Adverse drug reaction reporting in a pharmacovigilance centre of Nepal

Background

Pharmacovigilance is the “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems”. Nepal joined the international pharmacovigilance programme as a full member in 2007. KIST Medical College, Lalitpur, Nepal joined the national programme as a regional centre from mid-July 2008. Currently, the pattern and scope of adverse drug reactions (ADRs) in Nepal remains unexplored.

Aims

To observe and analyse the pattern of ADRs at KIST Medical College, Lalitpur, Nepal.

Method

A retrospective analysis of all ADRs reported to the centre from mid July 2008 to July 2011 was performed. Data was analysed for ADR severity, causality, and preventability.

Results

A total of 113 ADR reports were obtained from various clinical departments. The maximum number of reactions was due to antimicrobials, followed by anti-hypertensives and NSAIDs.

Conclusion

Antimicrobials were the commonest group of drugs causing ADRs and the most commonly seen ADR was maculopapular rash followed by diarrhea and vomiting.     

Lobeline and cytisine reduce voluntary ethanol drinking behavior in male C57BL/6J mice

Brain nicotinic acetylcholine receptors (nAChRs) have been implicated in the rewarding effects of ethanol and other drugs of abuse. The present study examined the effects of two important nicotinic ligands that target nAChRs, on ethanol consumption in drinking-in-the-dark or continuous access two-bottle choice drinking procedures in C57BL/6J mice. Nicotinic alkaloids such as lobeline or cytisine were administered via subcutaneous (s.c.) injections about 25 min before offering ethanol solutions. Pretreatment with lobeline (4 or 10 mg/kg, s.c.) or cytisine (1.5 or 3 mg/kg, s.c.) significantly reduced ethanol drinking-in-the-dark (g/kg) post 2-h and 4-h treatment, relative to control. In continuous access drinking procedure, pretreatment with lobeline (4 or 10 mg/kg, s.c.) significantly reduced ethanol consumption post 1-h, 2-h, 4-h and 12-h treatment and pretreatment with cytisine (0.5, 1.5 or 3 mg/kg, s.c.) significantly reduced ethanol consumption across 4-h post treatment, relative to control. Neither lobeline nor cytisine significantly affected water or sucrose solution (10% w/v) intake during drinking-in-the-dark or continuous drinking procedures, relative to control. These findings provide evidence that nAChR-mediated signaling plays a critical role in ethanol drinking behavior in mice and nicotinic ligands have therapeutic potential for cessation of binge-like ethanol drinking and dependence in humans.     

A procedure for removing high titer antibodies by extracorporeal protein-A-sepharose adsorption in hemophilia: substitution therapy and surgery in a patient with hemophilia B and antibodies

A 37-yr-old hemophiliac with factor IX antibody in high titer required operation for a pseudotumor growing invasively into the bone in his left elbow. Exchange plasma-pheresis was not feasible, mainly because of possible stimulation of factor IX inhibitor. In addition, the patient had antibodies against tissue antigens. The factor IX antibodies were of IgG type and adsorbable to protein-A-agarose. The antibodies were removed by extracorporeal adsorption of the plasma (separated intermittently in a cell centrifuge) to sterile protein-A- Sepharose in columns, operated by a computer. The treated plasma was retransfused. In this manner, a total of 6000 ml of plasma was depleted of antibodies, and the antibody titer, as well as the total immunoglobulin content, decreased to one-fifth of the original values. The remaining antibodies were neutralized by infusion of factor IX concentrate. Conventional substitution therapy, in combination with immunosuppression, was then possible. The operation was performed without complications. No signs of hemolysis, complement activation, or activation of the coagulation system occurred. In principle, the same form of treatment can be used in patients with other forms of antibodies.     

Enhancing healthcare quality and outcomes for peritoneal dialysis patients in Thailand: An evaluation of key performance indicators and PDOPPS cohort representativeness

Aim

To assess whether the peritoneal dialysis (PD) centres included in the Peritoneal Dialysis Outcomes and Practise Patterns Study (PDOPPS) in Thailand are representative of other PD centres in the country, based on 8 key performance indicators (KPIs 1–8).

Methods

A retrospective analysis was conducted comparing PD-related clinical outcomes between PD centres included in the PDOPPS (the PDOPPS group) and those not included (the non-PDOPPS group) from January 2018 to December 2019. Logistic regression analysis was used to identify predictors associated with achieving the target KPIs.

Results

Of 181 PD centres, 22 (12%) were included in the PDOPPS. PD centres in the PDOPPS group were larger and tended to serve more PD patients than those in the non-PDOPPS group. However, the process and outcome KPIs (KPIs 1–8) were comparable between the 2 groups. Large hospitals (≥120 beds), providing care to ≥100 PD cases and having experience for >10 years were independent predictors of achieving the peritonitis rate target of <0.5 episodes/year. Most PD centres in Thailand showed weaknesses in off-target haemoglobin levels and culture-negative peritonitis rate.

Conclusions

The PD centres included in Thai PDOPPS were found to be representative of other PD centres in Thailand in terms of clinical outcomes. Thus, Thai PDOPPS findings may apply to the broader PD population in Thailand.     

BIOCHEMICAL IDENTIFICATION OF ALCOHOL ABUSE

Biochemical test abnormality can indicate chronic alcohol abuse with good clinical sensitivity and specificity. Serum gamma glutamyltransferase and carbohydrate-deficient transferrin are the tests most frequently abnormal.     

Oral manifestations of inflammatory bowel disease: a review based on the observation of six cases

Inflammatory bowel disease (IBD) comprises two chronic, tissue‐destructive, clinical entities: Crohn's disease (CD) and ulcerative colitis (UC), both immunologically based. Bowel symptoms are predominant, but extra‐intestinal complications may occur, including involvement of the oral cavity. Oral involvement during IBD includes several types of lesions: the most common are aphthae; uncommon lesions include, among others, pyostomatitis vegetans and granulomatous lesions of CD. Starting with a presentation of six patients with oral manifestations, which were crucial for the final diagnosis of IBD, a review on the subject is presented. Oral involvement in IBD may be previous or simultaneous to the gastrointestinal symptoms. However, in the majority of cases, bowel disease precedes the onset of oral lesions by months or years. In many patients, the intestinal symptoms may be minimal and can go undetected; thus, most authors believe that the bowel must be thoroughly examined in all patients with suspected IBD even in the absence of specific symptoms. Usually, the clinical course of oral lesions is parallel to the activity of IBD; therefore, oral manifestations are a good cutaneous marker of IBD.