Transcript infomedbaseproducts

– an academic spin off company
www.medbase.fi
• According to Lazarou et al., JAMA 1998 (metaanalysis) - 39 prospective studies with in-patients in
USA:
Serious drug injuries found:
– 6.7% - 2 216 000 patients p.a.
– Fatality rate 0.32% - 106 000 patients p.a.
– Is amongst top 5 in cause of deaths list in USA. As
common as accidents, diabetes or pulmonary diseases.
– Direct cost for hospitals and healthcare system 1.56 – 4
billion USD
• 1500 new publications every year – we read them!
• Medbase is founded by highly trained medical doctors
specialised in drug therapy
• Medbase products improve drug safety in the main problem
areas of:
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Drug interactions
& adverse drug reactions
Drug use in pregnancy and lactation
Renal failure
Hepatic impairment
Natural products
• Recommendations save time and reduce the need for
consultation
• Recommendations on dosage modification or alternative drugs
• Holistic clinically oriented recommendation on patient monitoring
• Quarterly updates guarantee always up-to-date information
• Easily integrated SQL databases to portals, EPRs, pharmacy
IT-systems, mobile & PDA solutions
• New language versions easy and inexpensive to produce
• Easy integration to local drug registries
– Generic drug name, fully ATC- and RxNorm- code compliant
• Designed for point of care
Interaction Database
• SFINX contains information on more than 17.000 drug interactions
(5/2014) - one of the most comprehensive drug interaction databases in
the market
• SFINX gives a warning on the potential clinical problem with a
specific drug interaction taking into account the formulation of the drug
• SFINX provides medical expert recommendations on circumventing or
controlling the clinical problem, e.g. by suggesting an alternative
choice of drug
• The database covers the explanation of interaction mechanisms and a
summary of the documentation the interaction is based on, as well as
key references
Pharmacological Assessment
On-line
Purpose
• A tool to analyse 9 clinically important
adverse drug effects from patient’s medication:
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Anticholinergic effect
QT-prolongation
Sedation
Orthostatic hypotension
Renal toxicity
Seizure risk
Risk for bleeding
Constipation
Serotonergic overstimulation
• More than 1400 drugs analysed/characterised
• Scoring based on SOP specifically designed
for each adverse effect
• Scoring:
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0 - No effect
1 - Mild
2 - Moderate
3 - Severe
• Over 12000 scores
• A specific algorithm designed to relate the
score to the level of severity (A-D) for each
adverse effect:
• Standard phrases (easy to translate) for each
adverse effect, e.g. anticholinergic effect:
Consequence
There is a high risk for anticholinergic effects such as dry mouth,
constipation, urinary impairment or retention, risk of falling, cognitive
impairment and confusion.
Recommendation
The risk is additive. Consider reducing the number of anticholinergic
drugs.
• Decision support for drug use in pregnancy and lactation – Concise understanding on the of the safety of clinically
used drugs during different stages of pregnancy and during
lactation, including information on:
– Clinical, ultrasound, laboratory etc. monitoring
– Dosage modification, recommendation on folic acid substitution
– Vitamins, micronutrients, illicit drugs
– Covers extensively the documentation from the medical
literature, manufacturer given information and different
national surveillance registers
– Same structure as SFINX has (similar easy integration)
– Enables quick comparison of different drug within one drug group to ease the
right choice of medication
http://www.terveysportti.fi/terveysportti/gravbase.home
• The most comprehensive database in the world for
drug dosing in renal failure
• Information on the safety and detailed dosage
recommendations of drugs in renal failure
• Dosage recommendations based on glomerular
filtration rate (GFR)
• Evaluation of nephrotoxicity
• A fully referenced, ATC & RxNorm-compliant
decision support database for portals and integration
Prevalence of renal failure
• In the U.S. 35.000.000 people are estimated to
suffer from chronic renal failure
• 13% of the population
• Measured GFR<60 ml/min or demonstrated renal injury
• A recent meta-analysis estimated that in the
Western population 23%-36% of people >64years
of age has GFR<60 ml/min
Karolinska Institute: reasons for hospitalisation due to
ADR (n=115; 96% of ADRs type A)
12%
Odar-Cederlöf I et al. Läkartidnigen 2008;105:890-3.
Blix HS et al.
Nephrol Dial Transplant 2006;21:3164-71.
• Prospective study in general hospitals
• 201 patients (GFR<60 ml/min; 25% of the whole population) used an
average of 10 drugs
• Approximately 40% of drugs were harmful to the kidneys or required
modification of the dose; 5% fully contraindicated
• Almost all patients were co-administered a minimum of two harmful
drugs
• Typical risk drug toxicity in 62% of exposed patients
• 26% of risk drug exposures caused toxicity
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Beta-lactam antibiotics, ciprofloxacin, aminoglycosides
antithrombotic agents and anticoagulants
anti-inflammatory drugs, codeine, tramadol
ACE-inhibitors/sartans, spironolactone/potassium
Allopurinol, metformin, sulphonylureas
Classification
Degree of renal failure, based on glomerular filtration rate (GFR), is divided into four categories,
according to the classification by the European Medicines Agency (EMEA):
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GFR 80-50 ml/min (mild renal failure)
GFR 50-30 ml/min (moderate renal failure)
GFR 30-10 ml/min (severe renal failure)
GFR <10 ml/min (end-stage renal failure; dialysis patient)
The safety and need for dosage recommendations is classified into four different categories (A to
D), clarified by a colour coding system:
No need for dosage modification
The information is not available or the recommendation is estimated based on the
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pharmacokinetic characteristics of the substance
Modification of the dose or dosage interval is needed
C
The use should be avoided
D
For categories B and C, a detailled numerical information on the magnitude of dosage
modification is provided whenever available.
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http://www.terveysportti.fi/terveysportti/renbase.home
Drug treatment in hepatic
impairment
• The disease state that affects drug treatment is
cirrhosis
– Prevalence about 0.3% of the population
• One of the key disease states that requires
documentaion for new drugs
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dosing of about 1400 drugs is
characterised in hepatic impairment
Hepatic impairment and AEs
Eur J Clin Pharmacol. 2013;69:1565-73.
• Retrospective chart study in 400 patients with
cirrhosis at hospital admission (Child-Pugh: A 18%; B
39%; C 43%)
• Altogether 1653 prescriptions (0-15 / patient)
– Every fifth (336) prescription with an error (184 patients)
• 36 contraindicated; 300 too high dose (no adjustment)
– 69 adverse events related to non-adjustment of the dose in
relation to the hepatic function
• 68% preventable
– Flaws in prescribing led to 94 extra in-hospital days
– Problems drugs:
• NSAIDs (g-i bleeding), hypnotics and other benzodiazepines,
• PPIs (peritonitis)
Classification
Degree of hepatic impairment, based on Child-Pugh classification, is divided into three categories,
according to the classification by EMA and FDA:
A
B
C
Child-Pugh 5-6 (mild hepatic impairment)
Child-Pugh 7-9 (moderate hepatic impairment)
Child-Pugh >10 (severe hepatic impairment)
The safety and need for dosage recommendations is classified into four different categories (A to
D), clarified by a colour coding system:
No need for dosage modification
The information is not available or the recommendation is estimated based on the
B
pharmacokinetic characteristics of the substance
Modification of the dose or dosage interval is needed
C
The use should be avoided
D
For categories B and C, a detailled numerical information on the magnitude of dosage
modification is provided whenever available.
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In pipeline
• Decision support databases for:
• Cross allergies
Partnering Strategy
Local partner
-Translations and feedback
-Customising for the national formulary
-Expertise in the market
-Rapid spreading of the decision support system
-Service in end-user’s native language
-Long-lasting national collaboration
-Well-organised end-user service
• Customer support:
• Content-related questions from end-users
• Experience from making the connection between
medbase databases and various drug registries
– Lists of drug formulations – SFINX etc. code for each
formulation
– Combination preparations
• Consultations regarding the technical structure of the
XML-export