Compounding pharmacies are making a comeback after the devastating news that came out in 2012 that a New England compounding center had sent out to medical centers steroid shots that were contaminated with deadly black mold. This mistake led to the deaths of 64 people in the U.S. and a spreading suspicion of compounding facilities.
The compounders suffered through the punishing public relations disaster, though, and survived. Now, having restored much of the public’s confidence in the years since, many find themselves poised for a renewed growth in the industry. What is the cost of hormone therapy? Demand is rising as factory-produced medications are delayed and unavailable and as doctors and patients turn to more customized therapeutic alternatives.
What is a Compounding Pharmacy?
Unlike their corner drugstore counterpart, compounding pharmacies are not dispensers of drugs that are mass manufactured by the large pharmaceutical companies. Rather, they specialize in creating customized therapies designed for individuals who may need a drug presented in a different form, such as in suppositories, liquids, creams, or even lollipops rather than as pills. Others may need compounding to address allergies to commercial formulations or they may need a certain strength that is not commercially available.
Compounding pharmacies can personalize any drug by removing unwanted ingredients like sugar, preservatives, or dyes. They also can add flavoring to make each dose easier to take and provide strengths of adult medication that are suitable for children.
The rise in the popularity of bioidentical hormone replacement therapy to help women with the symptoms of menopause has been a major factor in the increase in the number of compounding pharmacies available in communities. They also are seeing more use by doctors who want personalized care for their patients in the realm of anti-aging formulations, topical pain relievers, dermatological preparations, and allergy-free medicines. Hospitals turn to compounding pharmacies, often keeping one on the premises, to prepare medications that are hard to get commercially or are in short supply.
Considerations and Tips in Choosing a Compounding Pharmacy
Before selecting a compounding provider, individuals and doctors will obviously look carefully for one that has the best of reputations for quality and accuracy. Following the black mold incident, for example, many are testing each and every batch of medications to ensure safety and quality.
There also are a number of other facts to consider when choosing a compounding pharmacy in NYC, including the provision of clean rooms, HEPA filtration in laboratory suites, and a detailed quality control program.
In finding the right pharmacy, some telling questions that can be asked during the selection process may include:
Does a licensed pharmacist review every step of the process, from prescribing and compounding to labeling and dispensing?
Is the pharmacy a member in good standing of the PCCA, or Professional Compounding Center of America?
Is the pharmacy licensed to practice in the state and are they in good standing with the state board of pharmacy?
Does the pharmacy run its preparations through tests for sterility and potency? For example, does it perform post-filtration testing of filter integrity?
Is an independent, third party lab available to conduct sterility analysis on sterile compounds?
Does the pharmacy get regular independent certification of its clean rooms and does it have a sterile environment monitoring program to ensure conditions are aseptic?
Is there a procedure in place to handle sterility failures, customer complaints, or adverse events and, if needed, issue a recall?
Does the pharmacy maintain master formulas as well as records for lot-specific batch compounds?
Is the pharmacy able to, without notice, trace back a prescription to the original batch and determine the source of ingredients?
Does the pharmacy verify the potency of the finished product through checks by weight, volume, and yield?
Is the pharmacy staff willing and able to help resolve problems and do they have experience in the physician’s area of practice?
Does the staff undergo continuing education courses as they relate to compounding?
Is the pharmacist skilled and experienced in the art and science of compounding?
What a compounding pharmacy consumer should be looking for is a facility in which a competent staff has the experience and motivation to abide by internal measures that ensure quality. They also should have their products tested independently for sterility, potency, and endotoxins.
A true compounding pharmacy will be designing medication formulations on a case-by-case basis for each individual patient. So ask if a licensed and certified compounding pharmacist will be the one assigned to formulate your specific prescription. Other questions to ask are provided on the compounding pharmacist assessment questionnaire, which is available on the International Academy of Compounding Pharmacists web site.
Other facts to consider when choosing a compounding pharmacy in NYC include costs and stock on hand. A pharmacy’s inventory of ingredients is an item that often is overlooked. However, if a pharmacy is running low on needed ingredients or has insufficient stocks, it likely is not the best one to select for the job.
As for costs, engaging with a high priced compounding pharmacy is no guarantee of the best in quality and safety. Neither do you want to deal with a pharmacy known for having the lowest prices. Rather, look for one that is providing medications at market value. This can be determined by asking a number of pharmacies in the region about their going rates and comparing them.