A situation that places patients in a bad position has been developing for quite awhile. In many hospitals and clinics throughout the US, professionals administer patient medications to treat cancer, pain, etc. In many cases, more than one drug must be administered or the drugs are not commercially available. Consequently, the services of a compounding pharmacist are required to prepare the medication and provide it to the hospital or clinic for administration. Now, let's look at some of the problems/scenarios faced by the compounding pharmacist.

1. If the pharmacist compounds this as "office stock," but the physician bills the insurance company and receives payment and then reimburses the pharmacist, in the mind of the US Food and Drug Administration and many state boards of pharmacy this practice is considered "manufacturing."
2. If the pharmacist bills the patient, many patients cannot pay and Medicare Part D may not pay for it.
3. If the pharmacist bills the insurance company, the insurance company may not pay for it since it is a compounded medication and the patient is an outpatient.
4. If the compounded medication is a scheduled drug, how is the paperwork to be handled in the event of "office use only?" Proper records must be kept by all parties.

Other problems occur but let's just consider these for now.

Scenario 1 is by far the simplest way to handle this, however, the pharmacist is then put in a position outside the physician-pharmacist-patient triad relationship, and the relationship becomes similar to that of a manufacturer, i.e., providing medications to the professional for administration. However, is that all bad? Obviously not, as it is a very workable situation but it does not fit into our current "system" and some things would have to be changed.

Scenario 2 raises many, many questions. The reimbursement levels are so low for commercial drugs that one shudders to think what it would be for compounded prescriptions. So, this is not a reasonable approach in the near future.

Scenario 3 is a real thorn in the flesh. Insurance companies don't pay for compounded medications! Right? Absolutely wrong! Insurance companies discriminate against their own patients and pharmacists as they do reimburse "some" compounded prescriptions but not others. Think about it—insurance companies don't think twice about reimbursement for hospital compounded intravenous admixtures, pediatric medications, cancer chemotherapeutic cocktails, etc., but they will not reimburse for "compounded prescriptions" from community pharmacies; those medications that help keep the costs of healthcare down and keep patients out of hospitals! Also, in some hospitals, these compounded medications are prepared "outside" the hospital through a contractual arrangement. In the US we have made a lot of progress in eliminating discrimination�however, this is discrimination that is costly to patients and to pharmacists and needs to be addressed!

Scenario 4 impacts all the other listed scenarios in some way or another.

Let's look back at Scenario 1. Is it so much different from the hospital scenario? From the professional standpoint, the patient, physician, and pharmacists are all working together for the benefit of the patient. The geography may be different. But wait, how about all these outpatient surgery and day-surgery clinics? The hospital is reaching out into the ambulatory market. The ambulatory market now consists of many clinics, similar to the hospital clinics. Where is the line drawn? How can one say it is okay for hospitals and hospital clinics to be reimbursed for compounded prescriptions but not for community clinics and community pharmacies to be reimbursed? Also, why not look at nuclear pharmacy compounding? Those compounded medications are reimbursed by insurance, but many, if not most, are compounded off-site and sent to the hospital for administration by professionals. This is "office use" compounding and is reimbursed.

In summary, we have the mechanisms in place if we can work out the regulations at the state and federal level to accommodate the changes in pharmacy compounding for the individual needs of the patient. It is going to take considerable effort to go against the insurance companies to fight the discriminatory reimbursement policies they currently have in place. We must not forget that the patient suffers from many of these regulations, laws, and standards that were developed to protect them.

Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

Want to know the adverse effects of green tea and the cardiovascular benefits of chocolate? Look no further than CompoundingToday.com's literature database. A database of citations and abstracts of articles related to compounding topics. This week over a dozen abstracts on green tea and chocolate were added along with 71 discussing the treatment of chronic nonmalignant pain, principally neuropathic pain, with an emphasis on adjuvant medications and combination therapy.

Here is a sample of the articles added:

• Altier N, Dion D, Boulanger A et al. Management of chronic neuropathic pain with methadone: A review of 13 cases. Clin J Pain 2005; 21(4): 364-369.
• Backonja MM, Serra J. Pharmacologic management part 2: Lesser-studied neuropathic pain diseases. Pain Med 2004; 5(Suppl 1): S48-S59.
• Gilron I, Max MB. Combination pharmacotherapy for neuropathic pain: Current evidence and future directions. Expert Rev Neurother 2005; 5(6): 823-830.
• Lynch ME, Clark AJ, Sawynok J et al. Topical amitriptyline and ketamine in neuropathic pain syndromes: An open-label study. J Pain 2005; 6(10): 644-649.
• Offenbaecher M, Ackenheil M. Current trends in neuropathic pain treatments with special reference to fibromyalgia. CNS Spectr 2005; 10(4): 285-297.

Product Contains Dangerous Levels of Endotoxin

See www.fda.gov/bbs/topics/news/2006/NEW01315.html for full details.

Use of the drug isotretinoin (Accutane) has been linked to many dangerous and even life-threatening adverse effects. Here are just a few of the treatment-related health hazards listed on the product package:

• Birth defects
• Psychiatric disorders, including depression and suicidal tendencies
• Central nervous system ailments
• Liver disease
• Inflammatory bowel disease, including ulcerative colitis, Crohn's disease, and rectal bleeding
• Hearing and vision problems
• Bone and muscle (musculoskeletal) damage
• Pancreatic damage

Even though Accutane is dangerous and may cause death in treated patients, it remains available on the US market. All the doctor, patient, and pharmacist must do to obtain that drug is to jump through a few MedGuide hoops.

Accutane prescriptions must be written on a valid prescription paper (prescriptions submitted by telephone, fax, or computer are not valid) that has been flagged by a yellow sticker featuring a registration number. A patient education booklet must be dispensed each time the prescription is refilled. An Accutane prescription cannot be written for more than a 1-month supply of the drug, and all Accutane prescriptions must be filled within 7 days after the date listed on the prescription.

Women patients are required to provide evidence of a current negative-result pregnancy test before they can receive Accutane. The doctor, patient, and pharmacist must all be registered with the MedGuide program; Uncle Sam knows who is taking this drug!

Making Accutane more difficult to obtain probably won't reduce the incidence of its dangerous adverse effects, but there will be a better record of its use, and patients who suffer the consequences of treatment will have no recourse for damages against anyone involved in the sale of that drug.

Joint Commission of Pharmacy Practitioners Recounts Initial Experiences with Medicare Part D and the Impending Cash Flow Challenges

Member organizations of the Joint Commission of Pharmacy Practitioners held their regularly scheduled quarterly meeting on Tuesday, January 31, 2006, in Alexandria, Virginia. Executive officers and presiding officers of several pharmacist-practitioner organizations recounted their initial experiences with implementation of Medicare Part D—the prescription drug benefit that began on January 1, 2006 for many senior Americans. It was noted that first and foremost during this stressful implementation process was the overall pharmacist concern that ambulatory and institutionalized patients potentially eligible for the benefit actually received life-sustaining medications. It was reported that in many instances pharmacists gave patients medications at no charge because it was not possible to verify patient inclusion in plans, and because patients were given cards or letters with identification numbers that were not acknowledged by claims processors.

As of the Commission meeting date (January 31, 2006), many if not most pharmacists who have dispensed medicines to plan-enrolled beneficiaries have not been compensated for their professional services. Of even greater concern, these pharmacists have not been reimbursed for the costly medicines that were ordered from pharmaceutical product wholesalers and dispensed to their patients. Therefore, cash flow is a serious impending problem for many pharmacists who must either find ways to finance the implementation of this federally-sponsored program or close their pharmacies. Individuals present at the Joint Commission meeting were told that solutions to cash flow problems created by Medicare Part D must be identified immediately in order to forestall pharmacy closings.

Pharmacists expressed special concern for patients who live in rural areas where the number of pharmacies is limited (sometimes one per community), and patients who reside in economically stressed urban areas where consumers and fragile patients typically have few pharmacy choices. Pharmacists who serve patients in nursing homes and related facilities expressed similar grave concerns with cash flow related to Medicare Part D implementation.

Member organizations of the Commission resolved to investigate potential solutions to prevent the closing of pharmacies in order that Americans of all ages can continue to benefit from the unique health services that only can be offered in face-to-face encounters with pharmacists.

The Commission then considered how pharmacists in a variety of patient care settings can systematically provide medication therapy management (MTM) services to patients via programs sponsored by a variety of groups or organizations. An invited speaker described how Community MTM is building a web-based platform for pharmacist service programs. Kurt Proctor, Chief Operating Officer, noted that the platform provides a neutral industry solution and, therefore, will be widely available and adaptable to a variety of potential MTM programs.

A second invited speaker described the SureScripts program, an innovative joint venture that involves one participant—the National Association of Chain Drug Stores. The purpose of SureScripts is to connect physicians and pharmacists so that prescriptions and, eventually, other patient-specific data and information, might be transmitted electronically in a secure manner. Kevin Hutchison, President and Chief Executive Officer, indicated that SureScripts is a membership organization resembling a not-for-profit organization. He noted that the SureScripts "process" is now active in 47 states and suggested that many physicians now envision electronic patient records and electronic prescribing as a future certainty for their practices.

Containers breaking in the freezer?
We all know that when an aqueous liquid freezes, it expands. When a container is set in the freezer vertically, as the liquid freezes and expands in all directions, it puts pressure on the walls of the container (beaker, syringes, etc.) and it may break. However, if you place the containers in the freezer at an angle, about 30� to 45�, then as the liquid freezes and expands, it "slides" up the sides of the container into the headspace and does not place pressure on the walls�so the container should not break.