy and Therapeutics and Formulary Meeting Minutes. Authorization for use of items not in the national formulary must be requested from the Medical Director through the BOP Chief Pharmacist, using the "Non-Formulary Drug Authorization" form (BP-S802). • The form will be completed and sent to the Chief Pharmacist for each medication order requesting a non-formulary item. • The completed "Non-Formulary Drug Authorization" form will be sent electronically upon receipt of this module from the pharmacy software vendor. • Emergency requests may be made by phone. • The institution pharmacy will maintain a copy of all approved and disapproved non-formulary requests. The original will be filed in section 6 of the Health Record. • Prescribing a formulary medication against a restriction placed on it during the National P&T meeting requires a non-formulary drug authorization unless otherwise stated in the formulary. • A new non-formulary request is not required for intra- system transfers who previously had a non-formulary medication approved. The approved form, located in Section 6 of the Health Record, will be copied and retained in the pharmacy of the current institution. The "Request for Addition to Formulary" form (BP-S804) must be used to request a drug item be added to the National Formulary. This form should be routed through the local P&T Committee and then sent to the BOP Chief Pharmacist. • All requests will be reviewed at the annual National Pharmacy and Therapeutics (P&T) Meeting. EFTA00039316

P6360.01 1/15/2005 Page 6 • Recommendations for formulary deletions, restrictions, etc., must also be submitted on this form. Updates to the National Formulary will be published regularly following National P&T review. Comments and suggestions should be directed to the BOP Chief Pharmacist. Unless indicated as a non-substitutable product (i.e. negative formulary), proprietary (brand) names are used as examples for identification purposes only. All institutions will use the least expensive A/B rated generic when possible. "Dispense as Written" (DAW) orders will be processed as a non-formulary medication order and must include appropriate justification from the prescriber. The institution P&T Committee may use a local formulary based on the National Formulary. • A local formulary can only be more restrictive than the National Formulary. Medications may not be added or restrictions removed. • Local formularies will be made available to all of the institution's health services staff and consultants. c. Training and Education. Pharmacy personnel will participate in relevant education programs, including orientation of new employees, in-service, and outside continuing education. The institution Chief Pharmacist will maintain participation documentation. All health care providers performing pill line, physicians, and pharmacy technicians will complete pharmacy orientation as part of the Health Services Orientation. These staff will have documentation in their credentialing file indicating they have completed the Pharmacy Services Orientation, before beginning work in the Pharmacy. • After completing this orientation, these providers can administer medication doses, or distribute medication orders to inmates, but they cannot dispense medication orders. d. Patient Safety. The institution Chief Pharmacist will ensure there are written procedures in place for patient safety and the control, accountability, and distribution of drugs. These procedures will be reviewed/revised annually, as necessary, and are subject to local negotiation. EFTA00039317

P6360.01 1/15/2005 Page 7 • All drugs will be labeled adequately, including the addition of accessory or cautionary statements, and the expiration date, if appropriate. • Discontinued and outdated drugs and containers with worn, illegible, or missing labels will be returned to the pharmacy for proper disposition. e. Dispensing Medication Orders. Before a medication order is dispensed, a pharmacist will review it prospectively for the following: • drug/drug interactions; • drug/disease interactions; • drug/food interactions; • therapeutic duplications; • over use/under use; • allergies; • therapeutic appropriateness; • appropriate dose; • appropriate route of administration; • duration of therapy; • adverse drug reactions; • proper laboratory monitoring; • appropriate clinical outcomes; and • provide the final check of the medication order to ensure it contains the correct drug. The label will contain the correct directions and patient information pursuant to the medication order. Proper cautionary statements will be included on the vial. Any items which are changed must be documented in the Health Record justifying the need for the change. A practitioner with "independent status" (i.e. physician or pharmacist) must check each medication order before it is dispensed to the patient, ensuring the appropriate prospective review has been completed. • Although dentists have "independent status" they are not allowed to dispense as a majority of medications fall outside the scope of their practice. • Health care providers, such as MLPs, EMTs, nurses, medical technicians, and pharmacy technicians do not have independent status. As such, health care providers will not be assigned Pharmacist duties. EFTA00039318

P6360.01 1/15/2005 Page 8 (1) In order to satisfy these requirements during evenings and weekends, each institution will use a "drug administration cabinet". This may be as sophisticated as a Pyxis Medstation, a Meditrol, or a Documed Station, or as simple as a locked, metal cabinet in the urgent care room, or a designated area in the pharmacy. • This cabinet will contain a limited number and supply of urgently needed drugs that are commonly used after hours in the institution. • These drugs should be in single dose or single day packages but in some cases may be in a three day supply to ensure coverage for weekends and holidays. • These medications will be pre-labeled with standard directions and the name and strength of the drug. (2) When the after-hours health care provider needs to give an inmate a medication, the following options will be used. (a) The inmate may be placed on pill line to be administered single doses of the prescribed medication until a medication order can be dispensed. (b) The health care provider may access the off-shift drug administration cabinet, remove a pre-packaged container, and: • write the inmate's name and number; • the date; • the provider's name; • the expiration date on the package; and • distribute it to the inmate. (c) A medication order will be written for the pharmacist to review retrospectively. (d) A log book will be maintained for the off-shift medication cabinet, to record drugs and doses that are distributed from the cabinet. The log book will contain: • date; • time; EFTA00039319

P6360.01 1/15/2005 Page 9 • inmate name; • register number; • drug; • amount dispensed; and • provider's signature. (e) Where an automated medication distribution system is used as the drug administration cabinet, the distribution/administration report will provide documentation of these occurrences in lieu of the log book. (f) The next working day, the pharmacist will: • enter the order into the pharmacy computer; • review the order retrospectively; • fill the order for the amount written less the dose(s) distributed or administered by the health care provider; • provide a "final check" of the medication order; and • dispense the completed order to the inmate. (g) The practice agreement for MLPs will state specifically they may access the drug administration cabinet and pill line stock. Pill line stock will not be bulk stock containers. Local procedures will specify the system in use at each institution. Pill line stock may include: • unit-dose packaging appropriately labeled; • medication order labeled vials with a seven to 30 day supply of the inmate's medication; • heat-sealed blister cards filled or checked by the pharmacist; and • automated medication administration cabinets (e.g. Pyxis Envoy). (h) Non-pharmacist health care providers will not have access to bulk stock packages that would permit them to actually dispense a medication order or administer doses. • The only exception to the above is described in Section 9.c. EFTA00039320

P6360.01 1/15/2005 Page 10 (3) Inmates transferring to other institutions in/out of the Bureau will have their medications listed on a Medical Summary of Federal Prisoner/Alien in Transit (BP-5659) form, which is delivered in a timely manner to the pharmacy for processing. f. Inspections. The Chief Pharmacist or designee will conduct at least quarterly inspections of all areas where medications are dispensed, administered, or stored. The Chief Pharmacist will maintain a record of quarterly inspections for at least two years. g. Drug Monitoring. The Chief Pharmacist will provide drug monitoring services keeping with each patient's needs, FDA and manufacturer recommendations, and practices recommended through drug information references. 8. DEA CONTROLLED SUBSTANCES a. Applicability of Federal Law. Drug Enforcement Administration (DEA) controlled substances are drugs and drug products under jurisdiction of the Controlled Substances Act of 1970 and are divided into five schedules (I, II, III, IV, and V). • Nothing in this chapter will be construed as authorizing or permitting any person to engage in any act that is not authorized or permitted under existing federal laws, or that does not meet regulations published in the most recent edition of Title 21, Chapter II, of the Code of Federal Regulations (21 CFR, Part 1300 to end). Application for a new or renewed registration number under the Controlled Substances Act includes the following procedures. (1) To obtain an initial DEA registration number, each Chief Pharmacist will complete and forward a New Application for Registration form (DEA-224), to the BOP Chief Pharmacist for certification. • For renewal, Form DEA-224a will be sent to the Central Office, Attn: Chief Pharmacist, BOP, 320 First Street NW, Washington, DC 20853 for certification (there is no cost for new or renewal registration). • The BOP Chief Pharmacist will verify fee exemption status. • The phone number for DEA registration and renewal is 1-800-882-9539. EFTA00039321

P6360.01 1/15/2005 Page 11 (2) "Registration Classification" on Form DEA-224 will be checked as "hospital/clinic." There will be only one official registration number for each Bureau institution. (3) The DEA registration number will be used only for official federal business. (4) The BOP Chief Pharmacist will forward the certified form to the DEA, which will send the new or renewed registration number to the institution. (5) The institution Chief Pharmacist will complete and submit these forms. At institutions without a pharmacist on staff, the HSA will retain this responsibility. b. Responsibility. The Chief Pharmacist will be the responsible authority for all DEA controlled substances. The main stock will be kept locked and stored in a vault or safe to which only the Chief Pharmacist and/or pharmacist designee(s) has the combination or keys. • The HSA will ensure that a duplicate set of keys or combinations of all vaults and safes in the HSU will be sealed in separate envelopes, plainly marked with contents, and filed in the Warden's or security officer's vault or safe. • The Chief Pharmacist or designee must be present for any inventories, inspections, searches, or shakedowns of the storeroom, vaults or safes. • The Chief Pharmacist will ensure that all combinations or locks to main stock vaults or safes storing DEA controlled substances are changed: (1) At transfer, reassignment, or termination of applicable HSU administrative or pharmacy personnel, or (2) When unusual circumstances dictate increased internal control measures. c. Purchasing/Receiving. Purchase orders for controlled substances will be prepared by a designated employee without the knowledge or assistance of inmates. • Controlled substances will be stocked in single-dose packaging when available. EFTA00039322

P6360.01 1/15/2005 Page 12 • The Chief Pharmacist will establish a proper system of security for their receipt. d. Records. The pharmacist will maintain adequate main stock records for each controlled substance. Headings will indicate: • sub-stock unit; • date; • record number/P.O. number; • quantity received; • quantity issued to sub-stock; and • balance on hand. Sub-stock records address the administration of medication on medical/nursing units or on pill line. Sub-stock will have records maintained for proof of use for each DEA controlled substance on hand. Each proof of use sheet will contain: • name and strength of drug; • date issued; • amount issued; • pharmacy control number; • department location (if applicable); • date and amount returned; • date and time of administration; • name and number of inmate; • dosage administered; • corresponding medication order number (CIPS); • signature of person administering; and • balance on hand. The completed proof of use sheet will be returned to the pharmacy, and kept with controlled substances records. At the start of each shift, staff will conduct a complete DEA sub-stock inventory in accordance with local procedures. If the inventory is not correct, staff will attempt to resolve the differences immediately. • The staff member discovering the discrepancy will write a memo to the Chief Pharmacist explaining the event. • If the discrepancy is not resolved, the Chief Pharmacist or designee, will notify the HSA, to ensure that its possible cause(s) is identified. • For institutions using a computer driven medication station, the pharmacist will generate sub-stock discrepancy reports daily. EFTA00039323

P6360.01 1/15/2005 Page 13 • The pharmacist will review and sign these reports and file them with the controlled substance main stock records. The staff member completing the sub-stock inventory certification sheet will return it to the pharmacy. The pharmacist will review and retain the forms for two years prior to the last federally mandated biennial inventory. The change of shift record will include: • date and time of the count; • signature of off going and oncoming staff; and • exact quantity of all controlled substances on hand in that sub-stock at that time. The use of automated medication administration cabinets (e.g. SureMed, Pyxis) negates the necessity for shift inventories, proof of use sheets, and disposition sheets for DEA controlled substances, needles, and syringes. All inventories and listings in the controlled substance records will be exact using tablets, capsules, vials, etc., not in units of bottles or other bulk measurements. When a Chief Pharmacist permanently departs from an institution, he/she and the oncoming Chief Pharmacist (or the acting Chief Pharmacist or the HSA) will complete an immediate inventory of: • main stock controlled substances; • perpetual inventory; • purchase orders; • federal order forms; • receivers; and • invoices. When a newly selected Chief Pharmacist arrives at an institution, he/she and the HSA will complete a similar inventory immediately. Controlled substances in sub-stocks are to be used for administration only. Any dispensing of controlled substances will be accomplished through main stock. e. Security. The DEA, per 21 CFR Part 1301.72, requires safeguarding and accounting for all controlled substances. EFTA00039324

P6360.01 1/15/2005 Page 14 • Main stock controlled substances will be stored in a vault or safe. • Sub-stock controlled substances will be stored in a stationary, approved steel cabinet with two separately key-locked steel doors, a safe with a keyed padlock, or an automated medication cabinet (e.g., SureMed, Pyxis). • When a controlled substance requires refrigeration, the medication must be secured in a locked refrigerator or in a locked drawer within the refrigerator. f. Biennial Inventory. The Controlled Substances Act requires each registrant to make a complete and accurate record of all controlled substance stock on hand every two years. The Chief Pharmacist will complete the biennial inventory on the date mandated by federal law (May 1 of odd-numbered years for institutions registered before May 1, 1971; for institutions registered after May 1, 1971, every two years on the date of the initial inventory). The actual taking of the inventory will not vary more than four days from the biennial inventory date. The Chief Pharmacist will maintain the inventory with the controlled substances records. The inventory record must: (1) List the registrant's name, address, and DEA registration number; (2) Indicate the date and time the inventory is taken (i.e., opening or close of business); (3) Be signed by the person or persons responsible for taking the inventory; (4) Be maintained at the location appearing on the registration certificate for at least two years prior to the last federally mandated inventory; (5) List the name of each controlled substance; (6) List the dosage form and unit strength of each controlled substance; (7) List the number of units in each container of each controlled substance; (8) List the number of each container of each controlled substance; EFTA00039325

P6360.01 1/15/2005 Page 15 (9) Separate Schedule II controlled substances from all others; and (10) Include main stock and all sub-stocks. g. Additional Auditing Requirements. Corrected or amended medication orders may not be processed for controlled substances. A new medication order will be written. Any record keeping error will be corrected by the person who made the error by drawing one line through the error, writing an explanation directly below, and initialing. Errors may not be "blacked out." (1) Theft or Loss. Any incident of theft or loss must be documented by the individual discovering it. A copy of the documentation will be sent to the Chief Pharmacist for review and filing. The Chief Pharmacist will in turn send a memo to the HSA, with a copy to the Warden. The Warden will notify the DEA via DEA Form 106. In accordance with 21 CFR 1301.76(b), the DEA Form 106 must contain: (a) Name and address of the facility; (b) DEA Registration Number; (c) Date of the theft; (d) The fact that the local police department was notified; (e) The type of theft; (f) A list of the symbols or cost code (if any) used by the facility; and (g) A list of the controlled substance(s) missing. The report is made in triplicate. The pharmacy keeps the original copy, and forwards the other two copies to the Regional DEA Office. (2) Controlled Substances Inventory Team. The HSA will designate, in writing, a Health Services supervisor as Chair of the Quarterly Controlled Substances Inventory Team. The Controlled Substances Inventory Team will consist of the chair and at least one other supervisor. • The Chief Pharmacist will be a technical advisor and will be present during the inventory, but may not be a team member. EFTA00039326

P6360.01 1/15/2005 Page 16 • The team will conduct a quarterly count of all main stock controlled substances. • Each team member will then sign the Quarterly Controlled Substance Audit Team Certificate form to be filed with the controlled substance records. A copy of this form does not need to be sent to the BOP Chief Pharmacist. • This count may be done at anytime within the time frame of the quarter. (3) Quarterly Report. At the end of each quarter, the Chief Pharmacist will complete a Quarterly Report for Narcotics and other Controlled Substances inventory form. An electronic copy will be submitted to the BOP Chief Pharmacist within 30 days of the end of the quarter. Each quarterly report will reflect the usage pertaining to the following dates (variance from these dates will not be allowed): • 1s° Quarter = October 1 to December 31 2nd Quarter = January 1 to March 31 3' Quarter = April 1 to June 30 th a Quarter = July 1 to September 30 h. Disposal. The Chief Pharmacist or designee will dispose of controlled substances when necessary, in the manner prescribed by the DEA in 21 CFR 1307.21. This disposal will be accomplished in one of two methods: (1) Request from the Special Agent-in-Charge at the Regional DEA Office, in writing, that permission be granted for the facility to self-dispose of controlled substances; or (2) By transfer to a DEA approved vendor that is certified to dispose of controlled substances. 9. DISPENSING AND ADMINISTRATION a. Definitions I Administration is defined as providing one dose of medication to be applied or consumed immediately. (2) Dispensing is defined as placing multiple doses in a properly labeled container for use over a period of EFTA00039327

P6360.01 1/15/2005 Page 17 time, i.e., filling a medication order. Dispensing is the act of prospectively reviewing the medication order as described in Section 7.e. • Only pharmacists may dispense medications. (3) Distribution is defined as physically handing a filled medication order or OTC (over-the-counter) product to an inmate. Any health care provider who has completed the Pharmacy Training and Orientation Program can distribute or administer medications. b. Prescribing Restrictions. All DEA controlled substances, psychiatric medications, and other medications restricted to "physician use only" by the BOP National Formulary prescribed by a MLP must be countersigned by a staff physician before the medication order may be processed and dispensed. • Local policies will address a process of review in the absence of a full time physician. c. Options During the Absence of the Pharmacist. During periods when a pharmacist is not available (e.g. annual refresher training, CME, etc.) one of the following options will be used: • Contracting (Amend Existing Contract). Incorporate a requirement for pharmacist back-up coverage in the comprehensive medical contract. • Contracting (Establish Separate Contract). Contract with a firm that is capable of providing temporary pharmacist services using open market procurement procedures or existing Federal Supply Schedules (FSS). The Bureau of Prisons Acquisition Policy (BPAP), Part 37, stipulates various requirements relating to using private sector temporary services. The Chief Executive Officer and Regional Director must approve a written justification prior to the acquisition. • Interagency Agreements. Establish an interagency agreement with another government agency (e.g., VA or DOD) to provide pharmacist coverage on an "as needed" basis. • TDY Within the Bureau. Arrange/plan for TDY pharmacist assistance from another Bureau institution with more than one pharmacist. EFTA00039328

P6360.01 1/15/2005 Page 18 • Use PHS Officers from Outside the Bureau. Secure TDY assistance from PHS officers assigned to other government agencies. (The institution needing the pharmacist is responsible for travel, lodging, and per diem.) The BOP Chief Pharmacist can help identify pharmacists in this category or use a PHS inactive reserve corps officer through the BOP-PHS liaison and the PHS Inactive Reserve Coordinator. • Obtain the Services of a Second Pharmacist for larger institutions, particularly those with a satellite camp or FDC. In this situation, pharmacy hours of operation could be extended, vacations, training, and sick leave covered, and quality services can be maintained. Physicians are responsible for diagnosing and treating patients and may only dispense medications in emergency situations. All of the above options must be actively pursued and exhausted. Institutions without the services of a pharmacist for more than three days will contact the Medical Director for guidance. d. Administration. To ensure that medications are actually consumed at pill line, the following procedures will be followed. • The pharmacist or pharmacy technician will prepare a CIPS-generated Medication Administration Record (MAR) sheet for use at pill line. • The person administering the medication will identify each inmate by examining two forms of identification (e.g. photo ID, DOB, registration number, name, etc.) of anyone who arrives to receive medication. • The inmate will swallow the dose of medication and the water while being observed directly by the staff member. • The inmate will then show the empty dose cup and water cup to the person conducting pill line before disposal. • The inmate will be asked to open his/her mouth to show that the medication has not been "cheeked" before leaving the window. • Medications should not be removed from their packaging or labeling until being administered. EFTA00039329

P6360.01 1/15/2005 Page 19 • The administration of medication should be documented in the MAR after it is completed. • When an inmate refuses to take a prescribed pill line or inpatient administered medication, or is a "no-show," that decision will be documented on the MAR. Unless local institution security requirements dictate otherwise, medication dispensing will be in light-resistant, moisture-resistant vials and not plastic bags. e. DEA Controlled Substances. The physician or dentist will initiate or countersign the medication order in the health record which will include: • controlled substance; • DEA number; • strength; • directions; and • duration of therapy. Health Services staff may accept a verbal order, but the physician or dentist must countersign the verbal order within 24 hours or by the close of the next workday. Schedule II controlled substance orders will be valid for 72 hours only (with the exception of detox medications). Schedule III, IV, and V orders may be written for not more than 30 days. • An exception to this requirement is when DEA controlled substances are used for seizure disorders unless otherwise restricted in the BOP National Formulary. Then, medication orders can be written for up to 180 days. • All orders for controlled substances used for hypnotic purposes will be valid for not more than seven days. • All orders for substances (Schedule II - V) used in cases of chronic or terminal illness resulting in unremitting pain not likely to abate in the short term and drugs used for narcolepsy or ADHD will be valid for up to 30 days. • All such orders must be supported by on-going documentation in the health record or inpatient record. EFTA00039330

P6360.01 1/15/2005 Page 20 Accountability. Consistent with 21 CFR, Part 1300, Section 1304.4, the Chief Pharmacist will maintain all records pertaining to purchase, administration, inventory, and audits for at least two years prior to the most recent federal biennial inventory. These records will be kept in a vault, safe, or other secure area. No other items may be stored with DEA controlled substances or their records. • Daily, the pharmacist will generate a CIPS controlled substance report. The report will be maintained with other controlled substance documentation in accordance with DEA regulations. Controlled substances that are damaged, expired, or retrieved from inmates through R/D will be segregated in the safe from other controlled substances. • A separate "Outdate & Confiscate" log will serve as an inventory as long as the medications are in the facility. Ordinarily, all DEA controlled substances taken by mouth will be crushed or administered in liquid form. Pharmacy staff will issue crushed medication in single dose packaging already crushed. f. Restricted Drugs. Restricted drugs are defined as non-DEA controlled drugs that may be abused or those that require Directly Observed Therapy (DOT). Ordering, prescribing, dispensing, and accounting for restricted medications will be in accordance with local and Bureau procedures. The Chief Pharmacist will ensure that medication is not subject to excessive exposure to heat, light, and moisture. All restricted drugs to be taken by mouth will be administered in single doses, and swallowed in the presence of an employee to ensure that the medication is ingested, in accordance with the procedures outlined in Section 9.d. g. Medication Orders. A medication order is any medication a health care practitioner orders for a patient. A health care practitioner will reevaluate each medication order prior to writing a renewal order. EFTA00039331

P6360.01 1/15/2005 Page 21 • All medication orders for chronic care medications are valid for no more than 30 days with five refills totaling 180 days (except for controlled substances unless used for seizure control and other medications specifically restricted by the BOP National Formulary). • When available, the Prescriber Order Entry (POE) will be used to prescribe and process all medication orders. This does not negate the need for the pharmacist to have access to the patient's health record. • Local CIPS data will be backed up each work day. All institutions will have a system(s) in place for ensuring medications not picked up by inmates are logged into the CIPS computer system along with documentation in the inmate health record. The distribution of drug samples within the institution is prohibited. A staff physician will review and cosign orders written by consultant physicians. • The pharmacy department will have a means to identify the signatures of all staff practitioners authorized to prescribe. When an inmate is hospitalized, undergoes surgery, or is transferred from outpatient to inpatient status, or inpatient to outpatient status, current drug orders are to be discontinued automatically. • Local procedures will determine automatic stop orders for drugs in other circumstances. (Stop order dates for DEA controlled substances are addressed in Section 9.e. All medications arriving with inmates through receiving and discharge as new commitments will be given to the Chief Pharmacist or designee. • The Chief Pharmacist will dispose of all DEA controlled substances in a manner prescribed by the DEA. • Pharmacy staff will dispose of all other medications according to local procedures. EFTA00039332

P6360.01 1/15/2005 Page 22 • During the intake screening process, health care staff will determine the need for any medication orders. The Pharmacy will ensure that adequate supplies are on hand prior to disposal. These medications, if appropriate, will be administered on pill line until the pharmacy is able to obtain the drug(s). • An inmate may retain medications prescribed by another Bureau institution if they are not otherwise restricted by policy (e.g. controlled substance). h. Medications for Inmates in Special Housing Units (SHU). Every workday, the Chief Pharmacist will obtain a list of all inmates placed in a SHU during the previous 24 hours (e.g. SENTRY, Operations Lieutenant). Using this list, the pharmacist will issue current medication(s) and ensure the MAR is available for administration of all restricted medications during SHU rounds. • Local procedures will be developed and negotiated to retrieve the inmate's confiscated medication. Health Services staff will determine if the medication should be administered or redistributed to the inmate, if appropriate. • Local policies and procedures will stipulate the medication(s) and amount (number of days) an inmate in SHU may maintain in their cell. • Under no circumstances will medication be locked up with the inmate's property, thrown in "hot trash," or distributed or administered to an inmate by anyone other than a health care provider. i. Psychiatric Medication. Refer to Program Statement on Psychiatric Services for procedures on obtaining informed consent, non-compliance, and patient counseling. Informed consent will be obtained and documented before dispensing or administering psychiatric medication. Ordinarily, the prescribing physician will be responsible for obtaining the informed consent. • Psychiatric medication for a current DSM Axis III diagnosis does not require an informed consent (e.g. amitriptyline for trigeminal neuralgia or headache disorder), but does require routine patient counseling procedures. EFTA00039333

P6360.01 1/15/2005 Page 23 (1) Continuity of Care. All institutions will have a system(s) in place for ensuring continuity of care for all inmates receiving psychiatric treatment. This system will include: • Review of psychiatric history prior to incarceration; • Review of psychiatric treatment prior to intra-system transfer; • Monitoring compliance with psychiatric medications; and • Maintaining documented informed consent in the health record. (2) Non-Compliance. All institutions will have a system(s) in place for timely notification of noncompliance. Such notification will be made to the CD and other relevant mental health staff, such as the Chief of Psychology, treating staff, or contract psychiatrist. • At Psychiatric Referral Centers (PRCs), the treating psychiatrist and Chief Psychiatrist will be informed of any noncompliance issues. j. OTC Medications. See the Program Statement on Over-the- Counter Medications. k. Outdated Medications. The Chief Pharmacist will maintain adequate records and procedures to ensure that outdated medications are not used. • Expired medications must be stored separately. • Expiration dates will be the last day of the month unless otherwise specified. • Local procedures will be written for disposal of expired medications. When multi-dose vials of injectable medications are opened, the expiration date will be regarded as the manufacturer's expiration date as long as aseptic technique is used, unless otherwise stated by the manufacturer in the package labeling. 1. Hormone Maintenance Drugs. Refer to the Program Statement on Patient Care. m. Investigational/Experimental Drugs. Refer to the Program Statement on Patient Care. EFTA00039334

P6360.01 1/15/2005 Page 24 MEDICATION ERRORS . Definitions (1) A medication error is a dose of medication that deviates from the physician's order as written in the inmate's health record or from the expected standard of care, or institution policy and procedures. • With the exception of errors of omission, the patient must actually receive the drug for the incident to be classified as a medication error. (2) A potential error is a mistake in prescribing, dispensing, or planned medication administration that is detected and corrected through intervention, by another health care provider or the inmate, before actual medication administration. • Documentation of instances in which an individual has prevented the occurrence of a medication error will help identify system weaknesses and reinforce the importance of multiple checks in the medication use system. b. Types of Medication Errors. Based on the American Society of Health Systems Pharmacists (ASHP) Guidelines, medication errors will be categorized as follows: • Prescribing Error. An incorrect drug selection (based on indicators, contraindications, known allergies, existing drug therapy, and other factors), dose, dosage form, quantity, route, concentration, rates of administration, or instructions for using a drug product ordered or authorized by a physician (or other legitimate prescriber). This includes illegible medication orders that lead to errors that reach the patient. • Omission Error. The failure to administer an ordered dose to a patient before the next scheduled dose, if any. • Wrong Time Error. Administration of a medication outside a predefined time interval from its scheduled administration time. EFTA00039335

P6360.01 1/15/2005 Page 25 • Unauthorized Drug Error. Administration to the patient of medication not authorized by a legitimate prescriber for the patient. • Improper Dose Error. Administration to the patient of a dose that is greater than or less than the amount ordered by the prescriber or administration of duplicate doses to the inmate. • Wrong Dosage Form Error. Administration to the patient of a medication in a different dosage form than ordered by the prescriber (e.g., intramuscular instead of intravenous). • Wrong Drug-Preparation Error. Medication incorrectly formulated or manipulated before administration. • Wrong Administration Technique Error. Inappropriate procedure or improper technique in the administration of a drug. • Deteriorated Drug Error. Administration of a medication that has expired or for which the physical or chemical dosage form integrity has been compromised. • Monitoring Error. Failure to review a prescribed regimen for appropriateness and detection of problems, or, failure to use appropriate clinical or laboratory data for adequate assessment of patient response to prescribed therapy. • Compliance Error. Inappropriate patient behavior regarding adherence to a prescribed medication regimen. • Other Medication Errors. Any medication error that does not fall into one of the above predefined categories. c. Applicability and Procedures. Listed below are the required elements of the institution's Medication Error Program. The Pharmacy Technical Reference Manual (TRM) should be used as a reference for the institution program. • The monitoring and reporting of medication errors will be conducted in a blame-free manner and focus primarily on systems and continuous quality improvement activities rather than on individuals. EFTA00039336