Lior - Bracco Radiology Symposia Booklet

www.ismp.org

Improving Medication Safety in the Radiology SettingBreakfast Symposium Monday, December 8, 2014

This symposium is funded through an educational grant from Bracco Diagnostics.

A breakfast symposium conducted at the 49th ASHP Midyear Clinical Meeting and Exhibition

Improving Medication Safety in the Radiology Setting

© 2014 Institute for Safe Medication Practices

AGENDA

11:30 AM – 11:40 AM 6:15 AM – 6:45 AM Breakfast

11:30 AM – 11:40 AM 6:45 AM – 6:55 AM

Welcome and Introductions Janice Dunsavage, RPh, MAS Director of Pharmacy, PinnacleHealth, Harrisburg, PA Chair, Board of Directors, Institute for Safe Medication Practices (ISMP), Horsham, Pennsylvania

6:55 AM – 7:25 AM

Primer on Medication Administration Systems and Medications Used in Radiology Lior Molvin, (MBA) (RT) (R) (CT) CT Protocol Technologist, CT Protocol Development and Education Team, Stanford University Medical Center and Stanford Medicine, Imaging Center, Palo Alto, CA

7:25 AM – 8:00 AM Medication Safety Issues and Recommended Strategies

Matthew P. Fricker, Jr., MS, RPh, FASHP Program Director, Institute for Safe Medication Practices (ISMP) Horsham, Pennsylvania

8:00 AM – 8:35 AM Centers for Medicare & Medicaid Services (CMS) and

The Joint Commission Requirements Darryl S. Rich, PharmD, MBA, FASHP Medication Safety Specialist, Institute for Safe Medication Practices (ISMP)

8:35 AM – 8:45 AM

Question and Answer Session

8:45 AM Adjourn

1



FACULTY INFORMATION

Janice M. Dunsavage, RPh, MAS Director of Pharmacy, PinnacleHealth Harrisburg, PA Janice M. Dunsavage, RPh, MAS, received a BS in pharmacy degree from the Philadelphia College of Pharmacy and Science, now the University of the Sciences in Philadelphia, and a Master of Administrative Science degree from Johns Hopkins University. Her past employment includes various positions at the Johns Hopkins Hospital and Sinai Hospital in Baltimore, MD. She has served on the Board of Directors of both the Maryland and Pennsylvania Societies of Health System Pharmacists. She has also served for many years in the House of Delegates as well as on several councils of the American Society of Health System Pharmacists. Janice has been a representative on the Pennsylvania State Patient Safety Collaborative. Presently she is serving on the Joint State Government Commission’s Advisory Committee on Opioid Addiction in Pennsylvania. Ms. Dunsavage is currently the System Director of Pharmacy for PinnacleHealth in Harrisburg, PA, a position she has held for 19 years. She has served on the Board of Trustees for the Institute for Safe Medication Practices since 2001, currently as Chair. Lior Molvin, (MBA) (RT) (R) (CT) CT Protocol Technologist, CT Protocol Development and Education Team Stanford University Medical Center and Stanford Medicine, Imaging Center Palo Alto, CA Lior Molvin is currently the lead CT Protocol technologist at Stanford Hospital and Clinics. Lior was trained at Mills Peninsula School of Radiologic Technology where he completed his training as a Radiologic Technologist from 2004-2006. Lior studied biology while working prior to attending a school of Radiologic Technology. Lior furthered his education studying healthcare administration in his undergraduate degree, and recently Lior completed his MBA in 2014. In 2006, Lior started his career at Stanford University where he rotated through all shifts and developed his keen interest for CT technology. In 2008, Lior Molvin was the key technologists to staff a new outpatient imaging center equipped with, and continuously updated with, the latest CT technology from two major vendors. The challenges of developing new protocols for new and evolving applications, close interaction with subspecialty radiologists, researchers, and the CT manufacturers are the basis of his unique practical CT expertise, which he is sharing with others through many educational efforts. In his current role Lior is charged with developing, implementing, and maintaining CT protocols enterprise-wide on all inpatient and outpatient scanners. He is also closely involved and co-developer of the Stanford Dose Monitoring Program, which records and benchmarks each diagnostic CT acquisition within and across the Department of Radiology. Lior is a key participant in the Stanford CT Technologist Training and Education program. Lior is a sought-after speaker and has lectured on CT and contrast medium topics locally and nation-wide. For his contributions to Stanford Radiology, Lior was awarded the Technologist of the Year in 2013.

2



Darryl S. Rich, PharmD, MBA, FASHP Medication Safety Specialist, Institute for Safe Medication Practices Horsham, PA Prior to joining ISMP, Darryl Rich was a surveyor for The Joint Commission in the hospital, home care, and ambulatory accreditation programs. In addition, he worked for the Standards Interpretation Group serving as an internal resource for The Joint Commission related to pharmacy and medication management . Dr. Rich served as Field Director for Surveyor Management and Development at The Joint Commission prior to becoming a surveyor. Before starting at The Joint Commission in 1993, Dr. Rich was National Director of Pharmacy Services for Critical Care America, Inc., a national home infusion company. He previously served as Director of Pharmacy Services at Boston University Medical Center and Clinical Assistant Professor of Pharmacy at Northeastern University. Dr. Rich is an active member and Fellow in the American Society of Health System Pharmacists and a past President of the New England Council of Health-System Pharmacists. He has received numerous awards, given over 640 invited presentations and has authored 76 publications in refereed journals, including eight books and four video series. Dr. Rich received his Bachelor of Science from The University of California at Davis, his Doctor of Pharmacy degree from the University of California at San Francisco and a Master’s in Business Administration in Health Care Management from Bryant University in Rhode Island.

Matthew P. Fricker, Jr, MS, RPh, FASHP Program Director, Institute for Safe Medication Practices Horsham, PA Prior to joining ISMP, Matt was employed in the acute care setting for over 27 years, most recently as director of pharmacy and materials management and Institutional Review Board chairman. In addition to performing onsite medication safety risk assessments and speaking about medication safety in hospitals throughout the United States, he has managed several medication safety collaboratives designed to improve safety with high alert drugs, including anticoagulants and opioids. Matt created program tools and content for the Regional Medication Safety Program for Hospitals, a collaborative program with the Health Care Improvement Foundation of the Delaware Valley Healthcare Council and ECRI Institute. He has also co-developed medication safety programs for critical access hospitals in Pennsylvania and throughout the US. Matt received his BS in Pharmacy and MS in Hospital Pharmacy Administration from Temple University and has published numerous articles in the pharmacy and medical literature.

3



ACTIVITY OVERVIEW

Radiology departments often use medications in ways that are different from other clinical areas of the hospital, and staff may not be aware of the significant safety issues that can arise. This symposium will explore current medication safety issues in the radiology setting, such the safe use of contrast, appropriate labeling of containers, beyond-use dating, and patient identification. Nationally known experts will discuss actual cases where errors have occurred and risk reduction strategies, including use of technology and best practices. A new Imaging Bulk Package for contrast recently approved by the FDA as well as the regulatory and Joint Commission accreditation requirements for use of contrast and other medications in radiology will also be discussed.

OBJECTIVES The target audience for this activity includes pharmacists in health-system settings. At the completion of this symposium, the participant should be able to:

Describe how medications and contrast agents are ordered, stored, prepared, and utilized in the radiology setting.

Explain the difference between the new FDA classification of an imaging bulk package vs. a pharmacy bulk package of contrast, and why the FDA developed this new product type.

Identify system-based causes of medication errors associated with the use of medications and contrast agents in radiology.

Prioritize selected strategies to prevent harm and improve medication safety in radiology. Describe current regulatory and accreditation requirements related to the use of medications and

contrast agents in radiology, and the role of the pharmacy in assuring compliance to the standards.

4



The Institute for Safe Medication Practices (ISMP) is the nation’s only nonprofit, charitable organization dedicated entirely to medication error prevention and safe medication use. ISMP is known and respected worldwide as the leading resource for independent and effective medication safety recommendations. The Institute’s strategies are based on up-to-the minute information gained from analysis of reports to the voluntary ISMP National Medication Errors Reporting Program and onsite visits to individual healthcare organizations. ISMP’s highly effective initiatives, which are built upon system-based solutions, include: five medication safety newsletters for healthcare professionals and consumers that reach more than three million total readers; educational programs, including conferences on medication use issues; confidential consultation services to healthcare systems to proactively evaluate medication systems or analyze medication-related sentinel events; advocacy for the adoption of safe medication standards by accrediting bodies, manufacturers, policy makers and regulatory agencies; independent research on evidence-based safe medication practices; and a consumer website (www.consumermedsafety.org) that provides patients with access to free medication safety information and alerts. ISMP works with healthcare practitioners and institutions, regulatory and accrediting agencies, consumers, professional organizations, the pharmaceutical industry, and others to accomplish its mission. It is a federally certified patient safety organization (PSO), providing legal protection and confidentiality for patient safety data and error reports it receives. As an independent nonprofit, ISMP receives no advertising revenue and depends entirely on charitable donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue its lifesaving work. For more information or to make a donation that will make a difference to patient safety, visit ISMP online at www.ismp.org.

5



CCOONNTTIINNUUIINNGG EEDDUUCCAATTIIOONN IINNFFOORRMMAATTIIOONN

This CE activity is jointly provided by ProCE, Inc. and the Institute for Safe Medication Practices (ISMP). ProCE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number 0221-9999-14-227-L05-P has been assigned to this knowledge-based live CE activity (initial release date December 8, 2014). This CE activity is approved for 2.0 contact hours (0.20 CEUs) in states that recognize ACPE providers. This CE activity is provided at no cost to participants. Successful completion of the online post-test and evaluation at www.ProCE.com no later than January 9, 2015 is required to receive CE credit. CE credit will be automatically uploaded to NABP/CPE Monitor within 1 to 2 weeks of the completion of the post-test and evaluation. No partial credit will be given. It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. The following staff and speakers have disclosed that they do not have any financial arrangements or affiliations with corporate organizations that either provide educational grants to this program or may be referenced in this activity. Furthermore, the below-referenced speakers have also attested that their discussions will not include any unapproved or off-label use of products.

Janice Dunsavage, RPh, MAS, Lior Molvin, (MBA) (RT) (R) (CT), Matthew P. Fricker, Jr, MS, RPh, FASHP Darryl S. Rich, PharmD, MBA, FASHP

Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature.

6



CE Activity Information & Accreditation

2

This CE activity is jointly provided by ProCE, Inc. and the Institute for Safe Medication Practices (ISMP). ProCE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This CE activity is approved for 2.0 contact hours (0.2 CEUs) in states that recognize ACPE providers.

Disclosure

3

It is the policy of ISMP and ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation.

Today’s speakers have no relevant commercial and/or financial relationships to disclose.

Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature.

7



Online Evaluation and Statement of Completion

• www.ProCE.com

• Register with username and password

• Deadline: Friday, January 9

4

Event Code = ??????Event Code = ??????

Objectives

The target audience for this activity includes pharmacists in health-system settings. At the completion of this symposium, the participant should be able to:

• Describe how medications and contrast agents are ordered, stored, prepared, and utilized in the radiology setting.

• Explain the difference between the new FDA classification of an imaging bulk package vs. a pharmacy bulk package of contrast, and why the FDA developed this new product type.

• Identify system-based causes of medication errors associated with the use of medications and contrast agents in radiology.

• Prioritize selected strategies to prevent harm and improve medication safety in radiology.

• Describe current regulatory and accreditation requirements related to the use of medications and contrast agents in radiology, and the role of the pharmacy in assuring compliance to the standards.

5

6

Primer on Medication Administration Systems and Medication Used in Radiology

Lior Molvin (M.B.A)(R.T)(R)(C.T.)Stanford Radiology CT Protocol and Educational Development

Stanford Health Care

[email protected]

8



7

Preface:• Radiopaque Iodinated Contrast Media is widely used in CT and

Angiography. • My Background is in CT the main focus will be contrast

administration in CT• Last Fiscal Year 55% of our CT scans were performed with IV

Contrast.

8

Objectives:

•CT Contrast Media What is it?

•CT System Fundamentals How they work

•Contrast Agents Positive and Negative

•Administering Contrast Agents Bolus injections Power injections Packaging

•Storing Contrast Agents Warmers Viscosity

•Non Contrast Drugs How to Store Who Administers them

•Contraindications to Iodinated contrast media Screening

•Contrast Utilization Waste reduction

9

What is an IV Iodinated Contrast Media

•Extracellular fluid marker•Non-Ionic low osmolality •Half Life ~ two hours with normal renal

function•No significant metabolism of contrast media

takes place in the body•Excretion through the kidneys•Increase in X-ray absorption of Iodine is

related to blood flow.

9



10

X-Ray Systems:A medical X-ray system is used to

measure density

•The CT system removes density superimposition to generate 2,3, and 4 dimensional imaging.

Standard X-Ray With Densities

Superimposed

11

The Density Measured is Relative to Water (Hounsfield Scale HU)

Air is BlackBone is WhiteSoft Tissue is

Grey

Contrast agents are used to

augment the grey scale

12

Types of Contrast Agents in CTR.T.’s administer in California but state laws vary…

•Positive Agents >=200 HU (Iodine, Barium)

•Negative Agents Density <=0 HU (Water)

10



13

Methods of CM Administration in CTR.T.’s administer in California but state laws vary…

•Contrast Delivery Routes: IV (Indirect)

Iodine Oral/Rectal

Barium Iodine Water Carbon dioxide

Inspiratory Xenon Gas

(Not found commonly in clinical practice)

14

Iodinated Intravenous Contrast Media

•CM is Excreted by the Kidneys

•Require Adequate Renal function: eGFR >45 Creatinine of 0.6-

1.1ml/dl Woman 0.6-1.3 Men

BUN no longer used as primary measure of renal function

Prophylactic TX- Pre-hydration

15

Poor Renal Function/DiabetesSwitch from 370- 300Reducing Iodine load

Metformin Screening

11



16

Drug Interactions: Iodinated Contrast Media and Metformin

•In the rare circumstance of contrast induced renal failure:

•Metformin Accumulation in Kidneys can occur Causes Lactic acidosis

•Patients taking Metformin are advised to discontinue taking it for 48 hours post contrast administration and consult their primary care provider regarding resuming medication. Some physicians will request Creatinine and eGFR

screening prior to resumption of medication Several drugs contain *Metformin

PMID: 9640281 [PubMed - indexed for MEDLINE]

17

IV Contrast is Routinely used in 55% of CT

The Contrast WarmerWarms CM to Body Temperature

The Power InjectorPrecise injection Control

18

CT Syringe (Power Injection)

CT Syringe 200ml Capacity compared to standard 10ml Saline syringe

Saline Sold Separately

12



19

Loading a Syringe

Connect the straw to the Syringe

Fill the Syringe with Vacuum Pressure

20

Loading a SyringeAttach IV Tubing

Connection and remove air (Priming)

Tilt syringe down during use.

21

Contrast Media is Denser than Bone and has a High Viscosity

13



22

Improper Injection Technique Without Warming the CM Can Damage the Local

TissuesContrast Extravasation

• Pain• Swelling• Compartment Syndrome• Necrosis

Barrett, B. P. (2006). Clinical Practice. Preventing Neuropathy Induced by Contrast Medium. N. Engl. J. Med, 354(4):379–86.doi: 10.1056/NEJMMcp050801.PMID16436769.

23

Power injections require knowledge,IV assessment skills, and safety checks and balances.

PSI at Injector Interdepartmental Communications

PSI of a Car Tire

24

Contraindications for Contrast Media

•Reduced Renal Function eGFR <30ml/min/1.73m2 (MDRD) or Creatinine >1.5ml/dl

•Allergy to Iodinated Contrast Media Patients who have had minor reactions such as

hives and/or hay fever may still receive contrast Administer preventative corticosteroid and anti-histamine

therapy.– 50mG PO Prednisone 13 hours prior– 50mG PO Prednisone 7 hours prior– 50mG PO Prednisone 1hour prior + 50 mG Benadryl

Anaphylactic allergies to contrast media are true contraindication

14



25

Additional Screening For Contrast Media

•Diabetes•Renal Function•History of renal failure/transplant•Previous allergies to iodine (Not Shellfish)•Asthma•Heart Disease•Sickle cell anemia•Pheochromocytoma•Multiple Myeloma

26

Additional Non Contrast MedicationsAdministered by RN or M.D.

•Beta Blockers Reduce Heart Rate

Heart Motion Suppression

Reduced Exposure Settings

•Nitroglycerin Dilating small

blood vessels

•Lasix Stimulate Urinary

tract for visualization

•Glucagon Reduce Peristalsis

(MRI)

•Allergy Medications Benadryl (Minor) Corticosteroids Epinephrine

27

Contrast Use in RadiologyContrast Waste ReductionNon Weight Based versus Weight Based

Old Injection Protocol120ml @ 2ml/sec

or140ml @ 4ml/sec

Weight based Protocol 300, 350, 370 Conversions

Single use contrast (Optimized Image Quality)

Successful waste reduction ~6%

15



28


Multi-Pack

Residual WasteWeight Based Single Versus Multi-Pack


Single

*Multi-Pack decreased waste and enhanced workflow ,New Products on Market that meet Joint Commission Standards

29

Potential Future of Pharmacy Radiology Interaction in Contrast Dosing

•There is a clear benefit in waste reduction if healthcare organizations can successfully integrate the multipack safely-

Economies of Scale (Bulk Packaging) Workflow Enhancements

Missing Radiologic Knowledge base in the pharmacy from a distribution perspective. Two Key elements to contrast administration

30

First Key Element:Optimizing Injections Based on Patient Weight (BSA)

250 lb Patient 128 lb Patient

16



31

Second Key Element:Visualization of Arteries Capillaries and Veins

Injection Volumes & Rates:

Arteries:Average Catheter Size:18G/20GCM Volume::~1ml 370/KgIodine Load: ~0.37 g/KgFlow Rate:~5ml/SecondExample 75 kG Patient: 75ml@ 5ml/Sec

Capillaries (Body Organ Imaging):Catheter Size: 20G/22GCM Volume:~1.5ml 370/Kg Iodine Load: ~0.55 g/kGFlow Rate:~3ml/SecondExample 75 kG Patient: 113ml@ 3ml/Sec

Veins:Catheter Size:18G/20GCM Volume: ~2ml 370/KgIodine Load: ~074 g/kGFlow Rate:~3ml/SecondExample 75 kG Patient: 150ml@ 3ml/Sec

Hemodilution

32

Conclusion• CT Contrast Media• CT System Fundamentals• Contrast Agents• Administering Contrast

Agents• Storing Contrast Agents• Non Contrast Drugs• Contraindications to

Iodinated contrast media• Contrast Utilization

33

Thank You

Lior Molvin (M.B.A)(R.T)(R)(C.T.)Stanford Radiology CT Protocol and Educational Development

Stanford Health Care

[email protected]

17



Medication Safety Issues and Recommended Strategies

Matthew P. Fricker MS RPh, FASHP

Program Director

Institute for Safe Medication Practices

34

Objectives for Presentation

• Identify system-based causes of medication errors associated with the use of medications and contrast agents in radiology

• Provide / prioritize strategies to prevent harm and improve medication safety in radiology

35

Who is prescribing, preparing, and administering medications?

36

18



Pharmacy Oversight

• Radiology (and other procedural areas)

‒ Commonly have minimal pharmacy oversight

‒ Limited visibility - not on pharmacy radar screen

‒ Often none or weak relationship between pharmacy and radiology managers and staff

37

Recommended Strategies

• Provide pharmacy oversight

‒ Establish relationships

‒ Learn medication use/needs

‒ Assign a pharmacy liaison to each area

‒ Regular “walkrounds” (more than to check stock medications)

‒ Evaluate the need for ADCs to store medications and if feasible have pharmacy review orders for medications before they are obtained

38

Medication Errors in Radiology

Event Type Total % of Total Reports (N=985)

Wrong drug 141 14.3%

Dose Omission 133 13.5%

Wrong dose/overdosage 105 10.7%

Wrong rate (IV) 61 6.2%

Documented allergy 50 5.1%

Other 125 12.7%

39

PSA. Medication Errors Occurring in the Radiologic Services Department. June 2009. 6 (2). 46-50.

19



Radiology Errors Reported to PA Patient Safety Authority

• 11% of all reports showed breakdowns with the use of infusion pumps and the handling of IV lines:

‒ Misprogrammed infusion pumps

‒ Infusions that were stopped but not restarted

‒ Tubing misconnections

‒ Wrong-patient errors


40

Multi-nodal Error Potential

• Errors occur in all nodes*

‒ Prescribing

‒ Transcribing

‒ Dispensing

‒ Administration

‒ Monitoring

*most errors occur in prescribing or administration nodes

41

Communication

42

20



Recommended Strategies (general)

• Patient Information

‒ Ensure that essential elements of patient information are readily accessible to all practitioners providing care for the patient

diagnosis / comorbidities

allergy information (including reaction)

actual patient weight (kg not lbs)

renal function

43

Recommended Strategies (general)

• Communication

‒ Handoffs -> share critical information when patient transported from care unit to radiology (and back)

critical drugs infusing (dual chamber pumps?)

condition of patient

what to do “if”…..

‒ Who is handing off the patient?

44

Events Related to Prescribing

• Patient information

‒ Failure to consider essential patient formation

‒ Failure to adjust doses for decreased renal function

• Communication

‒ Frequent use of verbal orders

‒ Incomplete orders / Unapproved protocols

• Oversedation requiring the use of reversal agents

45

21



Recommended Strategies (prescribing)

• Ensure that all verbal orders are repeated back to prescriber

• Clarify all orders that are ambiguous, missing key information or do not follow approved protocols

• Ensure that key patient information is readily accessible and used

46

Events Related to Dispensing

• Radiology technician

‒ Retrieves wrong contrast agent from inventory

‒ Dispenses wrong product to patient

• Pharmacy

‒ Errors when restocking automated dispensing cabinets (ADCs)

‒ Expired medications in ADCs

‒ Frequency of use not periodically reviewed

‒ Excess inventory

47

Recommended Strategies (dispensing)

• Ensure all storage locations are labeled properly

• Segregate look alike products in radiology inventory

• Use meaningful auxiliary warning labels

• Regular discussions between department staff and pharmacy to review items in ADC inventory

48

22



Meaningful

49

Events Related to Administration

• Patient Identification

‒ No identification bands (outpatient?)

‒ Failure to properly identify the patient

not using two identifiers

stating versus asking

‒ Not using barcode medication verification system

50


• Patient on heparin infusion at 1,000 units/hour transported to radiology for an MRI. Nurse in radiology discontinued the use of the pump and regulated the heparin infusion with a manual flow device

Result:

‒ Nurse inadvertently altered the heparin infusion rate 8,000 units/hr were administered

51

MedMarx database, access June 2011

23




• To position patient, IV tubing was removed from pumps and inadvertently returned to the wrong pump

Result:

‒ Fentanyl infusing at 125 mL/hour; ordered at 2.5 mL hour (received 75 mcg before discovery)

‒ Large volume IV infusing at 2.5 mL/hour; ordered at 125mL/hour

52



• Radiology technician used DOBUTamine infusion line to flush contrast media through IV tubing and catheter

• Pediatric patient in MRI suite was given 2 mL of fentaNYL 50 mcg/mL instead of 2 mL of 1 mcg/mL

Results: Imagine

53



• “Patient presented to ED with chest pain

pain score stated as 10/10

‒ Sent to cardiac catheterization lab

‒ Received a bolus of Angiomax based on a weight documented in ED of 73 kg

‒ Actual weight was 112 kg”


54

24



Recommended Strategies (administration)

• Ensure safe hand-off from patient care unit to radiologic staff

‒ Communicate that infusion pumps should not be turned off and lines should not be switched or removed from pumps

‒ Label IV contrast infusion line

‒ Check compatibility before flushing IV lines

‒ Need to call before drug infusion bag is empty

55

Drug Labeling, Storage and Standardization

• Labeling issues

‒ Inconsistent use of labels or failure to record Beyond Use Date (BUD) on labels

‒ Technicians dispense oral contrast in unlabeled cup

palatable drink used as vehicle

cups not labeled with patient name, date, name of contrast

56

Drug Labeling, Storage and Standardization

• Poor storage of drugs and contrast

‒ Often multiple drugs stored in one bin

‒ Different contrast agents not sufficiently segregated from one another

‒ Contrast stored in warmers without a modified BUD to reflect modified storage conditions

57

25



Drug Storage and Standardization

• Drug kits

‒ Multiple varieties and titles

emergency kit

hypersensitivity kit

Transport kit

‒ Many created spontaneously by department

‒ Pharmacy may not be aware of kit / contents

‒ Contain excessive types and quantities of drugs

58

Recommended Strategies(storage and standardization)

• Ensure that all containers are labeled properly

• Record BUD on all labels

‒ Apply modified BUD for contrast placed in warmers

• Use single dose and multiple dose vials correctly

• Store drugs safely, effective segregation of different products with proper labeling

• Limit and manage emergency kits

59

Sterile Compounding in Radiology

26



Recommended Strategies

• Avoid sterile compounding unless emergent

‒ Discuss needs for compounded products and determine if products can be prepared by pharmacy

• Ensure that all admixture instructions are well written and vetted by pharmacy prior to use

61

Key Medication Safety Concerns

• Environment

‒ Lighting

• Staff knowledge/competency

‒ Not all areas use licensed staff to prepare and administer medications

• Focused care/invasive procedures

‒ May not focus on medications/infusions not associated with the exam or procedure

62

Recommendations

• Invite department managers to Patient Safety or Medication Safety Committee meeting to voice needs / concerns

• Use procedural “time outs”

• Standardize handoffs

• Consider RN/certified staff in Radiology and other high volume departments

• Regularly perform a risk assessment

63

27



Perform a Risk Assessment

• Does radiology…

‒ Obtain medications, fluids or contrast agents from outside vendors, hospital purchasing

‒ Require the same medication administration competencies and policies employed in other departments

‒ Track patient outcomes post-procedure

64

Perform a Risk Assessment

• Does radiology…

• Participate in hospital wide medication safety initiatives

• Report errors/near misses

• Debrief after an event

• Request assistance from medication safety committee to assist with analysis of event

65

Risk Reduction Strategies

• Examine the medication use process in radiology areas

• Patient care units transferring patients to radiology can proactively address a plan for management of patient’s infusion therapy while in radiology

• Some organizations employ nurses dedicated to radiology services

66

28



Risk Reduction Strategies

• Adequate supervision by physician or nurse where technicians are administering contrast media or other medications

• Include radiology staff when evaluating or validating competencies for medication administration

• Consider recent patient information before ordering, dispensing or administering medication

67

Centers for Medicare & Medicaid Services (CMS) and

The Joint Commission Requirements

Darryl S. Rich, PharmD, MBA, FASHP

Medication Safety Specialist

Institute for Safe Medication Practices

68

Top TJC Medication Standards ScoredNon-Compliant

• MM.03.01.01 Medication Storage 33%

• MM.04.01.01 Medication Orders 23%

• MM.05.01.01 Pharmacist Review 15%

• NPSG.03.04.01 Labeling in Procedures 12%

• MM.01.01.03 High Alert Medications 6%

• MM.05.01.09 Medication Labeling 6%

• NPSG.03.06.01 Medication Reconciliation 5%

• MM.05.01.07 Medication Preparation 5%

From TJC presentation ASHP Summer Meeting, June 2014

69

29



MM.03.01.01 Medication Storage

• Medication security

• EP 3 - Stores all medications in a secure area

• EP 6 - Prevents unauthorized individuals from obtaining medications

• Issues: • Medication carts (code carts) not in view of staff

• Medication storage unlocked after hours

• Medications left out unsecure on counters

§482.25(b)(2)(iii)

§482.25(b)(2)(i-ii)

70

Medication Storage Issues

• EP 7 - Stored medications and components used in their preparation are labeled with contents, expiration date, and any applicable warnings

• Issue: No or wrong expiration date on products• If not labeled with an expiration date by manufacturer, then

one must be assigned

• Once opened or stored in different conditions (e.g., warmer) must have a revised beyond use date - per package insert

§482.25(b)(3)

71

Beyond Use Date

• The Joint Commission requires organizations to re-label all drugs with a “beyond use date” once the original manufacturer’s container is opened• Includes IV’s stored after the overwrap is removed and

contrast in warmers • Date must be the last date that the product is to be used –

cannot be the date opened – see FAQ• If manufacturer specifies a beyond use date in the

package insert, must use• Multi-dose vials must have a beyond use date not to

exceed 28 days from date opened.• Issue: Non-contrast medications in Nuclear Medicine,

Cardiac Stress Lab, Interventional Radiology

72

30



Medication Storage

• EP 2 - Stores medications according to the manufacturers’ recommendations or, in the absence of such recommendations, according to a pharmacist’s instructions

• EP 8 - Removes all expired, damaged, and/or contaminated medications and stores them separately from medications available for administration

• EP 18 - Periodically inspects all medication storage areas

§482.25(b)(3)

§482.25(b)(3)

§482.25(a)

73

Medication Storage

• Issues:

• Expired drugs stored in areas for patient use

• Products stored under conditions not allowed in package insert• Cannot store contrast in warmer if manufacturer does not

specify it can in package insert (e.g. if closure entered, syringes), or other document from manufacturer

• Cannot store at room temperature if manufacturer specifies it must be refrigerated

74

The Bulk Contrast Vial Issue

Pharmacy Bulk Package (PBP)vs.

Single Dose Vials (SDV)

75

See ISMP Medication Safety Alert!, September 20, 2012

31



Pharmacy Bulk Package• NOT a multi-dose vial – no preservative

• Approved uses:• Pharmacy to break down into single dose syringes in

a ISO 5 environment (laminar flow hood)

• Large volume single dose vial (1 patient/1 case)

• Special multi-dose contrast injectors in angiography• Bracco ACIST CVi® and MedRad AVANTA®

• NOT for multi-patient use with regular contrast injectors or multiple transfers outside of an ISO 5 environment

76

And the package insert says…

• Transfer should be performed in a suitable ISO 5 work area, such as a laminar flow hood, utilizing aseptic technique.

• The container closure may be penetrated only one time, utilizing a suitable transfer device.

• Once punctured, the PBP should not be removed from the aseptic work area during the entire period of use.

• A maximum use time of 8- 10 hours from initial closure entry to complete fluid transfer, depending on product.

77

Pharmacy Bulk Package

• FDA interpretation (10/31/2011)–

• “An aseptic area is one that meets the following criteria:• Engineering controls such as HEPA-filtered laminar air flow

that meets the standards for ISO Class 5

• Appropriate cleaning and disinfecting procedures

• Periodic microbiological monitoring of the area”

• “We do not regard PBP’s as appropriate for use in the CT suite unless the suite meets these specific criteria”• Sterile tubing does not constitute an aseptic area

78

32



Imaging Bulk Package - History

• 2011: FDA alerted to inappropriate multi-patient use of PBP in CT suites outside of an aseptic area

• FDA determined that approved device instructions for contrast injectors contradicted contrast package insert

• Required manufacturers to prove sterility of contrast when used in their equipment.

• FDA created a new category of vial (Imaging Bulk Package – IBP) for multiple patient use in radiology.

• First IBP approved in October 2014

79

Imaging Bulk Package• Approved for dispensing multiple single doses of contrast for

multiple patients, using an automated contrast injection system or contrast management system approved or cleared for use with the IBP.

• The container closure may be penetrated only one time with a suitable sterile component of the approved automated contrast injection system or contrast management system using aseptic technique.

• Once punctured, the IBP should not be removed from the work area and the bottle should be maintained in an inverted position such that contents are in continuous contact with the dispensing set.

• A maximum use time of 8-10 hours from initial closure entry to complete fluid transfer.

80

Current Status

• FDA• Created new container - Imaging Bulk Package

• Requiring equipment manufacturers to prove sterility w/ IBP

• CMS

• Drugs are used within the pharmaceutical parameters approved by the FDA and manufacturer’s recommendation

• Joint Commission• Not surveying use of bulk package in CT, provided risk assessed

• Surveying: beyond use dating/timing, use in warmers.

• Legal risk of lawsuit

81

33



CDC Safe Injection Practices

• Required adherence to CDC Safe Injection Practices guidelines

• IC.01.05.01, EP 1 Must incorporate CDC Safe Injection Guidelines in policies and procedures

• IC.02.01.01, EP 2 Must follow CDC Safe Injection Guidelines in practice

• Joint Commission Perspectives - October 2010

• For CDC guidelines see:• http://www.cdc.gov/injectionsafety/unsafePractices.html

§482.23(c)

82

CDC Safe Injection Practices

• Examples from CDC Guidelines:

• “Do not administer medications from single-dose vials or ampules to multiple patients” • propofol, contrast

• “Do not use bags or bottles of IV solution as a common source of supply for multiple patients” • Interventional Radiology (IR), Nuclear Medicine

83

Report – MMWR July 13, 2012• When: April 2012 - Arizona

• Who: Three patients who received pain remediation and contrast injections

• Breaches: Use of single-dose/single-use vials of contrast media and saline solution for multiple patients and failure to wear facemasks during injection procedures

• Patient Impact: Three patients admitted to the hospital for severe infections including mediastinitis, bacterial meningitis, epidural abscess, and sepsis. A fourth patient who received contrast from the same vial was found deceased at home. Invasive MRSA infection could not be ruled out.

84

34



MM 05.01.01Pharmacist Review of Orders• EP 1 - Before dispensing or removing medications

from floor stock or from an automated dispensing machine, a pharmacist reviews all medication orders unless:• a LIP controls the ordering, preparation, and

administration of the medication• LIP must be present at the patient’s bedside during

administration of the drug

• when a delay would harm the patient in an urgent situation (including sudden changes in a patient’s clinical status) • First dose only

§482.25(b)

85

MM 05.01.01

• Footnote:

• Radiology: Pharmacist review of contrast orders (including radiopharmaceuticals) is exempted. However, the hospital is expected to define, through protocol or policy, the role of the LIP in the direct supervision of a patient during and after IV contrast media is administered• See ACR guidelines for IV contrast administration

• Issue: IV contrast administered per protocol without specifying role of MD in supervision of patient before and during IV contrast administration in the policy or protocol

86

MM 05.01.01

• Issue: No pharmacist review when required

• Non-contrast medications in diagnostic areas for scheduled cases when no LIP at the patient bedside during administration of the drug

• Non-profiled ADCs for all drugs• Cardiac Stress: DOBUTamine, Lexiscan®, adenosine

• Nuclear Medicine: furosemide, etc.

• Radiology: LORazepam, others given by RN

87

35



MM.05.01.07Drug Preparation

• EP 1 - A pharmacist, or pharmacy staff under the supervision of a pharmacist, compounds or admixes all compounded sterile preparations except in urgent situations in which a delay could harm the patient or when the product’s stability is short

• Presence of LIP (or admixture performed by LIP) is not an exception! Neither is being a “procedural area”.

• Issues: Heparin drips, irrigations and other IV admixtures (often non-standard concentration)

* =direct impact EP

§482.25(b)(1)

88

MM.05.01.07Drug Preparation

• Definition from glossary of CAMH:

• Intravenous admixture: addition of a measured amount of drug to a 50ml or greater bag or bottle of fluid given by any sterile route. Add-a-vial systems, syringes and reconstitution of vials exempt

89

MM.05.01.09Medication Labeling• EP 1 - Medication containers are labeled whenever

medications are prepared but not immediately administered

• TJC defines an immediately administered medication as “one that an authorized staff member prepares or obtains, takes directly to a patient, and administers to that patient without any break in the process” • This is a different definition than USP 797

• EP 4 - All medications prepared are labeled with the expiration date when not used within 24 hours

§482.23 (c), §482.25(b)(3)

90

36



Medication Labeling

• Issues:• Not all medications labeled after transfer to

another container• Medication name and strength

• Expiration date, if not used the same day

• Expiration time, if it expires in less than a day.

• Patient name (if patient specific)

• Diluent, Date Prepared (if IV admixture*)

* 50ml or greater volume bag/bottle.

91

Labeling in Procedures

• NPSG 03.04.01: Label all medications and solutions on and off the sterile field

• Issues in Interventional Radiology:

• Not all solutions labeled

• No strength on label

• Actual containers not labeled

• Not labeled immediately before or after addition of drug to the container

• Verbal & visual check in 2 person handoff

• Not discarding medications at end of procedure

§482.23 (c), §482.25(b)(3)

92

NPSG 03.06.01Medication Reconciliation

• EP 2: Define (in writing) the types of medication information to be collected in non–24-hour settings and different patient circumstances

• OP Radiology, Diagnostics

• Can say no drug information collected for oral contrast, or only check if on metformin and similar drugs for IV contrast

• Can say only drug name – no dose, route, etc. for ED• Issue: Many have changed practice but not policy

93

37



Other Standard Issues

• MM.02.01.01 – Selection of medications• EP 1-5: Formulary Process

• EP 9: Annual review process based on safety and efficacy

• EP 10-15: Drug shortage process• Above include contrast, radiopharmaceuticals, other diagnostics

• EP 6*: Standardizes and limits the number of drug concentrations available

• MM.03.01.03 – Emergency drugs • EP 2*: Emergency medications and associated supplies are

readily accessible in patient care areas• Includes diagnostic & procedural areas

• Age-specific (pediatrics)

* =direct impact EP

§482.25 (b)(9)

§482.51 (b)(3)

94


• MM.05.01.11 – Safely dispenses medications

• EP 2: Hospital dispense medications and maintain records according to law, regulation & standards of practice

• Issue: Dispensing practices not the same as the pharmacy (e.g. lack of control records; labeling with patient name, directions, warnings, etc.)• Dispensing oral contrast (legend drug) by radiology to

outpatients to take home

§482.25 (b)

95


• MM.06.01.01 – Safely administers medications

• Defines in policy, who can administer medications• Must include radiology/nuclear medicine technologists.

§482.23 (c)

96

38




• HR.01.06.01 - Staff are competent to perform their responsibilities.

• EP 5: Staff competence is initially assessed and documented as part of orientation.

• EP 6: Staff competence is assessed and documented once every three years, or more frequently as required by hospital policy or in accordance with law and regulation.• CMS specific orientation, training, and competency

requirements in IV administration

§482.23 (c)(3)

97


• NPSG 01.01.01: Uses at least two patient identifiers when administering medications

• Issue: Done on entry to department – and not prior to each medication or contrast administration, as required

• RI.01.01.01 – Respects, protects and promotes patient rights

• Issue: Not protecting patient personal information/privacy while gathering data in waiting room

§482.13 (c) (1)

§482.23 (c)

98


• MM.07.01.03 – Adverse drug event reporting

• EP 6: Medication administration errors, adverse drug reactions, and medication incompatibilities as defined by the hospital are reported to the attending physician or clinical psychologist, immediately when possible, and as appropriate to the organization-wide PI program

§482.25 (b)(6)

99

39




• MM. 08.01.01 –Evaluation of the effectiveness of the medication management system

• EP 1 - Data collected on performance of MM system

• EP 3 - Data analyzed to identify risk points

• EP 5 - Improvements identified based on data analysis, literature, best practices

• ISMP Medication Safety Alert!

• Issue: Not including diagnostic areas in data collection or evaluation

§482.21 (a)(2), §482.21 (e), §482.23 (c)(5)

100

Parting Suggestions

• Periodic review of all areas where medications are used

• Be sure to address hot patient safety issues in media

• Work with your Joint Commission Coordinator

• Don’t panic – focus on big issues not the obscure

• Direct impact EP’s – 3 in Manual

101

Final Point

“ Safety in health care depends more on dynamic harmony among actors than on reaching an optimum level of excellence at each separate organizational level.”

René Amalberti, MD, PhD

102

40



Sources of Information

• www.jointcommission.org

• FAQ for current standards

• FAQ for current NPSG

• Copy of 2009 NPSG

• Current and Past Copies of:

• Sentinel Event Alert

• Joint Commission Online

• Pre-publication Standards

Current Standards (CAMH) and Perspectives must be obtained from hospital TJC coordinator

103

QuestionsFor questions about the interpretation of Joint Commission standards, organizations (or the public) can submit their questions by either:

• Calling the Standards Interpretation Unit at 630-792-5900

• Submitting the question in writing by using the following on-line form: http://www.jointcommission.org/Standards/OnlineQuestionForm/

104

Online Evaluation and Statement of Completion

• www.ProCE.com

• Register with username and password

• Deadline: Friday, January 9

105

Event Code = GJ3YJ6Event Code = GJ3YJ6

41



CCEE AACCTTIIVVIITTYY EEVVAALLUUAATTIIOONN AANNDD CCRREEDDIITT IINNSSTTRRUUCCTTIIOONNSS

1. To receive CE credit for this activity, you must complete the post-test and activity evaluation online no later than Friday, January 9, 2015.

2. Read the CPE Monitor information below.

3. Visit www.ProCE.com/evaluation.

4. Click on the Evaluation button which is listed with the Improving Medication Safety in the Radiology Setting - December 8, 2014 CE activity.

5. Enter the Event Code for this CE activity: GJ3YJ6 (you will need this code to access the post-test and activity evaluation).

6. Follow the online instructions to complete the post-test and activity evaluation, and to receive CE credit.

7. If you need assistance or have questions, please contact ProCE at 630.540.2848 or via email at [email protected].

CCPPEE MMOONNIITTOORR -- FFOORR PPHHAARRMMAACCIISSTTSS AANNDD PPHHAARRMMAACCYY TTEECCHHNNIICCIIAANNSS

CPE Monitor is a collaborative program between the National Association of Boards of Pharmacy (NABP) and the Accreditation Council for Pharmacy Education (ACPE). This national e-system is designed to store and authenticate data for completed CPE units for both pharmacists and pharmacy technicians. To create a new user account at the ProCE LMS (Learning Management System), you will need to enter your NABP e-Profile ID and the month and day of your birthday (in MMDD format). For more information, click

the hyperlink near the top of the ProCE evaluation web page (i.e., where you see Pharmacists and Pharmacy Techs: Click to access CPE Monitor and latest CE information). Note: It is ProCE policy that CE requirements (i.e. post-test, if applicable for the specific CE activity, and evaluation) be completed within 30 days of the live activity date to ensure an on-time submission to your CPE Monitor account. ProCE uploads completed CE activities to NABP/CPE Monitor once each week, usually on Mondays.

42

Documents

Lior - Bracco Radiology Symposia Booklet