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Large Populous Large Populous Nations Nations China, India, Brazil & China, India, Brazil & others: others: Are now more affluent and are Are now more affluent and are making more generic drugs and making more generic drugs and using more domestically. using more domestically. Expensive biologic drugs are Expensive biologic drugs are so unaffordable to their so unaffordable to their citizens these nations have citizens these nations have and are replicating them and are replicating them causing the patent holders to causing the patent holders to complain and then provide complain and then provide significantly lower prices to significantly lower prices to these nations. these nations.

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Page 1: Large Populous Nations

Large Populous NationsLarge Populous Nations

China, India, Brazil & others:China, India, Brazil & others: Are now more affluent and are Are now more affluent and are

making more generic drugs and making more generic drugs and using more domestically.using more domestically.

Expensive biologic drugs are so Expensive biologic drugs are so unaffordable to their citizens unaffordable to their citizens these nations have and are these nations have and are replicating them causing the replicating them causing the patent holders to complain and patent holders to complain and then provide significantly lower then provide significantly lower prices to these nations. prices to these nations.

Page 2: Large Populous Nations

Large OpportunityLarge Opportunity

Billions of generic, oral Billions of generic, oral solid pharmaceuticals, solid pharmaceuticals, cheap, costing pennies, cheap, costing pennies, most made in foreign most made in foreign countries, without any or countries, without any or close inspection by our close inspection by our FDA, must be counted FDA, must be counted out, pill by pill from large out, pill by pill from large containers of 100 pills or containers of 100 pills or more into orange 10 cent more into orange 10 cent vials in pharmacies. Why?vials in pharmacies. Why?

Page 3: Large Populous Nations

Habits Die HardHabits Die Hard

You’ve watched your entire lives, manyYou’ve watched your entire lives, many

supposedly well educated professionalsupposedly well educated professional

people do the same repetitive tasks, people do the same repetitive tasks,

hour after hour, day after day, yearhour after hour, day after day, year

after year their whole lives, never everafter year their whole lives, never ever

trying to change anything, or inventtrying to change anything, or invent

ways to improve or make it easier,ways to improve or make it easier,

better and more profitable?better and more profitable?

I’m speaking of Pharmacists.I’m speaking of Pharmacists.

Page 4: Large Populous Nations

A Profession locked into A Profession locked into Its own historyIts own history

Pharmacies started as individualPharmacies started as individual

pharmacists each manufacturingpharmacists each manufacturing

single doses of medicine orderedsingle doses of medicine ordered

by individual physicians, sort of likeby individual physicians, sort of like

““short order cooks”.short order cooks”.

Safety was not a big concern asSafety was not a big concern as

only one person at a time could beonly one person at a time could be

killed or harmed. Until events likekilled or harmed. Until events like

the New England Compoundingthe New England Compounding

Center Disaster- the last of many!Center Disaster- the last of many!

Page 5: Large Populous Nations

Pharmacy grows into a Pharmacy grows into a wholesale businesswholesale business

80 years ago, pharmacists80 years ago, pharmacists

Working with physicians, made Working with physicians, made

mostly liquid medicines with mostly liquid medicines with

narcotic ingredients.narcotic ingredients.

Some made these better thanSome made these better than

others so, pharmacists like: Eli others so, pharmacists like: Eli

Lilly, Charles Pfizer, GeorgeLilly, Charles Pfizer, George

Searle, John Wyeth and othersSearle, John Wyeth and others

made their drugs in large batchesmade their drugs in large batches

and sold them locally to others. and sold them locally to others.

Page 6: Large Populous Nations

Pharmacy wholesaler Pharmacy wholesaler Kills hundredsKills hundreds

In 193In 1937, S.E. Massengill, Bristol, TN7, S.E. Massengill, Bristol, TNadded diethylene glycol [a type ofadded diethylene glycol [a type ofantifreeze], to make a new liquidantifreeze], to make a new liquidsyrup form of a sulfer drug. Theysyrup form of a sulfer drug. Theyadded this for flavor, as alladded this for flavor, as allmanufacturers did to mask bittermanufacturers did to mask bittertastes, but this was poison.tastes, but this was poison.

105 died in 15 states and Congress105 died in 15 states and Congresspassed the Food and Drug Act inpassed the Food and Drug Act in1938 for drug Manufacturing safety,1938 for drug Manufacturing safety,exempting retail pharmacistsexempting retail pharmacistsdispensing drugs as not beingdispensing drugs as not beingmanufacturing.manufacturing.

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Drugs change form to Drugs change form to oral solidsoral solids

After WW II drugs changed formAfter WW II drugs changed formfrom liquids and powders to tabletsfrom liquids and powders to tabletsand capsules, mainly pain pillsand capsules, mainly pain pillsand anti-biotics, whose dosesand anti-biotics, whose dosesand the available amber glassand the available amber glassbottles caused them to bebottles caused them to bepackaged in bottles of 100.packaged in bottles of 100.

This caused Pharmacist to haveThis caused Pharmacist to haveto count out the proper number,to count out the proper number,usually 30 to 60, as normalusually 30 to 60, as normaldoses of these drugs were 1 to 4doses of these drugs were 1 to 4tablets or capsules a day.tablets or capsules a day.

Page 8: Large Populous Nations

Oral solids change dose Oral solids change dose

Drugs developed in the 70’s and 80’sDrugs developed in the 70’s and 80’sto treat many diseases, but had toto treat many diseases, but had tobe taken multiple times a day whichbe taken multiple times a day whichwas problematic.was problematic.

Brand drug manufacturers changedBrand drug manufacturers changeddrugs to slow release, extendingdrugs to slow release, extendingpatents, and brand drug sales intopatents, and brand drug sales intothe 90’s when generics for them the 90’s when generics for them were tested and approved by thewere tested and approved by theFDA, replacing brands, molecule byFDA, replacing brands, molecule bymolecule and now are 90% of Globalmolecule and now are 90% of Globalsales, most not made in the USA.sales, most not made in the USA.

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Today’s Pharmacy Today’s Pharmacy ChallengesChallenges

US Pharmacies have decreasedUS Pharmacies have decreasedin number since 1990. They just getin number since 1990. They just getlarger and increase front storelarger and increase front storespace for non-pharmaceuticals.space for non-pharmaceuticals.

Today pharmacy techs count mostToday pharmacy techs count mostpills, as over 12 billion pills arepills, as over 12 billion pills are““manufactured” into 4 billionmanufactured” into 4 billionprescriptions in 65,000 pharmacies,prescriptions in 65,000 pharmacies,mostly 30 cheap generic pills, somemostly 30 cheap generic pills, someuninspected by FDA in foreign plantsuninspected by FDA in foreign plantsfrom bottles of 100 to 5,000 pills intofrom bottles of 100 to 5,000 pills into10 cent orange vials; pill by pill.10 cent orange vials; pill by pill.

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UNMET NEEDS INUNMET NEEDS INU.S. HEALTHCAREU.S. HEALTHCARE

– Physicians [too few]Physicians [too few]– Nurses [too few]Nurses [too few]– Tests [many missed]Tests [many missed]– Hospitals [unbalanced] Hospitals [unbalanced] – Emergency Care [scattered]Emergency Care [scattered]– Transportation [unsure]Transportation [unsure]– Pharmaceuticals [unsafe]Pharmaceuticals [unsafe]– Standards [unchecked]Standards [unchecked]– Rules [ignored]Rules [ignored]– Safety [unverified]Safety [unverified]– Vigilance [none]Vigilance [none]

Page 11: Large Populous Nations

UNIVERSAL U.S. UNIVERSAL U.S. HEALTHCAREHEALTHCARE

With unmet needs in every With unmet needs in every segment of our healthcare segment of our healthcare system, how do we meet system, how do we meet needs without increased needs without increased personnel? What can be personnel? What can be increased quickly?increased quickly?

Not Physicians, Nurses, Not Physicians, Nurses, hospitals or the rest, only hospitals or the rest, only pharmaceuticals can and will pharmaceuticals can and will be. But supplies are being be. But supplies are being limited and are unsafe to use limited and are unsafe to use many uninspected by the FDA many uninspected by the FDA made in factories in like India made in factories in like India and China?and China?

Page 12: Large Populous Nations

WHO MAKES WHAT WHO MAKES WHAT AND WHERE?AND WHERE?

It’s on the labels right?It’s on the labels right?

While the FDA keeps labels onWhile the FDA keeps labels on

file and these are required to befile and these are required to be

put on bottles, and they are oftenput on bottles, and they are often

incorrect as the FDA doesn’t requireincorrect as the FDA doesn’t require

The last “manufacturer” of a drugThe last “manufacturer” of a drug

Products’ drug ID to be shown:Products’ drug ID to be shown:

and only California requires theand only California requires the

LOT numbers to be placed onLOT numbers to be placed on

prescription vials.prescription vials.

Consumers get more information onConsumers get more information on

underwear and fruit labels! underwear and fruit labels!

Page 13: Large Populous Nations

VISITED YOUR VISITED YOUR PHARMACY LATELY?PHARMACY LATELY?

If you have, you noticed forIf you have, you noticed for

every pharmacists, usuallyevery pharmacists, usually

on the phone, or on theon the phone, or on the

computer while 4 or 5computer while 4 or 5

techs are counting pills. techs are counting pills.

These “Techs” dispense drugs toThese “Techs” dispense drugs to

you and others, from bottles theyyou and others, from bottles they

have no idea who manufacturedhave no idea who manufactured

or where, when or how the FDAor where, when or how the FDA

drug identification number wasdrug identification number was

applied to labels . applied to labels .

Page 14: Large Populous Nations

DOES THE FDA KNOW DOES THE FDA KNOW THE DANGERS?THE DANGERS?

Nobody knows better, as safety hasNobody knows better, as safety hasbeen their only function since 1938.been their only function since 1938.

August, 2006 FDA proposed safetyAugust, 2006 FDA proposed safety““Requirements For Foreign andRequirements For Foreign andDomestic EstablishmentDomestic EstablishmentRegistration and Listing for HumanRegistration and Listing for HumanDrugs,Drugs, Including Drugs That AreIncluding Drugs That AreRegulated Under Biologics LicenseRegulated Under Biologics LicenseApplication and Animal Drugs;Application and Animal Drugs;requiring the last “manufacturer” fillingrequiring the last “manufacturer” fillingdrug containers to use only their owndrug containers to use only their ownFDA registered NDCs on labels. ItFDA registered NDCs on labels. Itwas withdrawn as drug repackagerswas withdrawn as drug repackagerscomplained.complained.

Page 15: Large Populous Nations

WHAT IS THE FDA WHAT IS THE FDA DOING NOW?DOING NOW?

As the FDA can’t keep their ownAs the FDA can’t keep their own

drug records and drug suppliesdrug records and drug supplies

safe, or inspect and regulatesafe, or inspect and regulate

foreign manufacturers, theirforeign manufacturers, their

current solution is to notcurrent solution is to not

require drugs meet U.S. FDA require drugs meet U.S. FDA

Standards and accept whateverStandards and accept whatever

these countries’ standards arethese countries’ standards are

as being “close enough” for U.S.as being “close enough” for U.S.

government needs, but everygovernment needs, but every

country is different.country is different.

Page 16: Large Populous Nations

HOW CAN SAFETY BE HOW CAN SAFETY BE RESTORED AND HELP RESTORED AND HELP

PHARMACY?PHARMACY?Since most drugs are now madeSince most drugs are now made

in foreign plants, and some ofin foreign plants, and some of

the manufacturers and countriesthe manufacturers and countries

regulatory agencies as stringentregulatory agencies as stringent

as we should be, establishingas we should be, establishing

contracts with the best with thecontracts with the best with the

most complete product lines,most complete product lines,

and testing before packagingand testing before packaging

solves the safety problem, butsolves the safety problem, but

we would do much more.we would do much more.

Page 17: Large Populous Nations

WHAT MORE CAN BE WHAT MORE CAN BE DONE?DONE?

Two different but essentialTwo different but essential

things are done in thethings are done in the

Repackaging process:Repackaging process:

Increased quality andIncreased quality and

education while;education while;

Decreasing pharmacy Decreasing pharmacy

inventory and labor costs.inventory and labor costs.

Page 18: Large Populous Nations

INCREASED QUALITY INCREASED QUALITY BY EDUCATION?BY EDUCATION?

Government records showGovernment records show

two things:two things:

Brand drugs changedBrand drugs changed

their products before their products before

patent expiration to keeppatent expiration to keep

high sales.high sales.

As Brand drugs lostAs Brand drugs lost

patent protection 90% ofpatent protection 90% of

sales shifted to generics thatsales shifted to generics that

always drop in price. always drop in price.

Page 19: Large Populous Nations

INCREASE KNOWLEDGE INCREASE KNOWLEDGE WITH EDUCATION?WITH EDUCATION?

As brand drugs become genericAs brand drugs become genericsome patients are switchedsome patients are switchedto the generic while:to the generic while:

Brand drugs, increase prices Brand drugs, increase prices making inventory and making inventory and

patient patient costs much more, andcosts much more, and

As this happens millions of As this happens millions of patients are switched to patients are switched to

generics and remain forever on generics and remain forever on older lessolder less

effective drugs, as equally low effective drugs, as equally low priced, better ones are priced, better ones are available. available.

Page 20: Large Populous Nations

DECREASE PHARMACY DECREASE PHARMACY INVENTORY AND LABOR INVENTORY AND LABOR

COSTSCOSTS

Brand drugs, especially less Brand drugs, especially less

popular strengths with higher popular strengths with higher

cost and slow sales of 1cost and slow sales of 1

bottle sold a quarter ties up bottle sold a quarter ties up huge amounts of inventoryhuge amounts of inventory

capital with high holding costs.capital with high holding costs.

The same happens to the The same happens to the same generic strengths, same generic strengths, doubling the bottles on doubling the bottles on shelves, consuming an equal shelves, consuming an equal amount of space. amount of space.

Page 21: Large Populous Nations

Change in HealthcareChange in Healthcare

ConstantConstant UnwantedUnwanted Uncertain and Uncertain and At Times:At Times:

1.1. UnnecessaryUnnecessary2.2. HarmfulHarmful3.3. UneconomicalUneconomical4.4. Foolish Foolish 5.5. Untried, but in drugs is;Untried, but in drugs is;

a. Very Importanta. Very Importantb. Logical & Established b. Logical & Established c. Extremely Necessary c. Extremely Necessary d. Profitabled. Profitable

Page 22: Large Populous Nations

MATCHING DRUG SUPPLYMATCHING DRUG SUPPLY WITH DEMAND WITH DEMAND

PHARMACEUTICAL DEMAND IS:PHARMACEUTICAL DEMAND IS:

INELASTIC [INELASTIC [DISEASE DISEASE SPECIFIC]SPECIFIC]

GROWING RAPIDLYGROWING RAPIDLY

DEVERSIFYINGDEVERSIFYING

CONTROLLEDCONTROLLED

MANIPULATEDMANIPULATED

COMPETITIVECOMPETITIVE

AND UNSAFE!AND UNSAFE!

Page 23: Large Populous Nations

MATCHING DRUG SUPPLYMATCHING DRUG SUPPLY WITH ORGNIZATION WITH ORGNIZATION

PHARMACEUTICAL SUPPLY IS:PHARMACEUTICAL SUPPLY IS:

SCATTEREDSCATTERED

DISTANTDISTANT

NONSTANDARDNONSTANDARD

UNCONTROLLEDUNCONTROLLED

UNREGULATEDUNREGULATED

UNINSPECTED, ANDUNINSPECTED, AND

VERY UNSURE!VERY UNSURE!

Page 24: Large Populous Nations

DRUG INELASTIC QUALITIESDRUG INELASTIC QUALITIES

PHARMACEUTICALS ARE PRODUCED BY PHARMACEUTICALS ARE PRODUCED BY CLASSCLASS

MANY DRUGS, SAME PURPOSEMANY DRUGS, SAME PURPOSEBRANDS AND GENERICS BRANDS AND GENERICS SIMILAR, NOT SAME MOLCULESIMILAR, NOT SAME MOLCULE

OROR::

PRODUCED AS SAME PRODUCED AS SAME MOLECULEMOLECULE

SAME DRUG, SAME PURPOSESAME DRUG, SAME PURPOSE BRANDS AND GENERICS BRANDS AND GENERICS EXACT SAME MOLECULESEXACT SAME MOLECULES

ALL THE ABOVE AREALL THE ABOVE ARE

PRODUCED BY MANY FIRMS INPRODUCED BY MANY FIRMS IN MANY COUNTRIES MOST NOT U.S.MANY COUNTRIES MOST NOT U.S. FIRMS NONE EXACTLY THE SAMEFIRMS NONE EXACTLY THE SAME

Page 25: Large Populous Nations

Some Main Drug ClassesSome Main Drug Classes Lipid Regulators Lipid Regulators Blood Pressure Blood Pressure AntidepressantsAntidepressants Narcotic AnalgesicsNarcotic Analgesics Anti diabeticAnti diabetic Respiratory AgentsRespiratory Agents Anti-UlcerateAnti-Ulcerate DiureticsDiuretics Anti-EpilepticsAnti-Epileptics TranquilizersTranquilizers Thyroid PrepsThyroid Preps Calcium Antagonists Calcium Antagonists Anti rheumaticsAnti rheumatics Hormonal ContraceptivesHormonal Contraceptives

Page 26: Large Populous Nations

MOLECULES IN ACE CLASS MOLECULES IN ACE CLASS BRAND (GENERIC)BRAND (GENERIC)

RED ARE OLDRED ARE OLD

ACE INHIBITORS B/PACE INHIBITORS B/P

Lotensin (benazepril) Lotensin (benazepril) Capoten (captopril) Capoten (captopril)

Vasotec (enalapril) Vasotec (enalapril)

Monopril (fosinopril) Monopril (fosinopril)

Prinivil, Zestril (Lisinopril)Prinivil, Zestril (Lisinopril) Univasc (Moexipril)Univasc (Moexipril)

Aceon (perindopril)Aceon (perindopril)

Accupril (quinapril)Accupril (quinapril)

Altace (ramipril)Altace (ramipril)

Mavik (trandolapril).Mavik (trandolapril).

Page 27: Large Populous Nations

ARE BRANDS & GENERIC ARE BRANDS & GENERIC

MOLECULES EQUALMOLECULES EQUAL? ?

They’re supposed to be. When a They’re supposed to be. When a drug is patented it files a New drug is patented it files a New Drug Application [NDA] and Drug Application [NDA] and receives an ID number called the receives an ID number called the National Drug Code [NDC]National Drug Code [NDC]After a patent expires all generic After a patent expires all generic companies must file Abbreviated companies must file Abbreviated New Drug Applications [ANDA] New Drug Applications [ANDA] and submit samples to FDA for and submit samples to FDA for testing to prove their products are testing to prove their products are equal. The FDA is required to equal. The FDA is required to inspect their facilities and Active inspect their facilities and Active Pharmaceutical Ingredients [API] Pharmaceutical Ingredients [API] and testing records to make sure and testing records to make sure all generics are made to the same all generics are made to the same NDA standards. But they aren’tNDA standards. But they aren’t

Page 28: Large Populous Nations

Why generics aren’t the Why generics aren’t the same.same.

Only batches called lots are Only batches called lots are exactly the same exactly the same

Every batch/lot differs slightly Every batch/lot differs slightly with standard tolerances with standard tolerances normally + or - 10%normally + or - 10%

Every Country has different Every Country has different procedures, standards, procedures, standards, tolerances, regulatory bodies tolerances, regulatory bodies and procedures.and procedures.

All manufacturers buy their All manufacturers buy their raw materials from different raw materials from different suppliers mainly on price and suppliers mainly on price and availability factors.availability factors.

Page 29: Large Populous Nations

Growing Sales and Growing Sales and Constant PharmaciesConstant Pharmacies

For over 2 decades the total For over 2 decades the total amounts of prescriptions filled amounts of prescriptions filled have increased 4 fold, while the have increased 4 fold, while the number of locations filling them number of locations filling them has remained the same. has remained the same.

Until 2000 pharmacists were Until 2000 pharmacists were allowed only one assistant allowed only one assistant which was increased by states which was increased by states to 4 or 5. Pharmacists are to 4 or 5. Pharmacists are supposed to supervise, while supposed to supervise, while increased prescriptions will increased prescriptions will probably add more techs. probably add more techs.

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Drug Sales MovementDrug Sales Movement

Top 200 drugs, 80% of sales Top 200 drugs, 80% of sales and 20% of prescriptionsand 20% of prescriptions

Bottom 40,000 drugs, 20% of Bottom 40,000 drugs, 20% of sales, and 80% prescriptions sales, and 80% prescriptions

70% must be repackaged 70% must be repackaged before dispensed, and are: before dispensed, and are:

66% of the work66% of the work

80% of inventory80% of inventory

25% of Profits25% of Profits

100% of inventory costs.100% of inventory costs.

Page 34: Large Populous Nations

Proper Sized Inventory itemsProper Sized Inventory items

30% of drugs are pre-sized, 30% of drugs are pre-sized, sold complete and cause no sold complete and cause no problems, like:problems, like:

Ointments, Creams, LotionsOintments, Creams, Lotions SuspensionsSuspensions SuppositoriesSuppositories PatchesPatches Popular Birth-Control PillsPopular Birth-Control Pills A few Acute Brand Drugs A few Acute Brand Drugs New expensive brand drugs New expensive brand drugs

All other drugs come in too All other drugs come in too large bottles and all must be large bottles and all must be repackaged in pharmacies.repackaged in pharmacies.

Page 35: Large Populous Nations

DRUG DISPENSING BOTTLE DRUG DISPENSING BOTTLE SIZE PROBLEMS SIZE PROBLEMS

MOST BRANDS GENERICMOST BRANDS GENERIC

SLOW SELLING STRENGHTS SLOW SELLING STRENGHTS

SLOW SELLING GENERICSSLOW SELLING GENERICS

MULTIPLE CLASSESMULTIPLE CLASSES

UNPOPULAR DRUGSUNPOPULAR DRUGS

DRUGS HARDLY USEDDRUGS HARDLY USED

Page 36: Large Populous Nations

BRANDS TURNING BRANDS TURNING GENERICGENERIC

Brands come in 3 or 4 strengths,Brands come in 3 or 4 strengths,

2 or 3 not often used.2 or 3 not often used.

Brands price all strengths equalBrands price all strengths equal

All come in 100 size bottlesAll come in 100 size bottles

Popular brand strengths sell 1Popular brand strengths sell 1

bottle/day, unpopular strengths bottle/day, unpopular strengths 1 bottle every 100 days1 bottle every 100 days..

As popular brands go generic,As popular brands go generic,

sales fall 90% to generics, sales sales fall 90% to generics, sales go generic or to other brands.go generic or to other brands.

Most brand drugs now genericMost brand drugs now generic

Page 37: Large Populous Nations

GENERIC REPLACEMENT GENERIC REPLACEMENT DRUG PROBLEMS DRUG PROBLEMS

HIGH VOLUME BRANDSHIGH VOLUME BRANDS

TURNING GENERIC ARETURNING GENERIC ARE

PROBLEMATIC.PROBLEMATIC.

SALES VOLUME DROPSSALES VOLUME DROPS STOCK LEFT UNSOLDSTOCK LEFT UNSOLD NO DEMAND NO DEMAND CAN’T RETURNCAN’T RETURN CAN’T SELLCAN’T SELL UNPOPULAR STOCK DIES UNPOPULAR STOCK DIES

Page 38: Large Populous Nations

LOW VOLUME BRANDSLOW VOLUME BRANDS

SMALL QUANTITIES OF SMALL QUANTITIES OF LARGE NUMBERS OF LARGE NUMBERS OF GENERICALLY REPLACED GENERICALLY REPLACED PRODUCTS SIT HALF PRODUCTS SIT HALF USED IN ALL PHARMACIES USED IN ALL PHARMACIES AWAITING GOING OUT OF AWAITING GOING OUT OF DATE, REQUIRED TO BE DATE, REQUIRED TO BE RETURNED.RETURNED.

PLACE U/D HOSPTAL PLACE U/D HOSPTAL STRIPS OF 10 AS STRIPS OF 10 AS STARTER SUPPLIES.STARTER SUPPLIES.

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LOW VOLUME GENERICSLOW VOLUME GENERICS

THERE ARE AS MORE THERE ARE AS MORE

QUANTITIES OF SIMILAR,QUANTITIES OF SIMILAR,

BUT NOT EXACT, GENERIC BUT NOT EXACT, GENERIC

DRUGS WITHIN THE SAME DRUGS WITHIN THE SAME

DRUG CLASS.DRUG CLASS.

STANDARDIZE ON BEST STANDARDIZE ON BEST

DRUG IN THE CLASS OR DRUG IN THE CLASS OR

TWO, TO REDUCE TWO, TO REDUCE

INVENTORY. INVENTORY.

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WHY IT WORKSWHY IT WORKS

DISPENSING SIZES ARE DISPENSING SIZES ARE EXACT AMOUNTS THEEXACT AMOUNTS THE DRUGS’ NDA WAS DRUGS’ NDA WAS APPROVED FOR.APPROVED FOR.

PHARMACISTS FIND PHARMACISTS FIND SMALLER, EXACTLY WHAT SMALLER, EXACTLY WHAT THEY NEED SIZES, EARN THEY NEED SIZES, EARN

MORE, AND COST LESS. BUY MORE, AND COST LESS. BUY THEM FOR CASH, AS THEY THEM FOR CASH, AS THEY KNOW WHEN THEY ARE KNOW WHEN THEY ARE NEEDED. PROVEN IN U.S.A. NEEDED. PROVEN IN U.S.A. AND IN EUROPE WHERE AND IN EUROPE WHERE

CALLED PATIENT PACKS.CALLED PATIENT PACKS.

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WHERE IT WORKSWHERE IT WORKS

DISPENSING SIZES OF 28’SDISPENSING SIZES OF 28’S ARE THE EUROPEAN SIZEARE THE EUROPEAN SIZE MONTHLY STANDARD, AS ALLMONTHLY STANDARD, AS ALL MONTHS HAVE 28 DAYS.MONTHS HAVE 28 DAYS.

WHOLESALERS BUY PATIENT WHOLESALERS BUY PATIENT PACKS OF 28 IN COUNTRIESPACKS OF 28 IN COUNTRIES WITH LOWER PRICES, AND WITH LOWER PRICES, AND REPACKAGE THEM BY REPACKAGE THEM BY REPLACING THE PACKAGING REPLACING THE PACKAGING OUTERWRAP AND DRUG ID’SOUTERWRAP AND DRUG ID’S SAVING GOVERNMENTSSAVING GOVERNMENTS MONEY, MAKING MORE FOR MONEY, MAKING MORE FOR THEMSELVES.THEMSELVES.

THIS IS PARALLEL TRADE. THIS IS PARALLEL TRADE.

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COMPITITION?COMPITITION?

EUROPE USES 28’S AND EUROPE USES 28’S AND CAN’T USE 30’S SINCE CAN’T USE 30’S SINCE GOVERNMENTS WON’T GOVERNMENTS WON’T PAY FOR EXTRA 2 PILLS.PAY FOR EXTRA 2 PILLS.

U.S. REPACKERS U.S. REPACKERS

STOPPED YEARS AGO, STOPPED YEARS AGO, BUT AS CHAINS MUST BUT AS CHAINS MUST HIRE MORE TECHS AND HIRE MORE TECHS AND

PHARMACISTS THEY’LL PHARMACISTS THEY’LL REPACK IN 30’S BUT ONLY REPACK IN 30’S BUT ONLY HIGH VOLUME,GENERICS, HIGH VOLUME,GENERICS, TO SAVE LABOR COSTS .TO SAVE LABOR COSTS .

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UPCOMING UPCOMING PHARMACY CHANGE PHARMACY CHANGE

TOP DRUG PRODUCINGTOP DRUG PRODUCING COUNTRIES [ASIA, COUNTRIES [ASIA,

AUSTRALIA, AND SOUTH AUSTRALIA, AND SOUTH AMERICA, WITH FAST AMERICA, WITH FAST GROWING POPULATIONS GROWING POPULATIONS WILL USE AS WELL AS WILL USE AS WELL AS PRODUCE MORE DRUGS PRODUCE MORE DRUGS CREATING SHORTAGES IN CREATING SHORTAGES IN THE U.S.THE U.S.DEPENDING ON NATIONS W/ DEPENDING ON NATIONS W/ UNSTABLE GOVERNMENTS UNSTABLE GOVERNMENTS WITHOUT THE ABILITY TO WITHOUT THE ABILITY TO PRODUCE DRUGS IN U.S.A. PRODUCE DRUGS IN U.S.A. IS RISKY.IS RISKY.

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PHARMACY 2014PHARMACY 2014

BRAND MANUFACTURERS BRAND MANUFACTURERS

WILL ONLY HAVE BIOLOGICAL WILL ONLY HAVE BIOLOGICAL DRUGS TO SELL EXCLUSIVELY, DRUGS TO SELL EXCLUSIVELY, IN U.S. AT DOUBLE WORLD IN U.S. AT DOUBLE WORLD PRICES, THEY CHARGE FOR ALL PRICES, THEY CHARGE FOR ALL THEIR DRUGS.THEIR DRUGS.

BIOLOGICAL PRICES ARE SOBIOLOGICAL PRICES ARE SO

HIGH THE U.S. GOVERNMENT HIGH THE U.S. GOVERNMENT ENTITLEMENT PROGRAMS CAN’T ENTITLEMENT PROGRAMS CAN’T AFFORD THEM AND CITIZENS AFFORD THEM AND CITIZENS WILL TRAVEL OUT OF THE WILL TRAVEL OUT OF THE COUNTRY TO BUY THEM AT 50% COUNTRY TO BUY THEM AT 50% LESS.LESS.

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IF NOT DISPENSING IF NOT DISPENSING SIZES WHAT?SIZES WHAT?

Prescriptions are familiar to Prescriptions are familiar to everyone, as is the fact that they will everyone, as is the fact that they will continue to be required to be continue to be required to be obtained from pharmacies with too obtained from pharmacies with too few pharmacists or techs, which are few pharmacists or techs, which are the most costly form of repackaging the most costly form of repackaging and can’t expand as they have run and can’t expand as they have run out of time and space.out of time and space.

Being focused on the Top 200 Being focused on the Top 200 generic drugs they’ll repackage generic drugs they’ll repackage these in dispensing sizes, ignoring these in dispensing sizes, ignoring the largest portion of their business the largest portion of their business costs – the drugs we’ll target. costs – the drugs we’ll target.

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HOW TO CREATE OUTLETS HOW TO CREATE OUTLETS AND SERVIES QUICKLY.AND SERVIES QUICKLY.

TRADITIONAL PHARMACY TRADITIONAL PHARMACY STARTUPS ARE NOW STARTUPS ARE NOW IMPOSSIBLE AS DRUG IMPOSSIBLE AS DRUG STOCK COSTS TOO MUCH.STOCK COSTS TOO MUCH.

DISPENSING SIZES OF DISPENSING SIZES OF BRANDS AND SLOW SELLING BRANDS AND SLOW SELLING GENERICS AVAILABLE GENERICS AVAILABLE OVERNIGHT CREATES OVERNIGHT CREATES ALMOST ZERO CASH NEED ALMOST ZERO CASH NEED AND DOESN’T NEED FRONT AND DOESN’T NEED FRONT END SALES, THAT MOST GO END SALES, THAT MOST GO TO “BIG BOX” STORES FOR.TO “BIG BOX” STORES FOR.