BLINATUMOMAB NOW INDICATED FOR CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA
The FDA has expanded the use of Amgen’s blinatumomab (Blincyto) to treat Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric patients.
Blincyto is a bispecific CD19-directed CD3 T-cell engager antibody construct that has previously been granted breakthrough therapy, priority review, and orphan drug designations by the FDA. It binds to CD19 on the surface of cells of B-lineage origin, as well as CD3 on the surface of T cells. It is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump, which should be programmable, lockable, nonelastomeric, and have an alarm.
The drug’s latest indication is based on results from a Phase 1/2 open-label, single-arm, multicenter trial designed to evaluate its safety and efficacy in pediatric patients with relapsed or refractory B-cell precursor ALL. With treatment completed, the study’s subjects are now being monitored for long-term efficacy.
Potentially life-threatening or fatal cytokine release syndrome and neurological toxicities have been reported in some patients who received Blincyto. Other warnings and precautions included in the drug’s label are serious infections, tumor lysis syndrome, neutropenia and febrile neutropenia, effects on driving ability, elevated liver enzymes, pancreatitis, and leukoencephalopathy.
Pharmacists should also be aware of the risk for preparation and administration errors, including underdose and overdose. Plus, vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of treatment, during treatment, and until immune recovery following the last cycle of Blincyto.
BIOGEN ALZHEIMER’S DRUG ADUCANUMAB EXCEEDS EXPECTATIONS
Massachusetts-based Biogen Idec (BIIB) revealed the results of a Phase Ib study today that looked at aducanumab as a form of treatment for prodromal or mild Alzheimer’s disease. The data showed that the drug, also known as BIIB037, could reduce amyloid plaque in the brain, which is thought to play a key role in the development of Alzheimer’s disease symptoms. Biogen Idec’s stock is now up 4 percent since closing on March 19.
The results from the study, also referred to as PRIME, will be presented at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Nice, France. PRIME is an ongoing Phase Ib randomized, double-blind, placebo-controlled, multiple-dose study designed to look at the safety, tolerability, pharmacokinetics and pharmacodynamics of aducanumab in patients with the disease.
A total of 166 patients participated in the 54-week-long study. At Week 54, the group of patients who had received aducanumab saw a significant reduction in amyloid plaque.
“This is the first time an investigational drug for Alzheimer’s disease has demonstrated a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease,” said Alfred Sandrock, group senior vice president and chief medical officer at Biogen Idec.
FDA APPROVES NEW INDICATIONS FOR HARVONI AND SOVALDI IN PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH CHRONIC HEPATITIS C INFECTION
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved supplemental indications for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi® (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg. Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection. Sovaldi was approved for pediatric patients with genotype 2 or 3 chronic HCV infection, in combination with ribavirin. There are an estimated 23,000-46,000 pediatric HCV patients in the United States, most of whom were infected with the virus at birth.
“The approvals of Sovaldi and Harvoni for pediatric patients will enable adolescents to finally benefit from interferon-free treatment for HCV infection,” said Karen Murray, M.D., professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s. “These therapies address a significant unmet medical need and represent an important advance for HCV-infected adolescents.”
“Gilead’s goal is to develop and deliver treatments that provide all patients with HCV the potential to be cured,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “For the first time, children 12 and older in the United States with genotypes 1 through 6 chronic HCV infection now have options of two direct-acting antiviral regimens that offer high cure rates while eliminating the need for interferon injections.”
Harvoni and Sovaldi each have a boxed warning in their respective product labels regarding the risk of hepatitis B virus reactivation in HCV/HBV co-infected patients. See below for important safety information.
TRESIBA LABEL SEEKS HYPOGLYCEMIA TRIAL DATA INCLUSION
Novo Nordisk has submitted a supplemental application to the FDA to include data from the 2 phase 3b SWITCH trials in the prescribing information for insulin degludec (Tresiba), a once-daily basal insulin that provides a duration of action beyond 42 hours for patients with type 1 and type 2 diabetes.
In the SWITCH 1 trial, patients with type 1 diabetes were randomized to crossover treatment with Tresiba and insulin glargine U100, both in combination with an oral antidiabetic agent. Those treated with Tresiba had an average of 11% fewer episodes of blood glucose-confirmed symptomatic hypoglycemia. They also had 35% fewer episodes of severe hypoglycemia and 36% fewer episodes of nocturnal blood glucose-confirmed symptomatic hypoglycemia.
In the SWITCH 2 trial, patients with type 2 diabetes were randomized to crossover treatment with Tresiba and insulin glargine U100, both in combination with an oral antidiabetic agent. During the study’s maintenance period, those who were given Trebsiba had 30% fewer episodes of overall blood glucose-confirmed symptomatic hypoglycemia. They also exhibited 42% fewer episodes of nocturnal blood glucose-confirmed symptomatic hypoglycemia.
In both trials, the mean HbA1C baseline was 7.6%, and both studies showed that Tresiba was noninferior to insulin glargine U100 in terms of HbA1C reduction, meaning the requirements for objectively comparing hypoglycemia episodes between the 2 treatments were met.
“Hypoglycemia continues to be a real challenge for many people with type 1 and type 2 diabetes,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, in a press release. “We believe that inclusion of the SWITCH trial results in the prescribing information for Tresiba will provide health care professionals with important information to make an informed choice when prescribing basal insulin.”
ASPIRIN, OMEPRAZOLE COMBINATION TREATMENT YOSPRALA APPROVED
The FDA recently approved Aralez Pharmaceuticals’ Yosprala, a once-daily, fixed-dose combination of the antiplatelet agent aspirin and the proton pump inhibitor omeprazole.
Yosprala is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events, as well as those at risk of developing aspirin-associated gastric ulcers. It contains 40 mg of immediate-release omeprazole and either 81 mg or 325 mg of delayed-release, enteric-coated aspirin. It is not interchangeable with the individual components of aspirin and omeprazole.
The drug’s launch is planned for the first week of October 2016.
“The approval of Yosprala …helps address the current public health dilemma around patient discontinuation of daily aspirin therapy, which has potentially serious consequences,” stated Aralez Chief Executive Officer Adrian Adams in a press release. “Yosprala is designed to help at-risk patients, who need the cardioprotective benefits of daily aspirin, stay on their important treatment while reducing the risk of developing gastric ulcers. We believe Yosprala represents an important new therapeutic option for this group of patients and health care providers who strive to improve patient adherence to daily aspirin therapy.”
Yosprala’s approval was based on the results from 2 randomized, double-blind, controlled clinical trials that compared Yosprala 325 mg/40 mg with 325 mg of enteric-coated aspirin. Each study achieved its individual primary endpoint with patients in the Yosprala arm experiencing significantly fewer endoscopic gastric ulcers than those taking enteric-coated aspirin alone. In addition, significantly fewer patients treated with Yosprala discontinued therapy because of prespecified upper gastrointestinal adverse events compared with those in the enteric-coated aspirin arm.
The most common adverse effects associated with Yosprala are indigestion, heartburn, nausea, stomach-area pain, diarrhea, growths in the stomach, and chest pain. Patients and health care professionals should also watch for kidney and liver problems, low magnesium and vitamin B12 levels, bone fractures, and diarrhea caused by Clostridium difficile during Yosprala use.
OHR PHARMA’S OHR-102 FAILS IN PHASE II, SHARES PLUNGE
New York-based Ohr Pharmaceutical released results from its Phase II IMPACT study today, which evaluated OHR-102 for the treatment of the wet form of age-related macular degeneration. The treatment failed to achieve its primary endpoint, and shares of the company are now down more than 60 percent.
OHR-102, a 0.2 percent squalamine lactate ophthalmic solution, is a combination therapy for back-of-the-eye diseases. IMPACT was designed to compare OHR-102 to Lucentis monotherapy in patients with wet-AMD. One group of patients received OHR-102 eye drops twice a day plus Lucentis PRN, while another group received Lucentis PRN and placebo eye drops.
The study results showed that there was not a significant difference in the benefit in the overall population of participants.
However, the researchers found that 42 percent of patients receiving OHR-102 achieved a 3-line gain at nine months, compared to 28 percent of those receiving Lucentis. Additionally, the positive effect on visual acuity in classic containing choroidal neovascularization persisted throughout the trial.
“Now that the full data from the Phase II study is available, we are thoroughly evaluating all of the underlying factors that may have contributed to variability in patient response,” said Jason Slakter, chief medical officer of Ohr Pharmaceutical. “These analyses will help guide and optimize the design of the Phase III trials of OHR-102 in wet-AMD.”
STUDY: MOOD-REPORTING APP COULD HELP UNDERSTAND PATIENTS WITH MODERATE-TO-SEVERE DEPRESSION
Research shows monitoring mood with an app can help gauge depression levels in patients. ( Christopher Furlong | Getty Images )
Major depressive disorder impacts approximately 14.8 million adults in the U.S. each year. To better understand depression, researchers recently looked at how mood-tracking could potentially help doctors assess the condition.
The results, which were presented last week at the American Psychiatric Association’s annual meeting, found that the solution could actually be as simple as an app.
Over the course of eight weeks, researchers looked at 25 patients with major depressive disorder, with or without comorbid anxiety disorder. They asked them to track their daily moods using a Smartphone and Online Usage-Based Evaluation for Depression app. The app, which was downloaded onto their mobile devices, could capture sensor data like text messaging time and phone calls. Actual depression and anxiety symptoms were measured bi-weekly using tools commonly utilized by clinicians to diagnose certain mental health conditions — the Patient Health Questionaire-9 (PHQ-9), the Hamilton Rating Scale for Depression (HAM-D) and the Hamilton Anxiety Rating Scale (HAM-A).
Nidal Moukaddam, who presented the results at the APA Annual Meeting, said that 82 percent of the study participants performed “fairly well,” inputting their daily moods into the app as instructed. According to app feedback, some were even “enjoying” it.
In regard to patients who had moderate-to-severe depression, there was a high correlation between self-reported mood and clinically-administered questionnaires. The study indicates that an app that requires mood-reporting may complement data that stems from the questionnaires issued by practitioners.
It’s also worth noting that there was not as much correlation in patients with milder depression. For this reason, the study suggestions that smartphone data may be more practical in better understanding patients with moderate-to-severe depression. The researchers behind the piece claim that their findings are still preliminary — more work needs to be replicated in larger studies for more information. They intend to expand upon their original work by examining adolescent and perinatal populations in the future.
Up to 80 percent of individuals who receive treatment for depression show an improvement in their symptoms within four to six weeks of beginning medication, psychotherapy or a combination of these treatments. However, nearly two out of three people living with depression do not actively seek or receive proper treatment.
[As seen on: Tech Times]
OXACILLIN LOT RECALLED DUE TO IRON OXIDE PARTICULATE MATTER
Sagent Pharmaceuticals is recalling one lot of injectable oxacillin because a single vial contained dark particulate matter identified as iron oxide.
The recalled product is packaged in cartons containing 10 x 10-g pharmacy bulk package bottles identified by NDC 25021-163-99, manufactured by Astral SteriTech Private Limited, and distributed by Sagent. The single lot number being recalled is Lot OXT512, which was distributed to hospitals, wholesalers, and distributors nationwide from June 2016 through July 2016 and expires in March 2017.
Oxacillin is indicated to treat infections cause by penicillinase-producing staphylococci that have shown susceptibility to the drug. If metal particulate is in the product and administered to a patient, it may cause local swelling, irritation of blood vessels or tissue, or blockage of blood vessels—the latter of which can lead to serious and potentially life-threatening adverse effects, such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
To date, Sagent is not aware of any known adverse events resulting from the use of the recalled product lot. Nevertheless, the company is encouraging its customers to contact their physician or health care provider if they have experienced any problems related to taking or using this product. Adverse reactions or quality problems should also be reported to the FDA’s MedWatch Adverse Event Reporting program.
Sagent is also instructing its customers to examine their inventory immediately and to quarantine, discontinue distribution of, and return any recalled product. Anyone who may have further distributed the product should identify their customers and notify them of this product recall immediately.
FDA EXTENDS REVIEW PERIOD FOR IDEGLIRA DIABETES TREATMENT
The FDA has extended the regulatory review period for Novo Nordisk’s IDegLira, a potential once-daily fixed combination of insulin degludec (Tresiba) and liraglutide (Victoza) for adults with type 2 diabetes.
Novo Nordisk originally submitted the New Drug Application for IDegLira in September 2015, and the product received a unanimous 16-0 vote in favor of approval from an FDA advisory committee in May 2016. However, the FDA just informed the manufacturer that a 3-month extension is required to complete its review of the drug.
With this extension, the FDA’s anticipated action date is now in December 2016.
Back in September 2014, the drug was granted marketing authorization by the European Commission under the brand name of Xultophy. In Europe, the product is indicated for the treatment of adults with type 2 diabetes to improve glycemic control in combination with oral glucose-lowering medicinal products when they alone or combined with basal insulin do not provide enough glycemic control.
“We believe that Xultophy represents a new paradigm with the potential to transform how type 2 diabetes is treated,” stated Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, at the time of the drug’s approval in Europe.
Xultophy has been shown to improve glycemic control in insulin-naïve patients with type 2 diabetes, as well as those uncontrolled on basal insulin. In the latter group, Xultophy has demonstrated significant reduction in HbA1C.
INVESTIGATIONAL ALZHEIMER’S TREATMENT RECEIVES FDA FAST TRACK DESIGNATION
The FDA has granted Fast Track designation to Lilly and AstraZeneca’s investigational treatment for Alzheimer’s disease.
AZD3293 is an oral beta secretase cleaving enzyme (BACE) inhibitor currently in phase 3 clinical trials, though the Fast Track designation may expedite its development and FDA review. Because BACE is associated with the development of amyloid beta, inhibiting this enzyme is expected to prevent the formation and build-up of amyloid plaque in the brain, which in turn may help slow the progression of Alzheimer’s disease.
“BACE inhibitors have the potential to transform the treatment of Alzheimer’s disease, one of the biggest challenges facing medical science today,” stated Craig Shering, AZD3293 project lead in global medicines development at AstraZeneca, in a press release.
Thus far, AZD3293 has been shown to reduce levels of amyloid beta in cerebrospinal fluid in patients with Alzheimer’s and healthy volunteers.
Lilly and AstraZeneca will continue the AMARANTH phase 2/3 study, and they are also planning to start a second DAYBREAK-ALZ phase 3 trial for AZD3293, which will examine the drug’s safety and efficacy in patients with mild Alzheimer’s dementia. Enrollment will begin in the third quarter of 2016.
“We are pleased the FDA places a high priority on the development of drugs that target Alzheimer’s disease,” stated Phyllis Ferrell, vice president and global development leader for Alzheimer’s disease at Lilly, in the press release. “Most importantly, this is a positive step forward for the millions of patients, families, caregivers, advocates and health care providers who fight every day for progress.”
NAVIGATING DIGITAL APPS FOR MULTI-CHANNEL MARKETING IN PHARMA
Approximately 70 percent of mobile searches lead to an online action within an hour, according to iAcquire, the digital marketing agency. As of 2012, eMarketer reported that more than 116 million Americans owned a smartphone. In order to go beyond white papers and case studies, pharma professionals must utilize digital apps to take advantage of multiple channels. As more consumers filter into the mobile channel, additional opportunities are sprouting for pharma professionals.
Prioritizing Marketing Needs
Today, there are several channels that can be used to reach out to specific audiences. Some of these include social media, the company blog and the company website. In order to make the most of these channels, pharma companies need to quickly determine which digital apps work best for their initiatives.
Take social networking, for example. It may be critical for a marketing team to use Facebook if its target demographic is frequently on the site. Facebook reported in March 2014 that it has one billion active users on its mobile app, according to The Verge. This information indicates that the marketers should utilize the Facebook app to work with this channel.
Understanding which channels create connections to the target audience is essential for pharma professionals navigating through digital apps.
Understanding the Customer
In the pharmaceutical industry, customers may range from medication distributors to patients. It’s critical for companies to focus on their primary audience above all else, as well as targeted messaging. Crafting highly specific campaigns and messaging remain top challenges for pharma professionals navigating through digital apps.
Identifying the specific pain points of the target customer can help companies use digital apps effectively. When pharma companies can pinpoint the problems of their prospects, they can provide more viable solutions via digital apps.
GRACE 2.0 from AstraZeneca is one example of an app that can uncover patients’ pain points, specifically for companies focusing on heart health. GRACE 2.0 is based on the Global Registry of Coronary Events, which holds information that is key to identifying high-risk heart patients and their complications.
Addressing Pharma App Overload
There are more than 7,000 medical apps in the iTunes store alone. The lack of curation in combination with the abundance of features make it challenging for pharma professionals to identify which apps are best for their strategy.
For this reason, self-curation is necessary for individuals to make most of available apps. Over time, there may be evident overlap in the functionality of numerous applications.
Medical Reader for iOS is one example of an app that can help pharma professionals slim down their number of applications. Although it does not provide access to full length articles, it stores the most recent pieces from the New England Journal of Medicine, The Lancet and Journal of the American Medical Association. This eliminates the need to download multiple apps for access to widespread information.
Ideas for the Future
As the pharmaceutical industry continues to evolve, companies need to be prepared to change alongside it. Furthermore, they need to be on top of channels as they grow over time. By aligning company strategy with the pain points of customers, pharma companies can increase their chances of success through multiple channels.
7 COMMON STERILE COMPOUNDING QUESTIONS RELATED TO USP 800
Handling hazardous drugs requires a certain amount of precautionary measures. For this reason, Chapter 800 has been created to address everything from HD handling to exposure levels. Additionally, it stresses Occupational Safety and Health Administration standards and continues to make them a priority, according to Gates Healthcare Associates. Let’s take a look at some of the most frequently asked questions associated with USP 800, as well as their answers.
- What are the Types of Exposure Addressed within USP 800?
As explained in Chapter 800 posted by USP.org, exposure may occur within the body when hazardous materials are inhaled, injected or ingested. Individuals may find themselves exposed to the product when they come into skin contact with it as well. Weighing or mixing chemicals, expelling HDs in a syringe, or unpacking HD orders can all put humans at risk. The OSHA, Environmental Protection Agency, and other administrations recommend that HD workers continue to expand upon their knowledge of handling these materials with educational materials as they become available.
- What is the Storage Protocol Associated with USP 800?
Within USP 800, it is stated that all hazardous materials should be labeled in their storage areas or containers to eliminate the risk of improper handling. HDs should also be stored separately from the rest of inventory to reduce the chance of contamination and human exposure. In the event that HDs need to be refrigerated, they should be done so in a refrigerator dedicated to HDs. Finally, these materials should be placed at or below eye level to prevent breakage.
- What are the Containment Primary Engineering Controls for Sterile Compounding According to USP 800?
The C-PEC should be placed in an ISO Class 7 buffer area, according to Chapter 800. This location should be separate from other preparation areas and have a minimum of 30 ACPH or HEPA-filtered supply air. Additionally, the buffer area should be maintained at a negative air pressure of at least 0.01 inches of water column (relative to adjacent spaces).
- Do the Standards Change for a Compounding Aseptic Containment Isolator that Meets Chapter 797 Requirements?
In the event that a CACI meets requirements listed in Chapter 797, it may be placed in a C-SCA that is physically separated. However, it does not need to be ISO 7 or contain HEPA-filtered air.
- What are the Benefits of Personal Protective Equipment?
PPE is essential for workers who are handling both nonsterile and sterile compounding tasks. They limit the amount of exposure to HD aerosols and drug residue, according to USP 800. Furthermore, they are necessary in the event of a spill or other cleaning tasks that enhance the risk of HD exposure. PPE should be worn while transporting compounded HDs, receiving intact supplies, collecting waste and handling broken supplies.
- What are the Transportation Standards Specified in Chapter 800?
In terms of USP 800, personnel responsible for handling HDs are encouraged to maintain everything from temperature to stability when transporting the products. Packing should be done according to the best methods that prevent breakage, leaking and other damage. Furthermore, compounding personnel are responsible for maintaining temperatures during transit. Proper labeling and storage instructions must be included on HDs.
- Who is Responsible for HD Dosage Forms?
Compounding personnel are responsible for making sure that HDs are appropriately measured, diluted, mixed and identified. They must also ensure they are sterile if necessary and maintain the cleanliness of conditions around the HDs. Labels should be provided, as well as supplementary instructions, for those who receive the products.
While there are more questions that may come up while reviewing USP 800, the Compounding Expert Committee and the Compounding with Hazardous Drugs Expert Panel have included extensive details online to address any concerns.
PROPOSED REVISIONS TO USP797
In an effort to prevent harm through contamination, the U.S. Pharmacopeial Convention proposed a series of changes to USP 797 in September 2015. Pending approval, a series of compounded sterile preparations (CSP) will be affected, including injections, irrigation solutions for internal body cavities, ophthalmics and aqueous bronchial inhalations.
Furthermore, the changes to USP 797 will apply to all individuals who prepare compounded sterile preparations, as well as those who work in these environments. Administrative professionals are exempt from the guidelines of USP 797.
The Purpose of Change
USP 797 is being altered to prevent harm through microbial contamination, excessive bacterial endotoxins and inappropriate quality of ingredients. Additionally, USP 797 will be updated to reduce risk associated with unintended physical and chemical contaminants, as well as variability in intended strength.
Currently, USP 797 is enforceable by the U.S. Food and Drug Administration, as well as 28 State Boards of Pharmacy.
Proposed Major Changes to USP 797
There are a series of major changes being proposed to USP 797, including the rejection of the following statement from Section 503A:
“Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling.”
Additionally, a new Beyond-Use-Date paradigm has been presented as a part of USP 797. The proposed rule states that the BUD can only be determined from the time that the CSP is compounded. Furthermore, the BUD cannot exceed 45 days, regardless of sterility testing.
Here is a summary of additional proposed changes to USP 797.
- Master formulation and compounding records will be required for all batch and non-sterile compounding activities.
- “In-Use Time” will be used to describe the time before which a manufactured product or compounded dilution bag must be utilized after it has been punctured.
- Sterile items, such as gloves and sleeves, need to be re-sterilized before further use.
- Viable air and Surface sampling is required each month.
- A visual observation of hand hygiene and garbing must be conducted every quarter.
- USP 800 will be used to outline Hazardous Drug requirements.
- Three risk levels have been changed to two categories, which are distinguished according to the conditions under which they are made and time within which used.
CSP Categories Under USP 797
The two categories under USP 797 would be titled “Category 1 CSPs” and “Category 2 CSPs.” Under the first category, endotoxin and sterility testing would not be required. The compounding environment also does not have to contain ISO classified air. Category 1 CSPs would have a BUD of 12 hours or less at room temperature and 24 hours or less when refrigerated.
The BUD for Category 2 CSPs would be the same, and endotoxin testing would not be required for sterile components. However, sterility testing would be recommended based on the BUD, and the environment is required to have ISO classified air.
Personnel Training Under USP 797
Depending on whether the personnel is working with Category 1 or 2 CSPs, their garbing may vary. In all cases, non-cotton, low-lint disposable gowns should be worn. Head and facial hair should also be covered, and sterile sleeves and gloves must be used.
However, Category 2 CSPs would require the use of a mask, unlike Category 1 CSPs. Eye shields would also be an option for personnel handing Category 2 CSPs.
A gloved fingertip test would be recommended each quarter under the new USP 797 guidelines, as opposed to semi-annually or annually. A media fill would also be required quarterly, instead of semi-annually or annually. Furthermore, a failed test would require three repeats prior to restarting. At the moment, a failure constitutes requalification.
Under USP 797, a compounding area must be free of cracks and crevices. The buffer area around the compounding location must also be free of water sources, such as sinks or floor drains.
Category 2 CSPs must have a positive pressure buffer room with access through a positive pressure anteroom. It also needs to be situated in an ISO Class 7 area, or cleaning room, where garbing is worn by personnel.
The room temperature in both Category 1 and 2 CSPs should be at 20 degrees or cooler with a relative humidity level of less than 60 percent. In these conditions, a CSP cannot be re-frozen after it has been thawed.
The Introduction of Urgent-Use CSPs
Assuming the changes to USP 797 are implemented, “Urgent-Use” will replace “Immediate-Use” in terms of specific CSPs that need to be utilized as soon as possible. The Urgent-Use guidelines state that a CSP can be prepared in conditions worse than ISO Class 5 air when it needs to be used for a single patient.
Compounding procedures are not permitted to exceed one hour, and an aseptic technique must be used during preparation.
Public responses to the proposed changes can be submitted on the Comment Submission Template, as seen on www.USP.org. Your comments will be accepted if they are sent to email@example.com January 31, 2016.
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