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Support Meeting for
               Aspergillosis Patients
                             LED BY GRAHAM ATHERTON
                                   SUPPORTED BY
                 GEORGINA POWELL, DEBBIE KENNEDY & DEBORAH HAWKER

                         NAC CENTRE MANAGER CHRIS HARRIS
                           ACHES & PAINS: LIBBY RATCLIFFE


                           NATIONAL ASPERGILLOSIS CENTRE
                                       UHSM
                                   MANCHESTER




Fungal Research Trust
Programme

 1pm Light lunch, Tea Coffee
 1.30pm Dr Libby Ratcliffe ‘Aches & Pains’
 2pm Graham Atherton ‘Submitting your side effects’


 2.20pm Break: Social time, chat to staff


 2.40pm Malcolm Richardson ‘Everyday Moulds’
 3pm Debbie Kennedy ‘Why we do drug levels’
 3.15pm Meet the Team: Questions & Answers


 3.30pm Close
Aches & pains
L. Ratcliffe
16.11.2012
Aches and Pains, Everyday Moulds & Facemasks
   Aches and pains
   Survival manual
Aches & pains & Aspergillus
   The Aspergillus diseases
   Other chronic diseases
       Arthritis
       Diabetes
       bronchiectasis
       Autoimmune diseases
       Other infections
       “chronic fatigue”
   Acute illneses
       Viral infections …
   Medications
   Other contributing factors
       alcohol
Muscle aches
   Injury or trauma including strains and sprains
   Overuse- using muscles too much, too often,
    too soon
   Tension or stress
   Drugs
   Diseases
   Electrolyte imbalance
Aspergillus & symptoms
   Fatigue
   Malaise
   Chest pain
   Fever, chills
   Headache
   Muscle aches
Aches & pains & medication
   Antifungal medication
   Other medication
       Statins
       Steroids
       Antihypertensives
       antibiotics
   Interactions
Itraconazole
   Adverse reactions
       N=189patients       (Tucker et al, 1990)
             1984-89
             Itra related AE                 39%
             Nausea/vomiting        10%
             Fatigue                1%
       Clinical trials of systemic fungal infections
             N=602 patients
             Fatigue                3%
             Malaise                1%
       Post marketing experience
             Myalgia, arthralgia
       SPC
             9% AE → 15% AE if prolonged usage
Voriconazole
   CPC (summary of product characteristic)
   Database >2000 patients
       1655 patients in therapeutic trials
           Heterogeneous populations
           Very common         ≥1/10
           Common              ≥1/102 - <1/10
           Uncommon            ≥ 1/102 -<1/103
           Rare                          ≥ 1/102 -<1/104
           Very rare           >1/104
   Back pain- common
   Arthritis- uncommon
Wermers et al. Clin Infect Dis 2011:52:1
Posaconazole
   CPC
   >2400 patients and healthy volunteers
       Clinical trials and post-marketing experience
   Most common:
       Nausea, vomiting, diarrhoea, pyrexia, increased billirubin
   Common:
       common
   Uncommon:
       Back pain
       Breast pain
       Pains
       Malaise
Other medication
   Statins
   Biphosphonates
   ACE inhibitors
   Linazolid, metronidazole long term
How to deal with it all?
Side Effects

What are they?

Why do they happen?

Why is this subject important for antifungal drugs in
particular?
What are side effects?

In medicine, a side effect is an effect, whether
therapeutic or adverse, that is secondary to the one
intended; although the term is predominantly
employed to describe adverse effects, it can also apply
to beneficial, but unintended, consequences of the use
of a drug.
When do they happen?

Some are predictable – we know if we suppress our
 immune system to enable an organ transplant we
 are also making ourselves more vulnerable to
 infection

Some less predictable – who could have predicted
 voriconazole would make many people sensitive to
 light?
Are side effect always bad?

Occasionally, drugs are prescribed or procedures
performed specifically for their side effects; in that
case, said side effect ceases to be a side effect, and is
now an intended effect.

For instance, X-rays were historically (and are
currently) used as an imaging technique; the discovery
of their oncolytic capability led to their employ in
radiotherapy (ablation of malignant tumours).
Examples of therapeutic side-effects

 Bevacizumab (Avastin) has been used against wet age-related macular degeneration, as well as
    macular edema from diseases such as diabetic retinopathy and central retinal vein occlusion.[1]
   Bupropion, an anti-depressant sold as Wellbutrin, is also used as a smoking cessation aid; this
    indication was later approved, and the name of the smoking cessation product is Zyban. In Ontario,
    Canada, smoking cessation drugs are not covered by provincial drug plans; elsewhere, Zyban is priced
    higher than Wellbutrin, despite being the same drug. Therefore, some physicians prescribe Wellbutrin
    for both indications.
   Carbamazepine is an approved treatment for manic depression and convulsions, but has side effects
    useful in treating attention-deficit hyperactivity disorder (ADHD), schizophrenia, phantom limb
    syndrome, paroxysmal extreme pain disorder, neuromyotonia, and post-traumatic stress disorder.[4]
   Dexamethasone and Betamethasone in premature labor, to enhance pulmonary maturation of the
    fetus.[5]
   Doxepin has been used to treat Angiodema and severe allergic reactions due to its strong
    antihistamine properties.[6]
   Gabapentin, approved for treatment of seizures and postherpetic neuralgia in adults, has side-effects
    which are useful in treating bipolar disorder, essential tremor, hot flashes, migraine prophylaxis,
    neuropathic pain syndromes, phantom limb syndrome, and restless leg syndrome.[7]
   Magnesium sulfate in obstetrics for premature labor and preeclampsia.[5]
   The SSRI medication sertraline is approved as an anti-depressant, but delays conjugal climax in men,
    and thus may be supplied to those in which climax is premature.[9]
Why do they happen?

 Developing drugs is difficult and complicated. Drugs are designed to
  work against a specific illness. In doing this they often interfere with
  other body systems.

 It is difficult to make a drug that targets one part of the body without
  affecting others.
 Every new drug is developed to hopefully be better than existing drugs.
 The current drugs may not be perfect, but they are better than they
  have ever been. And drugs in development now will hopefully be better
  still

 Genetic variability, Age
Why aren’t side effects prevented?

A lot of attention is given to minimising side effects in a new
drug – testing is extensive

BUT tests are generally carried out by giving human
volunteers ONLY the drug being tested. These test results are
used to provide the guidance to doctors and patients
contained in the pack leaflets

In the real world patients often do not take only one drug.
Medicines often interact with each other. Result = side effects
that were not predicted
How can we all help?

We can report all of our side effects to those whose job
it is to monitor them. This is especially important for
new drugs and for side effects NOT already listed in
pack leaflets.

Your doctor/nurse are the main reporters – and still
are as they have a good idea of what are unusual side
effects

So tell them!
MHRA – Yellow Card
Yellow Card Scheme

MRHA are encouraging everyone to enter side
 effects using their new website
http://yellowcard.mrha.gov.uk


Their software will highlight new side effects and
 interacting relationships with other drugs

You will be directly helping with Research !!
Yellow Card - offline

There will still be a way for people who cannot access
the internet to report side effects – forms available at
pharmacists and are downloadable to print out too
from MHRA website.

This is a UK scheme. US patients have their own
authority
FDA Adverse Event Reporting System (FAERS)
(formerly AERS) www.fda.gov
Facemasks

 HEPA filter. There are three grades of HEPA filters namely N95, N99
  and N100 and the numbers refer to the percent of particles 0.3micron
  in size that filter is capable of removing from air that passes through it.

 An N95 filter will therefore remove 95% of all particles 0.3 micron in
  size from air that passes through it. Fungal spores are 2-3 microns in
  size so an N95 filter will remove far more than 95% of fungal spores
  from the air, though some will still get through. This standard is
  generally thought to be the best combination of efficiency and cost for
  the average home user - such as a gardener. Industrial users (e.g.
  workers remediating mouldy homes or other premises) may be exposed
  to far more spores and may opt for the more efficient N99 or N100
  filters at higher cost.
Facemasks


UK - In the UK and Europe the standards referred to
 are FFP1 (not appropriate for this purpose), FFP2
 and FFP3. FFP2 is equivalent to N95 and FFP3 offers
 higher protection. Masks generally cost £2-3 each
 and are intended for single use.
More expensive masks are available which can be
 used more than once - see 3M for one possible
 supplier.
What else?

Is there anything you would like to suggest as a
 subject? – remember it can be any part of the service
 and only has to be enough to fill 10-15min

Leave suggestions (& criticisms) using forms provided
  – anonymously if you prefer.
or
Email to admin@aspergillus.org.uk
or
Phone 0161 291 5866 – leave message if no answer
Next Month


December 21st
Christmas Quiz

  Teams of 4
Everyday moulds

Malcolm Richardson PhD, FSB, FRCPath, FInstSSE
Mycology Reference Centre, Manchester
Toxic mould – media darling?
Fungi and the nose
Public concern!



 ”Exorcising a mold monster”
 ”Attack on the killer mold”
 ”It’s everywhere. Tales about rampant toxic
   mold get plenty of attention, but science tells
   a less dramatic story”
 ”The mold rush”
Sick buildings
Sick buildings
Sick buildings
Patients live in mouldy houses:
exposure to Aspergillus and more
Aches and Pains, Everyday Moulds & Facemasks
Bjerkandera adusta
Allergic fungal cough (fungus-associated chronic cough)

 Chronic cough
 Presence of environmental fungi, particularly
  Basidiomycetes in sputum
 Positivity in bronchoprovacation and lymphocyte
  stimulation tests
 Good response to antifungal drugs
Natural disasters
42 days LAMB
           Snell & Yavakoli 2007; 119: 448-449
Aches and Pains, Everyday Moulds & Facemasks
Aches and Pains, Everyday Moulds & Facemasks
Sporangiospores
Aches and Pains, Everyday Moulds & Facemasks
Joplin
 13 identified case-patients
    Median age: 48 years (13-76)
    2 diabetics (15%)
    10 admittted to ICU (77%)
 Case-patients: mean of 4 wounds: foreign material
  recovered from wounds in 6 patients (46%)
 Systemic antifungals; all case-patients:
  amphotericin B
 5 deaths (38%)
 Casepatients: all located in zone that sustained
  most severe damage

51st ICAAC Chicago (2011)
Aches and Pains, Everyday Moulds & Facemasks
Aches and Pains, Everyday Moulds & Facemasks
Aches and Pains, Everyday Moulds & Facemasks
Aches and Pains, Everyday Moulds & Facemasks
Aches and Pains, Everyday Moulds & Facemasks
Mouldy dishwashers
 189 sampled
 Environmental samples: 37C
 62% positive for fungi
    Exophiala dermatitidis
    Exophiala phaeomuriformis
 Risk factors:
    High temeperature
    High moisture
    Alkaline pH
Aches and Pains, Everyday Moulds & Facemasks
Dimorphic pathogens
 Histoplasma
 Blastomyces
 Coccidioides
 Paracoccidioides
Aches and Pains, Everyday Moulds & Facemasks
Aches and Pains, Everyday Moulds & Facemasks
Aches and Pains, Everyday Moulds & Facemasks
Aches and Pains, Everyday Moulds & Facemasks
Aches and Pains, Everyday Moulds & Facemasks
Aches and Pains, Everyday Moulds & Facemasks
A common grass and soil fungus:
Exserohilum rostratum
Fungal
meningitis:
32 deaths,
>400 sick
patients
Aches and Pains, Everyday Moulds & Facemasks
Thank You




“The best chance we have of beating this illness is to
                  work together”

    Living with it, Working with it, Treating it

                      Fungal Infection Trust

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Aches and Pains, Everyday Moulds & Facemasks

  • 1. Support Meeting for Aspergillosis Patients LED BY GRAHAM ATHERTON SUPPORTED BY GEORGINA POWELL, DEBBIE KENNEDY & DEBORAH HAWKER NAC CENTRE MANAGER CHRIS HARRIS ACHES & PAINS: LIBBY RATCLIFFE NATIONAL ASPERGILLOSIS CENTRE UHSM MANCHESTER Fungal Research Trust
  • 2. Programme  1pm Light lunch, Tea Coffee  1.30pm Dr Libby Ratcliffe ‘Aches & Pains’  2pm Graham Atherton ‘Submitting your side effects’  2.20pm Break: Social time, chat to staff  2.40pm Malcolm Richardson ‘Everyday Moulds’  3pm Debbie Kennedy ‘Why we do drug levels’  3.15pm Meet the Team: Questions & Answers  3.30pm Close
  • 3. Aches & pains L. Ratcliffe 16.11.2012
  • 5. Aches and pains  Survival manual
  • 6. Aches & pains & Aspergillus  The Aspergillus diseases  Other chronic diseases  Arthritis  Diabetes  bronchiectasis  Autoimmune diseases  Other infections  “chronic fatigue”  Acute illneses  Viral infections …  Medications  Other contributing factors  alcohol
  • 7. Muscle aches  Injury or trauma including strains and sprains  Overuse- using muscles too much, too often, too soon  Tension or stress  Drugs  Diseases  Electrolyte imbalance
  • 8. Aspergillus & symptoms  Fatigue  Malaise  Chest pain  Fever, chills  Headache  Muscle aches
  • 9. Aches & pains & medication  Antifungal medication  Other medication  Statins  Steroids  Antihypertensives  antibiotics  Interactions
  • 10. Itraconazole  Adverse reactions  N=189patients (Tucker et al, 1990)  1984-89  Itra related AE 39%  Nausea/vomiting 10%  Fatigue 1%  Clinical trials of systemic fungal infections  N=602 patients  Fatigue 3%  Malaise 1%  Post marketing experience  Myalgia, arthralgia  SPC  9% AE → 15% AE if prolonged usage
  • 11. Voriconazole  CPC (summary of product characteristic)  Database >2000 patients  1655 patients in therapeutic trials  Heterogeneous populations  Very common ≥1/10  Common ≥1/102 - <1/10  Uncommon ≥ 1/102 -<1/103  Rare ≥ 1/102 -<1/104  Very rare >1/104  Back pain- common  Arthritis- uncommon
  • 12. Wermers et al. Clin Infect Dis 2011:52:1
  • 13. Posaconazole  CPC  >2400 patients and healthy volunteers  Clinical trials and post-marketing experience  Most common:  Nausea, vomiting, diarrhoea, pyrexia, increased billirubin  Common:  common  Uncommon:  Back pain  Breast pain  Pains  Malaise
  • 14. Other medication  Statins  Biphosphonates  ACE inhibitors  Linazolid, metronidazole long term
  • 15. How to deal with it all?
  • 16. Side Effects What are they? Why do they happen? Why is this subject important for antifungal drugs in particular?
  • 17. What are side effects? In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequences of the use of a drug.
  • 18. When do they happen? Some are predictable – we know if we suppress our immune system to enable an organ transplant we are also making ourselves more vulnerable to infection Some less predictable – who could have predicted voriconazole would make many people sensitive to light?
  • 19. Are side effect always bad? Occasionally, drugs are prescribed or procedures performed specifically for their side effects; in that case, said side effect ceases to be a side effect, and is now an intended effect. For instance, X-rays were historically (and are currently) used as an imaging technique; the discovery of their oncolytic capability led to their employ in radiotherapy (ablation of malignant tumours).
  • 20. Examples of therapeutic side-effects  Bevacizumab (Avastin) has been used against wet age-related macular degeneration, as well as macular edema from diseases such as diabetic retinopathy and central retinal vein occlusion.[1]  Bupropion, an anti-depressant sold as Wellbutrin, is also used as a smoking cessation aid; this indication was later approved, and the name of the smoking cessation product is Zyban. In Ontario, Canada, smoking cessation drugs are not covered by provincial drug plans; elsewhere, Zyban is priced higher than Wellbutrin, despite being the same drug. Therefore, some physicians prescribe Wellbutrin for both indications.  Carbamazepine is an approved treatment for manic depression and convulsions, but has side effects useful in treating attention-deficit hyperactivity disorder (ADHD), schizophrenia, phantom limb syndrome, paroxysmal extreme pain disorder, neuromyotonia, and post-traumatic stress disorder.[4]  Dexamethasone and Betamethasone in premature labor, to enhance pulmonary maturation of the fetus.[5]  Doxepin has been used to treat Angiodema and severe allergic reactions due to its strong antihistamine properties.[6]  Gabapentin, approved for treatment of seizures and postherpetic neuralgia in adults, has side-effects which are useful in treating bipolar disorder, essential tremor, hot flashes, migraine prophylaxis, neuropathic pain syndromes, phantom limb syndrome, and restless leg syndrome.[7]  Magnesium sulfate in obstetrics for premature labor and preeclampsia.[5]  The SSRI medication sertraline is approved as an anti-depressant, but delays conjugal climax in men, and thus may be supplied to those in which climax is premature.[9]
  • 21. Why do they happen?  Developing drugs is difficult and complicated. Drugs are designed to work against a specific illness. In doing this they often interfere with other body systems.  It is difficult to make a drug that targets one part of the body without affecting others.  Every new drug is developed to hopefully be better than existing drugs.  The current drugs may not be perfect, but they are better than they have ever been. And drugs in development now will hopefully be better still  Genetic variability, Age
  • 22. Why aren’t side effects prevented? A lot of attention is given to minimising side effects in a new drug – testing is extensive BUT tests are generally carried out by giving human volunteers ONLY the drug being tested. These test results are used to provide the guidance to doctors and patients contained in the pack leaflets In the real world patients often do not take only one drug. Medicines often interact with each other. Result = side effects that were not predicted
  • 23. How can we all help? We can report all of our side effects to those whose job it is to monitor them. This is especially important for new drugs and for side effects NOT already listed in pack leaflets. Your doctor/nurse are the main reporters – and still are as they have a good idea of what are unusual side effects So tell them!
  • 25. Yellow Card Scheme MRHA are encouraging everyone to enter side effects using their new website http://yellowcard.mrha.gov.uk Their software will highlight new side effects and interacting relationships with other drugs You will be directly helping with Research !!
  • 26. Yellow Card - offline There will still be a way for people who cannot access the internet to report side effects – forms available at pharmacists and are downloadable to print out too from MHRA website. This is a UK scheme. US patients have their own authority FDA Adverse Event Reporting System (FAERS) (formerly AERS) www.fda.gov
  • 27. Facemasks  HEPA filter. There are three grades of HEPA filters namely N95, N99 and N100 and the numbers refer to the percent of particles 0.3micron in size that filter is capable of removing from air that passes through it.  An N95 filter will therefore remove 95% of all particles 0.3 micron in size from air that passes through it. Fungal spores are 2-3 microns in size so an N95 filter will remove far more than 95% of fungal spores from the air, though some will still get through. This standard is generally thought to be the best combination of efficiency and cost for the average home user - such as a gardener. Industrial users (e.g. workers remediating mouldy homes or other premises) may be exposed to far more spores and may opt for the more efficient N99 or N100 filters at higher cost.
  • 28. Facemasks UK - In the UK and Europe the standards referred to are FFP1 (not appropriate for this purpose), FFP2 and FFP3. FFP2 is equivalent to N95 and FFP3 offers higher protection. Masks generally cost £2-3 each and are intended for single use. More expensive masks are available which can be used more than once - see 3M for one possible supplier.
  • 29. What else? Is there anything you would like to suggest as a subject? – remember it can be any part of the service and only has to be enough to fill 10-15min Leave suggestions (& criticisms) using forms provided – anonymously if you prefer. or Email to admin@aspergillus.org.uk or Phone 0161 291 5866 – leave message if no answer
  • 31. Everyday moulds Malcolm Richardson PhD, FSB, FRCPath, FInstSSE Mycology Reference Centre, Manchester
  • 32. Toxic mould – media darling?
  • 34. Public concern! ”Exorcising a mold monster” ”Attack on the killer mold” ”It’s everywhere. Tales about rampant toxic mold get plenty of attention, but science tells a less dramatic story” ”The mold rush”
  • 38. Patients live in mouldy houses: exposure to Aspergillus and more
  • 41. Allergic fungal cough (fungus-associated chronic cough)  Chronic cough  Presence of environmental fungi, particularly Basidiomycetes in sputum  Positivity in bronchoprovacation and lymphocyte stimulation tests  Good response to antifungal drugs
  • 43. 42 days LAMB Snell & Yavakoli 2007; 119: 448-449
  • 48. Joplin  13 identified case-patients  Median age: 48 years (13-76)  2 diabetics (15%)  10 admittted to ICU (77%)  Case-patients: mean of 4 wounds: foreign material recovered from wounds in 6 patients (46%)  Systemic antifungals; all case-patients: amphotericin B  5 deaths (38%)  Casepatients: all located in zone that sustained most severe damage 51st ICAAC Chicago (2011)
  • 54. Mouldy dishwashers  189 sampled  Environmental samples: 37C  62% positive for fungi  Exophiala dermatitidis  Exophiala phaeomuriformis  Risk factors:  High temeperature  High moisture  Alkaline pH
  • 56. Dimorphic pathogens  Histoplasma  Blastomyces  Coccidioides  Paracoccidioides
  • 63. A common grass and soil fungus: Exserohilum rostratum
  • 66. Thank You “The best chance we have of beating this illness is to work together” Living with it, Working with it, Treating it Fungal Infection Trust