Ya Ping Lee

Proton Pump Inhibitor–Associated Hypomagnesemia: What Do FDA Data Tell Us?

BACKGROUND: Proton pump inhibitors (PPIs) are a class of medications indicated for the treatment of gastric acid–related diseases. Hypomagnesemia is a rare but serious adverse effect of PPIs. OBJECTIVE: To address the association between the use of different PPIs and hypomagnesemia by examining the frequency of occurrence of hypomagnesemia among the reported adverse drug reactions from the Food and Drug Administration (FDA) Adverse Event Reporting System database. METHODS: We conducted a cross-sectional study of PPI-associated adverse effect cases reported to the FDA between November 1, 1997, and April 1, 2012. Logistic regression was used to examine the association of sex, age, and different PPIs with hypomagnesemia. χ2 Analysis was conducted to investigate the association of PPI-associated hypomagnesemia with hypocalcemia and hypokalemia. RESULTS: Among 66,102 subjects identified as experiencing 1 or more adverse effects while taking a PPI, 1.0% (n = 693) were reported to have hypomagnesemia. The mean (SD) age of PPI users presenting with hypomagnesemia was 64.4 (12.9) years. Results from logistic regression indicated that, compared with esomeprazole, all other PPIs had a higher rate of hypomagnesemia, with pantoprazole having the highest rate (OR 4.3; 95% CI 3.3–5.7; p < 0.001). The risk of female subjects having hypomagnesemia (OR 0.83; 95% CI 0.71–0.97; p = 0.016) was significantly lower than that of males. Elderly subjects (age >65 years) were at increased risk of PPI-associated hypomagnesemia (OR 1.5; 95% CI 1.2–1.7; p < 0.001). χ2 Analysis showed strong association between hypomagnesemia and both hypocalcemia (p < 0.001) and hypokalemia (p < 0.001). CONCLUSIONS: All PPIs were associated with hypomagnesemia, with esomeprazole having the lowest risk and pantoprazole having the highest risk. The risk of PPI-associated hypomagnesemia was higher in males and the elderly population. Hypocalcemia and hypokalemia commonly coexisted with PPI-associated hypomagnesemia.

Nature and frequency of medication errors in a geriatric ward: an Indonesian experience

Purpose To determine the nature and frequency of medication errors during medication delivery processes in a public teaching hospital geriatric ward in Bali, Indonesia. Methods A 20-week prospective study on medication errors occurring during the medication delivery process was conducted in a geriatric ward in a public teaching hospital in Bali, Indonesia. Participants selected were inpatients aged more than 60 years. Patients were excluded if they had a malignancy, were undergoing surgery, or receiving chemotherapy treatment. The occurrence of medication errors in prescribing, transcribing, dispensing, and administration were detected by the investigator providing in-hospital clinical pharmacy services. Results Seven hundred and seventy drug orders and 7,662 drug doses were reviewed as part of the study. There were 1,563 medication errors detected among the 7,662 drug doses reviewed, representing an error rate of 20.4%. Administration errors were the most frequent medication errors identified (59%), followed by transcription errors (15%), dispensing errors (14%), and prescribing errors (7%). Errors in documentation were the most common form of administration errors. Of these errors, 2.4% were classified as potentially serious and 10.3% as potentially significant. Conclusion Medication errors occurred in every stage of the medication delivery process, with administration errors being the most frequent. The majority of errors identified in the administration stage were related to documentation. Provision of in-hospital clinical pharmacy services could potentially play a significant role in detecting and preventing medication errors.

Snapshot versus continuous documentation of pharmacists’ interventions: are snapshots worthwhile?

The documentation of pharmacists’ interventions is important but there are limited studies evaluating the different methods of documentation.

The Difference in Pharmacists’ Interventions across the Diverse Settings in a Children’s Hospital

Aims This study aimed to document and compare the nature of clinical pharmacists’ interventions made in different practice settings within a children’s hospital. Methods The primary investigator observed and documented all clinical interventions performed by clinical pharmacists for between 35–37 days on each of the five study wards from the three practice settings, namely general medical, general surgical and hematology-oncology. The rates, types and significance of the pharmacists’ interventions in the different settings were compared. Results A total of 982 interventions were documented, related to the 16,700 medication orders reviewed on the five wards in the three practice settings over the duration of the study. Taking medication histories and/or patient counselling were the most common pharmacists’ interventions in the general settings; constituting more than half of all interventions. On the Hematology-Oncology Ward the pattern was different with drug therapy changes being the most common interventions (n = 73/195, 37.4% of all interventions). Active interventions (pharmacists’ activities leading to a change in drug therapy) constituted less than a quarter of all interventions on the general medical and surgical wards compared to nearly half on the specialty Hematology-Oncology Ward. The majority (n = 37/42, 88.1%) of a random sample of the active interventions reviewed were rated as clinically significant. Dose adjustment was the most frequent active interventions in the general settings, whilst drug addition constituted the most common active interventions on the Hematology-Oncology Ward. The degree of acceptance of pharmacists’ active interventions by prescribers was high (n = 223/244, 91.4%). Conclusions The rate of pharmacists’ active interventions differed across different practice settings, being most frequent in the specialty hematology-oncology setting. The nature and type of the interventions documented in the hematology-oncology were also different compared to those in the general medical and surgical settings.

Indonesian students' participation in an interprofessional learning workshop

Abstract Interprofessional learning activities, such as workshops allow students to learn from, with and about each other. This study assessed the impact on Indonesian health students’ attitudes towards interprofessional education (IPE) from participating in a workshop on medication safety. The students attended a two-day IPE workshop on medication safety. Thirty-five (48.6%) students completed pre-/post-workshop surveys using a modified Readiness for Interprofessional Learning Scale (RIPLS) survey. The post-workshop survey also had a series of open-ended questions. Students’ responses to each RIPLS statement pre-/post-workshop were compared, whilst their responses to open-ended questions in post-workshop survey were thematically analysed. Students reported positive attitudinal changes on statements of shared learning and teamwork sub-scale (Wilcoxon p value <0.05). Analysis of the open-ended questions indicated that students perceived the workshop as having improved their understanding on the importance of teamwork and communication skills. This study found that learning with other health students through an IPE workshop improved medical, nursing and pharmacy students’ attitudes towards the importance of shared learning, teamwork and communication in healthcare service.

Response to “Proton Pump Inhibitor–Associated Hypomagnesemia: What Do FDA Data Tell Us?”

TO THE EDITOR: Thank you for your comments on our manuscript. We agree with the fact that the strength of the evidence in support of the association between proton pump inhibitor (PPI) use and hypomagnesemia is limited. Our observational study merely aimed to determine the prevalence of hypomagnesemia among all adverse effects associated with PPIs use reported to the Food and Drug Administration, not causality. This analysis showed that around 1% of subjects with reported PPI-associated adverse effects had hypomagnesemia, with the results suggesting that the risk of PPI-associated hypomagnesemia may be higher in males and the elderly population. Furthermore, the Food and Drug Administration reports did suggest a possible association between hypomagnesemia, and hypokalemia and hypocalcemia in PPI users. In contrast to the findings of Danziger et al and Koulouridis et al, El-Charabaty et al reported a significant association between PPI use, hypomagnesemia and cardiovascular events among 421 patients admitted to the critical care unit. They concluded that patients on PPI should be closely followed for magnesium deficiency, particularly those experiencing acute cardiac events. Their report highlights the fact that PPIs’ role in hypomagnesemia remains controversial. We would agree with the following statement from the recent review article by Famularo et al: “According to research findings available at this time, we need to know much more about the relationship linking exposure to PPIs and magnesium metabolism.” We also recommend that clinicians maintain an open mind about the potential for PPIs to cause hypomagnesemia, and vigilance in monitoring patients at high risk.