Traditionally, patients think of pharmacies as the local drugstore on the corner where they can go to have a prescription filled or stock up on common over-the-counter medications.
But what if they require a prescription in liquid form that can only be ordered from their pharmacy in a tablet, because they cannot swallow tablets? Or if they have an allergy to an inactive ingredient used in a cream that their traditional pharmacy stocks?
The patient does not need to forgo treatment and instead has options to have their prescription compounded. Compounding pharmacies can custom-tailor prescriptions to an individual patient’s needs, whether it is changing dosage forms, avoiding allergens, creating special dosages, or unique combinations of medications not commercially available.
Exploring The Origins Of Compounding And Medication Distribution
Pharmacists have played a critical role in a patient’s healthcare for many years. They were responsible for concocting the final therapeutic substances delivered to patients for hundreds of years. Before mass manufacturing, every pharmacist essentially was a compounder.
Physicians would prescribe specific combinations or concentrations of various ingredients to treat a wide range of patient ailments that pharmacists, then known as apothecaries, would mix and dispense.
Pre-Industrial Era
Physicians would prescribe patients tinctures, syrups, salves, and tablets that often contained herbs, plants, and roots, opium, heroin, morphine, alcohol, and animal products.
A pharmacy would stock all these raw ingredients and fulfill the physician’s order to ensure that the patient would receive the correct treatment for their ailment.
Industrial Revolution
With the rise of the Industrial Revolution, physician orders that once required admixing natural ingredients were beginning to be replaced by prescriptions that asked for mass-produced pharmaceuticals using synthetic and proprietary medications.
This led to a change in the pharmacist’s role: focus shifted from compounding to a more retail-based setting.
Early 1900s
Alongside this era of mass production, the Prohibition Period drove citizens across the country to their local corner drugstore. Pharmacies began to replace neighborhood bars as the new gathering place, serving soda fountain beverages.
Pharmacists were still allowed to use and dispense alcohol in prescriptions for medical purposes (under strict government regulation), but their soft drinks instead utilized the pharmacist’s knowledge in mixing various flavors and ingredients to sell popular soft drinks, a handful of which have become household names today.
1930s
While prescribing trends continued towards manufactured medications, approximately 75% of prescriptions still required in-pharmacy compounding. However, the emergence of pharmacies selling soft drinks, coupled with drug stores beginning to stock goods for sale in their store fronts, was slowly being driven away from prescriptions as those were no longer the majority of sales.
Rise in Hospital Pharmacy Compounding
The middle of the 20th Century saw the birth of clinical pharmacy services in hospital settings. Pharmacists began to prepare and dispense unit-dose medications in-house as well as compounded patient-specific treatments.
These ranged from chemotherapeutic drugs for cancer patients, Total Parenteral Nutrition (TPN) support in patients with gastrointestinal diseases, and life-saving complex therapies for patients undergoing and recovering from cardiac surgery.
1980s-2000s
By the end of the 20th Century, many pharmacies were dispensing mass-produced drugs; however, advanced therapies began to find their way into outpatient settings, such as clinics and even in patients’ homes.
Newer drug trends found their way in front of a pharmacist, such as intravenous antibiotic infusions and hormone replacement therapies, which again required custom dosing and formulation, ensuring the needs of individual patients were met.
Latest Trends In Compounding Medications And Quality Standards
Throughout the 20th Century, rules and regulations have evolved alongside pharmacies. In 1938, the FDA began the oversight of pharmaceutical manufacturing, and in 1997, Congress passed the Food and Drug Administration Modernization Act.
In 2013, the Compounding Quality Act was passed to regulate pharmacies to ensure that products being dispensed to patients, whether manufactured or compounded in-house, were safe for patient use.
Other organizations during the history of modern pharmacy have implemented regulations for pharmacies to adhere to ensure patients receive safe medications, such as the US Pharmacopeia (USP), the American Society of Health-System Pharmacists (ASHP), and the Pharmacy Compounding Accreditation Board (PCAB), as well as each state’s board of pharmacy.
Regulatory Developments In Medication Distribution
Regulations set by USP, among the other regulatory committees, have only one goal: to establish guidelines that ensure each prescription dispensed to a patient is safe to use.
Sterility Assurance
To comply with the regulations, any manufacturer or compounding pharmacy that is preparing sterile products must ensure that a sterile environment is always maintained.
This can be achieved by strict specifications set forth by USP pertaining to air supplies, types of work surfaces, compounding devices used, temperatures, and even cleaning and disinfecting products used.
Require Personnel Qualifications And Training
In a compounding pharmacy, personnel in the laboratories require extensive training to handle and compound the chemicals used. Pharmacists and pharmacy technicians are required to be licensed, as well as trained and sometimes certified to handle hazardous chemicals or work as sterile compounders.
Establish Environmental Control Standards
The different laboratories found in a compounding pharmacy will each require different environmental specifications. These can range from controls as basic as temperature and humidity to room pressure differentials to as complex as specifications stating how many particles and of what size can be found in the air.
Implement Quality Control Processes
The regulatory organizations list and recommend various standard operating procedures (SOPs) that will ensure the compounding pharmacy will maintain equipment, educate team personnel, properly store various chemicals, and ensure a standard for documentation for tasks, responsibilities, and procedures.
Detailed Documentation And Traceability
These SOPs, as recommended by USP, are to be reviewed to develop, implement, and enforce standards that the pharmacy must abide by. These can be broken down to focus on safety, quality assurance, and administration.
The administration category, while not directly specific to the products compounded, is particularly important as this category establishes officers responsible for each SOP, who are responsible for the implementation of each standard.
Quality Control In Pharmaceutical Compounding
Compliance with the USP regulations, as well as PCAB, ensures the pharmacy is operating to meet higher standards and more stringent requirements than those generally set by a state board of pharmacy.
This will lead to quality assurance that includes relevant personnel training, environmental monitoring, and equipment maintenance that will lead to the strongest product integrity and ultimately lead to patient safety.
Why Advanced Standards Matter In Today’s Compounding Industry
Not every pharmacy is necessarily required to adhere to all these guidelines set forth by the various regulatory organizations. Community pharmacies that dispense only mass-manufactured medications will only need to follow the regulations required for the scope of dispensing they perform.
Some compounding pharmacies may only compound with nonsterile nonhazardous chemicals and will comply with less strict rules than others that use hazardous chemicals or those that compound sterile products.
Compliance is critical for compounding pharmacies. Not complying with these standards and regulations will lead to medications that are unsafe for patients to use. ASHP, and then USP and PCAB, have been publishing guidelines that pertain to quality assurance and safety since 2000.
While most pharmacies and manufacturers comply with every regulation, there are occasionally those who do not. Since the beginning of these guidelines, there have been instances where contamination has occurred and led to patient harm, injury, and death.
Our Promise To Reliable Distribution And Quality Assurance
At Medivera, we strive for the highest level of compliance and quality control procedures attainable. We comply with USP regulations, and we are a PCAB-accredited compounding pharmacy.
The PCAB regularly reviews and assesses the standard operating procedures provided by USP at a compounding pharmacy. This accreditation signifies that we not only meet the rigorous standards outlined by USP but also go beyond, meeting PCAB’s standards of compounding practices.
Advanced Compliance And Technology
With our PCAB accreditation and strict standard operating procedures as outlined by USP, we operate with safety and quality assurance as our primary goals. When compounding with nonhazardous, hazardous, or even sterile chemicals, the safety of our medications is always in mind.
We follow USP guidelines for any product we compound, utilizing cutting-edge technology. This includes ISO-5 bench hoods, ensuring optimal sterility when compounding sterile products, and our ISO-7 clean rooms in our laboratories, keeping air particles to a safe and minimal standard.
All of our laboratories, equipment, compounding standards, and procedures comply with USP chapters 795 (nonsterile), 797 (sterile), and 800 (hazardous).
Providing Experienced Care Focused on Your Safety and Trust
Here at Medivera, our dedication to quality and safety, and our vision for staying at the forefront of the industry’s evolution, drive us to not only comply with but exceed the regulations expected of us to ensure every prescription is held to the highest standard.
Trust Medivera for advanced pharmaceutical distribution and quality control. Contact us to learn more.
References
- https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/compounding-sterile-preparations.ashx
- https://www.nature.com/articles/pr2003494#:~:text=Total%20parenteral%20nutrition%20(TPN)%20became,many%20pediatric%20and%20adult%20patients
- https://www.monahodgson.com/1920s-pharmacies-and-soda-fountains/
- https://ijpc.com/Abstracts/Abstract.cfm?ABS=4209
- https://pmc.ncbi.nlm.nih.gov/articles/PMC6789879/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC7605468/
- https://www.usp.org/sites/default/files/usp/document/get-involved/stakeholder-forums/compounding-activities-and-the-role-excipients-play.pdf
