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Drug, Healthcare and Patient Safety 2019The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), contains information on adverse drug events and medication error reports submitted to the...
BACKGROUND
The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), contains information on adverse drug events and medication error reports submitted to the FDA through the MedWatch program. A significant number of adverse events reported in the FAERS database have been for opioid use. The objective of this study was to determine the frequency counts and associated deaths of opioid drug names in the FAERS database.
METHODS
Drug data were obtained from the DRUG and OUTCOME files in the database. Drugs identified included: morphine, fentanyl, oxycodone, hydrocodone, tramadol, hydromorphone, methadone, codeine, oxymorphone, meperidine, propoxyphene, diphenoxylate, and heroin. Frequency counts and concomitant deaths of opioid drug names were determined via the MySQL database management system.
RESULTS
Fifteen different opioid drugs identified in the FAERS database were associated with ADEs, including death, and 3 drugs (oxycodone, hydrocodone, fentanyl) accounted for more than half of the reports. The highest frequency count value was 158,181 for oxycodone, which represents approximately 20.2% of the frequency counts for the opioids. The lowest frequency count value was 2,161 for dextromethorphan, which represents approximately 0.3% of the total. The opioid with the highest proportion of deaths to drug count was heroin (71.8%), followed by dextromethorphan (55.6%), methadone (37.2%), morphine (26.8%), and propoxyphene (23.7%).
CONCLUSION
The FAERS database represents an important source for detection and reporting of adverse drug events (ADEs), in particular the opioids and related drugs. It remains a challenge to estimate the true incidence of ADEs for this class of drugs in the general population.
PubMed: 31695510
DOI: 10.2147/DHPS.S214771 -
Medical Care Jan 2020Experts cautioned that patients affected by the November 2010 withdrawal of the opioid analgesic propoxyphene might receive riskier prescriptions. To explore this, we...
OBJECTIVE
Experts cautioned that patients affected by the November 2010 withdrawal of the opioid analgesic propoxyphene might receive riskier prescriptions. To explore this, we compared drug receipts and outcomes among propoxyphene users before and aftermarket withdrawal.
STUDY DESIGN
Using OptumLabs data, we studied 3 populations: commercial, Medicare Advantage (MA) aged (age 65+ y) and MA disabled (age below 65 y) enrollees. The exposed enrollees received propoxyphene in the 3 months before market withdrawal (n=13,622); historical controls (unexposed) received propoxyphene 1 year earlier (n=9971). Regression models estimated daily milligrams morphine equivalent (MME), daily prescription acetaminophen dose, potentially toxic acetaminophen doses, nonopioid prescription analgesics receipt, emergency room visits, and diagnosed falls, motor vehicle accidents, and hip fractures.
PRINCIPAL FINDINGS
Aged MA enrollees illustrate the experience of all 3 populations examined. Following the market withdrawal, propoxyphene users in the exposed cohort experienced an abrupt decline of 69% in average daily MME, compared with a 14% decline in the unexposed. Opioids were discontinued by 34% of the exposed cohort and 18% of the unexposed. Tramadol and hydrocodone were the most common opioids substituted for propoxyphene. The proportion of each group receiving ≥4 g of prescription acetaminophen per day decreased from 12% to 2% in the exposed group but increased from 6% to 8% among the unexposed. Adverse events were rare and not significantly different in exposed versus unexposed groups.
CONCLUSIONS
After propoxyphene market withdrawal, many individuals experienced abrupt discontinuation of opioids. Policymakers might consider supporting appropriate treatment transitions and monitoring responses following drug withdrawals.
Topics: Aged; Analgesics, Opioid; Dextropropoxyphene; Drug Substitution; Female; Humans; Hydrocodone; Male; Medicare; Middle Aged; Morphine; Regression Analysis; Safety-Based Drug Withdrawals; Tramadol; United States; Withholding Treatment
PubMed: 31651743
DOI: 10.1097/MLR.0000000000001221 -
Plant Physiology and Biochemistry : PPB Nov 2019The growth promoting activities of the isolated endophyte Aspergillus terreus from Aloe barbendsis was studied in the salt stressed Pennisetum glaucum (pearl millet). A...
The growth promoting activities of the isolated endophyte Aspergillus terreus from Aloe barbendsis was studied in the salt stressed Pennisetum glaucum (pearl millet). A significant (P = 0.05) increase in the root-shoot lengths, fresh and dry weights and chlorophyll content of pearl millet seedlings was noticed after colonization by A. terreus under normal conditions. At 100 mM NaCl stress and A. terreus inoculation, the growth rate of pearl millet seedlings were significantly (P = 0.05) inhibited. Furthermore, the IAA production, relative water content (RWC), chlorophyll, soluble sugar, phenol and flavonoid contents were significantly decreased, whereas proline content and lipid peroxidation were increased. On the contrary, pearl millet seedlings inoculated with A. terreus retained significantly (P = 0.05) higher amounts of RWC, chlorophyll, soluble sugar, phenol and flavonoid contents under 100 mM salt stress. The higher IAA production in A. terreus associated seedlings rescued the plant growth and development under salt stress. Moreover, the LC MS/MS analysis of A. terreus cultural filtrate revealed the presence of quinic acid, ellagic acid, calycosin, wogonin, feruloylquinic acid, caffeic acid phenylethyl ester, D-glucoside, myricetin, propoxyphene and aminoflunitrazepam. The results of the study conclude that innoculation of A. terreus improves the NaCl tolerance in pearl millet by ameliorating the physicochemical attributes of the host plants.
Topics: Aspergillus; Caffeic Acids; Chromatography, Liquid; Flavanones; Flavonoids; Indoleacetic Acids; Isoflavones; Pennisetum; Salinity; Seedlings; Sodium Chloride; Tandem Mass Spectrometry
PubMed: 31563093
DOI: 10.1016/j.plaphy.2019.09.038 -
Asian Journal of Psychiatry Aug 2019Prescription drug suicide merits study to guide the development of strategies to reduce suicide risk. We examined prescription drug suicide specifically in non-abusers...
BACKGROUND
Prescription drug suicide merits study to guide the development of strategies to reduce suicide risk. We examined prescription drug suicide specifically in non-abusers of prescription drugs; this is a relatively unexplored subject.
METHODS
Six-year data on prescription drug suicide in non-abusers were extracted from the records of the Department of Forensic Medicine at the All India Institute of Medical Sciences, New Delhi. These records contained information obtained from the scene of the suicide, from interviews with relatives of the deceased, and from forensic toxicological analyses at two laboratories.
RESULTS
There were 27 (8%) cases of prescription drug suicide in non-abusers out of 338 cases of suicidal poisoning. The mean age of this sample was 26 years. The sample was 74% male. Nearly half of the cases (44%) were students. A combination of dextropropoxyphene with dicyclomine, with or without paracetamol, was used by 41% of cases. Overdose was achieved through the ingestion of 10-40 (median, 30) tablets or by the injection of 2-3 (median, 2) vials of medication. In 52% of cases, it appeared that the drugs had been procured over the counter.
CONCLUSIONS
It is reassuring that the absolute number of prescription drug suicides in non-abusers was small; the findings, however, are important because they could serve as a baseline for assessing time trends in future studies. For the present, we suggest that prescription drugs of potential abuse, especially those containing opioids and antispasmodics, should be prescribed and dispensed judiciously, especially to youth.
Topics: Adult; Analgesics, Opioid; Drug Overdose; Female; Forensic Medicine; Humans; India; Male; Parasympatholytics; Physicians; Prescription Drugs; Retrospective Studies; Students; Suicide; Universities; Young Adult
PubMed: 31374376
DOI: 10.1016/j.ajp.2019.07.039 -
Archives of Pathology & Laboratory... Feb 2020Urine drug testing is frequently ordered by health care providers. Immunoassays are widely used for drug testing, yet have potential limitations, including variable...
CONTEXT.—
Urine drug testing is frequently ordered by health care providers. Immunoassays are widely used for drug testing, yet have potential limitations, including variable cross-reactivity. The last decade has seen worsening of a prescription drug abuse epidemic.
OBJECTIVE.—
To use data from a College of American Pathologists proficiency testing survey, Urine Drug Testing, Screening, to determine and summarize the characteristics, performance, and limitations of immunoassays.
DESIGN.—
Seven years of proficiency surveys were reviewed (2011-2017).
RESULTS.—
Rapid growth was seen in participant volumes for specific immunoassays for synthetic opioids (eg, buprenorphine, fentanyl, oxycodone) and 3,4-methylenedioxymethamphetamine ("ecstasy"). Participant volumes remained high for immunoassays targeting less commonly abused drugs such as barbiturates and phencyclidine. For opiate immunoassays, the number of laboratories using a 2000 ng/mL positive cutoff remained stable, and an increasing number adopted a 100 ng/mL cutoff. Opiate and amphetamine immunoassays showed high variability in cross-reactivity for drugs other than the assay calibrator. Assays targeting a single drug or metabolite generally performed well on drug challenges.
CONCLUSIONS.—
Survey results indicate strong clinical interest in urine drug testing and some adoption of new assays. However, urine drug testing availability does not parallel prevailing patterns of drug prescribing and abuse patterns. In particular, specific immunoassays for synthetic opioids and a lower positive cutoff for opiate immunoassays may be underused, whereas immunoassays for barbiturates, methadone, propoxyphene, and phencyclidine may be overused. Laboratories are encouraged to review their test menu, cutoffs, and assay performance and adjust their test offerings based on clinical needs and technical capabilities.
Topics: Analgesics, Opioid; Humans; Immunoassay; Laboratory Proficiency Testing; Retrospective Studies; Substance Abuse Detection
PubMed: 31313960
DOI: 10.5858/arpa.2018-0562-CP