Medication Management and Use System. 6 th Edition

Transcription

1 Medication Management and Use System 6 th Edition 1

2 Medication Prescription medication Sample medication Herbal remedies Nutraceuticals Vaccines Diagnostic and contrast agents Radioactive medications Vitamins Intravenous solutions Parenteral nutrition 2

3 Medication Management and Use (MMU) Organization and Management Selection and Procurement Storage Ordering and Transcribing Monitoring Administration Preparing and Dispensing 3

4 Changes in 6 th Edition 6 th Edition Standard(s) Number Description of Changes MMU.1.1 Introduce a new standard that identifies the requirements for organizations to develop and implement a program for antibiotic stewardship MEs 1 through 5 include requirements for - a program that involves all staff and includes patients and families - a program that is based on scientific evidence - Proper use of prophylactic antibiotics - Oversight of the program - Monitoring the effectiveness of the program New Standard New ME(s) 4

5 Changes in 6 th Edition 6 th Edition Standard(s) Number Description of Changes MMU.5.1 Adds language to the intent and ME 2 clarifying who may perform an appropriateness review Adds new ME 4 and language to the intent identifying the critical aspects of an appropriateness review for the critical aspects may be performed, and the time frame for the full appropriateness review to be conducted Eliminates ME 3 (5 th edition), which required a process to contact the individual who prescribed/ordered a medication when questions arose; requirement covered in MMU.4.1, ME 2 Adds language to ME 6 clarifying that print reference materials as well as computer programs for crosschecking drugs must by current and updated New Standard New ME(s) 5

6 Changes in 6 th Edition 6 th Edition Standard(s) Number Description of Changes MMU.5.2 Adds language to the intent clarifying what is meant by medications dispensed in the most ready-to-administer format Provides examples of situations in which the most ready-to-administer format is critical Adds language to ME 1 identifying that dispensing and distribution comply with laws and regulations Adds language to ME 2 that addresses the use of the most ready-to-administer format that is available Adds new ME 3 that requires a system to support accurate and timely dispensing and requires documentation of dispensing practices Adds language to ME 4 (formerly ME.2, 5 th edition) that requires the use of two patient identifiers when labeling medications prepared but not immediately administered New Standard New ME(s) 6

7 Changes in 6 th Edition 6 th Edition Standard(s) Number Description of Changes MMU.6.1 Adds new ME 4 and renumbers MEs accordingly ME.4 Patients are informed about the medications that they are going to be given and have an opportunity to ask questions. New Standard New ME(s) 7

8 Medication Management and Use (MMU) Organization and Management Selection and Procurement Storage Ordering and Transcribing Monitoring Administration Preparing and Dispensing 8

9 MMU.1 Organization and Management MMU.1 Medication use in the hospital is organized to meet patient needs, complies with applicable laws and regulations, and is under the direction and supervision of a licensed pharmacist or other qualified professional. Pharmacy Therapeutic and Transfusion (PT&T) Committee Pharmacy Therapeutic and Transfusion (PT&T) Committee Doctors Nurses Pharmacists Medical Technologist Nutritionist Information Technologist Quality Coordinator A written document addressing a) Planning b) Selection and procurement c) Storage d) Ordering e) Preparing and dispensing f) Administration g) Monitoring h) Evaluation Plans and policies comply with laws and regulations System review of medication management at least once a year Appropriate sources of drug information are available. 9

10 Plan and Policy Policy Medication Management and Use Plan Patient Safety Goal 3: Safety of High-alert medications Patient Safety Goal 3: Control of high concentration medications/solution in patient care unit Document No. P/L-01-BHMC-013 S/P-02.1-BHMC-005 S/P-02.1-BHMC-006 Medication Reconciliation Policy Policy for the Safe Prescribing Safety of Medication Use Brought in Medication S/P-02.1-BHMC-009 S/P-02.1-BHMC-013 S/P-02.1-BHMC-018 S/P-01-BHMC

11 MMU.1 Organization and Management New MMU.1.1 The hospital develops and implements a program for the prudent use of antibiotics based on the principle of antibiotic stewardship. Introduce new standard of antibiotic stewardship Requirements of the program include: involving all staff and includes patients and families is based on scientific evidence proper use of prophylactic antibiotics oversight of the program monitoring the effectiveness of the program 11

12 What is antibiotic stewardship? Antibiotic stewardship refers to the optimal selection, dosage, and duration of antimicrobial treatment that results in the best clinical outcome for the treatment or prevention of infection, with minimal toxicity to the patient and minimal impact on subsequent resistance. (Antimicrobial Stewardship, Mayo Foundation for Medical Education and Research, Shira Doron, MD. And Lisa E. Davidson, MD.) According to US CDC, drug-resistance bacteria cause 23,000 deaths and 2 million illness each year. Some estimate that more than 700,000 deaths occur worldwide per year due to antibiotic resistance. การใช ยา Antibiotics อย างเหมาะสมท งชน ด ขนาดและระยะเวลาในการให ยา โดยม ระบบและ มาตรการต างๆ เพ อสน บสน นการใช ยาอย างสมเหต สมผล เช น การประเม นการใช ยา, การจ าก ดต าร บยาของรพ., การขออน ม ต ก อนการใช ยา (pre-authorization), การสร างและใช แนวทางเวชปฏ บ ต (Clinical Practice Guideline) (ภก.ส จจา ศ ภรพ นธ, งานเภส ชกรรมผ ป วยใน รพ.ศ ร ราช) 12

13 US CDC (Centers for Disease Control and Prevention) Core Elements Top leadership: dedicate resources, financial, staff time; training and education, information technology Accountability: Appoint a single Physician leader for the program (Inf. Dis., Hospitalist). Add this to job description Drug Expertise: Appoint a single Pharmacy leader responsible for improving Abx use. Add this to job description Expand Pharmacy Committee oversight Other key staff: Infection Control, Lab, Nurses (frontline), Dept.Leaders, Quality Program staff, IT staff 13

14 US CDC Core Elements Tracking: monitor and measure Abx prescribing patterns, and drug resistance patterns Reporting: regular reporting to Physicians and Nurses of overall use and resistance Education: reinforce teaching of optimal prescribing with clinicians; increase motivation like with AMI and CHF Action: Implement at least one recommended action at a time 14

15 MMU.1.1 Survey Expectations Hospital develops and implements a program; involves key staff, patients, and families Program based on CPGs and laws/regulations Program includes proper use of Abx., including prophylaxis Mechanism for oversight : small work group, a coordinating committee, a task force Effectiveness monitored (data collected, analyzed and used) 15

16 MMU.1.1 Survey Expectations Implement the program formally; top leadership support Start small and expand; use data to guide when possible Some specifics are largely up to you and your organization Who is responsible and overseeing? Sample tools Measures with data to evaluate effectiveness Short-term evaluate compliance: evidence of a decrease in the inappropriate use of antibiotics, documentation that prescribers are following accepted practice guidelines. audits with feedback; tie to SQE Long term might consider evaluate resistance, CDI (Clostridium difficile Infections) cases, decreased LOS 16

17 Medication Management and Use (MMU) Organization and Management Selection and Procurement Storage Ordering and Transcribing Monitoring Administration Preparing and Dispensing 17

18 MMU.2 Selection and Procurement MMU.2 Medications for prescribing or ordering are stocked, and there is a process for medications not stocked or normally available to the hospital or for times when the pharmacy is closed. Orphan Drug Life Saving 18

19 MMU.2 Selection and Procurement MMU.2.1 There is a method for overseeing the hospital s medication list and medication use. Risk Side effects Drug-drug, drug-food interaction Look alike sound alike Restriction to use Benefit FDA-approved indications Therapeutic outcomes Drug evaluation Pharmacology and mechanism of action Dosage forms and storage, Recommended dosage regimens Pharmacokinetic considerations Use in special populations (e.g., children, elderly, patients with renal or liver failure) Pregnancy category and use during breast-feeding Cost per treatment Reference: 19

20 Number of medications Number of medication list in BHQ hospital formula Yr SMP Drugs Caused ADR

21 Medication Management and Use (MMU) Organization and Management Selection and Procurement Storage Ordering and Transcribing Monitoring Administration Preparing and Dispensing 21

22 MMU.3 Storage MMU.3 Medications are properly and safely stored. 22

23 Storage Inside Pharmacy room Out of Pharmacy room 23

24 High Alert Medication Specific storage of high alert medications is uniform throughout the hospital. No high concentrated medication/solution kept in patient care unit 24

25 Storage Area Inspection % compliance to checklist Inspect 67 areas outside Pharmacy 25

26 MMU.3 Storage MMU.3.1 There is a process for the management of medications and nutritional products that require special handling. Radioactive safety risk Brought in medication identification and storage Sample medication - abuse or misuse Breast milk proper labeling and storage Surveyor Tips New language, but concepts were here before for labeling Need policies, then document tracking these required items for these special medications and products Problem areas: breast milk, meds brought in from home, and samples 26

27 MMU.3 Storage MMU.3.2 Emergency medications are available, uniformly stored, monitored, and secure when stored out of the pharmacy. Example: In each emergency cart, the emergency medications are in the same drawer and laid out in the same manner within the drawer of each cart. Storage of medications in pediatric emergency carts is different from adult carts; however the medications are stored uniformly within each type of cart. Surveyor Tips Store emergency meds exactly the same way All adult carts the same; all pediatrics the same Arrangement and location of meds; labeling of compartments; high alert or LASA??; required numbers Checklists daily? Security of carts/locks Tracking break-away locks: where stored, numbers, log How are meds replaced? How often is there a routine check if cart not opened? 27

28 MMU.3 Storage MMU.3.3 The hospital has a medication recall system. Expired = expire date on original packaging from manufacturer Outdated = when it is opened, how long it is safe and effective to use for a short period of time (shelf life) Ex. Insulin 30 days after open. Surveyor Tips Have any recall data to show us How determined the safe timeframe for outdated meds? Multidose vials, nitro, pills open in a bottle? Not those in individual blister packs and watch the lot numbers and expiry dates on these packs Do you destroy or return expired or outdated meds? 28

29 Medication Management and Use (MMU) Organization and Management Selection and Procurement Storage Ordering and Transcribing Monitoring Administration Preparing and Dispensing 29

30 MMU.4 Ordering and Transcribing MMU.4 Prescribing, ordering, and transcribing are guided by policies and procedures. 30

31 MMU.4 Ordering and Transcribing MMU.4.1 The hospital defines the elements of a complete order or prescription. Surveyor Tips Revises language in the intent and ME 1 to clarify requirements including: Rates of administration for IV infusions Special orders such as titration, tapering or range orders. Clarifies the need to identify precautions for ordering medication with look-alike or sound-alike names Required elements in Intent need to be defined by you PRN make more specific Intravenous infusion rates not Saline 1 liter Titration: can be heart rate, blood pressure, urine output Weight-based: chemo, children, ICU 31

32 MMU.4 Ordering and Transcribing MMU.4.2 The hospitals identified individual permitted to prescribe or to order medications. Only those permitted by hospital prescribe or order medications. There is a process to place limit : controlled substances, chemotherapy, radioactive and investigational medications. Individuals are known to pharmaceutical service 32

33 MMU.4 Ordering and Transcribing MMU.4.3 Medication prescribed and administered are written in the patient s medical record. Medications prescribed or ordered are recorded for each patient. Medication administration is recorded for each dose, including as needed Medication information is kept in the patient s medical record. 33

34 Medication Management and Use (MMU) Organization and Management Selection and Procurement Storage Ordering and Transcribing Monitoring Administration Preparing and Dispensing 34

35 MMU.5 Preparing and Dispensing MMU.5 Medications are prepared and dispensed in a safe and clean environment Clean, uncluttered, safe and functionally separate areas with appropriate equipment and supplies. Adhere to laws, regulations and professional standards of practice. Well trained staff aseptic techniques. 35

36 MMU.5 Preparing and Dispensing MMU.5.1 Medication prescriptions or orders are reviewed for appropriateness ME.4 When the designated licensed professional is not available to perform the full appropriateness review, a trained individual conducts a review of critical elements h) through k) in the intent for the first dose and a full appropriateness review is conducted by the designated licensed professional within 24 hours 36

37 MMU.5 Preparing and Dispensing MMU.5.1 Medication prescriptions or orders are reviewed for appropriateness 1 st review : appropriateness a) through g) done by Pharmacist at the time of prescribing / ordering 2 nd review : verification at the time of administration The review may be performed by other trained professionals, make sure the competency. A Full review need to be done within 24 hour by pharmacist. Surveyor Tips Continues the standard verification during normal work hours Subgroup of critical component at a minimum after hours Show us: pharmacy verifications (and actions taken); training and competency for other staff to perform (such as nurses); documented reviews of critical items; ensure access to a med profile after hours; current/updated references 37

38 MMU.5 Preparing and Dispensing MMU.5.2 A system is used to safely dispense medication in the right dose to the right patient at the right time. Surveyor Tips Labels. And two patient identifiers The most ready-to-administer ***Drugs that are not immediately administer must be labeled. ***Medication prepared for use during a surgical procedure in OR and unused portions are discarded immediately after procedure, the patient s name and expiration date may not be necessary. Fastest available form especially in emergencies Accurate and timely dispensing; we also look for administration times against orders and MAR sheets Continued frequent problems in OR, other sterile fields with incomplete or missing labels; also now watch 2 IDs Focus area : Cath lab 38

39 Medication Management and Use (MMU) Organization and Management Selection and Procurement Storage Ordering and Transcribing Monitoring Administration Preparing and Dispensing 39

40 MMU.6 Administration MMU.6 The hospital identifies those qualified individual permitted to administer medications. Specific knowledge and experience Permitted by licensure, certification, laws or regulations Place limit, when appropriate, such as controlled substances or radioactive and investigational medications. 40

41 MMU.6 Administration MMU.6.1 Medication administration includes a process to verify the medication is correct based on the medication prescription or order. New Requirements ME.4 patients are informed about the medications that they are going to be given and have an opportunity to ask questions. Surveyor Tips ***Verify with prescription or order. Can be documented in different places on a PFE sheet, progress notes, unit orientation for patients/families. Can be at different times on rounds, prior to administration, among others. 41

42 MMU.6 Administration MMU.6.2 Policies and procedures govern medications brought into the hospital for patient self-administration or as samples. Medication brought in Sample Self-administration Medication brought in by the patient or family, Sample, Selfadministration is known to the patient s physician and noted on the patient s medical record. 42

43 Medication Management and Use (MMU) Organization and Management Selection and Procurement Storage Ordering and Transcribing Monitoring Administration Preparing and Dispensing 43

44 MMU.7 Monitoring MMU.7 Medication effects on patients are monitored. To evaluate the medications effect on the patient s symptom or illness. To evaluate the patient for adverse effects. Closely monitor the patient s response to the first dose(s) of a medication new to the patient. Monitor effects and side effects document record in medical record document and report adverse effects in the time frame required. 44

45 MMU.7 Monitoring MMU.7.1 The hospital establishes and implements a process for reporting and acting on medication errors and near misses. Defining a medication error and near miss Reporting system and acting Identify those accountable for taking action Use reporting information to improve medication use processes. 45

46 46 Tel. 1719