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Safe, effective use of medicines, patient information and advertising standards were key topics at the UK Clinical Pharmacy Association symposium, held in Leeds, UK, on 16–18 November 2007.
The Prescription Medicines Code of Practice Authority (PMCPA) administers the Association of the British Pharmaceutical Industry’s (ABPI) code of practice, at arm’s length from the association itself. The code covers promotion of medicines to health professionals and provision of information to patients about prescription-only medicines. Etta Logan (secretary, PMCPA) explained some of the key issues and potential pitfalls.
She said promotion must be in accordance with the marketing authorisation, accurate, balanced and up to date and must not mislead or exaggerate. It must also be supported by evidence. Also, promotion must be tailored to the audience at whom it is directed, of a high standard and unlikely to cause offence. Promotion must not bring discredit to the pharmaceutical industry, disparage competitors or health professionals or be disguised. For example, an advertisement for sibutramine for weight loss which suggested that patients with breast cancer and colorectal cancer might be among those who would benefit from the drug was held to be misleading, as sibutramine has no action against cancer.
When professional meetings are sponsored by the drug industry, it should be the programme that attracts participants and not the venue or the hospitality level. Indeed, the code specifies that hospitality provided should be at a level delegates themselves would normally pay for. The code also covers activities of representatives, gifts and promotional aids, and medical and educational goods and services.
The PMCPA can impose a number of sanctions if companies are found to have breached the code. These include rapid cessation of promotion, public reprimand, publication of corrective statements and, in the last resort, suspension or expulsion by the ABPI board of management.
Etomidate for intubation
A study has failed to confirm an association between etomidate use and be used for intubation, Robert Shulman (University College Hospital and the School of Pharmacy,
London) told the audience.
Etomidate is the ideal agent for intubation because it has a rapid onset of action and a predictable recovery profile. In addition, it causes limited suppression of ventilation, has good cardiovascular stability and does not provoke histamine release.
In 1984 a study showed that mortality in intensive care unit (ICU) patients increased from 25% to 44% when etomidate replaced benzodiazepines for intubation. Patients who received etomidate required higher doses of vasopressors and had low cortisol levels. Experimental evidence suggests that etomidate inhibits cytochrome p450 and thereby interferes with corticosteroid synthesis. Studies comparing the effects of etomidate and midazolam and thiopentone on cortisol levels showed that the response to adrenocorticotropic hormone was blunted in etomidate-treated patients. These results led to the recommendation in 2005 that the use of etomidate for intubation be discontinued and that hydrocortisone should be given to those who had received etomidate. However, these results should be interpreted cautiously because fewer than 200 patients in total were involved in the studies,
Dr Shulman commented.
A retrospective review of 104 patients – 55 who had received etomidate compared with a matched control group of 49 patients – was carried out. There were no differences in mortality, the use of vasopressors, organ function or intravenous colloid use. This study was powered to show a 28% difference in mortality. In order to show a 5% difference, 1,500 patients would be needed in each group,
Dr Shulman pointed out.
The researchers had concluded that etomidate-treated patients did not have worse outcomes than the control group and as a result the ICU team at University College Hospital has decided to continue to use etomidate for intubation.
Dr Shulman and colleagues received The GSK Advanced Practitioner Award for this piece of work.
Adverse drug reactions in inpatients
Adverse reactions to medication occurred in 15% of inpatients in a study conducted by Emma Davies and colleagues (Royal Liverpool and Broadgreen University Hospital Trust).
Two-thirds of patients experienced symptoms due to adverse drug reactions (ADRs) and more than 50% were classified as “definitely or possibly avoidable”.
The study involved 12 wards over a 12-month period and 3,695 patient episodes were recorded. A total of 559 episodes resulted in one or more ADRs, giving a total of 750 ADRs. The causative drugs were prescribed in hospital on 82% of occasions and the vast majority (94%) were ADRs of type A – that is, they were pharmacological, dose-related and reversible. Just over 50% ADRs involved drug-drug interactions.
The most frequent ADRs were electrolyte disturbances (22%), constipation (14%) and raised INR values (8%). The top 10 ADRs also included hypotension, hypoglycaemia and Clostridium difficile infection. The most frequent causative drugs relative to usage were warfarin, streptokinase, unfractionated heparin and loop diuretics. Warfarin was generally less well monitored than streptokinase, Ms Davies commented. Moreover, some drugs that commonly cause ADRs, such as daunorubicin, were not
prescribed in the sample patient group.
Patients who experienced ADRs were receiving an average of nine regular medicines compared with six in non-ADR patients. In addition, the median length of stay for ADR patients was 20 days compared with eight days for non-ADR patients. In 147 patients the prolonged hospital stay was directly related to the adverse drug reaction. This was equivalent to 4% of all inpatient episodes, Ms Davies noted.
Mortality was greater in the ADR groups (10.4% vs 4.0%) and 14 deaths were linked to ADRs. These involved renal failure, C. difficile infection, gastrointestinal bleeding and ischaemic bowel.
It was possible that this study underestimated the true frequency of ADRs, Ms Davies said. She concluded that ADRs usually affect the most severely ill patients, are often caused by “everyday” drugs and are usually preventable.
Ms Davies was awarded the Hameln prize for the best oral presentation.
Swallowing difficulties
As many as 25% of hospitalised patients and up to 65% of acute stroke patients are dysphagic, according to Portia Jackson (Norfolk and Norwich
Hospital).
Ms Jackson and her colleagues investigated the administration of oral medicines in patients with dysphagia and in patients with nasogastric tubes in situ to find out how far guidelines for good practice were being followed.
Over a four-week period nine patients were recruited in whom 147 administrations were observed – 106 in dysphagic patients and 41 in patients with nasogastric tubes.
For dysphagic patients tablets were commonly crushed or dispersed in water and mixed with a thickening agent. On several occasions tablets were crushed and added to liquid medicines, Ms Jackson noted. For patients with nasogastric tubes, tablets were commonly dispersed in water.
About 40% of administrations were potentially inappropriate and 12% were potentially inappropriate for more than one reason. Crushing tablets when a licensed liquid preparation was available or crushing or dispersing multiple preparations together were the main reasons for inappropriateness. Inappropriate tube flushing was common in patients with nasogastric tubes.
When nurses sought advice about medicines administration their first choice was the speech and language therapy team; pharmacists were the second choice. The most common question was whether or not to crush a product.
Ms Jackson concluded that there should be a greater pharmaceutical input on stroke units and individualised pharmaceutical care plans should be prepared for patients. Guidelines should be more prominent and explicit and deficiencies in nurse education in this field should be addressed. It might also be helpful to identify patients with swallowing difficulties by applying fluorescent stickers to prescription documents, she suggested.
Information about analgesics
Extensive consultations with surgical postoperative patients were a key step in the development of information leaflets about analgesics, in a project undertaken by Dawn Farmer and Linda Cairney (clinical pharmacy manager and pharmacy technician, Hairmyres Hospital, East Kilbride, Scotland).
A questionnaire was designed to find out what postoperative patients knew about their analgesic treatment and what information they wanted. The results showed that information about side-effects, interactions and the availability of products was required.
A leaflet was prepared to include information about co-codamol, diclofenac, etoricoxib, ibuprofen, morphine, oxycodone and paracetamol.
A second survey was conducted to assess patients’ level of satisfaction with the information provided. The majority of patients were satisfied with the final document. One patient had commented: “Today’s medicines all seemed to have two names, different colours and were very confusing”. Another commented that “some [medicines] taste vile” and “at home it’s so difficult to get tablets out of vacuum packs”.
The leaflet is available on the local intranet at Hairmyres Hospital and has now been put into routine use. Surgical pre-assessment clinics are now thinking of using the leaflet to make sure that patients are well-informed in advance, Ms Farmer said.
Ms Farmer and Ms Cairney received the Napp Pain Award for 2006.
Redesign of ICU and HDU medicines chart
The introduction of a new prescription document in intensive care and high-dependency units (HDUs) brought about a reduction in prescribing and administration errors and improved patient safety, according to Patricia Ging (senior clinical pharmacist, Mater Misericordiae University Hospital, Dublin, Irish Republic).
Prescribing and administration were separated in the original document so that it was difficult to follow treatment. Each morning doctors rewrote prescriptions in the prescribing section and nurses were responsible for transferring the information to the administration section. Frequent crossings-out and rewrites meant that by the end of the day it was difficult to interpret the prescriptions correctly. This was a major problem in day-to-day use, Ms Ging said.
Further difficulties arose if the doctors did not rewrite the prescription until late in the day. Nurses dealt with the problem by copying the previous day’s administration record, without referring to the prescription at all. A short survey had shown that this gave rise to a number of administration errors – prescribed medications were not given and
discontinued medications were given.
“No more separate prescribing and administration records” was a key principle in the redesign of the prescription document, Ms Ging explained. In addition, the new document no longer required
doctors to rewrite prescriptions daily.
The introduction of the new prescription document led to reductions in transcription and administration errors. Other important results were that prescriptions were ready by 14h30 and allergy boxes were usually completed – neither of which had been the norm beforehand.
Some further refinements were made to the final document, such as adding the “day of therapy” to antibiotic prescriptions so that users were made aware of the current duration of treatment.
The new prescription has multiple sections and is 12 pages long. One unexpected benefit of its introduction is that it now takes less time to check prescriptions than before, Ms Ging said. Furthermore, when patients are transferred to general wards it is easy to follow their treatment records.
Ms Ging was the recipient of the Lilly UK Critical Care Award. ■
