PHARMACY

Walgreens unveils Missouri medication disposal kiosks

BY David Salazar

Walgreens’ safe medication disposal kiosks have entered their 46th state. The chain on Tuesday unveiled the first disposal kiosks at one of the 14 locations in the state that house them alongside Missouri Gov. Mike Parson.

“We are excited to bring a year-round opportunity to safely dispose of unwanted medications in a convenient pharmacy setting at no cost to Missourians. Every day will now be drug take back day in Missouri,” said Marcel Naddaf, Walgreens regional healthcare director in Missouri. “Our kiosk program is one of several steps Walgreens has taken to address the opioid epidemic, along with expanding access to naloxone and installing high-secure time-delay safes to secure controlled substances in our pharmacies.”

The kiosks can be used to dispose of expired, unwanted or unused prescriptions, including controlled substances and OTC medications. Since Walgreens’ disposal program launched, in partnership with AmerisourceBergen, Pfizer and Prime Therapeutics, it has collected more than 400 tons of medication. The kiosks are available during pharmacy hours.

Walgreens said that it also is able to dispense opioid overdose-reversal drug naloxone at all of its Missouri pharmacies without a prescription. It also has installed time-delay safes in all of its pharmacies in the state, which removes the immediate availability of them while still meeting patient needs, Walgreens said.

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FDA issues draft guidance to ensure safety of compounded drugs

BY Sandra Levy

In an effort to assure the quality of compounded drugs, The Food and Drug Administration issued a revised draft guidance with recommendations for protecting patients from the risk of contaminated or otherwise substandard products produced by outsourcing facilities.

“As we continue to implement our 2018 Compounding Priorities Plan, our mission is to preserve patient access to compounded drugs to meet patients’ individual medical needs while also protecting patients from the risks of contaminated or otherwise harmful products,” FDA Commissioner Scott Gottlieb said. “We’re especially focused on the importance of ensuring compounded product quality. Through enforcement actions, we’ve been addressing insanitary conditions and manufacturing quality issues at compounders’ facilities across the country. More activities are planned, and we’ve stepped up our collaborative work with the Department of Justice. But preventing problems before they put patient safety at risk is our key objective to protect consumers.”

Gottlieb emphasized that although compounded drugs can serve an important role for certain patients whose medical needs cannot be met by an FDA-approved drug product, it’s important to understand that compounded drug products haven’t undergone FDA premarket review for safety and effectiveness.

“Compounders who are uniquely permitted under law to compound and distribute certain compounded drugs without receiving patient-specific prescriptions are referred to as outsourcing facilities. There has been a lot of discussion around the issue of “office stock” — the drugs that doctors may keep on hand for certain procedures. If certain conditions are met, the law allows outsourcing facilities to provide hospitals, physicians’ offices and other healthcare facilities with supplies of compounded drugs to keep on hand as “office stock” for their patients, who may need quick or emergency medication upon diagnosis,” Gottlieb said.

Gottlieb continued, “While this practice is permitted, outsourcing facilities must comply with certain requirements, including current good manufacturing practice, or CGMP requirements, and FDA routinely inspects outsourcing facilities to determine whether their products are manufactured appropriately. Today we’re updating some of our proposed policies related to these outsourcing facilities. Among our goals is to make it more feasible for compounding pharmacies to become outsourcing facilities.”

Compliance with CGMP is particularly important in outsourcing facilities as they often operate on a larger scale than other compounders, and their compounded drug products may reach many patients across the country.

Gottlieb also said that ensuring that their products are not contaminated, contain the right amount of each component, and maintain quality while stored on the shelf for a period of time are critical for office stock production. “By adhering to CGMP requirements, such product quality problems and potential patient harm are more likely to be avoided. But, unfortunately, we continue to find concerning conditions and practices that can lead to contaminated, super or sub-potent, or mislabeled products. This is especially true when the compounder does not adhere to CGMP requirements, which we often observe in compounding pharmacies not registered as outsourcing facilities that are subject to CGMP and other requirements because they continue to engage in activities, such as providing office stock,” Gottlieb said.

Gottlieb said the FDA’s aim for this guidance is to recognize the differences in drug production between outsourcing facilities and conventional drug manufacturers. The guidance is intended to provide clarity on quality assurance, maintaining suitable facilities, sterility, stability testing, and beyond-use or expiration dates for products that don’t go through the FDA drug approval process.

“This revised draft guidance includes changes intended to help achieve this goal, particularly through revisions related to release testing, stability testing and beyond-use dating, as well as policies that differentiate between the production of sterile and non-sterile drug products,” Gottlieb said.

The FDA also will be holding a public meeting in May to solicit comments on the potential impact of the policies, if finalized as described in the updated draft guidance, on outsourcing facilities supplying compounded drugs for office stock.

The FDA plans to advance other new efforts to promote oversight in this sector to make it more feasible for compounding pharmacies to become outsourcing facilities, and for outsourcing facilities to meet provider requests.

“We’ll also continue to conduct a risk-based inspection and enforcement efforts with respect to compounders not registered as outsourcing facilities, especially if they appear to be distributing compounded sterile drugs nationwide without valid patient-specific prescriptions. Our goal is to ensure industry compliance. And the FDA will take action against facilities with deficient practices to try and stop issues before they lead to patient harm,” Gottllieb said.

The agency also will be taking action to further define what substances can be used in compounded products by traditional compounders.

“We’ll be issuing a final rule that identifies the criteria we are using to evaluate bulk drug substances for the list of bulk drug substances that may be used in compounding under section 503A, or 503A bulks list. This final rule will also identify bulk substances the agency has evaluated and will or will not place on the 503A bulks list. It’s key to balancing access to appropriately compounded drugs and protecting patients from compounded products that could cause harm. We’ll continue our rulemaking effort and plan to seek public comment on additional bulk drug substances for the 503A bulks list,” Gottlieb said.

The FDA today also added two new entries to the “withdrawn or removed” list of drug products that cannot be compounded because they’ve been found to be unsafe or ineffective.

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HFAP unveils compounding pharmacy certification

BY Sandra Levy

HFAP, a healthcare accreditation program founded in 1945, is launching a Compounding Pharmacy Certification program that enables pharmacies to demonstrate their commitment to excellence and quality control.

Compounding pharmacies meticulously prepare, mix, assemble, alter, package and label medications and medical devices to meet the specifications of patient prescriptions and medical orders. Attention to detail is key, as the smallest of errors can lead to devastating consequences for patient health and safety. To ensure these preparations are successful, compounding pharmacies must establish a risk management protocol that keeps patient safety and quality of services top-of-mind.

“With a focus on accuracy and consistency, the HFAP Compounding Pharmacies Certification Standards provide guidance on how best to assess and reduce risk,” CAE director of accreditation/certification operations, Marci Ramahi, said. “While a certification is not required, the HFAP program aims to instill best practices into everyday activities, ensuring pharmacies and specialized pharma products meet the highest standards of quality.”

During the on-site HFAP survey, the surveyor will provide an overview of the process, review all required information and assess compliance with the applicable standards through written documentation, responses to interview questions and direct observation.

The HFAP standards for Compounding Pharmacy Certification are divided into three sections: governance functions, clinical functions and support functions, with the clinical requirements adapted from the USP Compounding Compendium and segmented into two subcategories of sterile and non-sterile compounding.

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