Compounding in the 1800s

In the late 1800s, the main role of pharmacists was compounding, which is collecting active and inactive ingredients and putting them together in unique combinations. They were often referred to as the Apothecary or Chemist in many countries because of their knowledge of medicine and chemistry. Historically, pharmacists had tremendous knowledge about drugs, their chemical properties, and their effects on patients. They were the professionals who possessed the skills and authority to combine chemicals and medicines, and to prepare and package treatments to meet the specifications and directions prescribed by the physician. This meant that every transaction was a customized creation, made to order each time a patient presented a prescription at the pharmacy. Besides working with and preparing these curative or therapeutic treatments, the pharmacists also provided important information on the benefits, risks, proper administration, and use of medicines.


Novel Therapies in the 1900s

In the early 1900s, there was an explosion of new drug treatments and mass manufacturing, and the pharmaceutical industry grew at a rapid pace. Increasing research and development led to novel therapies, both in the form of new medicines and increasing manufacturing efficiencies. Manufacturing standards and consistency of ingredients and products were moved to an even higher level. Automation, machinery, equipment, and large-scale production brought down the costs of manufacturing and acquiring medicines for treating ailments, so the need for pharmacists to compound widely-used medications decreased.


Pharmacists Roles Today

Today, pharmacists are mainly recognized for their expertise in acquiring and distributing the medicines from manufacturers, dealing with drug shortages when manufacturing does not meet demand, prescription drug labelling, record keeping, patient education on drug therapies, and identifying and resolving drug-related issues encountered by patients. Commonly, you will see pharmacists staring intently at a computer screen and documenting information, assessing for drug interactions and drug concerns, or speaking with patients about the use, risks, and benefits of their medicines.

However, you will also notice a growing number of pharmacists reigniting their passion to actively compound medications, making a dosage form that is customized and created for a single patient. With mass production, manufacturers tend to eliminate from the production line medicines or dosage forms that are not in high demand. As a result, that medicine, or the particular form of it, may no longer be commercially available. In these cases, compounding is an irreplaceable part of the solution for patients.

For example, some medicines are not manufactured as liquids due to low usage, and for someone who requires that medicine and has trouble swallowing a pill, the lack of a liquid form might mean using another drug which may be less effective, but is available in liquid form. While it is possible to mix crushed tablets or powder from a capsule into food or slurry it into your favourite drink, the taste and texture can be downright awful. This is likely going to make your favourite drink become your least-liked drink very quickly. Pharmacy compounding can be the solution.

Pharmacists with specialized compounding training and knowledge can make the active drug ingredient into a desired liquid consistency and flavoured to your liking. Ensuring the drug and the other non-active components of the preparation (excipients) are brought together in a manner that preserves the efficacy and stability of the drug in the liquid, while ensuring its palatability to the patient, is a balance involving both science and artistic creativity.


Applications of Pharmacy Compounding

There are many applications for pharmacy compounding, which may include customizing the strength of a treatment, such as in the case of tears in the lining or the skin around the anus (anal fissures). The symptoms of anal fissures can include pain, itching, and irritation around the anus. Rather than orally taking a medication in pill form to treat pain and exposing your entire body to a higher than necessary level of the drug, a topical cream or gel can be applied to the affected area, limiting side effects, if there are any, to the local area and minimizing exposure to the rest of the body. Customizing the strength of medication in the topical cream can allow adjustment to just the right strength to treat the condition, as in the example of using nifedipine 0.2% to 0.5% for treating anal fissures.

It is often difficult to find a manufactured preparation at just the right drug strength and right level of skin penetration off the shelf. With compounding, all of this is customizable by choosing not only the drug concentration, but also the cream base, which has differing skin penetration properties.

In some cases, a topical treatment is not available commercially, such as topical diltiazem, which can help reduce rectal bleeding, promote healing of anal fissures, and decrease the internal anal sphincter pressure. With a pharmacist compounding such a preparation, the benefits are not limited to compounding a cream with diltiazem, but also adding lidocaine to the preparation to treat the severe acute pain from a new tear with the anal fissure. This approach is more convenient and can also result in lower costs compared to using multiple topical preparations, each containing one ingredient.


Benefits to Children

One of the more obvious situations resolved by pharmacy compounding is treating illnesses in children, since they are often particular about taste and what they will take orally when it comes to medications. There are relatively few liquid medications manufactured and many of them would be described as bitter tasting or medicinal at best. A pharmacist can derive a recipe for medicinal lollipops containing the necessary drug, which a child might be more likely to consume. This may open up another issue to contend with, such as keeping such medicines away from children so they do not overdose, but if getting the medication into the child and ensuring adherence to the treatment to cure an infection or treat an illness is the goal, then such options are likely to outweigh the risks. Precautions with children need to be taken when using such compounded treatments.


Individualized Treatment

With the many specific and efficacious agents available, customized and individualized treatments are becoming more common and will help to maximize the beneficial effects while reducing unwanted side effects. After all, one size does not fit all. More pharmacies are now offering specialized compounding and the National Association of Pharmacy Regulatory Authorities (NAPRA), Canada’s national pharmacy regulation group, has recognized the need to refine standards to safeguard the public and ensure safe and effective practices.

Recently, NAPRA approved and released Model Standards of Practice for Canadian Pharmacists for the preparation and compounding of sterile products, e.g., drugs for injection and administration into the body or eye, which include additional requirements that may not be in place in all compounding pharmacies dealing with sterile preparation. Standards with respect to non-sterile pharmacy compounding (e.g., most topical and orally administered drug preparations) are expected to be updated soon by NAPRA.

Equipment, study data, and techniques in pharmacy compounding have been improving over time and access to compounding pharmacies has become more prevalent. If a suitably manufactured product is not available for your individualized needs, then a compounded product may be worth considering. Speak with your physician and pharmacist to determine if a compounded product might be a more effective and suitable treatment for you.

First published in the Inside Tract® newsletter issue 202 – 2017
Alan Low, BSc.(Pharm.), Pharm. D., RPh, ACPR, FCSHP, CCD
Clinical Associate Professor, Faculty of Pharmaceutical Sciences, UBC
Board Advisor, GI Society and CSIR
Primary Care Pharmacist, BioPro Biologics Pharmacy