23 minute read
Not safe to touch: bad ergonomics puts compounders at risk
Revised USP <797> Will Call for More Resources
By David Wild
Now that USP has released its longawaited proposed revisions to General Chapter <797>—and assuming the chapter will not change significantly in its finalized form—hospital pharmacies are gearing up to meet the necessary requirements.
“Implementing the proposed revisions will come with challenges regarding costs and resources, but the safety of patients and compounding employees far outweigh these costs,” said Mary Nazzal, PharmD, the director of field operations, Kastango Consulting Group, a TRC Healthcare Company. “The USP <797> 2021 proposed revisions address many concerns, including clarifying requirements, providing expanded guidance for assigning beyond-use dates [BUDs], and renaming risk levels, which we saw in the 2019 version and are a move in the right direction for safety.”
Much Attention Paid to BUD Changes in <797>
Most of the attention regarding the proposed revisions to USP <797>— which was published in September 2021—has centered on the creation of
Category 1 CSPs Category 2 CSPs Category 3 CSPs
May be prepared in a PEC located in an unclassified segregated compounding area Must be prepared in a cleanroom suite Have additional requirements that must be met at all times
Assigned a BUD of ≤12 hours at controlled room temperature or ≤24 hours when refrigerated May be assigned a BUD of >12 hours at controlled room temperature or >24 hours if refrigerated May be assigned a BUD longer than established for Category 2 CSPs, up to 180 days
BUD, beyond-use date; CSPs, compounded sterile preparations; PEC, primary engineering control
three categories of compounded sterile preparations (CSPs) and their BUD requirements (Table). Under the proposed revisions, compounders who are willing to meet the most stringent quality assurance parameters can assign BUDs up to 180 days, Brenda Jensen, CPhT, CNMT, MBA, the chair of the USP Compounding Expert Committee, explained in a presentation at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually.
According to Ms. Jensen, the quality assurance requirements for “Category 3” CSPs include stringent sterility testing and endotoxin testing, when compounding from non-sterile starting ingredients, as well as more frequent personnel qualification evaluations, sterile garbing requirements, increased use of sporicidal disinfectants and more frequent environmental monitoring.
However, these very stringent Category 3 BUD requirements are less of a concern for many hospitals, most of which do not compound this category of CSPs, said Kenneth Jozefczyk, MS, the director of central pharmacy services, BayCare Health System, in Tampa, Fla. “I’m pretty sure we won’t be veering into this third category because it requires a significant investment in garb, equipment and workflow,” said Mr. Jozefczyk, who was not involved with the ASHP presentation.
Although Category 1 and 2 compounders do not need to meet the level of stringency required for Category 3 agents, as Ms. Jensen noted during her talk, they will still need to perform more frequent monitoring and testing than was in previous versions of USP <797>.
For example, while the still official 2008 version of USP Chapter <797> requires that surface sampling be done “periodically,” the proposed revision would require monthly surface sampling for Category 1 and 2 compounds. The proposed revisions also would mean more frequent evaluation of
see USP <797>, page 9
The 10 Principles of Compounding Ergonomics
By David Wild
Although compounding medications can be rewarding, the repetitive tasks involved can strain the muscles and joints. In light of the risk for injury, one expert who spoke on the topic at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually, emphasized the importance of preventing musculoskeletal injuries before they occur.
“Every colleague I have talked to has at least one associate with an injury, and recovery can take months and be debilitating for activities of daily living as well as for work,” said Dennis Tribble, PharmD, the director of clinical innovations and medical affairs for Medication Management Systems at BD.
To help prevent compounding-related injuries, Dr. Tribble shared 10 principles of compounding ergonomics: Work in a neutral posture. “The first and foremost notion in ergonomics is maintaining an appropriate posture and an ‘S-curve,’ to the spine,” Dr. Tribble said. To help achieve this, use chairs with lumbar support and orient work to keep elbows at the side and to avoid excessive reaching or leaning. Reduce excessive force. “The force required to push 20 mL through a 27-gauge syringe with a 1.5-inch needle over 20 seconds is about 10 pounds, and you can imagine the stress it places on the hands and wriststo do that tens or hundreds of times a day,” Dr. Tribble said. To mitigate this effect, he recommended using the smallest syringe possible to deliver a dose along with the largest needle that will also avoid coring, and to consider using a spike adapter for multiple draws from the same vial. Pharmacy pumps and IV robotics can also help reduce the force required with repetitive dose preparation and delivery, he said. Keep everything within easy reach. “It can be tricky to put everything in the hood within arm’s reach, but you really want to do that,” Dr. Tribble said. For example, IV workflow equipment should be within easy reach while preserving the direct compounding area.
Work at the proper
height. “Ordinarily, work at elbow level is the most ergonomic, but there are exceptions,” he said. “If you have to read documents with small fonts or perform close visual inspection, working at eye level is better than having to bend or extend the neck.” Reduce excessive motion. “Wrist extension and inflection are probably the two things we do most when manipulating syringes, so you want to be sure these motions are not exaggerated because it can lead to repetitive strain injury,” he said. When drawing multiple doses from large compounding vials, a spike adapter and rearranging the working layout to keep the direct compounding area clear can minimize the amount of reaching. Minimize fatigue and static load. “If you can provide compounders with footrests and other accommodations that permit occasional shifting of foot or leg positions and that are easy to disinfect, that may keep them more comfortable for longer periods of time,” Dr. Tribble said. Minimize pressure points. Squeezing fingers or leaning arms and legs against edges of work surfaces can lead to injuries. Padding is the best option to mitigate this. Provide clearance. “We don’t often think of this when we think about ergonomics, but providing an unobstructed ability to perform the ordinary motions of your job is critical,” Dr. Tribble said. Assess the compounding area and ensure compounders have the clearance needed to do their work, he advised. Move, exercise and stretch. “Doing anything in one place for a long time in one position can cause injuries, so you really want to find ways to move, stretch and exercise,” he said. Break times should be scheduled, and staff can be rotated through the cleanroom. Maintain a comfortable environment. “I’ve been in a few cleanrooms where the fan drivers of a hood were out of balance to the point that someone using a gravimetric system couldn’t get the scale to settle because the vibrations were so bad,” Dr. Tribble said. Resolve these issues, because physical vibrations and noise can also prompt workaround behaviors that, in turn, lead to inappropriate posture.
For more information, visit the Occupational Health and Safety Agency for Healthcare’s ergonomics guide for hospital pharmacies (www.osha.gov/ ergonomics).
To avoid repetitive motion injuries,IV workflow equipment should be within easy reach while preserving the direct compounding area. Dr. Tribble reported that he is an employee and shareholder of BD.
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INDICATIONS AND USAGE
Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
IMPORTANT SAFETY INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning. • Morphine Sulfate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. • Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
Morphine Sulfate Injection is contraindicated in patients with: • Significant respiratory depression. • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. • Known or suspected gastrointestinal obstruction, including paralytic ileus. • Hypersensitivity to morphine. Cardiovascular Instability: High doses are excitatory. Have Naloxone Injection and resuscitative equipment immediately available. Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma. The most serious adverse reactions encountered are respiratory depression, apnea, circulatory depression, respiratory arrest, shock and cardiac arrest. Common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, constipation and diaphoresis.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Morphine Sulfate Injection if serotonin syndrome is suspected. Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Morphine Sulfate Injection because they may reduce analgesic effect of Morphine Sulfate Injection or precipitate withdrawal symptoms. Pregnancy: May cause fetal harm. Overdosage: Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose.
This important safety information does not include all the information needed to use MORPHINE SULFATE INJECTION safely and effectively. Please see full prescribing information, including Boxed Warning, for MORPHINE SULFATE INJECTION at www.fresenius-kabi.com/us.
Simplist® Morphine Sulfate Injection, USP CII for intravenous or intramuscular use.
BRIEF SUMMARY OF PRESCRIBING INFORMATION
This brief summary does not include all the information needed to use MORPHINE SULFATE INJECTION, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for MORPHINE SULFATE INJECTION, USP at www.fresenius-kabi.com/us.
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse Morphine Sulfate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Morphine Sulfate Injection, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions].
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Injection. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Injection, or following a dose increase. Because of delay in maximum CNS effect with intravenously administered morphine (30 min), rapid IV administration may result in overdosing [see Warnings and Precautions].
Neonatal Opioid Withdrawal Syndrome Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions and Drug Interactions]. • Reserve concomitant prescribing of Morphine Sulfate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions], reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., nonopioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia
CONTRAINDICATIONS
Morphine Sulfate Injection is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions]. • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment [see Warnings and Precautions]. • Concurrent use of mon oamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions]. • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions]. • Hypersensitivity to morphine (e.g. anaphylaxis) [see Adverse Reactions].
WARNINGS AND PRECAUTIONS (also see BOXED WARNING)
• Addiction, Abuse, and Misuse: Morphine Sulfate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death [see Drug Abuse and Dependence]. Assess each patient’s risk prior to prescribing Morphine Sulfate Injection, and monitor all patients regularly for the development of these behaviors and conditions. • Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate
Injection. Monitor for respiratory depression, especially during initiation of
Morphine Sulfate Injection, or following a dose increase. Because of delay in maximum CNS effect with intravenously administered morphine (30 min), rapid IV administration may result in overdosing [see Overdosage]. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper. • Neonatal Opioid Withdrawal Syndrome: Prolonged use of Morphine
Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific
Populations]. • Risks from Concomitant Use with Benzodiazepines or Other CNS
Depressants: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Morphine Sulfate Injection with benzodiazepines or other CNS depressants (e.g. non-benzodiazepine sedatives/ hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. Follow patients closely for signs and symptoms of respiratory depression and sedation. • Cardiovascular Instability: High doses are excitatory. Have Naloxone Injection and resuscitative equipment immediately available. • Life-Threatening Respiratory Depression in Patients with Chronic
Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients:
Monitor closely, particularly during dose initiation and titration. • Interactions with Monoamine Oxidase Inhibitors (MAOIs): Morphine
Sulfate Injection should not be used in patients taking MAOIs or within 14 days of stopping such treatment. • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. • Risks of Use in Patients with Increased Intracranial Pressure, Brain
Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma. • Risks of Use in Patients with Gastrointestinal Conditions: Morphine
Sulfate Injection is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. • Increased Risk of Seizures in Patients with Seizure Disorders: Monitor patients with a history of seizure disorders for worsened seizure control. • Withdrawal: Use of mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms. • Central Nervous System Toxicity: Dysphoric reactions may occur after any size dose and toxic psychoses have been reported. • Exposure, Hypothermia, Immersion and Shock: Caution must be used when injecting any opioid intramuscularly into chilled areas or in patients with hypotension or shock, since impaired perfusion may prevent complete absorption; if repeated injections are administered, an excessive amount may be suddenly absorbed if normal circulation is re-established. • Risks of Driving and Operating Machinery: Morphine Sulfate Injection may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of
Morphine Sulfate Injection and know how they will react to the medication.
ADVERSE REACTIONS [see Boxed Warning and Warnings and Precautions] Serious adverse reactions associated with Morphine Sulfate Injection
included: addiction, abuse, and misuse, lifethreatening respiratory depression, neonatal opioid withdrawal syndrome, interactions with benzodiazepines or other CNS depressants, cardiac instability, adrenal insufficiency, severe hypotension, gastrointestinal adverse reactions, seizures, withdrawal, respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest. Rarely, anaphylactoid reactions have been reported when morphine or other phenanthrene alkaloids of opium are administered intravenously. The most frequently observed adverse reactions included: sedation, lightheadedness, dizziness, nausea, vomiting, constipation and diaphoresis. Other possible adverse reactions include: euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, visual disturbances, transient hallucinations and disorientation, constipation, biliary tract spasm, tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension, oliguria and urinary retention, pruritus, urticaria, skin rashes, opioid-induced histamine release (flushing of the face, diaphoresis, pruritus, and wheals and urticaria at the site of injection), androgen deficiency, anaphylaxis, serotonin syndrome, and adrenal insufficiency.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, at 1-800-551-7176, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS
Clinically significant drug interactions with Morphine Sulfate Injection: benzodiazepines and other central nervous system (CNS) depressants; serotonergic drugs; monoamine oxidase inhibitors (MAOIs); mixed agonist/ antagonist and partial agonist opioid analgesics; muscle relaxants; cimetidine; diuretics; anticholinergic drugs; and oral P2Y12 inhibitors.
USE IN SPECIFIC POPULATIONS
• Pregnancy: May cause fetal harm [see BOXED WARNING for Neonatal Opioid
Withdrawal Syndrome]. • Labor or Delivery: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Naloxone must be available for reversal for reversal of opioid-induced respiratory depression.
Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. • Lactation: Present in breast milk. Lactation studies have not been conducted and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Monitor infants for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of opioid analgesic is stopped, or when breast-feeding is stopped. • Females and Males of Reproductive Potential: Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible. • Pediatric Use: The safety and effectiveness in pediatric patients below the age of 18 have not been established. • Geriatric Use: Elderly patients (aged 65 years or older) may have increased sensitivity to morphine. Monitor for signs of central nervous system and respiratory depression. Start at the low end of the dosing range, titrate the dosage slowly and monitor for signs of CNS and respiratory depression. • Hepatic and Renal Impairment: Morphine sulfate pharmacokinetics are altered in patients with cirrhosis and renal failure. Start these patients with a lower than normal dosage and monitor for signs of respiratory depression, sedation, and hypotension.
OVERDOSAGE
Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose. In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. Because the duration of opioid reversal is expected to be less than the duration of action of morphine in Morphine Sulfate Injection, carefully monitor the patient until spontaneous respiration is reliably reestablished.
For full Prescribing Information please go to www.simplist-us.com
USP <797>
continued from page 6
compounders’ competencies and more frequent media fill testing, which would require two incubators to accommodate changes in incubation temperatures.
“This update seems to be of concern to many in the field, as they often don’t have two incubators available or don’t have the space to add an additional incubator,” Dr. Nazzal said.
One tactic that some hospital pharmacies have taken when their incubation needs have exceeded their in-pharmacy capacity has been to ask their hospital’s microbiology laboratory to add “a few extra samples to their incubator, but now they’re going to need a little bit more of a formal plan to get incubator space or, in some cases, purchase incubators,” Mr. Jozefczyk said.
The Ins and Outs of Testing
Hospitals that outsource their environmental testing should prepare to perform some testing internally, said Patricia Kienle, RPh, MPA, the director of accreditation and medication safety at Cardinal Health, who was not involved with the ASHP presentation but is a member of the USP Compounding Expert Committee. “It’s unlikely that a hospital pharmacy would be able to get their certifiers to perform environmental testing every month, because of the cost and because certifiers are busy, so they’ll need to buy the equipment to do part of this testing themselves,” she said.
For these individuals, more frequent testing also will require access to a microbiologist, whether contracted or in-house, as well as additional testing kits or media, if incubating in-house, Ms. Kienle said. “I would encourage hospital pharmacies to get up to speed on this and figure out how they’re going to meet these requirements,” she added.
Changes to Ophthalmic Preparations
One concern that came up during the development of the proposed Chapter <797> centered on the revised requirements for preservative-free ophthalmic preparations. “To prevent contamination, these need to be packaged in unit-dose ophthalmic containers, but unit-dose devices are only available to manufacturers,” Ms. Jensen said. “A hospital pharmacy would need to package those preparations in unit-dose syringes instead of containers, which comes with the risk of accidentally being injected.”
The USP Compounding Expert Committee ultimately decided to allow ophthalmic compounds to be packaged in multidose containers as long as they are assigned BUDs according to the requirements for Category 1, 2 and 3 CSPs, Ms. Jensen said. “The caveat is that once opened, the container must be discarded after 24 hours when stored at room temperature and after 72 hours if stored refrigerated.”
Despite that accommodation, “the chatter in the field is that this update will significantly impact those who prepare non-preserved ophthalmic CSPs,” Dr. Nazzal said. “Many of these CSPs are antibiotics and given over seven to 14 days, so they are noncompliant with the requirement [for a maximum BUD of 72 hours].”
To be compliant, she said, pharmacies would need to build more robust processes—such as Chapter <51> on antimicrobial effectiveness testing and Chapter <1207> on container closure integrity testing—and potentially dispense separate multiple containers to accommodate the need for shorter BUDs.
“I am sure the USP committee will get tons of feedback on this section, and I look forward to seeing what they come up with,” she said.
Noting that the proposed USP <797> revisions are open for public comment until Jan. 31, 2022, Dr. Nazzal said, “I hope that USP and compounding pharmacies can agree on the standards in the next release, so that pharmacies are not afraid to move forward. The longer we wait for the final version, the longer patients may be subjected to suboptimal care by compounding pharmacies doing things they should not be doing.”
Free CE/CME now available!
1.0 AMA PRA Category 1 Credit™
Ms. Jensen and Ms. Kienle are members of the USP Compounding Expert Committee. Ms. Kienle noted that her comments are her own. Dr. Nazzal and Mr. Jozefczyk reported no relevant fi nancial disclosures.
Managing HIV Multidrug Resistance: A Persistent Challenge
RELEASE DATE: DECEMBER 1, 2021 EXPIRATION DATE: DECEMBER 31, 2022
This activity is jointly provided by Global Education Group and Applied Clinical Education.
This activity is supported by an educational grant from ViiV Healthcare and Merck & Co., Inc.
Distributed by Infectious Disease Special Edition and CMEZone.com
Faculty
Paul E. Sax, MD
Clinical Director, Division of Infectious Diseases Professor of Medicine, Harvard Medical School Brigham and Women’s Hospital Boston, Massachusetts
Julia Garcia-Diaz, MD, MSc, FACP, FIDSA, CPI
Director Clinical Infectious Diseases Research Director Medical Student Research Associate Professor, University of Queensland Brisbane, Australia Department Infectious Diseases Ochsner Health System New Orleans, Louisiana
