FEBRUARY 1999 MEETING

TOPIC: "COMPOUNDING MEDICATIONS"

The East Bay Headache Support Group met on February 9, 1999 to hear Jim Linman, Pharm.D., speak on compounding medications. The meeting was held in the Ball Auditorium at John Muir Medical Center with 20 people in attendance.

Dr. Linman is a compounding pharmacist at Newell Pharmacy in Walnut Creek, and an early member of the Professional Compounding Centers of America (PCCA). PCCA

was founded in 1981 when a patient required a discontinued medication and needed the professional skills of a compounding pharmacist. The patient’s physician challenged a Houston-area pharmacist to compound the anti-nausea medication. The pharmacist consulted with other pharmacists and finally contacted University of Houston Pharmacy Professor Dr. George Webber. With Dr. Webber’s help they procured the chemicals necessary to compound the medication.

After dispensing the medication to the patient, the pharmacist realized other pharmacists had similar demands to meet the needs of patients who required compounded medications. This network of pharmacists, committed to meeting patient needs, was the foundation of the Professional Compounding Centers of America. Today, PCCA has flourished into an incorporated repackager of unformulated chemicals used by pharmacists to fill prescriptions for compounded medications, and has more than 2,200 retail pharmacists/

customers worldwide. Its extensive support system allows pharmacists to solve patients’ problems, and to meet its goal of achieving a positive therapeutic outcome for patients.

Dr. Linman told us Dr. Seymour Diamond, founder of a famous headache clinic in Chicago, said in 1993 that Imitrex was the greatest discovery in forty years for migraine sufferers. Imitrex has been on the market for six years now, and three other triptans have recently been introduced. Dr. Linman said we haven’t quite gotten there yet (finding a cure for headaches), but there is hope.

The compounding pharmacist works in concert with the prescribing physician. There are 12,000 to 15,000 different ready-made medications, so why is compounding needed?

Dr. Linman gave us some examples, such as: if a medication is only available in tablet form, but the patient is nauseous, then the compounding pharmacist can put the medication in the form of a suppository or troche (pronounced tró kee).

Allergies are another reason to compound medications. Progesterone, given as part of hormone replacement therapy for menopausal women, is prescribed in a capsule with a peanut oil base, or a projesterone injection with a sesame oil base—and many people are allergic to peanuts and sesame. Also, most tablets made by the pharmaceutical companies have lactose in them, but large numbers of people are lactose-intolerant. Dr. Linman said that calcium carbonate can replace lactose as the filler in Inderal capsules. And, many people need to use preservative-free eyedrops. He said that most eyedrops have mercury as one of the ingredients, and many are allergic to it. Another common allergy people have is to the red or yellow dye used in many medications, ostensibly to make them more appetizing-looking.

DHE nasal spray and Lidocaine nasal spray are now available commercially from pharmaceutical companies, but compounding pharmacists have been able to provide them in this form for some years. Lidocaine was mentioned by Dr. Dean Edell recently on TV so there is a lot of interest in it right now.

A compounding pharmacist can also help when a particular drug is no longer manufactured by a pharmaceutical company, such as Cafergot-PB suppositories. The Cafergot-PB formula is still very popular—Dr. Linman can make up a half-strength suppository, or full strength with only half-strength caffeine, or use a different amount of phenobarbitol, or add an anti-emetic (anti-nausea agent).

Dr. Linman talked about transdermal gels and a nitroglycerin patch. He said some drugs work well when they are transported through the skin rather than through the digestive tract. For example, ketoprofen (a nonsteroidal anti-inflammatory) can be prescribed in a transdermal gel. He said it might work to relieve a headache when applied to the skin on your head or neck, but this has not been fully tested.

Vicodin can also be made up using very little acetominophen in it, if requested by the patient’s physician. Ten to fifteen grams of acetominophen can be toxic to the liver, and twenty grams have been known to be fatal. Some people take up to forty tablets a day, so Dr. Linman can make up a Vicodin formula with the acetominophen reduced.

The state of California is about to do away with its current method of keeping track of dangerous prescriptions (the prescription is written up in triplicate and a copy is given to the state). Under the new policy, the pharmacist reports usage of Class II electronically to the center in Atlanta, who then sends this information back to the state.

Headaches triggered by hormones are a concern for many women. A compounding pharmacist can purchase each hormone in its purest state and work with the physician and patient to develop the best method of delivering the hormone in the amount that meets the body’s need yet reduces the potential for headaches.

Dr. Linman told us that there is now a new birth control pill with only two days that are hormone-free, instead of the standard pill in which no hormones are given for seven days each month. Since scientists believe that hormonally-related headaches are triggered by the fluctuation of the hormones rather than the hormones themselves, this two-day pill should be especially useful for women who suffer from menstrual migraine.

As a result of networking through the Professional Compounding Centers of America, Dr. Linman said that compounding pharmacists learn cutting edge technology in their field.

Dr. Linman then discussed Imitrex. He said he feels sorry for a patient who is prescribed Imitrex, but doesn’t have insurance to pay for it, as the patient must pay a minimum of $10 per tablet, or $40 per injection. Imitrex can, however, be put into a sublingual troche (a lozenge you melt under your tongue), which contains only 5 to 6 milligrams of sumatriptan, and would cost much less than a tablet containing 25 to 50 mgs. The smaller dosage is also better tolerated by patients (causing fewer side effects).

One problem that compounding pharmacists see a lot is that it’s always a battle to get the insurance companies to pay. The pharmacist needs an NDC number to bill the insurance company for the medication, but when the compounding pharmacist uses a pure drug (which he can get from the Professional Compounding Centers of America), there is no NDC number. This can cause a problem if the compounding pharmacist is audited.

Most of the time, Dr. Linman says his customers pay for their prescriptions, and they’re given paperwork to submit to their insurance company for reimbursement. The insurance company may or may not honor the request. If you are a member of the Kaiser HMO, and if your doctor prescribes a medication that Kaiser’s pharmacy cannot provide, you will be given a blue card—which means Kaiser will give you a cash refund for prescriptions you have to have a compounding pharmacist fill. Also, note Kaiser has a compounding pharmacy in Livermore now.

The HMO’s are putting limits on how much they’ll pay for prescriptions because of the high price of new drugs. The development of a new drug takes many years of testing and getting FDA approval, and to recoup their expense in getting it to market, the pharma-

ceutical company must price its product much higher than what it takes to manufacture it.

In closing, Dr. Linman gave us a list of dosage forms available from a compounding pharmacist, which includes, capsules, creams, lotions, dental products, topical gels, suppositories, and tablet titrates.

Questions and Answers

Q. How do you get the right amount into a capsule?

A. Dr. Linman said he has a machine that measures out the proper amount of ingredients into 100 capsules at a time.

Q. Who are the compounding pharmacists in the Contra Costa/Alameda County area?

A. Newell Pharmacy, Newell Avenue, Walnut Creek (Jim Linman)

Doc’s Pharmacy, La Casa Via, Walnut Creek (across from John Muir Medical Center)

(Bob Horwitz)

Medicine Shoppe, Monument Boulevard, Concord

Q. What is the lead time required to fill a compounded medication?

A. Dr. Linman said he requires at least a day’s notice to fill a prescription, unless it’s an emergency. Remember, if you want or need an uncommon dosage form (like a troche), your physician must prescribe it that way.

Q. Does a compounded prescription cost more, or less than a brand name drug?

A. Dr. Linman said that most everything a compounding pharmacist can do can be done for less than a brand name drug.

Q. Is there a difference between brand name and generic drugs?

A. He answered that generally a generic drug will be equivalent to the brand name drug, but the brand name drug is more expensive. Yes, a patient should feel comfortable in taking a generic drug. Dr. Linman explained that when a pharmaceutical company develops a new medication they have 18 years of patent rights to that formula. After that, other companies are free to sell the drug. When a patent on a drug expires, then only one company is allowed to manufacture it for several months, and then the field is wide open for any manufacturer to produce and sell it.

Q. Dr. Linman was asked about Botox injections for migraines.

A. He answered that he has heard of it, and he will call back with an answer.

Q. One member of the audience asked for information about hydrocodone, the active ingredient in Vicodin.

A. Vicodin is the most common pain reliever. It is a Class III drug so pharmacists don’t have to write up paperwork in triplicate when they fill a prescription for it. Codeine is also a Class III drug, and demerol and morphine are examples of Class II drugs.

Q. Does Imitrex have a barbiturate in it? Is it a painkiller?

A. Dr. Linman answered that Imitrex is not a painkiller. It does not contain a barbiturate.

Q. Is Imitrex the most effective medication for migraine?

A. Dr. Linman answered that Imitrex itself is probably not the most effective, but that the class of drugs it’s in, the triptans, is probably the best for relieving migraines. That class currently includes Imitrex, Amerge, Zomig, and Maxalt; and more are expected to be on the market soon.

Q. How much does an Imitrex troche cost?

A. An Imitrex troche would cost about 50 to 60 percent of the cost of an Imitrex tablet. He added that Valley Pain Center has a troche that works in about five minutes.

Q. Is it important to know if your headaches are migraines, or if they are tension or another type of headache?

A. Dr. Linman answered that your headaches must be diagnosed as migraines by a physician before you can get a prescription for one of the triptans, like Imitrex. This drug is not for headaches other than migraines.

Q. Do you compound decongestants with sudaphedrin?

A. A compounding pharmacist can compound antihistamines without certain ingredients. A discussion followed about drug abusers who can take sudaphedrin and transform it into speed. (The class of drug that includes sudaphedrin shrinks the nasal passages.)

The intention of the East Bay Headache Support Group is to provide information and resources. It does not provide medical advice, which should be obtained directly from a physician.