Tareq L. Mukattash

Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials.

ObjectivesTo investigate the knowledge and views of a range of healthcare professionals (consultant paediatricians, general practitioners (GPs), community pharmacists and paediatric nurses) regarding the use of unlicensed/off-label medicines in children and the participation of children in clinical trials.MethodsA regional study in which a survey instrument with 39 items was issued to 500 randomly selected GPs, all community pharmacists (n = 512), 50 hospital consultants and 150 paediatric nurses in Northern Ireland.ResultsApproximately half (46.5%) of the 1,212 healthcare professionals approached responded to the questionnaire. The majority of respondents indicated their familiarity with the term unlicensed (82.9%) or off-label (58.6%) prescribing with the most frequently quoted reason for such prescribing being younger age (33.6%). Apart from community pharmacists, most respondents reported having gained their knowledge through personal experience. Even though a large percentage of respondents expressed concerns about the safety (77.8%) or efficacy (87.9%) of unlicensed/off-label prescribing in children, only 30.7% reported informing parents/guardians of these concerns on the use of such medicines in children. In addition, only 56% of respondents believed that unlicensed/off-label medicines should undergo clinical trials in children. Overall, 28.4% of respondents (20.1% of GPs, 41.4% of community pharmacists, 27.7% of paediatric nurses and 94% of consultant paediatricians) indicated their willingness to be actively involved in, and recruit their patients for paediatric clinical research.ConclusionThe use of unlicensed and off-label medicines remains a major issue in paediatric medicine. Until such times as more licensed medicines are available for children, clear guidance should be developed to allow consistency in practice across the spectrum of healthcare professionals who are involved with such medicines in their routine practice.

Public awareness and views on unlicensed use of medicines in children.

AIMS To explore awareness and views of the general public on unlicensed use of medicines in children and on the participation of children in clinical trials. METHODS Members of the public completed a questionnaire survey administered by face-to-face interview in public areas in N. Ireland. The main outcome measures were the views on unlicensed use of medicines in children and on clinical trials in children. RESULTS One thousand participants (59.2% female) took part; 610 were parents. Most participants (86%) had no previous knowledge about unlicensed use of medicines in children. Being a parent did not influence this nor did being a parent of a child who suffered from a health problem (P > 0.05). Most participants (92%) felt that parents should be told about unlicensed use of medicines, with the doctor most frequently selected as the person who should inform parents. At the outset, only 1.8% of participants felt that the use of medicines in children was unsafe. However, having been informed about unlicensed use of medicines, this proportion increased dramatically (62.4%; P < 0.001). Views on whether participants would enter a child of their own into a clinical trial varied according to the health status of the child (P < 0.05) i.e. a child in good health (3.9%) vs a child with a life-threatening condition (41.9%). CONCLUSIONS There is limited public knowledge of unlicensed use of medicines in children and a general reluctance to involve children in clinical trials unless the child to be involved has a life-threatening condition.

Public knowledge and awareness of cardiovascular disease and its risk factors: a cross-sectional study of 1000 Jordanians

Objective  To assess the level of the current knowledge and understanding of cardiovascular disease (CVD) among Jordans general public, their behaviour towards CVD and the factors associated with different CVD knowledge levels.

Dispensing of non-prescribed antibiotics in Jordan

Objective Current regulations in Jordan state that antibiotics cannot be sold without a medical prescription. This study aimed to assess the percentage of pharmacies that dispense antibiotics without a medical prescription in the Kingdom of Jordan and identify and highlight the extent and seriousness of such practices among Jordanian pharmacies. Methods A prospective study was performed, and five different clinical scenarios were simulated at pharmacies investigated including sore throat, otitis media, acute sinusitis, diarrhea, and urinary tract infection in childbearing-aged women. Three levels of demand were used to convince the pharmacists to sell an antibiotic. Results A total of 202 total pharmacies in Jordan were visited in the present study. The majority of pharmacies (74.3%) dispensed antibiotics without prescription with three different levels of demand. The percentage of pharmacies dispensing antibiotics without a prescription for the sore throat scenario was 97.6%, followed by urinary tract infection (83.3%), diarrhea (83%), and otitis media (68.4%). The lowest percentage of antibiotic dispensing was for the acute sinusitis simulation at 48.5%. Among the pharmacies that dispensed antibiotics, the pharmacists provided an explanation as the number of times per day the drug should be taken in 95.3% of the cases, explained the duration of treatment in 25.7%, and inquired about allergies prior to the sale of the antibiotic in only 17.3%. Only 52 pharmacies (25.7%) refused to dispense any kind of antibiotics, the majority (61.5%) of this refusal response came from acute sinusitis cases, while the minority (2.4%) came from the sore throat cases. Conclusion The results of this study demonstrate that antibiotics continue to be dispensed without prescription in Jordan in violation with national regulations regarding this practice. The findings of this study could provide a layout for governmental health authorities to implement strict enfrorcment of national regulations regarding antibiotic dispensing in order to avoid the serious complications that could arise in the future as a result of such practices.

Perceptions and attitudes of Jordanian paediatricians towards off-label paediatric prescribing

Objective To assess current experiences and attitudes of hospital based paediatricians towards off-label medicine prescribing. Setting Paediatric hospital wards and out-patient clinics. Design A prospective, questionnaire based study. Results A 30 item questionnaire was sent to 300 hospital based paediatricians and 250 (83%) were returned completed. Over 69% of responders were familiar with the term off-label medicines. However, only 28% were knowingly prescribing off-label medicines to children. The majority of respondents (90%) expressed concerns about the safety and efficacy of off-label medicines. Only 15% had observed Adverse Drug Reactions, and 31% a treatment failure. The vast majority of respondents (83%) did not obtain informed consent or tell parents they were prescribing off label medicines to their children. Conclusions Off-label prescribing of medicines to children is a familiar concept to the majority of paediatricians in Jordan although only a smaller number are aware that it is common in their practice. Respondents showed concern about off label prescribing, although the majority do not consider it necessary to inform parents. More comprehensive research is needed in this area in Jordan and other Middle Eastern countries.

Cardiovascular Safety of Oral p-Synephrine (Bitter Orange) in Healthy Subjects: A Randomized Placebo-Controlled Cross-Over Clinical Trial

Bitter orange (Citrus aurantium) extract and its primary protoalkaloid p‐synephrine are widely consumed in combination with multiple herbal ingredients for weight management and sports performance. p‐Synephrine is also present in juices and foods derived from a variety of Citrus species. Questions exist regarding the safety of p‐synephrine because of structural similarities with other biogenic amines. This study assessed the cardiovascular (stimulatory) effects of bitter orange extract (49‐mg p‐synephrine) given to 18 healthy subjects (nine men and nine women) in a double‐blinded, placebo‐controlled cross‐over study. Heart rates, blood pressures, and electrocardiograms were determined at baseline, 30, 60, 90 min, 2, 4 , 6, and 8 h. Blood samples were drawn at baseline, 2 h and 8 h for serum chemistries, blood cell counts, and p‐synephrine and caffeine levels. No significant changes occurred in electrocardiograms, heart rates, systolic blood pressure, blood chemistries, or blood cell counts at any time point in either control or p‐synephrine treated group. A small (4.5 mmHg) decrease in diastolic blood pressure occurred in the p‐synephrine treated group at 60 min. No adverse effects were reported. Caffeine ingestion varied markedly among the participants. p‐Synephrine does not act as a stimulant at the dose used. Copyright

Identification of Drug-Related Problems: A Prospective Study in Two General Hospitals

UNLABELLED Drug-related problems (DRPs) can reduce the potential clinical benefits of treatment with medicines and waste valuable resources. No previous studies were published to examine the nature and frequency of drug related problems among hospitalized patients in Palestinian hospitals. METHODOLOGY Prospective observational study was conducted to report and record the natural and frequency of drug related problems in two general hospitals. RESULTS The study included 212 patients, 54.4 % female, with a mean age 62.2 (±10.6 SD). 88% of the patients were reported with one or more DRPs, with an average of 1.9 DRPs per patient were found. The most prevalent DRP was incorrect dosing regimen which was represented by (22.2%), followed by drug-drug interaction (19.4%), drugs need laboratory tests (15.2%). Ceftriaxone, warfarin, enoxapirin and dogixin were the drugs causing most frequent DRPs. The drug groups causing most DRPs were anti-infective agents, anti-thrombotic agents and non-steroidal anti-inflammatory agents. Once discovered, the majority of DRPs (71.6%) were accepted by the physicians and solved immediately, while 11.5 % of pharmacist advice was not approved. Multiple regression analysis indicated that the number of medications (RR 1.99; 95% CI 1.31-3.76) and the number of medical conditions (RR 1.81; 95% CI 1.11-3.13) independently predicted the number of DRPs. CONCLUSION DRPs in general hospitals are frequent, serious and predictable. Most of the problems identified as DRPs by the pharmacists were accepted by the physicians and solved. Pharmacists in the hospital setting are well suited to identify and resolve DRPs.

An audit on the knowledge, beliefs and attitudes about the uses and side-effects of antibiotics among outpatients attending 2 teaching hospitals in Jordan

This study aimedto assess general knowledge, beliefs and attitudes of people towards the use of antibiotics. Individuals referring to the outpatient pharmacies of 2 major teaching hospitals in the north of Jordan completed a self-administered, validated questionnaire. A total of 1091 individuals (56.8% males) participated in the study. Of these, 20.1% of the participants stated that antibiotics were used for bacterial infections, while 18.3% thought they were used for viral infections and 43.6% for mixed bacterial/viral infections. The average knowledge score of the participants about antibiotic uses and side-effects was low. Middle-aged participants and those with an education beyond high school had significantly higher knowledge scores about antibiotics use. Almost 75% of the participants disagreed that antibiotics could be given without a prescription.

The role of adiponectin gene variants in glycemic control in patients with Type 2 diabetes.

Abstract The aim of this study was to investigate the association between glycemic control in Type 2 diabetes mellitus patients and common genetic variants of ADIPQO gene. A total of 427 Type 2 diabetes patients were recruited in the study and divided into two groups: 172 patients with good glycemic control and 249 with poor glycemic control. Genotyping of C11377G, G276T and T45G ADIPQO SNPs were carried out using restriction fragment length polymorphisms-polymerase chain reaction. The results showed that C11377G ADIPQO SNP is strongly associated with glycemic control in Type 2 diabetes patients. Patients with the GG genotype at adiponectin C11377G had better glycemic control than those with CC or CG genotypes. However, other examined SNPs were not correlated with glycemic control in Type 2 diabetes patients. Other parameters that impacted glycemic control include duration of the disease (p < 0.01), use of insulin therapy (p < 0.01) and presence of neuropathy complications (p < 0.01). However, no contribution was observed for gender, statin use, lipid profile and other oral medications to glycemic control (p > 0.05). Glycemic control among Type 2 diabetes patients might be affected by variants in ADIPQO gene.

Prevalence of non-adherence among psychiatric patients in Jordan, a cross sectional study

It has been estimated that up to 50% of any patient population is at least partially non‐adherent to their prescribed treatment. Identifying barriers to adherence is required to develop effective interventions for psychiatric patients.