Dra. Awilda Soto Lorenzo

Moca, Puerto Rico

November 14, 2024

APhA

Greetings. I hope that everybody is doing well. By this means, I am making a comment regarding the Bills submitted to Congress.

If they are not kniwledgeable about the situations, are not in position to make wise decisions.

Pharmacy is a very regulated profession:

An act is an act, a bill is a bill, a rule is a rule, a regulation is a regulation, a law is a law. Therefore must look after the best interests of the country, of the nation, from all perspectives, points of view seeking for what is best not only economically, but in health. They are aware of it. Always wanting a healthy strong nation, safe and well educated .

In terms of IRA Inflation Reduction Act

There are many factors involved in the cost and price of medications, treatments, billing process, and so.

When a company develops a medication, they undergo many steps:

Medication research, design, in vitro testing, in vivo, permits, ANDA, NDA, clinical trials, post marketing, and so forth. Those, besides being time consuming, are expensive, necessary and required by law. After exclusivity pattents years passes, biosimilar, bioequivalents, generics are produced at a cheaper price (the company did not have to invent anything), they have to test bioavailability. The cGMP, ISO, Compounding chapters, State Department laws, Federal Laws, all those are mandatory. Accreditations are also necessary and mandatory. Joint Commission, for example has requirements for hospitals.

Those have economic impact. The documentation, the personnel, the storage, shipping, handling, the dispensing, counseling, and much more...all that costs.

So, after the medication has been designed, developed, compounded, tested and launched to market, has not had sales yet, therefore, no profit has been obtained until marketed. Upon dispensing, the prescription bottles, labeling, tape, involved personnel, electric power, handling, storage, disposal (including biohazard waste disposal), testing, pharmacokinetics, needles, syringe, alcohol pads, refrigeration along with temperature reading and recordings from thermometers, IV hoods, IV rooms, ground, air, sea transportation, ...all that has costs implied. Nobody opens a business to lose money. It is not only the price per unit vial, but per overall treatment. Guidelines have been developed to assist in costeffective selection per patients' peculiarities and comorbid conditions. Originally, the initial intention of the PBMs was to serve as quality standards and metrics and manage the costs, inflation, and make sure that the guides were followed and payment of submitted claims were done properly. These days there is payment per outcomes awarding 5 star scale ratings per service. Pharmacoeconomics is the discipline involved here. Poor managerial skills, not noticing where the money is going, not performing business financial analysis, inventories, loss prevention, adjustments affects the net margin pushing to below the break even point.

Not having the numbers to bill will not allow to do so.

As gas price increases, that will be added to shipping and handling.

Even legal issues and frivolous law suits have impact in pricing. Logistics must be included. Going up a hill will use more gas than gowing down a hill or straightforward. Not to mention the maintenance, oil, tires, water, neatness, and so forth.

One of the things seen is not billing for the goods and services properly. Upon billing, it is not only the cost per unit, but overall treatment, dispensing, storage, good shipping and handling, proper monitoring, pharmacokinetics, imaging, lab tests, medication clinical pharmaceutical counseling, medications side effects and adverse reaction prevention, assessment and management, the outcomes, disposal, waste management, documentation, audits, and much more. The utilities and human resources cannot be forgotten.

Another detail is purchasing, stocking, and inventory management. Wholesalers give discounts in prices to the pharmacies when they pay prior certain days. Taking advantages of those discounts allows the pharmacy to pass that discount to the customer, or if not doing so, that small benefit will be seen in their net margin.

Remember the concepts return on investments, breakeven point, gross margin, net margin, and personnel turnover rate. Unfortunately, frustration comes along bringing up personnel turnover, burnout syndrome, stress, fatigue, which affects the service. Remember that it is the provided service that what makes you keep a customer's loyalty. That service is from the employees, from human resources context.

The initial intention of the pharmacy benefit management was to provide that care. When prior authorization messages were displayed on the computer screens, the intention was to see if there were more cost-effective medications, outcome monitoring, treatments assessments, guidelines followed or not, and much more. Fraud and waste were also being addressed.

So, patients got upset and in dispair brought arguing against the system. That is seen as a factor that affects the overall service. An upset customer impacts adversely the image of the provider among other customers. This decreases trust and sales. Things like this could happen when the healthcare service is provided by people that are not properly educated, trained or lack information, not patient centered, lack of updates or a robust system. Most close the place. Others sell.

Analyze: Who will do what? When? How,? Where? All along with performance metrics, analysis, tools like fishbone, root-cause analysis, and so forth.

It seems to me that every scenario has to analyze their performance, view how they are doing things, do a process walk, stream value map, fishbone, root cause analysis and prepare to move forward.

In pharmaceutical industry costs include many aspects such as incoming process, testing raw material, mixing, compounding, compressing preventing chipping and capping, do lab tests, weighing, storage and handling, disposal.

In warehousing the logistics.

It is not the same to hand in something personally, next block, nearby neighbor, near town than across the entire nation.

As pharmacists, we go through a tough education, college degree, board tests, continuing education, training, certifications, and much more. Because of that it is well ranked as most trusted profession. Prepared for the worst case scenario and expecting the best outcome ever. It is being heard and remembered not only when needed the most such as in illness, but always, as friends, helping hands.

That is a lecture and goes way beyond legislation.

On health services, must remember pharmacogenome, some treatments are for genetic conditions.

When pharmacies shut down, it is not only the center, but the access to the healthcare professional as well. Cannot rely on computer applications and artificial intelligence. Wrong data entered in the systems generates non accurate reports leading to wrong decisions. Nothing substitutes clinical professional judgement.

Details such as: protein binding, amount of proteins excreted (proteinuria), amount of water, of fat, cytochromes, hepatic function, renal function, metabolism, temperature, heat, cold, pregnancy, breastfeeding, age, and so impacts treatments. Even test results may be affected by medications, and so. That is why cannot be relying on computer application entirely. These require validation.

Another risk appears when non knowledgeable patients use selfcare apps. The computer will not see a butterfly rash due to a medication induced systemic lupus erythematous.

A system that goes against the healthcare professional affects patient's access to healthcare, which is guaranteed by the Constitution. Not having accessibility to the healthcare professional is also a risk.

Continuity of care would be adversely affected. Patient centered

Interprofessional team approach access.

I want to congratulate you all for the effort and awesome performance.

My personal and humble opinion. Thanks and have a nice day.

Cordially,

Dr. Awilda Soto Lorenzo

Awilda Soto Lorenzo, R.Ph., Pharm.D.

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