Hospital Pharmacist
Vol 10 No 11 p501-502
December 2003

Procuring safer medicines

The Procurement and Distribution Interest Group (PDIG) of the Guild of Healthcare Pharmacists held its autumn symposium in Coventry on 13 November. Gareth Jones reports

How do you decide whether to award a contract to a particular company? Use that decision, which is a powerful lever, to encourage manufacturers to produce safer packaging and labelling, suggested ANDY ALLDRED, pharmacy procurement manager from Leeds NHS Trust and winner of the Pharmacia/ Pfizer 2002 award. He described a purchasing strategy used by the Yorkshire NHS consortium where a risk assessment is undertaken on any product before decisions are made about awarding a contract.

They have developed a systematic approach to assessment of products by writing a risk assessment tool. The risk assessment criteria include quality of general labelling and packaging, labelling of blisters, patient information leaflets, tablet or capsule markings, closures, etc. Contracts are therefore awarded for products that have an inherently low risk. This means that the lowest priced tender does not always win. There are examples of where the contract has been awarded to a more expensive, but safer, product. Feedback has been provided to suppliers with poor packaging to encourage change. There are clearly concerns that this approach may lead to an increase in the overall drug bill but, according to Mr Alldred, the financial impact of this strategy has been insignificant.

The policy of making safety one of the criteria for awarding contracts has met with a mixed response from the pharmaceutical industry, said Mr Alldred. Although generic manufacturers were positive towards the change, there was initially much resistance from big pharmaceutical companies. They believed that the safety aspects of the labelling and packaging are a small element of what the products has to offer, and should therefore not be an element of the contract process. But Mr Alldred said that the National Patient Safety Agency (NPSA), The Medicines and Healthcare products Regulatory Agency and the NHS Purchasing and Supply Agency (PASA) have all been supportive of the policy.

Best practice guidance has now been developed with the pharmaceutical industry, and significant changes have been seen in the livery and packaging of products. There has also been constructive feedback and dialogue with industry in contract debriefs.

This new strategy has been developed in part because of the goal of reducing serious errors in the use of prescribed medicines by 40 per cent by 2005. The next stage of this project is a national roll-out, and a draft model was due to be published in November.

Buy safe medicines

When making procurement decisions it is important to choose medicines which are safe in use, and not just of the required quality and purity, according to Professor DAVID COUSINS, head of safe medicine practice at the NPSA. Products should be designed to be safe in practice, because slips and lapses will always occur, however experienced the health care professional handling the product. Confusing, ambiguous and indistinct labelling and packaging should be avoided. Professor Cousins also criticised pharmaceutical companies that produce similar packaging for all their products.

Professor Cousins discussed some of the projects that the NPSA is undertaking in relation to pharmaceutical product safety.

The National Reporting and Learning System (NRLS) will provide a single point for reporting patient safety incidents involving NHS patients. When a report is logged electronically, the reporter will immediately be given access to any other reports of a similar nature. Medicinal products which are involved in patient safety incidents will be identified. The NRLS codes will be incorporated into hospital trust risk management software and incident report forms during 2004.

Turning to the issue of potassium chloride, Professor Cousins said that 69 per cent of trusts had implemented safe procedures by January 2003, compared with just 25 per cent before the NPSA alert issued last year. Potassium chloride vials have now been removed from 83 per cent of medical wards and 85 per cent of surgical wards. Professor Cousins encouraged participants to use this data to persuade colleagues in their hospitals who had resisted moves to remove potassium chloride from their wards.

Professor Cousins is currently considering five intravenous infusions including potassium chloride, which he hopes will obtain product licences (further information available from Hospital Pharmacist 2003;10:317 [September]).

In the past nine years, there were 137 reported cases of medication errors with methotrexate, and in 25 cases the patient died. Prescribing the wrong frequency, a lack of monitoring and dispensing errors are some of the most common causes of patient safety incidents. One of the solutions suggested by the NPSA to increase safety with methotrexate is to improve the labelling and packaging, in partnership with the manufacturers.

Professor Cousins also highlighted The Medicines and Healthcare products Regulatory Agency best practice guide on packaging and labelling. This is available as a PDF file (170K). Advice from the NHS Purchasing and Supply Agency on purchasing for safety is available here

Industry investment

The pharmaceutical industry should invest in safer packaging and labelling as part of the development process for new products, according to RICHARD NEEDLE, chief pharmacist at Colchester General Hospital.

This is an opportunity for industry to innovate, and prove their products have safer packaging and labelling than the competition, he said. Patient safety and risk reduction are two issues that are now much higher up on the NHS agenda. This was as a result of the “Organisation with a memory” report which called for a reduction by 40 per cent in medication errors by 2005.

In addition, the NHS litigation authority has noted that the three areas generating the highest numbers of claims are medicines practice related — prescription, administration and reaction.

Mr Needle asked manufacturers to give consideration to how their product will be given, as patients can die as a result of poorly designed products. Errors occur in about half of all intravenous drugs prepared and administered on a ward. The most common errors are giving bolus doses too quickly and mistakes in preparing doses that require multiple steps. Multi-step products, multiple dilution products and products requiring mixing should be avoided. Where appropriate, rate control devices should be incorporated into products.

There will be an additional cost for safer products, which the NHS will have to meet. But with these patient-ready products, there is higher product quality and a lower risk. Savings can be made from existing services, as there may be less work for the aseptic unit. Pharmacists working in procurement and distribution should therefore expect to pay a premium when buying products with safer packaging to the overall benefit of the patient.