teaser
Yaakov Cass
BSc MSc FRPharmS
Regional Pharmaceutical Officer
Israel Ministry of Health
Ramle
Israel
E:[email protected]
Israel, a small country about the size of Wales tucked in the eastern corner of the Mediterranean Sea, stands at the crossroads of three continents: Africa, Asia and Europe. It is the centre of the three monotheistic religions and the Bahai faith. The sun shines every day, there is as much rainfall as in London but all in the space of two months; deserts have been made to bloom, and modern technology and architecture are intertwined with ancient biblical history. The population of some 6.5 million is a melting pot of immigrants from all over the world speaking Hebrew, English and many other languages. About 80% of them are Jewish, and 20% are Christian, Muslim, Druze, Bahai, Armenian or from other religions. It is a democratic country without discrimination against any of its citizens. Most people are very outspoken, very informal and very down to earth.(1,2)
Pharmacists and medicines
By law, only pharmacists may dispense medicines from the hospital pharmacy managed by the government-approved superintendent pharmacist. Registration requires a local degree in pharmacy or a degree obtained outside Israel followed by a preregistration examination. There are some 3,000 practising pharmacists in Israel, of whom approximately 150–200 are employed in hospitals, and 1,000 qualified pharmacist’s assistants who may dispense under supervision; no other personnel may handle medicines. Unlike Britain, there is no self-governing professional body. The administration of pharmacy matters and the licensing of pharmacists and medicines come under the control of the Ministry of Health. The pharmaceutical administration is responsible for the national Drug Book Register, medical devices, cosmetic preparations and pesticides for human use. It supervises the importation of medicinal products (including controlled drugs) and medical devices.
Any preparation that bears a claim to treat or heal is regarded as a medicine and, after rigorous testing and checking, it is released on the market. The six district pharmacists represent the Ministry of Health’s executive arm, inspecting community and hospital pharmacies, the pharmaceutical industry and wholesalers, as well as extending professional training to their pharmacists. Budgetary arrangements are approved by the Treasury, which, traditionally, does not place health issues high on its list of priorities.
Hospital pharmacy
There are 30,000 hospital beds distributed between 25 very small hospitals, and 50 hospitals with between 300 and 1,200 beds. There are 12 specialist tertiary care centres, six of which have facilities to perform bone marrow transplantations. Hospitals are owned and administrated by the Ministry of Health or the Kupat Cholim Klalit (General Health Insurance Fund); in addition, some hospitals are privately owned. Hospital pharmacy represents the biggest challenge to the pharmacist in the clinical sphere and in areas unique to the hospital setting.
The problems facing clinical pharmacy in Israel will be familiar to many worldwide. The six-month internship required for a licence in pharmacy does not provide exposure to clinical pharmacy functions, but rather to traditional distributive tasks. Over the last 20 years, nearly 100 students have graduated locally with a master’s degree in clinical pharmacy. However, less than half of them actually practise in hospitals, the others having moved to the private sector and its attractive high salaries. Nevertheless, many occupy senior positions at places such as the Ministry of Health, industry and hospitals, and their clinical orientation often enlightens their drug policies.
Only a few hospital pharmacists serve as providers of drug information or as clinical pharmacists. Some serve as ward pharmacists, but the majority of the Israeli pharmacists working in hospitals do not have the time, the support from their management or the training to practise effective clinical pharmacy. The lack of certified pharmacy technicians is another reason why Israeli pharmacists cannot be freed to practise clinical pharmacy or pharmaceutical care in the manner that is practised in the USA. Despite all the obstacles and the debate notwithstanding, clinical pharmacy is advancing day by day. While clinical pharmacy services vary from centre to centre, many hospitals have excelled themselves over the years, reaching international standards both in medicine and pharmacy services.
Until fairly recently every hospital in Israel spent much of its time and resources on large- and small-scale sterile and nonsterile manufacturing.
The trend over the last 10 years has been a steady decline in both manufacturing and use of total parenteral nutrition (TPN). The days of bottle washing for recycling are definitely part of history! Meanwhile, other functions have come to the fore, such as centralised intravenous additive service (CIVAS), nuclear medicine, dispensing clinical trials material and cytotoxic reconstitution. The Ministry of Health has encouraged hospitals to rationalise resources in light of the new reality, and many pharmacies have undergone refurbishment. Typically, they are equipped with:
- Two manufacturing/service areas.
- A sterile suite to produce CIVAS, TPN (in reduced quantities) and sterile “specials” (eyedrops, small volume, single-use parenterals, etc).
- A nonsterile area divided into various functions, including a reduced galenical laboratory for extemporaneous preparations and a unit dedicated to control of clinical material, dispensing off-label and unregistered drugs and, in larger hospitals, drug information units.
- Management offices, a dispensary and storage areas.
Cytotoxics were first recognised as a potential hazard to healthcare providers in the late 1970s, and they are accepted as carcinogenic, mutagenic and teratogenic. In 1984, the Ministry of Health first issued guidelines on the safe handling of cytotoxic drugs; these guidelines were general and limited in scope. Importantly, however, they called for preparation in laminar flow hoods situated in pharmacy-run dedicated areas. Nursing staff reconstituting cytotoxics was strongly discouraged. A 1995 survey showed that 23 hospitals provided a wide range of pharmacy-based cytotoxic reconstitution services, preparing 25–300 items daily with staff levels ranging from one to three pharmacists per unit.(3)
With the objective of standardising and harmonising the level of pharmaceutical oncology services in Israel, a multidisciplinary select committee was appointed in 1996. The committee was mandated with developing guidelines that would ensure maximum protection from the hazards of cytotoxic drugs. The revised guidelines emphasised a number of criteria – first, minimising exposure of personnel to cytotoxic drugs both in hospital and industry. Guidelines were needed to deal with a broad spectrum of activities, including transport, storage, handling, preparation, administration, handling of spillage and waste of antineoplastic agents. Secondly, these guidelines recommended ensuring that the best possible service was made available to the patient. This aspect demands quality control procedures during preparations, coupled with clinical pharmacy surveillance at the ward level. It was further agreed that recognition of clinical oncology pharmacy as a specialty within the pharmacy profession was needed. In 2004, after the National Institute for Occupational Safety and Health (NIOSH) released its alert on the dangers of preparing and administering antineoplastic agents, current measures designed to prevent environmental contamination and employee exposure to hazardous pharmaceutical products were deemed inadequate.(4) Consequently, a decision was made to recommend the use of a closed system when preparing and administering cytotoxics.
Twenty hospitals have nuclear medicine departments, using about 270,000 doses yearly. Traditionally, injections were prepared in the nuclear medicine department by technicians with no pharmaceutical background, in far from ideal conditions. Hospital pharmacies were basically excluded from involvement. This clearly unsatisfactory state of affairs was the status quo for many years.
An important move forward was made when two commercial nuclear pharmacies began operations supplying unit-dose radioactive medications according to a physician’s prescription. Hospitals were quick to realise the advantages of obtaining unit-dose syringes prepared in conditions complying with both good radiological and pharmaceutical practices.
Over 90% of the requirements were outsourced. A few months ago, a new law was passed handing over global responsibility for all aspects of radio‑pharmaceuticals in hospitals to the pharmacy. Pharmacies have two years to prepare for the change, which includes providing one pharmacist with appropriate training.
Conclusion
Israel’s fast-growing population, from half a million in 1948 to over six million in 2003, means that hospitals have grown rapidly in size, with a commensurate fast change in the demands made on hospital pharmacists. Overall, they have done a remarkably good job and are a credit to their profession.
References
- Cass Y, Rice H, Seaton I. Pharmacy in Israel. Pharm J 1996;257:292-3.
- Cass Y, Rice H, Seaton I. Israel pharmacy faces changes. Int Pharm J 1996;10:126-8.
- Carstens G, Cass Y, et al. Cytotoxic drug service in Europe. Pharm Worl Sci 1996;18 Suppl:A2.
- Gebhart F. NIOSH to issue chemo alert. Drug Topics 2004;148:HSE1.
