Large Populous Nations

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

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

3. Habits Die Hard You’ve watched your entire lives, many supposedly well educated professional people do the same repetitive tasks, hour after hour, day after day, year after year their whole lives, never ever trying to change anything, or invent ways to improve or make it easier, better and more profitable? I’m speaking of Pharmacists.

4. A Profession locked into Its own history Pharmacies started as individual pharmacists each manufacturing single doses of medicine ordered by individual physicians, sort of like “short order cooks”. Safety was not a big concern as only one person at a time could be killed or harmed. Until events like the New England Compounding Center Disaster- the last of many!

5. Pharmacy grows into a wholesale business 80 years ago, pharmacists Working with physicians, made mostly liquid medicines with narcotic ingredients. Some made these better than others so, pharmacists like: Eli Lilly, Charles Pfizer, George Searle, John Wyeth and others made their drugs in large batches and sold them locally to others.

6. Pharmacy wholesaler Kills hundreds In 1937, S.E. Massengill, Bristol, TN added diethylene glycol [a type of antifreeze], to make a new liquid syrup form of a sulfer drug. They added this for flavor, as all manufacturers did to mask bitter tastes, but this was poison. 105 died in 15 states and Congress passed the Food and Drug Act in 1938 for drug Manufacturing safety, exempting retail pharmacists dispensing drugs as not being manufacturing.

7. Drugs change form to oral solids After WW II drugs changed form from liquids and powders to tablets and capsules, mainly pain pills and anti-biotics, whose doses and the available amber glass bottles caused them to be packaged in bottles of 100. This caused Pharmacist to have to count out the proper number, usually 30 to 60, as normal doses of these drugs were 1 to 4 tablets or capsules a day.

8. Oral solids change dose Drugs developed in the 70’s and 80’s to treat many diseases, but had to be taken multiple times a day which was problematic. Brand drug manufacturers changed drugs to slow release, extending patents, and brand drug sales into the 90’s when generics for them were tested and approved by the FDA, replacing brands, molecule by molecule and now are 90% of Global sales, most not made in the USA.

9. Today’s Pharmacy Challenges US Pharmacies have decreased in number since 1990. They just get larger and increase front store space for non-pharmaceuticals. Today pharmacy techs count most pills, as over 12 billion pills are “manufactured” into 4 billion prescriptions in 65,000 pharmacies, mostly 30 cheap generic pills, some uninspected by FDA in foreign plants from bottles of 100 to 5,000 pills into 10 cent orange vials; pill by pill.

10. UNMET NEEDS INU.S. HEALTHCARE • Physicians [too few] • Nurses [too few] • Tests [many missed] • Hospitals [unbalanced] • Emergency Care [scattered] • Transportation [unsure] • Pharmaceuticals [unsafe] • Standards [unchecked] • Rules [ignored] • Safety [unverified] • Vigilance [none]

11. UNIVERSAL U.S. HEALTHCARE With unmet needs in every segment of our healthcare system, how do we meet needs without increased personnel? What can be increased quickly? Not Physicians, Nurses, hospitals or the rest, only pharmaceuticals can and will be. But supplies are being limited and are unsafe to use many uninspected by the FDA made in factories in like India and China?

12. WHO MAKES WHAT AND WHERE? It’s on the labels right? While the FDA keeps labels on file and these are required to be put on bottles, and they are often incorrect as the FDA doesn’t require The last “manufacturer” of a drug Products’ drug ID to be shown: and only California requires the LOT numbers to be placed on prescription vials. Consumers get more information on underwear and fruit labels!

13. VISITED YOUR PHARMACY LATELY? If you have, you noticed for every pharmacists, usually on the phone, or on the computer while 4 or 5 techs are counting pills. These “Techs” dispense drugs to you and others, from bottles they have no idea who manufactured or where, when or how the FDA drug identification number was applied to labels .

14. DOES THE FDA KNOW THE DANGERS? Nobody knows better, as safety has been their only function since 1938. August, 2006 FDA proposed safety “Requirements For Foreign and Domestic Establishment Registration and Listing for Human Drugs,Including Drugs That Are Regulated Under Biologics License Application and Animal Drugs; requiring the last “manufacturer” filling drug containers to use only their own FDA registered NDCs on labels. It was withdrawn as drug repackagers complained.

15. WHAT IS THE FDA DOING NOW? As the FDA can’t keep their own drug records and drug supplies safe, or inspect and regulate foreign manufacturers, their current solution is to not require drugs meet U.S. FDA Standards and accept whatever these countries’ standards are as being “close enough” for U.S. government needs, but every country is different.

16. HOW CAN SAFETY BE RESTORED AND HELP PHARMACY? Since most drugs are now made in foreign plants, and some of the manufacturers and countries regulatory agencies as stringent as we should be, establishing contracts with the best with the most complete product lines, and testing before packaging solves the safety problem, but we would do much more.

17. WHAT MORE CAN BE DONE? Two different but essential things are done in the Repackaging process: • Increased quality and education while; • Decreasing pharmacy inventory and labor costs.

18. INCREASED QUALITY BY EDUCATION? Government records show two things: • Brand drugs changed their products before patent expiration to keep high sales. • As Brand drugs lost patent protection 90% of sales shifted to generics that always drop in price.

19. INCREASE KNOWLEDGE WITH EDUCATION? As brand drugs become generic some patients are switched to the generic while: • Brand drugs, increase prices making inventory and patient costs much more, and • As this happens millions of patients are switched to generics and remain forever on older less effective drugs, as equally low priced, better ones are available.

20. DECREASE PHARMACY INVENTORY AND LABOR COSTS • Brand drugs, especially less popular strengths with higher cost and slow sales of 1 bottle sold a quarter ties up huge amounts of inventory capital with high holding costs. • The same happens to the same generic strengths, doubling the bottles on shelves, consuming an equal amount of space.

21. Change in Healthcare • Constant • Unwanted • Uncertain and • At Times: • Unnecessary • Harmful • Uneconomical • Foolish • Untried, but in drugs is; a. Very Important b. Logical & Established c. Extremely Necessary d. Profitable

22. MATCHING DRUG SUPPLY WITH DEMAND • PHARMACEUTICAL DEMAND IS: INELASTIC [DISEASE SPECIFIC] GROWING RAPIDLY DEVERSIFYING CONTROLLED MANIPULATED COMPETITIVE AND UNSAFE!

23. MATCHING DRUG SUPPLY WITH ORGNIZATION • PHARMACEUTICAL SUPPLY IS: SCATTERED DISTANT NONSTANDARD UNCONTROLLED UNREGULATED UNINSPECTED, AND VERY UNSURE!

24. DRUG INELASTIC QUALITIES PHARMACEUTICALS ARE PRODUCED BY CLASS MANY DRUGS, SAME PURPOSE BRANDS AND GENERICS SIMILAR, NOT SAME MOLCULE OR: PRODUCED AS SAME MOLECULE SAME DRUG, SAME PURPOSE BRANDS AND GENERICS EXACT SAME MOLECULES ALL THE ABOVE ARE PRODUCED BY MANY FIRMS IN MANY COUNTRIES MOST NOT U.S. FIRMS NONE EXACTLY THE SAME

25. Some Main Drug Classes • Lipid Regulators • Blood Pressure • Antidepressants • Narcotic Analgesics • Anti diabetic • Respiratory Agents • Anti-Ulcerate • Diuretics • Anti-Epileptics • Tranquilizers • Thyroid Preps • Calcium Antagonists • Anti rheumatics • Hormonal Contraceptives

26. MOLECULES IN ACE CLASS BRAND (GENERIC)RED ARE OLD • ACE INHIBITORS B/P Lotensin (benazepril) Capoten (captopril) Vasotec (enalapril) Monopril (fosinopril) Prinivil, Zestril (Lisinopril) Univasc (Moexipril) Aceon (perindopril) Accupril (quinapril) Altace (ramipril) Mavik (trandolapril).

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

28. Why generics aren’t the same. • Only batches called lots are exactly the same • Every batch/lot differs slightly with standard tolerances normally + or - 10% • Every Country has different procedures, standards, tolerances, regulatory bodies and procedures. • All manufacturers buy their raw materials from different suppliers mainly on price and availability factors.

29. Growing Sales and Constant Pharmacies • For over 2 decades the total amounts of prescriptions filled have increased 4 fold, while the number of locations filling them has remained the same. • Until 2000 pharmacists were allowed only one assistant which was increased by states to 4 or 5. Pharmacists are supposed to supervise, while increased prescriptions will probably add more techs.

33. Drug Sales Movement • Top 200 drugs, 80% of sales and 20% of prescriptions • Bottom 40,000 drugs, 20% of sales, and 80% prescriptions • 70% must be repackaged before dispensed, and are: • 66% of the work • 80% of inventory • 25% of Profits • 100% of inventory costs.

34. Proper Sized Inventory items • 30% of drugs are pre-sized, sold complete and cause no problems, like: • Ointments, Creams, Lotions • Suspensions • Suppositories • Patches • Popular Birth-Control Pills • A few Acute Brand Drugs • New expensive brand drugs All other drugs come in too large bottles and all must be repackaged in pharmacies.

35. DRUG DISPENSING BOTTLE SIZE PROBLEMS • MOST BRANDS GENERIC • SLOW SELLING STRENGHTS • SLOW SELLING GENERICS • MULTIPLE CLASSES • UNPOPULAR DRUGS • DRUGS HARDLY USED

36. BRANDS TURNING GENERIC • Brands come in 3 or 4 strengths, 2 or 3 not often used. • Brands price all strengths equal • All come in 100 size bottles • Popular brand strengths sell 1 bottle/day, unpopular strengths 1 bottle every 100 days. • As popular brands go generic, sales fall 90% to generics, sales go generic or to other brands. • Most brand drugs now generic

37. GENERIC REPLACEMENT DRUG PROBLEMS • HIGH VOLUME BRANDS TURNING GENERIC ARE PROBLEMATIC. • SALES VOLUME DROPS • STOCK LEFT UNSOLD • NO DEMAND • CAN’T RETURN • CAN’T SELL • UNPOPULAR STOCK DIES

38. LOW VOLUME BRANDS • SMALL QUANTITIES OF LARGE NUMBERS OF GENERICALLY REPLACED PRODUCTS SIT HALF USED IN ALL PHARMACIES AWAITING GOING OUT OF DATE, REQUIRED TO BE RETURNED. • PLACE U/D HOSPTAL STRIPS OF 10 AS STARTER SUPPLIES.

39. LOW VOLUME GENERICS • THERE ARE AS MORE QUANTITIES OF SIMILAR, BUT NOT EXACT, GENERIC DRUGS WITHIN THE SAME DRUG CLASS. • STANDARDIZE ON BEST DRUG IN THE CLASS OR TWO, TO REDUCE INVENTORY.

40. WHY IT WORKS • DISPENSING SIZES ARE EXACT AMOUNTS THE DRUGS’ NDA WAS APPROVED FOR. • PHARMACISTS FIND SMALLER, EXACTLY WHAT THEY NEED SIZES, EARN MORE, AND COST LESS. BUY THEM FOR CASH, AS THEY KNOW WHEN THEY ARE NEEDED. PROVEN IN U.S.A. AND IN EUROPE WHERE CALLED PATIENT PACKS.

41. WHERE IT WORKS • DISPENSING SIZES OF 28’S ARE THE EUROPEAN SIZE MONTHLY STANDARD, AS ALL MONTHS HAVE 28 DAYS. • WHOLESALERS BUY PATIENT PACKS OF 28 IN COUNTRIES WITH LOWER PRICES, AND REPACKAGE THEM BY REPLACING THE PACKAGING OUTERWRAP AND DRUG ID’S SAVING GOVERNMENTS MONEY, MAKING MORE FOR THEMSELVES. • THIS IS PARALLEL TRADE.

44. COMPITITION? • EUROPE USES 28’S AND CAN’T USE 30’S SINCE GOVERNMENTS WON’T PAY FOR EXTRA 2 PILLS. • U.S. REPACKERS STOPPED YEARS AGO, BUT AS CHAINS MUST HIRE MORE TECHS AND PHARMACISTS THEY’LL REPACK IN 30’S BUT ONLY HIGH VOLUME,GENERICS, TO SAVE LABOR COSTS .

45. UPCOMING PHARMACY CHANGE • TOP DRUG PRODUCING COUNTRIES [ASIA, AUSTRALIA, AND SOUTH AMERICA, WITH FAST GROWING POPULATIONS WILL USE AS WELL AS PRODUCE MORE DRUGS CREATING SHORTAGES IN THE U.S. DEPENDING ON NATIONS W/ UNSTABLE GOVERNMENTS WITHOUT THE ABILITY TO PRODUCE DRUGS IN U.S.A. IS RISKY.

46. PHARMACY 2014 • BRAND MANUFACTURERS WILL ONLY HAVE BIOLOGICAL DRUGS TO SELL EXCLUSIVELY, IN U.S. AT DOUBLE WORLD PRICES, THEY CHARGE FOR ALL THEIR DRUGS. • BIOLOGICAL PRICES ARE SO HIGH THE U.S. GOVERNMENT ENTITLEMENT PROGRAMS CAN’T AFFORD THEM AND CITIZENS WILL TRAVEL OUT OF THE COUNTRY TO BUY THEM AT 50% LESS.

47. IF NOT DISPENSING SIZES WHAT? • Prescriptions are familiar to everyone, as is the fact that they will continue to be required to be obtained from pharmacies with too few pharmacists or techs, which are the most costly form of repackaging and can’t expand as they have run out of time and space. • Being focused on the Top 200 generic drugs they’ll repackage these in dispensing sizes, ignoring the largest portion of their business costs – the drugs we’ll target.

48. HOW TO CREATE OUTLETS AND SERVIES QUICKLY. • TRADITIONAL PHARMACY STARTUPS ARE NOW IMPOSSIBLE AS DRUG STOCK COSTS TOO MUCH. • DISPENSING SIZES OF BRANDS AND SLOW SELLING GENERICS AVAILABLE OVERNIGHT CREATES ALMOST ZERO CASH NEED AND DOESN’T NEED FRONT END SALES, THAT MOST GO TO “BIG BOX” STORES FOR.