Thyroid Stimulating Hormone as a Possible Additional COVID-19 Outcome Marker.

Background and Objectives: The interaction between thyroid and SARS-CoV-2 is complex and not yet fully understood. This study aimed to identify a predictive value of serum TSH levels on the short-term and middle-term outcomes of patients hospitalized for COVID-19. Materials and Methods: We retrospectively analyzed electronic records (ERs) data for hospitalized COVID-19 patients between March 2020 and June 2021 and their ERs during outpatient visits, 6-8 weeks post-discharge, in cases of known serum TSH levels and no previous thyroid disorder. The short-term (length of hospital stay, MSCT findings of lung involvement, required level of oxygen supplementation, admission to the ICU, and death) and middle-term outcomes after 6 to 8 weeks post-discharge (MSCT findings of lung involvement) were analyzed. Results: There were 580 patients included: 302 males and 278 females, average age of 66.39 ± 13.31 years, with no known thyroid disease (TSH mean 1.16 ± 1.8; median 0.80; no value higher than 6.0 mIU/L were included). Higher TSH was observed in patients with less severe outcomes and was associated with significantly higher SpO2 during hospitalization. Patients who required overall more oxygen supplementation or HFOT, mechanical ventilation, and patients who were more frequently admitted to the ICU or were more often treated with corticosteroids had lower TSH than those who did not show these indicators of disease severity. Lower TSH was also present in non-survivors when compared to survivors (all p < 0.01). Patients with low TSH during hospitalization more often had persistent lung involvement during the post-COVID-19 period (p = 0.028). In the post-COVID-19 period, there was an overall, statistically significant increase in the TSH levels when compared to TSH during hospitalization (p < 0.001). Conclusions: Low/suppressed serum TSH levels during acute COVID-19 may be an additional laboratory test that should be included in the prediction of unfavorable short- and middle-term outcomes.

Ocular myasthenia gravis-like symptoms associated with erenumab: Case report.

OBJECTIVE: We present a case of a patient who developed myasthenia gravis (MG)-like symptoms during erenumab treatment. CASE REPORT: The patient had a years-long history of chronic migraine with visual and sensory aura. Two months after the beginning of erenumab therapy, she reported intermittent bilateral weakness of the eyelids, with ptosis. The eyelid ptosis was severe enough to block the patient's vision. The symptoms would usually last between 5 and 10 minutes and resolve completely spontaneously, but they repeated on a daily basis. Antibodies against acetylcholine receptors and muscle-specific kinase were all negative, and other work-up excluded the usual etiology of ptosis. Since the cause of symptoms was not detected, we suspected they were induced by erenumab. The treatment was discontinued, and after 7 weeks from the last dose of erenumab, ocular symptoms resolved completely. In the presented case, other possible causes of MG-like symptoms were excluded by diagnostic tests and clinical course of the disease. The temporal relationship between the administration of erenumab and occurrence of ptosis, with regression of the symptoms after the drug discontinuation supports the hypothesis of causal relationship with erenumab. According to the Naranjo's Adverse Drug Reaction Probability Scale, erenumab-related MG-like symptoms were rated 'probable'. Reviewing the literature, we identified no similar case reports. CONCLUSION: Drug-induced MG-like symptoms might be life threatening. Therefore, clinicians should be aware of these adverse reactions during the use of erenumab.

Consumption of high-dose statins in patients older than 65 years in the Republic of Croatia in the period 2005 - 2015.

OBJECTIVE: Patients over 65 years of age on high-dose statins are most sensitive to the development of adverse effects of statins. The objective of this study is to analyze the consumption of high-dose statins in this patient group in Croatia in the period of 2005 - 2015. MATERIALS AND METHODS: For the period of January 1, 2005 to December 31, 2015, the Croatian Institute for Health Insurance provided us with the total number of: all insured, insured over 65 years of age, insured using statins, insured using high-dose statins, insured over 65 using statins, insured over 65 using high-dose statins, number of packages dispensed through all community pharmacies for all statins registered in Croatia divided by year and sex. Studied high-dose statins were: simvastatin 40 mg; atorvastatin 40 mg, 60 mg, 80 mg; fluvastatin 80 mg; rosuvastatin 40 mg. The yearly consumption of each form of statin was calculated in DDD/1,000 insured/day and was statistically processed. RESULTS: The consumption of all statins increased by 194%, while the consumption of high-dose statins in patients over 65 increased by 296%. The number of all patients on statin therapy increased by 58%, the number of patients over 65 on statin therapy increased by 87%, and the number of patients over 65 on high-dose statins increased by 326%. 60% of all patients over 65 receiving high-dose statins were women. The most used high-dose statins were atorvastatin and simvastatin. CONCLUSION: Consumption of all statins increased, mostly high-dose statins in the 65+ age group, the most sensitive population for adverse effects. The number of 65+ patients on high-dose statins grew much faster than the general statin user group, thus increasing the risk potential. Women are dominating all age and dose groups of statin users.

Impact of an integrated medication reconciliation model led by a hospital clinical pharmacist on the reduction of post-discharge unintentional discrepancies.

WHAT IS KNOWN AND OBJECTIVE: There is no optimal standardized model in the transfer of care between hospitals and primary healthcare facilities. Transfer of care is a critical point during which unintentional discrepancies, that can jeopardize pharmacotherapy outcomes, can occur. The objective was to determine the effect that an integrated medication reconciliation model has on the reduction of the number of post-discharge unintentional discrepancies. METHODS: A randomized controlled study was conducted on an elderly patient population. The intervention group of patients received a medication reconciliation model, led entirely by a hospital clinical pharmacist (medication reconciliation at admission, review and optimization of pharmacotherapy during hospitalization, patient education and counselling, medication reconciliation at discharge, medication reconciliation as part of primary health care in collaboration with a primary care physician and a community pharmacist). Unintentional discrepancies were identified by comparing the medications listed on the discharge summary with the first list of medications prescribed and issued at primary care level, immediately after discharge. The main outcome measures were incidence, type and potential severity of post-discharge unintentional discrepancies. RESULTS AND DISCUSSION: A total of 353 patients were analysed (182 in the intervention and 171 in the control group). The medication reconciliation model, led by a hospital clinical pharmacist, significantly reduced the number of patients with unintentional discrepancies by 57.1% (p < 0.001). The intervention reduced the number of patients with unintentional discrepancies associated with a potential moderate harm by 58.6% (p < 0.001) and those associated with a potential severe harm by 68.6% (p = 0.039). The most common discrepancies were incorrect dosage, drug omission and drug commission. Cardiovascular medications were most commonly involved in unintentional discrepancies. WHAT IS NEW AND CONCLUSION: The integrated medication reconciliation model, led by a hospital clinical pharmacist in collaboration with all health professionals involved in the patient's pharmacotherapy and treatment, significantly reduced unintentional discrepancies in the transfer of care.

Patients perspectives on drug shortages in six European hospital settings - a cross sectional study.

BACKGROUND: It is known that drug shortages represent a major challenge for all stakeholders involved in the process, but there is little evidence regarding insights into patients' awareness and perspectives. This study aimed to investigate the patients-perceived drug shortages experience and their view on outcomes in different European hospital settings. Furthermore, we wanted to explore information preferences on drug shortages. METHODS: A retrospective, cross sectional, a mixed method study was conducted in six European hospital settings. One hospital (H) from each of this country agreed to participate: Bosnia and Herzegovina (H-BiH), Croatia (H-CR), Germany (H-GE), Greece (H-GR), Serbia (H-SE) and Poland (H-PO). Recruitment and data collection was conducted over 27 months from November 2017 until January 2020. Overall, we surveyed 607 patients which completed paper-based questionnaire. Questions related to: general information (demographic data), basic knowledge on drug shortages, drug shortages experienced during hospitalization and information preferences on drug shortage. Differences between hospital settings were analyzed using Chi-squared test or Fisher's exact test. For more complex contingency tables, Monte Carlo simulations (N = 2000) were applied for Fisher's test. Post-hoc hospital-wise analyses were performed using Fisher's exact tests. False discovery rate was controlled using the Bonferroni method. Analyses were performed using R: a language and environment for statistical computing (v 3.6.3). RESULTS: 6 % of patients reported experiences with drug shortages while hospitalized which led to a deterioration of their health. The majority of affected patients were hospitalized at hematology and/or oncology wards in H-BiH, H-PO and H-GE. H-BiH had the highest number of affected patients (18.1 %, N = 19/105, p < 0.001) while the fewest patients were in H-SE (1 %, N = 1/100, p = 0.001). In addition, 82.5 %, (N = 501/607) of respondents wanted to be informed of alternative treatment options if there was a drug shortage without a generic substitute available. Majority of these patients (66.4 %, N = 386/501) prefer to be informed by a healthcare professional. CONCLUSIONS: Although drug shortages led to serious medical consequences, our findings show that most of the patients did not perceive shortages as a problem. One possible interpretation is that good hospital management practices by healthcare professionals helped to mitigate the perceived impact of shortages. Our study highlights the importance of a good communication especially between patients and healthcare professionals in whom our patients have the greatest trust.

Impact of pharmacotherapeutic education on medication adherence and adverse outcomes in patients with type 2 diabetes mellitus: a prospective, randomized study.

AIM: To evaluate the impact of pharmacotherapeutic education on 30-day post-discharge medication adherence and adverse outcomes in patients with type 2 diabetes mellitus (T2DM). METHODS: The prospective, randomized, single-center study was conducted at the Medical Department of University Hospital Dubrava, Zagreb, between April and June 2018. One hundred and thirty adult patients with T2DM who were discharged to the community were randomly assigned to either the intervention or the control group. Both groups during the hospital stay received the usual diabetes education. The intervention group received additional individual pre-discharge pharmacotherapeutic education about the discharge prescriptions. Medication adherence and occurrence of adverse outcomes (adverse drug reactions, readmission, emergency department visits, and death) were assessed at the follow-up visit, 30 days after discharge. RESULTS: The number of adherent patients was significantly higher in the intervention group (57/64 [89.9%] vs 41/61 [67.2%]; χ2 test, P=0.003]. There was no significant difference between the groups in the number of patients who experienced adverse outcomes (31/64 [48.4%] vs 36/61 [59.0%]; χ2 test, P=0.236). However, higher frequencies of all adverse outcomes were consistently observed in the control group. CONCLUSION: Pharmacotherapeutic education of patients with T2DM can significantly improve 30-day post-discharge medication adherence, without a significant reduction in adverse clinical outcomes. ClinicalTrial.gov identification number: NCT03438162.

Clinical pharmacist-led program on medication reconciliation implementation at hospital admission: experience of a single university hospital in Croatia.

AIM: To evaluate the clinical pharmacist-led medication reconciliation process in clinical practice by quantifying and analyzing unintentional medication discrepancies at hospital admission. METHODS: An observational prospective study was conducted at the Clinical Department of Internal Medicine, University Hospital Dubrava, during a 1-year period (October 2014 - September 2015) as a part of the implementation of Safe Clinical Practice, Medication Reconciliation of the European Network for Patient Safety and Quality of Care Joint Action (PASQ JA) project. Patients older than 18 years taking at least one regular prescription medication were eligible for inclusion. Discrepancies between pharmacists' Best Possible Medication History (BPMH) and physicians' admission orders were detected and communicated directly to the physicians to clarify whether the observed changes in therapy were intentional or unintentional. All discrepancies were discussed by an expert panel and classified according to their potential to cause harm. RESULTS: In 411 patients included in the study, 1200 medication discrepancies were identified, with 202 (16.8%) being unintentional. One or more unintentional medication discrepancy was found in 148 (35%) patients. The most frequent type of unintentional medication discrepancy was drug omission (63.9%) followed by an incorrect dose (24.2%). More than half (59.9%) of the identified unintentional medication discrepancies had the potential to cause moderate to severe discomfort or clinical deterioration in the patient. CONCLUSION: Around 60% of medication errors were assessed as having the potential to threaten the patient safety. Clinical pharmacist-led medication reconciliation was shown to be an important tool in detecting medication discrepancies and preventing adverse patient outcomes. This standardized medication reconciliation process may be widely applicable to other health care organizations and clinical settings.

Peripheral mononeuropathy associated with valproic acid poisoning in an adult patient.

OBJECTIVE: To present the case of axillary nerve neuropathy associated with valproic acid (VPA) poisoning. CASE REPORT: A 26-year-old man was hospitalized because of a suicide attempt with VPA overdose. Toxicology analysis revealed high serum VPA level (2,896 µmol/L; therapeutic range: 350 - 690 µmol/L). Three days after admission, the patient complained of weakness in his right arm. Neurological examination revealed weakness of flexion and abduction of the right arm and loss of sensation in the skin over the lateral upper right arm. A nerve conduction velocity test was normal in the ulnar, radial, median, musculocutaneous, and suprascapular nerves. Compound muscle action potential showed reduced amplitude and prolonged latencies in the right axillary nerve taken from Erb's point and absent taken from distal stimulation point. Right axillary nerve paresis was diagnosed and the patient underwent a physical therapy program, which resulted in gradual recovery. DISCUSSION: In the presented case, other possible causes of neuropathy were excluded by medical history, laboratory and radiological tests, and clinical course of the disease.The temporal relationship between the VPA poisoning and the occurrence of neuropathy supports the hypothesis of a VPA-caused axillary neuropathy. According to the Naranjo's Adverse Drug Reaction (ADR) Probability Scale, VPA-induced neuropathy was rated "probable". CONCLUSION: VPA-induced neuropathy may be a serious ADR, but it is potentially preventable and reversible. Thus, clinicians should be aware of this rare ADR.

Adverse drug reactions in elderly patients following discharge from an internal medicine clinic.

OBJECTIVE: The aim of this study was to evaluate the incidence and type of adverse drug reactions (ADRs) and identify risk factors for ADRs in elderly patients within 30 days following discharge from an internal medicine clinic. METHODS: A prospective observational study was conducted at the Internal Medicine Clinic of University Hospital Dubrava, Zagreb, Croatia, between September 1(st) and November 30(th) 2012. Patients aged ≥ 65 years discharged from the clinic during the study period were eligible for inclusion in the study. The follow-up visit was scheduled ~ 30 days after discharge. During the visit, the patients were assessed for the occurrence of ADRs. Two independent physicians evaluated each possible ADR by using the Naranjo ADR probability scale. Multivariate logistic regression analysis was used to identify predisposing factors for ADRs. RESULTS: There were 209 patients included in this study. A total of 72 ADRs were detected in 63 (30.1%) patients. The most frequent ADRs were bleeding disorders associated with warfarin therapy, followed by hypoglycemia associated with antidiabetics. Five (6.9%) ADRs, which resulted in hospital admission, were classified as serious. Multivariate logistic regression analysis indicated number of prescribed drugs ≥4 and prescription of furosemide and warfarin to be associated with increased risk of ADRs. CONCLUSIONS: Our study showed that ADRs are an important cause of morbidity in elderly patients after hospital discharge. Judicious prescription of drugs and careful and frequent monitoring of drug therapy are necessary to reduce the risk of ADRs.

Large chondrosarcoma of the lumbar spine--a rare yet important cause of lower back pain.

We report a case of a large chondrosarcoma of an L4 vertebral body causing iliac vein thrombosis. The slow-growing tumor eluded definitive diagnosis early in its development since the main symptom it caused was only lower back pain. Five years after onset of the disease, the patient presented with fever, tenderness and swelling in the leg, the tumor was diagnosed and found to be exerting a mass effect causing further pain and compressing the left common iliac vein. Due to inoperability of the tumor, a multidisciplinary surgical approach was used to resect the majority of the tumor as apalliative measure and rid the patient of her symptoms. Due to the chemoresistance and relative radioresistance of these tumors, prompt full surgical resection before the tumor invades vital structures remains the mainstay of successful treatment of chondrosarcoma of the spine.

Perspectives of primary care physicians on academic detailing for antimicrobial stewardship: feasibility and impact assessment.

OBJECTIVE: To understand primary care physicians' perspectives on academic detailing from an antimicrobial stewardship team to combat antibiotic overuse for upper respiratory infections and bronchitis in the COVID-19 era, which will help prevent avoidable outpatient visits. METHODS: In this prospective study, 14 female Croatian physicians completed standardized qualitative interviews using a semi-structured guide. The data were analyzed using inductive methodology based on reflexive thematic analysis. We used a theoretically informed approach based on a conceptual framework of healthcare intervention implementability focused on three domains: acceptability, fidelity, and feasibility. RESULTS: We identified six key themes highlighting barriers to changing prescribing practices, with patient pressure and specialist recommendations having an impact on the effectiveness of academic detailing. Despite challenges, primary care physicians described appreciation of direct interaction with evidence-based practices and reported usefulness, effectiveness, and further need for academic detailing. CONCLUSION: This study highlights the complex dynamics involved in implementing healthcare interventions and provides valuable insights for enhancing strategies directed at improving antibiotic prescribing practices. Specifically, our findings emphasize factors influencing behavior changes in physicians' antibiotic prescribing. The authors advocate for a collaborative approach involving community and hospital-based professionals to provide tailored guidance and address questions, ultimately improving prescribing practices.

Compensated Advanced Chronic Liver Disease and Steatosis in Patients with Type 2 Diabetes as Assessed through Shear Wave Measurements and Attenuation Measurements.

Patients with type 2 diabetes (T2D) are at risk of developing metabolic dysfunction-associated steatotic liver disease (MASLD). We investigated the prevalence of compensated advanced chronic liver disease (cACLD) and steatosis in patients with T2D using the new non-invasive diagnostic methods of shear wave measurements (SWMs) and attenuation (ATT) measurements in comparison with those of vibration-controlled transient elastography (VCTE) and the controlled attenuation parameter (CAP), which served as the reference methods. Among 214 T2D patients, steatosis at any grade and cACLD were revealed in 134 (62.6%) and 19 (8.9%) patients, respectively. SWMs showed a high correlation with VCTE (Spearman's ρ = 0.641), whereas SWMs produced lower (mean of -0.7 kPa) liver stiffness measurements (LSMs) overall. At a LSM of >11.0 kPa (Youden), SWMs had an AUROC of 0.951 that was used to diagnose cACLD (defined as a LSM of >15 kPa through VCTE) with 84.2% sensitivity and 96.4% specificity. The performance of ATT measurements in diagnosing liver steatosis at any grade (defined as the CAP of ≥274 dB/m) was suboptimal (AUROC of 0.744 at the ATT measurement cut-off of >0.63 dB/cm/MHz (Youden) with 59% sensitivity and 81.2% specificity). In conclusion, the prevalence of liver steatosis and previously unrecognized cACLD in patients with T2D is high and SWMs appear to be a reliable diagnostic method for this purpose, whereas further investigation is needed to optimize the diagnostic performance of ATT measurements.

Actual drug-drug interactions in elderly patients discharged from internal medicine clinic: a prospective observational study.

PURPOSE: The aim of the study was to evaluate the incidence and type of actual drug-drug interactions (DDIs) that result in adverse drug reactions (ADRs) or diminished therapeutic effect in elderly patients within 30 days of discharge from an internal medicine clinic. METHODS: A prospective observational study was conducted at the Internal Medicine Clinic of University Hospital Dubrava, Zagreb, Croatia, between October and December 2011. Patients aged ≥ 65 years discharged from the Internal Medicine Clinic during the study period with a prescription for two or more medications were eligible for inclusion in the study. A total of 222 patients were ultimately enrolled in the study. For each patient, potential DDIs were identified using Lexi-Interact software. The follow-up visit was scheduled approximately 30 days after discharge. Causality between DDIs and ADRs or diminished therapeutic effect of drugs was assessed by two independent clinicians. RESULTS: Potential DDIs were identified in 190 (85.6 %) patients. Actual DDIs were detected in 21 (9.5 %) patients. In 19 patients, DDIs resulted in an ADR. Diminished therapeutic effect resulting from DDIs was detected in two patients. Angiotensin-converting enzyme inhibitors were the drug class most frequently associated with DDI-related ADRs. CONCLUSIONS: A significant incidence of actual DDIs suggests that DDIs play an important role in patient safety. Drug therapy should be initiated if absolutely necessary, and the number of drugs used to treat elderly patients should be minimized to reduce the incidence of DDI-related adverse patient outcomes.

The relationship between methylenetetrahydrofolate reductase C677T gene polymorphism and diabetic nephropathy in Croatian type 2 diabetic patients.

Methylenetetrahydrofolate reductase (MTHFR) polymorphism has been shown to be associated with the development of diabetic nephropathy in many ethnic groups. In this study, we examined the correlation between MTHFR C677T polymorphism and microalbuminuria in patients with diabetes mellitus type 2 in Croatian patients. 85 patients with diabetes mellitus type 2 were recruited. Patients were classified into two groups--with and without diabetic nephropathy according to urinary albumin excretion rate in urine collected during 24 hours. The C677T genotype was determined by real-time PCR analysis. The genotype frequencies were CC 36.5%, CT 42.3% and TT 21.2% in diabetic patients without nephropathy versus CC 39.4%, CT 45.4% and TT 15.2% in those with nephropathy. There was no statistically significant difference in allele distribution between patients with nephropathy and those without (p = 0.788). Our study did not show a correlation between mutations in the MTHFR gene and diabetic nephropathy in Croatian patients. Diabetic nephropathy is influenced by multiple risk factors which can modify the importance of MTHFR polymorphism in its development.

Prevalence and predictors of potential drug-drug interactions in the elderly: a cross-sectional study in the brazilian primary public health system.

PURPOSE: The primary objective of this study was to investigate the prevalence of clinically important potential drug-drug interactions (DDIs) in elderly patients attending the public primary health care system in Brazil. The secondary objective was to investigate possible predictors of potential DDIs. METHODS: A cross-sectional study was carried out in 5 Brazilian cities located in the Ourinhos Micro-region, Sao Paulo State, between November 2010 and April 2011. The selected sample was divided according to the presence (exposed) or absence (unexposed) of one or more potential DDIs (defined as the presence of a minimum 5-day overlap in supply of an interacting drug pair). Data were collected from medical prescriptions and patients' medical records. Potential DDIs (rated major or moderate) were identified using 4 DDI-checker programs. Logistic regression analysis was used to study potential DDI predictors. RESULTS: The prevalence of clinically important potential DDIs found during the study period was 47.4%. Female sex (OR = 2.49 [95% CI 2.29-2.75]), diagnosis of ≥ 3 diseases (OR = 6.43 [95% CI 3.25-12.44]), and diagnosis of hypertension (OR = 1.68 [95% CI 1.23-2.41]) were associated with potential DDIs. The adjusted OR increased from 0.90 [95% CI 0.82-1.03] in patients aged 60 - 64 years to 4.03 [95% CI 3.79 - 4.28] in those aged 75 years or older. Drug therapy regimens involving ≥ 2 prescribers (OR = 1.39 [95% CI 1.17-1.67]), ≥ 3 drugs (OR = 3.21 [95% CI 2.78-3.59]), ≥ 2 ATC codes (OR = 1.19 [95% CI 1.12-1.29]), ≥ 2 drugs acting on cytochrome P450 (OR = 2.24 [95% CI 2.07-2.46]), and ATC codes B (OR = 1.89 [95% CI 1.05-2.08]) and C (OR = 4.01 [95% CI 3.55-4.57]) were associated with potential DDIs. CONCLUSION: Special care should be taken with the prescription and therapeutic follow-up of patients who present characteristics identified as predictors. Knowledge of potential DDI predictors could aid in developing preventive practices and policies that allow public health services to better manage this situation.

Enhanced anticoagulant effect of warfarin in a patient treated with cloxacillin.

OBJECTIVE: To present the case of warfarin-cloxacillin interaction that resulted in an increased international normalized ratio (INR). CASE SUMMARY: A 70-year-old man had been treated with warfarin for atrial fibrillation. He was hospitalized because of superficial thrombophlebitis of the left median cubital vein, which developed after venipuncture. An antibiotic therapy with cloxacillin was initiated immediately after the admission. Two days later, INR value increased from baseline 1.9 to 4.6. Anticoagulation therapy was discontinued and INR value was measured daily. His INR remained high for the entire duration of antibiotic therapy. Three days after the cloxacillin therapy was discontinued, the INR decreased to the baseline value. DISCUSSION: In the presented case, the temporal relationship between the administration of cloxacillin and increased INR suggests that the cloxacillin was responsible for the enhanced warfarin activity. According to the Drug Interaction Probability Scale, a causal relationship between the warfarin-cloxacillin interaction and increased INR value was rated "probable". CONCLUSION: Interactions between warfarin and cloxacillin can result in serious adverse reactions. INR value should be closely monitored when patients are prescribed this combination of drugs.

Effect of a 36-month pharmaceutical care program on the coronary heart disease risk in elderly diabetic and hypertensive patients.

PURPOSE: To examine the effect of a pharmaceutical care program on the coronary heart disease risk in elderly diabetic and hypertensive patients. METHODS: A total of 200 elderly (> 60 years) diabetic and/or hypertensive patients were recruited into a randomized, controlled, prospective clinical trial with a 36-month follow-up, developed in a public primary health care unit in a municipality in the Brazilian State of Sao Paulo. A range of clinical measurements were evaluated at the baseline and up to 36 months afterwards. The intervention group patients received pharmaceutical care from a clinical pharmacist, whereas the control group patients received their usual care from the medical and nursing staff. The Framingham scoring method was used to estimate changes in the 10-year coronary heart disease risk scores of all the patients. RESULTS: A total of 194 patients completed the study. Significant reductions (p < 0.05) in the mean values (baseline vs. 36 months) for the systolic blood pressure [156.7 mmHg vs 133.7 mmHg; P < 0.001), diastolic blood pressure (106.6 mmHg vs. 91.6 mmHg; P < 0.001),fasting glucose (135.1 mg/dL vs. 107.9 mg/dL; P < 0.001), hemoglobin A1C (7.7% vs. 7.0%; P <0.001), triglycerides (206.0 mg/dL vs. 152.5 mg/dL; P < 0.001), low-density lipoprotein (LDL)cholesterol (112.4 mg/dL vs. 102.0 mg/dL; P < 0.001), high-density lipoprotein cholesterol (55.5 mg/dL vs. 65.5 mg/dL; P < 0.001), total cholesterol (202.5 mg/dL vs. 185.9 mg/dL; P < 0.001), body mass index (26.2 kg/m2 vs. 26.1 kg/m2; P < 0.001), and abdominal circumference (103.2 cm vs. 102.5 cm; P= 0.001) were observed in the intervention group, whereas no significant changes were verified in the control group. The mean Framingham risk prediction score in the intervention group was 6.8% at baseline and decreased to 4.5%; P < 0.001) after 36 months, but remained unchanged in the control group. CONCLUSION: The pharmaceutical care program resulted in better clinical measurements and reduced the cardiovascular risk scores in elderly diabetic and hypertensive patients over a 36-month period.

Potentially inappropriate medications involved in drug-drug interactions at hospital discharge in Croatia.

Background The potentially inappropriate medications (PIMs) and drug-drug interactions (DDIs) can significantly affect patient safety in the elderly, especially at transition of health care. Objective The aim of this study is to evaluate PIMs involved in potentially clinically significant DDIs in prescribed pharmacotherapy of elderly patients at hospital discharge. Setting Internal Medicine Clinic of University Hospital Dubrava, Zagreb, Croatia. Method During a 16-month period, the pharmacotherapy data were assessed using Lexicomp Online screening software to identify category C (monitor drug therapy), D (consider therapy modification) and X (avoid combination) DDIs. The European Union (EU)(7)-PIM criteria were applied to detect inappropriately prescribed medications involved in DDIs. Clinical pharmacists obtained data from patients' medical records and patient/caregiver interviews. Main outcome measure The incidence of PIMs involved in potentially clinically significant DDIs. Results A total of 364 consecutive elderly patients were enrolled in the study. The mean number of prescription medications at discharge was 9.3. Overall, 2833 potentially clinically significant DDIs were identified: 2445 (86.3%) of them were category C, 347 (12.3%) category D and 41 (1.4%) were category X interactions. A total of 1164 PIMs were involved in 31.2% of category C interactions, 60.2% of category D interactions and 43.9% of category X interactions. The most frequent PIMs involved in potentially clinically significant DDIs were tramadol, benzodiazepines, moxonidine, vildagliptin and metoclopramide. Conclusion A very high incidence of DDIs in elderly patients and a high incidence of PIMs involved in DDIs was determined at hospital discharge.

Pharmacists' interventions improve health-related quality of life of rural older person on warfarin: a randomized controlled trial.

Warfarin therapy can significantly affect patients' quality of life and cause therapy discontinuation. This study aimed to investigate the effect of the pharmacists' interventions on the health-related quality of life (HRQoL) in older rural patients on warfarin therapy. Eligible older patients from rural area of Croatian province Slavonia were randomized into the intervention and control groups and followed for six months. Repeated education and a follow-up plan were provided to the participants in the intervention group, and if needed, the pharmacist intervened to optimize warfarin therapy. Secondary analysis on HRQoL data are presented here. Main outcome measure was Duke anticoagulation satisfactions scale questionnaire score. In total, 131 participants finished the study (median age 73 years; 51.1% male). Participants in the intervention group scored significantly lower (median being 86.5 and 66.0 in the control and intervention groups, respectively; p < 0,001), indicating higher HRQoL. Adverse drug reactions and pharmacist's intervention were identified as predictive factors for patients' HRQoL (r2 = 65.5%, P < 0.001). The study demonstrated that community pharmacist's interventions can improve HRQoL of older patients taking warfarin what is of particular significance for patients living in rural areas with less accessible healthcare and lower socio-economic status.Clinicaltrials.gov (ID: NCT03212898), 11/07/2017, retrospectively registered.

Liver and Nonliver-Related Outcomes at 2 Years Are Not Influenced by the Results of the FIB-4 Test and Liver Elastography in a Real-Life Cohort of Patients with Type 2 Diabetes.

Aims: To investigate morbidity and mortality in a real-life cohort of patients with type 2 diabetes (T2D) in relation to prevalence and severity of nonalcoholic fatty liver disease (NAFLD). Methods: Patients with T2D were referred for assessment of liver fibrosis by the FIB-4 test and liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE). Liver steatosis was quantified by the controlled attenuation parameter (CAP). These patients were followed until death or censored date. Results: Among 454 patients (52% males, mean age 62.5 years, BMI 30.9 kg/m2), 82.6% was overweight, 77.8% had fatty liver, and 9.9% and 3.1% had LSM and FIB-4 values suggestive of advanced fibrosis, respectively. During the follow-up period of median 2 years, 106 (23%) patients experienced adverse event (11% cardiovascular) and 17 (3.7%) died, whereas no liver-related morbidity or mortality was observed. Independent predictors of adverse outcomes were age and higher platelet count, while FIB-4, LSM, and CAP were not. Conclusion: In a cohort of T2D patients, no liver-related morbidity or mortality occurred during 2 years. Our patients probably have low real prevalence of advanced fibrosis which is likely overestimated by LSM ≥ 9.6 kPa. Liver fibrosis may be safely reassessed in the 2 years interval in noncirrhotic patients with T2D.