Initial development of the Systems Approach to Home Medication Management (SAHMM) model.

Res Social Adm Pharm. 2017 Jan - Feb;13(1):39-47

Authors: Doucette WR, Vinel S, Pennathur P

Abstract
BACKGROUND: Adverse drug events and medication nonadherence are two problems associated with prescription medication use for chronic conditions. These issues often develop because patients have difficulty managing their medications at home. To guide patients and providers for achieving safe and effective medication use at home, the Systems Approach to Home Medication Management (SAHMM) model was derived from a systems engineering model for health care workplace safety.
OBJECTIVE: To explore how well concepts from the SAHMM model can represent home medication management by using patient descriptions of how they take prescription medications at home.
METHODS: Twelve patients were interviewed about home medication management using an interview guide based on the factors of the SAHMM model. Each interview was audio-taped and then transcribed verbatim. Interviews were coded to identify themes for home medication management using MAXQDA for Windows.
RESULTS: SAHMM concepts extracted from the coded interview transcripts included work system components of person, tasks, tools & technology, internal environment, external environment, and household. Concepts also addressed work processes and work outcomes for home medication management.
CONCLUSIONS: Using the SAHMM model for studying patients' home medication management is a promising approach to improving our understanding of the factors that influence patient adherence to medication and the development of adverse drug events.

PMID: 26853834 [PubMed - indexed for MEDLINE]

Diffuse edema suggestive of cytokine release syndrome in a metastatic lung carcinoma patient treated with pembrolizumab.

Immunotherapy. 2017 Mar;9(4):309-311

Authors: Rassy EE, Assi T, Rizkallah J, Kattan J

Abstract
Immune checkpoint inhibitors (ICIs) are actually being indicated more commonly in the management of chemoresistant cancer patients in view of their favorable toxicity profile in comparison to cytotoxic chemotherapy. In this paper, we report, to our knowledge, the first case suggestive of cytokine release syndrome secondary to pembrolizumab in a patient with metastatic lung squamous cell carcinoma. In view of the quick approvals of ICI and the absence of sufficient knowledge of the corresponding toxicity profile, the occurrence of any clinical or biological sign or symptom in patients receiving ICI requires further investigation.

PMID: 28303768 [PubMed - indexed for MEDLINE]

Case report of nivolumab-related pneumonitis.

Immunotherapy. 2017 Mar;9(4):313-318

Authors: Tada K, Kurihara Y, Myojo T, Kojima F, Ishikawa Y, Yoshiyasu N, Morimoto M, Ito R, Koyamada R, Yamashita T, Bando T, Mori S, Heike Y

Abstract
We report a case with suggestive antiprogrammed death-1 inhibitor-related pneumonitis in an endometrial cancer patient. This case presented with fever and cough after three dosages of nivolumab. Computed tomography initially showed centrilobular nodularities in a unilateral lung, which was compatible with aspiration pneumonia. However, diffuse ground-glass opacities (GGO) rapidly developed in the unilateral lung over 4 days despite the use of broad-spectrum antibiotics. Development of GGO was considered to be related to a nivolumab-mediated immune reaction. Corticosteroid was administered and the GGO subsequently disappeared. The present report focuses on the computed tomography diagnostic features of nivolumab-related pneumonitis. The accumulation of knowledge regarding various types of antiprogrammed death-1-related pneumonitis will lead to appropriate treatment for this newly emerging adverse event.

PMID: 28303763 [PubMed - indexed for MEDLINE]

Show drugs work before selling them.

Nature. 2017 03 08;543(7644):174-175

Authors: Sipp D, McCabe C, Rasko JE

PMID: 28277530 [PubMed - indexed for MEDLINE]

Nurses' Perceived Skills and Attitudes About Updated Safety Concepts: Impact on Medication Administration Errors and Practices.

J Nurs Care Qual. 2017 Jul/Sep;32(3):226-233

Authors: Armstrong GE, Dietrich M, Norman L, Barnsteiner J, Mion L

Abstract
Approximately a quarter of medication errors in the hospital occur at the administration phase, which is solely under the purview of the bedside nurse. The purpose of this study was to assess bedside nurses' perceived skills and attitudes about updated safety concepts and examine their impact on medication administration errors and adherence to safe medication administration practices. Findings support the premise that medication administration errors result from an interplay among system-, unit-, and nurse-level factors.

PMID: 27607849 [PubMed - indexed for MEDLINE]

Anticholinergic properties of medications.

Geriatr Nurs. 2016 Jul-Aug;37(4):302-3

Authors: Simonson W

PMID: 27393158 [PubMed - indexed for MEDLINE]

15 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2017/07/18

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Medical treatment of erectile dysfunction: too many medical prescriptions?

Urologia. 2017 Jul 05;:0

Authors: Capogrosso P, Ventimiglia E, Oreggia D, Salonia A, Montorsi F

Abstract
Erectile dysfunction (ED) is a worldwide commonly reported condition; epidemiological data showed a prevalence ranging from 2.3 to 53.4% within different population subsets. In this context, the advent of phosphodiesterase type 5 inhibitors (PDE5is) in the second mid of 1990s has deeply changed the treatment scenario of this bothersome condition. Being user-friendly compounds with an excellent overall safety profile, PDE5is emerged as the first-line treatment for ED, thus overcoming topical alprostadil and intracavernous injections (ICIs). However, available data on treatment-utilization patterns and medical prescriptions of PDE5is showed a range of as wide as 22-78% of patients reporting to purchase PDE5is even without a proper medical prescription. Moreover, an increase in the recreational use of PDE5is among young men has been observed in the last decades, with a worrisome diffusion of potential health-risky behaviours associated with this habit. Indeed, treatment of ED should carefully follow internationally based clinical guidelines to avoid inappropriate drug prescriptions, which may eventually expose treated patients to drug-related side effects. Thereof, a careful assessment of the so-called modifiable and reversible ED risk factors along with a patient-tailored screening for potential contraindications to the treatment itself should be performed in every case. Lastly, although conclusive data still lack, the potential association between life-risky PDE5is side effects (i.e. cardiovascular adverse events, melanoma skin cancer and worsening of prostate cancer outcomes) should be carefully taken into account when counselling patients for ED treatment.

PMID: 28708203 [PubMed - as supplied by publisher]

The British National Formulary.

Nurs Stand. 2016 Nov 02;31(10):64-65

Authors: Tallo D

Abstract
What was the nature of the CPD activity, practice-related feedback and/or event and/or experience in your practice? The CPD article introduced the revised format of the British National Formulary (BNF) and explained how the information it contains may be accessed. It discussed the importance of developing healthcare professionals' knowledge and understanding of the BNF to enable safe and effective prescribing, dispensing, administration and monitoring of medicines.

PMID: 27861054 [PubMed - indexed for MEDLINE]

Life threatening torsades de pointes due to abiraterone-induced hypokaelemia in a patient with metastatic prostate cancer.

N Z Med J. 2016 Nov 18;129(1445):124-127

Authors: Khan A, Kneale B

Abstract
We present a case of a 77 year-old gentleman with previous coronary artery bypass grafting, admitted to hospital with recurrent torsades de pointes (TdP) due to abiraterone-induced hypokalaemia and prolonged QTc. The patient was on abiraterone and prednisone for metastatic prostate cancer. He required multiple defibrillations for recurrent TdP. Abiraterone is a relatively novel drug used in metastatic prostate cancer and we discuss this potential adverse effect and its management in this unusual presentation.

PMID: 27857247 [PubMed - indexed for MEDLINE]

Adverse drug reactions: classification, susceptibility and reporting.

Nurs Stand. 2016 Aug 10;30(50):53-63

Authors: Kaufman G

Abstract
Adverse drug reactions (ADRs) are increasingly common and are a significant cause of morbidity and mortality. Historically, ADRs have been classified as type A or type B. Type A reactions are predictable from the known pharmacology of a drug and are associated with high morbidity and low mortality. Type B reactions are idiosyncratic, bizarre or novel responses that cannot be predicted from the known pharmacology of a drug and are associated with low morbidity and high mortality. Not all ADRs fit into type A and type B categories; therefore, additional categories have been developed. These include type C (continuing), type D (delayed use), and type E (end of use) reactions. Susceptibility to ADRs is influenced by age, gender, disease states, pregnancy, ethnicity and polypharmacy. Drug safety is reliant on nurses and other healthcare professionals being alert to the possibility of ADRs, working with patients to optimise medicine use and exercising vigilance in the reporting of ADRs through the Yellow Card Scheme.

PMID: 27507394 [PubMed - indexed for MEDLINE]

Safety of Drugs during Pregnancy and Breastfeeding in Cystic Fibrosis Patients.

Respiration. 2016;91(4):333-48

Authors: Panchaud A, Di Paolo ER, Koutsokera A, Winterfeld U, Weisskopf E, Baud D, Sauty A, Csajka C

Abstract
Health management of cystic fibrosis (CF) patients should be maximized during pregnancy and breastfeeding because of its significant impact on the maternal and newborn outcomes. Thus, numerous drugs will have to be continued during pregnancy and lactation. Most of the drugs representing CF treatment lines cross the placenta or are excreted into human milk. Research addressing the risks and benefits of drugs used in CF patients during pregnancy and lactation is often incomplete or challenged by limited methodology, which often leads to conflicting or inconclusive results. Yet, potential treatment benefits for CF pregnant patients most often outbalance potential risks for the unborn child.

PMID: 26942733 [PubMed - indexed for MEDLINE]

20 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2017/07/14

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Efficacy and safety of micafungin versus extensive azoles in the prevention and treatment of invasive fungal infections for neutropenia patients with hematological malignancies: A meta-analysis of randomized controlled trials.

PLoS One. 2017;12(7):e0180050

Authors: Lee CH, Lin JC, Ho CL, Sun M, Yen WT, Lin C

Abstract
BACKGROUND: Current studies that compare the efficacy and safety of micafungin (MCFG) with that of triazoles for the prophylaxis and treatment of invasive fungal infections (IFIs) demonstrate a lack of sufficient evidence and yield conflicting results. To compare the efficacy and safety of MCFG and triazoles in the prevention and treatment of IFIs, we conducted a meta-analysis and trial sequential analysis (TSA).
METHODS: For the meta-analysis, we systematically searched the databases of PubMed, Embase and Cochrane Central Register of Controlled Trials and relevant database articles for randomized controlled studies published through November 2016. Comparative studies of the efficacy and safety of MCFG versus triazoles in the prevention and treatment of IFIs were selected. Meta-analysis was performed by R software with the "metafor" package. Pooled results were expressed as risk ratios (RRs) with corresponding 95% confidence intervals (CI). TSA was adopted to assess the studies' power with TSA version 0.9 beta.
RESULTS: Nine current studies were included in the meta-analysis (1049 cases and 959 controls). Pooled trial comparisons indicated that MCFG does have significantly higher treatment success rates (RR = 1.13; 95% CI, 1.02-1.25; p = 0.0205) and reduces the number of overall IFIs (RR = 0.75; 95% CI, 0.61-0.92; p = 0.0056). However, MCFG demonstrates no difference in all-cause mortality (RR = 0.76; 95% CI, 0.52-1.12, p = 0.1624). For the safety evaluation, MCFG had a significantly lower incidence of severe adverse events (AEs) (RR = 0.45; 95% CI, 0.25-0.83; p = 0.0105), hepatic impairment (RR = 0.70; 95% CI, 0.50-0.97; p = 0.0363) and premature discontinuation (RR = 0.51; 95% CI, 0.34-0.76, p = 0.0010). Meta-regression analysis disclosed the correction of mean age and treatment success rates (P < 0.0001). Meanwhile, TSA demonstrated sufficient power to show efficacy.
CONCLUSIONS: The treatment success rate of MCFG is superior to that of triazoles for the prophylaxis and treatment of IFIs, and correction of the mean patient age demonstrates that efficacy increases as patient age decreases. MCFG appears to be well-tolerated with manageable side effects and lower withdrawal rates. However, additional clinical trials should be conducted on specific drug-related mortality and AEs to gather sufficient evidence on these matters.

PMID: 28700646 [PubMed - in process]

Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries.

Malar J. 2017 Jul 11;16(1):282

Authors: Kovacs SD, Mills BM, Stergachis A

Abstract
BACKGROUND: Malaria control efforts have been strengthened by funding from donor groups and government agencies. The Global Fund to Fight AIDS, Tuberculosis and the Malaria (Global Fund), the US President's Malaria Initiative (PMI) account for the majority of donor support for malaria control and prevention efforts. Pharmacovigilance (PV), which encompasses all activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, is a necessary part of efforts to reduce drug resistance and improve treatment outcomes. This paper reports on an analysis of PV plans in the Global Fund and PMI and World Bank's grants for malaria prevention and control.
METHODS: All active malaria grants as of September 2015 funded by the Global Fund and World Bank, and fiscal year 2015 and 2016 PMI Malaria Operational Plans (MOP) were identified. The total amount awarded for PV-related activities and drug quality assurance was abstracted. A Key-Word-in-Context (KWIC) analysis was conducted for the content of each grant. Specific search terms consisted of pharmacovigilance, pregn*, registry, safety, adverse drug, mass drug administration, primaquine, counterfeit, sub-standard, and falsified. Grants that mentioned PV activities identified in the KWIC search, listed PV in their budgets, or included the keywords: counterfeit, sub-standard, falsified, mass drug administration, or adverse event were thematically coded using Dedoose software version 7.0.
RESULTS: The search identified 159 active malaria grants including 107 Global Fund grants, 39 fiscal year 2015 and 2016 PMI grants and 13 World Bank grants. These grants were primarily awarded to low-income countries (57.2%) and in sub-Saharan Africa (SSA) (70.4%). Thirty-seven (23.3%) grants included a budget line for PV- or drug quality assurance-related activities, including 21 PMI grants and 16 Global Fund grants. Only 23 (14.5%) grants directly mentioned PV. The primary focus area was improving drug quality monitoring, especially among the PMI grants.
CONCLUSIONS: The results of the analysis demonstrate that funding for PV has not been sufficiently prioritized by either the key malaria donor organizations or by the recipient countries, as reflected in their grant proposal submissions and MOPs.

PMID: 28693488 [PubMed - in process]

[Drug induced angioedema: a rare side effect of simvastatin].

Pan Afr Med J. 2017;26:213

Authors: El Mekki AB, Chaib A

PMID: 28690728 [PubMed - in process]

Quality of the record of drug-related problems in a database for voluntary adverse event reporting.

Farm Hosp. 2017 Jul 01;41(4):508-517

Authors: Aznar-Saliente MT, Roca-Aznar L, Talens-Bolós A, Herraiz-Robles P, Bonete-Sánchez M, Pons-Martínez L, Marcos-Ribes B

Abstract
OBJECTIVE: To determine the number and type of errors found in the record of drug-related problems in the SINEA database, an electronic system for voluntary reporting of adverse events in healthcare, in order to quantify the differences between the raw and refined databases, suggest improvements, and determine the need for refining said databases.
METHODS: A Pharmacist reviewed the database and refined the adverse events reported from January to August, 2014, considering the "describe_what_happened" field as the gold standard. There was a comparison of the rates of medication errors, both potential and real, adverse reactions, impact on the patient, impact on healthcare, and medications more frequently involved in the raw and refined databases. Agreement was calculated through Cohen's Kappa Coefficient.
RESULTS: 364 adverse events were reported: 66.7% were medication errors, 2.7% adverse reactions to the medication (2 were wrongly classified as both, showing a total percentage &gt;100%) and 31% were other events. After refinement, the percentages were 69.5%, 5.8% and 24.7%, respectively (κ=0.85; CI95% [0.80-0.90]). Before refinement, 73.6% of medication errors were considered potential vs. 82.3% after refinement (κ=0.65; CI95% [0.54- 0.76]). The medication most frequently involved was trastuzumab (20.9%). The  "molecule" field was blank in 133 entries. A mean of 1.8±1.9 errors per entry were detected.
CONCLUSIONS: Although agreement is good, the refinement process cannot be avoided, as it provides valuable information to improve pharmacotherapy. Data quality could be improved by reducing the number of type-in text fields, using drop-down lists, and by increasing the training of the reporters.

PMID: 28683702 [PubMed - in process]

[Systemic toxicity of local anesthetics].

Stomatologiia (Mosk). 2017;96(2):36-42

Authors: Rabinovich SA, Zavodilenko LA

Abstract
The paper presents characteristics of local anesthetics used in dentistry and maxillofacial surgery taking into account their effectiveness and toxicity. We described the main clinical symptoms of manifestation of systemic toxicity and measures for prevention of local anesthesia complications, as well as the detailed protocol of 'lipid rescue' and resuscitation at manifestation of systemic toxic reaction of local anesthetics with the mechanism of the fatty emulsion action.

PMID: 28514346 [PubMed - indexed for MEDLINE]

Medication errors in anesthesia: unacceptable or unavoidable?

Braz J Anesthesiol. 2017 Mar - Apr;67(2):184-192

Authors: Dhawan I, Tewari A, Sehgal S, Sinha AC

Abstract
Medication errors are the common causes of patient morbidity and mortality. It adds financial burden to the institution as well. Though the impact varies from no harm to serious adverse effects including death, it needs attention on priority basis since medication errors' are preventable. In today's world where people are aware and medical claims are on the hike, it is of utmost priority that we curb this issue. Individual effort to decrease medication error alone might not be successful until a change in the existing protocols and system is incorporated. Often drug errors that occur cannot be reversed. The best way to 'treat' drug errors is to prevent them. Wrong medication (due to syringe swap), overdose (due to misunderstanding or preconception of the dose, pump misuse and dilution error), incorrect administration route, under dosing and omission are common causes of medication error that occur perioperatively. Drug omission and calculation mistakes occur commonly in ICU. Medication errors can occur perioperatively either during preparation, administration or record keeping. Numerous human and system errors can be blamed for occurrence of medication errors. The need of the hour is to stop the blame - game, accept mistakes and develop a safe and 'just' culture in order to prevent medication errors. The newly devised systems like VEINROM, a fluid delivery system is a novel approach in preventing drug errors due to most commonly used medications in anesthesia. Similar developments along with vigilant doctors, safe workplace culture and organizational support all together can help prevent these errors.

PMID: 28236867 [PubMed - indexed for MEDLINE]

Successful TB treatment outcome and its associated factors among TB/HIV co-infected patients attending Gondar University Referral Hospital, Northwest Ethiopia: an institution based cross-sectional study.

BMC Infect Dis. 2017 Feb 08;17(1):132

Authors: Sinshaw Y, Alemu S, Fekadu A, Gizachew M

Abstract
BACKGROUND: Tuberculosis/Human immunodeficiency virus (TB/HIV) co-infection is bidirectional and synergistic which mainly affects interventions that have been taken on the area. Tb patients co-infected with HIV have poorer treatment outcome as compared to non-co-infected patients. There is limited information regarding successful TB treatment outcomes and its associated factors; a reason that this study was planned to investigate.
METHODS: An institution based cross sectional study was carried out from July 2010 to January 2016. Data were abstracted from patients' medical chart using data abstraction format. The completeness of the data was checked and cleaned manually. Then, it was entered and analyzed by using SPSS version 20.0. Bi-variable and Multi-variable logistic regression model was fitted to identify factors associated with successful Tb treatment outcome. Significance was obtained through adjusted odds ratio with its 95% CI and a p < 0.05.
RESULTS: Successful TB treatment outcome among TB/HIV co-infected patients in Gondar University Hospital was 77.3% [95%CI 72.6-81.9]. Being residing in outside the Gondar town [AOR = 0.44, 95%CI: 0.25-0.80], having less than the mean baseline weight (<43.7 kg) at initiation of TB treatment [AOR = 0.51, 95% CI: 0.29-0.89], being in the bedridden condition [AOR = 0.23, 95% CI: 0.1-0.23], and experiencing anti-TB treatment side effect [AOR = 0.35, 95% CI: 0.12-0.98] were the factors that resulted the patient in treatment failure.
CONCLUSION: Successful Tb treatment outcome among TB/HIV co-infected patients was lower than the target set by Global Plan to Stop TB 2011-2015. Strengthening collaborative TB/HIV management activities that would trace the identified factors shall be recommended to increase successful treatment outcome of TB.

PMID: 28178936 [PubMed - indexed for MEDLINE]