Here are a few comments on two different sections common to both reports, namely the

• lack of safety and efficacy documentation, and
• need for additional pharmacy education.

Safety and Efficacy Documentation
It is correct that more data is desired and that it would be advantageous to have complete data for each patient and each compounded preparation. However, such a situation is unrealistic or would even be unachievable for quite some time. Regarding the lack of safety and efficacy documentation which involves short- and long-term clinical studies for each "formulation" that is prescribed and compounded, along with numerous others studies involving formulation effectiveness, etc., these studies would be nice, but are costly, take time, and the physician has prescribed the specific formulation for the patient at this time (now).

Also, studies must be done on essentially the "same" product whereas compounded products vary depending upon the needs of the patient, and a single drug product may have up to 50 variations, which makes it impossible to do under the current requirements for valid clinical studies.

The current choice is to either compound the preparation for the patient as prescribed as long as it is reasonable and appropriate, or let the patient do without the medication with subsequent consequences. Marketed FDA-approved drug products today are only available in limited dosage forms (formulations) and one primary reason for compounding is to compound the drug in a formulation that is suitable for the specific patient.

In fact, the Report recognizes that compounding is tailored to meet the specific clinical needs of an individual patient; including children, the elderly, the hospitalized, those in long-term care, for ambulatory patients, and others. There are thousands of different formulations compounded each and every day to meet the needs of hundreds of thousands of patients. This explains why there is limited clinical data on a specific formulation, as the cost to obtain such data on even one formulation is extremely high, and there is no sponsor to obtain the information for thousands of compounded preparations for individual patients. Compounded preparations are prescribed for an individual patient for immediate use, and it is not practical to wait 2 to 10 years for clinical data to be produced on one specific formulation/product.

Pharmacy Education
Pain Report - Recommendation 3: To state boards of pharmacy, schools of pharmacy, and nonprofit professional societies and organizations within the medical and pharmaceutical sectors:

Require continued training for clinicians who prescribe compounded pain medication, particularly pain management specialists. Revise current educational requirements for compounding pharmacists and non-pharmacists who compound.

The Report is correct in recognizing that education on pharmaceutical compounding needs to be revised and increased. In the 1970s and 1980s, the science and technology related to drug products and laboratory experiences was decreased to make room for more "clinically-oriented" courses.

The Millis Report (1976) projected that pharmacists in the future would have less to do with the drug product and be more involved with a knowledge system, the product of which is a service; there will be many roles a pharmacist can perform. After almost 50 years, the purely clinical role has not been realized and, instead, the majority of pharmacists are still intimately involved in dispensing and counseling about the manufactured drug products and compounding nonsterile and sterile drugs in neighborhood pharmacies, hospitals, and specialty pharmacies.

The Millis Report says of clinical pharmacy¹:

...one must cite the growing interest and involvement in what is generally called clinical pharmacy. I have not found a definition to which all will agree. However, it is clear that it refers to a pharmacy practice centered on the drug-related needs of patients.

This Editor has often said that compounding pharmacists are clinical pharmacists, as they are intimately involved with the "drug-related needs of patients" and must work hand-in-hand with the physician and the patient to optimize the patient's drug therapy.

A competent compounding pharmacist must also be thoroughly trained in pharmaceutics/physical pharmacy, drug product formulation, clinical pharmaceutics, pharmaceutical chemistry, compounding pharmacy, as well as in clinical and administrative pharmacy.

Regarding the "curriculum," the Millis Report says:

A second recommendation concerning the curriculum is that it should be structured to produce competencies identified and defined as appropriate for the practices of pharmacy.

Note that the word is "practices," plural, as there are many different "practices" of pharmacy of which compounding is significant and vital, but there is insufficient training on it in the colleges.

The NASEM cBHT report even states that currently there are 26 to 33 million prescriptions for compounded hormone formulations alone with their costs upwards of $2 billion annually, and compounding is expected to continue growing. Keep in mind that cBHT accounts for only a portion of compounded medications, as there are many nonsterile as well as sterile products, including intravenous admixtures, compounded daily.

Summary

The concerns related to safety and efficacy evaluation and expectations involving them are questionable, as it is not feasible to require complete clinical studies for each and every compounded formulation. The educational curriculum for pharmacy does need to be addressed and more classes/laboratories provided in compounding and content related to compounding, both nonsterile and sterile.

Reference

1. Millis JS. Looking ahead - the report of the Study Commission on Pharmacy. Am J Hosp Pharm. 1976; 33: 134-138.

News

Covid-19 Drug Remdesivir to Cost $3,120 for Typical Patient
Gilead Sciences announced Monday that it expects to charge U.S. hospitals $3,120 for a typical COVID-19 patient who requires its drug remdesivir. Gilead expects to have sufficient supply by September to keep up with demand and distribute the drug in the same way it distributes other medicines. The company set a higher price for most U.S. patients, but a lower price will be extended to certain federal agencies. The government price will be $390 per dose, or $2,340 per patient for the shortest treatment course and $4,290 for a longer treatment course. Gilead says it will charge nongovernment buyers such as hospitals about $520 a dose for U.S. patients who are commercially insured, totaling $3,120 for a patient receiving the shorter course of treatment, and $5,720 for the longer treatment duration. The U.S. is the only developed country where Gilead will charge two prices. In other nations, governments negotiate drug prices directly with drugmakers.
https://www.wsj.com/articles/covid-19-drug-remdesivir-to-cost-3-120-for-typical-patient-11593428402

The FDA to Require COVID-19 Vaccine to Be Effective in 50 Percent of Recipients for Approval
The FDA said that to win regulatory approval, any COVID-19 vaccine will have to prevent disease, or decrease its severity, in at least 50 percent of the people who receive it. The standards apply to full approvals. But the agency didn't rule out temporary approvals, which typically are based on less stringent requirements.
https://www.washingtonpost.com/health/2020/06/30/coronavirus-vaccine-approval-fda/

Did You Know ...

...that Will Rogers said the following?

"We don't seem to be able to check crime, so why not legalize it and then tax it out of business?"

Tip of the Week

"We pay a tremendous crime bill each year, but we do get a lot of crime for our money." (Anon.)

Independence Day! In remembering all the great men and women that gave us freedom and a great country, it seems that Patrick Henry's famous statement of "Give me liberty or give me death" has been changed by many today and leaves out the words "liberty" and "death"!

IJPC Now on Facebook and Youtube

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - https://www.facebook.com/IJPCompounding

View our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/IJPCompounding.

Looking Back

Cattle crossing,
Means go slow,
That old bull,
Is some cow's beau!
     Burma-Shave