Asian Pac J Trop Dis 2014; 4(Suppl 1): S347-S352 Contents lists available at ScienceDirect Asian Pacific Journal of Tropical Disease journal homepage: www.elsevier.com/locate/apjtd Document heading doi: 10.1016/S2222-1808(14)60469-2 襃 2014 by the Asian Pacific Journal of Tropical Disease. All rights reserved.
Therapeutic adherence: A prospective drug utilization study of oral hypoglycemic in patients with type 2 diabetes mellitusGulam Haidar Khan1, Mohd Aqil2, Krishna Kolappa Pillai2, Md Afroz Ahmad2, Prem Kapur3, Md Ruhal Ain4, Saeed Saeed Al-Ghamdi5, Naiyer Shahzad5*1Safety Processing Expert, Drug Safety & Epidemiology, Novartis Healthcare Pvt. Ltd. Hyderabad, India2Faculty of Pharmacy, Hamdard University, Hamdard Nagar, New Delhi, India3Majeedia Hospital, Jamia Hamdard, New Delhi, India4Department of Pharmacceutical Sciences, NIMS Institute of Pharmacy, Jaipur, Rajsthan, India5Department of Pharmacology and Toxicology, Faculty Medicine, Umm Al Qura University, Makkah-21955, Kingdom of Saudi Arabia PEER REVIEW ABSTRACT Objective: To determine the drug utilization pat erns and outcomes of treatment in terms of Dr. Sohail Akhter, Assistant Professor, metabolic control in the type 2 diabetic patients on oral hypoglycemic agents in the outpatient Utrecht Institute for Pharmaceutical department in the teaching hospital of Hamdard University, New Delhi, India. Sciences (UIPS), Utrecht University, Methods: Patients with established type 2 diabetes (n=184) visiting the outpatient department The Netherlands.
were interviewed using a structured questionnaire over a period of five months. Tel: +31-649517651 Results: Majority of the type 2 diabetic patients in this set ing were treated with a multiple oral hypoglycemic agents. The most commonly prescribed oral hypoglycemic agent was biguanides (metformin) fol owed by sulfonylureas (glimepiride), thiazolidinediones (pioglitazone), alpha- glucosidase inhibitors (miglitol) and dipeptidyl peptidase-4 inhibitors (vildagliptin). As This is a qualitative study carried out monotherapy metformin was the most common choice fol owed by glimepiride and voglibose, to analyze the drug utilization pat ern the most prevalent multiple therapy was a three-drug combination of glimepiride + metformin + in Indian medical system to diagnose pioglitazone. The study showed poor compliance to the prescribed therapy. the patient adherence to prescribed Conclusions: This study prospected the need of patient education and counsel ed to enhance therapy. The authors prospected the the patient compliance for prescribed oral hypoglycemic agents and concomitant drugs. There basic causes of non compliance, is need for diet control as well as blood glucose and HbA1c monitoring. Metabolic control negligence of medication. was found to be poor in the study population. HbA1c monitoring was underutilized. Clinical Details on Page S351 monitoring of patient's adherence to the prescribed treatment to achieve good glycemic control is recommended. Measures should be taken to improve patient's adherence to the prescribed KEYWORDSDrug utilization, Oral hypoglycemic agents, Adherence, Diabetes mel itus resulting from defects in insulin secretion, insulin action, or both with characteristic symptoms of blurring of vision, thirst, Diabetes mellitus is a metabolic disorder of multiple polyuria and weight loss[1]. Several pathogenic processes are etiologies; characterized by chronic hyperglycemia with involved in the development of diabetes include the processes disturbances of carbohydrate, fat and protein metabolism which destroy the beta cel s of the pancreas with consequent *Corresponding author: Dr. Naiyer Shahzad, Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al Qura University, Makkah 21955, Kingdom of Received 25 Nov 2013 Saudi Arabia.
Received in revised form 1 Dec, 2nd revised form 7 Dec, 3rd revised form 12 Dec 2013 Tel: +966506275989, +919990251291 Accepted 20 Dec 2013 E-mail: shahzad.naiyer@gmail.com Available online 28 Jan 2014 Gulam Haidar Khan et al./Asian Pac J Trop Dis 2014; 4(Suppl 1): S347-S352 S348insulin deficiency, and others that result in resistance to insulin individuals. This study included type II (non-insulin- action. The chronic hyperglycemia of diabetes is associated dependent) diabetes between the ages of 36 and 65 years. with long-term damage, dysfunction and failure of various Al subjects were recruited from clinics. Al patients with organs, especial y the eyes, kidneys, nerves, heart and blood established type 2 diabetes and those who were on oral vessels. A continuous medical care is essential to prevent hypoglycemic agents at ending the hospital were included in acute complications and to reduce the risk of long-term the study during the time period of January 2010 to May 2010. complications by patient's self-management and education[1]. Information on age, gender, weight, height, body mass index The number of cases of diabetes worldwide in 2000 among adults (BMI), waist to hip ratio (WHR), blood sugar levels, HbA1c levels, ≥20 years of age is estimated to be 171 mil ion and is projected drugs prescribed and recommendations on diet and exercise to rise to 366 mil ion in 2030. Based on sampling of studies were extracted from clinical records.
from dif erent parts of the world, the WHO has projected that the maximum increase in diabetes would occur in India[2]. In 2.3. Procedure recent years, India has witnessed a rapidly exploding epidemic of diabetes[3,4]. Indeed, India today leads the world with largest Patients were interviewed after informed consent obtained. number of diabetic subjects in any given country[4,5]. In 2000, Interviews were conducted using structured questionnaire WHO estimated that 31.7 mil ion individuals were af ected by (open question method) by direct conversation. In the patient diabetes in India and these numbers were expected to increase interviews, respondents were asked to either not fol ow the to 79.4 mil ion by the year 2030[2]. Indians have a low risk instructions at al or only fol ow them partly (noncompliance).
threshold for diabetes because of many reasons[6].
Drug utilization review is a structured process used to assess 2.4. Measures the quality of drug therapy by engaging in the evaluation of data on drug prescribing, dispensing and/or patient use in a given The morisky medication adherence scale was original y health care environment against predetermined, agreed upon developed to assess compliance to medication in patients with criteria and standards[7]. Drug utilization studies are powerful hypertension and has also been used to measure adherence to exploratory tools to ascertain the role of drugs in society. They antiretroviral therapy in patients who were HIV positive[10,11]. create a sound socio-medical and health economic basis for This simple 4-question survey assessed the likelihood that health care decision-making[3]. When drug therapy is indicated, patients took their drug therapy as prescribed.
metabolic control depends on adherence to both non- Morisky score was used to determine compliance by totaling pharmacological and pharmacological treatment. Tight blood the number of ‘NO' answers to the 4 questions of non- glucose control has been correlated with a reduction in diabetic adherence: whether they forget to take their medicine, are complications. Adherence to prescribed treatment is crucial they careless to take medicine at times, when they feel bet er, to achieve this control. In the United Kingdom Prospective whether they sometimes skip the dosing and when they feel Diabetes Studies (UKPDS), patient's adherence to prescribed worse, whether they take or stop the medication[12].
medications was 40-60%[8]. Drug utilization studies identify A higher score on the scale of 0-4 indicated bet er adherence treatment adherence problems or reasons of non-adherence to treatment (Yes=0; No=1). This technique is simple and i.e., whether inadequate control is due to missing doses or straightforward and could be easily incorporated into patient inadequate prescription. Thus, drug utilization studies design care processes.
interventions to improve drug use. Drug utilization studies provide physicians with feedback on their performance[9]. They also assist to design educational programs that may improve 3. Results prescribing and drug use.
The decision is made to carry out the study with the objective 3.1. Study sample characteristics to determine the drug utilization pat erns and outcomes of treatment in terms of metabolic control in the type 2 diabetic Total 184 patients with type 2 diabetes visited hospital out of patients on oral hypoglycemic agents in the outpatient which 81 (44.03%) were males and 103 (55.97%) were females. The department of Majeedia Hospital, Jamia Hamdard, New Delhi, mean age of the patients included in the study was (51.4依12.2) years. The mean BMI of the study population was (25.2依4.2) kg/ m2, as high as 71.2% male (40.02% female) of the study population (BMI>23 kg/m2). The mean WHR of the female population was 2. Materials and methods found to be 0.87依0.035 (higher than the acceptable limits of 0.85) and 0.89依0.031 in male population. About 58.7% (68.9% females) 2.1. Study centre of the total diabetic patients had WHR more than the normal limits. Mean waist circumference of the female subjects was The study was carried out in the outpatient department of (83.46依8.5) cm (higher than the normal, 80 cm) and (85.13依7.39) Majeedia Hospital, Hamdard University, New Delhi, India. It cm in male subjects; close to 43.5% (59.2% females) of the total was a prospective study of drug utilization pat erns in diabetic patients had waist circumference higher than the acceptable limits. A total of 27.2% patients had a positive family history of diabetes, 50.5% of the type 2 diabetic patients were having a 2.2. Participants history of diabetes since 2-5 years fol owed by 14.1% since 5-10 The subject sample for this study consisted of 84 diabetic years where 79.9% of the total type 2 diabetic patients were non- Gulam Haidar Khan et al./Asian Pac J Trop Dis 2014; 4(Suppl 1): S347-S352 condition of the study population was hypertension (46.7%) fol owed by dyslipidemia (13.1%). 3.2. Drug utilization patterns of oral hypoglycemic Table 2Oral hypoglycemic monotherapy.
No. of patients receiving % of patients receiving Utilization pat erns of oral hypoglycemic agents.
prescriptions Percentage Oral hypoglycemic agents multiple therapy.
Combination therapy a-Glucosidase inhibitors Glimepiride + Pioglitazone Glipizide + Pioglitazone Metformin + Pioglitazone Metformin + Rosiglitazone Metformin + Vildagliptin Metformin + Sitagliptin The average number of oral hypoglycemic agents per 3-drug therapy Glimepiride + Metformin + Pioglitazone prescription was found to be 2.25. The data col ected during + Metformin + Miglitol this study showed that the most commonly prescribed oral Gliclazide + metformin + Miglitol hypoglycemic drug is metformin + Pioglitazone + Miglitol (34.5%), followed by the Gliclazide + Metformin + Pioglitazone class sulfonylureas (28.9%), thiazolidinediones (20.3%), alpha- Gliclazide + Pioglitazone + Acarbose glucosidase inhibitors (10.14%) and DiPeptidyl Peptidase-4 (DPP4) Metformin + Rosiglitazone + Acarbose (6.03%). Among sulfonylureas, glimepiride 109 (26.3%) was the most commonly prescribed drug fol owed by gliclazide 9 (2.2%) 4-drug therapy Glimepiride+Metformin+Pioglitazone+Miglitol 15 and glipizide 2 (0.5%) (Table 1). Among the thiazolidinediones, pioglitazone 79 (19.1%) was most commonly prescribed fol owed by rosiglitazone 5 (1.2 %). Among the a-glucosidase inhibitors, (6.2%) was the most commonly prescribed drug fol owed by voglibose and acarbose 8 (1.6%) respectively. Among The data for fasting blood glucose (FBG) levels was available DPP4 inhibitors vildagliptin 19 (4.59%) was most commonly for 132 patients during the study period. The mean FBG of the type prescribed drug fol owed by sitagliptin 6 (1.44%). Majority of 2 diabetic patients was (161.8依75.7) mg%. Postprandial (PP) blood the type 2 diabetic patients in this set ing were treated with a glucose levels data was available for only 90 patients during the multiple oral hypoglycemic therapy (71.7%) when compared to study period. The mean PP blood glucose was found to be (239.0 the single drug therapy (28.3%). Two-drug therapy was most 依109.1) mg%. The data for glycated hemoglobin was available prevalent (30.4%) fol owed by three-drug therapy (29.3%) and for only 14 diabetic patients out of which 10 patients had HbA1c 4-drug therapy (12%). As monotherapy metformin was the most within the currently accepted range (i.e., <7.0%). In the present common choice fol owed by glimipiride (Table 2). Metformin study, only 48.4% patients have shown good adherence with the was prescribed in 10.9% of the total type 2 diabetic patients. prescribed therapy (Table 4).
The most common two-drug therapy was a combination of Table 4 glimepiride + metformin (13.04%) fol owed by vildagliptin + Responses for the morisky medication adherence scale.
metformin (6.50%). The most prevalent three-drug therapy was Morisky score Male Female No. of patients + metformin + pioglitazone (23.9%) and glimepiride + metformin +pioglitazone +miglitol (8.2%) was the most common four-drug combination prescribed (Table 3). In this study, 2.7% of patients showed an increase in dose within the study period. 3 Dose reduction in the patient therapy was found to be 1.6% of 4 (high adherence) the study subjects. In 14.1% of the patients, addition of another oral hypoglycemic therapy was initiated. It was found that 2.7% of patients switched to dif erent agents within the study 4. Discussion period. Concomitant disease in addition to diabetes was found in 67.9% of the patients. The most frequent concomitant chronic The mean age of the patients (51 years) was less than that Gulam Haidar Khan et al./Asian Pac J Trop Dis 2014; 4(Suppl 1): S347-S352 S350reported in a study carried out in Spain (68 years)[13], and India pancreatic β-cel s would have started failing. In lean and (53 years)[14], and was more prevalent in the age group of 51-70 thin type 2 diabetic patients where pancreatic β-cel failure years indicating that type 2 diabetes is more prevalent in the predominates, the choice of glimepiride is more justified. middle-aged and elderly population. Glimepiride is more potent and yet behaves more like glipizide Females predominated in the study population, which was than glyburide, with good postprandial insulin response and a similar to that reported in other studies in India[15] and Spain[13] lower incidence of hypoglycemia than other sulfonylureas[29]. but dif erent from a study carried out in the United States[16], Decreased protein binding property of glimepride in patients where the majority of the cohort was male.
with renal insuf iciency results in unchanged elimination, In this study, the mean BMI of the study population was (25.4 makes it a safer option for patients with renal impairment[30]. 依4.5) kg/m2, higher than the acceptable limits but less than Higher prescription rates of glimepiride also reflect the that reported (30 kg/m2) in Spanish study[13], and 71.20% (40.02% aggressive marketing of a new molecule in Indian market. The female) of the study population had a BMI >23 kg/m2. A lower reason for lesser prescribing rates of other sulfonylureas is their cut-of value of BMI (<23 kg/m2) in Indian population when adverse ef ect profile.
compared to western population was reported earlier in Indian Among the thiazolidinediones, pioglitazone was most studies[17,18]. The strong association between the BMI and commonly prescribed followed by rosiglitazone. A lower diabetes indicated that even minor changes in BMI had adverse prescribing rate of a-glucosidase inhibitors was noted in this ef ects in this population.
study probably due to high cost and lack of studies showing In several ethnic populations including the relatively non- long term benefits with these group of drugs. Among these, obese South Indian population, the android pat ern of body miglitol was the preferred choice because of its decreased fat, typified[19] by more upper body adiposity measured[20] as gastrointestinal side ef ects.
WHR was found to be a greater risk factor for type 2 diabetes Most patients with type 2 diabetes require a combination than general obesity. Central obesity is common in Indians therapy to reach an acceptable level of glycemic control. despite low rate of obesity[18]. Indians with low BMI have WHR Moreover, because type 2 diabetes mel itus is a progressive comparable to the Mexican Americans, who are obese[21]. disease, even patients with a good initial response to oral There had been an increase in the waist circumference and the agents eventual y require a second (or third) medication[31]. As WHR only increased in women over the years. WHR is strongly monotherapy, metformin was the most common choice fol owed associated with insulin resistance and diabetes and this might by glimepiride. Metformin has been recommended as the first explain the female predominance in the prevalence of diabetes line treatment in obese patients with type 2 diabetes mel itus in this population[19,22]. A total of 27.2% patients had a positive and the combined use of a sulfonylurea with metformin is often family history of diabetes. Majority of these are females and this synergistic because of insulinogenic ef ect of the former[32] goes with the fact that type 2 diabetes does not run in families. and the beneficial ef ects of the lat er on insulin resistance[33]. The average number of antidiabetic drugs per prescription Both of these factors are important in the pathogenesis of was found to be 2.25, which is higher than the previous records type 2 diabetes mel itus[1]. The high prescription rates of of 1.95[15] in India and less than 2.9[23], 2.27[7] that reported metformin alone and in combination with a sulfonylurea and/or in Hong Kong and India respectively. The data col ected thiazolidinedione correlate wel with the relatively high BMI in during this study showed that the most commonly prescribed our study population.
antidiabetic drug is metformin (34.5%), a biguanide, similar to Increase in the doses for the oral hypoglycemic agents was not that reported in earlier studies in Hong Kong[24] and England fairly common, with 2.7% of patients having an increase in dose studies and dif erent from that reported in previous Indian[7,15], within the study period. This was much less than that reported Hong Kong[23], Bahrain[25]and Spain[13] where glibenclamide by Bocuzzi et al., 25.2%[16]. This reflects that the fol ow-up by was reported to be the most commonly prescribed drug. The the patients is poor. It was found that only 1.6% of the study high metformin prescription rates reflect the post UKPDS phase subjects had a reduction in the initial dose of oral hypoglycemic in diabetes management where metformin was found to be agents within the study period which was also less than that superior to sulfonylureas[26]. Metformin is a peripheral sensitizer reported previously, 10.92%[16]. The fewer changes observed of insulin and has beneficial ef ects on insulin resistance, an in the dose and frequency of the treatment prescribed may be important factor in pathogenesis of type 2 diabetes. at ributed to the short duration of the study. Metformin is the therapy of choice for overweight and obese Addition of another oral hypoglycemic therapy was initiated patients with type 2 diabetes[27]. The ef ect of metformin is in 14.1% of the patients during the study period, less than that largely independent of body weight, age and duration of reported earlier, 14.7%[16]. It was found that 2.7% of patients diabetes. It can be equal y ef ective in normal weight patients. switched to dif erent agents within the study period, less As monotherapy is in patients who are not adequately control ed than that reported previously, 10%[16]. The changes in the oral on non-pharmacological therapy, optimal y titrated metformin hypoglycemic agent treatment were not fairly common during therapy typical y reduces fasting plasma glucose by 2-4 mmol/ the study period. L, corresponding to a decrease in HbA1c by approximately Concomitant disease in addition to diabetes, which was found 1-2%[28]. Metformin is unlikely to cause severe hypoglycemia to be proportionately less than that reported in a previous because it does not stimulate insulin release. Boccuzzi et study, 87%[13]. Concomitant disease in form hypertention and al., reported the distribution of oral hypoglycemic agents as dyslipidemia was found to be similar as reported in earlier 66.4% sulfonylureas, 24.3% metformin, 6.6% troglitazone, 1.5% studies[13,26]. Most commonly prescribed concomitant drugs repaglinide, and 1.1% alpha-glucosidase inhibitors[16].
in type 2 diabetic patients were in the order ACE inhibitors > By the time, diabetes is diagnosed in type 2 diabetic patients, multivitamins > statins > proton pump inhibitors > aspirin > Gulam Haidar Khan et al./Asian Pac J Trop Dis 2014; 4(Suppl 1): S347-S352 diuretics > b-blockers > antibiotics > NSAIDs > CCBs. The large sample size is being explored.
use of multivitamins and proton pump inhibitors was found to be higher. Only 42.4% patients were having the FBG levels within the acceptable limits. The mean FBG of the type 2 Conflict of interest statement diabetic patients was (162.8依76.7) mg%, higher than the acceptable limits (i.e., <130 mg%). This figure was however We declare that we have no potential conflict of interest.
less than that reported earlier in Spain, 166 mg%[13] and higher than that reported in Indian studies, 156 mg%[14].
The mean PP blood glucose was found to be (240.0依110.1) Acknowledgements mg% which is higher than that reported earlier in India, 226 mg%[14]. Only 33.9% of these patients had their PP blood Author(s) are thankful to al the patients and physicians glucose levels under control. The higher values of the blood of Majeedia Hospital who participated in the study. The sugar levels reflect the poor compliance of the patients with author(s) received no financial support. Study protocol was the therapy and with the prescribed blood sugar testing, approved by the Jamia Hamdard Institutional Review Board poor physical activity and a poor awareness about the cut- (JHIRB) vide Approval Let er No. 02/10 dated 29 January 2010.
The data for glycated hemoglobin was available for only 14 diabetic patients, out of which 10 patients had HbA1c Comments within the currently accepted range, <7.0%[1]. Despite that HbA1c reflects the patient's metabolic control of Background preceding three months and patient adherence, the HbA1c India is a vast country and diabetes is epedemic leading monitoring in type 2 diabetic patients is underutilized in the world giving big burden over health care system. WHO this hospital set ing. This may be at ributed to a high cost estimated 31.7 mil ion individuals were af ected by diabetes of this test, low awareness and lack of patient education. in 2000 and expected to rise to 79.4 mil ions by the year 2030. Patient adherence was calculated based on the scores of morisky medication adherence scale[34]. Morisky scale is a Research frontiers robust and useful tool for assessing patient's adherence to Poor education and economy in Indians are major medication therapy. Morisky score is associated with HbA1c contraventions of patient compliance and negligence to values; the bet er the adherence to the medical regimen, the prescribed medication. Use of interventions to improve lower the patient's HbA1c values. Only 48.3% of the study adherence are rare in routine clinical practice in light of population showed good adherence with the prescribed main theme of the article, so the authors have tackled one of therapy, which was found to be lesser than 85%[35], 67.2%[36] the neglected aspect medical system. and higher than 44%[37] reported earlier. Good adherence (morisky score 3-4) was associated with a 10% lower total Related reports HbA1c value[34]. Metabolic control was found to be poor in This study is at variance with the study done by Bocuzzi this study population. More than half of the type 2 diabetic et al. with respect to the increase in the doses for the oral patients showed higher fasting and PP blood glucose levels hypoglycemic agents, reduction in the initial dose of oral than recommended. HbA1c monitoring was underutilized. hypoglycemic agents, addition of another oral hypoglycemic Improved glycemic control is needed. More than half of agents and patients switched to dif erent agents. the type 2 diabetic patients showed poor adherence to the Innovations & breakthroughs The result shows that measures should be taken to The present study identifies treatment adherence problems improve patient's adherence to prescribed medication which or reasons of non-adherence i.e., whether inadequate can be improved by comprehensive patient management control is due to missing doses or inadequate prescription. which includes diet control, life-style modification, use Thus drug utilization studies design interventions to improve of hypoglycemic, care and prevention of cardiovascular drug use.
complications. It can be achieved by patient education and counseling for rational use of oral hypoglycemic and Applications concomitant drugs, routine examinations (blood glucose and It provides physicians with feedback on their performance. HbA1c levels), diet control as wel as diabetic complications. Drug utilization studies also assist to design educational Drug utilization studies should be carried out in a large programs that may improve prescribing and drug use population and at dif erent locations in India so that the minimizing prescription and medication error. utilization pat erns may be compared and improved further. The present study was conducted on a small sample Peer review size for four-month duration only which is too short for This is a qualitative study carried out to analyze the drug comprehensive assessment of drug utilization in diabetic utilization pattern in Indian medical system to diagnose patients. The proposition of long term exhaustive studies on the patient adherence to prescribed therapy. The authors Gulam Haidar Khan et al./Asian Pac J Trop Dis 2014; 4(Suppl 1): S347-S352 S352prospected the basic causes of non compliance, negligence Das AK, et al. High prevalence of diabetes and impaired glucose of medication.
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the year in science Two of the biggest breakthroughs of this leap year relied on breathtaking amounts of data. The ENCODE project has generated 15 terabytes of data over the past five years to uncover the functions of human DNA sequences; CERN has stored 26 petabytes of data this year alone from its Large Hadron Collider, as physicists worked to prove the existence

Microsoft word - edwards palliative care nurse practitioner formulary v6

Palliative Care Nurse Practitioner Sydney Adventist Hospital DRUG FORMULARY for JULIE EDWARDS Palliative Care Nurse Practitioner Julie Edwards Palliative Care Nurse Practitioner Drug Formulary SAH Page 1 of 27 C: Documents and Settings ledwa Desktop EDWARDS Palliative Care Nurse Practitioner formulary v6 1.doc The formulary provides for the poisons and restricted substances that may be possessed, used, supplied or prescribed by JULIE EDWARDS as a Nurse Practitioner under Section 17A of the Poisons and Therapeutic Goods Act 1966 (1) and the Poisons and Therapeutics Goods Regulation 2008 (2) It is the Nurse Practitioners responsibility to use this formulary in conjunction with the most recent MIMS/MIMS Online (3), Australian Medicines Handbook (4) and Therapeutic Guidelines: Palliative Care (5). Any alteration must be submitted to the Chief Nursing and Midwifery Officer (CNMO) NSW for approval. This document is invalid if any alterations or amendments are made without the approval from the CNMO NSW. Introduction: The Palliative Care Nurse Practitioner (PCNP):