Pharmacy & Pharm.D

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Investigation of the interchangeability between Cefuroxime Axetil tablets marketed in Palestine. Is there a quality reason behind the price?
(2012-04-26) A Za’areer; S Abdelhafez; O Alqaryouti; A Saleem; Prof. Abed Naser Zaid
Background: According to Food and Drug Administration (FDA), therapeutically equivalent antibiotics are expected to have equivalent clinical efficacy and safety when used under the conditions of their labeling. However, any defect in the quality of an antibiotic may negatively affect its efficacy and safety and accordingly are considered a substandard drug. Cefuroxime is a semi-synthetic, broad-spectrum cephalosporin antibiotic intended for oral administration. Any quality defect in this product may cause inefficacy and future bacterial resistance. Objective: The aim of this study was to evaluate the quality and cost price of all commercial Cefuroxime Axetil tablet products available on the Palestinian market (One brand and two generic products). Method: A survey on the price of all commercial tablet products was conducted. To assess quality, all products were examined visually for their general appearance. They were tested for weight uniformity, friability, disintegration, and dissolution profile, and assayed for Cefuroxime content. Results: The original brand was more expensive than the two locally produced generic products. Based on our testing procedure, all Cefuroxime tablet products were equivalent to the brand product. Although, the two generic products released more than 85% of their Cefuroxim content within 15 minutes, while the brand released only 74.5%. Conclusion: These results demonstrate that generic Cefuroxime tablets produced by local manufacturers are often comparable in vitro to the brand product and have lower price. Accordingly, we encourage our physician to prescribe the local product since they may be interchangeable and have same safety and efficacy profile.
In vitro and in vivo postmarketing surveillance of Valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients
(2012-05-20) D Shweiki; H Shtewi; R Shaheen; S Al Helaly; Z Khayyat; Prof. Abed Naser Zaid
Objectives: to evaluate the general quality of the most prescribed products of valsartan (VL) (alone or in combination) and to evaluate their efficacy and safety among Palestinian population through in vivo post-marketing surveillance. Methods: The first part was pharmacopeial quality control (QC) assay including dissolution, disintegration, friability and weight uniformity for VL. The second part was 3-months, cardiology clinics, observational, post marketing surveillance pilot study that included 103 hypertensive patients who were prescribed valsartan 80 or 160mg as monotherapy or combination therapy. The endpoint was the reduction of blood pressure (BP) and the rate of incidence of adverse effects (AEs) at weeks 4 and 8. Results: according to our QC tests all VL products showed high quality standards according to the international guidelines. A reduction of BP was observed at week 4 and 8 and no significant difference was observed between 80 and 160 strengths, higher BP reduction was observed after the use of combination therapy. Moreover, VL was well tolerated; most of AEs were of mild to moderate intensity. In general, the most frequently reported AEs included headache (17.5%), dizziness (11.75%) and weakness (11.7%). No serious AEs or Death cases were reported during the study period. Conclusion: High quality of the used VL tablet products, so the observed efficacy and safety results should be related to patient’s factors and not due to any product defects or substandard quality. Moreover, VL is an effective treatment for essential hypertension.
Evaluation and management of postoperative nausea and vomiting
(2012-05-26) Alla Nader; Bayan Ghazal; Dr. Samah Al- Jabi , Dr. Sa'ed Zyoud
Introduction: Nausea and emetic episodes are common complaints following anaesthesia and surgery and are among the leading cause to decrease patient satisfaction after surgery. Objectives of the study:To Recognize a predictive risk factors that would be unique in the Palestinian population, quantification of the relative impact of the risk factors on postoperative nausea and vomiting (PONV) and to develop a model to stratify risk categories and identify those patients at higher risk for PONV . Method: We enrolled a sample of inpatients over 18 years old from 1 July to 1 November 2012 in this prospective observational cohort study. The patients were interviewed 6 hr and 24 hr postoperatively using a data collection form concerning the patient’s subjective sensation of feeling sick or wishing to vomit and PONV intensity scale. Logistic regression analysis was performed to predict the occurrence of PONV Results:One hundred and fifty nine (39.8%) out of the 400 patients who were included in the study had experienced PONV during their hospital stay. Using a univariate analysis female gender (P=0.014), Previous PONV (P=0.001), Post-operative opioid use (P=0.003) and propofol use (P=.043) were the main predictors in assessing PONV. And it showed that the use of propofol may significantly reduce the risk of PONV (p = 0.043). The results of the binary logistic regression analysis showed that the occurrence of PONV was 1.7 times higher in females comparing to males. In addition, the odds of PONV were 2.5 times higher in patients who had had a previous PONV, and 2.2 times higher in patients who used opioids post-operation. On the other hand, using propofol in anesthetic medication regimen could reduce the risk of the occurrence of PONV by 50%. Using the binary logistic regression we developed this equation for calculating the overall risk of PONV: P (probability of PONV) =1/1+e-Z /Where Z=0.517 (gender) +0.910 (history) + 0.784 (use of post-operative opioid)-0.624(Propofol use). [Gender: female=1, male=0; history of previous PONV or motion sickness: yes=1, no=0; use of post-operative opioid: yes=1, no=0; use of propofol yes=1, no=0] Conclusion:The occurrence of PONV is common with a percentage of 39.8%, the major predictive risk factors for PONV in the Palestinian population were identified which are female gender, history of PONV, post-operative opioid use and the use of propofol .In addition, a predictive model has been developed for assessing PONV among a group of Palestinian patients.
Biowaiver studies of amlodipine (5 mg/tablet): An alternative to in vivo bioequivalence studies
(2012-05-26) I Issa; A Khraim; S Hirzallah; Prof. Abed Naser Zaid
Background: Amlodipine is an anti hypertensive agent. According to the BCS, AM can be classified as class I, especially for 5 mg dose. Objectives: The aim of this study was to prepare a biowaiver monograph based on both literature data and in vitro testing of AM as the only API present in tablet products. This kind of studies is based on the BCS properties and the risk of waiving in vivo studies of the API. Methods: Literature data regarding safety, permeability & physicochemical properties of AM was collected using Pubmed & Google Scholar. In vitro testing was conducted to measure the dissolution behavior in three pH (1.2, 4.5, 6.8) media for the brand and generics. AM content was assessed using UV spectrophotometer as reported in the USP and similarity and non similarity factors were calculated. Results: Release of AM from generics and brand tablet products showed comparable dissolution behavior in all three recommended pH media for similarity studies. Similarity factor in three media was more than 50 and non similarity factor was less than 15 in all three media for both Amlovasc & Vascopin. Conclusion: Based on the current BCS-based biowaiver criteria, the in vivo bioequivalence requirements can be waived for AM (5mg/tablet).
Relation between Clinical and Therapeutic variables and Quality of Life in Palestinian Hypertensive Patients
(2012-06-25) Saleem Hayat Alayasah Mohammad Badwan; Aysha Wild Ali; Hanan Saleem; Hayat Alayasah; Mohammad Badwan; Dr. Samah Al-Jabi Dr. Sa'ed Zyoud
Background:The ability to identify indicators of poor health-related quality of life HRQoL is very important for both improving clinical care and making interventions to improve treatment outcome. Objectives:In this study we aimed to assess HRQoL among hypertensive Palestinian patients and to determine the socio-demographic and therapeutic characteristics associated with poor HRQoL. Methods:A cross-sectional descriptive study was undertaken with a cohort of hypertensive patients attending the outpatients’ clinics at the Al-Makhfyah primary health care clinic and from Alwatani hospital, Nablus - Palestine. The EuroQoL EQ-5D scale was used for the assessment of HRQoL. Descriptive statistics were used to describe socio-demographic and disease-related characteristics of the patients. HRQoL was scored using values adapted from the United Kingdom general population survey. All analysis were performed using SPSS version 15.0. Results: The study sample was 410 patients, of these 213 (52%) were female. The mean age of the study sample was 58.38 ± 1.065 years, 192 patients were obese, 81.2% of the patients were nonsmokers, and the majority of the patients (86.8%) were on combination antihypertensive therapy. HRQoL was good, the mean of the EQ-5D index was 0.80 ± 0.16 and the mean of the EQ-5D visual analogue scale (EQ- VAS) was 74.1 ± 15.6. A significant difference in EQ-5D index value was found between patients when grouped according to age, occupation, marital status, educational level, income, duration of the disease, total number of chronic diseases and total number of medications (Kruskal-Wallis p < 0 .05) as well as gender and therapy type (Mann-Whitney p < 0.05). Conclusion: Palestinian hypertensive patients have good quality of life (QoL). Socio-demographic, co-morbid diseases and therapeutic regimen have a great impact on QoL. The study findings could be helpful in clinical practice, mainly in the early treatment of hypertensive patients, at a point to improve HRQoL.
Pharmacist's knowledge, certainty and risk of error in active pharmaceutical ingredients and pharmaceutical excipients: a study from Palestine
(2013-05-20) Mohammed Al-Rjoub; Mohammed M Al-Horoub; Wasif Al-Hroub; Bisan Al-Rjoub; Bashaaer Abd Al-Nabi
Purpose: Pharmaceutical products contain active pharmaceutical ingredients (APIs) and pharmaceutical excipients which could be contraindicated in some patients or could cause serious adverse effects. The aim of this study was to investigate community pharmacists’ knowledge of adverse effects and contraindications of pharmaceutical products, certainty and risk of error. The study also investigated the association of different factors with knowledge, certainty and risk of errors. Methods: The knowledge of community pharmacists was assessed in a cross-sectional design using a multiple-choice questions test on the adverse effects and contraindications of APIs and excipients. Self-rated certainty scores were also recorded for each question. Knowledge and certainty scores were combined to estimate the risk of error. Results: 129 community pharmacists completed the study and the response rate was 41%. The mean score of pharmacists was 11.0/15.0 (±2.3) and 9.3/15.0 (±2.7) in MCQs related to APIs and excipients, respectively. Scores in MCQs related to APIs and excipients positively correlated (Pearson’s r = 0.353, p<0.001). Knowledge on APIs was associated with the year of graduation and obtaining a license to practice pharmacy. Knowledge on excipients was associated with the degree obtained. There was higher risk of error (p<0.01) in questions related to excipients as compared to questions related to APIs. Conclusions: The knowledge of community pharmacists who participated in our study was found to be insufficient with high risk of errors. Our study suggests a need for improving the knowledge of community pharmacists on the safety issues of medications and pharmaceutical excipients.
Breast milk lead levels in 3 major regions of the West Bank of Palestine
(2013-05-20) Jamela Dwikat; Maram El-Helo; Bayan Yacoub; Dr. Ramzi Shawahna
Background: Lead is a neurotoxic pollutant that is ubiquitously spread in our environment. Breast milk contaminated with lead poses potential risk of exposing recipient infant to lead. Objectives: The primary aims of this study were to evaluate the breast milk lead levels (BMLLs) in breastfeeding mothers in three major regions of the West Bank of Palestine and to investigate the effects of some sociodemographic variables on the BMLLs. Methods: Breast milk samples were collected from 89 breastfeeding mothers from Nablus, Ramallah and Jerusalem regions and analyzed for their BMLLs using graphite furnace atomic absorption spectrophotometry. Breastfeeding mothers were interviewed and responded to a sociodemographic questionnaire. Results: The median BMLL was 4.0 µg/L, ranging from 2.0 to 12.0 µg/L. BMLLs in 19.1% of the samples analyzed were higher than the World Health Organization’s safety limits of 2.0 to 5.0 µg/L for occupationally unexposed population. BMLLs were significantly higher in breast milk of mothers who lived in cities and refugee camps (p < 0.01), had lower monthly household income level (p < 0.05), lived close to paint shops (p < 0.05), lived in houses with peeling or chipping paint (p < 0.05), used eye kohl (p < 0.01), and worked in agriculture for a duration longer than 3 years (p < 0.01). Conclusions: BMLLs were higher than the safety limits for occupationally unexposed populations. Authorities need to implement measures to eliminate or reduce lead exposure, especially in refugee camps and cities. Marketed eye kohl preparations should be tested for their lead contents.
Arsenic in Rice
(2013-05-25) Saja Ibrahim El-hour; Sadeya Abu Radi; Hilda Salah Titi; Dr. Hamzeh Al Zabadi
Arsenic (As) is considered one of the most important toxic elements in the environment because of its potential risk to human and to ecosystem. Arsenic is a relatively inert, odorless, white or colorless Tasteless powders that do not evaporate. A part from drinking water, rice consumption may be the most important pathway of human arsenic uptake. Arsenic could be found in two forms, either inorganic or organic substances. An inorganic arsenic compound is more toxic which used in pesticides. The World Health Organization (WHO) and the U.S. Environmental Protection Agency have recommended a threshold of 10 μg/L for inorganic arsenic concentration in drinking water. The International Agency for Research on Cancer (IARC) classifies arsenic as (Group 1) human carcinogen. Brown rice contains arsenic more than white rice. Countries produce rice do not affect the production country only, but also other rice imported countries could be affected around the world who import rice mainly from India, China, Thailand and California
Exhaustive extraction for Erodium lacinatium member of Palestinian flor
(2013-05-25) Rand Nassouh Badran; Dr.Nidal Jaradat
Many bioactive ingredients are derived from natural sources such as plants, animal glands, or fungi.Medicinal plants are the richest bioresource of drugs and there is an increasing need for substances with antiviral, antibacterial, anticancer activity. The aim of this research was to determine the percentage yield of the organic and aqueous phase of the exhaustive extraction of Erodium lacinaitum plant.Erodium lacinatum is a genus of the botanical family Geraniaceae. The genus includes about 60 species, for the most part originating in the Mediterranean or Western Asian regions, and it is one of the Palestinian flora. Exhaustive extractions done for our plant as we weight 25g of dried plant and soak it in ethanol 50% and hexane with shaking for 72 hours at room temperature. Then after filtration we dried the aqueous face by rotary evaporator and freeze drying and organic faces by decrease the pressure separately. The yield of organic face was0.28%and the aqueous face was 15.56%, then we dissolved the organic layer in dimethy sulfoxide (DMSO), and we dissolved the aqueous layer in phosphate buffer saline (PH 7, 4) as they are ready for biological activity.
Impact of Treatment Pattern and Current Clinical Status on Complications among Type 2 Diabetic Patients: a Cross- Sectional Study from Palestine
(2013-05-25) Asma' Mara'beh; Asma' Alnatsheh; Raghad Shahin; Rawya Abu Allan; Sabreen Mara'beh; Dr. Samah Al-Jabi
Introduction: diabetes mellitus (DM) type 2 is one of the most rapidly growing disease worldwide, and is a prime cause of excess cardiovascular morbidity and mortality. In addition, DM can lead to long term complications that affect many organ systems. Objectives: the main objectives of this study were to identify the characteristics and the current staus of type 2 diabetic patients, estimate the prevalence of vascular complications and other risk factors, and assess the impact of treatment pattern of using anti-diabetic medication classes and the use of other medications, the current clinical status on complications among the diabetic patients. Methods: A five-month period cross sectional study that included type 2 diabetic patients was done. Information was gathered from face to face interviews as well as patients' records. A data collection form concerning socio-demographic, clinical characteristics, medications that they were prescribed, patients’ complications and the extent of patients’ adherence to these medications were included. Results:A total of 451 patients who were diagnosed with type 2 DM and agreed to be interviewed were assessed. The results showed that the disease was more prevalent among females than males (1.9:1) ratio. In terms of patients' complications, one or more microvascular or macrovascular complications developed in (80.9%) diabetic patients. Regarding medications used, insulin and oral antidiabetic agent were the most been used; (68.1%) patients were on insulin injection and (71%) were on oral antidiabetic agent. In addition, β-blockers were used by (11.3%) patients. Angiotensin related anti hypertensive medications were used by (34.1%) patients; among those (28.8%) patients were on ACEI and (5.5%) were on ARB medications. Furthermore, antiplatelet agents were used by (46.3%). Regarding antihyperlipidemic agents, (58.3%) patients were using statins. Patients using insulin, ACEI or ARB, antiplatelet, antihyperlipidemic or diuretics developed significantly at least one complication than medications non-users (73.2 versus 46.5% (p = 0.000) , 36.4% versus 24.4% (p = 0.034), 49.3% versus 33.7% (p = 0.009), 64.9% versus 36.0%) (p = 0.000), 15.9% versus 5.8% (p = 0.015), respectively). However, patients who did not use the oral anti-diabetic agents developed significantly at least one complication than oral anti-diabetic agents users (81.4% versus 68.5%, p = 0.018)). Conclusion: Understanding diabetes and its risk factors can help control the disease. Lifestyle modifications are important elements for avoiding the complications of diabetes. Patients having hypertension, dyslipidemia, and arrhythmia were significantly developed complication than those without hypertension, dyslipidemia, and arrhythmia. Patients with at least one complication are usually using insulin, ACEI or ARB, antiplatelet, antihyperlipidemic or diuretics. However, patients who did not use the oral anti-diabetic agents developed significantly at least one complication than oral anti-diabetic agents users.
Impact of Treatment Pattern and Current Clinical Status on Complications among Type 2 Diabetic Patients: a Cross- Sectional Study from Palestine
(2013-05-26) Asma' Mara'beh; Asma' Alnatsheh; Raghad Shahin; Rawya Abu Allan; Sabreen Mara'beh; Dr. Samah Al-Jabi
Introduction: diabetes mellitus (DM) type 2 is one of the most rapidly growing disease worldwide, and is a prime cause of excess cardiovascular morbidity and mortality. In addition, DM can lead to long term complications that affect many organ systems. Objectives: the main objectives of this study were to identify the characteristics and the current staus of type 2 diabetic patients, estimate the prevalence of vascular complications and other risk factors, and assess the impact of treatment pattern of using anti-diabetic medication classes and the use of other medications, the current clinical status on complications among the diabetic patients. Methods: A five-month period cross sectional study that included type 2 diabetic patients was done. Information was gathered from face to face interviews as well as patients' records. A data collection form concerning socio-demographic, clinical characteristics, medications that they were prescribed, patients’ complications and the extent of patients’ adherence to these medications were included. Results:A total of 451 patients who were diagnosed with type 2 DM and agreed to be interviewed were assessed. The results showed that the disease was more prevalent among females than males (1.9:1) ratio. In terms of patients' complications, one or more microvascular or macrovascular complications developed in (80.9%) diabetic patients. Regarding medications used, insulin and oral antidiabetic agent were the most been used; (68.1%) patients were on insulin injection and (71%) were on oral antidiabetic agent. In addition, β-blockers were used by (11.3%) patients. Angiotensin related anti hypertensive medications were used by (34.1%) patients; among those (28.8%) patients were on ACEI and (5.5%) were on ARB medications. Furthermore, antiplatelet agents were used by (46.3%). Regarding antihyperlipidemic agents, (58.3%) patients were using statins. Patients using insulin, ACEI or ARB, antiplatelet, antihyperlipidemic or diuretics developed significantly at least one complication than medications non-users (73.2 versus 46.5% (p = 0.000) , 36.4% versus 24.4% (p = 0.034), 49.3% versus 33.7% (p = 0.009), 64.9% versus 36.0%) (p = 0.000), 15.9% versus 5.8% (p = 0.015), respectively). However, patients who did not use the oral anti-diabetic agents developed significantly at least one complication than oral anti-diabetic agents users (81.4% versus 68.5%, p = 0.018)). Conclusion: Understanding diabetes and its risk factors can help control the disease. Lifestyle modifications are important elements for avoiding the complications of diabetes. Patients having hypertension, dyslipidemia, and arrhythmia were significantly developed complication than those without hypertension, dyslipidemia, and arrhythmia. Patients with at least one complication are usually using insulin, ACEI or ARB, antiplatelet, antihyperlipidemic or diuretics. However, patients who did not use the oral anti-diabetic agents developed significantly at least one complication than oral anti-diabetic agents users.
Pharmacist's knowledge, certainty and risk of error in active pharmaceutical ingredients and pharmaceutical excipients: a study from Palestine
(2013-05-26) Mohammed Al-Rjoub; Mohammed M Al-Horoub; Wasif Al-Hroub; Bisan Al-Rjoub; Bashaaer Abd Al-Nabi; Dr. Ramzi Shawahna
Purpose: Pharmaceutical products contain active pharmaceutical ingredients (APIs) and pharmaceutical excipients which could be contraindicated in some patients or could cause serious adverse effects. The aim of this study was to investigate community pharmacists’ knowledge of adverse effects and contraindications of pharmaceutical products, certainty and risk of error. The study also investigated the association of different factors with knowledge, certainty and risk of errors. Methods: The knowledge of community pharmacists was assessed in a cross-sectional design using a multiple-choice questions test on the adverse effects and contraindications of APIs and excipients. Self-rated certainty scores were also recorded for each question. Knowledge and certainty scores were combined to estimate the risk of error. Results: 129 community pharmacists completed the study and the response rate was 41%. The mean score of pharmacists was 11.0/15.0 (±2.3) and 9.3/15.0 (±2.7) in MCQs related to APIs and excipients, respectively. Scores in MCQs related to APIs and excipients positively correlated (Pearson’s r = 0.353, p<0.001). Knowledge on APIs was associated with the year of graduation and obtaining a license to practice pharmacy. Knowledge on excipients was associated with the degree obtained. There was higher risk of error (p<0.01) in questions related to excipients as compared to questions related to APIs. Conclusions: The knowledge of community pharmacists who participated in our study was found to be insufficient with high risk of errors. Our study suggests a need for improving the knowledge of community pharmacists on the safety issues of medications and pharmaceutical excipients.
Biowaiver eligibility of a lower strength Ramipril/Hydrochlorothiazide immediate release tablets using a new validated HPLC analytical method. Drug Research
(2013-05-26) L Maqboul; H Zaid; A Mahasne; Prof. Abed Naser Zaid
Bioequivalence studies are expensive, time consuming and invasive to humans. Accordingly, an alternative in vitro study (biowaivers) has been introduced for drugs which belong to BCS class I and III and for other strengths of already approved higher drug strength. The main objective of this study was to prove the biowaiver eligibility of a lower strength Ramipril/ Hydrochlorothiazide (2.5/12.5 mg) tablets. Visual and pharmacopoeial quality tests were performed on the higher and lower generic and on the reference listed drug to determine whether they are pharmaceutically equivalent. All products were investigated using the biowaiver criteria. Dissolution profiles were conducted at pH values 1.2, 4.5, and 6.8. Difference factor (f1) and similarity factor (f2) were calculated. The tested products were successfully complied with pharmacopeial requirements. f1was below 15 andf2was above 50 in all dissolution conditions. Precisely, Ramipril showed release higher than 85% within 15 minutes.f1andf2for Hydrochlorothiazide were 8 and 61 respectively at the recommended discriminative pH media.These results suggest that the current biowaiver criteria could be a sufficient guarantee of bioequivalence of the lower strength of Ramizide assuming that the product is manufactured at the same site and contains same quality and grade of excipients and in a proportional amounts.
Biowaiver eligibility of a lower strength Ramipril/Hydrochlorothiazide immediate release tablets using a new validated HPLC analytical method. Drug Research
(2013-05-30) L Maqboul; H Zaid; A Mahasne; Prof. Abed Naser Zaid
Bioequivalence studies are expensive, time consuming and invasive to humans. Accordingly, an alternative in vitro study (biowaivers) has been introduced for drugs which belong to BCS class I and III and for other strengths of already approved higher drug strength. The main objective of this study was to prove the biowaiver eligibility of a lower strength Ramipril/ Hydrochlorothiazide (2.5/12.5 mg) tablets. Visual and pharmacopoeial quality tests were performed on the higher and lower generic and on the reference listed drug to determine whether they are pharmaceutically equivalent. All products were investigated using the biowaiver criteria. Dissolution profiles were conducted at pH values 1.2, 4.5, and 6.8. Difference factor (f1) and similarity factor (f2) were calculated. The tested products were successfully complied with pharmacopeial requirements. f1was below 15 andf2was above 50 in all dissolution conditions. Precisely, Ramipril showed release higher than 85% within 15 minutes.f1andf2for Hydrochlorothiazide were 8 and 61 respectively at the recommended discriminative pH media.These results suggest that the current biowaiver criteria could be a sufficient guarantee of bioequivalence of the lower strength of Ramizide assuming that the product is manufactured at the same site and contains same quality and grade of excipients and in a proportional amounts.
Medication administration errors from a nursing viewpoint: a formal consensus of definition and scenarios using a Delphi technique
(2013-05-30) Dina Masri; Rawan Al-Gharabeh; Rawan Deek; Lama Al-Thayba; Masa Halaweh; Dr. Ramzi Shawahna
Aims and objectives: To develop and achieve formal consensus on a definition of medication administration errors (MAEs) and scenarios that should or should not be considered as MAEs in hospitalised patient settings. Background: MAEs occur frequently in hospitalised patient settings. Currently, there is no formal consensus on a definition of MAEs or scenarios that should or should not be considered as MAEs. Design: This was a descriptive study using Delphi technique. Methods: A panel of experts (n=50) recruited from major hospitals, nursing schools and universities in Palestine took part in the study. Three Delphi rounds were followed to achieve consensus on a proposed definition of MAEs and a series of 61 scenarios representing potential MAE situations formulated into a questionnaire. Results: In the first Delphi round, key contact nurses’ views on MAEs were explored. In the second Delphi round, consensus was achieved to accept the proposed definition of MAEs and to include 36 (59%) scenarios and exclude 1 (1.6%) as MAEs. In the third Delphi round, consensus was achieved to consider further 14 (23%) and exclude 2 (3.3%) as MAEs while the remaining 8 (13.1%) were considered equivocal. Of the 61 scenarios included in the Delphi process, experts decided to include 50 scenarios as MAEs, exclude 3 scenarios and include or exclude 8 scenarios depending on the individual clinical situation. Conclusion: Consensus on a definition and scenarios representing MAEs can be achieved using formal consensus techniques. Relevance to clinical practice: Researchers should be aware that using different definitions of MAEs, inclusion or exclusion of MAE situations could significantly affect the rate of MAEs reported in their studies. Consensual definitions and MAE situations can be used in future epidemiology studies investigating MAEs in hospitalised patient settings which may permit and promote direct comparisons of different studies.
Effects of daily supplementation with high dose ascorbic acid on lead levels in broiler chicken after intentional exposure to a concentrated source of lead
(2013-05-30) Suheir Shehadeh; Tamara Idkeidek; Sawsan Abu-Rwess; Dr. Ramzi Shawahna
The present study was conducted to determine the amount of lead deposited in chicken blood, eggs and tissues after exposure to a concentrated source of lead for 1 week and to determine the effect of 4 week daily supplementation with high dose ascorbic acid on the levels of lead in blood, eggs and tissues. Ten clinically normal mixed-breed adult laying chickens were used. Chickens received lead acetate (200 mg/kg/day) for 1 week. A group of chicken received ascorbic acid (500 mg/kg/day) for 4 weeks and another group did not receive any treatment. Blood, eggs and tissues were collected and analyzed for lead contents using a graphite furnace atomic absorption spectrophotometer. The baseline blood lead level was 47.5 ± 38.0 µg/L and increased significantly to 2755 ± 576 µg/L after 1 week of lead acetate treatment (P < 0.001). Ascorbic acid treatment reduced blood lead levels significantly (P < 0.05). Similarly, ascorbic acid reduced lead levels in ovaries, liver, eggshell, albumen, and yolk by 3, 2, 2.8, 6.8, and 2.2-fold, respectively. Ascorbic acid reduced concurrent elevated lead levels in chicken tissues and eggs. Supplementing feed with daily high doses of lead might protect from lead exposure when chickens are exposed to environmental lead pollution.
Knowledge and Satisfaction toward Oral Contraceptive and Intrauterine Device Use among Women in Nablus-Palestine
(2014-05-20) Jameelah Qassem; Lara Ghanem; Saja Othman; Ahmad Mdallal; Heba AL-Masri; Heba AL-Masri
Introduction:Societies in both the developing and developed world suffer from unacceptably high rates of unintended and unwanted pregnancies, despite the availability of safe and effective forms of contraception Objectives of the study:The main objective of our study was to estimate knowledge and satisfaction toward oral contraceptive (OCP) or intrauterine device (IUD) use among women in Nablus-Palestine. Methods:A cross- sectional questionnaire based study design that was conducted at the Governmental Primary Clinics that deal with maternity and child care, Rafedia Governmental Hospital, and the Palestinian Family Planning and Protection Association at Nablus – Palestine. Data collection was achieved by face-to-face interviews during the period of study between August 2014 and January 2015. The data collection form involves: socio-demographic characteristics, medication and reason for choosing, knowledge about contraceptive, satisfactionandside effects. Results:A total of 287 women were included. 182 of them use IUD and 105 use OCP. Out of 105 women used OCP 64 (61%) of them use OCP because it is easy to use, compared with women using IUD, 115 out 182 women (63.2%) using this way because its efficacy in preventing pregnancy. Regarding the knowledge about OCP use, 69% knew what to do if they forget to take their pill. However, low percentage of OCP users knew what to do in case of vomiting or diarrhea. For women using IUD, 88.5% knew that IUD is safe and effective. While low level of knowledge was observed regarding the expected failure rate of IUD (22.5%), the proper time for replacing IUD (8.6% for Copper and 2.6% for hormonal IUD), and how quickly fertility return (34.6%). Regarding the overall satisfaction rating of both IUD and OCP, the majority of IUD users 121 (66.5%) reported good overall satisfaction rate. In addition, the majority of OCP users 72 (86.6%) reported good overall satisfaction rate. Regarding to the side effect of (OCP), most women suffer from gaining weight (46.7%), regarding to IUD the most common side effect is heavy period 54.9%. Conclusion:women have low to moderate level of necessary knowledge about the use of either OCP or IUD. However, good level of overall satisfaction was reported by the study participants. On the other hand, weigh gain, nervousness and leg pain were the most complaints from women using OCP; while heavy period, leg pain and headache were the most complaints from women using IUD.
Respiratory Occupational Health Effects of Automobile Painting Profession: A study from Palestine
(2014-05-20) Yara Hamadallah; Ohoud Taqatqah; Isra’a Shadeed; Dr. Belal Rahhal
Background : Workers in automobile painting workshops in West Bank (Tulkarm and Nablus cities) were reported to develop respiratory problems mainly due to exposure to chemicals found in paint products. However, to date, no studies have been published about the occupational effects of this profession on respiratory health in Palestine. This study aims to determine the respiratory occupational health effects of automobile painting profession. Methods: A case-control study consisted was conducted. Forced spirometry was used to measure the forced expiratory volume in 1 second(FEV1)and forced vital capacity (FVC), the FEV1/FVC ratios and prevalence of restrictive lung disease of the two groups were investigated and compared. Results: Twenty two cases and 45 control groups were studied. The case and control groups have similar demographic characteristics. According to the type of lung status, 81.82% of the workers showed lung diseases, 68.18% were restrictive lung disease, 13.64% were obstructive lung disease and 18.18% workers were normal. In comparison, 57.8 % of non-workers were normal and 42.2 % showed lung diseases, 40% were restrictive lung diseases and 2.2% were obstructive lung disease. There were 18 (26.87%) subjects who had decreased FEV1 values. Among the 22 cases, 14 (63.6%) had decreased of FEV1 value, while (8.9% ) in control group had decreased FEV1 values (P-value of 0.001). On the other hand, (44.77%) had decreased FVC values (53.73%) had normal FVC values and (1.5%) had increased FVC values. Between 22 (cases ) workers , 15 workers (68.2%) had decreased FVC values , 7 worker s( 31.8%) had normal FVC values and 0% had increased FVC values. In comparison with workers group only 15 of the non workers group (33.3%) had decreased FVC values and (2%) had increased FVC values, 29 workers (64.4%) had non- decreased FVC values and 1 worker (2.2%) had an increased FVC values. The results show that the decrease in FVC values among workers in Automobile painting workshops in comparison with the non workers was almost significant with a P-value of 0.007. If the entire ratio population is taken together, 3% had a decreased ratio, 71.64 % had normal ratio and 25.3% with increased ratio. Among 22 cases (workers), 9% of them had decreased ratio 63.6% had normal ratio and 27.3% with increased ratio .In comparison with controls, no one of the control group had decreased ratio but 75.5% had normal ratio and 24.2% had increased ratio. The results that the association between working in Automobile painting workshops FEV1/FVC ratio is not significant with a P-value of 0.1 Conclusion: In this study, we concluded that working in automobile painting workshops and exposure to chemicals mainly Hydrocarbons and Volatile Organic Compounds (VOCs) , toxicants and irritants leads to respiratory problems (Obstructive and Restrictive diseases) .
Pharmaceutical quality of generic Atorvastatin products compared with the innovator product: A need for revising pricing policy in Palestine
(2014-05-30) A Hroub; E Abed; S Jibali; R Al-Saghir; Prof. Abed Naser Zaid
Atorvastatin reduces morbidity and mortality due to cardiovascular events. This study was conducted to assess the prices and pharmaceutical quality of innovator atorvastatin 20 mg with its locally available generics in Palestine and to assess the suitability of their interchangeability. The prices of innovator and generic atorvastatin 20 mg were determined and compared. Innovator atorvastatin and four generic products were tested for their pharmaceutical quality. Tablets were tested for their drug contents, weight uniformity, hardness, disintegration and dissolution. Three out of four generics were less expensive than the innovator. Pharmaceutical quality assessments were satisfactory and within limits for all atorvastatin tested products. The average weight ranged from 206.6 ± 8.40 to 330 ± 3.92 mg and the %RSDs were within the permitted limits as per USP. Tablet hardness ranged from 102 ± 1.41 to 197.4 ± 6.88 kg and drug contents ranged from 92.2% to 105.3%. All products disintegrated within permitted time limits and showed very rapid dissolution. Products released more than 85% of their drug contents in less than 15 min. Our results showed that all tested innovator and generic atorvastatin products were of good pharmaceutical quality. Despite the lack of in vivo evaluation, our results indicate that these products are equivalent in vitro. Considering the in vitro release characteristics, these products might be used interchangeably. However, regulatory authorities permit the use of in vitro data in establishing similarity between immediate release oral dosage forms containing biopharmaceutical classification system class I and III drugs only.
Medication dispensing errors in Palestinian community pharmacy practice: a formal consensus using the Delphi technique
(2014-05-30) Aseel Haddad; Baraa Khawaja; Rand Raie; Sireen Zaneen; Tasneem Edais; Dr. Ramzi Shawahna
Background :Medication dispensing errors (MDEs) are frequent in community pharmacy practice. A definition of MDEs and scenarios representing MDE situations in Palestinian community pharmacy practice were not previously approached using formal consensus techniques. Objective: This study was conducted to achieve consensus on a definition of MDEs and a wide range of scenarios that should or should not be considered as MDEs in Palestinian community pharmacy practice by a panel of community pharmacists. Setting Community pharmacy practice in Palestine. Method : This was a descriptive study using the Delphi technique. A panel of fifty community pharmacists was recruited from different geographical locations of the West Bank of Palestine. A three round Delphi technique was followed to achieve consensus on a proposed definition of MDEs and 83 different scenarios representing potential MDEs using a nine-point scale. Main outcome : measure Agreement or disagreement of a panel of community pharmacists on a proposed definition of MDEs and a series of scenarios representing potential MDEs. Results In the first Delphi round, views of key contact community pharmacists on MDEs were explored and situations representing potential MDEs were collected. In the second Delphi round, consensus was achieved to accept the proposed definition and to include 49 (59%) of the 83 proposed scenarios as MDEs. In the third Delphi round, consensus was achieved to include further 13 (15.7%) scenarios as MDEs, exclude 9 (10.8%) scenarios and the rest of 12 (14.5%) scenarios were considered equivocal based on the opinions of the panelists. Conclusion : Consensus on a definition of MDEs and scenarios representing MDE situations in Palestinian community pharmacy practice was achieved using a formal consensus technique. The use of consensual definitions and scenarios representing MDE situations in community pharmacy practice might minimize methodological variations and their significant effects on the number and rate of MDEs reported in different studies.

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