Validation of a new tool for evaluating subjects' satisfaction with medicine package leaflets: a cross-sectional descriptive study.

Sao Paulo Med J. 2019 Sep-Oct;137(5):454-462

Authors: Pires C, Rosa PJ, Vigário M, Cavaco A

Abstract
BACKGROUND: Package leaflets of medicines need to be intelligible, but tools for their evaluation are scarce.
OBJECTIVE: To validate a new tool for assessing subjects' satisfaction with medicine package leaflets (LiS-RPL).
DESIGN AND SETTING: Cross-sectional descriptive study conducted in two regions of Portugal (Lisbon and Centre).
METHODS: 503 participants (53.1% male) were selected according to convenience and homogenously distributed into three groups: 1 to 6; 7 to 12; and > 12 years of schooling. LiS-RPL was developed based on international regulation guidelines and was initially composed of 14 items. Twelve package leaflets were tested. Dimensionality calculations included: exploratory factor analysis and minimum rank factor analysis; Kaiser-Meyer-Olkin index and Bartlett's sphericity test to assess matrix adequacy for exploratory factor analysis; exploratory bifactor analysis with Schmid-Leiman solution to detect possible existence of a broad second-order factor; and Bentler's Simplicity Index and Loading Simplicity Index to assess factor simplicity. Diverse coefficients were calculated to assess reliability.
RESULTS: Minimum rank factor analysis detected a two-factor or single-factor structure. Exploratory factor analysis with 12 items showed a two-factor structure, explaining 69.11% of the variance. These items were strongly correlated with each other (r = 0.80). Schmid-Leiman: all items seemed to represent the general factor (loadings above 0.50), which was 76.4% of the extracted variance. Simplicity indices were good (percentile 99): Bentler's Simplicity Index of 0.99 and Loading Simplicity Index of 0.48. Internal consistency indexes indicated good reliability. LiS-RPL was shown to be homogenous.
CONCLUSION: LiS-RPL is a validated tool for evaluating subjects' satisfaction with medicine package leaflets.

PMID: 31939571 [PubMed - indexed for MEDLINE]

Evidence-based development of a nephrotoxic medication list to screen for acute kidney injury risk in hospitalized children.

Am J Health Syst Pharm. 2019 10 30;76(22):1869-1874

Authors: Goswami E, Ogden RK, Bennett WE, Goldstein SL, Hackbarth R, Somers MJG, Yonekawa K, Misurac J

Abstract
PURPOSE: Medications are commonly associated with acute kidney injury (AKI). However, in both clinical practice and research, consideration of specific medications as nephrotoxic varies widely. The Nephrotoxic Injury Negated by Just-in-time Action quality improvement collaborative was formed to focus on prevention or reduction of nephrotoxic medication-associated AKI in noncritically ill hospitalized children. However, there were discrepancies among institutions as to which medications should be considered nephrotoxic. The collaborative convened a Nephrotoxic Medication (NTMx) Subcommittee to develop a consensus for the classification of nephrotoxic medications.
SUMMARY: The NTMx Subcommittee initially included pediatric nephrologists, a pharmacist, and a pediatric intensivist. The committee reviewed NTMx lists from the collaborative and identified changes from the initial NTMx list. The NTMx Subcommittee conducted a literature review of the disputed medications and assigned an evidence grade based on the reported association with nephrotoxicity and the quality of the data. The association between medication exposure and AKI was also determined using administrative data from the Pediatric Health Information Systems database. The NTMx Subcommittee then came to a majority consensus regarding which medications should be included on the list. The subcommittee's recommendations were presented to the larger collaborative for approval, and consensus was achieved. The list continues to be reviewed and updated annually.
CONCLUSION: Formation of a multicenter quality-improvement initiative exposed current limitations as to which medications are considered nephrotoxic in clinical and research settings and presented an opportunity to approach this problem using an evidence-based process. A consensus definition of nephrotoxic-medication exposure was achieved.

PMID: 31665764 [PubMed - indexed for MEDLINE]

[Development of Hospital Formulations Based on Medical Need].

Yakugaku Zasshi. 2019;139(10):1275-1280

Authors: Kawano Y, Hanawa T

Abstract
Aphthous stomatitis is induced by chemotherapy and radiotherapy. It has been reported that 100% of patients administered high-dose chemotherapy and 80% of patients receiving radiotherapy develop stomatitis. The most serious cases are accompanied by pain and bleeding of the ulcers, which cause significant suffering and reduce patients' quality of life. Rebamipide (RB) was developed in Japan as a treatment for gastric ulcer. In this study, we prepared and evaluated a mouthwash for stomatitis taking into consideration the solubilization of RB. RB nanoparticles were prepared by the wet-milling technique using various forms of hydroxypropyl cellulose (HPC-L, -SL, and -SSL) and sodium lauryl sulfate (SLS). RB nanoparticles sized between 126.6 and 286.8 nm were obtained under various conditions. From the results of zeta potential measurement and evaluation of their dispersibility, it appeared that the prepared nanosuspensions were stable. Furthermore, adhesion of the nanoparticles to the mucous membrane in the oral cavity was evaluated using quartz crystal microbalance with dissipation monitoring (QCM-D) technology. From the changes in the thickness of the gold sensor observed in QCM-D measurement, it was suggested that HPC-SSL molecules interact with mucin mounted on the gold sensor. It appears feasible to utilize RB nanoparticles dispersed in HPC-SSL solution in mouthwash to prevent stomatitis.

PMID: 31582612 [PubMed - indexed for MEDLINE]

Toxicologic Pathology Forum*: Commentary on "Opinion on Designation of Adverse and Nonadverse Histopathological Findings in Toxicity Studies: The Pathologist's Dilemma".

Toxicol Pathol. 2019 07;47(5):574-576

Authors: Patrick DJ, Troth SP

Abstract
In the article "Opinion on Designation of Adverse and Nonadverse Histopathological Findings in Toxicity Studies: The Pathologist's Dilemma," the authors Gopinath and Mowat provide a framework for designation of adversity supplemented with photomicrographic examples. Given that adversity designation can significantly impact the no observed adverse effect level and clinical trial design, it is important to carefully consider all of the criteria by which such assignments are made. We highlight some of the specific assertions within the article that could benefit from a more detailed discussion. Our primary criticism surrounds the authors' primary reliance on histopathology in isolation for adversity designation, which in our opinion provides an overly simplified depiction of the process. We provide additional perspective on how context beyond histopathology often plays a critical role in adversity designation and highlight areas where inclusion of some of these scenarios would have provided the reader a more realistic view of the complex process of assigning adversity. * This is an opinion article submitted to the Toxicologic Pathology Forum. It represents the views of the authors. It does not constitute an official position of the Society of Toxicologic Pathology, British Society of Toxicological Pathology, or European Society of Toxicologic Pathology, and the views expressed might not reflect the best practices recommended by these Societies. This article should not be construed to represent the policies, positions, or opinions of their respective organizations, employers, or regulatory agencies.

PMID: 31303126 [PubMed - indexed for MEDLINE]

Awareness, knowledge, attitude and practice of adverse drug reaction reporting among health workers and patients in selected primary healthcare centres in Ibadan, southwestern Nigeria.

BMC Health Serv Res. 2019 Dec 03;19(1):926

Authors: Adisa R, Omitogun TI

Abstract
BACKGROUND: Higher incidence of adverse drug reactions (ADRs) is a global health problem requiring attention of all stakeholders regardless of the practice settings. This study therefore aimed to evaluate awareness, knowledge, attitude and practice of ADR reporting among health workers and patients in 10 primary healthcare centres (PHCs) in Ibadan, southwestern Nigeria.
METHODS: Questionnaire-guided cross-sectional survey among 80 health workers and 360 patients enrolled from the selected PHCs between October and December 2018. The semi-structured questionnaires generally comprised open-ended and closed-ended questions to explore general knowledge and awareness of ADRs and pharmacovigilance, while other question-items evaluated attitude towards ADR reporting and ADR reporting practice. Overall percent score in the knowledge and attitude domains for the health workers was developed into binary categories of > 80 versus ≤80% for "adequate" and "inadequate" knowledge, as well as "positive" and "negative" attitude, respectively. Data were summarised using descriptive statistics, while Chi-square test was used to evaluate categorical variables at p < 0.05.
RESULTS: Overall, 58(72.5%) health workers had heard of pharmacovigilance, but only 3(5.2%) correctly understood the pharmacovigilance concept. Twelve (15.0%) showed adequate knowledge of ADRs, while 37(46.2%) demonstrated positive attitude towards ADR reporting. Thirty (37.5%) health workers had come across ADR reporting form, while 79(98.8%) expressed willingness to report all ADRs encountered. Of the patients, 31(8.6%) had heard of pharmacovigilance, 143(39.7%) correctly cited ADR definition, while 67(18.6%) reported the previously experienced ADRs. Informing healthcare professional (38; 38.8%) was the most common measure taken by patients when they experienced reaction(s). Nurses significantly had adequate knowledge of ADRs (p < 0.001) compared to other cadres.
CONCLUSIONS: Health workers in the selected PHCs were largely aware of pharmacovigilance but show low level of knowledge about ADRs and pharmacovigilance concept, with moderately positive attitude towards ADR reporting. Patients on the other hand demonstrate low level of awareness of pharmacovigilance and ADR reporting, with less than one-fifth who reported the previously experienced ADRs. This perhaps underscores a need for regular mandatory education and training on ADRs/pharmacovigilance concept among the PHC health workers, while continuous public enlightenment and awareness campaign on spontaneous reporting of ADRs is advocated in order to enhance reporting rate.

PMID: 31796034 [PubMed - indexed for MEDLINE]

Identification of discrepancies between adverse drug reactions coded by medical records technicians and those reported by the pharmacovigilance team in pediatrics: An intervention to improve identification, reporting, and coding.

Arch Pediatr. 2019 Oct;26(7):400-406

Authors: Soyer J, Necsoiu D, Desjardins I, Lebel D, Bussières JF

Abstract
OBJECTIVE: To identify the discrepancies between the adverse drug reactions (ADRs) identified by medical records technicians and the ADRs identified by the pharmacovigilance team, and to validate the quality of the information collected by the medical records technicians. To propose improvements to the method for detection of serious ADRs by medical records technicians and the pharmacovigilance team to meet the new requirements of Canada's amended Food and Drug Act (Vanessa's Law) and its regulations.
METHODS: This was a descriptive and retrospective study. We included all ADRs identified by medical records technicians in the coding of records after hospitalization, including active ADRs present at admission or identified during hospitalization between 1 April 2017 and 31 October 2017, and all ADRs identified and reported by the pharmacy through its pharmacovigilance program during the same period. We identified the discrepancies between the two identification systems and revised all cases from patient records. In addition, we identified improvements in the method for detecting and reporting serious ADRs.
RESULTS: This study identified 343 ADRs, 322 of which were coded by the medical records technicians and 21 identified by the pharmacovigilance team for a period of 7 months in a mother-child university hospital center. Only 1.5% of the ADRs were identified by both medical records technicians and the pharmacovigilance team. The code Y43, which corresponds to the largest number of identified ADRs, mainly includes anticancer drugs and immunosuppressant drugs. Three corrective actions were set up: 1) implementation of a form to explain the addition and coding of an ADR to a patient's file, 2) weekly transmission of a working file between the medical records technicians and the pharmacovigilance team so that the files would be reviewed and a declaration made to the regulatory authority, and 3) creation of a standardized pharmacist's note to add to the patient file.
CONCLUSION: It is possible to increase the reporting of ADRs, improve the quality of coding, and reduce discrepancies between the ADRs coded by these two teams through a structured intervention.

PMID: 31611146 [PubMed - indexed for MEDLINE]

Nurse-led medicines' monitoring in care homes, implementing the Adverse Drug Reaction (ADRe) Profile improvement initiative for mental health medicines: An observational and interview study.

PLoS One. 2019;14(9):e0220885

Authors: Jordan S, Banner T, Gabe-Walters M, Mikhail JM, Panes G, Round J, Snelgrove S, Storey M, Hughes D, Medicines’ Management Group, Swansea University

Abstract
INTRODUCTION: Preventable adverse effects of medicines often pass unnoticed, but lead to real harm.
INTERVENTION: Nurse-led monitoring using the structured Adverse Drug Reaction (ADRe) Profile identifies and addresses adverse effects of mental health medicines.
OBJECTIVES: This study investigated the implementation and clinical impact of ADRe, and barriers to and facilitators of sustained utilisation in routine practice.
METHODS: Administration of ADRe was observed for 30 residents prescribed mental health medicines in ten care homes. The study pharmacist reviewed completed ADRes against medication records. Policy context was explored in 30 interviews with service users, nurse managers and strategic leads in Wales.
RESULTS: Residents were aged 60-95, and prescribed 1-17 (median 9 [interquartile range (IQR) 7-13]) medicines. ADRe identified a median of 18 [IQR 11.5-23] problems per resident and nurses made 2 [1-2] changes to care per resident. For example: falls were reported for 9 residents, and care was modified for 5; pain was identified in 8 residents, and alleviated for 7; all 6 residents recognised as dyspnoeic were referred to prescribers. Nurses referred 17 of 30 residents to prescribers. Pharmacists recommended review for all 30. Doubts about administering ADRe, sometimes expressed by people who had not yet used it, diminished as it became familiar. ADRe was needed to bridge communication between resident, nurses and prescribers. When barriers of time, complacency, and doctors' non-availability were overcome, reporting with ADRe made prescribers more likely to heed nurses' concerns regarding residents' welfare. Clinical gains were facilitated by one-to-one time, staff-resident relationships, and unification of documentation.
IMPLICATIONS: To our knowledge, ADRe is the only instrument that brings a full account of patients' problems to medication reviews. This juxtaposition of signs and symptoms against prescriptions facilitates dose adjustments and de-prescribing and leads to: reduced pain and sedation; early identification of problems linked to ADRs, such as falls; and timely medication reviews e.g. for dyspnoea.

PMID: 31509537 [PubMed - indexed for MEDLINE]

Prevalence of potential drug-drug interactions in Swedish pediatric outpatients.

PLoS One. 2019;14(8):e0220685

Authors: Holm J, Eiermann B, Kimland E, Mannheimer B

Abstract
PURPOSE: To describe the occurrence of potential drug-drug interactions (DDIs) in prescribed drugs, dispensed to pediatric outpatients in Sweden.
METHODS: A cross sectional study was conducted based on data from a national register of prescribed drugs, dispensed at pharmacies, to children 0-17 years old. The study period was January 1 to April 30, 2010. Drug dispensing data was linked to the DDI database SFINX. Prevalence and frequencies of potential interactions were investigated, and drugs commonly involved in interactions were identified. The study focused on clinically relevant potential interactions, class D (should be avoided), and class C (can be handled, e.g. by dose adjustment).
RESULTS: In the Swedish pediatric population, 0 to 17 years of age, 12% (n = 231 078) of children had at least two dispensed drugs. In this group of patients, 0.14% had potential D-interactions and 1,3% had potential C-interactions. The number of D- and C-interactions that may lead to reduced effects were 181 (52%), and 1224 (32%) respectively. The ten most frequent drugs were involved in 78% and 65% of all potential D-, and C-interactions respectively. Furthermore, 80%, and 58% of the D-, and C-interactions respectively occurred in patients aged 12 to 17.
CONCLUSIONS: We identified a limited number of drugs that were represented in the majority of potential interactions. Interactions that can lead to a reduced treatment effect constituted approximately half of D-interactions, and a third of C-interactions. The frequency of potential interactions was higher in older children. The results may contribute to increased prescriber awareness of important potential drug interactions among pediatric outpatients.

PMID: 31381591 [PubMed - indexed for MEDLINE]

Common Insomnia Drugs Receive Black Box Warning.

Am J Nurs. 2019 08;119(8):22

Authors: Aschenbrenner DS

PMID: 31356323 [PubMed - indexed for MEDLINE]

23 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 2020/03/07

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13 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 2020/03/06

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13 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 2020/03/05

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.

[HIV pre-exposure prophylaxis care in intersectoral collaboration : Interim analysis of a monocentric, prospective study in Germany].

Hautarzt. 2020 Mar 03;:

Authors: Ahaus P, Potthoff A, Kayser A, Wach J, Brockmeyer NH, Skaletz-Rorowski A

Abstract
BACKGROUND: HIV pre-exposure prophylaxis (PrEP), a further opportunity to prevent HIV, is available at the WIR-Walk In Ruhr, Centre for Sexual Health and Medicine, as part of an innovative model project for intersectoral PrEP care.
RESEARCH OBJECTIVES: The present study describes the collective of persons provided with PrEP and how PrEP use influences sexual risk behaviour, the incidence of sexually transmitted diseases (STD) and adverse drug reactions.
METHODS: A total of 139 men who started PrEP between 10/2017 and 12/2018 have been included in the study. During a period of 13 months of PrEP treatment, all PrEP users received questionnaires; side effects, HIV and other STI were also monitored via clinical laboratory examinations.
RESULTS: The participants' average age was 38 years and 98.6% of them were men who had sex with men (MSM). Most of them had a high educational background; the unemployment rate was low. The average number of sexual partners within the last 6 months increased significantly, while the use of condoms decreased. In all, 44 STI were found in 34 participants within the first 4 months. No one was infected with HIV. Within the first 4 weeks of PrEP, 38.8% of the participants suffered from side effects, mainly gastrointestinal symptoms.
CONCLUSION: Most of the participants were working in a job or a vocational training. The sexual risk behaviour increased in the course of using PrEP resulting in a high incidence of STD. Side effects appeared most frequently in the first few weeks after starting PrEP.

PMID: 32125439 [PubMed - as supplied by publisher]

Immunoassay interference on thyroid functions tests during treatment with nivolumab.

Thyroid. 2020 Mar 02;:

Authors: Paragliola RM, Corsello A, Papi G, Melfa E, Urbani A, Pontecorvi A, Corsello SM, Carrozza C

Abstract
BACKGROUND: Immune checkpoint inhibitors (ICI) are associated to several endocrine side effects. In particular, the use of PD-1/PD-L1 inhibitors is related to a higher incidence of thyroid dysfunction.
PATIENT FINDINGS: A 85 years-old patient, diagnosed with a metastatic melanoma treated with nivolumab, presented to our hospital with severe ICI-related thyrotoxicosis. The diagnosis was complicated by a biochemical interference on thyroid hormones assay, probably induced by nivolumab.
SUMMARY: Baseline laboratory examination conducted before the onset of anticancer therapy showed normal thyroid function test (TFTs). A few days after receiving the second nivolumab administration, the patient developed a severe thyrotoxicosis. According to destructive thyroiditis, in a short period thyroid-stimulating hormone (TSH) levels normalized and rapidly increased, but free thyroxine (FT4) levels were inappropriately elevated and did not decrease as expected. The sample was processed by using a Siemens Centaur® immunoassay. We reanalyzed the same sample at another laboratory and with a different immunoassay method (Roche Elecsys®). The results obtained from this assay confirmed severe hypothyroidism with appropriately low FT4 levels. We suspected a possible nivolumab-associated interference on the FT4 assay. Therefore, we subjected the same sample a polyethylene glycol (PEG) 6000 precipitation, a simple method for the removal of macromolecules, before assaying for FT4 levels. The evaluation of the post-PEG-precipitation sample (Siemens Centaur® immunoassay) revealed appropriately low FT4 levels. The patient was started on levothyroxine therapy, with monthly TFT monitoring using the Roche immunoassay. Approximately 9 months after starting nivolumab therapy, the patient was advised treatment cessation. A month later, the TFTs were retested on a Siemens Centaur® immunoassay, and appropriate FT4 levels were observed in accordance with normal TSH levels on adequate levothyroxine replacement therapy.
CONCLUSIONS: We report a possible novel nivolumab-induced biochemical interference on assays of FT4 levels. The hypothesis of a biochemical drug-induced interference is further supported by the disappearance of the interference after the withdrawal of nivolumab. Further studies are needed to prove the biochemical mechanisms of this interference.

PMID: 32122271 [PubMed - as supplied by publisher]

Immunotherapy against Systemic Fungal Infections Based on Monoclonal Antibodies.

J Fungi (Basel). 2020 Feb 29;6(1):

Authors: Boniche C, Rossi SA, Kischkel B, Barbalho FV, Moura ÁND, Nosanchuk JD, Travassos LR, Taborda CP

Abstract
: The increasing incidence in systemic fungal infections in humans has increased focus for the development of fungal vaccines and use of monoclonal antibodies. Invasive mycoses are generally difficult to treat, as most occur in vulnerable individuals, with compromised innate and adaptive immune responses. Mortality rates in the setting of our current antifungal drugs remain excessively high. Moreover, systemic mycoses require prolonged durations of antifungal treatment and side effects frequently occur, particularly drug-induced liver and/or kidney injury. The use of monoclonal antibodies with or without concomitant administration of antifungal drugs emerges as a potentially efficient treatment modality to improve outcomes and reduce chemotherapy toxicities. In this review, we focus on the use of monoclonal antibodies with experimental evidence on the reduction of fungal burden and prolongation of survival in in vivo disease models. Presently, there are no licensed monoclonal antibodies for use in the treatment of systemic mycoses, although the potential of such a vaccine is very high as indicated by the substantial promising results from several experimental models.

PMID: 32121415 [PubMed]

13 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 2020/03/03

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.

13 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 2020/03/03

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.

Using a clinical process map to identify prescribing cascades in your patient.

BMJ. 2020 Feb 19;368:m261

Authors: Piggott KL, Mehta N, Wong CL, Rochon PA

PMID: 32075785 [PubMed - indexed for MEDLINE]

Biochemical and Electroretinographic Characterization of the Minipig Eye in the Context of Drug Safety Investigations.

Int J Toxicol. 2019 Sep/Oct;38(5):415-422

Authors: Negro Silva LF, Li C, de Seadi Pereira PJB, Tan W, Dubuc-Mageau M, Sanfacon A, Forster R, Tavcar R, Makin A, Authier S

Abstract
Minipigs are an emerging nonrodent alternative for ocular toxicology owing to anatomical similarities in the minipig eyes when compared to humans. Ocular structures and components from Göttingen minipigs were characterized and compared to species commonly used in toxicology. Ocular reference data from Göttingen minipig including intraocular pressure, vitreous electrolyte and thiol concentration, and electroretinography (ERG) data are essential to model characterization and data interpretation during drug safety assessments. Intravitreal positive control agents including gentamicin, indocyanine green, and glycine were used to demonstrate ERG alterations caused by retinal cell toxicity, light transmission obstruction, or neurotransmission interferences, respectively. Electrolyte concentrations of the aqueous and vitreous humors from Göttingen minipigs were similar to other species including humans. The reference data presented herein supports the use of the Göttingen minipig as an alternate nonrodent species in ocular toxicology.

PMID: 31470746 [PubMed - indexed for MEDLINE]

Inappropriate prescribing defined by STOPP and START criteria and its association with adverse drug events among hospitalized older patients: A multicentre, prospective study.

PLoS One. 2019;14(7):e0219898

Authors: Fahrni ML, Azmy MT, Usir E, Aziz NA, Hassan Y

Abstract
OBJECTIVES: To provide baseline information on inappropriate prescribing (IP), and to evaluate whether potentially inappropriate medications (PIMs), as defined by STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions) criteria, were associated with preventable adverse drug events (ADEs) and/or hospitalization.
METHODS: We prospectively studied older patients (n = 301) admitted to three urban, public-funded hospitals. We scrutinized their medical records and used STOPP-START (Screening Tool to Alert Prescribers to Right Treatment) criteria to determine PIM and potential prescribing omissions (PPO) respectively- together these constitute IP. Prescriptions with PIM(s) were subjected to a pharmacist medication review, aimed at detecting cases of ADE(s). The vetted cases were further assessed by an expert consensus panel to ascertain: i) causality between the ADE and hospitalization, using, the World Health Organization Uppsala Monitoring Centre criteria, and, ii) whether the ADEs were avoidable (using Hallas criteria). Finally, percentages of PIM-associated ADEs that were both preventable and linked to hospitalization were calculated.
RESULTS: IP prevalence was 58.5% (n = 176). A majority (49.5%, n = 150) had moderate to severe degree of comorbidities (Charlson Comorbidity Index score ≥ 3). Median age was 72 years. Median number of medications was 6 and 30.9% (n = 93) had ≥8 medications. PIM prevalence was 34.9% (117 PIMs, n = 105) and PPO 37.9% (191 PPOs, n = 114). Most PIMs and PPOs involved overuse of aspirin and underuse of both antiplatelets and statins respectively. With every increase in the number of medications prescribed, the likelihood of PIM occurrence increased by 20%, i.e.1.2 fold (OR 1.20, 95% CI: 1.1-1.3). Among the 105 patients with PIMs, 33 ADEs (n = 33); 31 ADEs (n = 31) considered "causal" or "contributory" to hospitalization; 27 ADEs (n = 27) deemed "avoidable" or "potentially avoidable"; and 25 PIM-associated ADEs, preventable, and that induced hospitalization (n = 25), were identified: these equated to prevalence of 31.4%, 29.5%, 25.7%, and 23.8% respectively. The most common ADEs were masked hypoglycemia and gastrointestinal bleed. With every additional PIM prescribed, the odds for ADE occurrence increased by 12 folds (OR 11.8, 95% CI 5.20-25.3).
CONCLUSION: The majority of the older patients who were admitted to secondary care for acute illnesses were potentially exposed to IP. Approximately a quarter of the patients were prescribed with PIMs, which were plausibly linked with preventable ADEs that directly caused or contributed to hospitalization.

PMID: 31348784 [PubMed - indexed for MEDLINE]