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Safety Information

Revised: 3 July 2013

Adverse Reaction Reporting by Community Pharmacists

Community pharmacists encouraged to report

For some years now the New Zealand adverse reaction reporting card has specified ‘pharmacist’ as a potential reporter of adverse reactions, but very few pharmacists report. In fact the proportion of the total adverse reaction reports received by the Centre for Adverse Reactions Monitoring (CARM) from community pharmacists is less than 2%. This low level of reporting is unfortunate because with increasing numbers of medicines being given an OTC classification and increasing use of herbal and other complementary healthcare products, many medicines are used without the intervention of a medical practitioner.

New allergic adverse reactions to Difflam™ identified by pharmacist reporting

Reports by pharmacists can make a difference as the following example illustrates. Several years ago pharmacists reported a series of 4 cases of systemic reactions to topical benzydamine-containing preparations (Difflam™). In one case, an erythematous maculopapular rash, fever and myalgia developed after the application of Difflam gel for a sprain. Sucking a Difflam lozenge was followed by a widespread macular rash in a second case and by dizziness and inco-ordination in a third. In the fourth case constriction of the throat with difficulty breathing occurred 8 minutes after gargling with Difflam solution. The reporting of these adverse reactions resulted in publication of a Prescriber Update article1 and a modification of the information about systemic adverse reactions, including mention of hypersensitivity skin reactions, in the data sheets for the Difflam products.

Pharmacist’s particular niche: adverse reactions to OTC products

The inside back cover of the New Ethicals Catalogue indicates what adverse reactions should be reported—those that are serious or unexpected or interactions with other medicines, healthcare products or foods. Generally medical intervention would be required for serious adverse reactions, and an interaction may demand a change in prescribed medication. However, pharmacists are likely to be consulted about, and be in a good position to report, non-serious, but troublesome, unexpected reactions to medicines or complementary healthcare products. If the medicine was prescribed, it may be helpful, with the patient’s consent, to advise the patient’s GP or the prescriber about the adverse effect. In cases of a serious reaction, it would be important for the medical practitioner to be advised.

Report even if unsure of causality

It is not necessary to be certain that an adverse reaction is caused by a medicine in order to make reporting worthwhile. The nature of some adverse reactions is such that it is impossible to know in the particular instance whether there is a causal association. Venous thromboembolism with combined oral contraceptives is an example of one such adverse reaction. In cases like this a handful of reports with a temporal relationship to a medicine can raise suspicion and trigger further investigation.

Supply as much detail as possible

A copy of the adverse reactions reporting card is inserted in each issue of the New Ethicals Catalogue and further supplies are obtainable from CARM (PO Box 913, Dunedin). The form can also be downloaded from this website. Further information about adverse reaction reporting and advice about assigning causality can be obtained from this subsection of the site. This simple adverse reaction reporting form indicates the information required when submitting a report. The more detail (e.g. temporal relationship with the use of the medicine, description of the adverse event) supplied the better, but reports lacking in detail are nevertheless valuable.

Patient’s personal details important

The form asks for the personal details of the patient. Personal information is necessary to check that the event has not been reported previously and to identify the reaction specifically with the patient so that the details can be entered in the danger/warning system against the patient’s name. Serious or potentially serious adverse reactions are entered on the National Patient Database as a "danger" or a "warning" to provide an alert on admission to a hospital anywhere in the country. A "danger" entry indicates that further exposure may be life-threatening or result in serious harm.

For a reaction involving a prescribed medicine, the name of the patient’s GP should also be supplied, because CARM may need to make contact. An informative letter of reply is sent to the reporter in response to each adverse reaction report.

Adverse reaction reports used to increase the safe use of medicines

Anonymised data from the adverse reactions database are used in a variety of ways. The information is sent to the international adverse reactions database held by the World Health Organisation. Serious or unusual adverse reactions are reviewed by the Medicines Adverse Reactions Committee at its quarterly meetings. The Committee makes recommendations on appropriate action, for example publication of a Prescriber Update article or a change in the medicine data sheet. In addition, data from the CARM database can be obtained on request if there is a particular interest or concern.

Community pharmacists are uniquely placed to fill a niche in adverse reaction reporting, particularly for reactions occurring with OTC medicines, or complementary healthcare products, and for non-serious and unexpected or unknown adverse reactions. However, pharmacists need not feel they cannot also report serious adverse reactions to prescribed medicines. The information gained will lead to a safer use of these products.

1. PI Pillans. Reactions to topical benzydamine. Prescriber Update No.5, May 1994, p.14.

UK initiatives for pharmacist reporting

Adverse reaction reporting by all community pharmacists was introduced in the United Kingdom in November 1999, following a pilot introduction in four areas (Wales, West Midland, Mersey and Northern) in April 1997.1

A survey2 of the reports received from pharmacists during the first year of the pilot programme found that pharmacists reported adverse reactions for the entire range of medicines, and that they were more likely than GPs to report adverse reactions to herbal medicines and instances of suspected generic inequivalence.

86% of GPs and 96% of pharmacists in Wales who responded to a questionnaire considered that community pharmacists had a responsibility to report adverse reactions.3 There was no evidence of pharmacist reporting causing difficulties between the pharmacist and the general practitioner. The two major reasons given for not reporting adverse reactions was that the adverse effect was known (64%) or the pharmacist was uncertain of causality (24%).

As part of the new initiative, pharmacists reporting an adverse reaction were being encouraged to discuss it with the patient’s general practitioner prior to sending it in.1

  1. Pharmaceutical Journal 263:776, 13 Nov 1999.
  2. S Davis, R Coulson. Pharmaceutical Journal 263:786-8, 13 Nov 1999.
  3. J Houghton, F Woods, S Davis, R Coulson, PA Routledge. Pharmaceutical Journal 263:788-91, 13 Nov 1999.

 

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