Compounding Pharmacy Accreditation: Ensuring Safety Amidst Rising Demand

Amidst growing concerns over safety and quality, a spotlight shines on the critical role of compounding pharmacy accreditation. This comes as demand for compounded medications rises, fueled by drug shortages and direct-to-consumer advertising. Accreditation, particularly thru the Pharmacy Compounding accreditation Board (PCAB), ensures adherence to stringent standards, safeguarding patients from potential risks associated with inconsistent or improperly formulated drugs.

The Growing need for Compounding Pharmacy Oversight

compounded drugs, customized formulations created by pharmacists, are not subject to the same premarket approval process as brand-name or generic medications. While the FDA monitors drug shortages, allowing compounding pharmacies to produce these drugs, the oversight differs considerably from that of manufactured drugs.This distinction can lead to inconsistencies in quality, safety, and efficacy.

The rise in popularity of glucagon-like peptide-1 (GLP-1) receptor agonists, like semaglutide (Ozempic, Wegovy), illustrates the need for vigilant oversight. Originally intended for diabetes and heart disease, these drugs have gained traction for weight loss, leading to shortages and the emergence of compounded versions.

Did You Know? According to a recent study, the global market for pharmaceutical compounding is projected to reach $16.7 billion by 2028, highlighting the increasing reliance on these specialized medications.

A Kaiser Family Foundation poll from May 2024 revealed that 1 in 8 adults in the U.S. have used a GLP-1 medication, with 40% using it for weight loss ¹.This surge in demand has strained supply chains, creating opportunities for compounding pharmacies but also raising concerns about quality control.

Health care providers express reservations about compounded GLP-1 drugs, with 42% advising against their use for weight loss due to safety and regulatory concerns. Furthermore, over 100 telehealth platforms actively market these medications, often without adequate patient-physician interaction ².

Compounded medications, unlike FDA-approved drugs, may lack standardization, contain unverified ingredients, and be produced in facilities with varying quality control levels. The FDA has received reports of adverse events linked to compounded GLP-1 drugs, particularly when dosages were incorrect or formulations inconsistent.

Direct-to-Consumer Marketing and Its Impact

the proliferation of direct-to-consumer (DTC) advertising has further complicated the landscape of compounded medications. The Super Bowl featured an ad by hims & Hers promoting GLP-1s for weight loss, resulting in a significant increase in online traffic and consumer interest.

Hims & Hers experienced a surge in stock value following the introduction of its semaglutide offerings.However, the FDA later removed semaglutide from the drug shortage list, setting a deadline of April 22, 2025, after which compounding of these drugs would no longer be legally permissible ³. This regulatory shift underscores the complexities and potential risks associated with the uncontrolled distribution of compounded medications.

PCAB Accreditation: A Vital Safeguard

The Pharmacy Compounding Accreditation Board (PCAB), a service of ACHC, is recognized as a benchmark for quality in compounding practices. PCAB accreditation ensures that compounded medications meet rigorous quality and consistency standards.

Pro Tip: When choosing a compounding pharmacy, always verify their accreditation status with PCAB or other recognized accrediting bodies.

PCAB-accredited pharmacies must adhere to thorough quality control measures, contamination prevention protocols, and proper training and oversight for pharmacists and technicians. This accreditation supports patient safety by ensuring responsible dispensing within an established patient-physician relationship.

Without proper oversight, compounded medications can pose significant risks due to inconsistencies in potency, contamination, and improper formulation. PCAB accreditation demonstrates a pharmacy’s commitment to best practices in both sterile and nonsterile compounding.

The Future of Compounded Medications

The compounding pharmacy industry faces a critical juncture. While personalized medicine and drug shortages drive demand, maintaining the quality, safety, and integrity of compounded drugs remains paramount.

PCAB accreditation provides pharmacies with the framework needed to meet these challenges and reinforce public trust. As health care evolves, patients and providers must prioritize accredited pharmacies to ensure the safety and effectiveness of compounded medications.

With the increasing prevalence of DTC advertising, especially in weight loss and specialty treatments, responsible oversight is more crucial than ever. PCAB accreditation remains the gold standard for compounding pharmacies, protecting patients and upholding the industry’s integrity.

As the regulatory landscape evolves, ACHC remains dedicated to supporting accredited pharmacies and advocating for higher standards in compounding.

Disclaimer: This article provides general information and should not be considered medical advice. Consult with a qualified healthcare professional for personalized guidance.

What are yoru thoughts on the role of compounding pharmacies in modern healthcare? How can patients better protect themselves when considering compounded medications?

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Continuous Glucose Monitors Offer Type 2 Diabetes Patients Real-Time Health Insights

chicago, IL – Continuous glucose Monitors (cgms) are revolutionizing type 2 diabetes (T2D) management by providing patients with a comprehensive, real-time view of their health. At the 85th Scientific Sessions of the American Diabetes Association (ADA), Dexcom CEO Kevin Sayer highlighted how cgms act as a “scoreboard,” offering immediate insights into the effects of medications, meals, and lifestyle choices on blood sugar levels. This technology empowers individuals to make informed decisions and proactively manage their condition.

The Power of Real-Time Data

Customary methods of diabetes management often rely on infrequent finger-prick tests, providing limited snapshots of blood sugar levels. CGMs, however, continuously track glucose levels, offering a dynamic picture of how various factors influence blood sugar throughout the day and night. This constant stream of data allows patients to identify patterns and understand the impact of their actions in real-time.

Did You Know? The global continuous glucose monitoring market is projected to reach $10.4 billion by 2029, growing at a CAGR of 11.2% from 2022 [Source: Fortune Business Insights].

Benefits of CGM Adoption for Type 2 Diabetes

The adoption of CGMs offers numerous benefits for individuals with type 2 diabetes. These include:

• Improved A1c Levels: Studies consistently show that CGM use leads to a reduction in A1c levels, a key indicator of long-term blood sugar control.
• Increased Confidence and Reduced Stress: Real-time data empowers patients, fostering a better understanding of their condition and reducing diabetes-related anxiety.
• Potential Cost Savings: By enabling better management, CGMs can lead to fewer doctor visits, reduced hospitalizations, and adjustments in medication, resulting in cost savings.
• Improved cardiovascular and Kidney Health: Emerging research suggests that CGM use may contribute to better cardiovascular and kidney health outcomes in individuals with diabetes.

Moreover, the integration of artificial intelligence (AI) is enhancing CGM capabilities. AI-powered features can identify meal-related glucose spikes and provide personalized feedback, further optimizing diabetes management.

CGMs as a “Scoreboard” for Health

Sayer emphasized that CGMs provide patients with a clear understanding of how their daily choices affect their diabetes health. For example,a patient might observe a significant glucose spike after consuming a particular meal or realize that their blood sugar remains elevated after a night of poor sleep. These insights enable individuals to make informed adjustments to their diet, exercise routine, and medication regimen.

Pro Tip: Share your CGM data with your healthcare provider to facilitate more informed discussions and personalized treatment plans.

The Future of CGM Technology

The future of CGM technology is promising, with ongoing developments focused on enhancing accuracy, convenience, and integration with other health technologies. AI-driven features are expected to play an increasingly vital role in providing personalized insights and support for individuals with type 2 diabetes.

AI Integration for Enhanced Insights

Dexcom, as a notable example, has launched a meal feature with its G7 CGM, utilizing AI to identify meals and match them with glucose spikes. This feature will be valuable for type 2 diabetes management, allowing patients to understand how different foods affect their blood sugar levels.

What lifestyle changes have you found most effective in managing your type 2 diabetes? How has technology impacted your approach to diabetes management?

Disclaimer: This article provides general facts about continuous glucose monitors and type 2 diabetes management. It is indeed not intended to provide medical advice. Consult with your healthcare provider for personalized recommendations.

Share this article with someone who could benefit from learning about continuous glucose monitors! Leave a comment below with your experiences using CGM technology.

Oral PCSK9 Inhibitor Enlicitide Decanoate Shows Promise in Lowering

Shore Medical Center’s innovative Approach to Opioid Stewardship

Shore Medical Center has implemented a pharmacy-driven intravenous (IV) to oral opioid conversion protocol as a cornerstone of its comprehensive opioid stewardship initiative. This protocol is designed to improve patient safety by decreasing the use of IV opioids, thereby mitigating risks such as respiratory depression and facilitating a more seamless transition to outpatient care.

The Pharmacist’s Central Role

Pharmacists are integral to this process. They proactively identify suitable conversion opportunities, determine equipotent oral doses using a standardized chart, and select preferred oral opioids while maintaining the original dosing frequency with minimum limits.

Purpose of the Opioid Conversion Initiative

The primary goal of the Pharmacy-Driven IV to Oral Opioid Conversion Protocol is to promote safer and more effective pain management by minimizing unnecessary IV opioid use. IV opioids are associated with a higher risk of adverse events (aes), including increased sedation, respiratory depression, and potential intubation. According to Elizabeth DeMarco, PharmD, BCPS, pharmacy clinical coordinator at Shore Medical Center, prioritizing oral opioids reduces these risks, supports a smoother transition to outpatient care, and aligns with multimodal pain management strategies.

This initiative is part of a broader institutional effort to combat the opioid epidemic through stewardship efforts. In addition to this protocol, we’ve implemented several other initiatives-including prioritizing non-opioid analgesics in the emergency department (ED) and establishing a partnership with an outpatient treatment center to support patients transitioning from detox to outpatient care. Together, these efforts reflect [Shore Medical’s] commitment to reducing opioid-related harm while maintaining effective pain control in the acute care setting.
Elizabeth DeMarco, PharmD, BCPS, pharmacy clinical coordinator at Shore Medical Center

Maintaining Dosing Frequency

The policy ensures continuity and consistency in pain management by maintaining the same dosing frequency as the original IV opioid order. The protocol establishes minimum dosing frequency limits to support a safe and effective transition to oral therapy. For instance, oral oxycodone or hydromorphone shoudl not be administered less frequently than every 4 hours, and oral tramadol should not be administered less frequently than every 6 hours. These parameters are intended to preserve adequate analgesic coverage during the conversion process and prevent gaps in pain control.

Preferred Oral Opioids and Alternatives

When an IV opioid order has been active for at least 24 hours, the pharmacist evaluates its appropriateness for conversion to an equipotent oral regimen. Oral oxycodone is the preferred agent for most patients due to its effectiveness and availability. However, alternatives are selected based on specific patient factors:

• Oral hydromorphone is preferred in patients with renal impairment (defined as CrCl <30 mL/min), as oxycodone concentrations can increase significantly in renal dysfunction.
• Oral tramadol is preferred in patients with a true hypersensitivity to oxycodone or other natural/semisynthetic opioids (eg, morphine, hydromorphone).

this patient-specific approach ensures the safest and most appropriate oral opioid is selected during the conversion process.

Special Considerations for Sickle cell Disease

Patients with sickle cell disease experiencing acute vaso-occlusive crises require a diffrent approach to pain management compared to the standard IV-to-PO opioid conversion process. In this population, around-the-clock opioid therapy is essential, and patient-controlled analgesia (PCA) is the preferred method of administration rather than transitioning to oral opioids. PCA offers several benefits, including improved analgesic control, faster access to pain relief, and greater patient autonomy.

Literature supports the use of PCA in this population because it is associated with decreased time to adequate pain control and reduced hospital length of stay. As a result, [patients with sickle cell disease] are excluded from the standard IV-to-PO opioid conversion protocol, and their management follows a separate pathway that prioritizes IV PCA therapy.
Elizabeth DeMarco, PharmD, BCPS, pharmacy clinical coordinator at Shore Medical Center

The Pharmacist’s Role in the conversion Process

Pharmacists play a central role in identifying opportunities to safely transition patients from IV to oral opioid therapy. They review active IV opioid orders for clinical appropriateness, assess eligibility based on protocol criteria, and determine whether de-escalation or conversion is appropriate. When conversion is appropriate, the pharmacist calculates an equipotent oral dose and modifies the order accordingly in line with the protocol.

In addition, pharmacists collaborate closely with nursing staff and the care team to ensure that changes are clearly communicated and implemented safely. This process supports opioid stewardship efforts by reducing unnecessary IV opioid use while maintaining effective pain management.
Elizabeth DeMarco, PharmD, BCPS, pharmacy clinical coordinator at Shore Medical Center

Determining the Appropriate oral Opioid Dose

Pharmacists determine the appropriate oral opioid dose by calculating equipotent dosing using morphine milligram equivalents to ensure a clinically appropriate and safe conversion. The protocol includes a dosing conversion chart that serves as a standardized reference, outlining recommended oral doses for oxycodone, hydromorphone, and tramadol based on the specific IV opioid and dose administered.This tool helps guide consistent and evidence-based conversions while allowing pharmacists to tailor therapy based on patient-specific factors such as renal function, allergy history, and pain control needs.

What Makes This Initiative Unique?

what makes this initiative unique is that it is pharmacy-driven, meaning pharmacists at Shore Medical Center evaluate, modify, and convert IV opioid orders to oral without needing to wait for a physician to initiate the change. This proactive approach streamlines the transition from IV to oral therapy.

Additionally, shore has embedded this protocol into a broader opioid stewardship initiative, which includes prioritizing non-opioid therapies in the ED, establishing care coordination with community partners, and maintaining criteria for IV opioid use.

Few institutions of our size have implemented such a robust, pharmacist-led protocol with clearly defined criteria, exclusion populations, and a detailed conversion framework. This initiative reflects Shore’s commitment to interdisciplinary collaboration and reducing opioid-related harm while still ensuring effective pain control.
Elizabeth DeMarco, PharmD, BCPS, pharmacy clinical coordinator at Shore Medical Center