Recommended
Recommended
More Related Content
What's hot
What's hot (20)
Viewers also liked
Viewers also liked (18)
Similar to Commercial Products Hospitals Need
Similar to Commercial Products Hospitals Need (20)
Recently uploaded
Recently uploaded (20)
Commercial Products Hospitals Need
- 2. Commercial Products Hospitals Need Changing product needs Evolving practice Advancing Standards Expanding knowledge 2 Healthcare is experiencing rapid change - Particularly in pharmacy • Expanding knowledge • Advancing standards • Evolving practice We need products that support our practice
- 3. 3 Purchasing for Safety Products designed with safe use in mind Influence Influence Product Offerings Practice What We Have What We Need Product OfferingsPractice Commercial Products Hospitals Need
- 4. Current Challenges Commercial product offerings fall short of hospital needs High alert drugs supplied in dosage and packaging formats associated with significant risk to patients Hazardous oral drugs supplied in format that we now know poses risk of exposure for hospital staff and care providers Products offerings that do not support current practice 8 When product offering falls short, pharmacy must pick up the slack Commercial Products Hospitals Need
- 5. Hazardous & Allergenic Oral Drugs in Unit Dose Format Ready-to-Use range of formats, that support current clinical practice 5 Commercial Products Hospitals Need
- 6. 6 We need true unit dose packaging for: Hazardous & Allergenic Drugs in Unit Dose Format Hazardous drugs* (antineoplastic, non-antineoplastic) Drugs with reproductive hazards Highly allergenic drugs * Highest priority
- 7. Hazardous Drugs due to their inherent toxicity present an occupational hazard to healthcare workers 7 Hazardous & Allergenic Drugs in Unit Dose Format • Carcinogenic • Teratogenic • Reproductive toxicity • Toxic at low doses • Genotoxic Highly Allergenic Drugs may trigger a serious allergic reaction • Antibiotics (penicillins, cephalosporins, sulfonamides, etc.)
- 8. Which medications should have special handling? Hazardous & Allergenic Drugs in Unit Dose Format National Institute of Occupational Safety and Health (NIOSH) • Antineoplastic – Hazardous • Non-antineoplastic – Hazardous • Non-antineoplastic – Reproductive effects University of Utah Drug Information Service • Oral medications that should not be packaged in the prepackage machine • Oral medications that require special handling precautions 13
- 9. Enforced by: • Professional practice regulators – hospital and retail pharmacy inspections • Accreditation Canada surveyors • Occupational Health & Safety inspectors Hazardous & Allergenic Drugs in Unit Dose Format 14 How are standards for safe handling being applied in Canada?
- 10. Hazardous & Allergenic Drugs in Unit Dose Format What is the risk? • Exposure of Healthcare Staff and Caregivers: – Skin contact or inhalation of dust from uncoated tablets when handling – Coated tablets and capsules pose a lower risk – but risk still present • Hospital pharmacy handles large volumes of hazardous and allergenic drugs every day: – Repeated exposure may pose a higher risk in the workplace • Cross contamination of other drugs 10
- 11. Special handling precautions must be followed to count, repackage, split or crush oral dosage forms Hazardous & Allergenic Drugs in Unit Dose Format NO Automated Counting or Packaging Machines Engineering Controls with Dedicated Equipment & Work Space Personal Protective Equipment (PPE) 16
- 12. Hazardous & allergenic drugs: • Should not require further manipulation before delivery to the patient • Products supplied in unit dose packaging should be dispensed in the original package • Manufacturers do this best • Should not be placed in packaging machines • May introduce powdered contaminants • Must repackage manually to comply with regulations Hazardous & Allergenic Drugs in Unit Dose Format X 12
- 13. Appropriate Personal Protective Equipment (PPE) is required when handling/manipulating hazardous drugs Hazardous & Allergenic Drugs in Unit Dose Format 18 Activity Gloves (1-2 pairs) Gown Respiratory Protection Repackaging (opening stock bottles, UD packaging) Cutting, crushing, manipulating product Patient administration from Unit Dose package X X X X X X Handling Product in Unit Dose Packaging None Required None Required None Required Best CaseBest case
- 14. Engineering controls with dedicated equipment & workspace for packaging • Negative pressure room, segregated from non-hazardous drugs • Dedicated equipment (chemo mat, counting tray, pill cutter, supplies, etc.); cleaned after each use Hazardous & Allergenic Drugs in Unit Dose Format • Compounding Aseptic Containment Isolators (CACIs) or Class 1 Biological Safety Cabinet if risk of particle generation 19
- 15. 20 Hazardous & Allergenic Drugs in Unit Dose Format Moved to active stock Segregated from non- hazardous stock Dedicated reprocessing area & equipment Verified for accuracy Repackaged manually with PPE Product in unit dose format Product not in unit dose format Barcode applied
- 16. 16 Oral Solids – Unit Dose Pack Each dose includes all appropriate label information and is ready for administration directly from the package Hazardous & Allergenic Drugs in Unit Dose Format
- 17. Is Blister Pack format “good enough”? • Does not suit in-hospital use • For hospital inpatient – single unit dose is administered to patient • Single dose removed from blister and repackaged • Unit dose is adaptable to retail or outpatient setting Blister pack is not adaptable to hospital inpatient setting • NEED – unit dose packaging with barcode on each unit of administration Hazardous & Allergenic Drugs in Unit Dose Format 22
- 18. Why is Unit Dose Format required? Hazardous & Allergenic Drugs in Unit Dose Format Hospitals require ready-to-use format in unit-of-use Does not require manipulation Other formats require repackaging and special handling enforced by regulators/inspectors Minimize occupational exposure and cross-contamination 23
- 19. Hazardous & Allergenic Drugs in Unit Dose Format 2 of 3 highest risk drugs are NOT available* in Unit Dose format 19 * Based on current HealthPRO contracts Highest Risk = NIOSH
- 20. What is the opportunity? 20 Healthcare workers prefer Unit Dose when choice available Growing market • 400 new cancer drugs in development • 25-50% are oral agents Hazardous & Allergenic Drugs in Unit Dose Format
- 21. 21 Ready-to-use formats that support current clinical practice
- 22. 22 Ready-to-use Formats that Support Current Clinical Practice Patient demographics are changing – Aging population – Increasingly complex patients Role of regulatory colleges in oversight of hospital pharmacy practice is increasing – Hospital inspections in British Columbia, Ontario; being considered by others Pharmacy practice environment is changing
- 23. Evolving Hospital Pharmacy Practice Standards continue to drive change, with a strong focus on Quality and Safety • Accreditation Canada Standards updated annually • ISMP list of High Alert Medications reviewed & revised regularly • CSHP Compounding Guidelines for Pharmacies 2014 • NAPRA Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations 2015 23 Ready-to-use Formats that Support Current Clinical Practice
- 24. Commercial product offerings created years ago do not meet the needs of today’s patient Regulatory Compliance vs. Fitness for Purpose 24 Ready-to-use Formats that Support Current Clinical Practice Product offerings satisfy regulatory criteria for efficacy, safety and quality Product offerings that satisfy current use and clinical practice “Procurement decisions must be based on detailed understanding of how healthcare staff and patients use and may misuse medicines.” Crowley C. Oxford Radcliffe Hospitals NHS Trust, 2009.
- 25. Ready-to-use Formats that Support Current Clinical Practice 25 • Demand for older drug molecule remains • Opportunities exists for alternate product formats to better meet patient needs Opportunities for commercial formats that: • Directly meet patient need • Support current clinical practice • Improve safety & efficiency
- 26. Ready-to-use Formats that Support Current Clinical Practice 26 Potential new product opportunities Ready to use high alert medications Single dose strengths & sizes
- 27. Ready-to-use High Alert Medications What is a high alert medication? 27 Associated with increased risk of patient harm Consequences of an error are serious Small incremental change has significant impact Concentrated electrolytes Narcotics Heparins Insulins Chemotherapy Sedation agents
- 28. Ready-to-use High Alert Medications 28 Accreditation Canada Required Organizational Practices (ROPs) Several relate to high alert medications Essential practices organizations must have in place to enhance patient safety and minimize risk Evidence-informed practices addressing high- priority areas, central to quality and safety
- 29. Ready-to-use High Alert Medications 29 Accreditation Canada ROPs for High Alert Medications Concentrations and volumes with potential to cause patient safety incidents: Must not be stocked in client service areas Use pre-mixed solutions – should not be mixed on the nursing unit Standardize medication concentrations and volumes
- 30. Products that satisfy the Required Organizational Practices (ROPs) are often not commercially available Pharmacies must: compound internally outsource to commercial compounder obtain a commercial product Ready-to-use High Alert Medications 30
- 31. Ready-to-use High Alert Medications Good Preparation Practices Ensure product is made to required quality specifications 31 Used with permission. Compounding: guidelines for pharmacies. Ottawa, ON. Canadian Society of Hospital Pharmacists; 2014.
- 32. Ready-to-use High Alert Medications CSHP Compounding Guidelines for Pharmacies 2014 USP <797> Pharmaceutical Compounding – Sterile Preparations 2012 32 Requires large capital investment for equipment, engineering controls, testing, training, maintenance, and quality assurance • Strict quality standards to ensure sterility of compounded preparations for direct patient use • Growing complexity; approaching commercial grade • New “use before” Beyond-Use Date (BUD) guidelines
- 33. Ready-to-use High Alert Medications 33 Compound Internally Invest to Maintain Compounding Standards Purchase from Commercial Compounder OUTSOURCING - Hospitals must determine whether they can compound within the standards or outsource where available Compound Internally Invest to Maintain Compounding Standards Purchase from Commercial Compounder Source must be reliable or default back to hospital compounding
- 34. 34 COMMERCIAL PRODUCTS – Preferred option Ready-to-use High Alert Medications How do we get there from here? Reduces workload Reduces wastage Commercial compounders may not always be able to supply Highest manufacturing standard (GMP) If product is commercially available, it should not be compounded (Health Canada)
- 35. Any medication should be received from manufacturer • in a dose/strength that the patient needs • in a format that is ready to be administered directly to the patient 35 Single Dose Strengths & Sizes Half-strength tablets Single dose vials and prefilled syringes Range of vial strengths
- 36. Single Dose Strengths & Sizes Single dose vials vs. multiple dose 36 Single dose vials for single use pose lowest risk • “One to One” relationship • May be dispensed direct to patient care area for immediate use Multiple dose vials (with preservative) often treated as single dose and wasted • Vial sharing discouraged Strict “use before” guidelines • “One to Many” relationship • Shorter “use before” dating if used for more than one dose • Based on chemical stability and microbial risk
- 37. Single Dose Strengths & Sizes Range of vial sizes/strengths Over-sized single dose packages associated with increased wastage • Mismatch between quantity of packaged drug and patient dose • Left over drug is rarely used – strict BUD guidelines • Must pay for wastage Need product offerings that better match the patient’s dose 37
- 38. Single Dose Strengths & Sizes 38 *Bach, PB. BMJ 2016 Case example*: Bortezomib • Average prescribed dose: 2.5 mg • Canadian vial size: 3.5 mg • 1 mg vial available in UK • Multiple sizes would support variable patient doses with less waste
- 39. Single Dose Strengths & Sizes Half-strength tablets • New evidence may drive changes in practice and dosing; often not supported by marketed tablet strengths • Splitting tablets creates significant challenges – Difficult for patients – Inconsistent dose delivery with each fractional tablet – Pharmacy workload – manual splitting and packaging; cannot use automated packaging machine Need ready-to-administer products in strengths that patients need 39
- 40. Single Dose Strengths & Sizes 40 Case example*: Zopiclone • Health Canada approved a lower starting dose of 3.75 mg for all patients due to evidence of side effects. • Only zopiclone 5 mg and 7.5 mg tablets are available. • Zopiclone 3.75 mg tablet would support safe use, and promote efficiencies. * Health Canada Summary Safety Review. Nov. 2014
- 41. WE NEED Ready-to-Use format – Dose, concentration, volume suitable for patient administration – Prefilled syringes, small volume pre-mixed IV containers – Greatest demand for high alert drugs Single dose vials – Minimal waste Strengths, sizes necessary to accommodate common patient doses – Range of strengths/sizes – Re-evaluate as practice evolves; reconfigure to meet patient needs 41 Ready-to-use formats that support current clinical practice
- 42. Commercial Products Hospitals Need Ideal state Commercial product with a barcode arrives and is distributed to the patient bedside ready to be directly administered “One to One” relationship not “One to Many” 42
- 43. Commercial Products Hospitals Need We know this is not 100% attainable Barriers: – Commercial viability – Inherent product features (stability, production issues) – Lack of standardization & rationalization – Lack of evidence base to meet regulatory requirements 43
- 44. Commercial Products Hospitals Need We know… 44 Standards and practices will continue to change We don’t have all the answers It can be better We can only get better with your help
- 45. Commercial Products Hospitals Need 45 Transforming together to address evolving product needs Hospital Pharmacy Community Front-line insights & Clinical expertise Supplier Community Business insights & Manufacturing expertise
- 46. We can get to a better state. Let’s Transform, Together