2/21/2015
2015
THE JOINT COMMISSION (TJC) MEDICATION MANAGEMENT (MM) STANDARDS
Andre Emont, M.S. R.Ph
Director of Pharmaceutical Services
University Hospital
1
Disclosures
• I do not have (nor does any immediate family member have) a vested interested in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation
2
Presentation Objectives
• Recognize 2015 TJC Medication Management (MM) standards and other applicable standards related to pharmacy practice
• Identify new and revised requirements for medication‐related standards in 2015
• Summarize a hospital’s organizational approach in meeting 2015 TJC MM standards
• Describe strategies and techniques that can assist hospital pharmacy departments with the survey process
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Top MM Standard Scored Non‐Compliant 2012 vs. 2013
MM.03.01.01 Storage and Security of Meds
MM.04.01.01 Medication Orders
MM.05.01.01 Medication Order Review
NPSG.03.04.01 Labeling in OR/procedures NPSG.03.06.01 Reconciling Medications MM.01.01.03 High Alert/Hazardous Meds
MM.05.01.09 Medication Labeling MM.05.01.07 Preparing Medications 2013
34.7%
22.4%
15.7%
13.0%
5.8%
4.8%
5.16%
4.8%
The Joint Commission Resources
2012
34.8%
25.8%
15.4%
13.9%
5.55%
5.3%
5.3%
4.9%
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TJC Definition of a Medication
• Any prescription medications, sample medications, herbal remedies, vitamins, nutraceuticals, vaccines, or over the counter drugs
• Diagnostic and contrast agents used on or administered to persons to diagnose, treat, or prevent disease or other abnormal conditions
• Radioactive medications, respiratory therapy treatments, parenteral nutrition, blood derivatives, and intravenous solutions (plain, with electrolytes and/or drugs) and any product designated by the Food and Drug Administration (FDA) as a drug
The Joint Commission Resources
5
TJC Definition of a Medication • This definition of medication does not include enteral nutrition solutions (which are considered food products), oxygen, and other medical gases
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MM.01.01.01
The hospital plans its medication management process
• Rationale: hospital plans each part of the process with care so safety and quality are maintained.
• ID Description
– The organization has a written policy that describes that the following information about the patient is accessible to licensed independent practitioners and staff who participate in the management of the patients medications
• Age
• Current medications
• Sex
• Height and weight
• Diagnoses
• Pregnancy and lactation • Allergies
• Laboratory results
• Sensitivities 7
MM.01.01.01
Example of “Active Integration”:
• Pharmacy – laboratory results interface: processing of a digoxin order for a patient with a high potassium level gives a warning of the potential for increased toxicity.
• Ideally, “Active Integration” of patient information in the medication use process would guarantee compliance with this standard.
8
MM.01.01.01
Another example of “Active Integration”:
• Verifying a Tetracycline order for a breast‐
feeding mother would provide a warning on the medications contraindication.
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How Will MM.01.01.01 Be Surveyed?
• Look over pharmacist’s shoulder as they are verifying medications to make sure the previous fields are populated before filling medication order.
• Surveyors make sure pregnancy and lactation status are available to pharmacists on the profile.
• Pharmacist will not fill any medication orders until all fields are populated
• If there is a change in allergy e.g. NKA to PCN, it must be communicated to pharmacy for profile update. Surveyors will specifically pick a chart with this change to make sure this communication has happened. • Real experience: Surveyors asked a pharmacist to access lab data while verifying and he/she fumbled. Surveyors response was “I guess you don’t look at lab data often enough.”
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The Pharmacy and Therapeutics (P&T) Committee
• The primary purposes of the Pharmacy and Therapeutics Committee are (1) advisory and (2) educational.
• The Pharmacy and Therapeutics Committee is an advisory group of the medical staff and serves as the organizational line of communication between the medical staff and the pharmacy. • This committee is composed of physicians, pharmacists, and other health professionals selected with the guidance of the medical staff.
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Adding New Drugs to the UH Formulary
• One‐time request for non‐formulary drug form
• New drug formulary addition request form
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Adding/Removing Drugs To/From the Formulary
• Any member of the Medical Staff may request the addition of a drug to the formulary ‐ request to the Pharmacy and Therapeutics Committee. • For each drug, specific consideration is given to: pharmacologic classification, therapeutic indications, dosage forms available, bio‐availability and pharmacokinetics, dosage range, known side effects and toxicities, advantages of the drug over similar agents, disadvantages of the drug compared to similar agents, therapeutic comparisons with other drugs or treatments, cost comparisons with other drugs or treatments.
• Request for deletion of a drug from the formulary shall be submitted in writing to the Director of Pharmacy and the Pharmacy and Therapeutics Committee for action. 13
Adding/Removing Drugs To/From the Formulary
• All non‐formulary drugs should be dispensed on the order of any attending for a twenty‐four (24) hour period on weekdays and forty‐eight (48) hours on weekends only if the drug is currently in stock. • The appropriate departmental approval or authorization of the P&T Chairman (for non‐
formulary drugs) may be obtained for the next working day with a non‐formulary request form completed and sent to the Pharmacy.
• Pediatric/Geriatric implications
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One Time Non‐Formulary Request Form (CPOM)
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New Drug Formulary Addition Request Form
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Investigational Medications
• Institutional Review Board (IRB)
• Before the initiation of any clinical drug research at the University Hospital and clinics, the IRB must approve both the protocol and informed consent document
• The Pharmacy Dept must store and dispense all investigational drugs to ensure timely distribution of doses, complete drug information for proper administration and monitoring, accurate dispensing and inventory records, and proper preparation and storage. • The safety and welfare of the patients involved in the clinical drug trial must be recognized as the prime consideration in the management of the clinical trial.
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Herbal (Natural) Products
• Herbal medicines are not permitted to be on the hospital formulary and shall be handled by special request (using non‐formulary drug request form) only by the treating physician for those patients who require such medicines.
• Pharmacy will not supply herbal medications. Individual situations will be evaluated on a case‐by‐
case basis. • The Pharmacy Dept cannot guarantee outcome, strength, dose or freedom from misbranding, mislabeling or tampering. • Herbal products are considered non‐formulary agents.
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Contracted Services Expectations: LD.04.03.09
• Clinical leaders and medical staff have input as to source for outsourced services
• Written description of scope and nature of outsourced services in contract
• Expectations for performance provided by hospital according to defined measures provided to provider
• Performance is monitored
• Steps taken to correct identified performance problems
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MM.01.02.01 Look‐Alike/Sound‐Alike Medications
Can you name this drug?
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MM.01.02.01 Look Alike/Sound Alike Medications
• Chemotherapeutic Products (e.g. Cisplatin and Carboplatin, Taxol and Taxotere, Vinblastine and Vincristine)
• Lipid‐based vs. Conventional Forms of Amphotericin • Avandia and Coumadin
• Celebrex, Celexa and Cerebyx
• Clonidine and Clonazepam
• Dopamine and Dobutamine
• Diflucan and Diprivan
• Heparin and Hespan
• Retrovir and Ritonavir
• Pitocin and Pitressin
• Insulin Products (e.g. Humalog and Humulin, Novolog and Novolin, Humulin and Novolin, Humalog and Novolog, Novolin 70/30 and Novolog Mix 70/30)
• Folic Acid and Folinic Acid (leucovorin calcium)
• HydrOXYzine and HydrALAzine
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MM.01.02.01 Look Alike/Sound Alike Medications
• All look‐alike sound‐alike medications are to be checked by two registered nurses before administering to the patients.
• For all verbal/telephone orders for look‐alike sound‐alike medications, the listener will read back the entire order and spell the product name.
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MM.01.01.03
High Alert and Hazardous Medications
• Know your hospital’s high alert medications • Know process for managing high alert medications: double checks, labeling, pop‐ups, etc.
• Biggest Issue: NOT following the process
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High Alert Medication Strategies
• How have you defined these?
• How have you defined strategies for reducing risk?
• How have you disseminated information about risk and new processes?
• Recommendation: address the specific risks of each high alert medication on your list
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High Risk/High Alert Medications • Chemotherapeutic Agents (e.g. Methotrexate, Cisplatin, Carboplatin, Paclitaxel, Docetaxel, Vinblastine, Vincristine etc.)
• Heparin
• Fosphenytoin/Phenytoin IV
• Digoxin IV
• Neuromuscular Blocking Agents (e.g. succinylcholine, rocuronium, cisatracurium) • Insulin Products (e.g. regular insulin, insulin aspart, insulin glargine)
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High Risk/High Alert Medications • Concentrated electrolyte solutions that have been removed from the patient care areas at University Hospital:
–
–
–
–
–
Concentrated Potassium Chloride Injection (vials)
Potassium Phosphate Injection (vials)
Sodium Phosphate Injection (vials)
Magnesium Sulfate Injection (greater than 2ml)
Sodium Chloride (greater than 0.9% limited to critical care areas only)
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Hazardous Medications
• Requirements are included in MM.01.01.03, EC.01.01.01, EC.02.02.01, EC.04.01.01, as well as LD, LS, and EM references
• Need a list! (MM.01.01.03)
• Defined by NIOSH
• Strategies to protect those who come in contact:
–
–
–
–
PPE
Other primary engineering controls
Processes
Training
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MM.01.01.03
Hazardous Medications
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MM.02.01.01
Selection and Procurement of Medications
• Medication use process: SELECTION, PROCUREMENT, AND STORAGE STANDARDS • The organization maintains a complete and readily available list of medications (including strength and dosage).
• Communicate any additions/deletions
– Update through quarterly Pharmacy Newsletter
– Available electronically and hardcopy
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What’s new?
MM.02.01.01
Updated criteria for medication selection including pediatric and geriatric populations
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MM.02.01.01 EP 10‐15
Medication Shortages or Outages
• Listing of drug shortages e‐mailed weekly for distribution to department chairs, housestaff, nursing staff, and other ancillary services
• All drug shortages are reported to P&T Committee monthly
• For long term shortages, the Clinical Pharmacy Division will develop and approve written medication substitution protocols
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Medication Shortages or Outages
Product
Phosphorus (mmol)
Sodium (mEq)
Potassium (mEq)
Neutra‐Phos (Phos‐NaK, 1 packet)
8
7.1
7.1
K‐Phos Original (500 mg tablet)
3.7
0
3.7
K‐Phos Neutral (250 mg tablet)
8
13
1.1
Fleet Phospho Soda (per mL)
4.15
4.82
0
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MM.03.01.01
• The hospital safely stores medications
• Problematic EPs:
– EP 2: Medications are stored according to manufacturer’s recommendations
– EP 3: all medications and biologicals are stored in secure areas to prevent diversion and locked when necessary, in accordance with law and regulation
– EP 4: written policy addressing the control of medication between receipt by an individual and administration of the medications, including safe storage, handling, security, disposition, and return to storage
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MM.03.01.01
• Problematic EPs (cont.):
– EP 6: the hospital prevents unauthorized individuals from obtaining medications in accordance with law and regulation
– EP 8: removes expired, damaged, and/or contaminated meds/stores separately – EP 9: Keep concentrated electrolytes in patient care areas only when patient safety necessitates their immediate use and precautions are used to prevent inadvertent administrations • See MM.01.01.03
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MM.03.01.01
• Medication Security – biggest issue
• Medication (carts) in unsecure areas
– Keep in locked room, secure area, or under constant surveillance of licensed personnel
– C‐ Section room, inpatient units, procedural areas
– Lack of policy on who can have access to medications (e.g. janitors, maintenance)
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Medication Storage Issues
• Major
– No action taken when refrigerator temperature out of range
– Issues with expiration date on multi‐dose vials
– Wrong date, no date, not following policy
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Medication Storage Issues
• Minor
– Not keeping most ready‐to‐administer form as floor stock, when commercially available
– Unit dose, prefilled syringe, premixed bag
• Including crash carts
– Not storing drugs per manufacturer’s recommendation (new wording for 2009)
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Medication Storage
• All medications are stored securely to prevent diversion
• All controlled substances are locked
• Hospital has a pharmacy directed by a registered pharmacist or a supervised drug storage area
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Storage
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Medication Storage
• The hospital safely controls medications brought into the hospital by patients or prescribers
• Before use, the medications are identified and visually evaluated for integrity
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Medication Storage
• Medications are labeled with contents, expiration date, and warnings
• Expired, damaged, or contaminated medications are separated from those available for administration
• Medications are in a ready‐to‐use form
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Implementation Suggestions at UH
• Staff are aware of the process and what their responsibilities are for monitoring temperatures
• For resolving problems related to temperatures that are out of range;
– Do they adjust the refrigerator/freezer temperature? – Re‐check after a specified interval?
– When do they involve pharmacy to determine if medications are still viable?
– When are facilities staff notified if equipment is malfunctioning?
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Implementation Suggestions at UH
• What happens to medications that are stored in a department that is not open on the weekend?
• How do you assure that the appropriate temperature is maintained?
• How do you know the process is working?
• Twelve months refrigerator sheets available
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Implementation Suggestions at UH
• Narcotics and others scheduled drugs locked at all times
• Narcotic counts are done as required
• Define the process for wasting of scheduled drugs‐ is it being consistently followed by the staff?
• Records of usage are appropriately maintained and any discrepancies are resolved within the defined time frame 44
Implementation Suggestions at UH
• Define the resolution process and what happens when a discrepancy cannot be reconciled
• Staff access must be current and promptly removed when staff members transfer or leave the organization
• Staff members log out after they have pulled the medications needed to administer in order to prevent someone else from removing narcotics after the staff member has left the device
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Implementation Suggestions at UH
• Staff members are NOT to pull medications for more than one patient at a time
• During what time frame can the staff member pull medications?
– How long before the medication is due?
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Implementation Suggestions at UH
• Who is authorized to access medication? (define in policy)
• Medication security‐ depending on state and/or federal law and regulation, this can include non licensed personnel
• If using automated distribution devices, access must be removed ASAP for staff who are terminated
• All stored medications and the components used in their preparation are labeled with content’s expiration date, and any applicable warnings 47
Floor Inspection
• Pharmacy conducts floor inspection monthly
• Define the process for managing expired , damaged, and/or contaminated medication
• How do staff determine that a medication is damaged and/or contaminated?
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Floor Inspection
• Where will the drugs be stored until sent back to pharmacy?
• Is that area secure and will it prevent diversion, and so forth?
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LS.02.01.20
Corridor Clutter
• Items which can be left in the corridors
– Isolation carts
– Emergency carts
– Chemotherapy carts
• What about computers on wheels?
– Rule of thumb: 30 minutes of inactivity – Must be stored when not in use
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Beyond Use Dating
Medication Expiration Dating Table
Drug Type
Date upon opening
Multi-dose injectable vials
(ex: insulin)
Yes
Single dose 10 mL injectable
vials of sterile water and
sterile normal saline
No
Commercially available
(manufacturer prepared)
allergens
Yes
Days to
expiration
28 days
(unless shorter
expiration date
recommended by
manufacturer)
N/A
Discard after initial
use
No
28 days
(unless shorter
expiration date
recommended by
manufacturer)
Manufacturer’s
expiration date
No
Exempt from
controlled storage
Yes
Vaccines and immunizations
No
Topical solutions (ex: 70%
alcohol,
hydrogen peroxide, sterile
water, tincture of benzoin)
No
Manufacturer’s
expiration date
No
No
Sterile pour bottle of Betadine
solution or
sterile normal saline
Baxter 50 mL or less PLAIN
IV bags once outer wrapper
removed (no additives)
Yes
1 Day
(24 hour)
Within 24 hours
Exempt
Yes
15 days
N/A
Exempt
Baxter 100 mL or greater
PLAIN IV bags once outer
wrapper removed (no
additives)
Yes
30 days
N/A
Exempt
Exempt
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Implementation Suggestions at UH
• “Beyond Use Date” has to be on the label
• You cannot use “Date Opened”, the standard says it has to be the last date the product can be used
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MM.03.01.01
Multi‐dose Vials
• Elements of Performance (EP) 7: all stored medications are labeled with expiration date
• Use of multiple dose vials in the immediate patient care areas (procedural areas/ORs/ patient rooms)
• Vaccines – CDC recommendation to keep vaccines in the center of fridge
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MM.03.01.03
• The hospital safely manages emergency medications
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MM.03.01.03
Emergency Medications
• The hospital safely manages emergency medications
– EP 1&2 – Emergency meds are readily accessible
– EP 3 – Emergency medications available in unit‐
dose, age specific, and ready to administer forms.
– EP 6 – Emergency meds are replaced as soon as possible after use
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Ready to Administer Forms
• Medications in the patient care areas are in the most ready‐to‐administer forms commercially available
• No pill splitting on floors
• Ready‐to‐use drugs in code carts
• Code carts must be in view of LIP
• Code cart cannot leave floor until new cart arrives
• Code cart blue lock must be placed on compromised/ returned code cart 56
MM.03.01.05
Patient’s Own Medications
• The hospital safely controls medications brought into the hospital by patients, their families, or licensed independent practitioners.
• At UH: Do not accept medications brought in by MDs for their patients (loss of control)
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MM.03.01.05 Patient’s Own Medications
• EP 1 – The hospital defines when medications brought into the hospital by patients, their families, or licensed independent practitioners can be administered.
• EP 2 – Before use or administration of a medication brought into the hospital, the hospital identifies the medication and visually evaluated the medication’s integrity.
• EP 3 – The hospital informs the prescriber and patient if the medications brought into the hospital by the patients, their families, or licensed independent practitioners are not permitted.
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Patient’s Own Medications
•
•
•
•
Need a prescriber’s orders
Patients can use medications brought from home
Patients can self‐administer medications
Physician may NOT bring in patient’s own medications
• Patient’s own medications must be sent to the pharmacy for verification
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What’s New? Medication Samples
Application of Medical Management (MM) Standards to Sample Medications:
• Clarifies which MM elements of performance apply to sample medications.
• The update applies to ambulatory care, behavioral healthcare, critical access hospital, home care, hospital, and office based surgery programs.
• Changes effective July 1, 2014
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Samples Policy and Procedure
• All new sample medications must be approved by P&T committee PRIOR to the requesting clinic stocking of said medication. • To add a new sample medication, the requesting clinic must complete and submit a “Sample Medication Formulary Request” form 61
Samples Policy and Procedure • Pharmacy Administration will confiscate medication samples throughout the UH that have not been identified by the Pharmacy Department and/or have not been approved by P&T committee.
• Medication Sample Recall
62
Samples Policy and Procedure
• Ambulatory clinics that store medication samples shall be identified. • All medication samples will be logged with the following information:
–
–
–
–
–
–
–
Name and strength of medication
Date received
Manufacturer and lot number
Expiration date of medication
Quantity of medication received
Balance
Signature of receiver
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Labeling Requirements for Sample Medications Dispensed by MD
• Sample medications shall be labeled and dispensed in a standardized manner according to hospital policy, applicable law and regulation and standards of practice.
• Dispensing labels will be supplied by the Pharmacy Department.
• Each medication sample dispensed shall be properly labeled with a dispensing label to include but not limited to the following information:
–
–
–
–
–
Patient name and date
Instructions for administration ‐ e.g. Take one tablet twice a day
Name of medication and strength
Prescribing physician
Relevant auxiliary labels (indicated on top of each log sheet) (supplied by the Pharmacy Department).
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MM.04.01.01
• Medication orders are clear and accurate
65
“PRN” Medications
• All “PRN” orders must include indication unless the medication is used for only one
indication • Valid order: Ondansetron 4 mg IV q4h PRN • Invalid order: Diphenhydramine 25 mg PO q4h PRN • Correct order: Diphenhydramine 25 mg PO q4h PRN rash or dystonia, or pruritus, or sleep
• Bisacodyl 5 mg PO daily PRN
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Dose Titration Policy
• Medications ordered for titration must be approved by the Pharmacy and Therapeutics Committee. Safe dose ranges for medications that are to be titrated must be reviewed and approved by that Committee. • For titrated mediations: A maximum and minimum dose limit must be established to indicate when the physician must be called. • For tapering medications: the tapering dose of the drug and frequency of administration along with other pertinent information such as route, duration of therapy, and date and time of physician order etc. must be included.
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Titrating Order Policy
68
Example of Tapering Order
• Prednisone 40 mg PO BID x 5 days,
• Then prednisone 40 mg PO q24h x 5 days,
• Then prednisone 20mg PO q24h x 5 days
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Range Orders
• Range orders cannot be accepted unless indication for different ranges are clearly stated on the order. • Range orders are accepted for pain medication based on the numeric pain scale.
Example:
Pain of 1‐4, one tablet or lower prescribed dose
Pain of 5‐10, two tablets or higher prescribed dose
• Invalid order: Morphine 1‐5 mg IV q3‐4 hrs prn
• Correct order: Morphine 1 mg IV q3h prn pain scale 2‐
4; Morphine 3 mg IV q3h prn pain scale 5‐7; Morphine 5 mg IV q3h pain scale >7
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MM.04.01.01
Clear and Accurate Medication Orders
• Problematic EPs:
– EP 7: the hospital reviews and updates preprinted order sheets, within the time frame it identifies or sooner if necessary based on current evidence and practice
71
MM.04.01.01 EP 4 Look Alike Sound Alike (LASA)
• The hospital must have a written policy that defines the precautions for ordering medications with look alike sound alike names (LASA)
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MM.04.01.01 EP 7
• Problematic Eps
‒ EP 7: the hospital reviews and
updates preprinted order sheets,
within the time frames it identifies or
sooner if necessary based on current
evidence and practice
73
MM.04.01.01 EP 8 Incomplete Medication Order Resume/Blanket Order • What an incomplete/illegal order looks like:
– “Resume all orders” (blanket order)
– “Renew antibiotics”
– Bisacodyl one po prn
– Reglan 10 mg IV prn
74
Verbal and Telephone Orders • Verbal communication of orders is discouraged.
• All verbal orders must be authenticated (reviewed and countersigned) as soon as possible, or within 48 hours of receipt of order
• As approved by the Medical Executive Committee, Registered Pharmacists are allowed to accept verbal clarification of ordered from Physician
– “Read Back Verified by Repetition”
• Questionable order:
– RPH will inform RN
– RPH will inform/clarify order with MD 75
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Sample Verbal Order
76
MM.04.01.01 EP 9
• EP 9: A diagnosis, condition, or indication for use exists for each medication order.
• As long as this element appears in the CPOM we do not require every medication order to contain an indication
77
MM.04.01.01 EP 10 (also MM.01.01.01 EP 1)
Pediatric Medication Orders Weight Based Dosing • Invalid order = Tylenol 65 mg PR q4h prn for a 6.5 kg infant • Correct order = Tylenol (10 mg/kg/dose) 65 mg PR q4h PRN temp > 101°F
• Use mg/kg/dose or mg/kg/day divided per dose
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MM.04.01.01 EP 15 Standing Orders/Protocols and Order Sets
• Requirements clearly specified • Medication orders initiated by RN prior to LIP order requires approval by MD, RPH and CNO
• Developed using nationally recognized and evidence based guidelines
• Regular review to determine continuing usefulness and safety
• Dating, timing and authentication according to law, bylaws or hospital polices
79
Order Sets • Standing Orders
• The order sets may be generated within a multidisciplinary process team • Evidence based order sets have Physician Champion, Clinical Pharmacist, Nursing Representation and QI input as needed with a final approval from the P&T Committee and MEC
80
CHF Sample Orderset
81
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Influenza and Pneumococcal Vaccination
• Ordering and transcribing • Influenza and pneumococcal vaccines require an order or a hospital specific protocol approved by a doctor of medicine or osteopathy
82
Standardizing Drug Concentrations
• Adults
• Pediatrics
83
Standardizing Drug Concentrations
84
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Top Findings in the Operating Rooms
•
•
•
•
•
•
•
Labeling in ORs
Handling of controlled substances
Pyxis anesthesia usage
Pre‐op/PACU and medication order review
Pain balls
Stashes of medication
Is your OR really secure?
85
Top Findings in the Operating Rooms
• Medication order review by the pharmacist: what are the expectations?
– Exceptions: urgent need and LIP at bedside
– Pre‐op workflows
– PACU workflows
86
Top Findings in the Operating Rooms
• Specialty products: who should prepare?
– Irrigations
– IV admixtures – Pain balls
“RX Should”
87
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Warming of IV/Irrigation Solutions and Contrast Media
• To provide irrigation/infusion solutions warmed to the temperature appropriate for the patient’s clinical need ensuring patient safety and comfort while maintaining medication integrity. • Examples include irrigation solutions (Arthromatic® and Uromatic®) and contrast media (Visipaque®, Omnipaque®) • Microwaving of drug is NOT acceptable
88
Warmers
89
Warming/Blanket Cabinet Temperature Log
90
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91
MM.05.01.01
• A pharmacist reviews the appropriateness of all medication orders for medications to be dispensed in the organization
• Current interim still in effect for Emergency Department
– No review required if LIP present in immediate area
92
MM.05.01.01
• Orders are reviewed for:
– EP 4 – Patient allergies or potential sensitivities
– EP 5 – Food/drug interactions
– EP 6 – Appropriate for medication, dose, frequency, and route
– EP 7 – Lab values checked
– EP 8 – Therapeutic duplication (e.g morphine 2 mg IV every 10 mins prn pain, Tylenol #3 tablet q4h prn pain)
– EP 9 – Other contraindications‐patient safety
– EP 10 – Variations from hospital‐approved indications
– EP 11 – Prescribers clarification of all concerns 93
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MM.05.01.01 Cont.
• A pharmacist reviews the appropriateness of all medication orders for medications to be dispensed in the hospital
• Problematic EPs:
– EP1: pharmacist reviews all medication orders/prescriptions before dispensing/remain from floor stock or automated dispensing
• The hospital dispenses medications within time frames it defines to meet patient needs
94
MM.05.01.01 Cont.
• EP 2: when on site pharmacy not open 24/7, qualified healthcare professional reviews the med order in pharmacist absence
• Followed by a review by pharmacist when pharmacy is re‐opened
95
MM.05.01.07
• The organization safely prepares medications
96
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2/21/2015
MM.05.01.07 Pharmacy Preparation of IV Admixtures
• IV admixture preparation away from nursing unit to pharmacy
• Exception‐ urgent situation
• Non 24/7 pharmacies, OR, off site clinics and ED
• Pharmacy should consider ways to make IV admixtures available when needed without admixture by nurses
97
Radiopharmaceuticals
• In‐house preparation of radiopharmaceuticals are done by, or under the supervision of, an appropriately trained pharmacist or doctor of medicine or osteopathy
98
Radiopharmaceuticals
•
•
•
•
From where are they obtained?
Are they unit‐dose, patient specific?
Is there an on‐site generator?
Are non‐radiopharmaceuticals obtained from the nuclear pharmacy?
• Are any CSPs mixed in the hot lab?
99
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Radiopharmaceuticals
100
MM.05.01.09
Labeling
• EP 1 – Labeled when not immediately given
• EP 2 – Information on medication labels is displayed in a standardized format
• EP 3 – Medication name, strength, and amount
• EP 4 – Expiration date, LVP’s max hang time 24 hrs
• EP 5 – Expiration time
• EP 6 – CSPs include date prepared and diluent
• EP 7 – If multiple patients, patient’s name
• EP 9 – If multiple patients, directions and cautions
• EP 10, 11, 12 – If prep by other person, patient’s name, location to be delivered, directions and cautions
101
MM.05.01.11
• The organization safely dispenses medications
102
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MM.05.01.11 CMS 482.23.c.(1) CMS ±30 Min Rule: Time‐Critical Scheduled Medications
• The hospital dispenses medications within time frames it defines to meet patient needs
• CMS ± 30 Min Rule ‐ Time‐Critical Scheduled Medications
• Medication Turn Around Time policy is crucial
• Ready to administer forms commercially available
• Medications pass 103
CMS and Timeliness of Medication Administration
• Hospitals expected to develop policies and procedures that include:
– Medications not eligible for scheduled dosing times
– Medications eligible for scheduled dosing times
– Administration of eligible medications outside of their scheduled dosing times and windows
– Evaluations of medication administration timing policies, including adherence to them
104
CMS and Timeliness of Medication Administration
• Medications not eligible for scheduling dosing times (examples):
– STAT doses (immediate)
– First time or loading doses (initial large dose of a drug given to bring blood, tissue or fluid levels to an effective concentration quickly)
– One time doses; doses specifically time for procedures
– Time‐sequenced doses; doses timed for serum drug levels
– Investigational drugs
– Drugs prescribed on an as need basis (PRN doses)
105
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CMS and Timeliness of Medication Administration
• Time Critical Medications (examples)
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–
–
–
–
–
–
Antibiotics
Anticoagulants
Insulin
Anticonvulsants
Immunosuppressive agents
Pain medications Medications prescribed for administration within a specified period of time of the medication order
– Medications that must be administered apart from other medications for optimal therapeutic effect
– Medications prescribed more frequently than every 4 hours
106
MM.05.01.13 • Hospital that provide 24 hour care do not provide 24 hour pharmacy services
• Who can obtain medication?
• Drug security • Quality control procedure
• On call pharmacist
107
MM.05.01.17 Drug Recall
• The hospital follows a process to retrieve recalled or discontinued medications
108
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MM.05.01.17 Drug Recall
• Once informed, pharmacy staff confiscates all recalled medications from patient care areas
– e.g. automated dispensing machine (Pyxis)
– Drug recall retrospectively reported at the Pharmacy and Therapeutics Committee and Patient Safety Committee
109
Drug Recall Cont. 110
MM.05.01.17 EP 4 Retrieve Recalled or Discontinued Medications
• Hospital inform patients that their medications have been recalled or discontinued for safety reasons by the manufacturer or FDA
111
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MM.05.01.17 Drug Shortages
• Every Friday, listing of drug shortages e‐mailed to the “Program Support Specialist for the University Hospital Medical Staff President” and then forwarded to all department chairs
• All drug shortages are reported to P&T committee monthly
• For long term shortages, the clinical pharmacy team will develop and approve written medication substitution protocols
112
113
MM.05.01.19 Returned Medications
• The hospital safely manages returned medications
• All outdated drugs, contaminated drugs, improperly stored drugs and containers with worn, illegible or missing labels shall be returned to the Pharmacy Department for proper disposal. 114
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MM.05.01.19 Cont.
• These drugs shall be stored in an isolated area in the Pharmacy Department that has been designated for the storage of such unusable drugs.
• Medications that are to be disposed will be sequestered and placed in the approved area of the Pharmacy Department designated “Expired Medications”
115
MM.06.01.01
• The organization safely administers medications
116
MM.06.01.01
• EP 1 & 2 – Only authorized LIPs and clinical staff (see also MM.06.01.03, EP 1)
• EP 3 – Check that med matches order and label
• EP 4 – Visual inspection of medication‐for particulates, discolor and loss of integrity (see also MM.03.01.05, EP2; MM.05.01.07, EP3)
• EP 5 – Verifies med is not expired
• EP 6 – No contraindications exist
• EP 7 – Given at correct time, dose and route
• EP 8 – Clarify concerns prior to administration
• EP 9 – Patient informed about new medication, informed potential clinically significant ADR (see also MM.06.01.03 EPs3‐6; PC .02.03.01, EP10)
117
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MM.06.01.03
• Self administered medications are administered safely and accurately.
• The term self administered medication(s) may refer to medications administered by a family member
118
MM.06.01.03
• Self‐administration
– EP 7 – Patient is competent
– Self administration is allowed via physician order
– The hospital educates patients and families involved in self administration about the following:
119
MM.06.01.03
• How to administer medication, including process, time, frequency, route, and dose
• Anticipated actions and potential side effects of the medication administered
• Monitoring the effects of the medication (see also MM.06.01.01, EP 9)
120
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MM.06.01.05
• The hospital safely manages investigational medications
121
MM.07.01.03 Adverse Drug Events/Medication Errors
• The hospital must have systems in place to respond to and monitor a patient in the event of an adverse drug reactions or medication error.
• There is IMMEDIATE notification to the practitioners.
122
Sentinel Event Alert (SEA) 49: Safe Use of Opioids in Hospitals
• Focus is on safe opioid use within the inpatient hospital settings; emergency department use of opioids is not directly addressed
• Opioid‐related ADEs reported to TJC included wrong dose errors (47%); inadequate monitoring (29%); other factors including excessive dosing, drug interactions(11%)
• Recommends screening for respiratory depression risk, taking an accurate medication history, and using extra precautions for patients new to opioids.
123
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Sentinel Event Alert (SEA) 49: Safe Use of Opioids in Hospitals
• Recommends nine specific evidence‐based actions to help avoid adverse events associated with the use of opioids – Effective processes – Safe technology
– Appropriate education and training
– Effective tools
124
Black Box Warnings
• A Black Box Warning is the strongest labeling requirement of the FDA and is intended to identify certain contraindications or serious warnings, particularly those that may lead to death or serious injury. • The warning provides a brief explanation of the risk and refer to more detailed information in the "Contraindications" or "Warnings and Precautions" section of the labeling.
125
Black Box Warnings
• Pharmacy shall provide an alert to be displayed in the electronic MAR under administration instructions as a reminder to the physician and the nurse when one of these medications is prescribed: "MEDICATION WITH BLACK BOX WARNING. REFER TO CLINICAL PHARMACOLOGY OR CONTACT PHARMACY".
• Product information will be available through Clinical Pharmacology drug information database which is available as a clinical link in Epic Rx or on the hospital Intranet 126
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Black Box Warnings
• Medical literature should be continually reviewed by the pharmacy staff
• New black box warnings are reported to the P&T committee monthly and any discussion regarding the formulary status of the product reported in the committee minutes
127
Black Box Warnings
128
Black Box Warnings
129
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Black Box Warnings
• Medical literature should be continually reviewed by Pharmacy staff
• Significant findings (new black box warnings) are reported to the P&T committee, and any discussion regarding the formulary status of the product (whether changed or not) is recorded in the Committee minutes
130
MM.07.01.01 • The hospital monitors to determine the effects of their medications
• Monitoring effects of medications on patients – 1st dose monitoring
• Monitor relevant lab values, clinical response, and medication profile
131
MM.07.01.03
• The hospital responds to actual or potential adverse reactions, significant adverse reactions and medication errors
• Review ADR/ME reports
• Patient Safety Net (PSN)
132
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ADRs/MEs
• Adverse Drug (medication) Reaction (ADR): a response to a drug that is noxious and unintended and that occurs when using the drug appropriately
• Medication Error (ME): an error or near miss in prescribing, transcribing, preparing, dispensing or administering a medication
133
ADRs/MEs
• Incident: the occurrence or potential occurrence of an event or circumstance that is a variation of the delivery of patient care that is not consistent with the routine safe care of patients or normal operation of the facility. Actual injury to the patient need not occur for an event to be considered an incident. The potential for injury to a patient is sufficient for a circumstance to be considered an incident. 134
Patient Safety Net (PSN)
• An electronic database maintained by University Healthcare Consortium, in conjunction with University Hospital, for reporting, tracking, and trending incidents
135
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MM.07.01.03
• A Harm Scoring System is used to classify Adverse Drug Reaction/Medication Errors (ADRs/MEs). The pharmacist investigating the occurrence assigns a preliminary level for ADR/ME. • The Pharmacy and Therapeutics Committee is responsible for reviewing all suspected ADRs/MEs and follow up as needed.
136
Harm Scoring System
• 1. Unsafe conditions
• 2. Near miss (requires selection of one of the following):
– Fail safe designed into the process and/or safeguard worked effectively
– Practitioner or staff who made the error noticed and recovered from the error
– Spontaneous action by a practitioner or staff member (other than person making the error) prevented the event from reaching the patient.
– Action by the patient or patient’s family member prevented the event from reaching the patient
137
Harm Scoring System REACHED THE PATIENT (MODERATE)
• 3. No harm evident, physical or otherwise: Event reached the patient, but no harm was evident
• 4. Emotional distress or inconvenience: mild and transient anxiety or pain or physical discomfort, but without the need for additional treatment other than monitoring (such as observation; physical examination; laboratory testing including phlebotomy; and/or imaging studies). Distress/inconvenience since discovery, and/or expected in the future as a direct result of event
• 5. Additional treatment: Injury limited to additional intervention during admission or encounter and/or increased length of stay, but no other injury. Treatment since discovery, and /or expected treatment in future as a direct result of event
138
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Harm Scoring System HARM (SEVERE)
• 6. Temporary harm: Bodily or psychological injury, but likely not permanent.
• 7. Permanent harm: Lifelong bodily or psychological injury or increased susceptibility to disease
• 8. Severe permanent harm: Lifelong bodily or psychological injury or disfigurement that interferes significantly with functional ability or quality of life.
• 9. Death: Dead at time of assessment
139
MM.07.01.03
• EP 5 – Defined processes are implemented
• EP 6 – Errors, ADRs, and medication incompatibilities are reported to the attending physician immediately when possible and as appropriate to the hospital‐
wide Quality Assessment and Performance Improvement Program (QA/PI program) • On the units, please know your ADR/ME trends
• Pharmacy sends out the data monthly and quarterly for the corrective action plans
140
MM.08.01.01
• The organization evaluates the effectiveness of its medication management system
• The hospital collects data on the performance of its medication management system e.g. Medications Turn Around Time (TAT).
• The hospital takes action when planned improvements for the medication management processes are either not achieved or not sustained e.g. implementation of Pyxis Connect, CPOM, EPIC Rx
141
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MM.08.01.01
• Based on the analysis of its data as well as review of the literature for new technologies and best practices, the hospital identifies opportunities for improvement in its medication management system.
142
MM.08.01.01
•
•
•
•
•
e‐MAR
EPIC‐CPOM
Pyxis Anesthesia
Pyxis Alaris SMART Pump
143
MM.08.01.01
•
•
•
•
IV Push Policy ‐ which floors/units can be give certain medications via IV ppush?
EPIC‐CPOM Implementation
Medication Usage Evaluations for the select high expenditure products to ensure appropriate usage
Enforce formulary restriction and preauthorization of target anti‐infectives to ensure appropriate usage
144
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Assuring Continuous Compliance with Other TJC Standards
• Leadership (LD)
– Scope of Pharmaceutical Services
– Outsource Pharmacy Services
– Mission, Vision, Values, Mottos of the Pharmacy Department
– Staffing Plan
– Table of Organization
• Human Resource (HR)
– Staff Orientation‐Training
– Competency
– Job description
145
Assuring Continuous Compliance with Other TJC Standards
• Management of Information (IM)
– Pharmacy Systems Downtime Policy and Procedures
– Pharmacy Charging and Billing Policy and Procedures
• Medical Staff (MS)
– Practitioners Privileges/Authorized Practitioners Prescribing
– Prescribers’ Drug Enforcement Administration Numbers
– Non‐Approved Dangerous Abbreviations
146
Resources
• 2015 The Joint Commission Requirements
• CMS Hospital Conditions of Participation and Interpretive Guidelines
• Joint Commission Comprehensive Accreditation Manual for Hospitals
• Joint Commission Perspectives
147
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