Radio Show Articles:
November 4, 2017

• Opioid vs. Prochlorperazine plus Diphenhydramine for Treating Migraine Symptoms
• Fitting Bariatric Surgery into Reproductive Life Plans
• Financial Incentives Improve Smoking Cessation Rates
• The FDA has estimated that several thousand unapproved drug products are
   commercially manufactured and marketed in the U.S.

Neurology 2017 Oct 18
Opioid vs. Prochlorperazine plus Diphenhydramine for
Treating Migraine Symptoms
Intravenous hydromorphone is a poor choice for first-line migraine treatment in the emergency department.
Unfortunately, despite extensive evidence specifically demonstrating lack of efficacy, parenteral opioids are commonly used to treat migraine headaches in the emergency department (ED). In a randomized double-blind trial, researchers compared the efficacy of intravenous hydromorphone (1 mg) versus IV prochlorperazine (10 mg) plus diphenhydramine (25 mg) in 127 adults with a diagnosis of migraine and no recent opioid use. Eligible patients presented to two New York City EDs with moderate to severe headache pain.
Patients were offered a second dose of medication 1 hour after the first. Symptoms were assessed on a 4-item headache pain scale (severe, moderate, mild, none) in the ED every hour for up to 4 hours, and by phone call at 48 hours. The primary outcome was sustained headache relief, defined as a reduction in pain to mild or none that was sustained at 48 hours after a single dose of medication.
A second dose was requested by 8% of prochlorperazine and 31% of hydromorphone recipients. The primary outcome was achieved in 60% of patients who received one dose of prochlorperazine, compared with 31% of those who received one dose of hydromorphone. Among patients who received one or two doses of medication, sustained relief was reported by 60% in the prochlorperazine group versus 41% in the hydromorphone group. The study was ended early because “overwhelming superiority” of prochlorperazine for the primary outcome was demonstrated.
COMMENT: This study confirms others: opioids are not effective for the treatment of migraine headache and should not be used.
CITATION(S): Friedman BW et al. Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine. Neurology 2017 Oct 18; [e-pub].
(http://dx.doi.org/10.1212/WNL.0000000000004642)
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Obstet Gynecol 2017 Nov; 130:979
Fitting Bariatric Surgery into Reproductive Life Plans
Contraceptive counseling is a critical part of bariatric care.
In the U.S., 40% of patients undergoing bariatric surgery are women of reproductive age. Bariatric surgery can alleviate many obesity-related conditions, including diabetes, hypertension, and pregnancy complications; thus, clinical guidelines recommend that women delay pregnancy for 12 to 18 months after bariatric surgery (NEJM JW Womens Health Mar 2017 and multiple citations). To evaluate contraceptive practices and conception rates among reproductive-aged women who underwent bariatric surgery, researchers analyzed data from 710 participants in a multicenter prospective cohort study at 10 U.S. hospitals between 2005 and 2009.
During the first year after bariatric surgery, 42% of women had unprotected intercourse while not trying to conceive. Among all women, first-year prevalence of intrauterine contraception (IUC) was 9%, while oral contraceptives were used by 11% — and by 21% of those undergoing Roux-en-Y gastric bypass (despite the U.S. Medical Eligibility Criteria for Contraceptive Use rating of Category 3 [risks outweigh benefits] for this form of contraception after malabsorptive bariatric procedures). Within the first 18 months after bariatric surgery, the conception rate was 4.2 per 100 woman-years.
COMMENT: These data indicate that many women undergoing bariatric surgery would benefit from more discussion and counseling about their reproductive life plans, contraceptive options, and ways to optimize pregnancy outcomes. Indeed, before any reproductive-aged woman undergoes bariatric surgery, pregnancy-related issues — including provision of contraception — must be addressed. Moreover, many clinicians in bariatric surgery programs could use more education about contraception (NEJM JW Womens Health Jun 2016 and Contraception 2016; 93:455). Collaborative practice arrangements that facilitate prompt access to highly effective reversible contraceptives such as IUC and subdermal contraceptive implants are also important.
CITATION(S): Menke MN et al. Contraception and conception after bariatric surgery. Obstet Gynecol 2017 Nov; 130:979.
(http://dx.doi.org/10.1097/AOG.0000000000002323)
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JAMA Intern Med 2017 Oct 30
Financial Incentives Improve Smoking Cessation Rates
Patients could earn as much as US$750 if they stopped smoking for 12 months.
Could two interventions that improve smoking cessation rates be combined for even better effectiveness? In a randomized trial, 352 low-income adults (mean age, 50; mostly black or Hispanic; household annual income, ≤US$20,000; education, high school diploma or less) were recruited from primary care clinics at a Boston safety-net hospital. Participants smoked ≥10 cigarettes daily and were in a contemplation or preparation stage of quitting.
Intervention patients received as many as 4 hours of patient navigation services for accessing smoking cessation resources and medications and were offered financial incentives ($250 if they had stopped smoking at 6 months; additional $500 at 12 months). Control patients were provided with educational materials and a list of smoking cessation resources. Smoking cessation was assessed biochemically with either salivary cotinine or urinary anabasine levels.
During the study, 51% of intervention patients and 26% of control patients received prescriptions for nicotine replacement therapy. Very few patients in either group accessed counseling or quit line services or received bupropion or varenicline prescriptions. At 12 months, 12% of intervention patients and 2% of control patients had stopped smoking. Patients who were older, female, and nonwhite and who had lower incomes were most likely to have quit.
COMMENT; In this study, 1 patient benefited for every 10 patients who received the intervention; this number needed to treat (NNT) is similar to NNTs for many other smoking-cessation interventions. The patient navigation support was not used often, but health systems should consider employing smoking cessation programs that focus on nicotine replacement therapy and financial incentives for low-income patients.
CITATION(S): Lasser KE et al. Effect of patient navigation and financial incentives on smoking cessation among primary care patients at an urban safety-net hospital: A randomized clinical trial. JAMA Intern Med 2017Oct 30; [e-pub].
(http://dx.doi.org/10.1001/jamainternmed.2017.4372)
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The FDA has estimated that several thousand unapproved drug products are commercially manufactured and marketed in the U.S.
Since the FDA considers all compounded preparations as unapproved drugs, this would include:

• all intravenous admixtures in hospitals,
• all in-syringe admixtures,
• pediatric and geriatric oral liquids,
• pain management injections, and
• ALL other compounded preparations.

Also, agencies of the federal government compounding unapproved drugs would have to be included, which involves the following:

• Department of Veterans Affairs,
• Indian Health Service,
• all branches of the armed services, and the
• Federal Bureau of Prisons.

Many state agencies (e.g., hospitals, prisons, welfare programs) and private and public healthcare organizations (e.g., hospitals, clinics) are involved in compounding unapproved drugs.
Regarding veterinary drug products, most commercially manufactured veterinary drug products are not FDA approved.
In addition, nonprescription drug products are not FDA approved but follow the over-the-counter (OTC) monograph system that allows them to be manufactured if they comply with the OTC monographs.
In summary, although partially true, not everything is presented in the 2017 NAMS Position Statement to make it complete and present the entire picture related to "approved" and "unapproved" drugs in the U.S.
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Table. Examples of Pre-1938 Drugs on the Market as Unapproved Drugs.
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