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1.
Am Surg ; : 31348241241634, 2024 Apr 02.
Article in English | MEDLINE | ID: mdl-38565216

ABSTRACT

This study aims to compare outcomes of rib fracture patients with and without COVID-19 in Michigan. Data from the Michigan Trauma Quality Improvement Program (MTQIP) identified adults hospitalized from January 1, 2020, to October 31, 2022, with at least one rib fracture and a completed COVID-19 test on admission. Patients were propensity score matched 1:1 using 20 variables. The primary outcome was hospital length of stay (LOS). Secondary outcomes were mortality, ventilator days, intensive care unit (ICU) LOS, pneumonia, and ventilator-assisted pneumonia (VAP). 13,305 total patients were identified. 232 patients matched into both the COVID+ and COVID- groups. COVID was associated with increased LOS (7 days vs. 5 days, P < 0.001). There were no significant differences between the two groups when evaluating secondary outcomes. Our study indicates that although COVID-19 infection is associated with increased LOS, COVID may not contribute to additional morbidity or mortality in traumatic rib fracture patients.

2.
Am J Surg ; 230: 35-38, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38061940

ABSTRACT

BACKGROUND: Cervical spine fractures are associated with high mortality in elderly patients. This study aims to identify patient-related and in-hospital factors contributing to this mortality. METHODS: A 3-year retrospective study of 235 patients aged 65+ presenting with cervical spine fractures was performed. Age cohorts were 65-74, 75-84, and 85+ years. Mortality was measured at 30, 90, 180 and 365-days post-discharge. RESULTS: Mortality was 11 â€‹%, 15 â€‹%, 19 â€‹%, and 22 â€‹% at 30-, 90-, 180- and 365-days respectively. Surgery and fracture pattern was not associated with mortality (p â€‹= â€‹0.37; p â€‹= â€‹0.28). Charlson Comorbidity Index (p â€‹< â€‹0.001; hazard ratio [HR] â€‹= â€‹1.3), functional dependency (p â€‹< â€‹0.001; HR â€‹= â€‹2.5) and delirium (p â€‹< â€‹0.001; HR â€‹= â€‹8.9) were associated with mortality between 0 and 365 days post-discharge. CONCLUSIONS: Mortality in cervical spine fractures is associated with CCI and delirium, but not associated with operative management or fracture pattern. This suggests the need for careful consideration in patient selection for cervical spine procedures and aggressive inpatient delirium management.


Subject(s)
Delirium , Spinal Fractures , Aged , Humans , Retrospective Studies , Aftercare , Patient Discharge , Spinal Fractures/surgery , Spinal Fractures/complications , Cervical Vertebrae/injuries
3.
J Trauma Nurs ; 30(5): 282-289, 2023.
Article in English | MEDLINE | ID: mdl-37702731

ABSTRACT

BACKGROUND: Emergent decompressive craniotomy/craniectomy can be a lifesaving surgical intervention for select patients with traumatic brain injury. Prompt management is critical as early decompression can impact traumatic brain injury outcomes. OBJECTIVE: This study aims to describe the feasibility and clinical impact of a new pathway for transporting patients with severe traumatic brain injury directly to the operating room from the trauma bay for decompressive craniotomy/craniectomy. METHODS: This is a retrospective cohort preintervention and postintervention study of severe traumatic brain injury patients undergoing decompressive craniectomy/craniotomy at a Midwestern U.S. Level I trauma center between 2016 and 2022. In the new pathway, the in-house trauma surgeon takes the patient directly to the operating room with the neurosurgery advanced practice provider to drape and prepare the patient for surgery while the neurosurgeon is en route to the hospital. RESULTS: A total of 44 patients were studied, five (5/44, 11.4%) of which were in the preintervention group and 39 (39/44, 88.6%) in the postintervention group. The median arrival-to-operating room time was shorter in the postintervention cohort (1.4 hr) than in the preintervention cohort (1.5 hr). In examining night shifts only, the preintervention cohort had shorter arrival-to-operating room times (1.2 hr) than the postintervention cohort (1.5 hr). CONCLUSION: The study demonstrated that the new pathway is feasible and expedites patient transport to the operating room while awaiting the arrival of the on-call neurosurgeon.


Subject(s)
Brain Injuries, Traumatic , Brain Injuries , Decompressive Craniectomy , Humans , Brain Injuries/surgery , Retrospective Studies , Operating Rooms , Craniotomy , Brain Injuries, Traumatic/diagnosis , Brain Injuries, Traumatic/surgery , Treatment Outcome
4.
Injury ; 54(7): 110831, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37236854

ABSTRACT

INTRODUCTION: Repair of multiple lower extremity long bone fractures with intramedullary nail (IMN) fixation is associated with significant cardiopulmonary burden and may result in mortality. These patients are at an increased risk for fat embolism syndrome, pulmonary embolism, Acute Respiratory Distress Syndrome (ARDS), and pneumonia. No standardized guidelines exist to guide treatment of these patients. Further, there is a paucity of data regarding the risk of simultaneous versus staged fixation of multiple long bone fractures that includes both tibial and femoral injuries, as patients with multiple concomitant fractures are often excluded from relevant analyses. Our level one trauma center aimed to identify whether simultaneous fixation, defined by definitive fixation of multiple lower extremity long bone fractures during one operative event, led to increased cardiopulmonary complications as compared to a staged approach, defined as multiple operations to reach definitive fixation. PATIENTS AND METHODS: The Michigan Trauma Quality Improvement Program (MTQIP) database from 35 Level I and II trauma centers was queried to identify patients from January 2016 - December 2019. The primary outcome was incidence of cardiopulmonary complications for staged and simultaneous IMN fixation. RESULTS: We identified 11,427 patients with tibial and/or femoral fractures during the study period. 146 patients met the inclusion criteria of two or more fractures treated with IMN fixation. 118 patients underwent simultaneous IMN fixation, and 28 patients received staged IMN fixation. There were no significant differences in injury severity score (ISS), demographics, pre-existing conditions, and cardiopulmonary complications between the two groups. There was a statistically significant difference in hospital length of stay (LOS) (p = 0.0012). The median hospital LOS for simultaneous fixation was 8.3 days versus 15.8 days for the staged cohort, a difference of 7.5 days. CONCLUSION: This is the largest retrospective study to date examining simultaneous versus staged IMN fixation in patients with multiple long bone lower extremity fractures. In contrast to previous studies, we found no difference in cardiopulmonary complications. Given these findings, patients with multiple long bone lower extremity fractures should be considered for simultaneous IMN, an approach which may decrease hospital LOS.


Subject(s)
Femoral Fractures , Fracture Fixation, Intramedullary , Tibial Fractures , Humans , Fracture Fixation, Intramedullary/adverse effects , Retrospective Studies , Femoral Fractures/diagnostic imaging , Femoral Fractures/surgery , Femoral Fractures/complications , Femur , Lower Extremity , Treatment Outcome , Tibial Fractures/diagnostic imaging , Tibial Fractures/surgery , Tibial Fractures/complications
5.
Emerg Radiol ; 30(3): 343-349, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37186087

ABSTRACT

INTRODUCTION: Incidental findings on comprehensive imaging in the adult trauma population occur at rates as high as 54.8%. We sought to determine the incidence of potentially malignant or pre-malignant incidental findings in a high-volume level 1 trauma center and to evaluate follow-up recommendations. METHODS: This was a retrospective review of all patients with incidental findings on imaging who were admitted to the trauma service at our level 1 trauma center between January 1st, 2014, and October 1st, 2019. A multi-disciplinary team characterized findings as potentially malignant or pre-malignant. RESULTS: The study included 495 patients who had incidental findings, 410 of whom had potentially malignant or pre-malignant findings on imaging, resulting in a cumulative incidence of 6.6%. The mean age was 65 and 217 (52.9%) patients were male. The majority of "incidentalomas" were discovered on CT imaging (n=665, 98.1%); over half were solid (n=349, 51.5%), while 27.4% were cystic (n=186) in nature. The lungs (n=199, 29.4%), kidneys (n=154, 22.8%), liver (n=74, 10.9%), thyroid gland (n=58, 8.6%), and adrenal glands (n=53, 7.8%) harbored the most incidentalomas. Less than half of patients with incidental findings received specific follow-up recommendations on the radiologist's report (n=150, 39%). Sixty-one percent of patients (n=250) had their incidentalomas detailed in the discharge paperwork. CONCLUSION: The results of our study suggest that potentially malignant or pre-malignant incidental findings are common among trauma patients. Specific follow-up recommendations were not presented in 61% of the radiology reports, highlighting the need to standardize medical record capture of an incidentaloma to ensure adequate and appropriate follow-up.


Subject(s)
Incidental Findings , Trauma Centers , Adult , Humans , Male , Female , Diagnostic Imaging , Retrospective Studies , Incidence
6.
Am J Surg ; 225(3): 504-507, 2023 03.
Article in English | MEDLINE | ID: mdl-36631372

ABSTRACT

INTRODUCTION: The impact of a visual pain medication schedule on opioid use among hospitalized trauma patients is unknown. We examined whether removal of this displayed schedule would decrease oral morphine equivalent (OME) use. METHODS: This retrospective cohort study compared OME use in trauma patients in the inpatient setting before and after removing the patient-facing pain medication schedule that is typically displayed on the patient's white board for all trauma admissions. RESULTS: 707 patients were included. The control (n = 308, 43.6%) and intervention (n = 399, 56.4%) groups were similar in age (p = 0.06). There was no difference in total inpatient OME use between the control and intervention groups, median 50 (IQR: 22.5-118) vs 60 (IQR: 22.5-126), p = 0.79, respectively. No difference in total OME use was observed when patients were stratified by age, sex, race, ISS, and length of hospital stay. CONCLUSION: Removing a visual display of the pain medication schedule did not decrease OME use in inpatient trauma patients.


Subject(s)
Analgesics, Opioid , Opioid-Related Disorders , Humans , Retrospective Studies , Inpatients , Morphine/therapeutic use , Pain, Postoperative/drug therapy
7.
Injury ; 53(11): 3715-3722, 2022 Nov.
Article in English | MEDLINE | ID: mdl-36075779

ABSTRACT

INTRODUCTION: Falls are the second leading cause of trauma-related deaths worldwide. Identifying fall risk patients and initiating interventions reduces injuries and mortality, particularly in the elderly. The primary aim of this retrospective study was to identify missed opportunities for fall risk identification and intervention for geriatric trauma patients. PATIENTS AND METHODS: In this retrospective observational cohort study, the trauma registry was queried to identify geriatric patients admitted for a fall over 36 months. The electronic medical record (EMR) was reviewed to evaluate patients' fall risk in the 12 months prior to the index fall admission. The EMR was also queried for repeat falls within 12 months after discharge, and to determine if fall prevention education was provided at discharge. RESULTS: 597 patients met inclusion criteria; 68.3% were female. 64.7% were at risk for falling in the year before admission. 2% had documented fall prevention education at discharge. 32% of patients fell again within a year of discharge and 19.4% were readmitted for a repeat fall. Patients at high risk for falls (on the Hester-Davis scale) were significantly more likely to be readmitted (p = 0.005) and expire within six months (p = 0.033) than moderate risk patients. Mortality at 12 months post-admission for all patients was 19.4%. CONCLUSION: This large study demonstrated that geriatric trauma patients admitted for a fall were already at risk for falling in the 12 months prior to admission. This is a novel finding that presents a substantial prevention opportunity for healthcare systems. Education and implementation of proven techniques to prevent falls as soon as at-risk patients are identified has the potential to change the course for a patient who may not only fall, but also fall again. This proactive approach could significantly impact the fall epidemic in our elderly population.


Subject(s)
Continuity of Patient Care , Hospitalization , Humans , Aged , Female , Male , Retrospective Studies , Risk Factors
8.
Clin EEG Neurosci ; 53(6): 513-518, 2022 Nov.
Article in English | MEDLINE | ID: mdl-35957599

ABSTRACT

Introduction: Patients with traumatic brain injury (TBI) are at risk for seizures and other abnormalities that can have permanent adverse effects on the brain. We aimed to report the incidence of seizures and continuous EEG (cEEG) abnormalities after TBI and identify any risk factors associated with the development of these abnormalities. Materials and Methods: This retrospective study identified 245 adult patients with mild to severe TBI who had a cEEG performed within one week of admission to a Midwest Level 1 Trauma Center between July 2014 and July 2019. Trauma registry and electronic medical record (EPIC) data were extracted. Results: Twelve percent of patients with TBI developed seizures and an additional 23% demonstrated electrographic patterns that are correlated with risk for seizures (such as lateralized periodic patterns and sporadic epileptiform discharges). Fifty three percent of seizures would have been missed unless a cEEG was performed. Age, history of epilepsy or prior TBI, hypertension, bleeding disorder, and dementia were associated with an increased risk of developing seizures or higher risk patterns. Conclusions: Thirty-five percent of patients who presented with TBI were noted to have seizures or electrographic patterns associated with a higher risk of seizures. The incidence of cEEG abnormalities in this study is higher than previously reported and these patients are at risk for permanent neurological injury. We recommend the routine use of cEEG for all critically ill patients with TBI as over half of the seizures would have been missed if cEEG was not employed.


Subject(s)
Brain Injuries, Traumatic , Epilepsy , Adult , Brain Injuries, Traumatic/diagnosis , Electroencephalography/adverse effects , Epilepsy/complications , Humans , Retrospective Studies , Seizures
9.
Am J Surg ; 224(1 Pt B): 602-606, 2022 07.
Article in English | MEDLINE | ID: mdl-35400530

ABSTRACT

BACKGROUND: There is no agreed upon triage criteria to identify traumatic rib fracture patients at the highest risk for decline. We developed a comprehensive triage tool that assigns patients to high, moderate, and low risk categories. The primary outcome of our study was to evaluate unplanned intensive care unit (ICU) admissions. METHODS: We conducted a single-center, retrospective review at our level 1 trauma center comparing two cohorts of patients (≥18 years of age) six months before and after implementation of our risk-associated rib fracture protocol. RESULTS: After implementation of the risk-associated rib fracture protocol, the unplanned ICU admission rate decreased from 6.60% (PRE) to 2.60% (POST) (p = 0.014). CONCLUSIONS: Implementation of our rib fracture protocol demonstrates that a comprehensive triage tool with a cascading risk associated treatment plan reduces in-hospital clinical decline of patients with traumatic rib fractures, as measured by unplanned ICU admissions.


Subject(s)
Rib Fractures , Clinical Protocols , Hospitalization , Humans , Infant , Intensive Care Units , Retrospective Studies , Rib Fractures/complications , Rib Fractures/therapy , Trauma Centers
10.
Surg Endosc ; 36(11): 8472-8480, 2022 11.
Article in English | MEDLINE | ID: mdl-35246743

ABSTRACT

BACKGROUND: Post-operative prescription of opioids has fueled an increase in opioid-associated morbidity and mortality. Alternative post-operative pain control with non-opioid pharmaceuticals can help counteract this effect. We investigated a non-opioid pain management protocol following emergent laparoscopic appendectomy and laparoscopic cholecystectomy. METHODS: Our tertiary referral center performed a prospective observational feasibility study of patients from October 2019 to 2020 who underwent emergent laparoscopic appendectomies and cholecystectomies. Patients aged 18-65 with no prior history of chronic pain or opioid abuse, no contraindications to taking acetaminophen and ibuprofen, and Glomerular Filtration Rate > 60 ml/min were included. Counseling was provided about non-narcotic pain control. Patients were not prescribed narcotics at discharge and were instead prescribed ibuprofen and acetaminophen. Patients were surveyed at their 2-week post-operative appointment to assess pain control and other patient-reported outcomes, including quality of life (QOL). RESULTS: Fifty-one patients met the inclusion criteria and completed the postoperative survey. Thirty-two were female (63%), average age 38, and BMI 30.4. 30 (59%) underwent laparoscopic appendectomy for acute non-perforated appendicitis and 21 (41%) underwent laparoscopic cholecystectomy for acute cholecystitis or symptomatic cholelithiasis. 88% of patients felt satisfied or neutral with their post-operative pain control at discharge. After 2 weeks, 34 patients (66.7%) rated QOL as high, 17 (33.3%) rated QOL as moderate, and none rated QOL as poor. Fascial suture was not associated with poor outcomes. Anxiety, depression, alcohol use, and prior abdominal surgery were not associated with increased need for post-operative narcotics. There were no significant differences between appendectomy and cholecystectomy in satisfaction with pain control or QOL (p > 0.05). CONCLUSION: Patients undergoing surgery have an increased risk of developing an opioid disorder. The NOpioid Project demonstrated a non-narcotic multimodal pain regimen can be effectively adopted in the post-operative period after an emergent laparoscopic appendectomy or emergent laparoscopic cholecystectomy.


Subject(s)
Analgesics, Non-Narcotic , Appendicitis , Humans , Female , Adult , Male , Acetaminophen/therapeutic use , Ibuprofen , Pain, Postoperative/drug therapy , Pain, Postoperative/etiology , Pain, Postoperative/prevention & control , Quality of Life , Narcotics , Feasibility Studies , Analgesics, Opioid/therapeutic use , Appendectomy/methods , Appendicitis/surgery
11.
Air Med J ; 41(2): 196-200, 2022.
Article in English | MEDLINE | ID: mdl-35307143

ABSTRACT

OBJECTIVE: Tranexamic acid (TXA) has demonstrated a reduction in all-cause mortality in trauma patients with hemorrhage. Administering TXA in the prehospital setting presents unique challenges because the identification of bleeding is based on clinical suspicion without advanced imaging or diagnostic tools. The objective of this study was to examine whether prehospital suspicion of bleeding is validated by in-hospital computed tomographic imaging and examination and to determine if patients received TXA in the absence of hemorrhage. The study was conducted at a level 1 trauma center supported by air medical transport services. METHODS: This is a retrospective cohort study examining 88 trauma patients receiving prehospital TXA to treat suspected hemorrhage. Adult trauma patients who received TXA during the study period and were transported to our level 1 trauma center were included. A panel of trauma surgeons reviewed CT imaging and examination findings to retrospectively identify significant hemorrhage. RESULTS: Forty-three percent of patients who received TXA during air medical transport did not have confirmed hemorrhage upon arrival. CONCLUSION: TXA was given to a significant number of patients who did not have confirmed hemorrhage upon arrival. We recommend that institutions using TXA perform this internal validation to ensure they are accurately identifying hemorrhage in the prehospital setting.


Subject(s)
Antifibrinolytic Agents , Tranexamic Acid , Wounds and Injuries , Adult , Altitude , Antifibrinolytic Agents/therapeutic use , Hemorrhage/drug therapy , Humans , Retrospective Studies , Tranexamic Acid/therapeutic use , Wounds and Injuries/complications
12.
J Surg Res ; 273: 93-99, 2022 05.
Article in English | MEDLINE | ID: mdl-35033822

ABSTRACT

INTRODUCTION: Ultrasound is the gold standard for workup of cholecystitis in the emergency department, and findings heavily influence clinical decision-making. Patients with negative imaging for acute cholecystitis may be inappropriately sent home. The purpose of our study was to review the pathology and outcomes of patients presenting with biliary pain and negative ultrasound findings of acute cholecystitis. MATERIALS AND METHODS: Emergency department patients who underwent laparoscopic cholecystectomy between January 2015 and February 2019 were reviewed retrospectively. Only patients with negative or equivocal imaging were included. The primary outcome was the incidence of cholecystitis on final pathology. RESULTS: Two hundred fifty-seven patients underwent laparoscopic cholecystectomy. Pathology demonstrated cholecystitis in 84% of patients. Only 15% of patients had cholelithiasis without cholecystitis on pathology. The incidence of cholecystitis was similar in negative and equivocal imaging groups (84% versus 83%; P = 0.960). The median time from admission to the operating room was 12.1 h (interquartile range 7.1-18.3 h), and hospital length of stay was 1.2 d (interquartile range 0.8-1.7 d). CONCLUSIONS: This study found that patients with negative or equivocal imaging had cholecystitis on pathology. On review of patient outcomes, those patients who underwent surgical intervention had a low rate of complications and short hospital stay.


Subject(s)
Cholecystectomy, Laparoscopic , Cholecystitis, Acute , Cholecystitis , Cholelithiasis , Cholecystectomy, Laparoscopic/adverse effects , Cholecystectomy, Laparoscopic/methods , Cholecystitis/diagnostic imaging , Cholecystitis/surgery , Cholecystitis, Acute/diagnostic imaging , Cholecystitis, Acute/etiology , Cholecystitis, Acute/surgery , Cholelithiasis/surgery , Humans , Length of Stay , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/surgery , Retrospective Studies , Treatment Outcome
13.
J Surg Res ; 268: 25-32, 2021 12.
Article in English | MEDLINE | ID: mdl-34280662

ABSTRACT

BACKGROUND: Sarcopenia is associated with increased morbidity and mortality in the trauma patient. The primary objective of this study was to determine the relationship of psoas cross sectional area with hospital mortality in patients with rib fractures over the age of 55 years. MATERIALS AND METHODS: We retrospectively reviewed 1223 patients presenting to a Level 1 Trauma Center between 1/1/2002 and 1/31/2019. Psoas cross sectional area was measured using a polygonal tracing tool. Patients were stratified into four quartiles based on sex-specific values. RESULTS: There was increased in-hospital mortality for patients with a lower psoas cross sectional area (10 %, 8%, 6%, and 4%, Q1-Q4 respectively; P=0.021). The logistic regression model determined for every increase in psoas cross sectional area by 1 cm2 the odds of in-hospital mortality decreased by 4%. CONCLUSIONS: In-hospital mortality is multifactorial; however, psoas cross sectional area may provide a clue in predicting adverse outcomes after traumatic rib fractures.


Subject(s)
Rib Fractures , Sarcopenia , Female , Humans , Male , Middle Aged , Psoas Muscles/pathology , Retrospective Studies , Rib Fractures/complications , Sarcopenia/complications , Trauma Centers
14.
J Safety Res ; 75: 173-177, 2020 12.
Article in English | MEDLINE | ID: mdl-33334475

ABSTRACT

INTRODUCTION: Motorcycles are colloquially referred to as "donorcycles" among medical staff. However, the actual impact of helmet laws and helmet use on organ donation is unknown. Michigan's 35-year-old universal helmet law (UHL) was repealed in April 2012 and replaced by a partial-helmet law. We hypothesized that there would be an increase in organ donation rates from unhelmeted motorcyclist fatalities. METHODS: Michigan's Gift of Life Michigan organ donation database was queried from April 2008 through May 2015 in conjunction with the Michigan Trauma Quality Improvement Program database from the same time period. All in-hospital motorcycle crash fatalities were examined. RESULTS: A three-fold increase was found in the rate of organ donation for unhelmeted motorcyclists compared to helmeted motorcyclists (p = 0.006). Motorcycle crash fatalities tended to be younger in age after the UHL repeal with an average age of 32.8 years versus 40.8, however, this finding was not statistically significant (p = 0.071). Additionally, there was no significant difference in organ donation rates pre-UHL repeal (2008-2012) versus post-repeal (2012-2015). CONCLUSIONS: This is the first study to demonstrate an increased rate of organ donation among unhelmeted motorcyclist fatalities compared to helmeted rider fatalities. There was no significant increase in the rate of organ donation following the Michigan UHL repeal. However, we identified that some motorcycle crash fatalities were from illegally unhelmeted riders in the past, prior to the repeal. Practical Application: Unhelmeted motorcyclists are three times more likely than helmeted riders to become organ donors, possibly due to the well documented increase in severe traumatic brain injuries in this population. From a public health perspective, helmets should be required for all motorcyclists and efforts to advocate in favor of helmet legislation should be supported by trauma systems and health professionals.


Subject(s)
Accidents, Traffic/statistics & numerical data , Brain Injuries, Traumatic/epidemiology , Head Protective Devices/statistics & numerical data , Motorcycles/statistics & numerical data , Tissue and Organ Procurement/statistics & numerical data , Brain Injuries, Traumatic/etiology , Databases, Factual , Michigan
15.
Glob Health Sci Pract ; 7(2): 300-316, 2019 06.
Article in English | MEDLINE | ID: mdl-31249025

ABSTRACT

BACKGROUND: While measuring, monitoring, and improving supply chain management (SCM) for antiretrovirals (ARVs) is understood at many levels of health systems, a gap remains in the identification and measurement of facility-level practices and behaviors that affect SCM. This study identifies practices and behaviors that are associated with SCM of ARVs at the hospital level and proposes new indicators for measurement. METHODS: We performed an in-depth literature review to identify facility-level practices and behaviors and existing indicators that are associated with SCM. We used the United States Agency for International Development's 2013 National Supply Chain Assessment Toolkit to define 7 supply chain function areas to frame the study. Qualitative, semistructured key informant and focus group interviews were conducted in hospitals with health professionals from Cameroon, Namibia, and Swaziland to understand facility-level practices and behaviors. RESULTS: Using the results from 54 key informant and focus group interviews from 12 hospitals, we identified 30 practices and behaviors that may affect ARV SCM at the facility level. The following practice areas were particularly associated with SCM: order verification, actions taken when ARV stock is received, changes in prescription and dispensing due to ARV stock-out, actions to ensure patient adherence, and communication with other affiliated facilities and higher-level SCM. We subsequently developed measurable indicators for future research. CONCLUSION: This study characterizes facility-level practices and behaviors that can affect ARV SCM. It also identifies gaps in their measurement. While this study uses ARVs as a tracer medicine to understand gaps in practices at the facility level, many of the findings are more broadly applicable to other medicines in an integrated setting. This study provides real-world evidence and the groundwork for further research to characterize the link between 30 facility-level practices and behaviors and ARV SCM at the facility and central levels.


Subject(s)
Anti-HIV Agents/supply & distribution , Delivery of Health Care , HIV Infections/drug therapy , Hospitals , Materials Management, Hospital , Anti-HIV Agents/therapeutic use , Anti-Retroviral Agents/supply & distribution , Anti-Retroviral Agents/therapeutic use , Cameroon , Eswatini , Focus Groups , Health Facilities , Humans , Namibia
16.
Global Health ; 14(1): 43, 2018 04 25.
Article in English | MEDLINE | ID: mdl-29695278

ABSTRACT

BACKGROUND: The spread of substandard and falsified (SF) medical products constitutes a growing global public health concern. Some countries use portable, handheld screening technologies (STs) in the field to accelerate detection of SF medicines and reduce the number of medicine samples that undergo costly and time-consuming confirmatory analysis. METHODS: A multi-country, multi-stakeholder landscape assessment utilizing qualitative methodology was used to examine practices and perceptions related to the use of STs. Qualitative interview guides were designed using the results of a literature review and comprised of open-ended questions with the study participants, who were from national medicine regulatory authorities, pharmaceutical manufacturers, pharmacies, and distributors. Ten geographically and economically diverse countries were selected: Argentina, China, Egypt, India, Jordan, Mexico, Nigeria, Philippines, the United States, and Zimbabwe. Of the completed 53 interviews, 32 were in-person, 16 were phone interviews, and 5 were via written questionnaires. RESULTS: Data analysis shows a wide variation in understanding and usage of STs in different sectors. Virtually all of the study participants indicated a lack of objective, accessible information on STs to advise them on what technologies would be beneficial for their needs. Study participants also described their ideal capabilities of the next generation of STs, including shareable spectral libraries, lower acquisition costs, lesser training requirements, and in-country maintenance and technical support. CONCLUSION: The results and recommendations presented in this article can be used to help regulators communicate and justify their needs to acquire and invest in new STs. There is a need for additional standardized, trustworthy and scientifically sound evaluations of STs, and to support regulators to effectively deploy the most promising technologies. ST manufacturers can take into account some of the limitations of the technologies the interviewees identified in this article, such as a dearth of technologies, which provide quantitative information about the active ingredient, and take steps to address them to better serve their customers. These results and recommendations, can catalyze research and actionable interventions into the development, review, application, and use of STs.


Subject(s)
Global Health , Pharmaceutical Preparations/standards , Quality Control , Technology , Argentina , China , Egypt , Humans , India , Jordan , Mexico , Nigeria , Philippines , Qualitative Research , Stakeholder Participation , Surveys and Questionnaires , United States , Zimbabwe
17.
Am J Trop Med Hyg ; 92(6 Suppl): 68-74, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25897073

ABSTRACT

Monitoring the quality of medicines plays a crucial role in an integrated medicines quality assurance system. In a publicly available medicines quality database (MQDB), the U.S. Pharmacopeial Convention (USP) reports results of data collected from medicines quality monitoring (MQM) activities spanning the period of 2003-2013 in 17 countries of Africa, Asia, and South America. The MQDB contains information on 15,063 samples collected and tested using Minilab® screening methods and/or pharmacopeial methods. Approximately 71% of the samples reported came from Asia, 23% from Africa, and 6% from South America. The samples collected and tested include mainly antibiotic, antimalarial, and antituberculosis medicines. A total of 848 samples, representing 5.6% of total samples, failed the quality test. The failure proportion per region was 11.5%, 10.4%, and 2.9% for South America, Africa, and Asia, respectively. Eighty-one counterfeit medicines were reported, 86.4% of which were found in Asia and 13.6% in Africa. Additional analysis of the data shows the distribution of poor-quality medicines per region and by therapeutic indication as well as possible trends of counterfeit medicines.


Subject(s)
Anti-Bacterial Agents/standards , Antimalarials/standards , Antitubercular Agents/standards , Pharmaceutical Preparations/standards , Africa , Antimalarials/chemistry , Antitubercular Agents/chemistry , Asia , Counterfeit Drugs , Databases, Factual , South America , Time Factors
20.
Article in English | MEDLINE | ID: mdl-24050066

ABSTRACT

The prevalence, availability, and use of antimalarial medicines (AMLs) were studied in six Cambodian provinces along the Thai-Cambodian border. The study was divided into two parts: the first looked at the quality of AMLs available in Pursat, Pailin, Battambang, Bantey Meanchey, Oddar Meanchey, and Preah Vihear and the second obtained information about the availability and use of AMLs. A randomized sampling methodology was used to select locations and collect samples, which were screened using Global Pharma Health Fund (GPHF) Minilabs. A subset of samples was sent to quality control laboratories for confirmatory testing. For the second part of the study, face-to-face interviews were conducted using standardized surveys with members of randomly selected households and staff of health facilities in the villages with highest malaria incidence to find out where they acquired their AMLs and which were most frequently used. The results showed an overall failure rate of 12.3% (n = 46 of 374 total AML samples). The causes of medication sample failure were low active pharmaceutical ingredient (API) content, failed dissolution properties, and unacceptably high levels of impurities. A total of 86.2% of survey respondents (n = 1,648 of 1,912) reported a member of their household having malaria in the previous year. The most commonly used medicines were paracetamol (67.1% of respondents), Malarine (A+M co-blistered, 28.6%), artesunate + mefloquine co-blistered (public sector product, 17.3%), quinine (16.7%), and artesunate monotherapy (11.9%). Health staff typically prescribed co-blistered artesunate plus mefloquine in the public sector (67.8%), the artesunate plus mefloquine "social marketing" product from Population Services International (PSI), Malarine (50.3%) in the private sector, artemether (49.7%), chloroquine (39%) and paracetamol (72.9%) to reduce fever.


Subject(s)
Antimalarials/standards , Antimalarials/therapeutic use , Health Services Accessibility/statistics & numerical data , Malaria, Falciparum/drug therapy , Technology, Pharmaceutical/standards , Antimalarials/supply & distribution , Biological Availability , Cambodia/epidemiology , Cross-Sectional Studies , Drug Therapy, Combination , Health Personnel , Humans , Malaria, Falciparum/epidemiology , Private Sector , Public Sector , Thailand
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