Inadequate pharmacotherapeutic data for drugs used in children: what can be done?

Although infants and children are affected by many acute and chronic diseases, nearly 80% of the drugs approved in the US for use in adults have not been labelled for paediatric use. This leads to the 'off-label' use of drugs which may produce suboptimal efficacy or harmful effects. Recent regulations proposed by the US Food and Drug Administration (FDA) require the industry to conduct paediatric studies in certain situations. However, some incentives will be provided to the industry to seek paediatric labelling. Paediatric practitioners and researchers will play an active role in conducting research and disseminating data about medication use in infants and children. However, increased funding is required for paediatric research. Industry, government, associations, academia and the public should work together to develop an agenda for action, with the goal of improving clinical outcomes and quality of life in infants and children.     

How can analytical diagnostics in clinical toxicology be successfully performed today?

ABSTRACT:: This article discusses current strategies for efficient analytical diagnostics in clinical toxicology. The tasks for such diagnostics, different analytical strategies and various methods were reviewed. They cover mainly gas chromatography-mass spectrometry and liquid chromatography-mass spectrometry procedures for target or comprehensive screening for drugs (of abuse) and poisons, and for quantification in blood. Quality control aspects and strategies for competent interpretation of the analytical result in correlation with the clinical signs presented by the patient are discussed.     

Drug development in NZ: can a country be a cluster?

The aims of this research were to assess New Zealand's (NZ) growing drug development industry, and compare it with drug development and biotechnology clusters overseas. This article presents the results of questionnaires administered dutring interviews with 60 senior people representing the industry. It narrates their expertise, knowledge management, and innovative behaviors. NZ's industry comprises highly qualified, very experienced, and motivated people. Their organizations have particular expertise in drug discovery, which has arisen from long‐term government support for biomedical research. There is also significant expertise in early‐stage clinical development and contract clinical research. Knowledge sharing was rated as better within organizations than externally. The participants gave the highest ratings of their organizations' innovative performance to solving problems that had caused others difficulty, teamwork and having new ideas; they prefer informal methods of knowledge acquisition. These factors may reflect the NZ approach of applying ingenuity to solve problems and preference for casual and internal knowledge sharing. NZ has a hub of drug development activity; however, its size, limited resources, and remoteness from major markets may limit the development of a complete pharmaceutical industry. NZ could be promoted as a unique “country cluster” offering niche areas of expertise especially in drug discovery and clinical research. Drug Dev Res 73: 51–58, 2012. © 2011 Wiley Periodicals, Inc.     

What is potent acid inhibition, and how can it be achieved?

The clinical response to antisecretory treatment correlates directly with the degree of inhibition of acid secretion achieved. Acid inhibition able to maintain the intragastric pH at a value greater than 4 for at least 16 h/day seems to heal even the most refractory acid-related diseases. It has also been shown that the degree of inhibition of acid secretion in response to antisecretory treatment depends on the genetic characteristics of the patient and on the presence of Helicobacter pylori infection. A possible definition of potent (or profound) acid inhibition is, therefore, the achievement of the aforementioned level of control of acid secretion regardless of patient characteristics or of the presence of H. pylori infection. Antisecretory drugs differ in their ability to reach potent acid inhibition. As far as the comparative efficacy of different drugs for inhibiting acid secretion is concerned, proton pump inhibitors are more efficient in inhibiting gastric acid secretion than histamine (H2) receptor antagonists. Among the different proton pump inhibitors, esomeprazole 40 mg/day exhibits greater antisecretory potency than the others at standard doses. Rabeprazole 20 mg/day and lansoprazole 30 mg/day exhibit a more rapid onset of action than omeprazole 20 mg/day or pantoprazole 40 mg/day.     

How should training of graduates in clinical pharmacology and therapeutics be delivered and assessed?

The UK postgraduate curriculum in clinical pharmacology and therapeutics (CPT) incorporates the common competencies required of all physicians and shows how trainees from other specialties, including primary care, can train in CPT. Various models of training and assessment are possible. Evolution of the current system to meet new challenges would maintain an established tradition, with a ready source of training funds. However, this would require greater input from all consultants in CPT, including the training and assessment of trainees. A joint venture with the Faculty of Pharmaceutical Medicine would have the advantage, if the Faculty agreed, of introducing ready-made curriculum modules and assessment tools that have been accepted by the General Medical Council. However, extra modules relevant to CPT would have to be constructed to complement the common areas already in the pharmaceutical medicine curriculum, and there would be a perceived loss of the independence that clinical pharmacologists currently enjoy when making decisions about manufacturers' products. Abandoning externally approved training in CPT would allow the specialty to devise its own training and assessment in the necessary skills. Critically, however, this would impair the status of the specialty and would incur loss of financial support from postgraduate Deaneries. To attract high-calibre trainees, we must completely define CPT training and assessment structures. Most clinical pharmacologists seem to prefer to allow the current structures to evolve under external guidance. However, this will not succeed unless all trained clinical pharmacologists contribute to development of both the curriculum and specific assessment tools, and open their teaching and assessment skills to scrutiny.     

Practicing and evaluating clinical pharmacy in oncology: Where are we now? A scoping review

BackgroundClinical pharmacy is a discipline structured around multiple activities whose objective is to secure patient care. Among all the specialties where it can be applied, oncology is a field of choice. More and more studies are being conducted on the impact of this activity, but their methodology and results seem at first sight very heterogeneous.Objective(s)The objective of this literature review was to describe the clinical oncology pharmacy activities found in the literature, and analyze the methodology used and the outcomes measured by the authors for their evaluation.MethodsThis literature review was based on the PRISMA-ScR criteria. The Embase, CINAHL, Google Scholar, and PsycINFO databases were searched. All studies reporting the evaluation of hospital-based clinical pharmacy activity in cancer patients were included based on a previously validated search equation. The search was conducted until the end of 2020. The quality of all studies was assessed using the MMAT.ResultsOf the 2521 results of the initial query, 93 were selected for complete review. The main interventions implemented were pharmaceutical analysis as well as pharmaceutical interviews. The indicators assessed most often were the number of pharmaceutical interventions as well as treatment-related problems. The overall quality assessment score was 55%.ConclusionClinical pharmacy activity in oncology still lacks robust studies, whether methodologically or of the measured indicator. Patient-centered impact indicators are still too rare. This area of research should focus on the homogenization of indicators and their relevance.     

Facilitating adherence to highly active antiretroviral therapy in children with HIV infection: what are the issues and what can be done?

Treatment of HIV infection with highly active antiretroviral therapy (HAART) requires sustained adherence to treatment to maintain efficacy. In pediatric patients, adherence to HAART represents a significant challenge for treated children and for their caregivers and healthcare providers. Many factors can affect adherence to HAART including: (i) factors related to the patient and his/her family; (ii) factors related to the drug/medication; and (iii) factors related to the healthcare system. Different strategies can be employed to tackle the specific obstacles identified in these three groups, and thus to facilitate adherence. Among the key interventions centered on the patient and his/her family are the tailoring of the HAART regimen to the daily activities of the child and his/her family, and the implementation of an intensive education program on adherence for the child and the caregiver, prior to starting the treatment. Specific medication-related problems (depending on drug pharmacokinetic and pharmacodynamic properties, taste and palatability, food interactions, etc.) exist; such problems can not be solved solely by clinicians or by families. Greater commitment of the pharmaceutical industry is needed, and innovative solutions have to be identified by clinicians in partnership with drug manufacturers. Furthermore, the development of an 'adherence strategy/program' can be recommended to all institutions working in pediatric HIV infection. Most of the necessary interventions to be included in such programs can be easily implemented, but they require trained and committed staff (and institutions), and time to be spent with patients and their caregivers.     

rhBNP therapy can improve clinical outcomes and reduce in‐hospital mortality compared with dobutamine in heart failure patients: a meta‐analysis

Aims

A meta‐analysis was performed to compare the therapeutic outcomes in patients treated for heart failure (HF) with recombinant human brain natriuretic peptide (rhBNP) and dobutamine.

Methods

PubMed, Embase and the Chinese Biomedical Database were exhaustively searched to identify studies relevant to this meta‐analysis. Eight cohort studies were found suitable for inclusion. Data regarding trial validity, methodological processes and clinical outcomes were extracted.

Results

Patients treated with rhBNP showed statistically significant reduction of in‐hospital mortality and re‐admission rates compared with the dobutamine treated patient group (both P < 0.05). Further, the rhBNP treated patient group showed higher survival outcomes, compared with dobutamine treated patients, when the post‐treatment follow‐up period was longer than 6 months (P < 0.05). Stratified analysis based on ethnicity showed a dramatic decrease of in‐hospital mortality among mixed race HF patients receiving rhBNP treatment (P < 0.05), but such decreases were not statistically significant in Asian and Caucasian populations (both P > 0.05). On the other hand, re‐admission rates were significantly lower in rhBNP treated Caucasian and mixed race populations (both P < 0.05). Notably, in rhBNP treated group, dose levels of 0.015 and 0.03 incrementally lowered the re‐admission rates, displaying dose effect, and the re‐admission rates at both rhBNP doses were significantly lower than the dobutamine treated group (both P < 0.05).

Conclusions

Our meta‐analysis results suggested that rhBNP therapy is associated with lower in‐hospital mortality and re‐admission rates in HF patients compared to the dobutamine regimen. Nevertheless, large scale prospective, randomized trials are necessary to confirm these findings.     

Alcohol prevention: What can be expected of a harm reduction focused school drug education programme?

Aim: This pilot study investigated what alcohol prevention benefits could be achieved by a harm reduction focused school drug education intervention that addressed all drug use, both licit and illicit.

Method: The study population comprised a cohort of 225 students in three intervention secondary schools and 93 students in a matched control school in Victoria, Australia. A classroom drug education programme, derived from evidence of effective practice and designed to reduce alcohol and other drug harm, was provided to the intervention students during years eight (13–14 year olds) and nine (14–15 year olds) by teachers trained in its delivery. The control students received the drug education programme normally provided by their school.

Findings: The students, who received the intervention, were more knowledgeable about drug use issues, communicated more with their parents about alcohol, drank less, got drunk less, and experienced fewer alcohol related harms. They also remembered receiving more alcohol lessons. They were, however, no less likely to have tried alcohol.

Conclusions: The findings are consistent with other studies that have demonstrated school alcohol education that focuses on harm reduction can be effective in reducing consumption, risk and harm. In this study, this was achieved even though the students were not persuaded against taking up drinking, and the intervention did not focus solely on alcohol. These findings have implications for both the goals and coverage of future school drug education programmes.