Introduction
The role of compounding pharmacies within the city of Edmonton and, more broadly, throughout Canada, has become increasingly important due to advancements in the healthcare system. Compounded medications have been a critical part of inpatients’ care for centuries, but the notion of compounded medications is worrying at times. While compounding medicines have the benefit of providing personalized doses and can be beneficial, are these simple benefits being obtained, or is compounding medicines simply a way for pharmacists to make money? That is the question that this essay seeks to answer. This essay will overview the regulations and operational environment of compounding, followed by a more in-depth analysis of the benefits and challenges of compounding in a pharmacy.
Compounded medications have been a crucial part of a facility’s care, particularly in pediatrics, since the institution of healthcare. Throughout the hospital, they would compound medications that accounted for special patient groups. In the modern day and age, certain care homes may have compounding clinical pharmacists or nurses. Patients’ belief, trust, and faith in compounders made them some of the first free-thinking and problem-solving groups in healthcare, something that can be lost in our current day-to-day pharmaceutical and healthcare industries. This essay will aim to address and analyze any existing evidence of the challenges and benefits of compounding within a pharmacy.
2. Overview of Compounding Pharmacies
A compounding pharmacy is a pharmacy that is licensed under the Alberta College of Pharmacists with the permit to create and dispense custom medications. The primary function is to make a medication that suits individual patient needs not commercially available. The practice of compounding dates back to the origins of the pharmacy profession. Prior to the advent of commercial drug manufacturing, the work of the apothecary included blending and mixing his own remedies. Over time, after the evident shift from compounding, the age of mass drug manufacturing started in the post-World War II years, increasing the technology and creating what was being marketed back to prescribers and pharmacists. As a result, pharmacists have redeveloped the art of creating compounded medications as a solution for unique needs in the patient population.
Compounded medications are prescribed for various reasons: when the patient or physician deems the medication is not available for unique situations, when an individual cannot tolerate commercially available, mass-produced medicine, or when there is a shortage available in the future. Compounding has grown in the pharmacy profession largely due to the increase in outpatient and ambulatory surgery. The expectation is for the medications to be manufactured under well-established standards determined by the provincial regulatory body. Most of the quality and safety regulations that define the direction of staff training, equipment required and use, physical site requirements, policies and procedures, and expectations for documentation are directed by the regulatory authorities. If these guidelines are followed, it protects the public’s trust in the practice of pharmacy.
2.1. Definition and Purpose
Compounding pharmacies are pharmacies that are specialized in preparing medications in a non-standard way, customized to meet the unique needs of a patient. In the field of compounding pharmacy, a “compounded medication” can refer to a medication that is prepared to match the unique dose, dosage forms, and/or ingredient requirements of a particular patient. These compounded medications can help patients who need medications in doses that are not commercially available, or who have difficulties with food chemicals and require alternative dosage forms. For instance, compounded medications may be allergic to dyes or preservatives, and in need of medications in a different dosage form (e.g., the patient can only take a medication as a gelatin capsule instead of a tablet, or as a cream or solution rather than a topical spray). In sum, a compounded medication can be precisely customized to suit an individual’s unique health circumstances. Examples of compounded medications include dye-free, preservative-free medications for children; preservative-free nasal sprays, hormone replacement products, personalized pain management treatments, and countless others. The use of compounded medications is a long-standing and integral part of providing patient-centered care. This approach may provide some patients with improvements in health outcomes. A compounding pharmacist has the special equipment needed to prepare these customized medications. This process involves preparing the appropriate ingredients in the proper strength and dosage form. Many medications can be customized to meet the specific needs of individual patients.
2.2. Regulations and Standards
As of May 2021, regulations and standards governing compounding pharmacies are very robust. Health Canada and the National Associations of Pharmacy Regulatory Authorities have published guidelines for pharmacies approved to compound medications. These guidelines provide the pharmacy with an outline for structures required to be in place to ensure patient safety. In addition to these guidelines, provincial colleges may also enact standards to further ensure patient safety in the preparation of compounded medications. These guidelines and standards help ensure a consensus in quality for patient care. Some compounding pharmacies may also pursue accreditation from organizations.
All compounded medications prepared by licensed or legitimate pharmacy professionals are prepared according to the regulations set by federal and provincial governing bodies. There are ongoing requirements for risk, intent, record keeping, and stability testing for compounded preparations that are required. Anyone who is not in compliance with these regulations is not acting in the best interest of the patient. Simply complying with these standards is also not an automatic pass that all medications are safe and effective. Regulations and standards for patient care also evolve over time due to new carcinogenic research and technological changes. It is important that pharmacies, healthcare providers, and professional pharmacy regulatory bodies continue to do their part to ensure the medications we prepare or provide to patients are safe and effective for patient assurance.
3. Benefits of Compounded Medications
There are innumerable benefits that come with using compounded medications, in which compounding pharmacies specialize. The most significant advantage of compounded medications is customization. For instance, medications can be compounded into specific doses to match a patient’s individual dosage requirements. This is especially helpful because there are many patients who cannot tolerate or do not get relief from commercially available drugs. By preparing these medications in a more palatable dosage form, such as creams, liquids, lozenges, or flavored chews, it becomes much easier for a patient to take their medication regularly. Additionally, medications can be compounded without undesirable inactive ingredients such as alcohol, dyes, gluten, lactose, preservatives, sugar, and/or yeast. These allergen-free medications help to avoid allergy irritants considerably, which a good number of commercially available medications contain.
Western prescriptions generally develop in standard sizes and dosages. However, patients come in all shapes and sizes, introducing the need for personalized doses of medications. Customized medications developed by a compounding pharmacy can cater to individual requirements, ensuring the effectiveness and safety of a patient’s medical treatment. As a compounding approach requires close consultations between patients, healthcare providers, and pharmacists, patients who receive personalized medications are more likely to take the recommended prescribed dosage and be more satisfied. With a tailored medication regimen, patient compliance is enhanced considerably, leading to a better chance for an improved health outcome. Moreover, compounded medications are less discouraging for patients to consume, promoting their overall wellness. Patients also use compounded pharmaceuticals to avoid typical allergens, such as corn, lactose, wheat, and preservatives, present in commercial drugs. Lastly, many patients use compounded drugs to adhere to a restricted diet, particularly those with special food sensitivities not managed by manufactured drugs.
3.1. Personalized Dosages and Forms
Personalized Dosages
An important aspect of the practice of compounding is what pharmacists often refer to as personalized dosages and forms. Compounding pharmacy allows flexibility in adjusting the dosage form and personalized dosages to cater to the needs of the individual patient. The pediatric and geriatric populations can experience difficulties with swallowing standard tablet or capsule formulations, especially if multiple medications have been prescribed for simultaneous administration. Treating some medical conditions is often hindered by the patient’s unwillingness to take the medication, which can hinder performance or potentially benefit from the pharmaceutical agent. This is especially important when dealing with an infant, toddler, or geriatric patient with Alzheimer’s or dementia. The lack of physician-tailored therapy can prolong treatment and increase discomfort or anxiety. This can result in missed doses or non-compliance. Personalized doses can be formulated to meet an individual patient’s needs. Trying to obtain tablets in the correct dose often results in the need for highly skilled administrators to manipulate the drug. Trying to break tablets in two can result in wastage. Compounding medicines in the dosage required for each patient often requires a wide variety of manufactured medicines but not in the dose required. The medication pharmacists compounded was tailored to the patient’s requirements. There were no wastage issues from breaking a standard tablet.
Medication Forms
Pharmacists can look at ways to help the patient take their medication in a more suitable form. This often includes prescribing liquid medication for pediatric patients or for patients who have swallowing difficulties, providing the medication in cream or gel formulation. Pharmacists, in conjunction with the health care provider, can add flavors to liquids taken orally to mask the taste of the medication to improve compliance with the treatment. If the health care provider would like to try a special form of medication, such as a troche, the compounding pharmacist can make up the troche. The pharmacist would need to be competent in packing the medication into pediatric dosing forms and would learn to do this through training and study. Helping to develop patient treatment options allows compounding pharmacists to work with health care providers to develop medications that may not be commercially available. Providing the patient with options through compounding would be useful, as long as the patient understood that there may be additives in the product that are not listed. We wanted to know how to address Todd’s question regarding the health care providers. The jury indicates that there is work on easier ways to get the doctors on board with patient therapy that may be prepared or compounded in advanced pharmacy using research around the product. We also need to look at ways of compiling data regarding the use of compounded medications. Each patient has unique circumstances. Pharmacists are finding out from patients that they are finding it easier to take the medication that has been compounded compared to manufactured medications. Compliance with patient therapy developed in consultation with the pharmacist and the health care provider works very well. Providing innovative and professional compounded medications gives the patient and the pharmacy a very unique selling point. Compounded medications also facilitate the continuity of care between the health care provider, the patient, and the pharmacist. Pharmacists need to provide a high level of customer service, be professional, and maintain excellent contact with both the patient and the health care provider.
3.2. Allergy-Friendly Formulations
Allergy-Friendly Formulations The ability to exclude allergens from compounded preparations is a major role of some compounding. Many patients have allergies that may manifest as a skin rash or as anaphylaxis to food or environmental substances. While the more serious allergies are mentioned here, there are medications and other substances that patients may be allergic to. Pharmacists need to assess what substance is suspected of causing allergies through physical assessment and by asking pointed questions. Patients can be asked when a reaction started, what type of reaction occurred, and if it has happened before if the potential allergen was ingested, applied, or if an injection was given. Pharmacists therefore need to ensure they compound a medication containing an allergen or a closely related substance or cross-reactivity.
Reactions to allergenic substances can occur and wax and wane. There is often no correlation between the amount of allergen consumed and the degree of the reaction observed. Even with the common knowledge base of the foods people eat and all medications taken by people, allergic reactions with an adverse outcome can occur. By asking these types of questions, pharmacists can ascertain the prevalence of the customer’s allergy to potentially use a medication lacking the substances they may be allergic to. Compounded safer alternatives can improve access and quality of life for the target population. There is a large variety of allergens. To name a few: some allergens might be shellfish, iodine, penicillin, benzoate, sulfites, and phenolics. Some substitutes for allergens may be glucose for fructose, dairy or soy-based creams for shea or cocoa butter, and povidone-iodine for betadine. In these situations, with accurate assessment and communication between pharmacist and patient, the allergy can be addressed preferably before it results in an anaphylactic reaction.
4. Challenges Faced by Compounding Pharmacies
In Edmonton, there are a few compounding pharmacies where pharmacists will prepare medications for individual clients. While these services are valuable, some challenges are faced by compounders, especially those in smaller facilities. Certainly, standards for the preparation of compounded medications need to be of sufficiently high standard so that the added risk of converting raw ingredients into doses intended to be taken by individual patients is reasonable for patients to take. However, the lack of appropriate resources and expertise can limit the potential for compounding in smaller sites. Additionally, limitations with regulation, credentialing, and access to funding make compounded medication costs prohibitive to some patients.
Many regulatory bodies or professional associations have developed technical standards to help ensure the safety of compounded medications, as well as the safety of health care professionals who prepare them. However, pharmacies that prepare medications are obliged to work in the best interests of patients and adhere to these standards. While no licensed practical pharmacist would deliberately prepare a contaminated product, there is always a risk of accidental contamination due to a lack of appropriate quality control testing. The potential for human error during the compounding process and the fact that the effective safety and production of drafts require constant vigilance are not always appreciated and may come as a surprise to health care practitioners. While education about these matters is not always at the forefront of working with compounded preparations involving non-pharmacists, it is an essential part of continued safe and effective practice.
4.1. Quality Control and Safety Concerns
Quality control and safety are key concerns for compounding pharmacies. Robust quality assurance measures and checklists need to be in place before medications are compounded, during, and at the end of the compounding process. Although not always feasible, the need to improve patient outcomes and the demonstrated ability to improve quality and process flow are often recognized by industries as a process improvement. The consequences can range from ineffectiveness of the medication to adverse patient reactions, medication poisoning, or irritations. Sterility of injectable medicines can be challenging to maintain in the laboratory. Often, we must sterilize water sources, chemicals, and filters so that we are absolutely confident that no bacteria are present. Different dosage forms require different processes, including sterilization of containers, filters and membranes, and chemical or high heat sterilization of ingredients. Purity of ingredients can also be an issue, i.e., non-sterile active pharmaceutical ingredients in powder form, as well as other adulterants in the ingredient. Inadequate quality control over these contaminants can cause adverse patient reactions. Medications themselves can be made in different dosage forms. Each of these ingredients may have additional processing considerations, including requirements with respect to storage, light, and water sensitivity. For example, some ingredients work best in oil, while one needs to be cognizant of sun sensitivity for certain medications. Furthermore, these natural ingredients are not always the purest. An individual item may have dozens of by-products that can be formed during their production through contamination or breakdown from other chemicals. Medicines compounded need to be free of these by-products, as they can be either harmful or change the efficacy of the compounded medication. Raw materials must meet recognized standards.
Few Canadian ingredients can meet pharmacopoeial standards, so many products used in compounding come from other regions. These raw products must be certified to meet recognized standards. Then, when received in Canada, they must meet other regulatory approvals. Knowledge and training are necessary to validate the quality and source of these materials. Current data for medicines being returned to the manufacturer under the recall reporting program are 10 recalled for one manufacturer, 0 for another, 1 for a third, and 0 for the compounder. Certainly, regular recalls of manufactured products are an indication that there are concerns that should be addressed by all suppliers of pharmaceutical ingredients. Finally, communication is part of the quality improvement process. One must have open lines of communication with the health care providers to ensure any specific needs for a particular patient can be met. Manufacturers do not communicate with their consumers, so they do not have the capacity to develop medications with health care providers for specific patient needs.
4.2. Insurance Coverage
Some insurance companies will cover the cost of compounded medications, while others will not. Typically, insurers look for the lowest cost for the same formulary item and decide to cover that. Insurance companies may also have a cap on the dispensing fee, and the cost of the compounded medication may not allow for that. Some insurance companies will cover the medication with approval, but that is on a case-by-case basis. Some insurance companies will cover the medication if it was approved before, but the patient has to resubmit every year. Many insurance companies will have a list of criteria that must be met. A typical example is the treatment inhibition requirement: patients must have tried three or four treatments before the compounding option could be considered. Both practitioners are involved in the advocating process. Working collaboratively, we are able to provide insurance companies with information to support paying for the cost of the combined and individual consultation when required. An average prescription price, despite insurance coverage, is CAD 60 to CAD 98, depending on their coverage plan.
Some patients are on a co-payment, deductible, or reimbursement plan. The discrepancy processing time could be a maximum of 10 business days. Additionally, some pharmacy software can download all insurance plan scenarios so that there is no need to contact each patient’s insurer at first for prior authorization. Many consumers do not realize that infusions or compounded injections are not covered by most insurers and then have to pay out of pocket. Ideally, a pharmacist breaks down the cost of treatment with medication in private counseling to avoid surprises. In Canada, no one should have to pay more than 3% of their annual income before taxes. These recipients include people covered under group benefits and those who pay for medications. Many want to have their policy changed to include payment for an integrative clinic or compounding pharmacy if requested by a doctor. Data on the benefits of compounded medication integration are not published. If many people were to write their paper, this could change in the future. Only one part-time compounding pharmacist writes, and we try our best to help consumers obtain financial assistance through their insurer.
5. Conclusion
In conclusion, compounding pharmacies play an integral role in the provision of adequately personalized medication to a diverse patient population and worldwide. Compounded medications can offer flexibility and options when manufactured medications do not fulfill patient needs. Thus, compounded medications can improve medication safety and adherence, improving the overall care of patients. Furthermore, the access afforded by access to multiple dose forms can play an instrumental role in addressing known health care disparities in certain patient populations. Compounding pharmacies contribute to filling medication therapy gaps, including the provision of tailor-made doses and the creation of hypoallergenic formulations, specifically meeting patient needs that manufactured commercial drugs cannot entirely meet. In the case of food and medication allergies, compounding has experienced significant patient benefits from offering allergy-friendly dosing options in topical and oral preparations.
Challenges with compounded medications still exist and must be addressed to ensure the best quality. Some of these would include dealing with non-traditional dosage forms, including bioidentical hormone replacement therapy, which is known to pose a particularly high quality control problem. As such, insurance companies may decline and should increase coverage for these dosage forms and chronic medications. As the pharmacy profession continues to evolve, compounded medications can continue to hold an instrumental role in pharmacy practice for individualizing and improving overall medication therapy. With appropriate ongoing support from regulating agencies and professional organizations, patient populations will continue to benefit from personalized dose forms. Despite the potential benefit of compounded medications, they are not without limitations or potential concerns. Quality control of the final dosage form and active pharmaceutical ingredients is at the forefront of the compounding pharmacist’s concern, though finance and legality can be equally concerning. Collaboration between health care providers, pharmacists, and regulators in the field is crucial in creating an expanded continuum for patient access to compounded medications. The future access to compounded medications may be determined by the combined realities and outcomes, expectations, and potential innovations for the future of the regulated pharmacy within the pharmaceutical society.
