These are the Frequently Asked Questions (FAQs) about Pharmaceutical Compounding
What is Pharmaceutical Compounding?
Pharmaceutical compounding is the process of making personalized medications for a particular patient that are not commercially available. This is done by using raw ingredients and therefore has endless potential for different combinations. Compounding is a creative endeavour, it is as much an art as it is a science. Pharmacists and pharmacy technicians involved in compounding are required to undergo special training for each kind of compounding they perform.
What is a Compounding Pharmacy?
Compounding pharmacies specialize in pharmaceutical compounding, meaning that they have all of the training for their staff, all of the facilities to be able to perform the compounding, and adhere to all of the regulations to ensure the quality of their product and the safety of their patients. Most pharmacies have historically been able to offer some simple compounds, but increasing safety regulations have made it much harder for non-compounding pharmacies to keep producing these compounds. The safest and most effective compounds will be made at a compounding pharmacy, as their staff will have all the specialized training and facilities in order to make the compound.
What are the Benefits of Pharmaceutical Compounding?
The primary reason to compound a medication is when that specific medication is not available on the market, or the one that is available on the market does not work for that particular patient. The goal of compounding is to improve adherence to the medication while at the same time decreasing the chances of side effects occurring.
A medication could leave the market quite suddenly if there is a shortage or a recall from the manufacturer, or if it becomes discontinued and is no longer being commercially produced. In that event, patients that may have been on the medication for years are suddenly left without options, which is where a compounding pharmacy can come in and create a similar medication from raw ingredients and ensure that patients are able to continue their therapy.
Similarly, a medication could be available on the market in a particular dose, but that dose might require a patient to take one eighth of a tablet or eight tablets altogether. A compounded medication can tailor the dose to specifically fit the patient’s needs and make the process of taking the medication as easy as possible for them. If a medication has a particularly bad flavour, a compounding pharmacy can flavour it differently to make it more palatable to the patient.
Sometimes, commercial medications contain fillers or dyes that some patients can have an allergic reaction to, making them virtually unusable for those patients. A compounding pharmacy has complete control over what ingredients go into a formulation, and thus can choose safe alternatives for each patient. Some ingredients may also be harmful to particular groups of patients, such as sugars to diabetics, and sugar-free versions of medications can help treat those patients without risking their other condition getting worse as a result.
Finally, even though some medications may be available on the market, there might be certain groups of patients that are physically unable to take them. Large tablets and capsules could be difficult to swallow for children or the elderly, who might prefer taking the medication as a liquid or chewable tablet. Certain medications take a long time to work once taken, and compounding them into rapid-dissolve tablets could significantly increase the speed at which they can act within the body.
What are the Risks of Pharmaceutical Compounding?
While compounding conveys a lot of benefits for patients, these do come coupled with some additional risks when performed by personnel that is not properly trained in compounding, or when compounds are made in facilities not specialized for compounding.
When receiving a medication that is commercially available, this medication usually come in a sealed bottle from the manufacturer, where it has undergone significant testing to ensure that the right amount of medication is present and that it has not been contaminated by other ingredients, some of which may be harmful to the patient. Pharmaceutical companies make large amounts of these medications so they are able to test all batches made. Compounds are typically made on an individual basis for each patient, and therefore cannot be quality-control tested the same way. Compounding pharmacies have special training programs in place for their personnel and get their personnel and facilities checked by independent bodies to ensure that all training and maintenance is kept up to date.
Since compounding pharmacies make individual compounds or very small batches of medication, they are not regulated nationally by Health Canada, unlike large drug manufacturers. The standards in large drug manufacturers are much stricter since a single lot of medication they make could affect thousands of patients. Recent changes in the regulation of compounding pharmacies has tightened the rules and regulations to minimize the chances of errors occurring during the pharmaceutical compounding process.
Will my Compounds be Covered by Insurance?
In general, most compounds are covered by most private insurance companies. Part of the training of specialty compounding pharmacies is centred around how to communicate with insurance plans to ensure coverage for compounds so that patients do not have to pay out of pocket.
Unfortunately, government plans such as the Ontario Drug Benefit, ODSP, and Trillium have very limited coverage of compounds due to compounds being quite pricey. A lot of manual labour goes into creating each compound as they have to be individually made, which increases their cost substantially compared to commercial medication made by large drug manufacturers.
Paying for compounds can be costly, but there is a lot of room for negotiation with most compounding pharmacies. Since compounding uses raw ingredients, there is often room to substitute something of slightly lower quality in terms of non-active ingredients that could make the compound cheaper. For example, a cream used to treat pain could use a cheaper base that might not feel as smooth on the skin, but would get the job done just as well.
If you have any further questions about compounding, speak to a compounding specialist at your local compounding pharmacy. If your own pharmacy does not offer compounding, they can often direct you to a nearby pharmacy that does.
Pharmaceutical Compounding Centres of America. (2020). What is Compounding?
Retrieved from: https://www.pccarx.ca/AboutUs/WhatisCompounding
If you have any questions or client issues regarding this article or its contents, feel free to reach out directly to Rx Infinity or contact us here at ASSOCIUM and we will facilitate the connection or you. If your issue or question is specific to your personal and prescribed medication, please contact your physician or your providing pharmacy.
This information is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health provider with any questions about your medical condition. Do not disregard professional medical advice or delay seeking advice or treatment because of something you have read here.