Palliative sedation: sleeping before we die

Conditions of Participation Management of Drugs and Biologicals- Best Practices HospiScript Services A Catalyst Rx Company  Describe the requirements of the regulations and best practices related to drugs and biologicals  Meeting the standard for drugs and biologicals  Drugs that are generally not cost effective  1st generation vs. 2nd generation antipsychotics Introduction to Conditions of Participation  The Hospice Final Rule was published in the Federal Register on June 5, 2008 and became effective December 2, 2008  Hospices had an additional 60 days for QAPI requirements which went into effect on February 2, 2009  The new COPs are patient-oriented, founded on evidence and standards of practice, and emphasize quality improvement and patient outcomes.
 Medication therapy management (MTM) is emphasized  The outcome-oriented survey process emphasizes the hospice’s  Surveyors instructed to focus on patient health and safety and to look at  All conditions viewed relative to outcomes for the patient/family  Goals should reflect patient/family preferences  Evaluate each CoP in the most efficient manner possible  Surveyor considers interrelatedness of the regulations while evaluating compliance through observations, interviews, home visits, and record reviews responsibilities, more in depth knowledge about the regulations may be required  Hospice providers should develop a strategy to remain compliant with the regulations all of the time  Survey readiness “flurry” is not productive  Compliance is not an EVENT, it is a PROCESS Meeting Standard: 418.106 Drugs and Biologicals  The hospice must employ or contract with and individual to assure that medications meet each patient’s needs  PBM or other company/individual that provides such  Internal resources that meet the standard  Pharmacist are not required to be a member of Meeting Standard: 418.106 Drugs and Biologicals Who is qualified to assure that medications meet the needs of the patient? 418.106 (1)(a) L 688  Hospices must confer with an individual with education and training in drug management  Physicians who are board certified in palliative medicine  RNs and NPs who complete a specific hospice or palliative  The hospice must be able to demonstrate that the person has specific education and training in drug management Meeting Standard: 418.106 Drugs and Biologicals  A hospice that provides inpatient care directly in its own facility must provide pharmacy services under the direction of a qualified pharmacist who is an employee of or under contract with the hospice. The provided pharmacist services must include evaluation of a patient’s response to medication therapy, identification of potential adverse drug reactions, and recommended appropriate corrective action.
 If ordered verbally or via electronic  Must be given to nurse, NP, MD or pharmacist  What about orders left on a recording?  OK, but must be reviewed by a pharmacist  Be sure to leave all pertinent information  Pharmacy must have a signed order PRIOR to dispensing unless “Emergency” order  Faxed, signed order may serve as the original- no follow up prescription needed  MDs may order 60 day supply- pharmacy can  Allowed in Alabama- not in all states  Verbal order may be accepted by pharmacist  Order may only be for emergency supply- in  Prescriber must make the call, not his/her agent  MD must send follow up signed order to the pharmacy within 7 days for emergency supply only  Pharmacy required to report to DEA if Rx not received 418.106 (c) Standard: Dispensing of Drugs  Have written policy that promotes dispensing  Maintain records of receipt and disposition of all 418.106 (d) Standard: Administration of Drugs  (1) The IDG must determine the ability of patient and/or caregiver to self-administer drugs in the home setting  (2) In an IPU, meds can be given only by:  Nurse, MD, other- according to State law  The patient- upon the approval by the IDG 418.106 (e) Standard: Labeling, Disposing, Storing of Drugs  (1)Labeling- in accordance with current  (2) Disposing of controlled drugs (i) In home setting- Hospice must have written P&P  (A) provide a copy of P&P to patient/family  (B) Discuss P&P with patient/family  (C) Document providing and discussing P&P 418.106 (e) Standard: Labeling, Disposing, Storing of Drugs  Disposing of controlled drugs (ii) In IPU, hospice must dispose of drugs in compliance with hospice policy and State and Federal requirements and maintain records of receipt and disposition of drugs.
418.106 (e) Standard: Labeling, Disposing, Storing of Drugs  (3) Storing- In an IPU- no specific storage  (i) Drugs must be stored in secure area in locked compartments. Only personnel authorized to administer drugs may have access to locked compartments  (ii) Discrepancies must be immediately investigated by the pharmacist and administrator and where required, reported to the appropriate State authority.
 A written account must be made available to State and Federal officials if required by law or regulation.  Work with facility to include needed hospice medications in the facility stat cabinet/ emergency kit  Hospice must maintain a coordinated agency-wide program for surveillance, identification, prevention, control, and investigation of infectious and communicable diseases  Must be an integral part of the hospice’s QAPI program  Monitor work related employee illness and infections  Analyze them in relation to patient infections  Take appropriate actions when an infection or communicable disease is present to prevent its spread among staff, patients, family and visitors  The hospice must provide infection control education to employees, contracted providers, patients, and family members and other caregivers  Is hospice staff aware of infection control principles and  Do they demonstrate this knowledge during home visits?  During home visits ask the patient/family or other caregivers to describe infection control education they have received  Ensure that you have an adequate “infection control nursing bag” policy/procedure for hospice staff that visits patients in their home  Ensure that patient/family received education materials and training about infection prevention and control in the inpatient and home setting  Consider adopting an annual infection control education update for  Promote infection prevention and control within the hospice organization  Display infection prevention and control posters  Support health promotion activities for hospice staff  Encourage hospice staff to obtain flu shots during flu season  Erytab 333- Generic- Enteric coated base- time released Possible Unnecessary Expense for Antibiotics  Receive effective pain management and symptom control  Be involved in developing the plan of care  Choose his or here attending physician  Receive information about services covered under the hospice  Receive information about the scope and limitations of services  Use all agents available as appropriate If we know that pain and suffering can be alleviated, and we do nothing about it, then we ourselves become the tormentors.
Meeting Standard 418.54 (c) Comprehensive Assessment  Describe process for medication review, including how adverse effects  Describe process followed in patient/family is non-compliant  Describe how patients/families are educated about pain management  Describe how symptoms are assessed and re-assessed  Describe how a patient is monitored when a new medication is added or the dose is altered or medication is d/c’d  Demonstrate that common side effects of medications were anticipated  Show that the medications the patient is currently taking are the same 418.54 (c)(6) Initial and Comprehensive Assessment – Medication Profile Review  A review of ALL prescription and OTC, herbal and alternate treatments. Includes but not limited to identification of the following:  Actual or potential drug interactions  Drug therapy associated with laboratory monitoring 418.54 (c)(6) Initial and Comprehensive Assessment – Medication Profile Review  Drug profile must be completed within 5 days of admission as part of the comprehensive and updated at least every 15 days or with a change in the patient’s status.
 Nurses should document a full medication profile, including OTC and herbal medications  Not required to document relationship of drug therapy to terminal illness or related condition but encouraged to do so. 418.54 (c)(6) Initial and Comprehensive Assessment – Medication Profile Review Best Practices for Performing a Medication Profile Review When obtaining a medication history, the nurse should:  Ask to look at all prescription bottles  Verify that medications are labeled correctly  Capture full dosing information for each medication Best Practices for Performing a Medication Profile Review  Use probing questions to trigger the patient’s memory on what they  What do you take only when you need it?  Do you ever NOT take your medication and why?  Ask about OTC and herbal meds and nutritional supplements  Ask about meds not taken orally- inhalers, patches, creams, drops  Assess the health literacy and compliance potential of the Best Practices for Performing a Medication Profile Review  Take steps to simplify the patient’s drug regimen  Consider non-pharmacological therapies  Use sustained release products if appropriate and cost effective  Use the fewest meds in the simplest form to achieve the therapeutic  D/C meds that are not effective or don’t meet goals of hospice care  Establish relationship of medication to terminal diagnosis Best Practices for Performing a Medication Profile Review  On admission and with medication changes, a review of the patient’s medications, allergies and medical conditions should be conducted to:  Assure accuracy and completeness of the order  Assess appropriateness of dose, route of administration, dosage  Identify previous allergic or adverse reactions to a previous medication or one that is chemically similar  Identify drug-drug or drug-disease interactions or Best Practices for Performing a Medication Profile Review  Verify that the medication is safe and effective and is the most cost effective solution for the patient’s symptom  Assess symptoms to determine if it may be the result of an adverse  Ensure that the patient is not receiving inappropriate duplicate  Multiple medications for the same reason  Use one medication to treat multiple symptoms when possible  Suggest alternate routes of administration when appropriate Medications that are generally NOT the most cost effective Atypical or Second Generation Antipsychotics (SGAs) vs. Conventional Agents Conventional Agents
What is CATIE? Clinical Antipsychotic Trials of Intervention Effectiveness  Phase I- Determine which meds provide best Tx Phase II- Help choose alternate med when 1st choice was not  Schizophrenia Study AD Study Compares Atypical and Conventional agents  Older agents generally performed as well as newer agents  EPS was not seen more frequently with older agents  On the whole, newer agents have no substantial advantage  Head to head drug comparisons
 Antipsychotic treatment must be individualized Newer agents cannot always be replaced with older agents  FDA classified Dypyridamole as a desi drug  Only official indication is IV to conduct a stress test  BI introduced Aggrenox on the strength of clinical trials that showed Aggrenox was better than placebo  Annualized sales of approximately $331 million for the Examples of Medication-Related QAPI Projects Queries by drug or drug class  Meperidine or Propoxyphene- reduce the use of inappropriate  Antipsychotics- examine use in dementia and if non-pharm measures  Antibiotic- Infection control measures  Patients receiving routine opioids not on a bowel regimen  Patients receiving long acting pain meds with no PRN breakthrough  PRN meds ordered at the appropriate interval  Patients receiving long acting inhaled beta agonists with no rescue  AW is a 54 yo female with end stage pulmonary  Pain score 9/10 most of the time, 5-6 at best Complaining of “lung pain” Current medications  WC is a 73 yo male with lung cancer with  Uncontrolled general pain and leg pain  Current pain meds are Fentanyl 100mcg 4 patches every 48 hours, MSIR 60mg q 1 h prn BTP Case Study - Recommendations and Follow Up  Recommend 30mg methadone q12h with 60mg  NSAID for bone mets  Monitor for excessive sedation Liberal use of BTP medication encouraged Follow up in 24 hours x 3  Subsequent follow up in 4 days- pain improved to 1-2/10 Subsequent follow up in 1 & 4 weeks- one additional  The new COPs have a strong emphasis on appropriate medication therapy management and monitoring  Hiring or contracting with an individual with special training in  Documentation of all medications on the drug profile

Source: http://www.oregonhospice.org/Downloads2010/ConferenceDwnloads/Redden2010PPE.pdf