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20 AJN ▼ August 2023 ▼ Vol. 123, No. 8

DRUG TO PREVENT PRETERM BIRTH IS WITHDRAWN

• Makena (hydroxyprogesterone caproate injection), the only approved drug for preventing preterm birth, has been with- drawn from the market after clinical trial findings suggest it is not effective.

Makena (hydroxyprogesterone caproate injection), the only

drug approved by the Food and Drug Administration (FDA) for preventing preterm birth, has been withdrawn from the market based on clinical trial findings suggesting it is not effective. According to the Centers for Disease Control and Prevention, about one in 10 infants in the United States is preterm (born before 37 weeks of pregnancy).1

Makena was granted acceler- ated approval in 2011. The post- marketing clinical trial sponsored by the drug’s manufacturer was a double-blind, placebo-controlled, international trial involving women who had a previous preterm single- ton birth: 1,130 women received Makena and 578 women received placebo. The study concluded that Makena did not decrease the num- ber of preterm births, and that there were no differences in the fre- quency of fetal/early infant deaths or in maternal outcomes between those who received Makena and those who received placebo.2

In October 2020, the FDA’s Center for Drug Evaluation and Research proposed that Makena be withdrawn from the market based on the trial’s findings. How- ever, the drug was allowed to re- main on the market while the manufacturer appealed the deci- sion. Two years later, in October 2022, the FDA’s Obstetrics, Repro- ductive and Urologic Drugs Advi- sory Committee met to hear the appeal and vote on whether they would recommend that Makena remain on the market; 14 voted no and one voted yes. (For more on

the advisory group meeting, go to www.fda.gov/advisory-committees/ advisory-committee-calendar/ updated-information-october-17- 19-2022-hearing-announcement- involving-obstetrics-reproductive- and.)

In April 2023, the FDA an- nounced that Makena would be withdrawn from the market. This decision affects both the brand name Makena and its generic for- mulations. The drug can no lon- ger be distributed in interstate commerce.

To read the FDA News Re- lease regarding Makena, see www.fda.gov/news-events/press- announcements/fda-commissioner- and-chief-scientist-announce- decision-withdraw-approval- makena.

REFERENCES 1. Centers for Disease Control and

Prevention. Preterm birth. Atlanta; 2022 Nov 1. Reproductive health; https:// www.cdc.gov/reproductivehealth/ maternalinfanthealth/pretermbirth.htm.

2. Blackwell SC, et al. 17-OHPC to pre- vent recurrent preterm birth in single- ton gestations (PROLONG study): a multicenter, international, random- ized double-blind trial. Am J Perinatol 2020;37(2):127-36.

OPIOID USE: REVISED WARNINGS, PATIENT EDUCATION, AND SAFETY CONSIDERATIONS

• The Food and Drug Administra- tion (FDA) is revising the label- ing of all prescription opioids in an effort to decrease the num- ber of deaths associated with these pain medications.

• Nurses and NPs looking for re- sources to use when providing patient education on safe use of opioids should be aware of a national FDA campaign called “Remove the Risk.”

• Nurses administering the long- acting opioid antagonist nal- trexone for extended-release injectable suspension (Vivitrol) should be aware of the high risk of clogging within the syringe.

The National Institute on Drug Abuse reports that in 2021 (the

most recent data available) there were 80,411 deaths from opioids, 16,706 of which were from pre- scription opioids.1 Although the overall national dispensing rate of opioid prescriptions has declined from 2012 to 2020, the Centers for Disease Control and Prevention reports that in 2020 more than 142 million opioid prescriptions were dispensed in the United States.2

Revised label warnings. In a continuing effort to decrease the number of deaths from opioid pain medications, the Food and Drug Administration (FDA) is re- vising the language used in prod- uct labeling and patient guidance. The labeling for all opioid pain medications, whether immediate release, extended release, or long acting, will now warn that the risk of opioid overdose increases as the dose increases. The labeling for immediate-release opioids will state that the drugs should not be used for an extended period unless the pain is so severe as to require continuing them and other forms of treatment have not been effec- tive. The prescribing information for extended-release and long- acting opioid pain medications will warn that these drugs should be reserved for severe, persistent pain when other types of pain treatment have been inadequate. The boxed warnings for opioids will also be revised to more prom- inently display the risk of life- threatening respiratory depression and the risks associated with the combined use of opioids and ben- zodiazepines and other central nervous system (CNS) depressants.

Also being added to all opioid labels is a new warning about opioid-induced hyperalgesia, a state of nociceptive sensitization where a paradoxical response to opioids occurs, making the pa- tient more sensitive to certain painful stimuli. This new warn- ing will include information

DRUG Watch

Information on drugs, including new approvals and indications, warnings, and other regulatory updates.

AJN ▼ August 2023 ▼ Vol. 123, No. 8 21

differentiating opioid-induced hyperalgesia from opioid toler- ance and withdrawal.

After assessing a patient’s pain, nurses and NPs should offer alter- natives to opioids when indicated. NPs who prescribe opioids should educate patients on the risks of opioid use, especially long-term use, and discuss treatment plans that include alternatives to opioids and how to balance the risks and benefits of opioid use. Nurses and NPs should educate patients on the risks of respiratory depression and overdose and encourage the purchase of naloxone at the same time the opioid prescription is filled. Patients who are also tak- ing benzodiazepines or other CNS depressants should receive educa- tion on the potential additive risk of respiratory depression. NPs prescribing pain medication for acute episodes of pain should con- sider limiting the number of pills in a prescription, as patients with acute pain are frequently pre- scribed a larger number than needed—extra pills that can lead to overdose or misuse. When pain assessments indicate that a patient requires opioids for pain relief, the lowest effective dose should be prescribed for the shortest dura- tion. NPs should only prescribe extended-release and long-acting opioids for severe, persistent pain that has not been controlled by other treatments.

Nurses and NPs should suspect opioid-induced hyperalgesia if there is increased pain intensity de- spite increasing opioid doses, de- creased pain intensity in response to a decrease in opioid doses, or hypersensitivity to nonpainful stimuli (in the absence of opioid tolerance or withdrawal). Nurses, NPs, and patients should report adverse effects from opioid pain medication to the FDA MedWatch program at www.accessdata.fda. gov/scripts/medwatch/index.cfm.

To read the full Drug Safety Com- munication on the opioid labeling

changes, see www.fda.gov/drugs/ drug-safety-and-availability/fda- updates-prescribing-information- all-opioid-pain-medicines-provide- additional-guidance-safe-use.

Patient education. One strategy for decreasing the incidence of opi- oid abuse is to keep opioids away from people who do not have a pre- scription for them. Nurses and NPs should tell their patients who are prescribed opioids about the na- tional campaign from the FDA called “Remove the Risk.” The website includes information on home use and safe disposal of opi- oids, and a toolkit of free resources such as public service announce- ments, social media images and posts, and fact sheets that can be used in outreach campaigns. To ac- cess these resources, go to www.fda. gov/drugs/buying-using-medicine- safely/fda-health-playbook; under the heading “Remove the Risk,” click on the links for “Remove the Risk Outreach Toolkit” and “Safe Disposal of Medicines.”

Safety considerations for Vivitrol. Prescribed opioids can be a gateway to misuse or abuse of opioids, including illegal opioids. Abuse of illegal opioids increases the risk of overdose, as street drugs are more likely to contain fentanyl or other highly potent drugs. An important strategy for decreasing opioid overdose deaths is to de- crease the number of people who abuse or misuse opioids. Drug therapy is part of the treatment plan for those who wish to over- come opioid abuse. Intramuscular naltrexone extended-release inject- able suspension (Vivitrol) is indi- cated for patients who wish to prevent relapse into opioid depen- dence (the drug is also prescribed to prevent relapses into alcohol abuse).

Naltrexone extended-release in- jectable suspension is an opioid an- tagonist. Patients prescribed this medication must have completed opioid detoxification. The drug comes with equipment to dilute,

draw up, and administer it, includ- ing unique needles. Because the mi- crospheres in the medication tend to clot, multiple needles are in- cluded in the packet. The Institute for Safe Medication Practices warns of reported problems with medica- tion clogging in the syringe, pre- venting administration.3 To prevent this, nurses must follow the direc- tions for preparation of the naltrex- one injection in the product’s labeling. Using the needle designed for preparation, nurses should thor- oughly mix the room temperature microsphere and diluent vials and shake vigorously to create a suspen- sion. Properly prepared, the prod- uct is milky white without clumps and moves freely in the vial. Nurses should then withdraw the suspen- sion into the syringe, replace the preparation needle with one of the administration needles, and admin- ister immediately to prevent the sus- pension from separating. The product should be administered only into a deep gluteal muscle.

For full prescribing information for naltrexone extended-release injectable suspension, including directions for mixing and adminis- tration, see www.accessdata.fda. gov/ drugsatfda_docs/label/2010/ 021897s015lbl.pdf. ▼

REFERENCES 1. National Institute on Drug Abuse.

Drug overdose death rates. Rockville, MD; 2023 Feb 9. Trends and statistics; https://nida.nih.gov/research-topics/ trends-statistics/overdose-death-rates.

2. Centers for Disease Control and Prevention. U.S. opioid dispensing rate maps. Atlanta; 2021 Nov 10. Drug overdose; https://www.cdc.gov/drug overdose/rxrate-maps/index.html.

3. Institute for Safe Medication Practices. Safety wires. Follow Vivitrol preparation instructions to minimize clogged syringes. ISMP medication safety alert! Nurse advise- ERR 2023;21(3):1-2. https://formweb. com/files/lhs/documents/2023.03%20 Nurse%20AdviseERR.pdf.

Diane S. Aschenbrenner is a former mem- ber of the faculty at Notre Dame of Mary- land University and the Johns Hopkins University School of Nursing. She coordi- nates Drug Watch: diane.aschenbrenner@ gmail.com.

By Diane S. Aschenbrenner, MS, RN