Phase 2 as Related to the DOH Survey Process Pharmacy Services Richard A. Zelkowitz, RPh, MS, FASCP President, Pharmacon Co. Pharmaceutical Consultants to Health Care Institutions (914) 961-3372 www.PharmaconConsulting.com
Phase 2 / DOH Survey Process “Final Rule” Implementation Three Phases… Phase 1: November 28, 2016 Phase 2: November 28, 2017 Phase 3: November 28, 2019
Phase 2 / DOH Survey Process Phase 1 Drug Regimen Review (DRR) Reported to attending physician, Medical Director and DNS Specifies attending physician’s documentation requirement in response to DRR recommendations. If disagree, why?
Phase 2 / DOH Survey Process Phase 1, cont. Policies/Procedures need to address Time frames for each step of the DRR process Pharmacist actions when need for urgent action to protect resident
Phase 2 / DOH Survey Process Phase 2 483.45 Pharmacy Services Redefines “Antipsychotic” to “Psychotropic ” Definition expanded to include Anti-psychotic Anti-depressant Anti-anxiety Hypnotic ALL REQUIRE GRADUAL DOSE REDUCTION
Phase 2 / DOH Survey Process Phase 2 483.45 Pharmacy Services Psychotropic PRN Orders limited to 14 days Unless Physician documents rationale and indicates duration of the PRN order. This includes meds other than antipsychotics Anti-anxiety (Ativan, Xanax) HYPNOTICS ( Ambien, Restoril) Alternative : MELATONIN
Phase 2 / DOH Survey Process Phase 2 483.45 Pharmacy Services ANTIPSYCHOTIC PRN Orders limited to 14 days Cannot be renewed unless the physician evaluates for the appropriateness of that medication. Use of Antipsychotic PRN’s are a Major Survey Risk as an Unnecessary Medication
Phase 2 / DOH Survey Process Survey Risk Areas Nursing Station Inspections Medication Pass Documentation
Phase 2 / DOH Survey Process Nursing Station Inspection Refrigerator Temperature 36-46 degrees F Keep Temperature Log Open Multi-dose Vials & Pens Must be dated when opened Discard after expiration date (varies) Refrigerator should be checked on a daily basis
Phase 2 / DOH Survey Process Food Storage Only in Pantry area None in medication room or REFRIGERATOR Discharged, Discontinued & Patient Property Must be segregated Suppositories Store as per manufacturer’s guidelines Room Temperature – In container in medication cabinet Cool or Cold – In refrigerator
Phase 2 / DOH Survey Process Medication Cart Dating of open containers Xalatan – 6 weeks from opening Advair – 30 days from opening Protein Supplements – 30 days Glucose Control Solutions – 30 days Expired medications Old blister cards – PRN meds over 90 days Stock medications Nebulizer Solutions – Albuterol & Ipratropium
Phase 2 / DOH Survey Process Controlled Medications Control Cabinet Metal, Double-locked (2 doors), TWO DIFFERENT KEYS, Mounted on the wall Same regulations apply to refrigerator. Controlled medications must be removed from medication cart after medication pass Only controlled medication stored in cabinet – No syringes, No jewelry, No wallets, No hearing aides or batteries. AVIOD CONSTANT OPENING
Phase 2 / DOH Survey Process Shift Audit NO BLANK SIGNATURE BOXES All shifts must reconcile controlled medication count Reconciliation of controlled medications by 2 nurses Separate sheet for each Rx
Phase 2 / DOH Survey Process CONTROLLED DRUG RECEIPT LOG Date Resident Drug Rx # Quantity Physician RN Signature Anticipated Quantity Date Received Name and Name & Signature of Date of Returned Returned Room # Strength Receiving Return Nurse
Phase 2 / DOH Survey Process Release of Control Medication Upon Discharge Physician must write order stating medication, strength and amount Must sign waiver for non-childproof container Release only to responsible party - not ambulance driver
Phase 2 / DOH Survey Process Emergency Kit Must be sealed Preferably with serial number on lock Expiration date must be clearly discernable Content list must agree with contents Should have name and date of sealing Pharmacist Use Swap System , Do not send individual medications Controlled Medication Emergency Kit Stored separately from routine controlled medications Must be counted each shift by nursing personnel Par levels MUST be maintained by informing vendor pharmacy each time medication is used
Phase 2 / DOH Survey Process Medication Pass Gastrostomy Tube: Infection Control Dilantin Suspension via G-Tube Must be separated from feeding – hold feed, wait 60 minutes, flush tube, administer, flush tube, wait 60 minutes, restart feed Viscous Medication Via G-Tube Dilute Watch for residue in cup
Phase 2 / DOH Survey Process Common Errors Wrong Number of Tablets Administered Highlight label and MAR Check ID Wait 3 minutes between 2 drops of same ophthalmic medication Wait 1 minute between each “puff” of inhaler.
Phase 2 / DOH Survey Process Measurement of Liquids On flat surface At eye level Use proper size water cup (5 oz. vs. 8 oz.) Charting Omissions & Transcription Errors Considered medication errors Check at end of shift Unavailable Medication / Delay of Delivery Do not borrow Do not chart “unavailable” Contact your pharmacy for availability (via supervisor) Contact physician for further orders “Hold until available”
Phase 2 / DOH Survey Process Crush vs. Liquid If medication is available in liquid form, even if it is crushable, Physician should order the medication in liquid form Crush only with MD order EACH MEDICATION CRUSHED SEPARATELY Infection Control HANDWASHING Gloves should be worn for all Injectable Administration
Phase 2 / DOH Survey Process Medication Strength & Type Make sure that actual strength and type of stock medication is the same as the medication order. Examples: Calcium with Vitamin D Fish Oil/Omega 3 Nephrocaps Vitamin D2 vs. Vitamin D3 Regular vs. Enteric Coated Aspirin
Phase 2 / DOH Survey Process DOCUMENTATION Medication orders Strength and quantity of liquids Route of Administration Must be consistent – PO or G/T Medication Indication for Use Antipsychotic – Must have Psychotic Indication (NOT DEMENTIA OR AGITATION) Schizophrenia, Bipolar NON-PHARMACOLOGIC INTERVENTIONS MUST BE TRIED FIRST ( EVEN AFTER FAILED GDR )
Phase 2 / DOH Survey Process PRN Use – Reason and Follow-Up Anti-anxiety Medication Must document failure of behavioral interventions Caution with use, MAY BE CONSIDERED CHEMICAL RESTRAINTS. 14 day limit Analgesics Acetaminophen < 3 gm/day Interactions Synthroid & Calcium Levaquin & Iron WARFARIN
Phase 2 / DOH Survey Process Medication Refusal Proper documentation by nursing and physician Proper destruction of refused dose Crush and destroy in water Prevnar 13 vs. Pneumovax 23 Check CMS site if previously administered Prevnar first One year (and one day) in between
Phase 2 / DOH Survey Process TREATMENT OF PAIN Frequent use of PRN Medications Order as routine Use of 2 or more analgesics Document need and efficacy Use pain scale Pre-treatment analgesia Must be timed properly
Phase 2 / DOH Survey Process MONITORING Warfarin INR: ordered, picked up, obtained, MD notified Increased monitoring with antibiotics Administer at 9 PM (allow time to adjust re: lab work) Anti-Diabetic Fingerstick – NO GAPS, Follow sliding scale Is Sliding Scale needed?? Anti-Hypertensive BP Parameters – NO GAPS MINIMIZE USE OF HOLD PARAMETERS
Phase 2 / DOH Survey Process Laboratory Tests Results should be filed in a timely manner Results should be signed and noted by physician Psychiatric Consults Should be done at least every 3 to 6 months Attempt at dose reduction or reason why not “I have personally assessed this resident to determine the need for a GDR and because he/she has a diagnosed enduring condition of _______, a GDR is clinically contra- indicated at this time.” Benefit vs. Risk
Phase 2 / DOH Survey Process New Concerns Interim MRR for new admission, significant change and short term residents Must have system in place May be done off-site
Phase 2 / DOH Survey Process Questions? rzelkowitz@pharmaconconsulting.com
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