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Evidence on the ‘Unmentionables’
BRENDALYNN ENS, DIRECTOR
KNOWLEDGE MOBILIZATION & LIAISON OFFICER TEAM, CADTH
JANET CRAIN, MANAGER
KNOWLEDGE MOBILIZATION, CADTH
EFTYHIA HELIS, KNOWLEDGE MOBILIZATION OFFICER, CADTH
KATHLEEN KULYK, LIAISON OFFICER-SASKATCHEWAN, CADTH
Disclosures
• I have no financial disclosures to declare.
• I have been an employee of CADTH for 10 years.
• Cost data shared are all-product combined averages from
available provincial information from 3S Health Shared
Services Saskatchewan and the Ministry of Health (March 2015).
Acknowledgements
Suzanne Boudreau-Exner
Director – Materials Management
Services
3S Health Shared Services
Susie Hilton,
Clinical Advisor
3S Health Shared Services
Pamela Bryce
Senior Policy Analyst
Drug Plan & Extended Benefits
Branch, Saskatchewan Health
Susan Yee
Manager - Client Services, Drug
Plan & Extended Benefits Branch,
Saskatchewan Health
Dave Morhart
Director - Client Services, Drug Plan
& Extended Benefits Branch,
Saskatchewan Health
What are the
‘unmentionables’?
Key Messages
• Common hospital products are overlooked for evidence-
based decisions; assumed to be cheap and inconsequential
in budgets.
• So many different products…so little time!
• Many unknowns: state-of-the-evidence, comparative data,
unit costs/patient, and reasons for usage, facility-based
economic analyses
• Absence of evidence does not mean evidence of
absence*
*Altman, D. G. & Bland, J. M. (1995). Absence of evidence is not evidence of absence. British Medical Journal; 311(7003);
485.
Images retrieved from: http://www.google.com/in2art.com and http://www.amazon.com
Discussion In Context
Focus is on:
• “Average” or most-common clients in common (non-specialized) health
care settings such as hospital units, long-term care facilities, community
centres and home usage
• Clients with common medical or surgical conditions with
usual/uncomplicated healing trajectory
• Standard usage rates and approved quantities for insurable benefits for
clients; known (documented) health care professionals and personal
care giver usage rates
What do we expect from evidence?
Source: http://ebp.lib.uic.edu/dentistry/?q=node/12
HTA
“health technology assessment”
Single-use disposable gloves
• No higher-pyramid evidence available showing:
• Safety differences, standardized clinical or cost-effectiveness across
products, allergy-potential comparison, effectiveness to prevent
pathogen transmission, or evidence-informed duration of use for
latex versus non-latex gloves.
• effects of prolonged usage, impact of perspiration or salts
• Moderate-lower pyramid evidence showing*:
• No difference in touch sensitivity or psychomotor performance
between latex and nitrile gloves;
• Comfort rating differences across health care professionals
• Latex gloves may be more resistant to punctures
• Vinyl gloves permeability to cytotoxic agents
*CADTH Rapid Response (2013). Disposable Gloves for Use in Healthcare Settings: A Review of the Clinical
Effectiveness, Safety, Cost-Effectiveness, and Guidelines http://www.bit.ly/1H6aCnW
Gloving Recommendations- WHO
• The World Health Organization
(WHO)* indications guide for
standard usage
• WHO loosely estimates usage
as 20-60 pairs of gloves used
daily by each health care
worker worldwide in clinical
care settings.
• Estimated Cost:
$ 0.07/glove**
*World Health Organization (2014) http://www.who.int/gpsc/5may/Glove_Use_Information_Leaflet.pdf.
** 3S Health Shared Services (Saskatchewan) Average procurement pricing for health care facility usage.
The Client at Home
A 3 month supply issued to individuals registered in the paraplegia program*
eligible for coverage for disposable gloves used by clients at home:
Oct – Dec 2014 Non-Sterile Glove Usage N = 275
# of Individual Gloves Used 86,110
Average Price Per Glove $0.13
Average # Used Per Individual in 3 month timeframe 313
Average # Gloves Used per Day Per Person 4
Total Cost for Coverage - 3 month $10,983
* Drug Plan & Extended Benefits Branch, Saskatchewan Health
Single-use disposable polypropylene
pleated face masks
There is no higher-pyramid evidence showing:
• Effectiveness of surgical face masks to protect from infectious material in
ORs or other controlled settings;
• Cross-brand comparative fluid or droplet permeability rates
• Safe wearability length of time to ensure personal protection***
Lower pyramid evidence suggests*:
• General benefit derived from wearing masks in health settings to reduce
acute bacterial transmission from staff-to-patients and patients-to-staff
• Lifespan recommendations for some products
Expert consensus without supporting evidence**:
• When masks have become damp, visibly soiled, or contaminated they are no
longer deemed effective; recommend to always change between patients
(IOM)
*CADTH Rapid Response (2013). Use of Surgical Masks in the Operating Room: A Review http://bit.ly/196aOVy
**Institute of Medicine IOM (US). Reusability of facemasks during an influenza pandemic. Washington: 2006
***Derrick JL, Gomersall ,CD. Protecting healthcare staff from severe acute respiratory syndrome: filtration capacity
of multiple surgical masks Hosp Infect. 2005 Apr; 59 (4):365-8.
Masking Recommendations- CDC
• Single-use disposable pleated polypropylene face masks are one of
many options of personal protective equipment (PPE)*
• Recommendations are for general for common or routine usage
• Recommendations for masks that cover both nose and mouth during
procedures and patient-care activities that are likely to generate
splashes or sprays of blood or body fluids.
• Cost: $0.15 per mask; No average usage estimates
* 2013 Centers for Disease Control and Prevention: http://www.cdc.gov
Call for evidence – Face masks
• Re-validation* that concepts of face mask usage more are entrenched
in clinical practice routines and trust that they prevent against airborne
transmission.
• Issues are more complex than initially thought...
• Facemasks plus gloves and/or regular hand hygiene may better
prevent infection in community settings.
• Respirators vs masks? No evidence
• Cloth masks? Not recommended
• Health economic analyses? Scarce
* MacIntyre, C. R. & Chughtai, A. A. (2015) Facemasks for the prevention of infection in healthcare and
community settings. BMJ; 350. http://www.bmj.com/content/350/bmj.h694 Published April 9, 2015
Stool softener medications
Docusate salts (sodium and calcium) are widely available, over-the-counter
medications classified as stool softeners. Their surfactant mechanism of action
has been (theoretically) believed to keep stool pliable and prevents straining
during defecation.
There is limited moderate-high pyramid evidence showing:
• Stool softener products do not increase stool frequency or soften stools
compared with placebo.
• They do not improve the symptoms of constipation.
• They do not improve the difficulties or completeness of stool evacuation in
patients taking opioids.
No rational argument for use of docusate in hospitalized patients or long-term care
residents.
* CADTH Rapid Response (2014). Dioctyl Sulfosuccinate or Docusate (Calcium or Sodium) for the
Prevention or Management of Constipation: A Review of the Clinical Effectiveness
http://bit.ly/1MR8IWR
Reduced Usage Recommendations
– Alberta Health Services
• In 2013 there were over 2.1 million doses of 100mg given to
patients within Alberta Health Services*.
• Based on an estimated cost of $0.26/tablet (OTC estimated
cost*), Docusate sodium (Colace) may in fact reflect
“money flushed down the toilet” **
* Pasay, D. (2014). Drug & Therapeutics Backgrounder – Stool Softeners: Why are they still being used? Alberta
Health Services.
** Mann, J. & Greenwood-Dufour, B. (2014) Docusate for constipation: money down the toilet?
http://hospitalnews.com/docusate-constipation-money-toilet/
So what?
Awareness of the state-of-the-evidence, existence of comparative data,
and actual unit costs can:
• Help to support optimal usage decisions
• Potentially mitigate against “hype” and assumed knowledge when
definitive high pyramid evidence is not available*
• Potentially assist in managing ever-increasing hospital medical
supply budgets
There is value in knowing & talking about the unmentionables!
*Altman, D. G. & Bland, J. M. (1995). Absence of evidence is not evidence of absence. British Medical Journal; 311(7003);
485.
Cadth 2015 b6 monday 1330hrs unmentionables presentation ble 3

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Cadth 2015 b6 monday 1330hrs unmentionables presentation ble 3

  • 1. Evidence on the ‘Unmentionables’ BRENDALYNN ENS, DIRECTOR KNOWLEDGE MOBILIZATION & LIAISON OFFICER TEAM, CADTH JANET CRAIN, MANAGER KNOWLEDGE MOBILIZATION, CADTH EFTYHIA HELIS, KNOWLEDGE MOBILIZATION OFFICER, CADTH KATHLEEN KULYK, LIAISON OFFICER-SASKATCHEWAN, CADTH
  • 2. Disclosures • I have no financial disclosures to declare. • I have been an employee of CADTH for 10 years. • Cost data shared are all-product combined averages from available provincial information from 3S Health Shared Services Saskatchewan and the Ministry of Health (March 2015).
  • 3. Acknowledgements Suzanne Boudreau-Exner Director – Materials Management Services 3S Health Shared Services Susie Hilton, Clinical Advisor 3S Health Shared Services Pamela Bryce Senior Policy Analyst Drug Plan & Extended Benefits Branch, Saskatchewan Health Susan Yee Manager - Client Services, Drug Plan & Extended Benefits Branch, Saskatchewan Health Dave Morhart Director - Client Services, Drug Plan & Extended Benefits Branch, Saskatchewan Health
  • 5. Key Messages • Common hospital products are overlooked for evidence- based decisions; assumed to be cheap and inconsequential in budgets. • So many different products…so little time! • Many unknowns: state-of-the-evidence, comparative data, unit costs/patient, and reasons for usage, facility-based economic analyses • Absence of evidence does not mean evidence of absence* *Altman, D. G. & Bland, J. M. (1995). Absence of evidence is not evidence of absence. British Medical Journal; 311(7003); 485.
  • 6. Images retrieved from: http://www.google.com/in2art.com and http://www.amazon.com
  • 7. Discussion In Context Focus is on: • “Average” or most-common clients in common (non-specialized) health care settings such as hospital units, long-term care facilities, community centres and home usage • Clients with common medical or surgical conditions with usual/uncomplicated healing trajectory • Standard usage rates and approved quantities for insurable benefits for clients; known (documented) health care professionals and personal care giver usage rates
  • 8. What do we expect from evidence? Source: http://ebp.lib.uic.edu/dentistry/?q=node/12 HTA “health technology assessment”
  • 9. Single-use disposable gloves • No higher-pyramid evidence available showing: • Safety differences, standardized clinical or cost-effectiveness across products, allergy-potential comparison, effectiveness to prevent pathogen transmission, or evidence-informed duration of use for latex versus non-latex gloves. • effects of prolonged usage, impact of perspiration or salts • Moderate-lower pyramid evidence showing*: • No difference in touch sensitivity or psychomotor performance between latex and nitrile gloves; • Comfort rating differences across health care professionals • Latex gloves may be more resistant to punctures • Vinyl gloves permeability to cytotoxic agents *CADTH Rapid Response (2013). Disposable Gloves for Use in Healthcare Settings: A Review of the Clinical Effectiveness, Safety, Cost-Effectiveness, and Guidelines http://www.bit.ly/1H6aCnW
  • 10. Gloving Recommendations- WHO • The World Health Organization (WHO)* indications guide for standard usage • WHO loosely estimates usage as 20-60 pairs of gloves used daily by each health care worker worldwide in clinical care settings. • Estimated Cost: $ 0.07/glove** *World Health Organization (2014) http://www.who.int/gpsc/5may/Glove_Use_Information_Leaflet.pdf. ** 3S Health Shared Services (Saskatchewan) Average procurement pricing for health care facility usage.
  • 11. The Client at Home A 3 month supply issued to individuals registered in the paraplegia program* eligible for coverage for disposable gloves used by clients at home: Oct – Dec 2014 Non-Sterile Glove Usage N = 275 # of Individual Gloves Used 86,110 Average Price Per Glove $0.13 Average # Used Per Individual in 3 month timeframe 313 Average # Gloves Used per Day Per Person 4 Total Cost for Coverage - 3 month $10,983 * Drug Plan & Extended Benefits Branch, Saskatchewan Health
  • 12. Single-use disposable polypropylene pleated face masks There is no higher-pyramid evidence showing: • Effectiveness of surgical face masks to protect from infectious material in ORs or other controlled settings; • Cross-brand comparative fluid or droplet permeability rates • Safe wearability length of time to ensure personal protection*** Lower pyramid evidence suggests*: • General benefit derived from wearing masks in health settings to reduce acute bacterial transmission from staff-to-patients and patients-to-staff • Lifespan recommendations for some products Expert consensus without supporting evidence**: • When masks have become damp, visibly soiled, or contaminated they are no longer deemed effective; recommend to always change between patients (IOM) *CADTH Rapid Response (2013). Use of Surgical Masks in the Operating Room: A Review http://bit.ly/196aOVy **Institute of Medicine IOM (US). Reusability of facemasks during an influenza pandemic. Washington: 2006 ***Derrick JL, Gomersall ,CD. Protecting healthcare staff from severe acute respiratory syndrome: filtration capacity of multiple surgical masks Hosp Infect. 2005 Apr; 59 (4):365-8.
  • 13. Masking Recommendations- CDC • Single-use disposable pleated polypropylene face masks are one of many options of personal protective equipment (PPE)* • Recommendations are for general for common or routine usage • Recommendations for masks that cover both nose and mouth during procedures and patient-care activities that are likely to generate splashes or sprays of blood or body fluids. • Cost: $0.15 per mask; No average usage estimates * 2013 Centers for Disease Control and Prevention: http://www.cdc.gov
  • 14. Call for evidence – Face masks • Re-validation* that concepts of face mask usage more are entrenched in clinical practice routines and trust that they prevent against airborne transmission. • Issues are more complex than initially thought... • Facemasks plus gloves and/or regular hand hygiene may better prevent infection in community settings. • Respirators vs masks? No evidence • Cloth masks? Not recommended • Health economic analyses? Scarce * MacIntyre, C. R. & Chughtai, A. A. (2015) Facemasks for the prevention of infection in healthcare and community settings. BMJ; 350. http://www.bmj.com/content/350/bmj.h694 Published April 9, 2015
  • 15. Stool softener medications Docusate salts (sodium and calcium) are widely available, over-the-counter medications classified as stool softeners. Their surfactant mechanism of action has been (theoretically) believed to keep stool pliable and prevents straining during defecation. There is limited moderate-high pyramid evidence showing: • Stool softener products do not increase stool frequency or soften stools compared with placebo. • They do not improve the symptoms of constipation. • They do not improve the difficulties or completeness of stool evacuation in patients taking opioids. No rational argument for use of docusate in hospitalized patients or long-term care residents. * CADTH Rapid Response (2014). Dioctyl Sulfosuccinate or Docusate (Calcium or Sodium) for the Prevention or Management of Constipation: A Review of the Clinical Effectiveness http://bit.ly/1MR8IWR
  • 16. Reduced Usage Recommendations – Alberta Health Services • In 2013 there were over 2.1 million doses of 100mg given to patients within Alberta Health Services*. • Based on an estimated cost of $0.26/tablet (OTC estimated cost*), Docusate sodium (Colace) may in fact reflect “money flushed down the toilet” ** * Pasay, D. (2014). Drug & Therapeutics Backgrounder – Stool Softeners: Why are they still being used? Alberta Health Services. ** Mann, J. & Greenwood-Dufour, B. (2014) Docusate for constipation: money down the toilet? http://hospitalnews.com/docusate-constipation-money-toilet/
  • 17. So what? Awareness of the state-of-the-evidence, existence of comparative data, and actual unit costs can: • Help to support optimal usage decisions • Potentially mitigate against “hype” and assumed knowledge when definitive high pyramid evidence is not available* • Potentially assist in managing ever-increasing hospital medical supply budgets There is value in knowing & talking about the unmentionables! *Altman, D. G. & Bland, J. M. (1995). Absence of evidence is not evidence of absence. British Medical Journal; 311(7003); 485.

Notas do Editor

  1. Why are we exploring/presenting on this topic? Our customers are asking Our customers are increasingly aware While they are not new and sexy, these unmentionable items make a substantive budgetary impact.
  2. Does not reflect any specific vendor or manufacturing group. I will not be mentioning any specific vendors or manufacturing companies in this presentation. I will be quoting or referencing procurement groups, insured benefits programs, and USA-based HMO and guidance groups whereby their information is readily available from their respective websites.
  3. Acknowledgement for their support of this presentation and sharing of provincial costs on the unmentionables. It is not just about hospital usage of products, but also about the impact on insurable benefits programs
  4. There are so many, and we take them for granted in virtually any/all health care setting. They also make up a good part of our home-based first-aid kits and in our bathroom drawers if we have experienced a health care issue whereby self-management of wounds, surgical incisions, drains, catheters or other devices required our attention either short or long term. For some, they are the compression stockings, the walkers/canes, the gauze and the tensor bandages we need. For others, they are the adult incontinence products, saline flush syringes, common face masks and even medications we take (either by prescription of over the counter) such as antacids and stool softeners.
  5. Common hospital products --- overlooked No evidence, assumed to be cheap In 2004, (Manager-CCU), my unit operating budget included cost-centre lines exceeding $200,000.00 annually; most managers take these for granted. I also had in excess of 5 different types of gloves, 4 different types of masks available in my unit, primarily due to physician or staff preference or general availability. I can also advise that our CCU had chosen different gloves and masks to stock on our shelves…different than other adjacent units leading to lack of consistency, and surreptitious access to our supplies by others in the building. The unmentionables remind that absence of evidence does not mean products are ineffective or shouldn’t be used*…. So shouldn’t we make an effort to be aware of the value and costs of our large volume consumables?
  6. For the sake of time, I have arbitrarily chosen 3 unmentionable products to illustrate. Common non-sterile vinyl gloves available in every hospital location, home care/public health units, easily purchasable in every large-chain drug store across the country. Secondly, standard-issue polypropylene face masks Lastly, a pharmacologic product type (family) ---- stool softeners
  7. I will try and illustrate 3 things: The evidence available to help inform us The guidelines and advice (not evidence based) that we rely on The estimated costs we are incurring from usage Note: I am not encouraging reduced usage through this presentation…. Just awareness and renewed interest in appropriateness….. The right product for the right reasons
  8. 8
  9. THE SO WHAT? While we are not likely to change gloving habits or protocols or use less, we could sure use research to help us determine comparative value for usage and more importantly, APPROPRIATE USAGE of specialty products emerging in health care.
  10. CDC recommendations outlined here are for NON-INFLUENZA and not H1N1! They represent general mask recommendations Consider the condition! Disposable pleased polypropylene face masks are readily available everywhere and suggested to be affordable by CDC THE SO-WHAT? Comparative evidence and an awareness of cost and efficacy can help us choose wisely as to which type of mask to use in what clinical situation as part of PPE
  11. It’s never a bad thing to put on a mask…either for yourself as protection, or for patient protection from you, but the availability of evidence to reassure and validate usage becomes a bit eye-opening….
  12. This begs the discussion of why docusate products are prescribed on practically all standing orders in all hospitals across Canada either PRN or by scheduled order, and patients often receive subsidiary prescriptions for same upon discharge, or from primary care prescribers.
  13. Absence of evidence is not evidence of absence (Altman)