A robust set of hospital pharmacy practice standards for Europe has been agreed at an international summit in Brussels. These standards should be met across European health systems to ensure safe, effective and optimal use of medicines in collaboration with multi-disciplinary teams. The standards, comprising 44 Statements of Practice, were agreed at the European Hospital Pharmacy Summit which concluded on Thursday 15 May, and was attended by more than 100 persons.
The statements were subject to open Delphi consultation with national hospital pharmacy associations, European patient groups, doctors and nursing organizations. The organizations then gave their final joint approval to each statement individually by a weighted voting method at the Summit event. The European Statements of Hospital Pharmacy include:
- All hospitals should have access to a hospital pharmacist who has overall responsibility for the safe, effective and optimal use of medicines.
- Hospital pharmacists should be involved in all patient care settings to prospectively influence collaborative, multidisciplinary therapeutic decision-making.
- All prescriptions should be reviewed and validated as soon as possible by a hospital pharmacist.
- Hospital pharmacists should play a full part in decision making including advising, implementing and monitoring medication changes in full partnership with patients, carers and other health care professionals
- Hospital pharmacists should have access to the patients’ health record. Their clinical interventions should be documented in the patients’ health record and analysed to inform quality improvement interventions.
- Clinical pharmacy services should continuously evolve to optimise patients’ outcomes.
The 44 European Statements of Hospital Pharmacy are available here.
European Association of Hospital Pharmacists (EAHP) President Dr Roberto Frontini said: “Through the new European Statements of Hospital Pharmacy, patients, hospital pharmacists and our sister healthcare professionals have set out a clear vision for what hospital pharmacy should be achieving in every European country.
"The task now turns immediately to implementation. EAHP will roll out a series of tools and initiatives to support the achievement of the statements, but a major onus now falls on health systems to prepare the way for improvement as well. The positive support from patient organisations and other healthcare professionals assures us that the statements are a shared aspiration and provide a route towards continuously improving patient care within hospitals in every European country.”
MPs want British #Vaping rules relaxed to help smokers quit
Vaping rules should be relaxed to allow the promotion of e-cigarettes as tools to help tobacco smokers quit, British lawmakers said on Friday (17 August), writes Ben Hirschler.
This could include prescribing medically licensed e-cigarettes to assist smoking cessation efforts.
Vaping, or using e-cigarettes, is estimated to be 95 percent less harmful than smoking conventional ones, according to the British parliament’s science and technology committee, which sees big health benefits if smokers can be encouraged to switch.
A study here this week, for example, found that e-cigarette vapour may cause adverse changes in lung cells.
It also called for incentives to promote them as a less harmful option, in the form of lower levels of taxation, a relaxation of curbs on their use in public places and a review of approval systems for prescribing them as quit-smoking products.
“Concerns that e-cigarettes could be a gateway to conventional smoking, including for young non-smokers, have not materialised,” said committee chairman Norman Lamb. “If used correctly, e-cigarettes could be a key weapon in the NHS’s (National Health Service) stop smoking arsenal.”
The charity Action on Smoking and Health welcomed the committee’s findings and said allowing e-cigarettes to be prescribed by doctors could be particularly important to people on low incomes and those with high levels of addiction.
Medical devices: #Health Committee MEPs approve stricter EU safety requirements
Plans for stricter monitoring and certification procedures to ensure full compliance and traceability of medical devices, such as breast or hip implants, were backed by Health Committee MEPs on Wednesday. MEPs also approved legislation to tighten up information and ethical requirements for diagnostic medical devices used for example in pregnancy or DNA testing. Both files were informally agreed with the Dutch Presidency of the Council.
"The metal-on-metal hip scandal highlighted weaknesses in the current system. So we’ve introduced much stricter requirements for the bodies that authorize medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, will be subject to additional assessments by experts before they can be authorised,” said Rapporteur on Medical Devices Glenis Willmott (S&D, UK). Her report was approved unanimously.
Stronger post-market surveillance, more information to patients
“We've also agreed a much stronger system of post-market surveillance so that any unexpected problems are identified and dealt with as soon as possible”.
“With the PIP scandal, many women simply didn’t know if they had received defective implants or not. So we’ve also introduced a Unique Device Identification (UDI) system so we know which patient has which device; this will make it much easier to trace patients if there’s a problem and patients will also be given an implant card with the UDI, which they can use to access information via a publicly accessible database", Wilmott added.
Learning the lessons of the breast and hip implants scandal
The agreement provides for:
Random inspections of producers’ facilities after devices have been placed on the market;
stricter controls on notified bodies, which will have to employ medically skilled people;
an additional safety checking procedure for high risk devices, such as implants or HIV-tests. Not only a notified body, but also a special committee of experts will check that all requirements are met;
an "implant card" for patients, enabling patients and doctors to track which product has been implanted, and;
clinical evidence of medical device safety to be provided by manufacturers (as for medicines), especially in the case of higher-risk classes.
"Pre-market scrutiny of high-risk devices was a priority for the Parliament so I'm particularly pleased that we successfully pushed for this and that these devices will now undergo additional assessment from expert panels", she concluded.
A separate law will also ensure that the new rules also apply to in vitro diagnostic medical devices, i.e. medical devices which are not in direct contact with the patient, but provide information on a person’s health, such as HIV, DNA or blood test devices.
“I am very happy that we finally got it done. People in Europe have a right that we learn the lessons of scandals such as that of the defective breast implants”, said rapporteur on in vitro diagnostic medical devices Peter Liese (EPP, DE).
“Problems occurred in other areas too, e.g. on stents that are implanted into the brain or an unsafe HIV test. The new regulation is good for patients, puts an end to fraudulent and shady producers and thus also strengthens respectable producers” he added. His report was approved unanimously.
Ethical requirements for DNA testing
The legislation would also require EU member states to inform patients of the consequences of DNA tests.
"DNA-tests can have severe consequences for the life of patients and they should not be carried out without proper information and counselling. Member states pointed out that this is first of all their responsibility and that they will therefore accept EU rules only to a certain extent. It is important that member states fulfil this obligation. We will be very vigilant on this question," said Liese.
Hospital pharmacists express concern to EMA about access to clinical trial information
The European Association of Hospital Pharmacists (EAHP) has written to the Board of the European Medicines Agency (EMA) expressing concern about proposals to restrict the viewing of clinical trial results to an ‘on screen only’ version. Such access would exclude the possibility of individuals being able to print, distribute, or transfer the information, making scientific analysis of clinical study data highly problematic.
EAHP has joined the voices of other organisations such as the European Ombudsman, the British Medical Journal, the AllTrials campaign, the European Consumer Organisation and Health Action International in urging a rethink by the EMA. EAHP’s intervention comes ahead of an EMA Board Meeting on Thursday 12th June, at which the proposed draft policy on ‘proactive publication of and access to clinical trial data’ could be finalised.
The development of new policy by the agency on clinical trial transparency comes as the result of intensive advocacy efforts by transparency campaigners, and after over a year of consultation by the EMA with patient groups, health care professionals and the pharmaceutical industry.
EAHP President Dr Roberto Frontini said: “Transparency in the reporting of clinical trial results matters. It matters because it is important in avoiding duplicated effort. It matters because patients participating do so on the basis that they are assisting wider scientific understanding of medical issues. It matters because independent secondary scrutiny of clinical trial results frequently yields new insights.
"Therefore, whilst we congratulate the European Medicines Agency on its efforts so far on trial result transparency, the news that access could be restricted to “on screen only” comes as a disappointment. Transparency is needed for the purposes of scrutiny. Yet if individuals may not print, distribute or transfer the information, it is hard to see how the purpose is served. Its an important moment for the Agency and its Board and we hope it will listen to what the European Ombudsman and stakeholders are saying: the transparency policy should go further.”
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