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Medication Safety: Sampling Identify the Safety Risk The use of samples leads to prescribing and use which may not be the most effective or efficient for patients: sample drugs represent potential risks as pharmacists are eliminated from the dispensing process. There is an increased risk of documentation errors, use of non-formulary drugs, outdated medications and drug interactions. It is recommended that clinics eliminate sampling of all prescription pharmaceutical products supplied by manufacturers. Clinics choosing to stock and dispense sample medications must follow safe medication practices consistent with JCAHO standards. HealthPartners identifies sampling of prescription pharmaceuticals as inconsistent with the six aims of quality, primarily due to concerns for patient safety. · Create labels for the samples and attach them prior to giving to the patient. · Provide educational handouts on each drug within the sample space and make sure adequate copies are available and easily obtainable for each sample. Place a copy of the education piece given to the patient in the log and in the medical record. · Make pharmaceutical representatives aware of your protocol and their roles in ensuring safe sample distribution. Consider a sign in/out log for pharmaceutical representatives to use during every visit. Enter a name, medication(s) delivered, lot numbers, quantity and expiration date. Clinic staff who remove samples should sign them out on the same log. · Assessments for hidden caches of samples within physician offices or exam rooms should be done regularly, perhaps every quarter to every six months. Suggestions for Improvement · Eliminate sampling. · Review or implement a sample drug protocol in your clinic. Form a work group to assess the protocol (providers, nurses, medical assistants). · · (Gunderson 22) Sample Forms Figure 8: Pharmaceutical Sampling Policy Implement protocol. If sampling is not yet eliminated, set a future date and goal for elimination. Other Resources - Links Determine which samples should be maintained, where they should be maintained and the level of security necessary. All samples should be locked in a secure place. · Eliminate drug samples from exam rooms and doctors’ offices and store them in a secure location in clear view of a nursing station. · Create a written documentation and monitoring system for samples and include duplicate written instructions to keep in the · · AHRQ: Data Collection · AHRQ: Selecting a Sample · Harvard Education/Patient Safety Strategies Works Cited The Ambulatory Patient Safety Toolkit is the copyrighted work of the Gunderson Lutheran Medical Center, developed for the Safety Collaborative for Outpatient Environment (SCOPE) Project, funded by the American Medical Group Association (AMGA) in 2003. Portions of the Ambulatory Patient Safety Toolkit are reproduced with permission of the Gunderson Lutheran Medical Center and will be referenced whenever used in this toolkit. log and to give to the patient. Include expiration date and drug details. Track the total starting number of samples per drug, the number distributed with the date distributed and the number of sample drugs remaining with a date. HealthPartners | Ambulatory Patient Safety Toolkit 6 Medication Safety: Therapeutic Monitoring Identify the Safety Risk Certain medications require annual monitoring due to increased risk of harm from drug side-effects and drug toxicity. Therapeutic monitoring of patients is essential to prevent avoidable adverse drug events related to specific high-risk drugs (e.g., Coumadin and Amiodarone monitoring). Ongoing provider monitoring will include the Health Plan Employer Data and Information Set (HEDIS) measure Annual Monitoring for Patients on Persistent Medications. Performance information will provide meaningful and useful information to clinicians for therapeutic decision making and management. This measure now includes - ACE inhibitors and combination products - ARBs and combination products - Digoxin - Diuretics - Anticonvulsants Suggestions for Improvement · Create or implement a protocol on therapeutic monitoring for patients on persistent medications. · Incorporate the protocol to align with your use of the HealthPartners registry monitoring system. Access to the registry data is available through healthpartners.com. · Form a work group to assess the policy and include providers, nurses, and medical assistants. · Evaluate HEDIS results for this measure. · Review the HealthPartners measurement summary of the HEDIS Annual Monitoring for Patients on Persistent Medications (Figure 9). Sample Forms Figure 9: HealthPartners Clinical Indicator: Annual Monitoring for Persistent Medications Figure 10: HPMG&C Amiodarone policy (example only – HealthPartners health plan does not endorse HealthPartners Commercial HEDIS Rates Annual Monitoring for Patients on Persistent Medications: 2011 2012 Results Results 2010 DOS 2011 DOS ACE Inhibitors or ARBs 84.25% 84.1% Digoxin 84.49% 86.5% Diuretics 84.84% 84.4% Anticonvulsants 71.59% 69.6% Total 84.2% 83.9% this specific protocol) Other Resources -Links · American Association for Clinical Chemistry · FDA Safety and Drugs Works Cited The Ambulatory Patient Safety Toolkit is the copyrighted work of the Gunderson Lutheran Medical Center, developed for the Safety Collaborative for Outpatient Environment (SCOPE) Project, funded by the American Medical Group Association (AMGA) in 2003. Portions of the Ambulatory Patient Safety Toolkit are reproduced with permission of the Gunderson Lutheran Medical Center and will be referenced whenever used in this toolkit. HealthPartners | Ambulatory Patient Safety Toolkit 7 Medication Safety: Do Not Use Abbreviations · Identify the Safety Risk (Gunderson 10) HealthPartners and Regions Hospital are part of a metro area-wide effort to eliminate unsafe prescribing practices and reduce medication errors. Our efforts are part of the Safest in America (SIA) and JCAHO initiatives to eliminate dangerous abbreviations, acronyms and symbols. We provide this information to encourage the elimination of unsafe prescribing practices in all clinical settings. Sample Forms Figure 11: Medication Discharge Sheet Figure 12: Clinic Pharmacy Prescription Sheet Figure 13: ISMP List of Error Prone Abbreviations Other Resources - Links Suggestions for Improvement · Establish a protocol and eliminate all hand written prescriptions. · Perform an audit of prescriptions written in the clinic on 20 records to monitor for compliance with your clinic’s protocol. If 100 percent compliance is not seen, share results with providers and set goals for improvement. Member interviews and pharmacy reports are additional resources to use in monitoring and validation checks. · HealthPartners Policy and Attachments: Do Not Use Error Prone Abbreviations · Harvard Education/Patient Safety Strategies · Joint Commission Do Not Use List Works Cited The Ambulatory Patient Safety Toolkit is the copyrighted work of the Gunderson Lutheran Medical Center, developed for the Safety Collaborative for Outpatient Environment (SCOPE) Project, funded by the American Medical Group Association (AMGA) in 2003. Portions of the Ambulatory Patient Safety Toolkit are reproduced with permission of the Gunderson Lutheran Medical Center and will be referenced whenever used in this toolkit. · Continue to monitor for compliance. Consider additional initiatives with providers if 100 percent compliance is not seen. · Obtain examples of poor prescription writing from pharmacies and have them block out the names to protect patient confidentiality. You can show these to providers as examples. · Assess prescription writing practice by assigning a nurse to review all of the prescriptions written in a day as patients exit the clinics (Figure 11). · Collaborate with a pharmacy and provide them with standards and a chart to track a clinic’s prescriptions. Ask them to assess every prescription for one week or one month and give feedback. Review at least 20 prescriptions. Generate provider specific data and give feedback with suggestions for improvement. We suggest monitoring every 3 to 6 months once standards are in place. · If a medical practice has an electronic medical record, an electronic prescription writing platform may already be in place. Create a monitoring system (through EMR data reports) to check for accuracy. HealthPartners | Ambulatory Patient Safety Toolkit 8 Medication Safety: Medication Reconciliation review their medication list tool and compare it to the list in the chart (Figure 15). Identify the Safety Risk Medication reconciliation is the process of comparing a patient's medication orders to all of the medications that the patient has been taking. This reconciliation is done to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions. It should be done at every transition of care in which new medications are ordered or existing orders are rewritten. HEDIS instituted a new measure in 2009 (2008 data year) regarding “Medication Reconciliation PostDischarge”. The specification from CMS requires that medication reconciliation occur within 30 days postdischarge from an inpatient facility. Even though this measure has a restricted population, the standard of care should apply to any member with complex medical care needs on multiple medications (Gunderson 4) · Develop scripting messages around medication reconciliation to promote consistency, assure a high level of service, help staff to handle difficult situations, and set clear expectations. Scripts also promote a verbal commitment and compel people to follow through. Commitment influences behavior and may increase compliance. · Try to include “Elements of Influence” in the scripting (Cialdini) - Suggestions for Improvement · · · Establish a spot in the medical record where the current medication list is stored. This should be accessed upon opening a medical record or on the encounter page in an electronic medical record (EMR). Implement a process for obtaining and documenting a complete list of each patient’s medications upon admission to clinic and hospital. Establish a communication method (fax or EMR) where an inpatient facility provides the patient’s current list of medications upon discharge from an inpatient facility. Develop a tool for the member to use and carry with them to bring for each visit to keep medications up to date (Figure 15). · Consider a pre-visit or a post visit phone call to review medications with the patient. · Establish an audit review system to check accuracy in the data provided between inpatient and outpatient systems. (i.e., do a comparative audit of 20 records each quarter). · Assign a nurse/medical assistant to choose 20 patients over several days each quarter to - Reciprocity exits: give before receiving Commitment: greater consistency Social proof: ‘everyone’s doing it’ Recognition of legitimate authority Scarcity of opportunity: makes us want it more Provide a reason for the request It helps if they know and like you · Include a statement in scripting about how the patient’s provider gives recognition of legitimate authority. For example, “Dr. X wants to know your medications and would like you to know them too”. · Consider personal reciprocity in your scripts - be nice to people and they will feel obligated to be nice to you. Use words like “will you please…”, and always give the patient the opportunity to respond. · Once you have developed the medication reconciliation script with input from front line staff, test it in a small group. Make changes as needed. HealthPartners | Ambulatory Patient Safety Toolkit 9 Medication Reconciliation Sample Forms Figure 14: Medication List and Allergy List Accuracy Test Figure 15: My Medicine List Tool Figure 16: Sample Pill Box Distribution Policy Figure 17: HEDIS 2010: Medication Reconciliation Other Resources - Links · AHRQ · NIH Seniors and Medication · Joint Commission Alert/Medication Reconciliation · Joint Commission Alert/Anticoagulants Works Cited Cialdini Robert B., Influence: The Psychology of Persuasion (New York: William Morrow and Company), 1984, 1993. Note: supported by ICSI The Ambulatory Patient Safety Toolkit is the copyrighted work of the Gunderson Lutheran Medical Center, developed for the Safety Collaborative for Outpatient Environment (SCOPE) Project, funded by the American Medical Group Association (AMGA) in 2003. Portions of the Ambulatory Patient Safety Toolkit are reproduced with permission of the Gunderson Lutheran Medical Center and will be referenced whenever used in this toolkit. HealthPartners | Ambulatory Patient Safety Toolkit 10 Medication Safety: Protocols for Use of Hazardous Drugs Identify the Safety Risk Coumadin, Amiodarone, Insulin and controlled substances are the most common potentially hazardous drugs prescribed in the outpatient setting. Research demonstrates that standardized prescribing of these medications may improve safety. Protocols for a Coumadin prescription, along with standing orders for INR determination are available through multiple sources, including the product manufacturer. Clinics should have standing orders that allow nurses to renew or alter doses based on lab test results or changes in the patient’s circumstances. Standing orders that require regular assessment of INR should also be in place. Sliding scales for Insulin have improved care by allowing those at the actual point of contact with the patient to modify medication orders based on point of care testing. Protocols, guidelines and standing orders should be developed to allow nurses to provide the greatest level of patient care in the safest manner. Use of chronic opioid therapy for chronic nonmalignant pain (CNMP) has increased substantially; therefore effective management is considered a major problem in both primary care and out-patient medicine. It presents a major challenge for both the patient and health care provider. Opioids are associated with potentially serious harms, including adverse effects and outcomes related to the abuse potential. Suggestions for Improvement · Establish protocols for the use of hazardous drugs in your clinic. Make sure that the protocol addresses standardized daily dosing algorithms, monitoring and management plans. Include details on lock up and sign out procedures for certain medications. · Form an improvement group of providers to review the current methods of providing safe care to patients who are on anticoagulants and for patients who are diabetic. Evaluate the results and implement change if improvement is needed. · Update protocols and standing orders as needed to be in compliance with guidelines. · Perform an audit of 20 records to compare with each of the medication guidelines and orders in your protocol(s). Review compliance outcomes with your clinic’s quality team. · Continue to monitor for compliance against the clinic protocols for hazardous drugs. · If you use an electronic medical record, and as computers become more common in exam rooms, incorporate the guidelines, standing orders and other safety tools into the work flow of patient care. · Review the HPMG & C Amiodarone policy (Figure 10) (Gunderson 25) Sample Forms Figure 10: Amiodarone Monitoring Policy Does your clinic have protocols in place and standing orders for Coumadin, Amiodarone, Insulin and controlled substances (CS)? Are CS locked in a safe place with a sign out procedure? How complete are the protocols for hazardous drugs? Have you compared them to guidelines? How well are the protocols and standing orders followed in your clinic? Figure 18: Warfarin Therapy Protocol Figure 19: Provider Letter: Controlled Medication Figure 20: Exceptional Use Program HealthPartners | Ambulatory Patient Safety Toolkit 11 Protocols for Use of Hazardous Drugs Other Resources - Links · ICSI Guidelines: Antithrombotic Therapy Supplement, Diabetes · AHRQ · AAEM Position · OSHA list of hazardous medications · MN Pharmacy Board: Prescription Monitoring Program · Clinical Guidelines for Opioid Therapyhttp://download.journals.elsevierhealth.c om/pdfs/journals/15265900/PIIS1526590008008316.pdf Works Cited The Ambulatory Patient Safety Toolkit is the copyrighted work of the Gunderson Lutheran Medical Center, developed for the Safety Collaborative for Outpatient Environment (SCOPE) Project, funded by the American Medical Group Association (AMGA) in 2003. Portions of the Ambulatory Patient Safety Toolkit are reproduced with permission of the Gunderson Lutheran Medical Center and will be referenced whenever used in this toolkit HealthPartners | Ambulatory Patient Safety Toolkit 12 Medication Safety: Antibiotic Prescribing Identify the Safety Risk Sample Forms To reduce risk, monitor the overuse (multiple dispensing) of antibiotics and/or inappropriate use of antibiotics. Some potent antibiotics, while very effective against certain types of infections, have a high risk for toxicity. This risk is even greater with patients who have impaired renal function. Figure 21: Pearl of Knowledge: Acute Bronchitis When using antibiotics that have a high risk of toxicity, such as aminoglycosides and vancomycin, use protocols or other standardized dosing guidelines to assist prescribers in selecting appropriate doses based on clinical condition and renal function. Ongoing provider monitoring completed by Minnesota Community Measurement includes the following measures: Other Resources - Links · Appropriate Treatment for Children with Upper Respiratory Infections · Appropriate Testing for Children with Pharyngitis · Avoidance of Antibiotic Treatment in Adults with Acute Bronchitis · AHRQ Antibiotic Report · AAP Guidelines · Pediatric Abstract article · NY Dept of Health · ICSI Guideline Respiratory Illness · HealthPartners and Flu Shots Performance information will provide meaningful and useful information to clinicians for therapeutic decision making and management. Suggestions for Improvement · Develop a protocol to follow with antibiotic prescriptions. · Review the Minnesota Community Measurement provider monitoring for the measures listed above. · Use existing guidelines and protocols with appropriate criteria to meet before ordering an antibiotic. If possible, implement these guidelines into your EMR or patient work flow to use when prescribing antibiotics. · Consider creating a tool with criteria to check for quarterly chart audits on children and adults who have received antibiotics. Review results and try to identify if greater action is needed for appropriate use of antibiotics. HealthPartners | Ambulatory Patient Safety Toolkit 13 Medication Safety: Prescription Refills Identify the Safety Risk All providers will have a process for prescription refills to insure patients receive approvals in a timely and safe manner. Providers should develop a standing order policy and procedure regarding frequent medication refills. Research studies have proven the effectiveness of automated or electronic prescription writing programs to reduce errors in handwritten prescriptions. Examples of electronic prescription tools include palm pilots, intranet, electronic formulary, or online drug information database. EPrescribing allows for clear, concise, and legible instructions. HealthPartners encourages the adoption of E-prescribing in all clinical settings. Electronic prescribing can offer enhanced safety features for patients. Prescriptions are legible, and pharmacists can eliminate worries over misunderstood phone messages for a prescription or refill of a medication consisting of a sound alike name. Online prescription refills is another technology that can reduce errors and improve prescription processing efficiency. With online refills, patients can submit their refill requests electronically. Suggestions for Improvement · Convert your refill process into an e-prescribing system. · Create or implement a protocol on prescription refills for your clinic. This could be incorporated into an electronic medical record or an on-line refill system. · · Integrate the clinic protocol parameters into the assessment. Complete a random audit of 20 members with refills. Use the assessment sheet to track audit results. · Form a work group to assess the audit data (providers, nurses, medical assistants). Compare data to the policy parameters. If parameters were not met, evaluate if changes are needed in the policy. · Review and analyze the other data results. Is there an area where improvement is needed in the refill process? If so, have the work group develop an improvement initiative. · Once the initiative is implemented, evaluate quarterly until improvement is seen, or until other changes are made. · Continue to monitor for compliance with your clinic’s prescription refill protocol on an ongoing basis. · Consider implementing a refill reminder system to increase compliance. (Gunderson 34) Sample Forms Figure 22: Medication Refill (Behavioral Health) Standing Order policy. Figure 23: Medication Refill (Non-Behavioral Health) Standing Order policy. These policies are for reference only. Please review and adapt to make your own policy. Create an assessment sheet for auditing purposes. The assessment could include how the refill was provided, by what provider, who picked up the order, what pharmacy refilled the prescription, did the member need to be seen prior to the refill, and, if so, was the member seen? HealthPartners | Ambulatory Patient Safety Toolkit 14 Prescription Refills Other Resources - Links · AHRQ Article · e Health Initiative-Electronic Prescribing · NPSF Pharmacy Safety Consumer Fact Sheet Works Cited The Ambulatory Patient Safety Toolkit is the copyrighted work of the Gunderson Lutheran Medical Center, developed for the Safety Collaborative for Outpatient Environment (SCOPE) Project, funded by the American Medical Group Association (AMGA) in 2003. Portions of the Ambulatory Patient Safety Toolkit are reproduced with permission of the Gunderson Lutheran Medical Center and will be referenced whenever used in this toolkit HealthPartners | Ambulatory Patient Safety Toolkit 15 Medication Safety: Generic Prescribing Identify the Safety Risk Generics are a safe, effective alternative to many branded drugs. Generic drugs, because they have been on the market for a long time, have well known side effects and a longstanding record making them a more reliable and safe choice compared to newly introduced drugs. Prescription drugs can be a costly medical expense, especially for older people and those who are chronically ill. However, each state has a law that lets pharmacists substitute less expensive generic drugs for many brand-name products. Generic drugs are less expensive because generic manufacturers don't have the investment costs that the developer of a new drug has. New drugs are developed under patent protection. The patent protects the investment - including research, development, marketing and promotion by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don't have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Generic Drug Use in Primary Care and in Specialty Care are Clinical Indicator measures. The rate represents the percentage of all prescriptions filled with generic drugs for HealthPartners members with a drug benefit. For prescriptions filled the first half of 2011, the generic drug use rate for primary care is 81.7 percent. The generic drug use rate for specialty care ranged from 75.7 percent to 93.6 percent. · Identify patients and target to move them toward generic conversion from the brand name drug to the equivalent generic. · Perform an audit to identify patients who are on the drugs and run a cost summary of the past year. The summary should include cost of the drug and cost to the patient. · Create a generic education sheet and describe the medication conversion you are focusing on. · Identify 20 patients and flag their medical record to focus on conversion to a generic equivalent on their next office visit. · Make a follow-up phone call to the patient three to five days after the prescription was written for conversion. · Submit a questionnaire to check on satisfaction and send to patients two months after conversion. Review the satisfaction outcomes and determine if you can broaden the conversion program. · Re-run the cost analysis data in three to six months and again in one year and compare that to the brand cost data. Other Resources - Links · FDA Generics · HealthPartners.com/formulary · HealthPartners Clinical Indicators Report Suggestions for Improvement · Create a generic drug protocol in your clinic. · Choose one common brand name drug to focus on in your clinic. HealthPartners | Ambulatory Patient Safety Toolkit 16 FIGURE 8 HealthPartners/GHI Subject Pharmaceutical Sampling Key words Drug samples, pharmaceutical sampling, drug dispensing, pharmacy Category Environment of Care, Work Service (EC) Attachments Yes No Number GHI EC HPMG Ops 03 Effective Date 11/09 Manual HealthPartners Medical Group and Clinic Operations Manual Last Review Date 11/09 Issued By HPMG Pharmacy Committee; HPMG Medical Council Next Review Date 11/12 Applicable HPMG and clinic staff Origination Date 11/90 Retired Date Review Responsibility HPMG Pharmacy Committee; HPMG Medical Council and clinic operations Contact Dir. of Pharmacy I. PURPOSE To ensure patient safety as it relates to drug samples. II. POLICY Individual clinics or care units wishing to continue or initiate storage and distribution of free drug samples must apply to the HPMG Pharmacy Committee for pharmaceutical sampling privileges. Clinics must provide a detailed written plan on how they will comply with outlined procedures. Applications will be reviewed and approved or denied by the Pharmacy Committee. The Chief of Professional Services or Department Head will be responsible for the implementation and compliance of the Pharmaceutical Sampling Policy for his/her clinic and/or department. III. PROCEDURE(S) Proposal Guidelines: 1. Identify the requesting physician and chief or department head (approving MD). 2. Identify the designated coordinator (oversight for daily operations). 3. Identify the clinic location and specific sample location within the clinic. 4. Describe the purpose for providing pharmaceutical samples. 5. Describe how the proposed sampling practice will meet with the following principles for drug dispensing/distribution: Safety—the use of pharmaceutical services/agents within our systems will not pose a threat to our patients/members. Effective—patients/members will receive the most appropriate pharmaceutical interventions, avoiding underuse and overuse. Equitable—pharmaceutical services/agents will be consistent and fair to all patients/member. Individual personal characteristics will only guide pursuit of optimal outcomes. Patient Centered—pharmaceutical services/agents will be respectful of individual patient/member needs, preferences and values. Timely—the delivery of pharmaceutical services/agents will eliminate unnecessary waits and @[email protected] 1 of 3 FIGURE 8 harmful delays to both patients/members and providers. Efficiency—pharmaceutical services/agents will be guided by wise stewardship of resources, avoiding waste and inefficiencies. Develop written proposed procedures that are consistent with JCAHO Requirements on Sampling (see below) and includes these at a minimum: A list of proposed sample medications. Identify responsible individual “designated coordinator” that will meet with Pharmaceutical representatives, maintain sample inventory, and implement policy. Provide approach of how to ensure proper storage and disposal of samples, secure locked storage, limited accessibility, and method to dispose of outdated, damaged, recalled drugs. Note: All out dated or discontinued samples are considered hazardous waste and must be placed in the black hazardous waste container in the clinic. Provide procedure for proper dispensing of drugs, including clarification on who will dispense, labeling of samples, written patient information, documentation in patient’s medical record. Provide approach to assure quality control of pharmaceuticals, including process to manage drug recalls, process to check for expired drugs, and process for self-audit. Process for documenting lot number and expiration dates will be in a log book. Specify exact location (s) where samples will be stored. Designate person in clinic responsible to assure overall compliance with sample program within this clinic. Outline communication plan to notify all staff of sample procedures and expectations. Forward all applications to the Chair of the HPMG Pharmacy Committee. Any additions/deletions/changes to the Sample Plan and the list of drugs must be provided to the Pharmacy Committee quarterly. Application renewal must be requested annually. 6. 7. 8. 9. JCAHO DRUG SAMPLES REFERENCE There is a system for the control, accountability, and security of all drug samples throughout the organization. This process should adhere to FDA and other laws and regulations regarding distribution of drug samples, and should be consistent with other organization policies and procedures for medication use. The drug samples are properly stored. Storage of drug samples are under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and safety according to manufacturer’s specifications and law and regulation (e.g. USP and OSHA requirements). Products that require refrigeration should be refrigerated. Stored drug samples should be organized to allow for easy retrieval yet segregated to prevent medication errors. All samples of the same drug should be stored together in the same sample storage area, although multiple storage areas for samples are allowed. Although not required, it is recommended that samples be stored by therapeutic class rather than alphabetically, since the chances of a serious dispensing error are less likely. In any case, throwing all samples of various types into a drawer is not acceptable. Also, OSHA requires that cytotoxic agents (e.g. cancer chemotherapy, gancyclovir, etc) be stored separately from non-cytotoxic drugs with special labeling of the storage area. Drug sample storage areas are routinely inspected. This inspection checks for expired and deteriorated sample medications; samples stored in the wrong place; drugs which can no longer be identified for name, strength, and expiration dates; and other medications that do not belong there. Drug samples for prescription or legend drugs are secure. Drug samples should be kept in an area where unauthorized access is not allowed or which is under constant supervision or surveillance (e.g. behind the receptionist, in a rocked room, in the physician’s private office etc.). If in areas not under constant surveillance by staff, and where visitors and patients are allowed (e.g. patient examination rooms) the drug samples must be locked in a drawer or cabinet. @[email protected] 2 of 3 FIGURE 8 Drug samples for prescription drugs are labeled and dispensed according to the same standardized method that the organization uses for non-sample prescription medications. The organization’s policies and procedures for dispensing medications to ambulatory patients should be followed. If the same system is not used, the same objectives and outcomes should be achieved. Handwritten and fill-in preprinted prescription labels are acceptable. If the organization normally provides written patient information with dispensed medications, the same should occur for samples. Documentation requirements for sample drugs should be the same as other non-sample medications ordered and dispensed by the clinic or organization. At a minimum, all documentation requirements for prescription drugs in the medical record (e.g. inclusion on the summary list, progress notes, etc.) should be followed. There is no requirement to conduct a perpetual documented inventory of non-controlled substance sample medications, unless such a process is desired or required by organization policy and procedure. There must be an effective recall mechanism for drug samples. There is no requirement to have a log of all dispensed sample medications and lot numbers, unless such a process is desired or required by organization policy and procedure (including pharmacy procedures for outpatient prescriptions). As long as all recalled medications can be quickly retrieved from patients and removed from stock, the process is acceptable. Thus, reviewing each patient’s chart to determine who received the drug under recall, and calling all patients to remove the drug (irrespective of lot number) or verifying with the patient the lot number on the package at the time of calling the patient, is an acceptable method. Many organizations, however, do not want to alarm patients who did not receive the affected lot of drugs, and thus maintain a log of dispensed medications by lot number or document that lot number in the medical record. That way, only patients who received the affected lot of the recalled drug are contacted. However, this is not a JCAHO requirement. IV. DEFINITIONS n/a V. COMPLIANCE Failure to comply with this policy or the procedures may result in disciplinary action, up to and including termination. VI. ATTACHMENTS n/a VII. OTHER RESOURCES Internal HealthPartners Safety Toolkit at Healthpartners.com/quality Other VIII. JCAHO Standard, TX.3.17 APPROVAL(S) Nancy McClure Senior VP, HPMG and Clinics IX. ENDORSEMENT @[email protected] Brian Rank, MD Medical Director, HMPG and Clinics n/a 3 of 3 FIGURE 9 Improving Quality of Care: Annual Monitoring for Persistent Medications The Opportunity: • • • Patient safety is highly important, especially for patients at increased risk of adverse drug events from long-term medication use. Appropriate monitoring of drug therapy remains a significant issue to guide therapeutic decision making and provides largely unmet opportunities for improvement in care for patients on persistent medications. Persistent use of these drugs warrants monitoring and follow-up by the prescribing physician to assess for side-effects and adjust drug dosage/therapeutic decisions accordingly. The drugs included in this measure also have more deleterious effects in the elderly. o Angiotensin Converting Enzyme (ACE) inhibitors o Angiotensin Receptor Blockers (ARBs) o Digoxin o Diuretics o Anticonvulsants (phenobarbital, carbamazepine, phenytoin, divalproex sodium and valproic acid) The Measure: • • Annual monitoring for select therapeutic agents has been established as a quality measure of the Healthcare Effectiveness and Information Set (HEDIS). This measure assesses whether persistent users of medications receive timely monitoring to prevent potential harms associated with persistent use of these drugs: o At least one serum potassium (K+) and either a serum creatinine (SCr) or a blood urea nitrogen (BUN) for prescribed ACE inhibitors, ARBs, digoxin and diuretics. o At least one drug concentration level monitoring test for prescribed anticonvulstants (phenobarbital, carbamazepine, phenytoin, divalproex sodium and valproic acid). The Approach: • • • Provide comparative performance information on therapeutic monitoring for ACE/ARBs and Diuretics for primary care and specialty providers. Publish annual comparative performance information in Clinical Indicators Report. Identify patients on CAD, Diabetes, Heart Failure and Hypertension registries that have been prescribed ACE/ARBs or Diuretics and have not received annual monitoring. Resources: • HealthPartners Ambulatory Patient Toolkit can be found at: www.healthpartners.com/quality Who to Contact: For Clinical Questions: Terry Crowson, MD at 952-883-7109 For Measurement Questions: Rene’ Fisher at 952-883-5113 July 2008RULJLQDO -DQXDU\UHYLVHG Annual Monitoring for Patients on Persistent Medications - Angiotensin Converting Enzyme (ACE) and Angiotensin Receptor Blockers (ARB) FIGURE Primary Care 2010 9 Description The percentage of members 18 years and older who received at least a 180-day supply of ambulatory medication therapy for ACE and/or ARB during the measurement year and had at least one therapeutic monitoring event for the therapeutic agent in the measurement year. Performance Measurement Period January 1, 2009 through December 31, 2009 Methodology Administrative Ages Included 18 and older Products All products Continuous Enrollment The measurement year Sample Size Full population Attribution The medical group of the prescribing provider’s primary location of the most recent script that qualified the member for the denominator. Includes only scripts written by providers with the reported specialty. Sample Method NA Frequency Annually Reported Provider eligibility is based on a minimum of 30 unique members for the measurement year. All provider groups are included in the overall rate calculation. Measures Annual Monitoring Rate Denominator Members 18 and older as of December 31st of the measurement year on persistent medications – defined as members who received at least a 180 days’ supply of ambulatory medication in the measurement year (NCQA's web site at www.ncqa.org provides a list of NDC codes for ACE/ARBS). To determine continuity of treatment during the 365 day period, sum the number of treatment days (days supply from all the scripts filled during the year) for a total of 180 days. NOTE: Members may switch therapy between ACE and ARB during the measurement year and have the days supply for those medications count toward the total 180 days supply (i.e. a member who received 90 days of ACE inhibitors and 90 days of ARB’s meets the denominator definition.) Numerator Number of members with at least one serum potassium (cpt 80047, 80048, 80050, 80051, 80053, 80069, 84132) and either a serum creatinine (cpt 80047, 80048, 80050, 80053, 80069, 82565, 82575) or a blood urea nitrogen therapeutic monitoring test (cpt 80047, 80048, 80050, 80053, 80069, 84520, 84525) in the measurement year. NOTE: The tests do not need to occur on the same service date, only within the measurement year. Rate Calculations Number of members with the required therapeutic monitoring test / Total number of members on persistent medications within each medical group. HealthPartners Internal Technical Specification Primary Care FIGURE 9 Annual Monitoring for Patients on Persistent Medications - Diuretics Primary Care 2010 Description The percentage of members 18 years and older who received at least a 180-day supply of ambulatory medication therapy for diuretics during the measurement year and had at least one therapeutic monitoring event for the therapeutic agent in the measurement year. Performance Measurement Period January 1, 2009 through December 31, 2009 Methodology Administrative Ages Included 18 and older Products All Products Continuous Enrollment The measurement year Sample Size Full population Attribution The medical group of the prescribing provider’s primary location of the most recent script that qualified the member for the denominator. Includes only scripts written by providers with the reported specialty. Sample Method NA Frequency Annually Reported Provider eligibility is based on a minimum of 30 unique members for the measurement year. All provider groups are included in the overall rate calculation. Measures Annual Monitoring Rate Denominator Members 18 and older as of December 31st of the measurement year on persistent medications – defined as members who received at least a 180 days supply of ambulatory medication in the measurement year (NCQA's web site at www.ncqa.org provides a list of NDC codes for Diuretics). To determine continuity of treatment during the 365 day period, sum the number of treatment days (days’ supply from all the scripts filled during the year) for a total of 180 days. Numerator Number of members with at least one serum potassium (cpt 80047, 80048, 80050, 80051, 80053, 80069, 84132) and either a serum creatinine (cpt 80047, 80048, 80050, 80053, 80069, 82565, 82575) or a blood urea nitrogen therapeutic monitoring test (cpt 80047, 80048, 80050, 80053, 80069, 84520, 84525) in the measurement year. NOTE: The tests do not need to occur on the same service date, only within the measurement year. Rate Calculations Number of members with the required therapeutic monitoring test / Total number of members on persistent medications within each medical group. HealthPartners Internal Technical Specification Primary Care FIGURE 10 HealthPartners/GHI Subject Amiodarone (low-dose) Monitoring Policy Key words Amiodarone, toxicity Attachments Yes No Number GHI - PC - HP Nursing xx Category Provision of Care (PC) Manual HP Nursing Issued By HPMG Nursing Administration Applicable Ambulatory clinic RN, LPN, CMA and RMA staff Review Responsibility HPMG&C MTM Pharmacists, Nursing Practice Committee, HPMG Cardiology Effective Date 10/10 Last Review Date 10/10 Next Review Date 10/13 Origination Date 3/02 Retired Date Contact Clinical Pharmacy Program Manager I. PURPOSE To provide a uniform and consistent policy for monitoring patients on low-dose amiodarone. Amiodarone is a medication typically used for the treatment of heart arrhythmias. II. POLICY All HPMG patients on amiodarone should be monitored per this amiodarone policy (these are minimum expectations). RNs can use the Medication Refill Standing Order to order monitoring lab tests and procedures. If laboratory or other monitoring tests are abnormal, the RN will consult the prescribing physician. The physician assumes responsibility for monitoring until the values are within established parameters. This policy focuses on monitoring low-dose amiodarone (< 400mg/ day) - additional monitoring may be recommended during initiation and for higher doses of amiodarone. Unless otherwise agreed upon, the prescribing physician is responsible for this monitoring. If other arrangements are made for follow-up, this plan should be documented in the medical record. III. PROCEDURE(S) Amiodarone toxicities that need monitoring are: 1. Pulmonary toxicity Pulmonary function tests should be completed at baseline, including diffusion capacity. Chest x-rays should be done at baseline and yearly. Patients should be referred to prescribing physician for additional testing if symptoms of pulmonary toxicity occur (unexplained cough, dyspnea). 2. Liver toxicity AST (SGOT) or ALT (SGPT) should be monitored at baseline and every 6 months. 3. Thyroid abnormalities Thyroid function, using TSH and free T4, should be assessed at baseline, 3 months and every 6 months. Refer to the prescribing physician for more frequent monitoring if thyroid abnormalities are amiodarone monitoring 10-10.doc Page 1 of 3 FIGURE 10 suspected. 4. Ophthalmic side effects An ophthalmologic exam, including funduscopy and slit-lamp examination should be completed at baseline. Refer to an ophthalmologist if the patient has with visual changes. 5. Cardiac effects EKGs should be done at baseline and yearly. Refer to the cardiologist if the patient has new-onset arrhythmias or bradycardia. 6. Renal function Serum creatinine, Bun and electrolytes (K, Mg, Na) should be done at baseline. 7. Interacting medications In the event of amiodarone dose changes, monitoring protocols should be followed for interacting medications like warfarin (Coumadin) and digoxin. Referrals may be made to anticoagulation nurse, cardiologist, or prescribing physician. Caution should also be used with simvastatin (increased risk of myopathy), sildenafil (increased levels), cyclosporine (increased levels), antiarrhythmic medications (additive effects), quinolones (increased risk of arrhythmias), antidepressants (increased risk of arrhythmias), and grapefruit (inhibits conversion of amiodarone to the active metabolite). IV. DEFINITIONS V. COMPLIANCE Failure to comply with this policy or the procedures may result in disciplinary action, up to and including termination. VI. ATTACHMENTS Amiodarone Monitoring worksheet VII. OTHER RESOURCES Internal – Medication Refill Standing Order Other VIII. APPROVAL(S) Robert H. VanWhy, Sr. Vice President, Primary Care and Practice Development IX. ENDORSEMENT Nursing Practice Committee, HPMG Cardiology amiodarone monitoring 10-10.doc Page 2 of 3 Updated October 2010 Amiodarone Monitoring FIGURE 10 Patient Name _____________________________ Primary MD ______________________________ Amiodarone start date ______________________ ID#: ____________________________________ Primary Clinic ____________________________ Coumadin Y/N ____________________________ DOB ____________________________________ Cardiologist ______________________________ Digoxin Y/N ______________________________ Patient Phone ____________________________ Cardiology Clinic Location ___________________ ________________________________________ ________________________________________ Open boxes are required monitoring, shaded boxes indicate routine monitoring is not required but can be completed if clinically indicated. Initial 3 months 6 months 12 months 18 months 24 months 2 ½ years 3 years Date Followed by * Symptoms ** TSH and T4(free) AST (SGOT) ALT (SGPT) Chest x-rays EKG Eye exam *** PFTS **** Creatinine***** BUN***** K ***** Na ***** Mg ***** * Monitoring values are not needed if amiodarone monitoring is done by consultants outside of HPMG. This can be noted with a check mark or the name of the group assuming responsibility for monitoring. ** Patients should be asked about symptoms, both for efficacy and for side effects. Specific questions should address respiratory symptoms, vision problems, thyroid abnormalities, cardiac symptoms, and GI pain. *** Patients should be evaluated for visual impairment/symptoms and considered for annual eye exams. No monitoring values are needed on this sheet. **** Pulmonary function testing is recommended at baseline and for otherwise unexplained dyspnea, particularly in patient with underlying lung disease, and for abnormalities on chest x- rays. ***** Serum creatinine and electrolytes are recommended at baseline and as necessary. Providers also need to be aware of multiple drug interactions, which include warfarin (Coumadin), and digoxin. This policy focuses on monitoring low-dose amiodarone (<= 400mg/ day) - additional monitoring may be recommended during initiation and for higher doses of amiodarone. amiodarone monitoring 10-10.doc Page 3 of 3 FIGURE 11 Reproduced with permission of the Gunderson Lutheran Medical Center, LaCross, WI 2006 FIGURE 12 Clinic Pharmacy Prescriptions Rx #s_____________________________ Dates of Rx’s__________________________ # of Rx’s written by prescriber ________________ Recommendations (Number of compliance failures) Totals Use ball point pen-no felt tip Medication name Dose Route of administration Frequency of use Purpose of medication Signature and printed name of prescriber Printed name is almost never present DEA number on Controlled Substance Rx’s Write out “unit” – no abbreviations Write mg, mcg, ml, %, etc. No drug name abbreviations Avoid Latin abbreviations (QD, QID, PRN, BID, TID, etc.) Use metric measurements Faxed Rx’s corrected before transmittal Reproduced with permission of the Gunderson Lutheran Medical Center, LaCross, WI 2006 Institute for Safe Medication Practices FIGURE 13 ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations T he abbreviations, symbols, and dose designations found in this table have been reported to ISMP through the ISMP Medication Error Reporting Program (MERP) as being frequently misinterpreted and involved in harmful medication errors. They should NEVER be used when communicating medical information. This includes internal communications, telephone/verbal prescriptions, computer-generated labels, labels for drug storage bins, medication administration records, as well as pharmacy and prescriber computer order entry screens. Abbreviations µg AD, AS, AU OD, OS, OU BT cc D/C IJ IN HS hs IU** o.d. or OD OJ Per os q.d. or QD** Injection Intranasal Half-strength At bedtime, hours of sleep International unit Once daily Orange juice By mouth, orally Every day qhs qn q.o.d. or QOD** Nightly at bedtime Nightly or at bedtime Every other day q1d q6PM, etc. SC, SQ, sub q Daily Every evening at 6 PM Subcutaneous ss SSRI SSI i/d TIW or tiw (also BIW or biw) U or u** UD © ISMP 2010 Intended Meaning Microgram Right ear, left ear, each ear Right eye, left eye, each eye Bedtime Cubic centimeters Discharge or discontinue Sliding scale (insulin) or ½ (apothecary) Sliding scale regular insulin The Joint Commission has established a National Patient Safety Goal that specifies that certain abbreviations must appear on an accredited organization's “do-not-use” list; we have highlighted these items with a double asterisk (**). However, we hope that you will consider others beyond the minimum Joint Commission requirements. By using and promoting safe practices and by educating one another about hazards, we can better protect our patients. Misinterpretation Mistaken as “mg” Mistaken as OD, OS, OU (right eye, left eye, each eye) Mistaken as AD, AS, AU (right ear, left ear, each ear) Mistaken as “BID” (twice daily) Mistaken as “u” (units) Premature discontinuation of medications if D/C (intended to mean “discharge”) has been misinterpreted as “discontinued” when followed by a list of discharge medications Mistaken as “IV” or “intrajugular” Mistaken as “IM” or “IV” Mistaken as bedtime Mistaken as half-strength Mistaken as IV (intravenous) or 10 (ten) Mistaken as “right eye” (OD-oculus dexter), leading to oral liquid medications administered in the eye Mistaken as OD or OS (right or left eye); drugs meant to be diluted in orange juice may be given in the eye The “os” can be mistaken as “left eye” (OS-oculus sinister) Mistaken as q.i.d., especially if the period after the “q” or the tail of the “q” is misunderstood as an “i” Mistaken as “qhr” or every hour Mistaken as “qh” (every hour) Mistaken as “q.d.” (daily) or “q.i.d. (four times daily) if the “o” is poorly written Mistaken as q.i.d. (four times daily) Mistaken as every 6 hours SC mistaken as SL (sublingual); SQ mistaken as “5 every;” the “q” in “sub q” has been mistaken as “every” (e.g., a heparin dose ordered “sub q 2 hours before surgery” misunderstood as every 2 hours before surgery) Mistaken as “55” Correction Use “mcg” Use “right ear,” “left ear,” or “each ear” Use “right eye,” “left eye,” or “each eye” Use “bedtime” Use “mL” Use “discharge” and “discontinue” Use “injection” Use “intranasal” or “NAS” Use “half-strength” or “bedtime” Use “units” Use “daily” Use "orange juice" Use “PO,” “by mouth,” or “orally” Use “daily” Use “nightly” Use “nightly” or “at bedtime” Use “every other day” Use “daily” Use “daily at 6 PM” or “6 PM daily” Use “subcut” or “subcutaneously” Mistaken as selective-serotonin reuptake inhibitor Spell out “sliding scale;” use “one-half” or “½” Spell out “sliding scale (insulin)” Sliding scale insulin One daily TIW: 3 times a week BIW: 2 times a week Mistaken as Strong Solution of Iodine (Lugol's) Mistaken as “tid” TIW mistaken as “3 times a day” or “twice in a week” BIW mistaken ad “2 times a day” Use “1 daily” Use “3 times weekly” Use “2 times weekly” Unit Mistaken as the number 0 or 4, causing a 10-fold overdose or greater (e.g., 4U seen as “40” or 4u seen as “44”); mistaken as “cc” so dose given in volume instead of units (e.g., 4u seen as 4cc) Use “unit” As directed (“ut dictum”) Mistaken as unit dose (e.g., diltiazem 125 mg IV infusion “UD” misinterpreted as meaning to give the entire infusion as a unit [bolus] dose) Use “as directed” Dose Designations Intended Meaning and Other Information Trailing zero after 1 mg decimal point (e.g., 1.0 mg)** No leading zero before 0.5 mg a decimal point (e.g., .5 mg)** Misinterpretation Correction Mistaken as 10 mg if the decimal point is not seen Do not use trailing zeros for doses expressed in whole numbers Mistaken as 5 mg if the decimal point is not seen Use zero before a decimal point when the dose is less than a whole unit Institute for Safe Medication Practices FIGURE 13 ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations Dose Designations and Other Information Drug name and dose run together (especially problematic for drug names that end in “l” such as Inderal40 mg; Tegretol300 mg) Numerical dose and unit of measure run together (e.g., 10mg, 100mL) Tegretol 300 mg Mistaken as Tegretol 1300 mg 10 mg The “m” is sometimes mistaken as a zero or two zeros, risking a 10- to 100-fold overdose Place adequate space between the dose and unit of measure The period is unnecessary and could be mistaken as the number 1 if written poorly Use mg, mL, etc. without a terminal period 100000 has been mistaken as 10,000 or 1,000,000; 1000000 has been mistaken as 100,000 Use commas for dosing units at or above 1,000, or use words such as 100 "thousand" or 1 "million" to improve readability Intended Meaning vidarabine zidovudine (Retrovir) Compazine (prochlorperazine) Demerol-Phenergan-Thorazine Diluted tincture of opium, or deodorized tincture of opium (Paregoric) hydrochloric acid or hydrochloride hydrocortisone hydrochlorothiazide magnesium sulfate morphine sulfate methotrexate procainamide propylthiouracil Tylenol with codeine No. 3 triamcinolone TNKase zinc sulfate Intended Meaning nitroglycerin infusion norfloxacin intravenous vancomycin Intended Meaning Dram Misinterpretation Mistaken as cytarabine (ARA C) Mistaken as azathioprine or aztreonam Mistaken as chlorpromazine Mistaken as diphtheria-pertussis-tetanus (vaccine) Mistaken as tincture of opium Correction Use complete drug name Use complete drug name Use complete drug name Use complete drug name Use complete drug name Mistaken as potassium chloride (The “H” is misinterpreted as “K”) Mistaken as hydrochlorothiazide Mistaken as hydrocortisone (seen as HCT250 mg) Mistaken as morphine sulfate Mistaken as magnesium sulfate Mistaken as mitoxantrone Mistaken as patient controlled analgesia Mistaken as mercaptopurine Mistaken as liothyronine Mistaken as tetracaine, Adrenalin, cocaine Mistaken as “TPA” Mistaken as morphine sulfate Misinterpretation Mistaken as sodium nitroprusside infusion Mistaken as Norflex Mistaken as Invanz Misinterpretation Symbol for dram mistaken as “3” Use complete drug name unless expressed as a salt of a drug Use complete drug name Use complete drug name Use complete drug name Use complete drug name Use complete drug name Use complete drug name Use complete drug name Use complete drug name Use complete drug name Use complete drug name Use complete drug name Correction Use complete drug name Use complete drug name Use complete drug name Correction Use the metric system Minim For three days Greater than and less than Symbol for minim mistaken as “mL” Mistaken as “3 doses” Mistaken as opposite of intended; mistakenly use incorrect symbol; “< 10” mistaken as “40” Mistaken as the number 1 (e.g., “25 units/10 units” misread as “25 units and 110” units) Mistaken as “2” Mistaken as “2” Mistaken as “4” Mistaken as a zero (e.g., q2° seen as q 20) Mistaken as the numerals 4, 6, or 9 100,000 units / (slash mark) @ & + ° Place adequate space between the drug name, dose, and unit of measure 100 mL Large doses without properly placed commas (e.g., 100000 units; 1000000 units) Drug Name Abbreviations ARA A AZT CPZ DPT DTO x3d > and < Correction Mistaken as Inderal 140 mg mg HCT HCTZ MgSO4** MS, MSO4** MTX PCA PTU T3 TAC TNK ZnSO4 Stemmed Drug Names “Nitro” drip “Norflox” “IV Vanc” Symbols Misinterpretation Inderal 40 mg Abbreviations such as mg. or mL. with a period following the abbreviation HCl © ISMP 2010 Intended Meaning (continued) mL 1,000,000 units Separates two doses or indicates “per” At And Plus or and Hour zero, null sign **These abbreviations are included on The Joint Commission’s “minimum list” of dangerous abbreviations, acronyms, and symbols that must be included on an organization’s “Do Not Use” list, effective January 1, 2004. Visit www.jcaho.org for more information about this Joint Commission requirement. Permission is granted to reproduce material for internal newsletters or communications with proper attribution. Other reproduction is prohibited without written permission. Unless noted, reports were received through the ISMP Medication Errors Reporting Program (MERP). Report actual and potential medication errors to the MERP via the web at www.ismp.org or by calling 1-800-FAIL-SAF(E). Use “for three days” Use “greater than” or “less than” Use “per” rather than a slash mark to separate doses Use “at” Use “and” Use “and” Use “hr,” “h,” or “hour” Use the number “0” or the word “zero” Institute for Safe Medication Practices www.ismp.org FIGURE 14 Reproduced with permission of the Gunderson Lutheran Medical Center, LaCross, WI 2006 My Medicine List Fold this form and keep it with you Name: Date of Birth: Allergic To: (Describe reaction) Emergency Contact/Phone numbers: Doctor(s): Pharmacies, other sources: Immunization Record (Record the date/year of last dose taken) Pneumonia vaccine: Tetanus: Flu vaccine(s): Hepatitis vaccine: Other: List all medicines you are currently taking. Include prescriptions (examples: pills, inhalers, creams, shots), over-the-counter medications (examples: aspirin, antacids) and herbals (examples: ginseng, gingko). Include medications taken as needed (example: nitroglycerin, inhalers). START DATE NAME OF MEDICATION DOSE DIRECTIONS (How do you take it? When? How often?) DATE STOPPED NOTES (Reason for taking?) FIGURE 15 www.mnpatientsafety.org Page ______ of ______ Directions for My Medicine List How does this form help you? 1. ALWAYS KEEP THIS FORM WITH YOU. You may want to fold it and keep it in your wallet along with your driver’s license. Then it will be available in case of an emergency. • This form helps you and your family members remember all of the medicines you are taking. • It provides your doctors and other providers with a current list of ALL of your medicines. They need to know the herbals, vitamins, and over-the-counter medicines you take! • With this information, doctors and other providers can prevent potential health problems, triggered by how different medicines interact. 2. Write down all of the medicines you are taking and list all of your allergies. Add information on medicines taken in clinics, hospitals and other health care settings — as well as at home. 3. Take this form with you on all visits to your doctor, clinic, pharmacy and hospital. 4. WRITE DOWN ALL CHANGES MADE TO YOUR MEDICINES on this form. When you stop taking a certain medicine, write the date it was stopped. If help is needed, ask your doctor, nurse, pharmacist, or family member to help you keep it up-to-date. For copies of the My Medicine List and a brochure with more tips, visit the Minnesota Alliance for Patient Safety’s Web site at www.mnpatientsafety.org or call (651) 641-1121. 5. In the “Notes” column, write down why you are taking the medicine (Examples: high blood pressure, high blood sugar, high cholesterol). 6. When you are discharged from the hospital, someone will talk with you about which medicines to take and which medicines to stop taking. Since many changes are often made after a hospital stay, a new list may be filled out. When you return to your doctor, take your list with you. This will keep everyone up-to-date on your medicines. FIGURE 15 (1/06) FIGURE 16 SAMPLE POLICY . Policy for Pill Box Distribution Purpose: Increase compliance with prescribed therapeutic regime and reduce the potential for medication errors by distribution of medication boxes to those patients determine to be high risk. Definition: A person considered being high risk if two or more of the following conditions are identified or present: • Greater than 5 prescriptions. • Greater than 12 doses of medications per day. • Four or more medication changes in the past 12 months. • More than 3 concurrent disease states. • On a medication that requires therapeutic monitoring (narrow therapeutic index). • History of non-compliance. Policy: After evaluation by a physician, pharmacist, or nurse, those patients meeting the above criteria of high risk will be offered a medication box to aid in the correct administration of their medications. Education of the proper use of the medication box will be provided for the patient/surrogate/or designated person by the physician, pharmacy, or nurse. The person providing the medication box should note this either in the discharge note or on the patient profile at the pharmacy. The patient or the patients surrogate will need to designate the person responsible for filling and monitoring the medication boxes. It is the patient or the patients’ surrogate responsibility to monitor the status of medication refills and notify the patient’s attending physician when refills are needed Reproduced with permission of the Gunderson Lutheran Medical Center, LaCross, WI 2006 FIGURE 17 Medication Reconciliation Medication reconciliation is the process of comparing a patient's medication orders to all of the medications that the patient has been taking. This reconciliation is done to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions. It should be done at every transition of care in which new medications are ordered or existing orders are rewritten. Hospital discharge is a critical transition point for all patients. High-risk patients with multiple medical issues and elderly patients are especially vulnerable to the consequences of ineffective discharge handoffs that leave the individual without clear understanding of discharge instructions that likely includes changes or additions to their pre-hospital medication list. HEDIS Measure: HEDIS instituted a new measure in 2009 (2008 data year) regarding “Medication Reconciliation Post-Discharge”. This measure continues as one of a select number of measures addressing the special needs of Medicare members enrolled in Special Needs Plans (SNPs). The specification from CMS requires that medication reconciliation occur within 30 days post-discharge from an inpatient facility. Even though this measure has a restricted population, the standard of care should apply to any member with complex medical care needs on multiple medications. HealthPartners Quality Improvement: HealthPartners, Inc., as part of their 2009 and 2010 Medical Record Documentation review, assessed the occurrence of medication reconciliation using the HEDIS specifications for a sample of Medicare members at multiple clinics that serve our members. Results showed that an average of 85 – 90% of the charts reviewed indicated post-discharge medication reconciliation was completed within 30 days post discharge. In 2011, HealthPartners entered a collaborative arrangement with other major health plans on a Performance Improvement Project (PIP) for our seniors. Each health plan will partner with a hospital and provider group to increase the number of members who are discharged from hospital to home that have a follow-up visit with their Primary Care Provider (PCP) within 15 days after discharge. The purpose of this visit is to promote a safe recovery and prevent rehospitalization. . An extremely important component of that is the inclusion of a thorough medication review and reconciliation. Sheila Dalen, Quality Consultant Quality Measurement & Improvement 02/02/11 FIGURE 18 SUBJECT: WARFARIN THERAPY DOSE PROTOCOL FOR MAINTENANCE EFFECTIVE DATE: APPROVED BY: 3/10 Beth Averbeck, MD Associate Medical Director, Primary Care Randy Hurley, MD Department Head, Hematology/Oncology Colleen Morton, MD Hematology/Oncology William Nelson, MD Department Head, Cardiology Doug Olson, MD Assistant Medical Director Pathology and Lab Rae Ann Williams, MD Department Head, Internal Medicine Art Wineman, MD Department Head, Family Medicine CONTACT: SUPERSEDES: Beth Averbeck, MD Associate Medical Director, Primary Care John Butler, MD Internal Medicine Jo McLaughlin, RN Director, Nursing and Nutrition Services Colleen Morton, MD Hematology/Oncology 3/09 REVIEW DATE: 3/11 PURPOSE To provide a population based standing order for Registered Nurses to manage anti-coagulation maintenance therapy for established and stable patients who are on an anti-coagulation medication (Coumadin). POLICY To provide in a safe, efficient manner, guidelines for the RN to manage patients’ dose therapy for their anticoagulation medication. The patient must be established and stable, meaning he/she must have been on anticoagulation therapy for at least one month and have at least three (3) INR readings within their ordered range. All patients should read and sign the Anticoagulant Medications health information sheet (H Ed master 120037). The nurse will review this information with patients with emphasis on patient responsibility, i.e. obtaining INRs as directed and contacting clinic or CareLine if a nurse doesn’t call with results within 36-48 hours. The standing order may be used for clinic visits or telephone encounters. The RN may adjust the patient’s anti-coagulation medication based on a complete and clear standing order originated by a HPMG provider annually and per the following procedure. The RN will use the Epic anticoagulation careplan and SmartForm for documentation. @BCL@741789C8 Page 1 of 16 FIGURE 18 Approval for use as a Population Based Standing Order: Beth Averbeck, MD Date Randy Hurley, MD Date Colleen Morton, MD Date William Nelson, MD Date Doug Olson, MD Date Rae Ann Williams, MD Date Art Wineman, MD Date @BCL@741789C8 Page 2 of 16 FIGURE 18 Anti-Coagulation Dose Protocol for Maintenance Therapy High Range 2.5-3.5 INR Result Low Range 2.0-3.0 INR Result Other Range First Action Weekly Dose Change Follow-up After Dose Change <1.6 Alert ♦ <1.3 Alert ♦ Range minus 0.9 Notify physician; consider risk factors in determining action. Per Physician Repeat INR in 3-5 days depending upon patient risk. 1.6-2.0 ♦ 1.3-1.5 ♦ Range minus 0.8-0.5 Consider Risk factors and Patient INR stability in determining action. Increase dose after first low reading or recheck in 3-7 days and then increase if still low. Repeat INR in 3-7 days depending upon patient risk. INR Result Change dose according to large increase column or by 7-14%. 2.1-2.4 1.6-1.9 Range minus 0.4-0.1 2.5-3.5 2.0-3.0 Ordered range 3.6-4.5 3.1-4.0 Range plus 0.1-1.1 4.6-5.0 4.1-5.0 Range plus 1.1-2.0 >5.0 Critical ● >5.0 Critical ● Range plus 2.1 Or > 5.0 If previous INR in range, repeat INR in 5-14 days depending on pt. risk factors & INR stability before changing dose Target Range If 2 consecutive low results, change dose according to small increase column or by 3 ½ -7 %. If previous INR in range, repeat INR in 5-14 days depending on pt. risk factors & INR stability before changing dose Hold scheduled dose for one day. If 2 consecutive high results, change dose according to small decrease column or by 3 ½ -7%. Notify Physician. Hold scheduled dose for 2 days. Consider risk factors in determining action. ● Per physician No Change Change dose according to large decrease column or by 7-14%. Repeat INR in 5-9 days or up to 14 days for established pts. at low risk who have had stable INRs in the past (see low risk definition) Repeat INR in 4-6 weeks Repeat INR in 5-9 days or up to 14 days for established pts. at low risk who have had stable INRs in the past (see low risk definition) Repeat INR in 5-9 days Repeat INR in 1-5 days ♦ Patients with mechanical prosthetic heart valves who require an INR range of 2.5-3.5 should be placed on enoxaparin (Lovenox) if their INR is <2. High Risk patients may require heparin or enoxaparin therapy while INR is subtherapeutic or warfarin is held for surgery. ● Risk factors for major hemorrhage include: history of GI bleed or any other major bleed, hypertension, stroke, renal disease, age>75, ASA, or NSAIDS. Low risk is defined as those patients with no recent venous thromboembolism (>3 months from the event), atrial fibrillation without history of stroke or other risk factors and bileaflet mechanical cardiac valve in aortic position (ACCP guidelines: Chest vol. 126, number 3 supplement, September, 2004) Depending upon risk, low dose Vitamin K may be indicated in non-urgent situations (RN consults with provider, provider orders Vitamin K therapy): INR 5-9 0, 1mg, or 2.5mg by mouth, depending on risk of bleeding. Since the tablet is only available as 5mg, these lower doses are most easily given using the injectable form diluted in a glass of water. Nursing will stock vitamin K vials (Lawson # 801861). INR >9 5-10 mg by mouth, consider fresh frozen plasma Serious bleeding at any elevation of INR 10 mg slow IV infusion and fresh frozen plasma, consider adding recombinant Factor VII for life-threatening bleed RNs may adjust a patient dose up to 7% per week (one daily dose per week) based upon patient history and nursing assessment and then recheck INR within 5-9 days. @BCL@741789C8 Page 3 of 16 FIGURE 18 The following guidelines may be useful in Anti-Coagulation dosing flexibility: Expect a 15% dose adjustment to result in an approximately 1.0 INR change. A 10% dose adjustment will result in an approximate 0.7-0.8 INR change. Steady state INR values will not be realized for up to 3 weeks following a dose adjustment. Patients with INR values by +/- 0.5% INR out of range should be considered for more frequent monitoring and should have a repeat INR within 7 days. The dose response relationship is best interpreted when at least 16 hours elapse between dose and lab draw. Any drug has the potential to interact with warfarin; in such circumstances close INR monitoring is required during initiation and discontinuation of the interacting agents. Refer to drug/food interactions tables for selected interactions. @BCL@741789C8 Page 4 of 16 FIGURE 18 Procedure for Reporting Low INR Results PURPOSE To provide a process for reporting low INR results when the clinic is closed 1.6 or below OR 2.0 or below for patients with a mechanical mitral valve as described in the policy. POLICY INR values of less than 1.6 OR less than 2.0 for patients with mechanical mitral valves are considered on Alert status and should be reviewed for possible adjustments in dosing decisions. All patients with mechanical heart valves who need an INR range of 2.5-3.5 are high risk patients and need low molecular weight heparin (Lovenox) if their INR is less than 2. This includes mitral valve and any aortic valve patients with additional risk factors. They should be seen emergently at Urgent Care or the ER and covered with low molecular weight heparin until their INR is raised to at least 2.5 or greater. These patients require an expeditious evaluation as to the origin of the declining INR and the INR needs to be rapidly corrected with close follow-up and monitoring. Patients with mechanical heart valves who need an IRN range of 2-3 are those with aortic valves, without additional risks; do not need low molecular weight heparin (Lovenox) with a low INR. An aggressive plan to raise their INR to an accepted normal range needs to be expeditiously pursued. PROCEDURE (For clinics that are evaluating INRs at the Point of Care, low INRs will be evaluated and adjusted at that time.) Action: 1. Ask patients, whenever possible, to have their INRs drawn before 1 p.m., Monday through Thursday. If an INR needs to be drawn on Friday, request that the patient comes in on Friday morning to facilitate the process of getting the INR result back to the clinic before the 5:00 closing time. Rationale: Receiving INR results back during the regular clinic hours facilitates communication between the nurse and physician regarding clinical decision making on anticoagulation dosing. 2. Monday-Thursday, INR results of less than 2.0 for patients with a mechanical heart valve that are not reported to the clinic before closing, will be called to the CareLine by Central Lab for follow-up. No action needs to be taken by Central Lab on INR results less than 2.0 for non-mechanical heart valve patients. Rationale: Mechanical aortic valve patients need emergent follow-up if their INR is less than 2.0. Dosing decisions for other patients with INRs less than 2.0 can wait overnight. 3. On Fridays, or the day before a holiday, INR results of less than1.6 OR less than 2.0 for patients with mechanical mitral valves, that are not reported to the clinic before closing, will be called to the CareLine by Central Lab. Rationale: Patients with mechanical heart valves, especially those with decreased LV systolic function and/or atrial fibrillation are a higher risk when exposed to a subtherapeutic INR. Patients with a St. Jude, bileaflet, aortic valve have a low risk for valve related thromboembolism. Notification of CareLine facilitates follow-up for patient management. 4. If a clinic nurse is concerned about dosing for a patient with an unreported INR result at the end of the day, the nurse will notify the CareLine that an INR result, for an at risk patient, has not come back and will provide the CareLine nurse with careplan directions. Rationale: Ensure continuity of care. 5. Document actions taken. 6. CareLine forwards a telephone encounter to the PCP’s clinic RN pool with the report of actions taken. Rationale: Ensure appropriate clinic follow-up. @BCL@741789C8 Page 5 of 16 FIGURE 18 Select Warfarin - Drug Interactions (not a complete list) Drug Interaction Effect Management Comments Acetaminophen (Tylenol) Elevations in INR have occurred within 1-2 weeks of initiating acetaminophen at moderate to high doses (2- 4 g/day Consider early and frequent monitoring of INR for several weeks when acetaminophen is added or discontinued. Effect is likely related to dose and length of treatment. Amiodarone (Pacerone, Cordarone) INR increases by 22108% Bleeding episodes 2 days to one month after initiation Monitor INR at least weekly1st month of combined therapy. Drop warfarin dose by 25% on start of amiodarone. Daily warfarin needs usually drop by 2550%. Potentiation occurs from 4 days to 2 weeks. May persist up to 4 months after amiodarone discontinued. Carbamazepine (Tegretol, Carbatrol) Cimetidine (Tagamet) Decrease in INR Monitor INR more closely Induces warfarin metabolism Can increase INR Dose dependents with at least 300800 mg/day Ciprofloxacin (Cipro) Levofloxacin (Levaquin) Moxifloxacin (Avalex) Clarithromycin (Biaxin) Erythromycin (Erytab, Erythrocin) Increase INR in 2-16 days Use alternative medication [e.g. ranitidine (Zantac), famotidine (Pepcid)] Monitor INR more carefully Increased INR seen within 7 days Monitor INR closely when add or stop clarithromycin or erythromycin Clopidogrel (Plavix) Increased risk of bleeding Inhibits platelet aggregation Corticosteroids (prednisone, methylprednisone, others) May increase INR Monitor INR more closely during initiation or discontinuation Monitor INR more closely during initiation or discontinuation Dronedarone (Multaq) May increase INR Limited data suggests up to 20% increase in S-warfarin concentration. Is structurally similar to amiodarone. Duloxetine (Cymbalta) Increase in INR Fluconazole (Diflucan) Itraconazole (Sporanox) Ketoconazole (Nizoral) Fluvoxamine (Luvox) Slight to 2 fold increase in INR Monitor INR closely when adding or stopping dronedarone. Monitor INR more closely during initiation or discontinuation of duloxetine Monitor every 2 days when add or stop fluconazole, itraconazole, or ketoconazole Levothyroxine (Levoxyl, Synthroid) Lovastatin (Mevacor) Simvastatin (Zocor) Metronidazole (Flagyl) Increased risk of bleeding NSAIDs (Aspirin, Ibuprofen, Naproxen, Diclofenac, Celebrex) Increased risk of bleeding @BCL@741789C8 Can increased INR May increase INR Increase in INR Monitor INR more closely for1-2 weeks after fluvoxamine is started. Monitor closely when add/change levothyroxine dose Monitor closely when add or stop lovastatin or simvastatin Monitor INR more carefully when starting and stopping metronidazole Monitor INR closely when add or stop NSAIDs Unpredictable but can be clinically significant, especially in the elderly Onset of INR effect is variable and may be anticipated 3-10 days after initiating steroid Increases metabolism of Vitamin Kdependent clotting factors Lovastatin commonly associated with hypoprothrombinemia Inhibits platelet aggregation &gastric erosion Page 6 of 16 FIGURE 18 Drug Interaction Effect Management Comments Nicotine Decrease INR Nicotine induces warfarin metabolism Omeprazole (Prilosec) Paroxetine (Paxil) Increase of INR after a few days Can increased INR Monitor INR more closely when stopping/starting nicotine replacement therapy or smoking more or less/day Monitor INR closely when add/change omeprazole dose Monitor INR frequently when paroxetine is added Penicillin (Veetids) Increased INR Phenobarbital (Luminal) Phenytoin (Dilantin) Decrease in INR Monitor INR more closely when add or stop penicillin Monitor INR more closely Penicillin reduces GI synthesis of vitamin K Induces warfarin metabolism Prasugrel (Effient) Increased risk of bleeding Induces warfarin metabolism, enhances metabolism of clotting factors Inhibits platelet aggregation Rifampin (Rifadin) Decrease INR within 2-4 days Increase in INR Monitor INR frequently for 1 month or more after phenytoin added Monitor INR more closely during initiation or discontinuation Monitor INR closely for 1-2 weeks after rifampin is added. Monitor INR more closely when starting and stopping Sulfamethoxazole Monitor INR more closely during initiation or discontinuation Sulfamethoxazole Tamoxifen (Nolvadex) @BCL@741789C8 Decrease in INR Increase in INR. A 35-60% reduction of warfarin dose may be required. Dose related Induces warfarin metabolism Use of sulfamethoxazole is not recommended if acceptable alternative exists. Use is contraindicated with warfarin therapy in high-risk women. Page 7 of 16 FIGURE 18 Select Warfarin - Food/Dietary Supplement Interactions (not a complete list) Drug Alcohol Interaction Effect Management Comments Can increase or decrease INR Caution pts to drink in moderation and to avoid binge drinking; start at lower doses in pt has liver damage Dong quai Can increase INR Ginseng Can increase INR Co-Q10 Decrease INR Cranberry Juice (100%) Can increase INR Garlic Can increase INR Glucosamine/chondroitin Feverfew Chondroitin may have anticoagulant activity increasing bleeding time and INR Potential to increase INR due to platelet aggregation inhibition Potential to decrease in INR due to Vitamin K content Can increase INR Monitor INR more closely when add or stop. Advise pt to use consistent dose if must use Monitor INR more closely when add or stop. Advise pt to use consistent dose if must use Monitor INR more closely when adding or stopping. Advise patient to use consistent dose if must use. Monitor INR more closely, advise pt to use consistent amount if drink cranberry juice Monitor INR more closely, advise pt to use consistent dose if must use. Monitor INR more closely when adding or stopping. Advise patient to use consistent dose if must use. Monitor INR more closely, advise pt to use consistent dose if must use Acute use may inhibit warfarin metabolism; chronic use induces warfarin metabolism; Cirrhosis is associated with reduced warfarin metabolism Inhibits platelet activation and aggregation. Fish oil Can increase INR Flaxseed oil Can increase INR Gingko Biloba Can increase INR Omega 3 Can increase INR Salvia Root (Danshen) Can increase INR St. John’s Wort Can decrease INR Vitamin K containing foods in large amounts (Leafy greens) Decrease INR Green Tea @BCL@741789C8 Monitor INR more closely, advise pt to use consistent dose if must use Monitor INR more closely when adding or stopping. Advise patient to use consistent dose if must use. Monitor INR more closely when adding or stopping. Advise patient to use consistent dose if must use. Monitor INR more closely, advise pt to use consistent dose Monitor INR more closely when adding or stopping. Advise patient to use consistent dose if must use. Monitor INR more closely, advise pt to use consistent dose if must use Monitor INR more closely, advise pt to use consistent dose if must use. Advise pt to keep diet steady. Inform clinic of major dietary changes. Pts don’t always consider dietary supplements medications. Inhibits platelet aggregation Inhibits platelet aggregation Contains small amount of Vitamin K Inhibits platelet aggregation May decrease platelet aggregation May decrease platelet aggregation Inhibits platelet aggregation May decrease platelet aggregation Inhibits platelet aggregation. May contain coumarin derivatives. Induces metabolism of warfarin Consistency and moderation is key. Page 8 of 16 FIGURE 18 Anticoagulant Medications What do anticoagulants do? Anticoagulants are medications that help keep blood from clotting. Warfarin, Coumadin, Jantoven and Lovenox are common anticoagulants. These medications were sometimes called “blood thinners” in the past. However, they do not make blood “thinner.” They make the blood less able to clot. What are the possible side effects of anticoagulants? Bleeding Easy bruising Diarrhea and decreased appetite are uncommon side effects of Coumadin/warfarin Patients on Lovenox must watch for leg or arm swelling that is new or gets worse, chest pain, difficulty breathing or skin breakdown at the site of injections. If you have any of these, contact your doctor immediately. These may be signs of a serious reaction to Lovenox. Why do I need to have my blood tested so much? Your doctor will monitor your blood with a test called an INR. This test is done more often at first. If possible, have the INR test done before1 p.m., Monday-Thursday (unless your doctor gives you other instructions). This is so that you get the results in a timely manner. This test helps your doctor decide how much anticoagulant you should take. Your doctor may change your dose several times to find what is best for you. A nurse will call you within a day of your test to let you know if you need to change your dose or not. If the nurse does not call you within 36-48 hours of a test, call your clinic or the CareLine (612-339-3663) to check on the results. Once the dose you need is stable, most of the time you’ll be able to have the test done monthly. It is very important that you take your anticoagulant medication the way your doctor tells you to. It’s also important to get the recommended blood tests. I agree to follow my doctor’s recommendation about when to have my blood test (INR) done. _____________________________________ Patient signature Continued FIGURE 18 How do I take this drug? Take the medication at the same time every day. It’s best to take it with your evening meal or at bedtime. Take each dose with a full glass of water. Do not stop taking this medication unless you are told to by your doctor. What if I miss a dose? Take it as soon as you remember. You can take your anticoagulant medication up to six hours after the usual time of your dose. After that time, count it as a missed dose. Do not take two doses at the same time. Write down the date of the missed dose and tell your doctor at your next visit. Missing a dose may change your blood test result. If you miss doses on two or more days, call your doctor right away. When should I call my doctor? Complications with medications are rare when you are closely monitored. Call your doctor right away if you have any of the following: Bleeding, including nosebleeds or bleeding gums Bleeding that does not stop after an injury Frequent bruises or bruises that keep getting larger Dark brown or red urine Vomiting or spitting up blood or brown material that looks like coffee grounds Bloody or black, sticky stool Severe headache, stomach ache, back or kidney pain Swelling, redness, warmth, pain, firmness or heaviness in an area Pain in any part of your leg Small red spots on your skin Sudden anxiety or restlessness Any changes in diet, activity level, how much alcohol you use, medications Cough or difficulty breathing Fast heartbeat Shortness of breath Heavy sweating when at rest Chest pain Faintness, dizziness or increased weakness A serious fall or injury to the head Fever or sickness that gets worse Women: heavier-than-usual periods Pregnancy or you plan to get pregnant Something unusual happens that you question If you plan to travel What you avoid when taking an anticoagulant Anticoagulants interact with many other medications, vitamins, herbs and certain foods. If any new drugs are prescribed for you, make sure your doctor, nurse and pharmacist know that you take an anticoagulant. Anticoagulants should not be taken during pregnancy. They may harm an unborn baby. Please discuss plans for pregnancy with your doctor. Then, safer medications may be prescribed. Continued FIGURE 18 Aspirin and NSAIDs Do not take aspirin or any nonsteroidal anti-inflammatory drugs (NSAIDs) until you have talked to your doctor. (See list below.) These drugs can increase your risk of bleeding. If you need something for pain, use acetaminophen (Tylenol® ). Do not take more than four extra-strength Tylenol® in a day (2000 mg). If you are unsure of what to do for your pain, ask your pharmacist, nurse or doctor. Do not take the following drugs while you are on anticoagulant medications. Generic Name Acetylsalicylic Acid Diclofenac Etodolac Flurbiprofen Fenoprofen Ibuprofen Indomethacin Ketoprofen Ketorolac Meclofenamate Mefenamic acid Naproxen Oxaprozin Piroxicam Sulindac Tolmetin Brand Names *Aspirin, Excedrin, Aspergum, Ecotrin, Bufferin, Ascriptin, Empirin, Midol Cataflam, Voltaren Lodine Ansaid Nalfon Motrin, Motrin IB, Haltran, Midol IB, Nuprin, Advil, Arthritis Foundation Indocin, Indocin SR, Indochron E-R Orudis KT, Actron, Orudis, Oruvail Toradol Meclomen Ponstel Aleve, Anaprox, Naprosyn, Naprelan Daypro Feldene Clinoril Tolectin 200, Tolectin 600, Tolectin DS *Many medications combine aspirin with another drug. Examples are: Percodan, Empirin with codeine, Fiorinal, Robaxisal, Soma Compound and Ascriptin with codeine. Please ask your pharmacist, doctor, or nurse if you have questions. Other substances to avoid Do not take any nonprescription drugs, herbal teas or vitamin supplements without talking to your doctor. Some herbs affect how anticoagulants work. Check with your doctor before using any of these herbs: garlic, ginger, fenugreek, feverfew, ginkgo biloba, ginseng, horse chestnut, red clover, and tonka beans. Do not eat large amounts of food with Vitamin K. This can reduce the effect of the anticoagulant. See the handout called “Guidelines for vitamin K intake for patients taking anticoagulants.” Avoid eating or drinking cranberry products. Continued FIGURE 18 What can I do to reduce the risk of bleeding when taking an anticoagulant? Take your medications exactly the way your health care provider tells you, and at the same time each day. Keep follow-up appointments for blood tests to monitor clotting times. Use a soft-bristle toothbrush and floss gently. Use an electric razor instead of a blade. Check regularly for bruises. Avoid contact sports and heavy physical activity that could cause injury. Tell other care providers about your blood thinner medication. Check with your doctor before scheduling surgery or dental work. Get a medical alert bracelet and carry a drug identification card if you will be on an anticoagulant for a long time. Check with your doctor before taking any other medications. Avoid alcohol, food fads, crash diets, or changes in your eating habits. Talk with your health care provider if you become pregnant or plan to become pregnant. Anticoagulants cause birth defects. You must take precautions against pregnancy while taking an anticoagulant. © 2003-9 HealthPartners 3-09/7.1/#120037 FIGURE 18 WARFARIN 2 MG DAILY DOSE Sunday Monday Tuesday Wednesday Thursday Friday Saturday Total mg./wk 1 1 1 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 4 1 2 2 2 1 1 2 2 3 3 3 2 2 3 3 4 4 4 3 3 4 4 5 5 5 1 1 1 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 4 1 1 1 2 1 2 2 2 2 2 3 2 3 3 3 3 3 4 3 4 4 4 4 4 5 1 1 1 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 4 1 1 2 2 1 1 1 2 2 3 3 2 2 2 3 3 4 4 3 3 3 4 4 5 5 1 1 1 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 4 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 January 2000 @BCL@741789C8 Page 13 of 16 FIGURE 18 2 MG DECREASE LARGE SMALL DECREASE DECREASE TOTAL/MG/WK TOTAL MG/WK 7 8 9 10 11 12 12 13 14 15 16 17 18 18 19 20 21 22 23 23 24 25 26 7 8 9 10 11 12 13 14 15 15 16 17 18 19 20 21 22 23 24 25 25 26 27 28 WEEKLY DOSE TOTAL MG/WK 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 INCREASE SMALL LARGE INCREASE INCREASE TOTAL/MG/WK TOTAL/MG/WK 8 9 10 11 12 13 14 15 17 18 19 20 21 22 23 24 25 26 27 29 30 31 9 10 11 12 13 14 16 17 18 19 20 22 23 24 25 26 28 29 30 31 January 2000 @BCL@741789C8 Page 14 of 16 FIGURE 18 WARFARIN 5 MG DAILY DOSE Sunday Monday Tuesday Wednesday Thursday Friday Saturday Total mg./wk 2.5 2.5 2.5 2.5 5 5 5 5 5 5 5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 10 10 10 10 10 10 10 2.5 5 5 5 2.5 2.5 5 5 7.5 7.5 7.5 5 5 7.5 7.5 10 10 10 7.5 7.5 10 10 12.5 12.5 12.5 2.5 2.5 2.5 2.5 5 5 5 5 5 5 5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 10 10 10 10 10 10 10 2.5 2.5 2.5 5 2.5 5 5 5 5 5 7.5 5 7.5 7.5 7.5 7.5 7.5 10 7.5 10 10 10 10 10 12.5 2.5 2.5 2.5 2.5 5 5 5 5 5 5 5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 10 10 10 10 10 10 10 2.5 2.5 5 5 2.5 2.5 2.5 5 5 7.5 7.5 5 5 5 7.5 7.5 10 10 7.5 7.5 7.5 10 10 12.5 12.5 2.5 2.5 2.5 2.5 5 5 5 5 5 5 5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 10 10 10 10 10 10 10 17.5 20 22.5 25 27.5 30 32.5 35 37.5 40 42.5 45 47.5 50 52.5 55 57.5 60 62.5 65 67.5 70 72.5 75 77.5 April 26, 2000 @BCL@741789C8 Page 15 of 16 FIGURE 18 5 MG DECREASE LARGE SMALL DECREASE DECREASE TOTAL/MG/WK TOTAL MG/WK 17.5 20 22.5 25 27.5 30 30 32.5 35 37.5 40 42.5 45 45 47.5 50 52.5 55 57.5 57.5 60 62.5 65 17.5 20 22.5 25 27.5 30 32.5 35 35 37.5 40 42.5 45 47.5 50 52.5 55 57.5 60 65 65 65 67.5 70 WEEKLY DOSE TOTAL MG/WK 17.5 20 22.5 25 27.5 30 32.5 35 37.5 40 42.5 45 47.5 50 52.5 55 57.5 60 62.5 65 67.5 70 72.5 75 77.5 INCREASE SMALL LARGE INCREASE INCREASE TOTAL/MG/WK TOTAL/MG/WK 20 22.5 25 27.5 30 32.5 35 37.5 40 45 47.5 50 52.5 55 57.5 60 62.5 65 67.5 70 75 77.5 22.5 25 27.5 30 32.5 35 40 42.5 45 47.5 50 52.5 57.5 60 62.5 65 70 72.5 75 77.5 January 2000 @BCL@741789C8 Page 16 of 16 FIGURE 19 Date Dr.«FirstName» «LastName» «Addr1» «Addr2» «City», «State» «ZipCode» Dear Dr.«Provider»: In the last month, your patient has been identified through pharmacy claims as obtaining six or more controlled substances, by at least three different prescribers and filled by at least three different pharmacies. In an effort to ensure your patient is getting appropriate, safe and high quality care, a subset of the patient’s prescription profile representing only the prescriptions you have prescribed has been attached. State privacy laws prevent us from disclosing the full prescription history. What can you do? • Review the complete patient profile for this patient’s controlled medications by using the Minnesota Prescription Monitoring Program. Minnesota law requires all pharmacies to report the dispensing of all controlled substances to the Minnesota Prescription Monitoring Program. To access this data please visit http://pmp.pharmacy.state.mn.us/. Registration is required. o Many states have similar programs. • If you believe that this patient would benefit from case management services, you can contact HealthPartners Connect (HealthPartners' case management program) to make a referral at 952-883-5469. If you have questions or suggestions regarding this communication, please contact Pete Marshall, PharmD, directly at (952) 967-5807. Thank you for your attention and partnership in providing appropriate care for this member. Sincerely, Terry W. Crowson, MD Medical Director Medical Management & Government Programs HealthPartners Health Plan (Optional) Physician Feedback -Fax back to HealthPartners (952) 967-6667 Yes -- I found this information helpful No -- I did not find this information helpful Comments: FIGURE 20 To ensure members are getting appropriate, safe and high quality care, HealthPartners developed the Exceptional Use Intervention Program for controlled substances. It targets members who received six or more controlled substance medications prescribed by three or more physicians or obtained from three or more pharmacies. The member is identified through pharmacy claims; we send a letter to the most recent prescriber describing the Exceptional Use Intervention Program and identifying the controlled substance prescriptions written by that provider. Physicians can re-evaluate the treatment plan and if they need a complete patient profile they can call HealthPartners Pharmacy Benefits Manager, or refer the member to our Case Management Program at the phone number listed below. Minnesota prescribers can log on to the Minnesota Prescription Monitoring Program. Minnesota law requires all pharmacies to report the dispensing of all controlled substances to the Minnesota Prescription Monitoring Program. Some states have similar programs. Alabama, Arizona, California, Colorado, Connecticut, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia, and Wyoming. Seven states (Alaska, Florida, Kansas, New Jersey, Oregon, South Dakota and Wisconsin) and one U.S. territory (Guam) have enacted legislation to establish a PDMP, but are not fully operational. <http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm> accessed 1.28.2011. Reports are compiled monthly and are reviewed for trends. Any member that recurs three times in a rolling 12-month period is automatically forwarded to our Case Management Program for investigation. If misuse is identified, HealthPartners can request system limitations that restrict the patient to a particular pharmacy or provider. Or, in the case of provider or pharmacy misuse, HealthPartners can restrict that provider or pharmacy or remove that provider or pharmacy from our network. FIGURE 21 Acute Bronchitis Summary Recommendation Antibiotics are NOT indicated in acute bronchitis unless in specific circumstances where pertussis is suspected or in patients with significant medical co‐morbidities. Introduction Acute bronchitis is one of the most common conditions encountered in clinical practice and is also one of the commonest causes of antibiotic misuse. Both the Centers for disease control and the American College of Physicians have stated unequivocally that the only indication for antibacterial agents in uncomplicated acute bronchitis is pertussis. Although the usage of antibiotics had decreased in recent years the prescriptions are now slanted towards broader spectrum antibiotics increasing risk for emergence of resistant strains. Microbiology Viruses are overwhelmingly the main causative agents for acute bronchitis. Influenza A and B, parainfluenza, coronavirus, rhinovirus, and respiratory syncytial virus are the predominant viruses implicated. Apart from pertussis bacterial etiologies are rare unless there are airway violations such as tracheostomy or endotracheal intubation or those patients with structural lung disease or immune suppression. Natural History In the first few days the symptoms are similar to any upper airway infection but with acute bronchitis the cough typically persists for 10‐20 days and occasionally for more than 4 weeks. 50% of patient swill report purulent looking sputum. Fever is relatively uncommon and when present may suggest either pneumonia or influenza. Reactive airways and wheezing is not uncommon. In the vast majority of patients symptoms resolve without antibiotic therapy. Bronchitis is often “under coded” when a diagnosis code is selected. If cough is the predominant feature of an upper respiratory infection, it usually should be coded “Bronchitis” rather than simply “URI or Upper Respiratory Infection.” This is more accurate, and it will make it easier to compare HealthPartners experience to national data. Diagnostic testing Pearl of Knowledge: Acute Bronchitis 2.10.10 FIGURE 21 In the presence of typical symptoms and the absence of abnormal pulmonary findings further testing is usually not indicated. Wheezing alone does not require tests. Specifically sputum gram stain and culture rarely leads to specific diagnosis. Spirometry and chest x rays are also not indicated for initial workup. Rapid tests can be used to diagnose influenza. PCR testing for pertussis is diagnostic if the typical symptoms are present especially in the presence of a known epidemic. Treatment Antibiotics are generally not recommended for acute bronchitis . Exceptions include extremes of age, patients with COPD, immune deficiencies, cystic fibrosis, pneumoconiosis or other structural lung disease. A Cochrane review of nine randomized controlled trials showed a significant but minor reduction in duration of cough (0.6 days) and decrease in duration of symptoms by one day. There was a non significant reduction in the number of days feeling ill and a non significant increase in adverse effects attributed to antibiotics. As mentioned both the CDC and the ACP guidelines state that antibiotics are not indicated except in cases of pertussis. The guidelines from the national institute for health and clinical excellence in the UK advise not treating acute bronchitis with antibiotics with the following exceptions: Preexisting comorbidity (heart, lung, renal, liver or neuromuscular disease or immunosuppression), 2. Patients over the age of 65 with acute cough and two or more of the following or patients over 80 with one or more of the following: admission to the hospital within the prior year, Diabetes, CHF or current use of steroids. 1. Antimicrobial therapy is indicated to limit transmission of pertussis. A Macrolide would be the first line treatment. Antibiotic therapy should be initiated within the first week where possible but there is no evidence that cough will be less severe or the course less protracted with treatment. Treatment with oseltamivir or zanamivir decreases duration of symptoms for acute bronchitis due to influenza by only one day and results in a slightly earlier return to work (0.5 days.) Symptomatic treatment with beta agonists for the cough may be beneficial in patients with airflow limitation. A recent Cochrane review however did not support this recommendation. In practice a short course of inhaled or oral steroids may be tried for troublesome cough. There are no compelling data from clinical trials supporting the use of antitussives or mucolytics in acute bronchitis. There are small studies to show benefit treating cough associated with allergic rhinitis with antihistaminics. A decongestant or antihistaminic could be used for cough associated with post nasal drip in the setting of acute bronchitis. Non specific antitussives like codeine are also prescribed for significant cough in acute bronchitis with very little evidence to support this. Pearl of Knowledge: Acute Bronchitis 2.10.10 FIGURE 21 References: 1. Gonzales R, Barltlet JG, Besser RE et al. Principles of appropriate antibiotic use for treatment of uncomplicated acute bronchitis: background. Ann Intern Med 2001;134:521‐529 2. Braman SS. Chronic cough due to acute bronchitis: ACCP evidence‐based clinical practice guidelines. Chest 2006;129:Suppl:95s‐103s 3. Bent S, Saint S, Vittinghoff E, Grady D. Antibiotics in acute bronchitis: a meta‐analysis. Am J Med 1999;107:62‐67 4. Wenzel P, Fowler AA. Acute Bronchitis. NEJM 2006;355:2125‐2130 Questions: Please reply to this e-mail, and your questions(s) will be directed to the author of this Pearl Pearl Archive: http://www.imehealthpartners.com All Pearl recommendations are consistent with professional society guidelines, and reviewed by HealthPartners Physician Leadership. Pearl of Knowledge: Acute Bronchitis 2.10.10 FIGURE 22 SUBJECT: MEDICATION REFILL (Behavioral Health) STANDING ORDER EFFECTIVE DATE: APPROVED BY: July 2010 Carol Novak, MD Department Head, Behavioral Health CONTACT: Jo McLaughlin, RN Director, Nursing and Clinical Dietitians Ryan Michels, PharmD BCPS, Clinical Pharmacist SUPERSEDES: July 2009 REVIEW DATE: July 2011 PURPOSE: To provide a process for RNs working in Behavioral Health to review and approve maintenance prescription refill requests for designated medications. POLICY: To provide in a safe, efficient manner, approval for a supply of medication for patients. The RN is the agent of the prescriber delegated to refill medications as per the following procedure. The prescription must clearly originate with HPMG physicians or other HPMG authorized prescribers. PROCEDURE: 1. Obtain information from the requesting pharmacy: patient’s name, medical number or date of birth, pharmacy, pharmacy phone number, medication requested, amount requested and the last date the medication was filled. Document the information in an EpicCare Refill Encounter or phone message. A 24 to 48 hour turn-around time on a medication request may be necessary. 2. Review the patient’s medical record for the following areas: a. Review the record for visit compliance. In order to refill mediations, a patient needs to be “current” or as indicated in the plan of the last visit. If the patient is overdue for a visit, contact the patient by phone to schedule a follow-up appointment. If unable to contact the patient to schedule an appointment, the pharmacy is notified that the patient needs to contact his/her provider’s clinic to schedule an appointment so that a refill can be authorized. All communications and outcomes are documented in the patient’s medical record. b. Verify the medication and dosage. The patient must be contacted if any discrepancies are noted, for example, a medication is being refilled too frequently for the way it is prescribed. Also, the patient is contacted for any p.r.n. medications that are being used with increased frequency, for example, benzodiazepines, sleeping pills or stimulants. Identified problems are clearly documented in the medical record. c. Verify that no lab testing/monitoring is required before ordering refills. (See Refill Guidelines attached.) If patient is due for testing/monitoring, a month refill may be provided to allow the patient the opportunity to see his/her provider/complete tests or monitoring. 3. The following medications are excluded from this policy. Refill requests must be routed to a licensed prescriber: a. Scheduled II Controlled Substances (medications such as oxycodone and morphine) b. Medications excluded per careplan c. Indications of non-compliance, including overuse or underuse d. Indications that the patient may be experiencing a side effect or drug interaction e. Specific medications as noted by the ordering prescriber f. Requests to change from a brand name medication to a generic when a physician specified the brand name to be used 4. Determine appropriate refill quantity @BCL@C0040D71 Page 1 of 4 FIGURE 22 If the patient has been keeping his/her appointments and is not overdue for a visit, refills may be given to last until the patient is due for his next visit, not to exceed one year from the last visit. b. If the patient has been keeping his/her appointments and is not overdue for a visit, RNs may increase the quantity from 30 to 90 days supply per patient request or to meet the mail order benefit. c. If the patient is overdue for a visit and the patient has scheduled a visit after being contacted, a refill can be called in by the nursing staff for one month or until the next scheduled appointment if it is beyond one month. d. If a patient’s appointment is canceled and rescheduled, a refill can be called in by the nursing staff for one month or until the next scheduled appointment if it is beyond one month. e. If a client cancels and reschedules a second consecutive time, nursing will only order enough days of non-scheduled medication to last to the scheduled appointment regardless of co-pay status. Further refills of scheduled medications require authorization by the provider. The client will be told at that time that there will be no further refills until he/she is seen. f. If a client cancels and reschedules a third time, there will be no refills until the client is seen by the provider. g. If a client is a no-show, there will be no refills until he/she has rescheduled another appointment, and then a refill of non-scheduled medications can be approved by the nursing staff for one month or until the next scheduled appointment if it is beyond one month. Scheduled medications refills will only be given for exactly the amount needed until the next scheduled appointment unless authorized by the provider. Refills are returned to or called into the pharmacy of the patient’s choice. Document that the medication was refilled per standing order (PSO). The RN may question any medication refill and refer to an ordering provider for review. If the medication refill is denied, the medical record should be routed to the physician for review and to determine if it is acceptable to deny. a. 5. 6. 7. 8. Monitoring Parameters for Selected Medications NOTE: This is not an all-inclusive list. The RN may refill any maintenance medication, including those not included in the following categories, unless it is identified in the exclusions. Although a specific drug may not be listed below, the monitoring parameters apply to all medications in the drug class. Antipsychotics Older Antipsychotics AIMS or DISCUS every 6 months Labs every 2 years: Fasting lipid profiles (total cholesterol, LDL, HDL, triglycerides) Atypical Antipsychotics AIMS or DISCUS annually Weight, calculated BMI every visit Labs at start, 4 months after start, then annually: Fasting plasma glucose level Fasting lipid profiles (total cholesterol, LDL, HDL, triglycerides); if LDL level > 130 mg/dl increase to every 6 months Haldol (haloperidol) Mellaril (thioridazine) Navane (thiothixine) Prolixin (fluphenazine) Thorazine (chlorpromazine) Trilafon (perphenazine) Abilify (aripiprazole) Fanapt, Fanapta (ioperidine) Geodon (ziprasidone) Invega (paliperidone) Risperdal (risperidone) Saphris, (asenapine) Seroquel (quetiapine) Zyprexa (olanzapine) @BCL@C0040D71 Page 2 of 4 FIGURE 22 Antipsychotics Clozaril, FazaClo (clozapine) WBC every week for 6 months, then every two weeks. If <3,000 increase frequency of monitoring. Antidepressants Effexor (venlafaxine) Prestiq (desvenlafaxine) Cymbalta (duloxetine) Remeron (mirtazepine) Blood pressure at all visits where the medication was started or raised at the last visit Blood pressure at all visits where the medication was started or raised at the last visit Weigh at each visit for one year then annually Tricyclics Weigh at each visit for one year then annually Note last blood level MAO Inhibitors Blood pressure every visit SSRI’s n/a Wellbutrin (bupropion) n/a Serzone (nefazodone) Inquire if patient has signs/symptoms of liver disease such as jaundice, malaise, nausea or anorexia. amitriptyline clomipramine desipramine doxepin imipramine nortriptyline isocarboxazid phenelzine tranylcypromine Celexa (citalopram) Lexapro (escitalopram) Luvox (fluvoxamine) Paxil, Pexeva (paroxetine) Prozac, Sarafem (fluoxetine) Zoloft (sertraline) ADHD Medications Stimulants Adderall (dextroamphetamine, amphetamine) Concerta, Metadate, Ritalin (methylphenidate) Daytrana (methylphenidate patch) Dexedrine (dextroamphetamine) Focalin (dexmethylphenidate) Provigil (modafinil) Vyvanse (lisdexamphetamine) Strattera (atomoxetine) @BCL@C0040D71 Blood pressure at all visits where the medication was started or raised at the last visit and every 6 months Weigh every visit under age 16 Height every 6 month under age 16 Weigh every visit under age 16 Page 3 of 4 FIGURE 22 Mood Stabilizers Depakote (valproic acid) Tegretol (carbamazepine) Lithium Topamax (topiramate) Weigh at each visit for one year then annually Labs at one month after start, 6 months after start then annual: CBC with platelets SGOT Valproate level Weigh at each visit for one year then annually Labs at one month after start, 6 months after start then annual: CBC with platelets Na (Sodium) SGOT Tegretol level Weigh at each visit for one year then annually Labs every 6 months: Lithium level BUN and Creatinine Annual Labs: TSH Labs at 3 months and 6 months after start then annually Basic Metabolic Panel (CHEM8) UA Annual eye exam for glaucoma screening Approval for use as a Population Based Standing Order: Carol Novak, MD @BCL@C0040D71 Date Page 4 of 4 FIGURE 23 SUBJECT: EFFECTIVE DATE: MEDICATION REFILL STANDING ORDER July 2010 Avandia removed 7/21/10 Celebrex & Azmacort removed 8/3/10 APPROVED BY: Debra Johnson, MD Department Head, Pediatrics & Adolescent Medicine Art Wineman, MD Department Head, Family Medicine Rae Ann Williams, MD Department Head, Internal Medicine Beth Averbeck, MD Associate Medical Director, Primary Care CONTACT: Jo McLaughlin, RN Director, Nursing and Clinical Dietitians Ryan Michels, PharmD, Clinical Pharmacist SUPERSEDES: July 2009 REVIEW DATE: July 2011 PURPOSE: To provide a process for RNs and Pharmacists to review and approve maintenance prescription refill requests. POLICY: To provide in a safe, efficient manner, approval for a supply of medication for patients (this would also include supplies for maintenance medications, for example, insulin syringes). The RN or Pharmacist is the agent of the prescriber delegated to refill medications as per the following procedure. Prescriptions must clearly originate with HPMG physicians or other HPMG authorized prescribers. PROCEDURE: 1. Obtain information from the requesting pharmacy: patient’s name, medical number or date of birth, pharmacy, pharmacy phone number, medication requested, amount requested and the last date the medication was filled. Document the information in a phone message or an EpicCare Refill Encounter. A 24 to 48 hour turn-around time on a medication request is necessary. 2. Review the patient’s medical record for the following areas: a. Review the record for compliance. In order to refill medications, a patient needs to be “current” that is, seen annually (primary care visit for any reason within the last 12 months) or as indicated in the plan of the last visit. If the patient is overdue for a visit, one refill is approved to allow the patient the opportunity to be seen by his/her provider. Contact the patient by phone or mail to explain the need for a follow-up appointment. The pharmacy is also notified that the patient needs to see his/her physician and should note this on the prescription. All communications and outcomes are documented in the patient’s medical record. b. Verify the medication and dosage. The patient must be contacted if any discrepancies are noted, for example, a medication is being refilled too frequently for the way it is prescribed. Also, the patient is contacted for any p.r.n. medications that are being used with increased frequency, for example, sublingual nitroglycerin, respiratory inhalers, migrane medications or narcotics. Identified problems are clearly documented in the medical record. c. Verify that lab testing/monitoring is not required before ordering refills. (See Refill Guidelines attached.) If patient is due for testing/monitoring, a month refill may be provided to allow the patient the opportunity to see the provider/complete tests or monitoring. The RN or Pharmacist will order the appropriate lab tests in Epic and will ensure communication of needed tests to patient. Medication Refill SO Policy_2010.doc Page 1 of 10 FIGURE 23 3. 4. 5. 6. 7. 8. d. If a medication alert appears when the refill order is placed, verify that the patient has had a previous order for this medication and history of tolerating the medication, and then proceed to refill. If there are any questions or concerns, forward to the ordering provider. The following medications are excluded from this policy. Refill requests including but not limited to the following list must be routed to a licensed prescriber. RN or Pharmacist use “.no standing order” or “.narcotics” for narcotic medications, to document that the request is being routed to a licensed prescriber. a. Controlled Substances b. Oral Steroids c. Cox II inhibitors d. Chemotherapeutic agents e. Antibiotics f. Indications of non-compliance, including overuse or underuse g. Indications that the patient may be experiencing a side effect or drug interaction h. Specific medications as noted by the ordering prescriber i. Requests to change from a brand name medication to a generic when a physician specified the brand name to be used Refills may be given to last until the patient is due for his next visit, not to exceed one year from the last visit. a. RNs or Pharmacists may increase the quantity from 30 to 90 days supply per patient request or to meet the mail order benefit. b. This exludes scheduled medications (II – V) and psychotherapeutic drugs and any medication excluded from this standing order (per section 3). The DISPENSING PHARMACIST may change the quantity and days supply dispensed on maintenance medications, up to a 3-month supply, to meet patient requests or a mail order benefit. This policy excludes all scheduled medications (II – V), psychotherapeutic drugs and any medication ordered by a behavioral health provider. Refills are returned to or called into the pharmacy of the patient’s choice. Document that the medication was refilled per standing order (PSO). The RN or Pharmacist may question any medication refill and refer to an ordering provider for review. If the medication cannot be filled per the standing order, the request should be routed to the physician for review. Monitoring Parameters for Selected Medications NOTE: This is not an all-inclusive list. The RN or Pharmacist may review any maintenance medication that falls into the categories below unless it is identified in the exclusions. Although a specific drug may not be listed below, the monitoring parameters apply to all medications in the drug class. For combination products, the RN or Pharmacist will review the parameters for each component. RNs and Pharmacists may also consult the PDR, Facts and Comparisons, or clinical Pharmacy Specialist for drug specific monitoring. Nonprescription/Over-the-counter (OTC) Medications (not listed elsewhere) Medications ALL Medication Refill SO Policy_2010.doc Monitoring Review for the following using a reputable drug information source, such as Micromedex or Up-To-Date: • No contraindications for use exist • Lack of significant drug, disease or dietary interactions. • Dosage/usage appropriate • Therapeutic benefit (effectiveness) demonstrated • Lack of significant adverse effects Page 2 of 10 FIGURE 23 Allergy Medications ANTIHISTAMINES (oral) • desloratidine (Clarinex®) • fexofenadine (Allegra®, Allegra-D®) • levocetirizine (Xyzal®) ANTIHISTAMINES (nasal) • azelastine (Astelin®) • olopatadine (Patanase®) NASAL STEROIDS • budesonide (Rhinocort®) • fluticasone (Flonase®) • mometasone (Nasonex®) • triamcinalone (Nasacort®) • ciclesonide (Omnaris®) • fluticasone furoate (Veramyst®) Monitoring Antidepressants Medications SSRI ANTIDEPRESSANTS • citalopram (Celexa®) • escitalopram (Lexapro®) • fluoxetine (Prozac®) • fluvoxamine (Luvox®) • paroxetine (Paxil®) • sertraline (Zoloft®) SNRI ANTIDEPRESSANTS • duloxetine (Cymbalta®) • desvenlafaxine (Prestiq®) • venlafaxine (Effexor®) • milnacipran (Savella®) TRICYCLIC ANTIDEPRESSANTS • amitriptyline (Elavil®, Endep®) • amoxapine (Asendin®) • clomipramine (Anafranil®) • desipramine (Norpramin®) • doxepin (Sinequan®) • imipramine (Tofranil®) • maprotiline (Ludiomil®) • nortriptyline (Aventyl HCL®, Pamelor®) • protriptyline (Vivactil®) • trimipramine (Surmontil®) • mirtazepine (Remeron®) • Monitoring Annually • BP • Heart rate Savella – FDA approved only for fibromyalgia Annually • BP • Heart rate • Weight Annually • Weight bupropion (Wellbutrin®) Anti-her petics Medications ORAL AGENTS • acyclovir • famciclovir (Famvir®) • valacyclovir (Valtrex®) TOPICAL AGENTS • acyclovir (Zovirax®) • penciclovir (Denavir®) Medication Refill SO Policy_2010.doc Monitor ing Annually in patient’s with known renal insufficiency • BUN • serum creatinine Page 3 of 10 FIGURE 23 Benign Prostatic Hyperplasia (BPH) • • • Medications alfuzosin HCl (Uroxatral®) silodosin (Rapaflo®) tamsulosin (Flomax®) Monitoring Annually/dosage change • BP Cardiovascular (not HTN) Medications All cardiovascular (not HTN) medications • amiodarone (Cordarone®) • • Monitoring BP annually Baseline, 3 months, and every 6 months: TSH Baseline and every 6 months: ALT Baseline and annually (or as needed per symptoms): chest radiograph and EKG Baseline and as necessary: Cr, BUN, K, Mg, Na, PFT, and eye exam refill only 6 months Baseline and annually (or as needed per symptoms): EKG Baseline and as necessary: K, Mg refill only 6 months • • • INR regularly Refer to Warfarin standing orders and SmartForm K+, Mg, BP, serum creatinine annually • • • • • • • • dronedarone (Multaq®) • isosorbide (Isordil®, Imdur®) nitroglycerin/ NTG (Nitrostat®, Nitrol®, Nitrek®, Minitran®) warfarin (Coumadin®) • • • digoxin (Lanoxin®) clopidroget (Plavix®) prasugrel (Effient®) • • Cholesterol Medications FIBRATES • gemfibrozil (Lopid®) • fenofibrate (Tricor®, Lofibra®, Antara™ , Triglide®, others) • fenofibric acid (Trilipix®) STATINS • atorvostatin (Lipitor®) • pravatatin (Pravachol®) • simvastatin (Zocor®) • fluvastatin (Lescol/ Lescol XL®) • lovastatin (Mevacor®, Altocor®, generics) • rosuvastatin (Crestor®) • simvastatin/ezetimibe (Vytorin®) • lovastatin/niacin ER (Advicor®) • Ezetimibe (Zetia®) NIACIN • Niacin ER (Niaspan®) Medication Refill SO Policy_2010.doc Monitoring Annually/dosage change • ALT • lipid panel Annually/dosage change • ALT Annually/dosage change • lipid panel New start or changing dose • ALT every 3-6 months for first year Annually/dosage change • Lipid panel Every 6 months • ALT Annually/dosage change • Lipid panel New start • ALT every 6-12 weeks for first year. Page 4 of 10 FIGURE 23 OMEGA-3 FATTY ACIDS • Omega-3-acid ethyl esters (Lovaza®) Annually/dosage change • ALT • lipid panel Diabetes Medications BIGUANIDES • metformin (Glucophage®, Glucophage XR®) INSULIN • insulin (Apidra®, Humalog®, Lantus®, Levemir®, Novolog®, NPH, Regular) • supplies GLUCAGON-LIKE PEPTIDE 1 AGONIST Exenatide injection (Byetta®) Pramlintide injection (Symlin®) DIPEPTIDYL PEPTIDASE IV INHIBITOR Saxagliptin (Onglyza®) Sitagliptin (Januvia®) SULFONYLUREAS • glimeperide (Amaryl®) • glipizide (Glucotrol®, Glucotrol XL®) • glyburide (Micronase®, Diabeta®) THIAZOLIDINEDIONES • pioglitazone (Actos®) Medication Refill SO Policy_2010.doc Monitoring Annually • serum creatinine • ALT • BP • Lipid panel • microalbumin Every three months • HgbA1c Annually • serum creatinine • BP • Lipid panel • microalbumin Every three months • HgbA1c Annually • serum creatinine • BP • Lipid panel • microalbumin Every three months • HgbA1c Annually • serum creatinine • BP • Lipid panel • microalbumin Every three months • HgbA1c Annually • serum creatinine • BP • Lipid panel • microalbumin Every three months • HgbA1c Annually • serum creatinine • ALT • BP • Lipid panel • microalbumin Every three months • HgbA1c • ALT Page 5 of 10 FIGURE 23 MEGLITINIDES • nateglinide (Starlix®) • repaglinide (Prandin®) COMBINATIONS • metformin/pioglitazone (Actoplusmet®) • metformin/rosiglitazone (Avandamet®) • metformin/glipizide (Metaglip®) • metformin/glyburide (Glucovance®) • glimepiride/pioglitazone (Duetact®) • metformin/sitagliptin (Janumet®) • metformin/repaglinide (Prandimet®) BLOOD GLUCOSE TESTING SUPPLIES Annually • serum creatinine • ALT • BP • Lipid panel • microalbumin Every three months • HgbA1c • ALT • Follow the monitoring guidelines of the medication components. Hormone Replacement • • • • • • • Medications conjugated estrogens (Premarin®) conjugated estrogens/ medroxyprogesterone (Combipatch®, Premphase®, Prempro®) esterified estrogen/ methyltestosterone (Estratest®, Estratest HS®) estrodiol (Estrace®, Estraderm®, Vivelle®) ethinyl estradiol/ norethindrone (FemHRT®) medroxyprogesterone (Provera®) progesterone (Prometrium®) Monitoring Annually • mammography • breast exam • Pap (3 normals then every 2-3 years) Oral Contraceptives Medications • various products Monitoring Annually • BP • Pap (3 normals then every 2-3 years) Hypertension Ace Inhibitors • • • • • • Medications captopril (Capoten®) benazepril/amlodipine (Lotrel®) enalapril (Vasotec®) enalapril/HCTZ (Vasoretic®) lisinopril (Prinivil®, Zestril®) lisinopril/HCTZ (Prinzide®, Zestoretic®) Monitoring Annually/dosage change • K+ • serum creatinine • sodium (only applies to medications that include a diuretic) • BP Alpha Blockers • • • Medications doxazosin (Cardura®) prazosin (Minipress®) terazosin (Hytrin®) Monitoring Annually/dosage change • BP Alpha/Beta Blockers • • Medications carvedilol (Coreg®, Coreg CR®) labetalol (Trandate®, Normodyne®) Medication Refill SO Policy_2010.doc Monitoring Annually/dosage change • BP Page 6 of 10 FIGURE 23 Angiotensin II Receptor Blockers • • • • • • Medications irbesartan (Avapro®) irbesartan/HCTZ (Avalide®) losartan (Cozaar®) losartan/HCTZ (Hyzaar®) telmisartan (Micardis®) telmisartan/HCTZ (Micardis HCT) Monitoring Annually/dosage change • K+ • serum creatinine • sodium (only applies to medications that include a diuretic) • BP Beta Blockers • • • • Medications atenolol (Tenormin®) atenolol/chlorthalidone (Tenoretic®) metoprolol (Lopressor®, Toprol XL) propranolol (Inderal®) Monitoring Annually/dosage change • BP • Heart rate Calcium Channel Blockers • • • • Medications amlodipine (Norvasc®) diltiazem (Cardizem®, Cardizem CD/SR®, Dilacor®) nifedipine (Procardia XL®) long acting verapamil (Calan®, Calan SR®, Isoptin®, Verelan®) Monitoring Annually/dosage change • BP • Heart rate (diltiazem, verapamil) Central Acting Antiadrenergics • • Medications clonidine (Catapres®, Catapres TTS®) methyldopa (Aldomet®) Monitoring Annually/dosage change • serum creatinine • BP Direct Renin Inhibitors • Medications aliskiren (Tekturna®) Monitoring Annually/dosage change • K+ • serum creatinine • BP Diuretics • • • • • • • • Medications furosemide (Lasix®) hydrochlorothiazide/ HCTZ (Hydrodiuril®) chlorthalidone (Thalitone®) indapamide (Lozol®) spironolactone (Aldactone®) eplerenone (Inspra®) triamterene/HCTZ (Dyazide®, Maxzide®) metolazone (Zaroxolyn®) Monitoring Annually/dosage change • K+ • serum creatinine • sodium • BP Hypothyroidism • Medications Levothyroxine (Synthroid®, Levothroid®) Medication Refill SO Policy_2010.doc Monitoring Annually/ dosage change (6wks) • TSH sensitive Page 7 of 10 FIGURE 23 Migraine • • • • • • Medications almotriptan (Axert®) eletriptan (Relpax®) rizatriptan (Maxalt®) sumatriptan (Imitrex®) frovatriptan (Frova®) naratriptan (Amerge®) Monitoring Non-Steroidal Anti-Inflammatory Drugs • • • • • • • • • Medications flurbiprofen (Ansaid®) ibuprofen (Motrin®) indomethacin (Indocin®) meloxicam (Mobic®) naproxen (Naprosyn®) piroxicam (Feldene®) salsalate (Disalcid®) sulindac (Clinoril®) tolmetin (Tolectin®) Monitoring Annually • serum creatinine • Hgb • ALT (if on sulindac [Clinoril®]) Osteoporosis Medications BISPHOSPHONATES • alendronate (Fosamax®) • alendronate/ cholecalciferol (Fosamax +D®) • risedronate (Actonel®) • ibraondranoate (Boniva®) Monitoring PUD (peptic ulcer)/ GERD (reflux) Medications H2 BLOCKERS • cimetidine (Tagamet®) • famotidine (Pepcid®) • ranitidine (Zantac®) PROTON PUMP INHIBITORS • dexlansoprazole (Dexilant®) • lansoprazole (Prevacid®) • omeprazole (Prilosec®) • pantoprazole (Protonix®) • rabeprazole (Aciphex®) • esomeprazole (Nexium®) Medication Refill SO Policy_2010.doc Monitoring Page 8 of 10 FIGURE 23 Respiratory Medications BRONCHODILATOR INHALERS • albuterol (Proair®, Ventolin HFA®) • albuterol/ipratropium (Combivent®) • ipratropium (Atrovent®) • pirbuterol (Maxair®) • salmeterol (Serevent®) • tiotropium (Spiriva®) BRONCHODILATOR for NEBULIZER • albuterol (Proventil®, Ventolin®) • albuterol/ipratropium (Duoneb®) • ipratropium (Atrovent®) LEUKOTRIENE MODIFIERS • montelukast (Singulair®) STEROID INHALERS • beclomethasone (QVar®) • mometasone furoate (Asmanex®) • budesonide (Pulmicort®) • fluticasone (Flovent®) • fluticasone/salmeterol (Advair®) • budesonide/formoterol (Symbicort®) STEROID for NEBULIZER • budesonide (Respules®) THEOPHYLLINE • various products Monitoring Each refill • Check for refill requests. If requests more frequently than provider ordered, route for provider review (may require adding or increasing dose of steroid inhaler). Albuterol • 4th refill request for an albuterol inhaler within 1 yr of the original prescription - RN assesses for increasing asthma severity level and/or need for controller medication. Review with provider. See Bronchodilator Inhaler monitoring Annually • theophylline level Seizures • • • • • • • • • • Medications carbamazepine (Tegretol®) phenobarbital (Luminal®) phenytoin (Dilantin®) valproic acid/divalproex (Depakote®, Depakote ER ®) gabapentin (Neurontin®) lamotrigine (Lamictal®) levitiracetam (Keppra®) oxcarbamazepine (Trileptal®) topiramate (Topomax®) zonisamide (Zonegran®) Monitoring Annually • drug level (carbamazepine, phenobarbital, phenytoin and valproic acid/divalproex) • Weight • CBC (carbemazepine only) • ALT (carbemazepine and valproic acid) • Sodium (carbamazepine, oxcarbamazepine) • BMP (topiramate) Supplements Medications • • • calcium Vitamin D potassium Monitoring Annual/change in dose • K+ level MULTIVITAMINS • multiple products Medication Refill SO Policy_2010.doc Page 9 of 10 FIGURE 23 Topical Agents Medications ACNE, ROSACEA, ECZEMA, PSORIASIS • adapalene (Differin®) • azelaic acid (Azelex®; Finacea®) • benzoyl peroxide (Benzac®, Brevoxyl®, others) • clindamycin (Cleocin T®) • metronidazole (MetroCream®, MetroGe®l, MetroLotion®) • tazarotene (Tazorac®) • tretinoin (Retin-A®, Retin-A Micro®) Monitoring Tazarotene should not be used during pregnancy. Urinary Incontinence • • • • • • Medications oxybutynin (Ditropan ®, Ditropan XL®, Oxytrol®) tolterodine (Detrol®, Detrol LA®) darifenacin (Enablex®) fesoterodine (Toviaz®) solifenacin (Vesicare®) trospium (Sanctura®) Monitoring Miscellaneous • Medications acetaminophen (Tylenol®) • allopurinol (Zyloprim®) • Nicotine patches (Nicoderm CQ®, Nicotrol®) Monitoring Annually (with frequent usage) • ALT • serum creatinine Annually • serum creatinine • ALT • CBC Annually • Heart rate • BP Drug Information: http://micromedex.HealthPartners.com Approval for use as a Population Based Standing Order: Debra Johnson, MD Date Art Wineman, MD Date Rae Ann Williams, MD Date Beth Averbeck, MD Date Medication Refill SO Policy_2010.doc Page 10 of 10