Vol 1 No 1/2 (2015)
Articles
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For the treatment of pain, opioids are the main analgesic approaches. Opioid therapy involves the use of either weak or strong opiates, and both are often prescribed in conjunction to adequately control acute pain. Strong opiates often have additional routes beyond oral administration. Poor understanding of opioids and concerns about governmental retaliation for prescribing opioids can lead to treatment failure. Desired goal in handling of patients with chronic pain is achieving and sustaining an acceptable quality-of-life. In this narrative review, we discuss classifying and clinical use of opioids.
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Background: Recent advances in the intravascular diseases have led to the entrance of drug-eluting balloon (DEB) technology. The DEB is a relatively new and easier way to treat vascular stenosis. In this study as part of rapid health technology assessment, we aimed to assess this technology in comparison with drug-eluting stent (DES), uncoated balloon and bare-metal stent in terms of efficacy and safety in common indications by reviewing available clinical evidences.Methods: In order to evaluate the safety and effectiveness of DEB, a non-systematic review on electronic databases including Cochrane, PubMed, INAHTA, CRD, Scopus, Medline, Trip database, and Google Scholar was conducted by keywords: “balloon angioplasty," “drug eluting balloon," “drug eluting stent."Results: DEBs could be suggested as a more effective and safe intervention compared with uncoated balloon angioplasty in patients with in-stent restenosis and peripheral vascular disease however there were not adequate evidences supporting the superiority of DEB compared with DES. There were not also adequate evidences comparing DEB with uncoated balloons or DES for decision making about de novo lesion and small vessel arteries.Conclusion: Conducting an economic evaluation to assess the cost effectiveness of this technology has to be also taken into account for more adequate decision making.
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Background: Elderly are prone to many acute and chronic age-related diseases, which needed multiple medicine usage. Therefore, evaluation of medicine use pattern in this group is very important and a significant issue in public health system policy.Methods: This study was a cross-sectional household survey conducted in 20 clusters of Tehran. Each cluster consists of 40 households who had at least one person over the 60 years old. Different medicine items used by the individuals over 60 years old were asked and recorded by the interviewers.Results: A total of 1054 men and women over 60 years old were enrolled to the study. About 49.4% were male and 50.6% were female. About 69% of the study population used at least one medicine per day regularly, and 46.2% used to consume medicines as self-medication. Mean items per prescription were 3.57 for patients who used medicines regularly every day. The most frequent medicines used in this group were cardiovascular (68.6%) and central nervous system medicines (61.7%). Aspirin 80 mg, atenolol, and calcium-D were the most frequent medicines used regularly, but not daily. Acetaminophen 325 mg and acetaminophen codeine were the most frequent self-medications.Conclusion: Since elderly people may have multiple comorbidities, which require poly-pharmacy use. Also, due to the high prevalence of drug use without prescription among this group of people, which was about 46% in our study, it is crucial that physicians and other health care providers consider the risk of adverse drug reactions and drug interactions in each visit of the patient.
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Introduction: Critical role of quality assurance (QA) system in the pharmaceutical industry could affect on product quality, market development, customer satisfaction, and other element of a successful drug company.Purpose of the Study: The main aim of this study is to evaluate of QA system, the relevant factors to the good manufacturing practice principles and detection of gap between knowledge and implementation of QA indices by their managers in pharmaceutical companies of Iran.Method: This study contains designing a validated questionnaire with the expert panel and completing it in the pilot and final phases.Results: This study have shown that there is a gap between knowledge of QA seniors and their practice in all categories of QA indices. Furthermore, it has been shown that measurement category has maximum gap. Moreover, machinery has minimum gap between all categories.Conclusion: The status of QA managers’ knowledge is appropriate, but implementation of QA indices in Iranian pharmaceutical industry is not appropriate.
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Introduction: Postoperative pain is considered frequently as one of the major problems in subjects after cesarean delivery. Meanwhile, the main analgesic drugs are opioids and non-steroidal anti-inflammatory drugs, side-effects such as nausea, vomiting, and sedation have been reported by opioids. Economic evaluation of analgesics is an important criterion in clinical practice and efficiency of the health system services. The aim of this study was to compare the efficacy and cost analysis of diclofenac versus tramadol for post-cesarean pain in postpartum women.Patients and Methods: This study has been undertaken based on a randomized clinical trial that has evaluated postoperative pain in a double-blinded, randomized, single-dose comparison of tramadol intramuscular injection, 100 mg (group T) and diclofenac suppository, 100 mg (group D) given alone-single dose in 200 patients who had elective cesarean delivery. All patients were assessed at 0, 6, 12, and 24 h post-operation for pain degree (by Visual Analog Score: 1-10), nausea and vomiting incidence. Our outcomes assessment was based on the reduction in pain degree. For cost estimating of therapeutic schemes, we computed the direct costs of the analgesics (unitary cost) and disposable materials such as needles, syringes, and alcoholic pads (Padcols®). Average cost-effectiveness ratio (ACER) calculated for comparison.Results and Discussion: The efficacy of tramadol and diclofenac were not different significantly (P = 0.06). Nausea and vomiting were minimal with all treatments. Total costs in T group were 43.35 USA Dollar (USD) and in D group were 12.1 USD. ACER for tramadol was 9.14 USD and 2.85 USD for diclofenac per one degree reduction in pain. Thus, ACER indicated that the cost of tramadol in this study was 3.21 times more than diclofenac resulted with the same effectiveness.Conclusions: It has been concluded that diclofenac is a more cost-effective choice of treatment in comparison with tramadol for post-cesarean pain management.
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Alzheimer's disease (AD) is a neurologic disorder that has affected more than 36 million patients all over the world and is expected to rise up to 100 million till 2050. AD cost has been calculated more than 600 million dollars worldwide during 2010. There are approximately 400000 AD cases in Iran. Indeed AD is a neuroendocrine disorder and named Type 3 diabetes mellitus (T3DM) and its reason is some insufficiency in insulin and IGF signaling pathway, which consist of impairments in synthesis of insulin and Insulin-like growth factor (IGF) in the brain. T3DM has large overlap with Type 1 diabetes mellitus (T1DM) and particularly with Type 3 diabetes mellitus (T2DM) from the point of view in both biochemical abnormalities aspects as well as its effects on the brain. Recently some research are published which show cognitive improvement in patients of AD that were treated with intranasal insulin and other anti-diabetic medicines.
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Background: Productivity is a key factor in assessing the degree of appropriate use of input. The present study aimed at investigating the effective indices in improving productivity in the production environment of pharmaceutical companies.Materials and Methods: The research method has been descriptive-analytical and applied studies, data was collected through questionnaire from 20 pharmaceutical companies, which were randomly selected.Results: From, among the 506 investigated indices, 46 were found to be the most influential ones in improving production productivity. About 8.7% of these indices belonged to the category of general efficiency, 10.9% were grouped as the financial indices, 41.3% were recognized as production indices, 21.7% belonged to quality indices, and 8.0% included other indices.Conclusion: Based on analyzing the questionnaire data and identifying the effective indices in each category, productivity can be improved in the production environment of pharmaceutical factories through calculating the determined indices in each area and preparing the ground for their improvement.
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One of the main elements for fulfilling Good Manufacturing Practice (GMP) requirements is validation performance. Therefore, those pharmaceutical factories trying to synchronize cGMP compliance should fulfill validation requirements. With accepting Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co- operation Scheme (PIC/S) standards by Iran Food and Drug Administration (FDA), pharmaceutical factories are required to perform such a validation. Despite the gap existing between production conditions and PIC/S standards, pharmacy factories are extremely rushing for their quality improvement. In this study, 84 factories were checked for having validation master plan (VMP), in their company. Then, a complete checklist was provided by checking WHO, PIC/S, and FDA guidelines of all VMP requirements. Those pharmaceutical factories, which have VMP or are providing it, have put in three categories. The first group performed validation project on their own. The second group got help from an Iranian adviser, and the third group performed it with foreign adviser company assistance. The results of these three categories are quantified and compared with each other by one-way ANOVA test. About 60 factories of 84 answered the initial questionnaire. About 26 factories of the same number introduced themselves for having VMP, and seven factories were providing it. Comparing these three categories, the second and third groups with P < 0.05 do not differ from each other very much statistically. With respect to quality of their VMP, the first group with P > 0.05 is very different from the two other groups, while it has a lower average from them.
