Hormonal Update Volume 1 Number 10
The Compounding Pharmacy
Filling a prescription for hormone replacement therapy (HRT) generally involves a visit to your local drugstore or supermarket. The pharmacist fills the prescription from a supply of pre-made pills then you are on your way. But did you know that this is not the only way to have a prescription filled? Having your prescription prepared for you by a compounding pharmacy is another. A compounded prescription is made by hand, on an individual basis, and the dosage is individualized to meet your specific needs. Compounding pharmacies specialize in formulating and preparing prescriptions that are designed especially for you.
Historically, all pharmacists compounded prescriptions to order. This practice allowed pharmacists to prepare and adjust prescription formulations so patients received maximum benefit with the least risk of side effects. In the late 1960s, however, the pharmaceutical industry began to change. The convenience of uniform doses and standard delivery systems became very popular, as they were considered time savers for both pharmacists and doctors. It was during that time that prescriptions began to be filled from pre-made, standard dose pills. As this change took place, compounding pharmacies became less popular. During the last decade, the upsurge of interest in natural hormones has brought with it a renewed interest in compounding pharmacies. In fact, in order to have a hormone prescription that consists of natural, bio-identical hormones that is customized especially for you, it must be prepared by a compounding
pharmacy.
While there are now about three thousand community-based retail compounding pharmacies across the country, it is important to know that a great deal of diversity exists among them - in the ingredients they use, and in the way they formulate and prepare prescriptions. Some compounding pharmacies specialize in women’s health and hormone replacement and some do not. In this Hormonal Update we are going to explain some important aspects of the compounding pharmacy.
The Doctor, Pharmacist, Patient Relationship
The success of a woman’s hormone replacement therapy depends almost exclusively on how well it works for her. If a woman is not getting the results she desires she may abandon her therapy completely. In fact, statistics show that, after one year, two out of three women who begin HRT give it up. This is unfortunate because a slight adjustment in the dosage or a change in delivery system may be all that is necessary to experience success with a prescription. When a woman first begins hormone replacement therapy, it can take a little trial and error to get it just right. After all, every woman is a unique individual.
Among the many advantages of working with a compounding pharmacy, the relationship that develops between the pharmacist, the doctor and the patient is one of the most important. The compounding pharmacist understands all the nuances of hormone absorption and can be very helpful in determining not only the right delivery system for your prescription, but also the right dosage.
Establishing an initial dosage is best done with a baseline saliva hormone level test. Your hormone level, combined with a list of symptoms, helps both your doctor and the pharmacist determine the correct dosage. Once you begin hormone replacement, monitoring your hormone level and assessing your symptoms are effective methods of determining whether or not a prescription is appropriate for you. Communicating with the pharmacist about how you are feeling on your prescription will give a good indication of how well it is working for you.
Once the pharmacist understands what you are experiencing and whether or not your symptoms are being relieved, he or she may help your doctor adjust the prescription if necessary. Because each person’s response to HRT is highly variable, even if your symptoms have been relieved, it is still best to monitor your hormone levels. This safeguard testing ensures that your prescription is tailored to meet your specific needs. This method of prescribing HRT works for everyone — the doctor and the pharmacist are successful and the patient feels good. Individualized hormone replacement therapy is an integrative, and very personal approach to your healthcare, with a very high success rate.
Special Delivery
As we discussed in Hormonal Update #4 a hormone prescription can produce many different effects in the body, depending on the delivery system used. The way you take a hormone determines how quickly your body absorbs it; how much of it actually enters your system and is available for use; and, to a great extent, how you feel. Understanding how the different delivery systems work can help you determine what choice is best for
you.
The goal of hormone replacement therapy is to mimic the body’s production of hormones, delivering replacement hormones into the system steadily in small amounts. Hormones that are taken orally in capsule or tablet form go through the digestive system before they are available for your body’s use. While capsules and tablets are very convenient, during this process as much as 80 to 90% of the hormone can be removed from circulation by what is known as first pass elimination by your liver. This removal leaves only about 10% of your original prescription dosage accessible, which means oral doses generally need to be very
high.
Creams
Hormone creams are transdermal preparations that deliver hormones into the bloodstream through the skin. Very popular because they are easy to use, many are available over-the-counter. However, creams, which are fat-soluble, have some disadvantages. Creams can be absorbed directly into the bloodstream, but they are also absorbed into the adipose or fatty layer of tissue in the skin. When this happens you can experience reabsorption and the release of hormone into the bloodstream can be very erratic, which will cause your hormone level to be erratic as well. Inconsistent hormone levels make it harder to predict how the patient is reacting to a particular dosage.
Gels
Hormone gels are also classified as transdermals. There are several gel formulations available. In general, gels are absorbed into the dermal layer of the skin and from there released into the bloodstream. Most compounding pharmacies use a PLO gel, which contains lecithin. The gel is absorbed into the tissue surrounding the area of application and then into the bloodstream. This movement happens quickly and causes a sudden elevation and subsequent decline in the hormone level. PLO gels do a good job of getting the hormone into the blood but, because of the spike followed by the sharp drop in the hormone level, they have to be applied more than once a day.
Water based gels are seldom used due to hormone insolubility in that type of gel. Alcohol based gels on the other hand can deliver sufficient hormone through the skin, but tend to cause drying at the application site. Some alcohols used in this type of gel are not recommended for long term use.
Percutaneous gels similar to those available in Europe offer the best mimicking of the physiologic release of hormones into the system. This continuous release should be the goal of all HRT. While no delivery system will do exactly what your body does, one preparation comes very close. A percutaneous gel developed by College Pharmacy called PerQgel™ stands out in accomplishing this goal. This gel uses the natural reservoir of the dermal layer of the skin to deliver an even flow of hormones into the body. It provides a steady release of hormone into the system over twenty-four hours. PerQgel applied to the skin only once a day will provide hormone levels closest to the natural levels in a woman’s body. Studies show that hormone levels remain constant throughout the
day.
Individualized HRT
The scientific literature clearly demonstrates that for most women the health benefits of HRT greatly outweigh the risks. Statistics indicate that HRT substantially decreases a woman’s risk for heart disease, osteoporosis, colon cancer and Alzheimer’s disease with the average hormone replacement therapy user living 3 years longer than the non-user. For a woman to have the optimal HRT experience, her prescription should be individualized. The wide variability among women’s hormone levels and response to therapy can be addressed when HRT preparations are personally formulated by a compounding pharmacy. In addition, when a prescription is compounded especially for you, more than one hormone can be combined in a single gel or cream preparation. Estradiol, progesterone and testosterone, for example, can be combined in a once-a-day percutaneous gel that will give you complete hormone protection. The more effective your hormone prescription is, and the easier it is to use, the more likely you are to continue using it.