Package inserts for prescribed medicines: what minimum information do patients need?

Hermann, F.; Herxheimer, Andrew; Lionel, N. D. W.

doi:10.1136/bmj.2.6145.1132

Cited by 46 publications

(26 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The leaflets were based on those piloted by George et al (1983) and developed by Gibbs et al (1987). Briefly, they are 'generic' and contain information suggested by Hermann et al (1978), with the exception of how to tell if the medicine is working, together with additional information requested by patients (Ridout et al, 1986). They were constructed according to general principles for design of technical information (Hartley, 1978) and each was 'style edited' by an educational psychologist to improve readability (Cripwell, 1981).…”

Section: Methodsmentioning

confidence: 99%

The benefits of prescription information leaflets (1).

Gibbs

Waters

George

1989

Brit J Clinical Pharma

142

View full text Add to dashboard Cite

1 Prescription information leaflets (PILs) giving information about non-steroidal antiinflammatory drugs (NSAIDs), ,B-adrenoceptor antagonists and inhaled bronchodilators were evaluated in three small Hampshire towns, while a fourth, in which no leaflets were distributed, acted as a control. 2 Seven hundred and nineteen (82%) patients prescribed one of these medicines agreed to be interviewed in their homes, 1 to 2 weeks after the medicine had been prescribed. Four hundred and nineteen of them had received leaflets, while 300 received no written information. Two hundred and sixty patients received their leaflets from a pharmacist while 159 were given them by their general practitioner. 3 Patients who received leaflets were better informed about every item of knowledge tested, except for the name of the medicine. Awareness of the side effects showed the greatest improvement, but there was no evidence that these leaflets produced spurious side effects. 4 Much improved levels of satisfaction were recorded amongst patients who received leaflets, especially those for NSAIDs (P < 0.001) and for ,B-adrenoceptor antagonists (P < 0.01). 5 Subsequently, three hundred and fifty-eight (77%) of the patients prescribed either a NSAID or a ,3-adrenoceptor antagonist 1 year earlier responded to a postal questionnaire. The benefits in terms of knowledge and satisfaction were still apparent, although less marked than previously. Of the patients still taking P-adrenoceptor antagonists 70% had retained their leaflets over the intervening 12 months. 6 Ninety-seven per cent of patients read their leaflet regardless of whether it was distributed by a general practitioner or pharmacist. However, those who obtained it from a pharmacist tended to be more knowledgeable and satisfied. 7 We conclude that patients welcome the idea of receiving PILs. They improve patients' knowledge of how to take their medicines correctly and their awareness of potential side effects. Importantly, patients who receive leaflets are more satisfied than those who do not. These overall benefits justify the use of leaflets on a routine basis.

show abstract

Section: Methodsmentioning

confidence: 99%

The benefits of prescription information leaflets (1).

Gibbs

Waters

George

1989

Brit J Clinical Pharma

142

View full text Add to dashboard Cite

show abstract

“…8 One has to also take into consideration that the package insert not only aids the physician but also provides assistance and a tool for learning to the patient. 9,10 As mentioned above, all the inserts obtained from the chemists were in English. This could pose a problem to the reader in terms of understanding the information provided.…”

Section: Discussionmentioning

confidence: 99%

Analysis of package inserts of orally administered drugs available in the Indian market

Chhaya

2017

Int J Res Med Sci

View full text Add to dashboard Cite

Background:The package insert of a medication forms an important source of information to the patient while taking a drug. The package insert is expected to contain complete information regarding the drug aiding the patient to obtain additional knowledge regarding the drug. Methods: 100 package inserts of orally administered drugs were obtained from local chemists and were analysed according to the Sections 6.2 and 6.3 of Schedule D (II), Drugs and Cosmetics Act (1940) and Rules (1945). Results: The posology and contraindications were mentioned in 98% and 96% of the inserts, respectively, whereas the list of excipients, incompatibilities and shelf life was mentioned in 12%, 19%, 16% of the inserts, respectively. Conclusions: There is a wide variation in the information available on the package inserts of drugs available in the Indian market. The package inserts should be carefully scrutinized for completeness before the respective drug is marketed.

show abstract

“…The majority of these consultations end with the issuing of a prescription. In order to derive full benefit and to escape harm from these prescriptions, patients should be aware of their purposes and of any possible hazards; they should be sure of when and how to take their medicines, how to store them and how to dispose of them safely (Herman et al, 1978). Doctors and pharmacists should, between them, make sure that patients receive this information but with over 389 million prescriptions dispensed in 1983 (Office of Population Censuses and Surveys, 1985), both are working against time and often fail to do this (Fletcher, 1973).…”

Section: Introductionmentioning

confidence: 99%

Knowledge of and attitudes to medicines in the Southampton community.

Ridout¹,

Waters²,

George³

1986

Brit J Clinical Pharma

View full text Add to dashboard Cite

1 A 1 in 200 sample of the Southampton electorate was sent a postal questionnaire in January, 1984. Of the 740 adults surveyed, 443 (59.9%) returned completed questionnaires. One hundred and eighty-eight (42.4%) of those replying had been prescribed a medicine within the previous month. 2 Two hundred and seventy-five respondents (62%) felt that not enough was explained about medicines by doctors or pharmacists. 3 Consistent with this, was the fact that 37% were unaware of safe methods of disposal of leftover medicines. In addition, 112 of 154 (72.7%) people currently taking a prescribed medicine knew of no side-effects which could result from this. 4 Eighty-three per cent of respondents thought an information leaflet would be helpful. Of nine items which previous authors had suggested should be included, seven were thought to be important by more than 75% of those replying. 5 Although 54% of people wanted detailed information, 43% stated a preference for short, summarized points. 6 We conclude that most patients need to have more information about prescribed medicines and they would welcome written leaflets. However, further work is necessary to determine the best format for such leaflets.Keywords prescription leaflets patient knowledge side effects Introduction Sooner or later almost everyone has a medicine prescribed by their general practitioner and for many this is a frequent experience. It has been estimated that males visit their general practitioner on average 3.5 times and females 5.0 times annually (Office of Population Censuses and Surveys, 1984). The majority of these consultations end with the issuing of a prescription. In order to derive full benefit and to escape harm from these prescriptions, patients should be aware of their purposes and of any possible hazards; they should be sure of when and how to take their medicines, how to store them and how to dispose of them safely (Herman et al., 1978). Doctors and pharmacists should, between them, make sure that patients receive this information but with over 389 million prescriptions dispensed in 1983 (Office of Population Censuses and Surveys, 1985), both are working against time and often fail to do this (Fletcher, 1973). In any case, verbal advice is often forgotten (Ley, 1979) and technical jargon may confuse patients (Boyle, 1970 1979;George et al., 1983). However, we could discover no recent systematic study of patients' knowledge concerning medicines or of attitudes to prescription information leaflets. We, therefore, decided to carry out our own survey in Southampton.S. Ridout, W. E. Waters & C. F. George about medicines can be improved by the use of simple informative leaflets (Morris & Halperin, MethodsA questionnaire was designed, piloted and printed (Appendix). It was sent in January, 1984 with a postage-paid return envelope to a 1:200 systematic sample from the latest electoral registers of Southampton Itchen and Southampton Test. A repeat questionnaire was sent to those who had not replied after 1 month.The questionnaire was divided in...

show abstract

Package inserts for prescribed medicines: what minimum information do patients need?

Cited by 46 publications

References 2 publications

The benefits of prescription information leaflets (1).

The benefits of prescription information leaflets (1).

Analysis of package inserts of orally administered drugs available in the Indian market

Knowledge of and attitudes to medicines in the Southampton community.

Contact Info

Product

Resources

About