Nonproprietary Name Research Articles

To keep INN or out

The Indian Patent Office recently proposed a requirement of disclosure of International Nonproprietary Names (INNs) in patent applications relating to pharmaceutical inventions. In this article, we attempt to explore the use of INNs as a proposed tool for searching prior art and whether this would indeed make things simpler for patent examiners in India.

Medical specialists' knowledge, perceptions and views about generic medicines in Malaysia: Findings from a qualitative study and the implications

Background and objective Medical specialists have an essential role in promotion of generic medicines. However, misconceptions and negative perceptions about generic medicines among them could be a barrier to utilization of generic medicines. Therefore, the aim of this study was to explore their knowledge, perceptions and views about generic medicines. Methods A qualitative methodology was adopted in this study. A qualitative descriptive study with phenomenology overtones was the research strategy. Face-to-face semi-structured interviews were conducted with a purposive sample of medical specialists until saturation of data was achieved. The interviews were audio taped and transcribed verbatim. Then, the subsequent transcripts were analysed using thematic analysis. The themes were generated using both deductive (theoretical) and inductive coding. To ensure reliability of data analysis, peer review and independent analysis of the data were done. Results Five major themes were identified: (1) factors affecting specialists' prescribing practice with regard to generic medicines and original brand medicines, (2) specialists' perceptions of efficacy, safety and quality of generic medicines, (3) specialists' knowledge and confidence with Malaysian generic regulatory approval system, (4) drug information sources used by the specialists and (5) international non-proprietary name prescribing. Conclusion The study findings showed that several factors influenced prescribing decision with regard to the brands of the medicines including familiarity and experience with generic medicines, clinical condition of the patient, availability of the medicine brand in the hospital and department financial allocations. Moreover, misconceptions about quality, safety, efficacy and bioequivalence of generic medicines were prevalent among some participants. Furthermore, many participants were not familiar with the Malaysian generic medicines approval system. Therefore, medical specialists' concerns need to be addressed. Some recommendations and suggestions were made to improve generic medicines utilization in the country.

PP.35.09

Objective: Analysis of arterial hypertension therapy for detection of drug interactions in routine ambulatory practice. Design and method: 402 case records of ambulatory hypertensive patients with comorbidity were analyzed. Evaluation of drug combinations from 27 agents with well-known metabolism each of them were conducted. Results: The mean number medications using by one comorbidity patient are 9,5 (from 5 to 14). The total number of used drugs are 95 (42 international nonproprietary names). Twenty two drug combinations (5,53%) were subsumed to major category. This category means the clinical significant drug interaction, and risk of drug adverse event exceeds them benefits. Most of major drug combinations were: simvastatine + amlodipine (0,73% among total medications, 13,2% among major combinations), simvastatine + itraconazole (0,44% and 8,09%, respectively), spironolactone + perindopril (0,57% and 10,34%, respectively). Besides that, combinations with amiodarone, spironolactone, simvastatin, amlodipine, diltiazem and clopidogrel are major drug combinations in 28,3%, 27,3%, 15%, 13%, 12,5% and 9% cases among total medical combinations. Twenty four drug combinations (5,73%) were subsumed to moderate category. This category means the moderate risk of drug adverse event development. Most of moderate drug combinations were: omeprazole + simvastatin (0,6% among total medications, 11,5% among moderate combinations), enalapril + medazolam (0,47% and 9,1%, respectively), fluvoxamine + losartan (0,44% and 8,5%, respectively). Fourteen percents of drug combinations with enalapril were subsumed to moderate category. Drug combinations with nifedipine, amiodarone and fluvoxamine were detected as moderate in 36%, 15,9% and 47,1% cases of total medical combinations. Conclusions: Drug administration for treatment of comorbidity patients in routine ambulatory practice usually performs without evaluation of possible drug interactions caused by changes of activity cytochrome P450 isozymes. About 11% of drug combinations which prescribes to ambulatory comorbidity patients are potential dangerous. In order to prevention of drug adverse event development in comorbidity patients is strongly effort to avoid combinations of drugs which have major or moderate profile.

Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants

The US Food and Drug Administration Adverse Event Reporting System (FAERS), one of the world's largest spontaneous reporting systems, is difficult to use because of report duplication and a lack of standardisation in the recording of drug names. Unresolved data quality issues may distort statistical analyses, rendering the results difficult to interpret when detecting and monitoring adverse effects of pharmaceutical products. The aim of this study was to develop and implement a data cleaning protocol to identify and resolve drug nomenclature issues. The key 'data treatment' plan involved standardising drug names held in the FAERS database. Four million five hundred and six thousand five hundred and seventy-seven. Individual Safety Reports submitted to the FAERS between 1 January 2003 and 31 August 2012 were included for this study. OpenRefine was used to standardise drug name variants in the database such that they were consistent with international non-proprietary nomenclature defined by the World Health Organisation Anatomical Therapeutic Chemical classification. Drug variants where generic constituents could not be confidently determined, undecipherable drug names and non-medicinal products were retained verbatim. After the standardisation process, more than 16 611 916 drug entries were cleaned to their relevant international non-proprietary name. The cleaned drug table comprised 71 858 drug name variants and includes both standardised and original terms. Ninety-nine per cent of drug names was standardised using this method. The millions of reports enclosed in the FAERS contain valuable information that is of interest to pharmacovigilance, toxicology and post-marketing surveillance researchers. With the standardisation of the drug nomenclature, the database can be better utilised by research groups around the world.

Assessment of pharmacists' views on biosimilar naming conventions.

As the date for the introduction of biosimilars in the United States approaches, questions remain regarding the naming, coding, and approval process for these agents that will need to be carefully considered. To (a) ascertain pharmacists' awareness of and comfort level with biosimilars and (b) determine the impact of identical or different nonproprietary names on pharmacists' confidence in substituting interchangeable biologics. The Academy of Managed Care Pharmacy, the American Pharmacists Association, and the American Society of Health-System Pharmacists fielded a survey to their membership or a partial segment of their membership. The survey consisted of 2 sections: (1) current processes for reporting biologics being dispensed and (2) familiarity and preferences regarding biosimilars. A substantial majority (70.1%) of respondents reported regularly using National Drug Code numbers as the identifier for biological products dispensed to patients; however, 10.4% of respondents reported using either the nonproprietary name or the Healthcare Common Procedure Coding System code as the identifier. When presented with 3 scenarios for naming conventions of interchangeable biosimilars and asked to rate their level of confidence (1 = not confident, 5 = very confident) to substitute, 74.6% of pharmacists indicated that they would be confident or very confident in substituting an interchangeable biosimilar with the reference product if both shared the same active ingredient or nonproprietary name of the reference biologic; 25.3% of pharmacists were confident in substituting when the nonproprietary name is not shared with the biologic; and 37.3% of pharmacists expressed confidence in substituting when the biologic and biosimilar product did not share the same nonproprietary name because of a prefix or suffix. The imminent entry of biosimilars into the U.S. market highlights the need to carefully evaluate current processes of identification, reporting, and recording of the biological products dispensed. The results of this survey indicate that the ultimate decision on the naming convention for biosimilars may influence dispensing pharmacists, with the majority of respondents being most comfortable with biosimilars having the same nonproprietary name as the reference biologic.

Nomenclature and traceability debate for biosimilars: small-molecule surrogates lend support for distinguishable nonproprietary names.

IntroductionThe purpose of the present study was to investigate the traceability of adverse events (AEs) for branded and generic drugs with identical nonproprietary names and to consider potential implications for the traceability of AEs for branded and biosimilar biologics.MethodsAdverse event reports in the Food and Drug Administration AE Reporting System (FAERS) were compared with those in a commercial insurance claims database (Truven Health MarketScan®) for 2 drugs (levetiracetam and enoxaparin sodium) with manufacturing or prescribing considerations potentially analogous to those of some biosimilars. Monthly rates of branded- and generic-attributed AEs were estimated pre- and post-generic entry. Post-entry branded-to-generic AE relative rate ratios were calculated.ResultsIn FAERS, monthly AE rate ratios during the post-generic period showed a pattern in which AE rates for the branded products were greater than for the generic products. Differences in rates of brand- and generic-attributed AEs were statistically significant for both study drugs; the AE rate for the branded products peaked at approximately 10 times that of the generic levetiracetam products and approximately 4 times that of the generic enoxaparin sodium products. In contrast, monthly ratios for the MarketScan data were relatively constant over time.ConclusionUse of the same nonproprietary name for generic and branded products may contribute to poor traceability of AEs reported in the FAERS database due to the significant misattribution of AEs to branded products (when those AEs were in fact associated with patient use of generic products). To ensure accurate and robust safety surveillance and traceability for biosimilar products in the United States, improved product identification mechanisms, such as related but distinguishable nonproprietary names for biosimilars and reference biologics, should be considered.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0193-5) contains supplementary material, which is available to authorized users.

The Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the United States Healthcare System.

Alongside the constitutional controversy ultimately addressed by the Supreme Court, the colossal Patient Protection and Affordable Care Act (ACA) ushered in a new paradigm for regulation of biologics by the Food and Drug Administration (FDA). Nestled within the expansive ACA, the Biologics Price Competition and Innovation Act (BPCIA) set forth an abbreviated pathway to market for "biosimilar" and "interchangeable" biological products. While the current BPCIA implementation debate focuses chiefly on the scope of scientific and technical assessments by the FDA and the effect on the emergent biosimilar industry, two issues will prove essential for determinations of access to and costs of the resulting products: how the biosimilar and interchangeable biosimilar biologics are to be named, and whether pharmacist substitution is appropriate for products the FDA deems interchangeable. This article examines the current debate surrounding the use of nonproprietary names for biosimilar biologics, as well as state efforts to reconcile automatic substitution laws for the eventual products. In particular, the article addresses the implications for patients and the United States health care system, highlighting the potential negative effect on anticipated cost-savings, hindrances for effective tracking and reporting of adverse events, and a general lack of consistency in state laws.

Phenobarbital induced erythroderma: a case report

Phenobarbital (PHB) (International Non-proprietary Name) or Phenobarbitone (British Approved Name) is a long acting barbiturate and the most widely used anti-seizure medication globally. Fever, skin reactions, limb edema, and drug-induced hypersensitivity have been reported in children because of various drugs, mainly aromatic antiepileptic drugs such as phenytoin, PHB, carbamazepine, and primidone. The skin reactions differ in severity and range from a mild maculopapular erythema to exfoliative dermatitis. A 2-month-old male baby was brought to the dermatology out-patient department with complaints of redness and scaling all over the body (erythroderma) after 2-3 weeks of PHB treatment for convulsions. PHB was stopped, and corticosteroids (topical and systemic) were started. The baby improved over a period of 2 weeks. According to Naranjo’s adverse drug reaction probability scale, the causality relation between erythroderma and PHB was found to be a probable one.

Efficiency of epilepsy treatment in the Moscow Region under the present-day conditions of drug provision

Objective : to evaluate the efficiency of epilepsy therapy in the two periods 2006–2007 and 2013–2014 due to drug provision-related changes: the use of antiepileptic drugs (AEDs) in accordance with their international nonproprietary name. Patients and methods. The continuous sample survey enrolled patients aged 18 years and older, who had been seen by an epileptologist at the Moscow Regional Research Clinical Institute in 2006–2007 (n=1200) and 2013–2014 (n=1450). The patients who had received initial therapy (n=384) were divided into 2 groups in accordance with the type of drug provision. Group 1 (n=124) had recommended AEDs. In Group 2 (n=260), there was switching between AED analogues in 80% of the patients. Therapeutic efficiency was comparatively analyzed in relation to the AEDs used and treatment policies. Results. In 2013–2014 versus 2006–2007, the rate of remissions and the number of respondents was halved. The analysis demonstrated significant differences (p<0.05) between Groups 1 and 2 in the following indicators: the number of respondents (75:52%), remission rates (58:38%), pharmacoresistance (25:47%), the frequency of use of brand (54:34%) and generic (45:65%) AEDs, and that of switching between AED analogues (0:80%).

A comparative review of the list of essential medicines of three Indian states: Findings and implications

International Journal of Medicine and Public Health,2015,5,1,71-76.DOI:10.4103/2230-8598.151266Published:January 2015Type:Original ArticleA comparative review of the list of essential medicines of three Indian states: Findings and implicationsVenkatesh Narayan, Maulik Chokshi, and Habib Hasan Venkatesh Narayan, Maulik Chokshi1, Habib Hasan1 International Clinical Epidemiology Network, 1Indian Institute of Public Health, New Delhi, India Abstract:Introduction: Essential medicines lists are a key instrument for improving quality and equitable access to health care. The National List of Essential Medicines of India 2011 is modeled on the WHO Essential Medicines List and Indian states (adopting the National List) are free to include other medicines as needed. Materials and Methods: National List of Essential Medicines of India 2011 contains a total of 287 medicines for provision at primary and secondary level of health facilities. The International Nonproprietary Name of these medicines was compared with the List of Essential Medicines (LEM) of three states, that is, Bihar, Rajasthan and Tamil Nadu for the inclusion patterns. Results: A large number of medicines from the National List of Essential Medicine (NLEM) were missing from the state LEM’s, especially Bihar. The sections on Anticonvulsants, Diuretics, Psychotherapeutic, Antiallergics and Oxytocics were comprehensively included by both Rajasthan and Tamil Nadu. Furthermore, the analgesic and anti-infective medicines were largely included. However, the sections of antidotes, diagnostic agents and ophthalmological preparations were grossly deficient. Similarities were found across states in their patterns of both inclusion and exclusion of medicines. Conclusion: The analysis reveals that the extent of inclusion of NLEM medicines in state LEM’s is deficient with variable patterns across states. This in turn has implications for drug availability, prescription patterns, and rational drug use. As some drugs are repeatedly there in NLEM but not included by states, a discussion based consultative approach for better coherence across the lists could lead to further optimization and utilization of LEM’s which would aid in improved access to medicines. Keywords:Essential medicines, inclusion of medicines, India essential medicine listView:PDF (507.02 KB)

Fluoroquinolones in pediatrics: review of hospital prescription use over 2 years.

Numerous studies have shown that the tolerance of children to fluoroquinolones (FQs) is satisfactory, and some indications have been recently agreed upon. However, vigilance is required when prescribing FQ to children. The aim of our study was to describe the prescription of FQs to children hospitalized in our hospital. This is a chart retrospective observational study at the Robert-Debré teaching Hospital between January 2009 and December 2010. Data was collected about patients (name, sex, weight, age) and prescribed treatments (indication, international nonproprietary names, dose, number of doses per day, administration route). Quality of collected data was assessed by analyzing the clinical files of 32 randomly selected patients. We analyzed data for 397 patients (3 days - 18 years old and 640 g - 115 kg). Ciprofloxacin was prescribed for 382 patients (96%), ofloxacin for 10 patients (3%), and levofloxacin for 5 patients (1%). Febrile neutropenia was the most common indication (108 patients, i.e., 27%), followed by inflammatory bowel disease (50 patients, 13%). Doses conformed to recommendations for 88% of the patients. Analysis of the 32 cases indicated an overall compliance percentage of 94.4%. This is the first study to collect so much data on FQ prescriptions for hospitalized children. Use in practice went beyond the licensed indication. Doses were consistent with those for recommended indications.

Review of ongoing initiatives to improve prescribing efficiency in China; angiotensin receptor blockers as a case history

Introduction: Pharmaceutical expenditure is rising by 16% per annum in China and is now 46% of total expenditure. Initiatives to moderate growth include drug pricing regulations and encouraging international non-proprietary name prescribing. However, there is no monitoring of physician prescribing quality and perverse incentives. Objectives: Assess changes in angiotensin receptor blocker (ARB) utilization and expenditure as more generics become available; compare findings to Europe. Methodology: Observational retrospective study of ARB utilization and expenditure between 2006 and 2012 in the largest hospital in Chongqing district. Results: Variable and low use of generics versus originators with a maximum of 31% among single ARBs. Similar for fixed dose combinations. Prices typically reduced over time, greatest for generic telmisartan (−54%), mirroring price reductions in some European countries. However, no preferential increase in prescribing of lower cost generics. Accumulated savings of 33 million CNY for this large provider if they adopted European practices. Conclusion: Considerable opportunities to improve prescribing efficiency in China.

Creation of computer-assisted drug prescription in a pediatric hospital: the 8 years experience of the Children’s Hospital of Geneva

The University Hospitals of Geneva (HUG) had an institutional project to implement a computerised physician order entry (CPOE) system to replace verbal and handwritten prescriptions as well as transcription, in order to decrease errors and related adverse drug events. Development of CPOE was first intended for adult patients. A dedicated working group, PRESCO-PED, was created in 2006 for the development of the paediatric drug database. This group was in charge of evaluating the needs and building and maintaining a database of the most-prescribed drugs in paediatrics. PRESCO-PED included physicians representing most paediatric specialties, such as intensive care, neonatology, emergency, oncology, general paediatrics, surgery, orthopaedic surgery, anaesthesiology, infectious diseases and psychiatry, in cooperation with nurse representatives, pharmacists, and computer specialists. The drug database had to be specific to paediatrics, structured, validated by experts, and easy to update. Several drug datasets were available in the institution, such as the injectable drug administration guide of the pharmacy, nurses’ protocols, and different published references. However, all were incomplete, not structured or not directly exploitable for the database. All the variables required per drug first had to be defined: brand name, international nonproprietary name (INN), unit dose, interval, maximal unit dose, maximal daily dose, route of administration, flow rate, formulation, specific dosage according to patient’s age, gestational age, body weight, body surface index, etc. The most frequently used drugs, corresponding to 346 drug records, were each distributed to two experts in the group, chosen according to the specialty in which the drug was mainly used. After validation by both experts, a database was compiled and verified again by PRESCO-PED. The additional aim of this database was to allow the system to suggest standard prescriptions schemes and to trigger alerts, for example when maximal doses were exceeded. The prescription of drugs in the database was then tested with mock patients by a subgroup of members of PRESCO-PED in addition to regular users, prior to implementation in a clinical setting. In order to facilitate acceptance by the end-users, in addition to drug prescription, PRESCO-PED decided to work on order sets, which simplified and accelerated prescriptions by combining in a single interface multiple orders (patient monitoring, laboratory tests, radiology, drugs, feeding and IV fluids, among others) associated with a specific clinical setting. With the same quality standards, a paediatric enteral nutrition prescription interface was also created. After 20 sessions of PRESCO-PED over a period of 10 months, all drugs and several order sets were available, with the database completed and ready for use. Drugs specific to paediatrics were easily differentiated from adult drugs in the prescription interface thanks to a characteristic pictogram. CPOE with drug prescription was first implemented in January 2007 in the paediatric surgery department, after structured training of all healthcare workers, and on-site assistance by medical IT personnel and members of PRESCO-PED. Over two months it was progressively deployed throughout the entire Children’s Hospital. Since the implementation of CPOE, PRESCO-PED remains active with monthly meetings, regularly updating the database, increasing the number of order sets, correcting errors, and improving the use of drug prescription. We will review the challenges, the difficulties and successes of our programme and will put our plans in perspective for the future.

Attitudes of physicians and pharmacists towards International Non-proprietary Name prescribing in Belgium.

International Non-proprietary Name (INN) prescribing is the use of the name of the active ingredient(s) instead of the brand name for prescribing. In Belgium, INN prescribing began in 2005 and a major policy change occurred in 2012. The aim was to explore the opinions of Dutch-speaking general practitioners (GPs) and pharmacists. An electronic questionnaire with 39 five-point Likert scale statements and one open question was administered in 2013. Multivariate analysis was performed with multiple linear regression on a sum score for benefit statements and for drawback statements. Answers to the open question were qualitatively analysed. We received 745 valid responses with a representable sample for both subgroups. Participants perceived the motives to introduce INN prescribing as purely economic (to reduce pharmaceutical expenditures for the government and the patient). Participants accepted the concept of INN prescribing, but 88% stressed the importance of guaranteed treatment continuity, especially in older, chronic patients, to prevent patient confusion, medication non-adherence and erroneous drug use. In conclusion, the current way in which INN prescribing is applied in Belgium leads to many concerns among primary health professionals about patient confusion and medication adherence. Slightly adapting the current concept of INN prescribing to these concerns can turn INN prescribing into one of the major policies in Belgium to reduce pharmaceutical expenditures and to stimulate rational drug prescribing.

What hinders general practitioners to prescribe cheaper? The use of International Non-proprietary Name (INN) in Belgium

Background Pharmaceutical expenses keep exerting pressure on health expenditures across Europe. A common strategy to stimulate the use of cheaper medicines is generic substitution and the use of the International Non-proprietary Name (INN) in medicine prescribing. Since 2006, Belgian physicians have to reach a minimum of ‘cheap’ prescriptions per year (including INN prescriptions). INN prescribing can result in considerable savings for patient and health insurance in Belgium. Since …

Ongoing initiatives to improve prescribing efficiency in China; statins as a case history

Pharmaceutical expenditure rose by 16% per annum in China during the past decade, and now represents 46% of total healthcare expenditure. Initiatives to moderate growth include pricing regulations for pharmaceuticals and encouraging International Nonproprietary Name (INN) prescribing. However, there is limited monitoring of physician prescribing and current incentives encourage hospitals and physicians to profit from drug procurement. The objective was to assess changes in statin utilization and expenditure as additional generics are launched. Subsequently, compare results in China with findings among European countries to provide future guidance. We used observational retrospective study of statin utilization and procurement expenditure from 2004 to 2013 in two large teaching hospital groups. The results were that statin utilization rose 32-fold in one hospital group and 54-fold in the other. Expenditure also increased but to a lesser extent, i.e. from just over Renminbi ‘yuan’ (CNY) 0.65 million in 2004 to CNY 15.3 million in 2013 in one hospital group and from CNY 0.49 to CNY 19.3 million in the other. Atorvastatin (originator) was the most utilized statin. Utilization of each generic statin was typically low, e.g. 10% in 2013 in one hospital group. Procurement prices fell over time, greatest for generic simvastatin (-74% to -91%) mirroring data from European countries. However, no increase in their prescribing was observed. In fact, a significant decrease in generic prescribing was seen in one hospital group between 2004 and 2013. There are considerable opportunities to improve prescribing efficiency in China based on European experience. However, current incentives encouraging hospitals and physicians to profit from drug procurement need to be addressed.

Development of dalfampridine, a novel pharmacologic approach for treating walking impairment in multiple sclerosis.

Walking impairment is a clinical hallmark of multiple sclerosis (MS). Dalfampridine-ER, an extended-release formulation of dalfampridine (also known by its chemical name, 4-aminopyridine, and its international nonproprietary name, fampridine), was developed to maintain drug plasma levels within a narrow therapeutic window, and assessed for its ability to improve walking in MS. The putative mechanism of action of dalfampridine-ER is restoration of axonal conduction via blockade of the potassium channels that become exposed during axonal demyelination. Two pivotal phase III clinical trials demonstrated that dalfampridine-ER 10-mg tablets administered twice daily improved walking speed and patient-reported perceptions of walking in some patients. Dalfampridine-ER was generally well tolerated, and, at the approved dose, risk of seizure was neither elevated relative to placebo nor higher than the rate in the MS population. Dalfampridine-ER (AMPYRA®) was approved in the United States for the treatment of walking in patients with MS as demonstrated by an increase in walking speed. The use of the dalfampridine-ER is contraindicated in patients with a history of seizure. It is the first pharmacologic therapy for this indication and has been incorporated into clinical management of MS.

Similar names for similar biologics.

Approval of the first biosimilar in the USA may occur by the end of 2014, yet a naming approach for biosimilars has not been determined. Biosimilars are highly similar to their biologic reference product but are not identical to it, because of their structural complexity and variations in manufacturing processes among companies. There is a need for a naming approach that can distinguish a biosimilar from its reference product and other biosimilars and ensure accurate tracing of adverse events (AEs) to the administered product. In contrast, generic small-molecule drugs are identical to their reference product and, therefore, share the same nonproprietary name. Clinical trials required to demonstrate biosimilarity for approval may not detect rare AEs or those occurring after prolonged use, and the incidence of such events may differ between a biosimilar and its reference product. The need for precise biologic identification is further underscored by the possibility of biosimilar interchangeability, a US designation that will allow substitution without prescriber intervention. For several biologics, the US Food and Drug Administration (FDA) has used a naming approach that adds a prefix to a common root nonproprietary name, enabling healthcare providers to distinguish between products, avoid medication errors, and facilitate pharmacovigilance. We recommend that the FDA implement a biosimilars naming policy that likewise would add a distinguishable prefix or suffix to the root nonproprietary name of the reference product. This approach would ensure that a biosimilar could be distinguished from its reference product and other biosimilars in patient records and pharmacovigilance databases/reports, facilitating accurate attribution of AEs.

Physicians’ perception of generic and electronic prescribing: A descriptive study from Jordan

ObjectivesThe aim of this study was to investigate Jordanian physicians’ perception and attitudes toward generic medicines and generic substitution. It also aimed to examine factors that affect physicians’ pattern of prescribing, and to evaluate their opinion regarding future introduction of Electronic Prescribing (EP) in Jordan.MethodsA cross-sectional descriptive study involving Jordanian physicians working in both public and private sectors was undertaken, using a self-administrated anonymous questionnaire. Frequency tables, cross-tabulation and chi square tests were used for data analysis. The response rate was 75.2% (n = 376/500).ResultsCost was claimed to be an important factor in the prescribing decision for 69.1% of the Jordanian physicians. The majority of physicians (77.4%) claimed that they often prescribe generic medicines. Jordanian physicians predominantly welcomed the implementation of an EP and International Nonproprietary Name (INN) prescribing systems with 92%, and 80.1% respectively. More than two thirds of the physicians (69.4%) accepted generic substitution by pharmacists, with a significant association with their employment sector; physicians who work in the private sector tended to oppose generic substitution compared with physicians who work in the public sector. Physicians mostly (72.1%) opposed that generic substitution should only be allowed upon patient request.ConclusionsJordanian physicians have a positive attitude towards generic medications and high willingness and acceptance of strategies that encourage generic utilisation such as EP, INN prescribing and generic substitution. All these strategies would help reduce the high expenditure on medicines in Jordan. These findings would provide baseline data to policy makers to develop a robust generic policy to achieve greater clinical effectiveness and economic efficiency from medicines prescribing.

FDA application of the USP salt policy.

How is FDA applying USP’s “salt policy”? Pharmacists are familiar with the potential for drug names (both brand names and generic, nonproprietary names), packaging designs, and labels to cause confusion and medication errors. For years, the Food and Drug Administration (FDA), patient safety