Information in Package Inserts: A study in Eastern India
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Introduction: Package insert (PI) is the printed leaflet available with the medicines containing information about the drug based on regulatory guidelines for its safe and effective use. Information in a PI is incorporated since the developmental phase of a pharmaceutical product with careful scrutiny of available information. PI contains evidenced based information about a drug, updated from time to time as soon as relevant preclinical and clinical data were obtained. Various studies had shown poor compliance 50-60% to the medicine prescribed for the treatment of chronic conditions like hypertension, diabetes and dyslipidemia. These diseases proved to be major cause of mortality and morbidity related to cardiovascular diseases in India. The information of the PI has an important impact on patients compliance and hence effectiveness of the drug used and for health professionals they can serve as reliable and accurate sources of drug information. Material & Methods: Present study was observational and Prospective with study duration of 1 month. 93 package inserts were collected from different pharmacies of the Patna on request. Analysis of content of Package Insert was based on criteria laid down by Indian Drug and Cosmetic Rules, 1945 under section 6.2 of schedule D. Result: A total number of 106 PI were received, among which 93 PIs were analysed for the result remaining 13 PIs were discarded due to duplicity and unauthenticity. Out of them, 87 were from Indian pharmaceutical companies and 6 from multinational companies [Graph-2]. All PIs of antihypertensives and hypolipedemic were of oral preparations. Out of 93 PIs 37 were antihypertensives, 34 were antidiabetics and 22 hypolipidemics. Out of 34 anti-diabetic PIs, 22 (59.6%) were oral and 12 (40.4%) were injectable preparations. Out of 93 PIs, 40 (43%) belonged to Grade A (including all injectable preparations) and remaining 53 (57%) to Grade B. No PIs belongs to Grade C.87 PIs were from Indian companies and 6 PIs were from multinational companies. It was observed that more PIs from Indian companies belonged to Grade A. Conclusion : we are facing the pandemic of diseases like hypertension, diabetes mellitus and other diseases. In such situation PI can play a vital role in improving the patient compliance and thereby the prognosis of disease. Hence a smart PI which is complete, reliable and up-to-date is the need of the hour.Keywords:
Package insert
New drug application
Dyslipidemia
Background
PIs add quality and safety to the drug treatment process, through records and their subsequent assessment.Purpose
To analyse the PIs made during the process of validating e-prescriptions at a regional hospital.Material and methods
A prospective, observational study of PIs made between August 2011 and August 2014 during the process of validating e-prescriptions by a software application (Silicon), in line with the adaption to Spain of the medication errors classification system of the National Coordinating Council for Medication Error Reporting and Prevention. The sections analysed were: wrong medicine, dose omission, incorrect dose, length of treatment, inadequate monitoring and other errors that included therapeutic duplication and exchange, the frequency, speed, route and technique of administration, preparation/handling and/or conditioning, and pharmaceutical method.Results
413 PIs were recorded: 16.5% medicines errors (22% inappropriate/wrong drug for treatment intended), 8.8% dose omission (80% without a prescription stating the medicine required), 26.3% incorrect dose (59.6% dose higher than stipulated), 3.9% length of treatment (69% longer than necessary), 21% inadequate monitoring (94.1% no clinical review) and 24% other errors (30% frequency of administrative error). 52.8% of the PIs were for women. Average age: 65.8. Service areas: 38% internal medicine, 14.5% orthopaedic, 12% general surgery, 10.7% infectious diseases, 7.4% respiratory, 5.5% digestion, other areas with fewer occurrences. Medicines: n = 107 home treatment, n = 19 acenocoumarol, n = 11 serum therapy, n = 13 omeprazole, n = 8 amoxicillin/clavulanic and digoxin, n = 7 furosemide, n = 6 amlodipine and n = 5 metamizole and amphotericin B liposomal.Conclusion
The results show that home treatment accounted for most PIs, which has led to the development of a medicines reconciliation project. Acenocoumarol (high risk drug according to the Institute for Safe Medication Practices) was the drug that generated most PIs, and incorrect dose was the most frequent error. The PI analysis quantified and provided information on the medicines that required intervention, in order to minimise drug-related administration errors.Reference
http://www.nccmerp.org/medErrorTaxonomy.html No conflict of interest.Cite
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Introduction: Inhaled corticosteroids (ICS) are the most common asthma controller medication. However, a high proportion of patients does not respond to this medication and suffer exacerbations. We performed a genome-wide association study (GWAS) to identify genes associated with asthma exacerbations in European children taking ICS. Methods: Within the PiCA consortium, we performed a GWAS meta-analysis of asthma exacerbations across three European cohorts (PACMAN, PASS, and followMAGICS) including 1,204 asthmatic children treated with ICS. Imputation of genetic variants was performed using the Haplotype Reference Consortium as reference panel by means of the Michigan Imputation Server. Association testing of 7.5 million genetic variants with minor allele frequency ≥1% was performed using logistic regression models and results were meta-analyzed. Results: A total of 74 variants were suggestively associated with asthma exacerbations despite the use of ICS (p≤5x10-6). The most significant variants were located in 9 different loci (minimum p-value=2.3x10-7), including one gene previously identified as associated with ICS response in Asian populations (ALLC). Additionally, novel associations were revealed in biologically plausible genes with drug metabolism functions and in genes belonging to the Wnt/β-catenin signaling pathway. Conclusions: We identified several novel genes suggestively associated with asthma exacerbations despite the use of ICS. Validation will be performed in further independent studies. Study supported by Instituto de Salud Carlos III (AC15/00015) and ERACoSysMed 1st Joint Transnational Call (SysPharmPedia). # shared first and last authors
Pharmacoepidemiology
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Package insert (PI) is a vital document accompanying a prescribed medication to provide information to the prescriber and end-user at a glance. Studies regarding PIs of Ayurvedic medicines in accordance with standard guidelines are lacking.Present study was undertaken to evaluate PI of Ayurveda drugs.PIs of Ayurveda drugs were obtained from five randomly selected Ayurveda medical shops located in three main zones of Mumbai. From each medical shop, a range of 15-20 PI was planned to be collected for different formulations. It was decided to collect a minimum fifty PIs/group for equitable distribution of various formulations in period of January-June2013. Checklist was prepared, and content validity was achieved. Final validated checklist contained a total of 13 items, and the presence or absence of information pertaining to these items on the PI was evaluated. Any other additional information present on PI was also noted. Each item was analyzed and expressed as percentages.The information on 258 PIs included: Name of ingredients (67%), quantity of ingredients (47.27%), route of administration (86.8%), dosage form (86.8%), indications (18%), dose (18%), contraindications (18%), side effects (9%), shelf life (5.81%), storage conditions (11%), and manufacturers name with contact details (34%).PIs accompanying Ayurveda medicinal products in India are deficient in information required to be furnished by them.
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Objective: The study analyzed the utilization pattern of antidiabetic drugs at the outpatient clinic of a teaching hospital in Nigeria to document information for enhancing the rational use of drugs in type 2 diabetes. Methods: A retrospective analysis of prescription records of patients with type2 diabetes, seen between the months of May and October, 2013 was carried out; adapting the World Health Organization’s (WHO) recommended drug use indicators. Data was analyzed for drug use indicators, concurrent illnesses and co-prescribed medications. Results: A total of 286 prescriptions of T2DM were collected and analyzed. Mean age of patients was 61(±11.8) years. The number of drugs per prescription averaged 4(±1.6), with majority of prescriptions, 70% containing between 3 and 5 drugs each. Metformin (55.8%) was the most commonly prescribed antidiabetic drug followed by glibenclamide (35.1%). Antibiotics were prescribed in 11% of encounters. The percentage of drugs prescribed by generic name was 58%. Hypertension was identified in 42.2% of the diabetic patients as the most co-existing condition. Conclusion: The study suggests a significant compliance to T2DM treatment guidelines but with scope for improved rational use of drug to reduce the risk of drug therapy problems and enhance patients’ quality of life. It provides a baseline data for further studies on institutional drug use in diabetes.
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Аim. Antihypertensive drugs (AHD) belong to the category of the most commonly used drugs in the pharmaceutical market of Ukraine. This is due to the significant prevalence of arterial hypertension (AH) in many countries of the world, including Ukraine. The purpose of this research is to develop a new approach to optimizing the pharmacotherapy of cardiovascular diseases in the framework of pharmaceutical care based on comprehensive clinical and economic assessments of the use of antihypertensive drugs of various clinical and pharmacological groups, conducted from the positions of pharmacy institutions and outpatient hospitals, taking into account the economic interests of patients.Materials and methods. The researсh was taken retrospectively in 100 commercial pharmacies in the city of Kyiv (daily visitors – 400–500). Analysis of the AHD assortment, which was presented in it in 2017, was carried out with the help of appropriate documentation of pharmacies. To assess the range of AHD on the domestic pharmaceutical market, the data of the "Medicines" information system of Morion Company were used (as of October 2017).Results. During the year, antihypertensive drugs were presented in pharmacies in a fairly wide assortment, mainly foreign products – 175 trade names (TN), 43 international non-proprietary names (INNs). In general, almost half of INNs (56.58 %) and 1/4 part of TN (28.78 %) were presented in pharmacies of the total amount of AHD in the pharmaceutical market of Ukraine. According to the results of the frequency analysis, the same AHD was in high demand by the population in pharmacies during the year but these drugs were differed in rating. These preparations make 21.41 % of all sold packages of AHD in pharmacies – 19.67 %. Only two drugs among the drug-leaders were foreign-made, others were domestic drugs. They had a relatively low packing cost – up to 10.00 UAH. Consequently, the price factor was often decisive in choosing AHD visitors to pharmacies. Рreparations of the first and second line of therapy, as well as combined AHD, are the drugs which were often bought by patients in pharmacies. Interestingly, all preparations of the first line of hypertension are representatives of ACE inhibitors (3 TN Enalapril and 1 TN of Captopril). In addition, the combined AHD Captopress-D also contains an ACE inhibitor Captopril. Preparations of this group have proved well in clinical practice, they can be used at any stage of hypertension, they improve the quality of life of patients and the prognosis of the disease, and the combination "ACE inhibitor + Thiazide diuretic" (among the leading drugs – the drug Captopress-D) is recognized as one of the most effective and appropriate for the appointment of combined antihypertensive therapy. Therefore, doctors often prescribe this pharmacological group to patients with AH. However, the high demand for them among drugstore visitors is likely related to their low cost.Conclusion. Acquiring most AHDs by patients in pharmacies was appropriate and necessary for the treatment of hypertension, because 94 % of TN AHDs from the range of the pharmacy were available in the State form of Ukraine (they had an index "V" based on the results of the VEN-analysis) in 2017
Pharmaceutical Care
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Diabetes mellitus is a chronic metabolic disorder associated with significant morbidity and mortality due to diabetic complications and other co-morbid conditions. Therefore, other drugs are also used commonly with antidiabetic drugs for the treatment of diabetic patients. A prescription is a written advice, mentioning the drugs and other instructions to a pharmacist to dispense the drugs properly to treat the disease. It becomes necessary to write the drugs and other parameters in a candid, concrete and clear manner on the prescription slip. It has been observed that prescriptions are generally vague which lead to misinterpretations and thereby resulting in failure of drug therapy, drug-drug interactions, overuse or underuse of drug and adverse drug reactions. WHO has set quality and quantity indicators to evaluate the use of drugs to be used in the hospitals/dispensaries. Prescription slips were randomly collected from the diabetic patients visiting the OPDs of the Guru Gobind Singh Hospital attached to Medical College, Faridkot, for analysis and evaluation. Prescriptions slips were taken from the patients after taking written consent and analyzed for quality and quantity prescriber indicators recommended by WHO. A total of 366 prescriptions were collected and analyzed for drugs used in diabetic patients. Average number of drugs prescribed is 4.98. The most commonly prescribed drugs were Oral antidiabetic agents, CVS related (antihypertensive, nitrate, antiplatelet, etc.), vitamins and minerals, insulin, GIT related drugs, lipid lowering drugs, antimicrobial, CNS related and NSAIDs and their percentages were 20.55%, 26.97%, 22.20%, 7.8%, 6.57%, 5.86%, 5.75%, 2.63% and 1.48% respectively. All the drugs were prescribed by non-generic (Trade) names, which included 31.36% drugs from the Essential Drugs List. Oral forms prescribed were 85.85% and injectable were 14.15% (insulin 7.8% and other injectable 6.35%).The average cost of the oral antidiabetic agent per day per prescription was ₹7.95/- and this cost increased to ₹10.15/- with addition of CVS related drugs, ₹17.23/- with vitamins& minerals and ₹10.57/- with lipid lowering agents and it was seen that if a patient was prescribed all these drugs then the average cost of the treatment got raised to ₹45/- (approx.) or $ 0.82 USD per day per prescription. There is a high tendency and frequency to prescribe more than two drugs but less used from the essential drugs list for the treatment of the diabetesand other co-morbid conditions. Most of the drugs prescribed were cardiovascular related drugs and multivitamins along with oral antidiabetic drugs. There is an urgent need to develop the prescription writing skills for budding doctors regarding the use of Essential Drugs List to reduce the cost of treatment. Key words: Prescription audit, prescribing indicators, Essential Medicine List (EML), Co-morbid conditions
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Background and Objectives: The Drug Package Insert (PI) is a written information provided by drug manufacturers to deliver essential information for the consumer. This study aimed to investigate quality of the labeling and content of PIs to identify if they meet the criteria of Iran’s Food and Drug Administration (FDA). Material and Methods: A cross-sectional descriptive study was used to evaluate the PPIs of top selling cardiac medications in Iran during March and September 2015 formed the population of this study. We used comparative and descriptive methods in conduction of the study. An evaluation checklist was built based on the regulations of PPI of Iranian Food and Drug Administration (FDA). The presence of criteria was considered as conformity and scored 1 and lacking the criteria was scored zero. The descriptive statistics parameters were used for data analysis using SPSS v.20. Results: A total of 66 PPIs of 13 cardiac drugs from top 33 selling medicines were evaluated using 27 criteria. None of the drug boxes included patient and professional package inserts separately, but the criteria of ‘general guidance to patients’ was observed in 59(89.39)of package inserts. About 64.59% of the information in PPI was consistent with the regulations of drug regulation of the FDA of Iran. All PPIs (100%) included brand name, contraindication, keeping conditions, and the name of the manufacturer. the revision date and resources observed in 4 (6.06%) and 19 (28.71%), respectively. Of total 64.59%. Conclusion : PPIs need to be improved by both quantity and quality to be appropriate use of patients and consumers.
Pharmaceutical drug
Drug Administration
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To analyze the prescriptions of out-patients for rational prescribing and dispensing and to evaluate the patient's knowledge regarding use of drugs, using INRUD indicators.A cross-sectional, descriptive study was conducted at the Manipal Teaching Hospital, Pokhara, Nepal during the time period from June 10th to August 19th 2004.Totally 247 prescriptions were randomly selected for analysis, wherein 720 drugs were prescribed. Only 15% of drugs were prescribed by generic name, 21.67% of the total drugs consisted of fixed-dose combinations, only 40% of drugs were from the Essential drug list of Nepal and 29.44% (n=212) were from the WHO Essential drug list. It was found that more than half (54.17%) of the drugs were from Nepalese National Formulary and 35.69% were from WHO model formulary. Dermatological products were most commonly prescribed followed by drugs acting on central nervous system, antimicrobials and drugs acting on cardiovascular system. Among the drugs dispensed, 79.16% were oral followed by topical (18.19%) and parenteral forms (2.98%). Diagnosis was mentioned only in 3.23% (n=8) of the prescriptions and the average cost per prescription was found to be 241.11 Nepalese rupees (US$ 3.26). It was found out that pharmacist labelled only 0.4% of the medication envelopes with the name of the patient. However, 82.6% of the medication envelopes were labelled with name of the drug and 87.0% with drug strength. Only 53.8% (n=133) of the patient knew both the duration of the therapy and administration time of drugs.There is a need for educational intervention for prescribers and both managerial and educational intervention for the hospital pharmacists to improve prescribing and dispensing.
Formulary
Essential drugs
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Background: - Pharmacotherapy is among the most powerful intervention to improve health outcomes and it is relatively safe, effective and inexpensive mode of treatment. Presently drug utilization studies are an evolving area. Their scope is to evaluate the present state and future trends of drug usage, to estimate crudely disease prevalence, drug expenditures, appropriateness of prescriptions and adherence to evidencebased recommendations. Aim: To evaluate factors related to the prescribing, dispensing, administering and taking of Medication at medicine OPD at tertiary care teaching hospital Materials And Methods:- Patients of all ages and both the sexes attending medicine O.P.D in two months duration and who gave inform consent were included in the study. Drug information of 538 patients was collected and then analysis was done by WHO recommended prescribing indicators. Results: - According to prescription of 538 patients, the average number of drugs per prescription was 2.73. Amongst which 54.16% of medicine was prescribed from national list of essential medicine. The average number of antibiotics per prescription was 37.40% and the use of injectables was 1.08%. The average number of drugs given by its generic name was 1.36%. The average duration of treatment was 9.23 days. Conclusion: - This study reveals that prescribing from NLEM was fair. The use of injections were low but drugs prescribed by its generic name needs to be increased.
Tertiary care
Pharmacotherapy
Drug Utilization Review
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Package insert
Flemish
Antihypertensive drug
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