| Abstract | Lijekovi danas manifestiraju sve brojnije pozitivne kliničke učinke te su uvelike doprinijeli smanjenju mortaliteta pacijenata, produljenju njihovog životnog vijeka te poboljšanju njihove kvalitete života. S druge strane, isti ti lijekovi povećavaju učestalost neželjenih reakcija, s obzirom da su upravo starija životna dob, prisutnost višestrukih komorbiditeta i polifarmacija jedni od najvažnijih čimbenika rizika za razvoj nuspojava lijekova. Premda je prijavljivanje nuspojava zakonska obveza svih zdravstvenih radnika, studije pokazuju kako se prijavljuje samo oko 6 % svih nuspojava. S obzirom na ograničenost podataka o epidemiologiji nuspojava, cilj ovog istraživanja bio je odrediti učestalost te klasificirati nuspojave kod pacijenata starijih od 65 godina s dijagnozom hipertenzije i barem jedne kardiovaskularne bolesti na razini primarne zdravstvene zaštite. Dodatno, cilj je bio utvrditi postoji li utjecaj sveobuhvatne usluge upravljanja farmakoterapijom (engl. Comprehensive Medication Management (CMM) services) na smanjenje učestalosti nuspojava. Provedeno je prospektivno, prije- i poslijeintervencijsko istraživanje s dvogodišnjim kontroliranim praćenjem pacijenata koji su uz uobičajenu skrb pruženu od strane drugih zdravstvenih radnika primili i CMM uslugu. Učestalost sumnji na nuspojave lijekova analizirana je s obzirom na redni broj konzultacije, dob, spol, broj komorbiditeta i broj lijekova pacijenata. Zabilježene nuspojave klasificirane su prema MedDRA (engl. Medical Dictionary for Regulatory Activities – Medicinski rječnik za regulatorne poslove) PT-u (engl. Preferred Term – Preporučeni pojam), MedDRA SOC-u (engl. System Organ Class – Klasifikacija organskih sustava), mehanizmu nastanka, ozbiljnosti i očekivanosti. Kod ukupno 65 pacijenata uključenih u ovo istraživanje zabilježeno je 596 sumnji na nuspojave lijekova (po pacijentu 9,2 ± 16,9). Uočena je snažna i statistički značajna povezanost između porasta broja korištenih lijekova i porasta broja nuspojava (r = 0,823; p = 0,000). Prema MedDRA PT-u predvodile su hipotenzija (42), glavobolja (29) i neučinkovitost lijeka (27), dok su prema MedDRA SOC-u predvodili Opći poremećaji i reakcije na mjestu primjene (103), Krvožilni poremećaji (71) i Poremećaji probavnog sustava (68). Prema mehanizmu nastanka, najveći udio u ukupnom broju nuspojava činile su nuspojave tipa A (75 %). Ozbiljne i neočekivane nuspojave činile su manji udio u ukupnom broju nuspojava (12 %, odnosno 19 %). Dodatno, uočen je pozitivan i statistički značajan utjecaj CMM usluge na smanjenje učestalosti nuspojava (p < 0,001). U svjetlu sve kompleksnijih terapija, povećanja broja korištenih lijekova, kao i broja zdravstvenih radnika koji mogu propisivati lijekove (često bez znanja što je drugi zdravstveni radnik propisao) s jedne strane te nedostatka kontrole nad propisivanjem i primjenom lijekova s druge strane, CMM usluga pažljivim bi odabirom i redovitim kontroliranjem propisane terapije mogla odgovoriti na problem kliničkog i financijskog tereta nuspojava te osigurati povećanje učinkovitosti i sigurnosti primjenjivanih lijekova. |
| Abstract (english) | Today, medications are manifesting ever more numerous positive clinical effects and have greatly contributed to a lowered mortality rate, prolonged life span and increased quality of life of patients. On the other hand, an increase in unwanted adverse effects of these medications is being marked due to old age, an overabundance of comorbidities and polypharmacy being some of the most important risk factors for the manifestation of the adverse drug reactions (ADRs). Although reporting ADRs is a legal obligation of all healthcare workers, studies show that only around 6 % of ADRs are actually reported. As a consequence, limited data exists on the epidemiology of ADRs. Bearing this in mind, the goal of this research was to determine the frequency of ADRs in a primary care setting and to classify them based on cases of patients that are older than 65 with a diagnosis of hypertension and at least one other underlying cardiovascular disease. An additional goal was to determine the effect of Comprehensive Medication Management (CMM) service on the frequency of ADRs. In the span of two years, a prospective pre-post study on continuously monitored patients that were receiving CMM service was conducted. The frequency of ADRs was analysed based on the sequence number of the patient and their age, sex, number of comorbidities and number of medications taken. The noticed ADRs were classified according to MedDRA (Medical Dictionary for Regulatory Activities) PT (Preferred Term), MedDRA SOC (System Organ Class), occurrence mechanism, seriousness and expectedness. In a total of 65 patients involved in this study, 596 suspicions of ADRs were noted (9,2 ± 16,9 per patient). A strong and statistically notable connection was found between the number of reported ADRs and the number of medications the patient is taking (r = 0,823; p = 0,000). According to MedDRA PT, the leading ADRs were hypotension (42), headache (29) and drug ineffectiveness (27), while according to MedDRA SOC, the leading ADRs were General disorders and administration site conditions (103), Vascular disorders (71) and Gastrointestinal disorders (68). Based on occurrence mechanism, the majority of the total number of reported ADRs was made up of type A ADRs (75 %). Serious and unexpected ADRs represented a lower ratio of the total number of ADRs (12 % and 19 %, respectfully). Additionally, a positive and statistically noticeable effect on the reduction of the frequency of ADRs was observed following the implementation of CMM service (p < 0,001). Taking into consideration both the ever more complex therapy regimens, the increasing number of medications being taken and the increasing number of healthcare workers that can prescribe medications (often without knowing what other healthcare workers have prescribed) and the lack of control over the prescription and consumption of medications, through more careful prescription methods and control of a patient’s therapy, CMM services could serve as a solution to the problem caused by the clinical and financial burden of ADRs, while increasing the efficacy and safety of the use of the prescribed medications. |
