RETROSPECTIVE ANALYSIS OF ADVERSE DRUG REACTION REPORTING FORMS ASSOCIATED WITH PENICILLIN FAMILY ANTIBIOTICS (PCNE-DRP 9.0) BASED ON DRUG-RELATED APPROACH
- Authors: Matveev A.V.1,2, Krasheninnikov A.E.1, Egorova E.A.2, Koniaeva E.I.2
-
Affiliations:
- Autonomous non-profit organization “National Pharmacovigilance Research Center”
- Medical Academy n. a. S.I. Georgievsky of Vernadskjy CFU
- Issue: Vol 8, No 1 (2020)
- Pages: 57-64
- Section: Articles
- URL: https://ogarev-online.ru/2307-9266/article/view/111633
- DOI: https://doi.org/10.19163/2307-9266-2020-8-1-57-64
- ID: 111633
Cite item
Full Text
Abstract
A widespread use of β-lactam antibiotics such as penicillins in practical medicine, and its authorized use in special categories of patients (e.g. children, pregnant and lactating women, the elderly) requires a critical investigation of their safety as well as the obligatory risk assessment before conducting antibacterial pharmacotherapy.
The aim of the work was the conduction of a retrospective study of adverse reactions cases, the identification and analysis of drug-related problems (DRP) associated with the use of penicillin family antibiotics.
Materials and methods. The objects of the study were adverse drug reactions (ADR) associated with the use of penicillin family antibiotics in inpatient and outpatient facilities, as well as the cases of self-treatment, which were recorded in the official ADR reports and then inputted in the regional (Republic of Crimea) database of spontaneous reports called ARCADe (Adverse Reactions in Crimea, Autonomic Database). The covered period is 2009–2018. The analysis of DRP was carried out using the 9.0 version of the qualification system DRP PCNE (Pharmaceutical Care Network Europe Foundation).
Results. The data analysis of ADR reporting forms has revealed that Amoxicillin clavulanate and Amoxicillin were the most frequent cause of ADR. A high incidence of penicillins ADR in pediatric patients (from 0 to 18 years) – 142 cases – has been found. The clinical manifestations of reactions included drug hypersensitivity reactions (309 cases), dyspeptic disorders (28 cases) and disorders of the central nervous system (5 cases). The incidence of serious ADR was 113 cases (33% of the total number of ADR in the study), which indicates a rather high risk of developing severe ADR for penicillins, resulted in a significant decrease in the quality of patients’ lives.
Conclusion. The detection of DRP using the PCNE V9.0 approach is a useful and promising tool important to improve the quality of pharmacotherapy and their adherence to treatment. The highest DRP values which were observed for Amoxicillin clavulanate and Amoxicillin, may indicate a high frequency of irrational use of these drugs.
Full Text
##article.viewOnOriginalSite##About the authors
Aleksandr V. Matveev
Autonomous non-profit organization “National Pharmacovigilance Research Center”; Medical Academy n. a. S.I. Georgievsky of Vernadskjy CFU
Email: avmcsmu@gmail.com
ORCID iD: 0000-0002-6636-3950
Candidate of Sciences (Medicine), Associate-Professor of Department of Internal medicine No.1 with Clinical Pharmacology, Medical academy n. a. Georgievskiy S. I., ,Vernadsky Crimean Federal University; Executive director of Autonomous non-profit organization “National Scientific Center of Pharmacovigilance”.
Russian Federation, Moscow; SimferopolAnatoliy E. Krasheninnikov
Autonomous non-profit organization “National Pharmacovigilance Research Center”
Email: anatoly.krasheninnikov@drugsafety.ru
ORCID iD: 0000-0002-7791-6071
Candidate of Sciences (Pharmacy), general director of Autonomous non-profit organization “National Scientific Center of Pharmacovigilance”.
Russian Federation, MoscowElena A. Egorova
Medical Academy n. a. S.I. Georgievsky of Vernadskjy CFU
Email: elena212007@rambler.ru
ORCID iD: 0000-0003-4012-2523
Candidate of Sciences (Pharmacy), Associate-Professor of Department of Internal medicine No.1 with Clinical Pharmacology, Medical academy n.a. S. I. Georgievskiy, Vernadsky Crimean Federal University.
Russian Federation, SimferopolElena I. Koniaeva
Medical Academy n. a. S.I. Georgievsky of Vernadskjy CFU
Author for correspondence.
Email: konyaeva.simferopol@gmail.com
Candidate of Sciences (Medicine), Associate-Professor of Department of Internal medicine No.1 with Clinical Pharmacology, Medical academy n.a. S. I. Georgievskiy, Vernadsky Crimean Federal University.
Russian Federation, SimferopolReferences
- Lazareva NB, Rebrova EV, Borisov MS. β-laktamnye antibiotiki:sovremennaya poziciya v pul’monologicheskoj praktike [β-lactam antibiotics: modern position in pulmonary practice]. Practical Pulmonology. 2018;2:76-82. Russian.
- Korotkov A. Samyj populyarnyj zashchishchennyj penicillin [The most popular protected penicillin]. Rossijskie apteki. 2011;10:66-9. Russian.
- Kuzmina AV, Polivanov AV, Asetskaya IL, Zyryanov SK. Medicinskie oshibki pri primenenii antibiotikov penicillinovoj gruppy [Medication errors associated with the use of Penicillins]. Clinical microbiology and antimicrobial chemotherapy. 2016;18(2):93-103. Russian.
- Shenoy ES, Macy E, Rowe T. Evaluation and management of Penicillin allergy. JAMA. 2019;321(2):188-99. doi: 10.1001/jama.2018.19283
- Jung IY, Kim JJ, Lee SJ, Kim J, Seong H, Jeong W, Kim JM. Antibiotic-related adverse drug reactions at a Tertiary Care Hospital in South Korea. Biomed Res Int. 2017. DOI: 10.1155 / 2017/4304973
- Andreyeva IV, Stetsyuk OU. Allergiya na antibiotiki u detej: kto vinovat i chto delat’? [Allergy to antibiotics in children: who is to blame and what to do?] Pediatric Pharmacology. 2013;10(6):42-52. Russian.
- Yakovlev SV. Novaya koncepciya racional’nogo primeneniya antibiotikov v ambulatornoj praktike [New concept of rational use of antibiotics outpatient patient]. Antibiotics and chemotherapy. 2019;64(3-4):48-58. doi: 10.24411/0235-2990-2019-100017. Russian.
- ATC/DDD Index 2019. [cited 2019 Aug 05]. Available from: https://www.whocc.no/atc_ddd_index/.
- Federal Law of the Russian Federation No. 61-ФЗ dated April 12, 2010 “On the Circulation of Medicines” [Federal’nyi zakon Rossiiskoi Federatsii №61-FZ ot 12 aprelya 2010 g. «Ob obrashchenii lekarstvennykh sredstv»]. [cited 2019 Sep 10]. Available from: http://www.consultant.ru/document/cons_doc_LAW_99350/. Russian.
- Uppsala Monitoring Centre. The use of the WHO-UMC system for standardised case causality assessment. [cited 2019 Sep 10]. Available from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf.
- Binu KM, Nimmy NJ, Varghese GP. A survey of Drug related problems identified by community pharmacy in South India. International Journal of Pharmaceutical, chemical and biological sciences. 2012;2(2):368-74.
- Van Mil JW, Westerlund LO, Hersberger KE, SchaeferMA. Drug-relatedproblemclassificationsystems. Ann Pharmacother. 2004;38(5):859-67.
- Matveev AV, Krasheninnikov АЕ, Egorova ЕА, Konyaeva ЕI. Primenenie sistemy problem, svyazannyh s lekarstvennymi preparatami (drug-related problems), na primere gruppy nesteroidnyh protivovospalitel’nyh sredstv [Application of drug-related problems approach to analysis of nonsteroidal anti-inflammatory drugs’ safety]. Pharmacy & Pharmacology. 2019;7(4): 215-223. doi: 10.19163/2307-9266-2019-7-4-215-223. Russian.
- Blix HS, Viktil KK, Moger TA, Reikvam AR. Risk of drug‐related problems for various antibiotics in hospital: assessment by use of a novel method. Pharmacoepidemiology and Drug Safety. 2008;17(8):834-41. doi: 10.1002/pds.1595
- Paulino EI, Bouvy ML, Gastelurrutia MA, Mara Guerreiro, Henk Buurma. Drug related problems identified by European community pharmacists in patients discharged from hospital. Pharm World Sci. 2004;26:353–6.
- Abunahlah N, Elawaisi A, Velibeyoglu FM. Drug related problems identified by clinical pharmacist at the Internal Medicine Ward in Turkey. Int J Clin Pharm. 2018;40:360–7. doi: 10.1007/s11096-017-0585-5
- Adusumilli PK, Adepu R. Drug related problems: an over view of various classification systems. Asian J Pharm Clin Res. 2014;7:7–10.
- Abdela OA, Bhagavathula AS, Getachew H. Risk factors for developing drug‐related problems in patients with cardiovascular diseases attending Gondar University Hospital, Ethiopia. J Pharm Bioallied Sci. 2016;8(4):289–95.
- Al‐Azzam SI, Alzoubi KH, Abu Ruz S, Alefan Q. Drug‐related problems in a sample of outpatients with chronic diseases: a cross‐sectional study from Jordan. Ther Clin Risk Manag. 2016;12:233–9. doi: 10.2147/TCRM.S98165
- Pharmaceutical Care Network Europe. PCNE DRP classification V 9.0 [cited 2019 Sep 08]. Available from: https://www.pcne.org/working-groups/2/drug-related-problem-classification.
- Eichenberger PM. Classification of drug-related problems with new prescriptions using a modified PCNE classification system. Pharmacy World & Science. 2010;3(32):362–72.
- Kozlov RS, Golub AV. Strategiya ispol’zovaniya antimikrobnyh preparatov kak popytka renessansa antibiotikov [Antimicrobial Stewardship as a Renascence of the ‘Golden Age’ of Antibiotics]. Clinical Microbiology and antimicrobial chemotherapy. 2011;13:322-34. Russian.
- Zhuravleva MV, Romanov BK, Gorodetskaya GI, Muslimova OV, Krysanova VS, Demchenkova EYu. Aktual’nye voprosy bezopasnosti lekarstvennyh sredstv, vozmozhnosti sovershenstvovaniya sistemy farmakonadzora [Topical issues of drug safety, possibilities of improving of pharmacovigilance]. Safety and Risk of Pharmacotherapy. 2019;7(3):109–19. Russian.
Supplementary files
