Drug Shortages

Drug Shortages: How Compounding Can Fill the Void

No medical professional wants to think that the prescription they write for a patient will remain unfilled. Modern medicine provides untold relief, but that relief only exists when patients can access the drugs and therapies they need. Fortunately for you, and your patients, compounding pharmacies offer an easy solution to drug shortages. 

Drug Shortages and COVID-19 

Drug shortages may occur for many reasons. Consider the effect of President Trump’s controversial “endorsement” of the antimalarial drug hydroxychloroquine as a COVID-19 treatment. The resultant surge in sales left lupus and arthritic patients unable to access the therapy they needed. VLS Pharmacy was able to compound a significant amount of this drug and donate to institutions in need.

It is no surprise, then, to hear that large pharmaceutical companies are struggling to keep up with the demand for proven treatments during this global pandemic. For instance, Johnson & Johnson has reported that they can’t meet the need for acetaminophen (branded as Tylenol), despite producing it at their maximum capacity. Acetaminophen is excellent for fever control, making its availability essential for consumers. However, availability can be challenging when the world market is impacted by events like the largest supplier of generic drugs, India, restricting the export of raw ingredients and medicines – and yes, they restricted the export of acetaminophen.

The COVID-19 pandemic has impacted drug production in multiple ways, including closed factories, shipping delays, and trade limitations or export bans such as the one imposed by India. “What makes the drug shortage such a challenging crisis is that no one organization or agency oversees this situation and responds accordingly,” said Stephen W. Schondelmeyer, the director of the PRIME Institute at the University of Minnesota, as reported by CNN. With this lack of coordination, the producers do what they can. Johnson & Johnson, for example, is encouraging stores to limit sales

The FDA maintains a database of shortages, and yet, the shortage problem impacted the healthcare world long before the pandemic hit. As the American Society of Health-System Pharmacists reported at the beginning of 2019, almost 80 percent of hospitals found it extremely challenging to obtain drugs, while nearly 80 percent revealed that drug shortages resulted in increased spending on drugs to a moderate or large extent.

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There is some good news! As a practitioner, you are not powerless in the face of such shortages. If you establish a relationship with a compounding pharmacy (like VLS Pharmacy), then you can feel confident that you can always source the drugs you need.

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about our compounding network.

How VLS Pharmacy Responded to a Recent Drug Shortage

Recalls are another factor that may create drug shortages. A recent recall that affected drug availability was carried out by RLC Labs when they recalled 483 lots of Nature-Throid and WP Thyroid in all strengths. The reason for the recall was that the FDA identified an issue with their quality assurance, finding sub-potent samples.

Hypothyroidism is a condition for which a proportion of patients do not report alleviation of symptoms despite the recommended treatment with T4 (Levothyroxine). T4 should convert to T3, the active ingredient. However, in some patients, this conversion is ineffective, and they require direct administration of T3 (Liothyronine). Traditionally, the synthetic T3 was made available as an immediate-acting preparation that could overstimulate the patient’s sympathetic nervous system and cause heart palpitations and other undesirable side effects.

VLS Pharmacy responded to both the pharmacological impact issue and the drug shortage. We provided physicians with a slow-release and long-acting form of T3. To identify the correct dosing regimen for individual patients, we also supplied pharmaceutical quality T3 and T4 in custom doses, allowing physicians to identify the ideal ratio to meet their patient’s needs.

As some patients had adapted to the desiccated natural thyroid (Thyroid USP – porcine), VLS Pharmacy also supplied the porcine powder. Since we work with the U.S. Pharmacopeia monograph and have an established quality assurance system, the required dosing was guaranteed for all patients. 

At VLS Pharmacy, we can fill your prescriptions with commercial T3 and T4, or we can compound if preferred.

Reach out to us today to learn more!

Why Choose VLS Pharmacy?

At VLS Pharmacy, we are agile and responsive. The technology and techniques that we use allow us to meet the custom needs of your patients, eliminating the need to suffer many market-related shortages of any essential therapeutic medicine. By reaching out to our compounding network, you can quickly establish a partnership with industry leaders and pharmaceutical experts to source quality medications. As a 503A pharmacy, we serve prescribers and their patients across the country and take pride in the trust that we have earned.

Our commitment to investment in technology and training and our excellence across all areas of our business is self-evident. We provide world-class quality controls that support our broad compounding capabilities. Patients do not always respond well to products on the market, but we have the capability to omit any inactive ingredient that individual patients have identified to be problematic. We can always be relied upon to have a solution.

Key Pillars To Our Success: 

  1. Qualifications: Our staff is highly trained and provides world-class expertise. We ensure that our pharmacists hold current accreditations and are qualified to create your medications.
  2. Secure Supply Chain: All active pharmaceutical ingredients are sourced from PCCA and have Material Safety Data Sheets and certificates of analysis to ensure their purity and potency levels. Every component is traced to verify that it is never contaminated or compromised throughout the compounding process.
  3. Quality Assurance: We conduct third-party potency and sterility testing and endotoxin detection.

Our Compounding Facilities

Our compounding facilities feature state-of-the-art labs equipped for sterile and non-sterile compounding – both at the highest quality standard set by USP. Because of this high level of service, we compound medications for ophthalmic, intravenous, and intramuscular administration. 

Our facilities boast:

  • USP <797> sterile rooms
  • USP <71> and USP <81> compliant for in-house sterility and antimicrobial assay testing
  • Cleanroom systems for product protection
  • HEPA-filtered airflow ISO Class 5 Laminar flow hoods to preserve uniform airflow, prevent sample contamination and create a particulate-free work area
  • Amber hood workbench technology uniquely used to compound photosensitive substances including hydroquinone, retinoic acid, and methylcobalamin

We continually go above and beyond state and federal standards to achieve an unprecedented level of quality control. Our lab is constantly monitored for temperature, humidity, and airflow, just like a large pharmaceutical manufacturing facility. In short, patient safety is the foundation upon which we are built.

Reach out to our team to learn about best practices and to partner with our experts on custom compounded medications for your patients. 

All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.

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