Uloga farmaceuta u zbrinjavanju pacijenta sa poremećajem rada tiroidne žlezde

Thyroid dysfunction is one of the most prevalent endocrine disorders, especially common in female patients. If patients are not diagnosed in time or adequately treated, the patients’ quality of life can be significantly impaired and additional health problems may occur, considering the key roles of thyroid hormones in the body. Therefore, it is necessary to raise awareness about the importance of recognition of symptoms that may indicate a potential problem with the thyroid gland and help to identify possible causes. For patients who are already being treated with levothyroxine (hypothyroidism), or thiamazole, carbimazole or propylthiouracil (hyperthyroidism), it is necessary to point out the necessity of proper, regular use of the drugs and implementation of accompanying nonpharmacological measures, as well as the potential for the occurrence of adverse reactions and interactions with other drugs or food. A significant role in the mentioned activities should be played by the pharmacist, as the most accessible member of the health team, who can, if necessary, refer the patient to a doctor for diagnosis, monitor the effectiveness and safety of the therapy, and provide appropriate patient counseling.Poremećaj funkcije tiroidne žlezde spada u najčešće endokrine poremećaje, posebno u ženskoj populaciji. Ukoliko se poremećaj ne ustanovi na vreme i ne leči adekvatno, kvalitet života pacijenta može biti narušen i može doći do dodatnih zdravstvenih problema, s obzirom na ključne uloge koje tireoidni hormoni imaju u organizmu. Stoga je neophodno podići svest o važnosti prepoznavanja simptoma koji ukazuju na potencijalni problem sa štitnom žlezdom, kao i moguće uzroke. Kod pacijenata koji su na terapiji levotiroksinom (hipotireoidizam) ili tiamazolom, karbimazolom ili propiltiouracilom (hipertireoidizam), potrebno je ukazati na značaj pravilne i redovne upotrebe lekova, uz sprovođenje pratećih nefarmakoloških mera, i ukazati na potencijal za pojavu neželjenih reakcija i interakcija sa drugim lekovima/hranom. Značajnu ulogu u navedenim aktivnostima bi trebalo da ima farmaceut, kao najdostupniji član zdravstvenog tima, koji može uputiti pacijenta lekaru radi postavljanje dijagnoze, pratiti efikasnost i bezbednost terapije, i pružiti pacijentu adekvatno savetovanje

Procena izloženosti ciklosporinu a i identifikacija faktora varijabilnosti u ranom posttransplantacionom periodu

Cyclosporin A (CyA) is an immunosuppressant used as part of a post-transplant therapeutic protocol to prevent graft rejection. Due to the large pharmacokinetic variability that characterizes it, it is necessary to conduct therapeutic drug monitoring (TDM). The aim of the conducted research is to assess the exposure of CyA in the period of up to 3 months after transplantation (early post-transplantation period) with the identification of factors that influence the values of the pharmacokinetic parameters of CyA. From pediatric patients with kidney transplants, at the University Children ́s Hospital Tiršova, data about dosage regimens, cotherapy, and measured CyA concentrations (C0 - immediately before the next dose and C2 - 2 hours after the morning dose) were collected retrospectively. Data were analysed in NONMEM® (version 7.4). Twenty six patients (up to 12 years old) were included in the analysis. The pharmacokinetic model that best described the data is a one- compartment model with first-order absorption. Haematocrit, serum creatinine and body mass were identified as the main factors of variability. In further analysis, it is necessary to include data about genetic polymorphism, which is expected to have the greatest impact on drug exposure and change the power ratio of factors that influence CyA parameter values and concentrations.The obtained results are expected considering the characteristics of CyA. In addition to identification, quantification of the influence of the mentioned factors is crucial for establishing an optimal dosing regimen in the early post-transplantation period in children, when the risk of graft rejection is the highest.Ciklosporin A (CyA) je imunosupresiv koji se koristi kao deo posttransplantacionog terapijskog protokola u cilju prevencije odbacivanja grafta. Zbog velike farmakokinetičke varijabilnosti koja ga karakteriše, neophodno je sprovođenje terapijskog monitoringa (therapeutic drug monitoring, TDM). Cilj sprovedenog istraživanja je procena izloženosti CyA u periodu do 3 meseca nakon transplantacije (rani posttransplantacioni period) uz identifikaciju faktora koji utiču na vrednosti farmakokinetičkih parametara CyA. Od pedijatrijskih pacijenata sa transplantiranim bubregom, u Univerzitetskoj klinici Tiršova, retrospektivno su prikupljani podaci o primenjenoj dozi CyA, koterapiji, izmerenim koncentracijama CyA (C0 – neposredno pred davanje naredne doze i C2 – 2 sata nakon jutarnje doze) i vrednostima laboratorijskih parametara od značaja. Podaci su obrađivani upotrebom populacione farmakokinetičke analize u programu NONMEM® (verzija 7.4). U analizu je uključeno 26 pacijenata starosti do 12 godina. Farmakokinetički model koji najbolje opisuje dostupne podatke je jednoprostorni model sa apsorpcijom prvog reda. Kao glavni faktori varijabilnosti identifikovani su hematokrit, serumski kreatinin i telesna masa. U daljoj analizi, neophodno je uključiti podatke o genetskom polimorfizmu, za koje se očekuje da će imati najveći uticaj na izloženost leku i promeniti odnos snaga faktora koji utiču na vrednosti parametara CyA i koncentraciju. Dobijeni rezultati su očekivani imajući u vidu karakteristike CyA. Pored identifikacije, i kvantifikacija uticaja navedenih faktora je ključna za uspostavljanje optimalnog režima doziranja u ranom posttransplantacionom periodu kod dece, kada je rizik od odbacivanja grafta najveći.VIII Kongres farmaceuta Srbije sa međunarodnim učešćem, 12-15.10.2022. Beogra

Community pharmacist-driven interventions in COPD: improving knowledge, attitude and health status

COPD is a chronic condition requiring care from a multidisciplinary team in which pharma- cists play an important role. We aimed to evaluate the impact of structured pharmacist-patient counsel- ing on patients’ knowledge, and attitudes about medicines and the impact of COPD on patients’ health status. A prospective study was conducted in ten community pharmacies. Patients were counseled using a detailed approach after completing validated questionnaires. The patients returned to a pharmacy for a follow-up after three months. Four validated questionnaires have been used to assess different aspects of patient’s knowledge about the disease, their attitudes about medicines, and the impact of the disease on patients’ health status: COPD Assessment Test (CAT), Modified Medical Research Council Dyspnea Scale (mMRC), Bristol COPD Knowledge Questionnaire (BCKQ), and The Beliefs about Medicines Question- naire (BMQ). Pharmacists recruited 83 COPD patients, from which 73 patients attended a follow-up visit. Before pharmacist intervention, the CAT median score was 20. After counseling, the CAT score decreased to 18 (p < 0.05). The highest improvement in patient knowledge was observed for inhaled bronchodila- tors (28.2%), vaccination (25.8%), oral steroids (24.4%), and smoking (24.2%). The median score for necessity increased, whereas the harm and concern median scores considerably decreased (p < 0.05) after counseling. The results showed significant improvements in all aspects covered throughout pharmacist- patient counseling. Based on our results, the proactive role of the pharmacist in the care of COPD patients may be beneficial to patients, physicians, and healthcare by improving care, and alleviating the strain on overloaded doctors by containing the costs.Link to the publisher: [https://www.ptfarm.pl/wydawnictwa/czasopisma/acta-poloniae-pharmaceutica/110/-/29839

Koncept i upotreba populacionih farmakokinetičkih i farmakokinetičko/farmakodinamičkih modela u razvoju leka i kliničkoj praksi

Due to frequent clinical trial failures and consequently fewer new drug approvals, the need for improvement in drug development has, to a certain extent, been met using model-based drug development. Pharmacometrics is a part of pharmacology that quantifies drug behaviour, treatment response and disease progression based on different models (pharmacokinetic - PK, pharmacodynamic - PD, PK/PD models, etc.) and simulations. Regulatory bodies (European Medicines Agency, Food and Drug Administration) encourage the use of modelling and simulations to facilitate decision-making throughout all drug development phases. Moreover, the identification of factors that contribute to variability provides a basis for dose individualisation in routine clinical practice. This review summarises current knowledge regarding the application of pharmacometrics in drug development and clinical practice with emphasis on the population modelling approach.Usled čestih neuspeha u kliničkim ispitivanjima i posledično manjeg broja odobrenja novih lekova, potreba za poboljšanjem u razvoju lekova je u određenoj meri zadovoljena korišćenjem pristupa razvoja lekova zasnovanog na modelu. Farmakometrija predstavlja granu farmakologije koja kvantifikuje ponašanje leka, odgovor na terapiju i napredovanje bolesti na osnovu različitih modela (farmakokinetički - FK, farmakodinamički - FD, FK/FD modeli itd.) i simulacija. Regulatorna tela (Evropska agencija za lekove, Uprava za hranu i lekove) podstiču primenu modelovanja i simulacija u svrhu lakšeg donošenja odluka tokom svih faza razvoja lekova. Štaviše, identifikacija faktora koji doprinose varijabilnosti predstavlja osnovu za individualizaciju doze u rutinskoj kliničkoj praksi. Ovaj revijalni rad sumira trenutno znanje u vezi sa primenom farmakometrije u razvoju lekova i kliničkoj praksi sa fokusom na populacionu analizu