Laurence A Goldberg FRPharmS
Editorial Consultant, HPE
Encouraging the development of pharmacist-led smoking cessation programmes and regulations that prohibit smoking in public places are ways to help the global problem of rising cancer rates, according to Barry Goldspiel (Deputy Chief, National Institutes of Health Clinical Centre Pharmacy Department, Bethesda, Maryland, USA). Dr Goldspiel is a past president of the International Society for Oncology Pharmacy Practice (ISOPP) and the founder of the Journal of Oncology Pharmacy Practice (JOPP). Working together in professional organisations is a powerful way for pharmacists to bring about changes to the good, he said. Dr Goldspiel, recipient of the 2011 Donald E Francke medal, challenged the audience to achieve five goals in the care of cancer patients through their practice.
The first goal is to ensure that all patients with cancer receive the same level of care throughout the world. Recent reports show that there was an annual incidence of 12.7 million new cancer cases and 7.6 million cancer-related deaths in the world – a death rate that is greater than the combined deaths from HIV/AIDS, malaria and tuberculosis, he noted. Moreover, the world cancer burden is predicted to reach 20 million cases by 2030. Against this background, the United Nations has formed the Non-Communicable Disease Alliance to tackle the growing problem of non-communicable diseases, including cancer. (www.ncdalliance.com)
The first step in ensuring that high-quality pharmaceutical care is delivered throughout the world is to ensure that all oncology pharmacists have uniform training and experience, said Dr Goldspiel. The Board Certified Oncology Pharmacist (BCOP) credential would be an appropriate way to ensure that training had reached the required level, he suggested. Although this examination is based in the United States, nearly 200 pharmacists from 16 other countries have already qualified.
The second goal is to ensure that all healthcare workers who handle hazardous medicines will be protected from the possible adverse consequences of exposure. In this area, US pharmacists have learned much from the rest of the world, he acknowledged. “Foreign countries were the first to use closed-system transfer devices and they continue to lead the research efforts in safe-handling techniques,” he said.
The third goal is to eliminate medication errors with anticancer agents. Reports of inadvertent intrathecal administration of vinca alkaloids continue to appear and in future there could be more errors with oral anticancer agents, said Dr Goldspiel. Fragmentation of patient care with more than one pharmacy dispensing for a patient is likely to increase the risk of errors. Pharmacists should take responsibility in their own institutions for undertaking a safety survey then identifying and addressing shortcomings, he added.
The fourth goal is to ensure that all institutions develop ethical plans to manage oncology drug shortages. Drug shortages are now occurring in many countries and the problem for cancer treatment is that the true effects of the shortages might not be known for many years. “For example, we do not know the effects of delaying treatment, omitting a drug from a multi-agent regimen or substituting a similar drug in a regimen because supporting studies are usually lacking,” said Dr Goldspiel. One important step here is to ensure that each institution has a policy for drug shortages that clearly outlines the priority order for allocation of drugs in limited supply.
The fifth and final goal is that pharmacists’ contributions to improved drug therapy outcomes will be recognised worldwide. Consistent availability of pharmacists on oncology teams is probably the key to this, he commented.
In conclusion, Dr Goldspiel said that passion and perseverance would be essential to achieve the goals he had outlined. As examples, he said that without passion and perseverance neither the BCOP credential, which was rejected when first submitted, nor the JOPP, which was rejected by three publishers, would exist today.
Data from the most recent pan-European hospital pharmacy survey help to identify priorities for action, according to Roberto Frontini (Director of Pharmacy, University Hospital, Leipzig, Germany, and President of the European Association of Hospital Pharmacists). The survey comprised 87 questions on hospital pharmacy practice and involved a direct approach to 4747 hospital chief pharmacists in 31 European member states. The overall response rate was 26%, with the lowest coming from France, UK and Poland, and the highest from Macedonia. Where the response rate was low, the distribution of hospitals was checked with national coordinators to ascertain whether the pattern was likely to be representative.
One limitation to the survey was that it had to cover 23 different languages written using three different alphabets. There was also a possibility that non-native English speakers could have misunderstood some questions, acknowledged Dr Frontini.
The majority (81%) of hospitals were public (government-owned). Almost 60% of staff were hospital pharmacists and pharmacy technicians. The levels of staffing varied widely; overall there was one pharmacist per 100 beds but this ranged from 3.5 pharmacists per 100 beds in the UK to 0.33 pharmacist per 100 beds in Germany. Staff shortages were a problem in most countries.
Turning to clinical services, Dr Frontini said that only 23% of responses indicated that pharmacists were working on wards and only 7% provided regular ward services. Nearly 19% of hospitals had pharmacokinetic services and 42% had clinical nutrition services. About a quarter (24%) of hospitals were keeping records of pharmacy interventions.
Three quarters of hospitals have safe medication policies and 55% have clinical incident reporting systems in place. At least one safe medication activity is undertaken by 80% of hospitals, the most common being centralised preparation of cytotoxics (44%) and provision of drug information (55%). About half of hospitals undertake activities to avoid medication errors but only 16% document their interventions in the medical records.
Chinese hospital pharmacy
Hospital pharmacists in China are involved in purchasing, storing, prescribing and dispensing medicines, Zhu Zhu (Professor, Peking Union Medical College Hospital, Beijing, China) told the audience. Hospital pharmacies are very busy, typically processing about 300 patients per hour and aim to deal with each within 15 minutes. Patients prefer to attend hospitals because the quality of primary care physicians is often poor, she explained. Most pharmacists are 25–35 years old and female.
Clinical pharmacy in China is growing and the education system and practice model are changing accordingly, said Professor Zhu. The role of the clinical pharmacist was officially recognised in 2002. In 2010, the Chinese Ministry of Health issued management guidance on evaluation of prescriptions. This requires pharmacists to take action on irrational prescriptions. Further guidance required pharmacists to take the lead in ensuring appropriate prescribing of antibiotics. Hospital pharmacists are now expected to review prescriptions and to ensure the safe and appropriate use of medicines. They are also expected to work alongside other healthcare professionals and to deliver patient-oriented pharmaceutical services.
Global public health programmes
The US President’s emergency plan for AIDS relief (PEPFAR) represents the largest commitment in history to a single disease, amounting to some 15 billion US dollars, Mike Hope (former Chief Pharmacist, Indian Health Service) told the audience. The goals of the programme had been to treat two million cases, prevent seven million cases and to provide care for ten million people. So far, all goals have been achieved and exceeded and additional funds have now been authorised and the targets increased, he said.
The wider Global Health Initiative (of which PEPFAR is a part) aims to tackle malaria, tuberculosis, child health, nutrition, family planning and neglected tropical diseases. In doing this, it focuses strongly on strengthening of existing healthcare systems. When the programme was started, the need for a safe, reliable supply chain quickly emerged, explained Mr Hope. Two key elements are product selection and forecasting of needs. The World Health Organisation (WHO) has standard guidelines for treatment but regimen optimisation is an important activity in selecting country-specific regimens. Transitions also have to be managed when the WHO changes its guidance, noted Mr Hope. Forecasting of demand is based on consumption data, although this does not exist in many countries and so epidemiological methods are used instead. PEPFAR is a major global buyer of anti-retroviral (ARV) drugs and such has been the success of the programme that there are now ARV regimens that cost less than $100 (US) per person per year.
Another initiative, the Tanzania quality project, has used near infra-red (NIR) spectroscopy to determine the quality of drugs. The advantages of NIR are that it can provide, at relatively low cost, rapid, accurate screening results with the immediate release of products from quarantine. Moreover, the procedure is non-destructive and can operate through packaging materials, explained Mr Hope.
Minimising IV compounding errors
Errors with intravenous (IV) injections have continued to occur and make headline news, said Rita Shane (Director, Pharmacy Services, Cedars-Sinai Medical Center, Los Angeles, California, USA). One problem lies in understanding the scale of the problem. Studies have shown that for every reported error there are 17 errors that would be found at chart review and 300 that would be detected by observation. Drug shortages are now compounding the problem because healthcare staff are having to cope with unfamiliar concentrations of drugs, she added.
A combination of strategies is required to enhance IV compounding safety and quality. These include the use of out-sourced compounding services to reduce the on-site workload and training of staff, including competency assessment, and assessment of the risks associated with the use of specific products. Intravenous treatment has not been an area of focus in pharmacy training – one recent survey showed that only 13% of pharmacy schools felt that students had adequate training in this area, said Dr Shane. Another study had shown that when a group of students was asked to compound simple solutions only 54% prepared solutions that were within 10% of the desired concentration; the remainder had errors ranging from less than 75% to more than 200%.
Important measures to increase safety include the use of bar-coding for accurate product identification, automated compounders, workflow software and appropriate validation technology. Methods to check the accuracy of compounded products could include spectroscopy for many products and refractometry for dextrose in parenteral nutrition solutions. Independent double checks are recommended when handling high-alert, high-risk drugs.
High-complexity business requires a highly empowered workforce to achieve consistent levels of quality, said Eric Kastango (President and CEO, Clinical IQ LLC, Madison New Jersey, USA). This involves employing suitable people and providing the correct training and working environment, he continued. It is important to establish objective behavioural criteria as well as key performance indicators. In addition, there must be unambiguous policies, procedures and documentation methods. These should set out how IV preparation is to be done by all staff and how it will be measured. “If it’s important, measure it; people respect what you inspect,” said Mr Kastango. “Professional discretion has no place in the clean room,” he added.
All levels of staff should be involved in the development of key performance indicators and all staff should feel comfortable in pointing out or correcting a breach of policy. As individuals demonstrate competence, then proficiency and, finally, mastery of a topic, they should be given more independence and authority, he advised.
Now is the time for pharmacy practitioners to use innovation and technology to change the current processes for preparing compounded sterile products because this will enhance safety and accuracy, explained William Churchill (Chief of Service, Department of Pharmacy, Brigham and Women’s Hospital, Boston Massachusetts, USA). In future, robotic preparation of many intravenous doses could become the norm. Ideally this would be linked electronically to the pharmacy information system so that transcription errors could be eliminated. However, robots cannot make all admixtures and safety tools, and software systems will be needed to ensure that all intravenous doses can be made with equal precision. Several workflow software packages have been evaluated including ScriptPro, DoseEdge and i.v. SOFT.
The results show that, when compared with manual systems, such packages are able to prevent many product selection errors and enable faster processing of compounded products. In future, another useful technique will be “drug fingerprinting” for instantaneous final product checks. Each drug, concentration and diluent is associated with a unique pattern or fingerprint and a device will be able to match electronically the product fingerprint with the fingerprint held in a library.
The implementation of a novel, high-alert labelling scheme for insulin resulted in a sharp fall in the incidence of insulin-related incidents in one UK hospital, according to Miriam Klein (Assistant Director of Pharmacy, Medication Safety, Kings County Hospital Center, Brooklyn, New York, USA) and colleagues. Their poster described how two products, Humalog and Humalog Mix 25 were frequently involved in errors. New high-risk labels, in the shape of a ‘stop’ sign were produced. Clear plastic trays replaced coloured trays for insulin storage in ward fridges. The trays were labelled with the high-risk labels.
The usage patterns of short-acting inhalational anaesthetics and rates of day-case surgery were not as closely linked as might be expected according to a study by Ray Fitzpatrick (Clinical Director of Pharmacy, Royal Wolverhampton Hospitals, Wolverhampton, UK) and Ron Pate (Secondary Care Pharmaceutical Adviser, Keele University, UK). The short-acting anaesthetic agents, desflurane and sevoflurane, are considerably more expensive than isoflurane; it had been expected that they would be reserved for day cases, which are usually short procedures. The results showed that there was no correlation between day case rates and the use of short-acting anaesthetics. The authors concluded that there was an opportunity to reduce anaesthetic costs in some hospitals in England.
A study by David Hellens (City Hospitals, Sunderland, UK) investigated the times taken to complete medicines reconciliation on a medical admissions ward. The results showed that it took just over 11 minutes on average to complete the task. A prioritisation scheme categorises patients who require medicines reconciliation into red, amber or green categories according to the urgency of the intervention required. This study confirmed the value of the scheme – red interventions took longer than the others and identified more discrepancies.