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NECC and the PBMs: Some Apparent Similarities
Since "Clinical Pharmaceutics" is the application of the unique knowledge base in pharmaceutics to patients and to clinical situations, the following occurred this past week. This case involves a PBM's unwillingness to pay for a proper compounded prescription for a neonate. The PBM's decision required that the pharmacist dispense the commercial solid dosage form with the instructions to place the preparation in water and measure a dose equivalent to a fraction of the commercial tablet!
A retail pharmacy experienced this unfortunate encounter with Express Scripts over the last few days. As is known, Express Scripts is denying coverage of most compounds by means of NDC rejection on OTC vehicles that are Generally Recognized as Safe (GRAS) by the FDA.
Situation:
"The pharmacy had a newborn baby with a life-threatening arrhythmia in the NICU who needed the antiarrhythmic propafenone. It was a very tense situation for a while until the patient was stabilized on the compounded medication in the hospital. Upon discharge, the insurance rejected the compounded formulation and would only pay for the tablets. So, unfortunately, we had to send them home with tablets where they had to dissolve a tablet in 10 mL of water and then give a partial amount to try to best approximate the desired dose. As you can imagine, this is not an ideal situation, especially for a neonatal patient with an arrhythmia. They did not give us or the MD any type of prior authorization option other than the parents seeking some sort of formalized appeal process "down the road." The cash cost for the compounded medication was too much out-of-pocket for the family. This action is absolutely heartless and Express Scripts needs to be held accountable for what happens to the child!"
Editor's Note: Propafenone is listed as "slightly soluble" in water (which is 1 part in 100 to 1000 parts); this encompasses from 10 mg/mL to 1 mg/mL water. Tablets contain either 150 mg or 225 mg of drug. Using the 150-mg tablet, it would take between 15 mL and 150 mL of water to dissolve the drug to obtain a "uniform dose." It is quite evident that all of the drug will not dissolve, and the patient's caregiver may not be aware they must obtain a uniform suspension in order to accurately measure the required dose for the infant.
Sad to say, this is only one of thousands of such stories that have been occurring over the years and have now escalated out of control. PBMs state that they require the use of commercial products in compounding, and yet they refuse to pay for them in a compounded preparation as shown in the example above with propafenone.
Let's look at the feasibility of using commercial products to compound some common topical pain preparations (Table 1) and oral preparations (Table 2). The tables below list common ingredients and a "usual concentration" used along with the quantity of drug required to compound 100 g or mL of the preparation. The next two columns show what commercial injections and solid dosage forms are available. The last column lists whether or not it is reasonable to use the commercial drug product as the drug source.
Table 1. Feasibility Chart of Using Commercial Drug Products in Compounding Topical Pain Creams/Gels.
| Active Pharmaceutical Ingredient |
Gen. Conc. in Pain Meds |
Req'd. Quantities / 100 g |
Injection Product Available |
Tablet/Capsule Available |
Feasible? |
| Amitriptyline Hydrochloride |
2% |
2 g |
Not Available |
10-150 mg |
? |
| Baclofen |
2% |
2 g |
Not Available |
10, 25 mg |
No |
| Clonidine Hydrochloride |
0.2% |
200 mg |
500 mcg/mL |
0.1-0.3 mg |
No |
| Gabapentin |
6% |
6 g |
Not Available |
600-800 mg |
? |
| Ketamine Hydrochloride |
10% |
10 g |
100 mg/mL |
Not Available |
No |
| Ketoprofen |
10% |
10 g |
Not Available |
75 mg |
No |
| Lidocaine |
2% |
2 g |
10% |
|
No |
| Nifedipine |
2% |
2 g |
Not Available |
90 mg |
No |
Table 2. Feasibility Chart of Using Commercial Drug Products in Compounding Oral Liquids.
| Active Pharmaceutical Ingredient |
Gen. Conc. of Oral Liquid |
Req'd. Quantities / 100 mL |
Products Available |
Feasible?/Comment |
| Baclofen |
10 mg / mL |
1000 mg |
10-20 mg tablets |
No/Excessive powder when using tablets. |
| 50 mcg/mL to 500 mcg/mL intrathecal pump injection |
No/Excess volume when using injection. |
| Bethanecol |
1 mg / mL |
100 mg |
5 to 50 mg tablets |
Yes |
| Clonidine Hydrochloride |
0.01 mg / mL |
1 mg |
0.1 to 0.3 mg tablets |
Yes |
| 100 to 500 mcg/mL injection |
| Clopidogrel (75 mL) |
5 mg / mL |
375 mg |
75 to 300 mg tablets |
Yes |
| Cyclophosphamide |
10 mg / mL |
1000 mg |
500 mg |
Yes/(stability study only performed using injectable product) |
| 1 and 2 g injectable |
| Etoposide |
10 mg / mL |
1000 mg |
50-mg capsules |
No/Excessive powder with capsules. |
| 20 mg / mL injection |
No/Excess liquid when using injection. |
| Methimazole |
10 mg / mL |
1000 mg |
5 and 10 mg tablets |
No/Excessive powder. |
| Tacrolimus |
0.5 mg / mL |
50 mg |
0.5 to 5 mg capsules |
Yes |
| Topiramate |
5 mg / mL |
500 mg |
25, 200 mg tablets |
Yes |
| Zonisamide |
10 mg / mL |
1000 mg |
25, 100 mg capsule |
Yes |
The bottom line is the following. Contrary to the lies PBMs have announced to the press:
- Medications needed by many patients ARE NOT available using manufactured drugs in the appropriate dosage form or strength.
- Most compounded oral preparations are made using FDA-approved dosage forms or powder and liquid medicines in their bulk chemical form that are in FDA-approved dosage forms.
- Due to the number of tablets or capsules or the volume of injections required, it is NOT always possible to use commercial dosage forms of many drugs to compound many prescriptions ordered by physicians.
- Without individualized medications, patients may not recover and lead useful lives but may continue with their disease/disorder that will lead to long-term costs to the PBMs that they will pass on to employers and patients who are the ultimate payors.
- A patient having undergone a stem cell transplant costing hundreds of thousands of dollars may not be able to receive the compounded oral preparations necessary to sustain this costly procedure after discharge because the medications are "compounded preparations"�the additional cost of the patient not doing well due to a lack of medication on which they were stabilized when in the hospital, may lead to additional costs passed from the PBM to employers and their employees (the patient or patient's family).
- Without individualized medications, patients may die as a result of the PBM decisions!
- PBMs are entrusted with the "investment of money" from patients to ensure their medication needs are met when needed. Now, however, it seems the PBMs are "stealing" even more of the money because they are making it so that patients cannot receive the benefits of their "insurance investment" when they need it!
- PBMs perform in this manner by stating they are managing patients' healthcare and saving money, yet they are compensating their CEOs millions of dollars each year.
In summary, it seems the PBMs are engaging in activities as serious as NECC; making poor decisions to make a buck! It seems the PBMs consider their million-dollar incomes, million-dollar homes, and skyboxes at professional sports stadiums to be more important than patients! This is what the owners of NECC thought also!!!! Employers and patients need to demand that this stop!
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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