Improving customer service through effective supply chain management in a pharmaceutical company

All organisations compete on the basis of service. In today‘s highly competitive world, organisations need to compete to retain their customers and to offer good customer service that will give them a competitive advantage. In the South African pharmaceutical market, the introduction of the Single Exit Price (SEP) and generic substitution have led to the price of equivalent medicines no longer being the differentiating factor in a customer deciding which manufacturer‘s product to purchase. The availability of generic medicines at the pharmacy or hospital has become the differentiating factor. Two types of customers exist in any organisation, namely, external customers and internal customers. Much has been written about the external customer, but less about the internal customer. Many managers do not perceive internal customer service as a priority. Any organisation attempting to deliver quality service to their external customers must begin by serving the needs of their internal customers. Internal service quality is characterised by the attitudes that people have towards one another and in the way that employees serve one another inside the organisation. By improving customer service, the organisation can improve its profitability, sustainability and customer retention. The aim of this study was to determine whether the levels of internal customer service between the three sections of Aspen Pharmacare are optimal. Determining the current performance levels between the staff of the sections will assist in highlighting the areas that require attention. The three sections of Aspen Pharmacare that are internal customers of one another and have been used in the study are: - production; - demand planning; and - distribution. The results of the study show that all three sections rate three service quality dimensions (communication, tangibles and reliability) as important. The results were used to develop an internal customer service model for Aspen Pharmacare

Typology of Knowledge and Skill Competencies Needed by Industrial Loss Control Managers

Occupational and Adult Educatio

Headache and Acute Illness in Children

Thirty-seven children with headaches who were seen in a walk-in clinic were matched to 37 headache-free controls. Thirty percent of the headache group and 11% of the headache-free control group had a body temperature above 38°C (p < 0.05). Nonrhythmic pain was more commonly associated with fever than was rhythmic pain (p < 0.05). Of 34 headache subjects who completed questionnaires, those with more intense headaches reported a greater number of headache-exacerbating factors (p < 0.01).Bilateral headaches were more painful than unilateral headaches, and in two thirds of the subjects, the intensity of pain paralleled the course of the underlying illness. A family history of migraine was more common in the headache group as compared to the headache-free control group (p < 0.05). Headaches associated with acute illnesses may be a precursor to later migraine. (J Child Neurol 1987;2:22-27)Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/68022/2/10.1177_088307388700200104.pd

Enhanced bioavailability and reduced pharmacokinetic variability of Oral PTH (1-34) in man

An orally administered PTH may have prodigious advantages in the treatment of hypoparathyroidism and osteoporosis. Unfortunately, the oral delivery of biologic macromolecules is characterized by a negligible bioavailability and a high dose-to-dose variability in absorption, resulting in difficulty in accurately titrating the drug effect. We present clinical study data of a novel oral peptide delivery technology demonstrating an enhanced bioavailability with reduced Cmax variability. Methods: A Phase I, open label crossover pharmacokinetic (PK) study to assess the safety and PK of oral PTH (1-34) in ten healthy male adult volunteers was conducted. The PK profile of a fixed dose - 1.5mg PTH (1-34) of three different oral formulations was compared. PTH (1-34) levels in the plasma of subjects was analyzed at a number of time points post administration, utilizing a PTH (1-34) immunoassay (IDS; Bolden, UK). In parallel, to assess the pharmacodynamic (PD) effect, serum calcium of subjects receiving the different formulations of oral PTH (1-34) was analyzed. Results: PK profiles of all oral PTH (1-34) formulations were characterized by a rapid absorption and elimination. The systemic exposure (AUC) of the basic oral formulation and two modified formulation versions were 3481 ±1843 pg*min/mL, 7976 ±2556 pg*min/mL and 11369 ±3719 pg*min/mL (mean ± SE). The maximal plasma concentration (Cmax) of these formulations were 145 ±56pg/mL, 375 ±108pg/mL, and 481 ±101pg/mL, respectively. Cmax coefficients of variation (CV%) of the same formulations were 123%, 91% and 67%, respectively. Similarly to the drug absorption, PD response of the modified formulations, presented as the maximal relative increase in albumin adjusted calcium, was improved from 0.07 ±0.29mg/dL to 0.32 ±0.24mg/dL. Discussion: Inherent to oral drug delivery of biopharmaceuticals is the extremely low bioavailability and high absorption variability. The current results indicate that Entera’s delivery technology can overcome these two principal obstacles by achieving repeatable, clinically relevant systemic drug exposure. Entera’s proprietary delivery platform was optimized and achieved anenhancement in drug bioavailability in parallel with the significant decrease in its absorption variability. Similarly, its effect on blood calcium was enhanced by the novel oral formulation of PTH (1-34) pointing out the potential of the drug to be a first line treatment of hypoparathyroidism and osteoporosis

The aicardi syndrome: Report of 4 cases and review of the literature

The findings in 4 cases of Aicardi syndrome (female infants with mental retardation, seizures, characteristic eye lesions, agenesis of the corpus callosum, vertebral anomalies, and abnormal but nondiagnostic electroencephalographic patterns) are compared to 39 previously reported cases. Available information suggests tha the syndrome results from an unknown intrauterine insult occurring no later than the first trimester. No familial cases have been reported, and the cause remains unknown.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/50294/1/410050513_ftp.pd

Published and not fully published double-blind, randomised, controlled trials with oral naratriptan in the treatment of migraine: a review based on the GSK Trial Register

Naratriptan 2.5 mg is now an over-the-counter drug in Germany. This should increase the interest in drug. The GSK Trial Register was searched for published and unpublished double-blind, randomised, controlled trials (RCTs) concerning the use of naratriptan in migraine. Only 7 of 17 RCTs are published in full. Naratriptan 2.5 mg is superior to placebo for acute migraine treatment in 6 RCTs, but inferior to sumatriptan 100 mg and rizatriptan 10 mg in one RCT each. This dose of naratriptan has no more adverse events than placebo. Naratriptan 1 mg b.i.d. has some effect in the short-term prophylactic treatment of menstruation-associated migraine in 3 RCTs. In 2 RCTs, naratriptan 2.5 mg was equivalent to naproxen sodium 375 mg for migraine-related quality of life. Naratriptan 2.5 mg (34% preference) was superior to naproxen sodium 500 mg (25% preference). Naratriptan 2.5 mg is better than placebo in the acute treatment of migraine. The adverse effect profile of naratriptan 2.5 mg is similar to that of placebo. The efficacy of naratriptan 2.5 mg versus NSAIDs is not sufficiently investigated. Naratriptan, when available OTC is a reasonable second or third choice on the step care ladder in the acute treatment of migraine

Safety and efficacy of oral human parathyroid hormone (1-34) in hypoparathyroidism: An open-label study

The standard treatment of primary hypoparathyroidism (hypoPT) with oral calcium supplementation and calcitriol (or an analog), intended to control hypocalcemia and hyperphosphatemia and avoid hypercalciuria, remains challenging for both patients and clinicians. In 2015, human parathyroid hormone (hPTH) (1-84) administered as a daily subcutaneous injection was approved as an adjunctive treatment in patients who cannot be well controlled on the standard treatments alone. This open-label study aimed to assess the safety and efficacy of an oral hPTH(1-34) formulation as an adjunct to standard treatment in adult subjects with hypoparathyroidism. Oral hPTH(1-34) tablets (0.75 mg human hPTH(1-34) acetate) were administered four times daily for 16 consecutive weeks, and changes in calcium supplementation and alfacalcidol use, albumin-adjusted serum calcium (ACa), serum phosphate, urinary calcium excretion, and quality of life throughout the study were monitored. Of the 19 enrolled subjects, 15 completed the trial per protocol. A median 42% reduction from baseline in exogenous calcium dose was recorded (p =.001), whereas median serum ACa levels remained above the lower target ACa levels for hypoPT patients (>7.5 mg/dL) throughout the study. Median serum phosphate levels rapidly decreased (23%, p =.0003) 2 hours after the first dose and were maintained within the normal range for the duration of the study. A notable, but not statistically significant, median decrease (21%, p =.07) in 24-hour urine calcium excretion was observed between the first and last treatment days. Only four possible drug-related, non-serious adverse events were reported over the 16-week study, all by the same patient. A small but statistically significant increase from baseline quality of life (5%, p =.03) was reported by the end of the treatment period. Oral hPTH(1-34) treatment was generally safe and well tolerated and allowed for a reduction in exogenous calcium supplementation, while maintaining normocalcemia in adult patients with hypoparathyroidism

Greater Response to Placebo in Children Than in Adults: A Systematic Review and Meta-Analysis in Drug-Resistant Partial Epilepsy

In a systematic review of antiepileptic drugs, Philippe Ryvlin and colleagues find that children with drug-resistant partial epilepsy enrolled in trials seem to have a greater response to placebo than adults enrolled in such trials

The development and assessment of biological treatments for children

The development of biological agents with specific immunological targets has revolutionized the treatment of a wide variety of paediatric diseases where traditional immunosuppressive agents have been partly ineffective or intolerable. The increasing requirement for pharmaceutical companies to undertake paediatric studies has provided impetus for studies of biologics in children. The assessment of biological agents in children to date has largely relied upon randomized controlled trials using a withdrawal design, rather than a parallel study design. This approach has been largely used due to ethical concerns, including use of placebo treatments in children with active chronic disease, and justified on the basis that treatments have usually already undergone robust assessment in related adult conditions. However, this study design limits the reliability of the data and can confuse the interpretation of safety results. Careful ongoing monitoring of safety and efficacy in real-world practice through national and international biologics registries and robust reporting systems is crucial. The most commonly used biological agents in children target tumour necrosis factor-α, interleukin-1, interleukin-6 and cytotoxic lymphocyte-associated antigen-4. These agents are most frequently used in paediatric rheumatic diseases. This review discusses the development and assessment of biologics within paediatric rheumatology with reference to the lessons learned from use in other subspecialties