More than 22,000 participants attended the 51st Midyear Clinical Meeting of ASHP. Programme highlights included implementation of second victim schemes, data-mining to optimise precision medicine, hepatitis C management and mental illness
Laurence Goldberg
Editorial Consultant, HPE
Christine Clark
Editor HPE
More than 22,000 participants attended the 51st Midyear Clinical Meeting of ASHP. Programme highlights included implementation of second victim schemes, data-mining to optimise precision medicine, hepatitis C management and mental illness
Laurence Goldberg
Editorial Consultant, HPE
Christine Clark
Editor HPE
When adverse events result in patient harm, support for the health care professionals involved is often neglected, sometimes with far-reaching, even fatal, consequences.
The term ‘second victim’ has been applied to these individuals, according to Natasha Nicol (Global Medication Safety Officer, Cardinal Health, US). Second victims have been defined as “those who suffer emotionally when the care that they provide leads to patient harm”. Two high-profile cases in the US illustrated the problem: Kim Hiatt, an experienced paediatric nurse, was dismissed after being involved in a fatal medication error. In spite of retraining, she could not find work and took her own life a few months later. Pharmacist Eric Cropp was involved in a fatal medication error. He was convicted of involuntary manslaughter and jailed; his pharmacy licence was permanently revoked.
Dr Nicol described her own experience in a busy, understaffed, poorly equipped hospital pharmacy. A potassium chloride injection that she had issued for a two-year-old child had caused a fatal cardiac arrest. She was horrified to see her initials on the label of the product and was plunged into a turmoil of emotions – shock, bewilderment, self-doubt and despair. That evening she considered leaving pharmacy altogether but then decided to fight for changes to prevent future incidents of the same type.
She told the hospital board that the pharmacy needed “the best automation”, facilities to segregate paediatric and adult services in the pharmacy and specialist paediatric pharmacists. The changes were made and the hospital pharmacy service improved dramatically over the next few years. Nevertheless, Dr Nicol admits that, even now, years after the event, there are few days when she does not remember the pain of the incident.
Previous work had shown that the most common source of support for second victims was colleagues and peers, Kara Berasi (Assistant Director, Ambulatory Pharmacy Services, University of Florida Health Shands Hospital, US) told the audience. The first step should always be to remove the individual, who is likely to be flustered and anxious, from the situation. It is important that health care professionals learn to recognise the signs of distress in a colleague and learn what to say. Questions such as, “Are you OK?” and, “How do you feel about what happened?” are appropriate. On no account should a colleague say things like, “Everything will be OK” or “Don’t worry about it”.
A six-phase recovery trajectory for second victims has been described (see Table 1).
About 30% of second victims experienced personal problems and 13% contemplated leaving their jobs or leaving their profession altogether, according to Jenna Merandi (Medication Safety Coordinator, Nationwide Children’s Hospital, Ohio, US). In July 2013 her hospital embarked on the development of the “You matter” campaign – a multidisciplinary initiative to support second victims. A four-hour training programme for peer supporters has been developed. This includes teaching of basic peer support skills by clinical psychologists.
Training programmes always start with people describing their own experiences of incidents – “Some people have shared things that they have not talked about for 20 years”, said Dr Merandi. More than 500 peer supporters have now been trained and more than 400 encounter forms have been completed, the majority of which come from the emergency room (ER) and intensive care unit (ICU). Trained peer supporters wear green ‘You matter’ badges, she added. One unexpected finding was that interpreters often became second victims; one had explained that it could be extremely traumatic to deliver bad news in a foreign language to a patient or relative.
Speakers agreed that awareness of the phenomenon of second victimhood and the existence of a non-punitive culture were important ingredients for setting up support schemes for second victims.
Informatics and precision medicine
‘Big data’ can be harnessed to guide and inform precision medicine, according to Russ Altman (Professor of Bioengineering, Genetics, Medicine and Biomedical Data Science, Stanford University, California, US). He described three landmark projects in this field.
Pharmacogenetics
A patient’s genetic status is “knowable in advance” and there is now sufficient evidence to make pharmacogenomics a useful tool in routine practice. The advent of rapid, cheaper, complete genome sequencing combined with user-friendly clinical guidelines, such as the pharmacogenomics implementation consortium (CPIC) guidelines, makes this possible, said Professor Altman. CPIC guidelines for specific drugs have been designed to make the research literature accessible and usable for practitioners rather than researchers.
The CPIC guidelines have been developed from the research-oriented pharmacogenomics knowledge base (PharmGKB) database that was produced in Professor Altman’s laboratory. A key feature of the database is pathway diagrams that show how every drug listed is metabolised. CPIC guidelines are now available for warfarin, tricyclic antidepressants, codeine and many others. However, physicians do not have the time or the knowledge to use genetic information (about medicines) routinely – ideally pharmacists should be selecting and prescribing the most suitable drugs and doses for individual patients, he said.
“Almost everyone has something that makes genome sequencing worthwhile,” said Professor Altman. For example, a colleague had turned out to be heterozygous for a null mutation in CYP2C19 – an enzyme that is critical for metabolism of proton pump inhibitors, anti-epileptics, clopidogrel and citalopram. When, in future, drug treatment is required, this information could be useful in selecting the most appropriate agents, he suggested.
Unexpected drug interactions
Existing databases contain a wealth of information that can be searched using appropriate techniques. In one such project, the 20 million abstracts in PubMed were searched to identify the 170,000 abstracts that contained a sentence that included a drug, a gene and an effect. Researchers argued that if a gene is involved in the metabolism of a number of drugs, then drug–drug interactions might occur as a result of competition for pathways. This hypothesis was tested by sifting the data to find drug combinations that were known to interact. Next, other combinations were explored. One of the predicted drug–drug interactions was metoprolol and dextromethorphan, both of which are metabolised by CYP2D6. The discovery of a published case study of a woman given the two drugs in hospital who suffered from severe side effects from both drugs confirmed the existence of the interaction, said Professor Altman.
Using records and FDA databases to discover drug interactions
The database of adverse reactions reported to the Food and Drug Administration (FDA) could be another source of information about hitherto unreported drug interactions. FDA releases all adverse reaction reports, but these reports are generally considered to be “very noisy data” and difficult to interpret, said Professor Altman.
One researcher analysed reports for patterns of events that predicted the likelihood of a drug altering blood glucose. In this way he was able to identify drugs that are known to alter blood glucose as a side effect – and this served as validation for the method. He then examined pairs of drugs, neither of which appeared to affect blood glucose alone, but when taken together, gave the same signal as known glucose-altering drugs. Many combinations were too rare to be of interest but the combination of pravastatin and paroxetine seemed likely to occur in practice. It was estimated that there could be 0.5–1.0 million Americans taking both drugs. In order to demonstrate an effect, it was necessary find patients who were taking one of these drugs, had had a glucose measurement and then were given the other drug and had a further glucose measurement within a 40-day time frame.
Only 11 patients could be found at Stanford but colleagues at Vanderbilt and Harvard supplied more than 100 additional cases. The pooled analysis showed an average increase in blood glucose levels of 16mg/dl. “This is not a class effect – it is specific to the pravastatin-paroxetine combination”, emphasised Professor Altman. The initial study excluded diabetics because it was reasoned they would have detected and corrected the rise in glucose as part of their routine monitoring. However, when diabetics were analysed, the average rise in blood glucose on the combination was 60mg/dl – “crazily high”, said Professor Altman. The effect was confirmed experimentally in a mouse model – the mice were fed on butter and Sprite.
In a further development of this work, the researcher examined Internet search logs (Bing) to see whether patients were experiencing symptoms and searching for information. He found that patients searching for information on the two drugs and phrases such as “peeing a lot” caused a ten-fold ‘bump’ above the baseline. As a result, the FDA has now started collaboration with Microsoft to identify signals of problems with newly released medicines. Such findings do not prove there is an effect but they do provide useful signals, said Professor Altman.
Tweets might also be a good source of information, but they are difficult to interpret using current techniques because tweets are not written in proper English, he added. He also acknowledged that if a side effect is mentioned in the news, many people search for it online and create a spurious peak in data.
Future developments in this field include ‘drug repurposing’ as informatics helps to uncover ‘unofficial’ effects of established drugs, suggested Professor Altman.
Hepatitis C
Working closely with patients on the management of hepatitis C is a big opportunity for hospital pharmacists to improve patient safety, outcomes and efficiency – and patient feedback indicates that pharmacists really add value, Carmen Rodriguez (Gregorio Marañón University Hospital, Madrid, Spain) told the audience at the International Pearls session.
Some 700,000 people in Spain are sero-positive for hepatitis C virus (HCV) and the Spanish national strategic plan calls for all patients with hepatic fibrosis of grade 2 or above to be treated with direct-acting antiviral drugs (DAAs) within two years. Three full-time pharmacists are involved in the multidisciplinary team that manages patients with HCV infection at the Gregorio Marañón University Hospital. During the 12-month period April 2015–April 2016, there were 4845 pharmacy consultations involving 1146 patients. About a quarter of patients were infected with both HIV and HCV and 62% had grade 3 or 4 hepatic fibrosis. The results showed that 92% of patients achieved a sustained virological response. The most common side effect was anaemia and approximately 7% experienced severe adverse events. Cost savings of nearly €1.5 million were achieved as a result of pharmacists optimising the DAA therapy, said Dr Rodriguez.
Psychiatric ‘inreach’ service
Patients with serious mental illness who are admitted for acute physical conditions can have significant unmet pharmaceutical needs in relation to their psychotropic medication. Raliat Onatade (Interim Pharmacy Services Manager, Medway Hospital NHS Foundation Trust, UK) described how a pharmacist from a nearby psychiatric hospital had been co-opted to provide specialist psychiatric pharmacy ‘inreach’ services on several days each week at Kings College Hospital, London, UK. “Where specialist clinical knowledge is lacking, pro-active review by a specialist is essential – you don’t know what you don’t know”, she explained.
During the period December 2015 to April 2016, 205 patient encounters and 313 clinical contributions were made. Patients taking clozapine or selective serotonin reuptake inhibitors were most likely to benefit from pharmacy interventions. The relative risk of a patient taking clozapine being at ‘high risk’ or ‘extreme risk’ without an intervention was 2.46 (95% CI 1.33–4.56, p=0.02), she said. The psychiatric pharmacist also developed a psychotropic medication review checklist for non-specialist pharmacists to use. It is not unusual for doctors to work across two or more organisations and it is a model that could usefully be adopted in pharmacy, concluded Ms Onatade.
