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Global initiatives and safe systems


Laurence A Goldberg FRPharmS
Editorial consultant

In recent years, new global health initiatives have dramatically affected the ways in which developing countries procure, distribute and manage pharmaceuticals, according to Douglas Keene (Strengthening Pharmaceutical Systems Program, Management Sciences for Health, Arlington, Virginia). One fund alone (The Global Fund) has approved grants for almost $20 billion (€14.4 billion), about half of which was allocated for medicines and commodities. Consequently, health supply systems in recipient countries have had to manage hugely increased volumes of medicines, in particular, those used to treat HIV, malaria and tuberculosis. In many cases this has uncovered weak infrastructures and poor human resource capacities.

Interventions to build pharmacy infrastructures in the poorest parts of the world have to be sustainable and they need to be designed specifically to fit the context in each country, explained Dr Keene.

Within his organisation they have developed a ‘six by five’ framework for strengthening health systems. In essence, this prioritises six measures that strengthen health systems including pharmaceutical, management, health care financing and health information, along with five target areas that increase overall health impact, including HIV and AIDS, tuberculosis, maternal, newborn and child health. In addition, a model is used to identify how pharmacy service fits into the different tiers (for example, national, regional, local) of an organisation and the different sectors (for example, public, private, partner bodies). The model helps to analyse weaknesses in the system, he commented.

Capacity building, both for individuals and institutions, is critical. If the target is for people to develop skills, then a key outcome is that they should be able to solve a problem, said Dr Keene.

Global expenditure on AIDS has increased sharply since 2000. The Global Fund to Fight AIDS, Tuberculosis and Malaria spends about 48% of its outgoings on drugs and commodities and this vastly overshadows expenditure on systems or equipment. The result has been a large influx of products into countries that are not equipped to deal with them, noted Dr Keene. For example, in countries such Ethiopia, Mozambique and Rwanda there are fewer than three pharmacists per 100,000 population. In such situations focusing on pharmacists would not be an effective intervention, he said. Given that $17.7 billion (€12.7 billion) has been pledged for 2011-2013 (for the Global Fund) a big effort is needed to ensure that recipient countries can use the medicines in the most effective way.

In Ethiopia, patients often have to wait outside pharmacies or clinics with no protection from the weather, whilst inside, storage facilities for medicines are cluttered and poorly organised. Interventions in Ethiopia have ensured that about 200,000 people are now receiving anti-retroviral drugs (ARVs) and have helped 544 hospitals to develop standard operating procedures (SOPs) for patient registration and inventory control. Furthermore, pharmacy counselling booths have been built, as part of a ‘renovation’ project, to give patients protection and privacy. There is still much to do – at present ARV outer packages are routinely discarded because they identify the owner as one who has AIDS (a condition that carries a heavy social stigma). The boxes are widely recognised since being shown on the television, said Dr Keene.

An initiative in Kenya supported by a grant from the Bill & Melinda Gates Foundation has improved the quality of drug treatment for many people. Retail drug outlets supply medicines to about 50% of the population in Tanzania. They are authorised to sell both over-the-counter (OTC) and prescription medicines but the staff are often untrained, the law relating to prescription medicines is not enforced and storage conditions are often very poor. A project was undertaken to create accredited drug dispensing outlets (ADDOs). The strategy was designed to bring drug sellers into the mainstream of healthcare delivery through accreditation and regulation. Incentives were provided and consumers assured ADDOs provided good quality products and service. ADDOs have provided opportunities for rural women; according to Dr Keene, 25-40% of ADDO owners and 90% of licensed dispensers are women. Moreover, ADDOs have served as a platform for other healthcare interventions such as the supply of artemisinin-based combination therapy and insecticide-treated nets to combat malaria. So far, 1720 ADDOs have been licensed and 3382 dispensers trained. The programme has helped create a new category of health worker and improved the performance of numerous previously untrained, unregulated individuals, said Dr Keene.

Agathe Wehrli – medal winner
The Donald E Francke Medal, awarded annually to a person who has made an outstanding contribution to pharmacy, was presented to Agathe Wehrli who worked for 33 years at the World Health Organization (WHO) in Geneva and since her retirement in 1998 has established Pharmabridge – with the International Pharmaceutical Ferderation (FIP) – a programme to strengthen pharmacy education and services in developing countries through support and links with pharmacists in more affluent areas.

Book donations from the USA constitute the backbone of the Pharmabridge programme. The American Society of Health-System Pharmacists (ASHP) has offered over 8000 reference books. Other publishers have also made donations.

The American Pharmacists Association (APhA) offers 10 sets of five reference books each year and Wolters Kluwer Health has made a one-time donation of 3000 books. Another element of Pharmabridge is the organisation of practice exposure (usually four weeks) for pharmacists from developing countries in practice sites in countries where pharmacy services and educational programmes are well advanced.

Reflecting on her experiences at WHO, Dr Wehrli described some of the landmarks in the development of pharmacy worldwide. In 1985, the World Health Assembly adopted the WHO strategy on the rational use of drugs. In 1988, New Delhi hosted the first meeting that addressed the role of the pharmacist in the healthcare system. The Delhi report defined the overall role of the pharmacist and provided pharmacists in developing countries with a document to inform ministers of health about how WHO experts saw the role of the pharmacist.

In 1993 a meeting in Japan focused on pharmaceutical care. This was critical because at the time Japanese physicians undertook most dispensing, and community pharmacists were left to sell over-the-counter (OTC) medicines, tonics and toothpaste, said Dr Wehrli.

In 1997 a meeting in Vancouver focused on curricular development. Shortly afterwards the pharmacist was recognised as an untapped source for the promotion of public health and in 2007 FIP, WHO and the United Nations Educational, Scientific and Cultural Organization (UNESCO) formed the Pharmacy Education Taskforce with the goal of catalysing actions to develop pharmacy education.

Reflections on medication errors
‘Pharmacy workers cannot rely on trust, they must check’, as Rita Shane, Director of Pharmacy at Cedars-Sinai Medical Center, Los Angeles, told the audience at a session focused on the impact of medication errors. Dr Shane described how she had been called late at night and told that in her hospital the twin babies of a VIP had been given the wrong dose of heparin (as a flush) because the concentrated form had accidentally been supplied to the ward.

“We had been trying for years to eliminate heparin flushes and substitute saline,” she said. The supply had been made from a mixed adult/paediatric satellite pharmacy. Again, they had already identified through prospective failure mode and effects analysis (FMEA) that separation of adult and paediatric functions was desirable. In the detailed analysis that followed, the experienced technicians involved in the error admitted that they trusted each other ‘because she always gets it right’ and so the double-checking procedure had failed. Shortly after the event a member of staff sold the story to the media and no fewer than seven regulatory reviews followed.

The first few months after the incident were the post-traumatic stress stage, said Dr Shane, accompanied by feelings of profound humiliation and embarrassment. There was a unpleasant period of ‘finger-pointing’ and safety procedures for pharmacy and nursing were critically revisited. As a result a number of lessons were learned and a strong bond was forged between pharmacy and nurses. Vigilance and error reporting increased in the hospital and one of the biggest contributory factors to errors was found to be people trusting each other. “Nurses were not doing real independent double checks,” said Dr Shane.

It is critical to balance a non-punitive culture with accountability; there is a difference between accidentally putting the wrong product in place and intentionally bypassing a policy. Amongst the measures that have been implemented to increase medicines safety at Cedars-Sinai there is now a pharmacy training programme (Residency) on medicines use systems and safety.

Healthcare practitioners who are involved in medication errors and adverse drug events can become the ‘second victim’, feeling guilty and abandoned by their peers. Current knowledge of the critical incident stress response should be extended to support such practitioners, Susan Paparella, Vice President of the Institute for Safe Medication Practices, Philadelphia, told the audience.

Nurses and other healthcare practitioners who are involved in errors display a  variety of responses after an event, often dictated by external forces. Sometimes responses are prompted by the misguided beliefs that good practitioners never make mistakes. Similarly, people say ‘It would not happen here’ and ‘We have good policies in place’. In reality, errors occur everyday but many are not reported. Sometimes this is because people do not report errors that do no harm or those that do not reach the patient. On occasions nurses have been known to get an order (prescription) written to cover a dose that was given in error. This makes the error into a ‘non-error’ that does not need to be reported in the nurse’s mind, Ms Paparella explained. However, errors can impact providers personally, socially and culturally. Individuals can be morally troubled, can feel abandoned by the system and can become professional outcasts. Many of these feelings are fuelled by fears, for example fears of patient harm, loss of reputation, litigation, job loss or criminalisation. Those involved in errors can become second victims by default through tacitly punitive organisational responses including lack of support, absence of employee assistance programmes and abandonment by co-workers, managers and the organisation itself. Ms Paparella recommended that effective institutional awareness of practitioner responses to errors should involve promoting an open dialogue about the issue, creating internal support mechanisms and using critical incident stress management (CISM) techniques.

Safety award
A project that focused on optimising medication use and outcomes in kidney transplant patients at the Medical University of South Carolina (MUSC) was the winner of the 2010 award for excellence in medication-use safety. The award worth $50,000 (€36,000) is the only national honour that recognises a pharmacist-led multidisciplinary team for implementing significant institution-wide improvements in medication safety.

Patients about to receive a kidney transplant have complex medication regimens when they enter the hospital. After transplant, they start completely different regimens to prevent organ rejection and infections. The team at MUSC knew that 29% of patients had longer than planned hospitalisations, often because of logistical problems with delivering discharge medicines. In addition, early readmissions of transplant patients were often due to inadequate education about the use of their medicines.

Over a period of 18 months the team at MUSC implemented a multiple-step initiative to decrease the length of hospital stay and preventable readmissions for kidney transplant recipients while optimising outcomes for the patients and their allografts.

The team revised transplant protocols, established a diabetes management service to manage the blood glucose levels of inpatients and outpatients and implemented intensive patient and care-giver education before and after discharge. In addition, the team developed a process to reconcile medication taken before and after transplant surgery and streamlined the way that discharge medicines are provided.

As a result of these measures, there was a 40% reduction in medication errors and adverse drug events amongst these patients. There were 14% fewer delayed discharges and the seven-day readmission rate fell by 50%. There were also clinical improvements – rejection rates fell by 25% and the infection rate fell by 10%.

Experts commented that the approach used by the team at MUSC could be a good model for best practice in other therapeutic areas.

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