How S.959 Will Affect Compounding Pharmacies, Their Prescribers and Patients

Transcription

1 How S.959 Will Affect Compounding Pharmacies, Their Prescribers and Patients

2 The Facts About S. 959

3 We provided these facts to respondents. Under this proposed law, a pharmacy would be required to register as a compounding manufacturer if all three of these condi>ons apply: You compound sterile prepara>ons for human use and You compound these prepara>ons in advance of receiving a prescrip>on (an>cipatory compounding) and You dispense any of these prepara>ons outside of the state in which you prepare the compound.

4 We provided these facts to respondents. The proposed law requires you to chose only one op>on: remain a "tradi>onal" compounding pharmacy or register as a "compounding manufacturer." You must pick one. You may not operate both types of en>ty from the same physical loca>on, unless you are a Pharmacy Benefits Manager (PBM.)

5 Registering as a compounding manufacturer means abandoning individual prescrip>ons and limi>ng non- sterile compounds that may be prepared to a posi>ve list defined by the FDA. If required to register as a compounding manufacturer you would no longer be permiped to fill individual prescrip>ons or fill orders for office use. You would only be permiped to sell to hospitals, clinics and prescribers on a purchase order. You also would be a compounding manufacturer for non- sterile compounding, and your non- sterile compounding would be limited to a posi>ve list developed by the FDA. Under the proposed legisla>on, the fee to register as a compounding manufacturer is at least $15,000 per year and could be substan>ally higher. The fee is reduced to $5,000 per year if you have gross annual sales of $1 million or less. In addi>on, if the FDA inspects you and finds something wrong, there is a $15,000 re- inspec>on fee for each re- inspec0on.

6 Remaining a tradi>onal compounder means new, federal- level responsibili>es and criminal penal>es for failure to comply... If you remain a tradi>onal compounder, your pharmacy prac>ce will face addi>onal administra>ve requirements from being under both state law and this federal law. For example, although states do not require it, if you dispense for office use, you will have a federal- law responsibility, under the threat of criminal penalty, to obtain, document and keep the names of all pa>ents to whom a physician has administered a compound from an office order.

7 and means new, federal- level responsibili>es and criminal penal>es for failure to comply. As a "tradi>onal" compounding pharmacy you would be able to fill prescribers' orders for office use. However, you would be required, in conjunc>on with each prescriber, to have them reconcile and report back to you within 14 days the names of all the pa>ents the medica>on was administered to or face possible criminal penal>es. The office- use compounds you dispense would be limited to no more than 10 percent of your total compounded drugs during any 30- day period, and you would be required to label a beyond- use date of 14 days or shorter from the date of dispensing.

8 Demographics

9 How many full- time equivalent (FTE) employees does your business employ? 78% of respondents are with business that have fewer than 20 employees. Only 5% are with companies with more than 50 employees. 46 to 50, 2% 21 to 25, 6% 31 to 35, 3% 26-30, 3% 36 to 40, 2% 41 to 45, 2% More than 50, 5% [CATEGORY NAME], [VALUE] 16 to 20, 10% 11 to 15, 14% 6 to 10, 29% Fewer than 5 6 to to to to to to to to 50 More than 50

10 What percentage of your sales would you estimate is dispensing patient- specific prescriptions? 71% of respondents say that from 81% to 100% of their pharmacy s sales are derived from dispensing pa>ent- specific prescrip>ons. 1 to 20%, 7% 41 to 60%, 6% 20 to 40%, 5% 61-80%, 11% %, 71% % 61-80% 1 to 20% 41 to 60% 20 to 40%

11 What percentage of your sales would you estimate are to customers located in the state in which your main compounding facility is located?? 68% of respondents say that from 81% to 100% of their pharmacy s sales are from in- state customers %, 5% 20-40%, 5% 61 to 80%, 12% 1-20%, 10% 81 to 100%, 68% 81 to 100% 61 to 80% 1-20% 41-60% 20-40%

12 Summary of the Findings

13 If S. 959 became law Given how they prac0ce pharmacy today, 41% of respondents would be required to abandon the pharmacy profession and register as a compounding manufacturer. The Senate HELP commipee says that only about 50 large pharmacies in the country would be affected by this legisla>on. Yet in this sample alone, 320 pharmacies would be forced to give up their pharmacy business or make changes to their business that would greatly reduce access to compounded prepara>ons, reduce revenues, increase costs and eliminate jobs. If this rate is typical, of 7,500 compounding pharmacies na>onwide, 3,075 pharmacies would be forced to give up their pharmacy business or change them in ways detrimental to them, the economy, their pa>ents and prescribers.

14 If S. 959 became law 39% say it is somewhat or extremely likely that they would close their business rather than register as a compounding manufacturer

15 The great majority of respondents say that five components of the legisla>on will have a large nega>ve impact on how they prac>ce and/or pa>ent outcomes. Possibility of federal official defining clinical difference: 87% Allowing FDA to decide what is demonstrably difficult to compound: 86% Federal officials determining permiped varia>ons of manufactured drugs: 87% Clinical Difference requirements: 74% Addi>onal administra>ve requirements: 78%

16 If choosing to remain as a tradi>onal compounder, respondents are somewhat or very likely to say that: Revenue would decrease: 85% Number of compounds would decrease: 82% They would reduce compounding for office use: 78% They could not serve the same pa>ent popula>ons: 73% They could not serve the same prescribers: 73% They would stop compounding for office use: 71% They would eliminate jobs: 69% 78% say that it s somewhat or not or not at all likely that they would hire the people and build the systems necessary to comply with the new requirements.

17 If choosing to register as a compounding manufacturer, respondents are somewhat or very likely to say that they would cover the new costs by: Increasing prices: 85% Reducing the number of prepara>ons made: 73% Absorbing the added costs: 13% Elimina>ng one or more jobs: 66% Making across- the- board salary and wage cuts: 57% Reducing expenses other than payroll: 51% Closing their business: 40%

18 If the FDA were given significantly greater authority over compounding pharmacies, respondents say it is somewhat or extremely unlikely that: Selec>on and availability of compounded prepara>ons would increase: 94% The cost of compounded medica>ons would decrease: 94% The administra>ve burden would not change: 90% There would be a posi>ve impact on pa>ents: 89% Pa>ent compliance would increase: 85% Pa>ent safety would increase: 77% Not change the prepara>ons they compound: 65%