Surveillance of adverse drug reactions at two multidisciplinary hospitals and an outpatient specialty clinic in India

Context — Adverse drug reaction (ADR) reporting is under‐developed in India, with only two of six national reporting centres currently functioning. Objective — To introduce an ADR monitoring programme at two hospitals and an outpatient skin specialty clinic in South India and to evaluate the programme. Design — An ADR monitoring programme was introduced in three participating centres and ADRs were documented and analysed over a period of six months. All unplanned admissions, all inpatients of the two participating hospitals and all outpatients of the skin specialty clinic were included in the study. A clinical pharmacist (the investigator) interviewed all patients on admission to identify suspected ADRs. For inpatients and clinic outpatients, suspected ADRs were documented by the treating doctor. A panel of four judges, including the investigator and the physician treating the patient with the suspected ADR, assessed the cases. Confirmed ADRs were then classified and categorised. Key findings — In total, 152 ADRs were documented. The percentage of patients with a reported ADR at each of the three centres was 3.5, 3.7 and 2.3. The gender of patients with reported ADRs was 53.9 per cent male and 46.1 per cent female. Most of the patients had a type “A” reaction (110, 72.4 per cent). Using Naranjo's probability scale, 25.7 per cent of ADRs were categorised as “probable” and 74.3 per cent as “possible.” Of the ADRs reported in the two hospitals, 31.1 per cent related to unplanned medication‐related hospital admissions and 68.9 per cent occurred during the hospital stay. Antibiotics (32.2 per cent), psychotropic drugs, steroids and non‐steroidal anti‐inflammatory drugs (11.8 per cent each) were the most common drugs that caused ADRs. General medicine (37.5 per cent) and dermatology (35.5 per cent) departments accounted for the highest number of ADRs. Pruritic rash (36.7 per cent) was the most common ADR reported at the skin clinic while pruritic rash, gastritis and diarrhoea (10.7 per cent each) and akathisia and hypoglycaemia (7.8 per cent) were the most common ADRs reported in the hospitals. Conclusion — This is the first study to evaluate an ADR reporting programme in India. Introduction of the ADR monitoring programme improved health care practitioners' awareness of the importance of pharmacovigilance. Occurrence of ADRs seemed to be similar to those reported in the developed world, with the exception of the proportion of severe ADRs (25 per cent), which was higher than reported elsewhere in published studies.     

Pollen challenge study of a phototherapy device for reducing the symptoms of hay fever

ABSTRACT

Objective: The objective was to investigate the effect of intranasal phototherapy delivered by a phototherapy device (allergy reliever SN-206) on symptoms of hay fever (seasonal rhinitis) due to grass pollen in adults. This registered class IIA medical device had been on sale for 15 months with no adverse effects reported but there had been no assessment of efficacy. Previous research had indicated that phototherapy could alleviate symptoms of allergic rhinitis but no double-blind, placebo-controlled trails had been done.

Research design and methods: The trial is a double-blind, placebo-controlled grass pollen challenge conducted out of the pollen season, on 101 adult male and female hay fever sufferers. Subjects were assigned to placebo or active groups by stratified random sampling using responses to a baseline questionnaire. All subjects used active or placebo devices three times a day for 14 days before pollen challenge. Subjects were monitored for 2.5 h after challenge.

Main outcome measures: Primary outcome measures were observed severity scores for sneezing, running eyes, running nose, and the amount of eosinophil cationic proteins (ECP) in nasal secretions. Secondary outcome measures were symptom scores by subject report (itching eyes, itching nose, itching throat, itching mouth/palate), and nasal peak inspiratory flow (PIFn) and peak expiratory flow (PEFn).

Results: Significant reductions in severity of symptom scores were found for sneezing, running nose, running eyes and itchy mouth/palate (p ≤ 0.05). No significant differences were found in the results for itchy eyes, itchy nose, itchy throat, ECPs, PIFn and PEFn. No adverse events occurred.

Conclusions: The results show that the device significantly reduced some hay fever symptoms. The study would have been improved if compliance was monitored electronically and if nasal congestion was monitored by report. The mode of action is unclear. The study does not consider long-term implications of the therapy.     

Methylprednisolone acetate and its use in the treatment of students with hay fever at examination time

Summary

Forty-five students and 2 University staff were seen at examination time and given 80?mg. (2 ml.) intramuscular methylprednisolone acetate (‘Depo-Medrone’) for their hay fever during a very severe grass pollen season.

The effectiveness of the treatment was assessed by studying the patients' previous history. It was found that 38 (74.5%) obtained partial or complete relief from their symptoms and that antihistamines were either not required or the need much reduced.

The use of intramuscular methylprednisolone in the management of hay fever among students faced with examinations is considered to be worthwhile.     

Validation of a “desire for information” scale

Objective — To validate a scale to measure patients' desires for information about their prescribed drugs. Methods — Both quantitative and qualitative methods were used. Standardised bedside interviews were conducted with general medical patients in three hospitals over an eight‐month period. The validity of the scale was explored by interfacing qualitative data from patients' perspectives and their scores to the scale. Setting — General medical wards at three teaching hospitals in London. Key findings — A total of 630 patients were recruited for interview; 50.2 per cent were male and 49.8 per cent female. The mean age for the population was 60 years. More than half (54 per cent) of the study population was retired, and the majority (82 per cent) described their cultural background as white. Through a factor analytic approach, the primary 12‐item scale was refined to six items (designated F1), measuring “extent of information desired”. A second extracted factor (designated F2) measured “inhibited desire for information”, but was not considered reliable. The responses to semi‐structured interviews gave valuable insights into the types of information sought: low‐scorers declared no need for detailed information as this would sometimes even worry or frighten them, while high‐scorers worried about not receiving enough information and requested specific details that would help them in their self care. Conclusion — Interfacing qualitative responses to semi‐structured and open questions and the quantitative scores contributed to the validation of a new six‐item scale and gave insights into the types of information patients seek. By developing a tool to identify patients' desires for information, pharmacists will be able to identify and meet the drug information needs of patients in an appropriate and timely way.     

Any place for depot triamcinolone in hay fever?

The prevalence of hay fever (seasonal allergic rhinitis) in the UK has been increasing; for instance, it doubled from 10 to 20 per 1000 people between the 1970s and 1980s. For a few patients with severe hay fever symptoms, it sometimes helps to give a systemic corticosteroid; one possible option is the injection of a long-acting corticosteroid, such as triamcinolone. We have previously concluded that systemic corticosteroids have only a limited role, that is, when complete control of severe symptoms is judged essential (e.g. for a wedding or exam). Here we reconsider the case for depot triamcinolone injections in the management of hay fever.     

Diurnal variation in the symptoms of hay fever: implications for pharmaceutical development

Summary

It is suggested that drug formulations should be developed with some reference to the diurnal variations in the symptoms of the disease for which they are prescribed. The suggestion is examined with regard to hay fever. As a result, interesting epidemiological data for the United Kingdom has been obtained. Hay fever is complained of more commonly in social classes A, B and C and in those living in London or South-East England. It is less common in the elderly. The principle symptom is sneezing, followed by stuffy nose, red itchy eyes, wheezing and coughing, in that order. These symptoms are commoner in the forenoon and are also, in general, more severe during this period. The theoretical implications of the data are discussed in the context of drug formulations.     

An audit of responding to symptoms in community pharmacy

A two-stage audit of community pharmacists' service in response to symptoms was carried out using a previously piloted method. Pharmacists from up to 46 pharmacies completed questionnaires indicating the advice they thought should be given in each of 12 scenarios that could present to community pharmacies. The six scenarios with the highest consensus response were later enacted in the same pharmacies by researchers. Three were used in the first stage and three in the second. Meetings were held between the stages to discuss the results and suggest ways of improving them. The consensus advice, determined by the questionnaire responses, was given on only 27 per cent of all visits — 18 per cent in the first stage and 35 per cent in the second. This was mainly due to non-drug advice being omitted. “Appropriate” products were recommended in 90 per cent of first stage visits but only 74 per cent of second stage visits. “Acceptable” advice was provided in 75 per cent of all visits, with little difference between the two stages. Questioning of the researchers was “good” in 35 per cent of first stage visits and 43 per cent of second stage visits. Inadequate questioning was significantly related to inappropriate advice being given. Inappropriate advice was given on 25 per cent of all visits, with equal frequency by both pharmacists and assistants. Participating pharmacists identified many problems that could contribute to a less than ideal service but most were outside their control, such as television advertising of products and customer expectations. The use of protocols, implementation of staff training and the audit were considered to have had a positive effect on the response to symptoms service. Most participants considered that the method used was acceptable and suggested a similar method should be used on a regular basis to monitor the service.     

A double blind, placebo controlled trial of inert cellulose powder for the relief of symptoms of hay fever in adults

OBJECTIVE: An inert cellulose powder has been on sale in the UK since 1994 as a remedy for hay fever but no scientific trials have been conducted previously. It is applied to the inside of the nose where it forms a gelatinous coating. The principal aim was to determine if there is a significant difference in the amount and type of rescue medication required for adult hay fever sufferers to control their symptoms while using either the inert cellulose powder or a placebo. The second objective was to see whether the cellulose powder resulted in an improvement in symptom control. RESEARCH DESIGN: A double blind, placebo controlled study was conducted of 97 adult hay fever sufferers, over the grass pollen season of 2004. Participants (selectively recruited to be living within the catchment area of a 50-km radius from Worcester, UK) were assigned randomly to two groups (A, Active and B, Placebo) matched by age by decades and gender. Of those completing the trial, group A had 19 males and 28 females and group B had 21 males and 29 females. There were no significant differences between the groups in age distributions, severity of symptoms over the last 2 years or in medication taken. They completed daily symptom diary score cards and were allowed to take any medications they wished in addition to the inert cellulose powder or placebo because medication use was taken as an outcome measure. Results were analysed in relation to pollen counts. RESULTS: Significant differences were found in the amounts of rescue medication taken by the active and placebo groups (p < 0.05). More people in the placebo group took rescue treatments than those in the active group.No significant differences were found (p < 0.01) between the active and placebo groups in Likert scores for any of the rhinitis nasal symptoms or in the total Likert symptom daily scores. No adverse events were reported during the study. CONCLUSIONS: The amount of rescue medication taken by the placebo group was significantly more than that taken by the active group both overall, considering all types of medication, and also in the individual cases of antihistamines, nasal sprays and eye drops. These results provide evidence that the inert cellulose powder reduces the need to take rescue medication for the symptoms of hay fever.     

A comparative study of beclomethasone dipropionate aqueous nasal spray with terfenadine tablets in seasonal allergic rhinitis

Summary

Forty-nine patients participated in a randomized double-blind, parallel group comparison of beclomethasone dipropionate aqueous nasal spray with terfenadine tablets in the treatment of hay fever. Symptom scores for nasal and ocular symptoms as well as grass pollen counts were registered daily for at least 1 month. Evaluation of daily symptom scores and the physicians' and patients' assessments of treatment demonstrated that both treatments were effective in controlling the symptoms of hay fever, with a similar incidence of side-effects. The beclomethasone dipropionate group, in general, had lower nasal symptom scores than the terfenadine group and this reached statistical significance on high pollen count days. In contrast, the terfenadine group had lower eye symptom scores than the other group and these were statistically significant during the first half of the study period. However, the use of additional medication for control of eye symptoms was similar in both groups. It is concluded that treatment with both beclomethasone dipropionate and terfenadine throughout the season was effective in controlling hay fever symptoms, but beclomethasone dipropionate is likely to provide better overall control since it prevented breakthrough of troublesome nasal symptoms during high pollen count days.     

Infant weaning and community pharmacy — the pharmacist's perspective

Community pharmacists' awareness of the COMA report on “Weaning and the weaning diet” and their knowledge of its recommendations was assessed in a questionnaire distributed to all (n=81) community pharmacists in the Western Health and Social Services Board in Northern Ireland. Sources of information and adequacy of training on childhood nutritional issues were determined. A knowledge score was computed for each pharmacist depending on their responses to questions based on key issues in the COMA report. Completed questionnaires were returned by 48 pharmacists (59 per cent). The COMA report had been read by 14.5 per cent of respondents while 12.5 per cent knew of its recommendations. Others had heard of it but not read it (52 per cent) or had never heard of it (21 per cent). The mean knowledge score was 66 per cent (±17.5). Scores ranged from 18 per cent to 90 per cent, indicating wide variability in pharmacists' knowledge of key recommendations for weaning. Only 29 per cent of pharmacists felt that they were adequately trained to give advice on weaning; 50 per cent felt that they did not have sufficient knowledge and 21 per cent were unsure. Pharmacists indicated that, on average, parents approached them weekly about a weaning topic, which emphasises the need for them to be well informed about current weaning recommendations.     

Survey of use of the Pharmacy Information and News Service (PINS) among community pharmacists

A postal survey was sent to all users of the Pharmacy Information and News Service (PINS) in May, 1990. Of 356 questionnaires (72 per cent) returned, 179 were from community pharmacists currently using PINS, and these were analysed. The PINS option which the greatest number of those respondents found “useful” or “very useful” was the news section, followed by the malaria prophylaxis and register inquiries sections. Some 59 per cent accessed PINS less than once a week, most claiming to use it less than they had envisaged when they became subscribers. Sixty-seven per cent indicated that the type and quality of information on PINS was what they had expected, but 58 per cent did not think the system was user-friendly.     

An investigation into adverse drug reaction monitoring by United Kingdom hospital pharmacy departments

Prior to the nationwide introduction of the Committee on Safety of Medicines “yellow card” adverse drug reaction reporting for hospital pharmacists, a study was carried out to investigate the activities undertaken by hospital pharmacists in adverse drug reaction (ADR) reporting. A survey of 200 United Kingdom hospitals was conducted and 172 (86 per cent) questionnaires were returned. Local ADR reporting schemes were in operation in 26 (15.1 per cent) surveyed hospitals. The majority used locally designed cards to report ADRs. The most common reasons for the lack of a local ADR scheme (n=141) were staffing, the fact that a scheme had never been considered, time factors and the lack of perceived need to operate a scheme. Of these 141 departments, 80.1 per cent said they would consider implementing schemes in their hospital. With the inclusion of pharmacists in the CSM “yellow card” scheme, there is an incentive for them to become officially and further involved in the management and reporting of ADRs. Local ADR reporting schemes encourage pharmacovigilance and could allow pharmacists to take a leading role in this area of clinical practice.     

National and local guidance on services for drug misusers: do they influence current practice?— results of a survey of community pharmacists in South East England

Objective — To investigate levels of awareness of national and local guidance about services for drug misusers and their effect on pharmacy practice. Method — A postal survey in 1997 to collect data on current involvement in services for drug misusers, awareness of and receipt of key documents pertaining to drug misuse, effects of guidelines and protocols on practice, and influences on decisions to provide services. Setting — A random one in two sample (n=1,582) of community pharmacies in the South East of England (North and South Thames regions). Key findings — A 65.1 per cent response rate was achieved. Just over half (54.7 per cent) were dispensing Controlled Drugs for the management of dependence, 47.2 per cent were selling clean injecting equipment and 15.5 per cent were offering a needle exchange service. Most respondents were unaware of key government documents, with the exception of “Health of the nation,” and only a small minority had received copies. The most influential factors on current position on service provision were “personal experience,” “local need” and “Royal Pharmaceutical Society of Great Britain (RPSGB) policy.” New local guidelines and initiatives mainly related to supervised consumption of methadone in pharmacies and pharmacy needle exchange. Conclusion — Community pharmacies are substantially and increasingly involved in providing*** primary care services for drug misusers. However, there is a disturbing lack of awareness of key government initiatives, possibly due to the lack of dissemination of such documents. RPSGB policy as a key influencing factor points to an opportunity for the profession to take a more influential position.