Compound pharmacies sell clinicians multi-use containers of compounded BLT to be used for many patients but prescribed for one. The legal risk is transferred to the prescriber who ordered the compound not the pharmacy providing it. STOP THE INSANITY! It is your practice and your good name. Here is your fix!
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NeuroMed BLT slide presentation
1.
2. Compounded BLT – the high risk option
• Drug diversion Exposure to the consequences of drug diversion –
procuring, using and passing a prescription drug ordered for one patient
but used on others and supplied to other clinicians is, in fact, illegal drug
diversion!
• Cross contamination Using multi-use containers on multiple patients
exposes patients to the risk of cross contamination
• Wasting time Time wasted waiting 45 – 60 minutes or more for anesthetic
action decreases practice revenue by tying up treatment rooms and
clinicians
• Cumulative systemic absorption risk Exposing patients to anesthetic on
the skin over a prolonged period of time increases risk of cumulative
systemic absorption
3. NeuroMed BLT – the solution option
• Eliminate legal exposure - NeuroMed BLT is a variety package that contains
benzocaine (20%), lidocaine (4%) and tetracaine (2%) – each is OTC with no
prescription required – all products packaged together for convenience and to
allow clinician application flexibility
• Eliminate cross contamination risk - Each of the included anesthetic analgesics is
packaged in single-use, metered dosed, sanitary packets for precision and
reduction in cross contamination risk
• Reduce onset wait time - NeuroMed products all include a proprietary
formulation designed to improve onset and efficacy – speeding onset and
reducing treatment time improves productivity and practice revenue
• Reduce systemic absorption risk - Reducing anesthetic analgesic time on skin
may reduce the risk of cumulative systemic absorption – in an IRB approved study
of the NeuroMed lidocaine product which included 239 human test subjects – no
active lidocaine nor its active metabolite MEGx entered the blood in even a single
subject after multiple applications in an 8 hour period
4. Contents
3 boxes each of 25 single-use, sanitary packets per product:
• Benzocaine 20% / 25 – 3 ml packet (NeuroMed FA)
• Lidocaine 4% / 25 – 4 ml packet (NeuroMed 7)
• Tetracaine 2% / 25 – 3 ml packet (NeuroMed LA)
6. Description and Explanation
• All include the standard Sambria Pharmaceuticals’ proprietary formulation
designed to improve delivery and rate of onset of the active
pharmaceutical ingredients (API’s) – the key technology used to create
stark product differentiation.
• Each type of anesthetic analgesic is packaged separately in individual 3-ml
packets (4-ml for lidocaine). Each anesthetic analgesic is packaged in boxes
of 25 units per box for a total combined 250 grams of product.
• All three boxes are wrapped in a single, combination variety package for
clinician convenience and ease of shipping.
7. Description and Explanation
• Clinicians are provided with the option of choosing the appropriate
anesthetic analgesic commensurate with specific applicable uses.
• This combination variety package also provides three individual API’s
which allow clinicians to use singly or otherwise as deemed medically
necessary at clinician discretion in a regulatory complaint manner
• For additional convenience, each individual 3-milliliter sanitary, single-
use packet (lidocaine – 4-ml) is supplied as a metered dose
application for dosing precision and wastage minimization.
8. Product Advantages
• Sanitary dose packaging
• Precision metered dose packaging
• Formulated to improve onset and efficacy
• Modular multiple options – fast-acting to long-lasting depending on
anesthetic analgesic application
• Increased therapeutic flexibility
• Designed to improve safety profile (in IRB approved study of the lidocaine
product – among 239 human test subjects none demonstrated plasma
lidocaine in the blood up to 12 hours after initial application)
• Cost-effective - competitively priced (MSRP - only $0.80 per gram to clinical
customer)
9. Samples packets are supplied three to a stip. Each strip has a perforation in
between to separate one from the other. Each individual packet includes its own
specific data box on the back of the package. The three combined packets have a
single tear off tab at the top for easy access and administration.
Samples
10. • Lidocaine-containing products play an integral role in cutaneous anesthesia by providing patient comfort
with minimal side effects. Careful attention must be paid to the particular anatomic location, the total
surface area covered, and the duration of anesthetic skin contact
• By reducing the duration of anesthetic contact with skin, clinicians can potentially decrease the risk of
cumulative anesthetic dose entry into the blood – NeuroMed brand topical anesthetics repeatedly
demonstrate reduced time to onset and peak action anecdotally
• This variety package has the potential to provide a strong solution to the regulatory obstacles currently
presented by the uniformly non-compliant vast pharmaceutical compounding marketplace (in particular,
anticipatory compounding and widespread clinician diversion)
• Sambria Pharmaceuticals is the first to market a comprehensive multi-API solution in a regulatory compliant
manner
• In instances where clinicians choose to combine two or three API’s, it is highly unlikely that any single API
product will match efficacy. At minimum safety profiles will not exceed those of currently marketed
compounded products due to the reduced time of contact on the skin. IRB approved study of the lidocaine
product presented no active lidocaine nor its primary metabolite MEGX found in blood samplings among
239 human test subjects when drawn at multiple intervals
• Unique metered dosed, sanitary packaging also provides for wastage minimization as well as more precise
dosing when compared to tube or jar packaging
Opportunity
11. Regulatory Compliance
Products are regulated by, marketed and manufactured in accordance
with the 21 CFR 348 Monograph OTC Topical Analgesics and
Anesthetics.
12. THANK YOU FOR YOUR TIME AND
CONSIDERATION
www.sambriapharma.com
info@sambriapharma.com
888.246.6601