1. Objective
To undertake a critical review of the current product check and release processes to ensure a robust, high quality and safe product approval system is in place to safeguard patient safety and to ensure compliance with standards and recommendations.
2. Background
The aseptic preparation of products at Northern Lincolnshire and Goole NHS Foundation Trust (NLAG) is carried out in an unlicensed unit under Section 10 exemption of the Medicines Act 1968. (1) It requires that the preparation is done by or under the supervision of a Pharmacist, who takes full responsibility for the quality of the product.
Until recently, in unlicensed units working under Section 10 exemption, even if the final checks were carried out by
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It provides a proposed product approval/Pharmacist supervision model that has been attached in Appendix 1.
Final product accuracy check and release at NLAG is undertaken by the Authorised Pharmacist (usually band 7 or above). The Authorised Pharmacist also undertakes the clinical checks/screening of the prescriptions. It has been discussed that undertaking these checks by different pharmacists will add an extra safety check in the process and there is a plan for separation of these roles in the near future. The plan is to have a Clinical Pharmacist undertaking the clinical checks in the clinical area and an Authorised Pharmacist in the Aseptic Unit undertaking the product check and approval (release). Another proposal has been suggested following this analysis.
There are some concerns regarding separation of the roles as the staff who may be involved in approving products (band 6 pharmacists) have a lack of knowledge and skills in aseptics. There is also a need for cost effective working and flexibility within the service, including appropriate skill-mix. This all emphasises a requirement for this critical analysis to ensure that a robust product check and release is undertaken.
Although errors in the preparation of injectable medicines within pharmacy aseptic environments are not very
It’s not simply the particular giving of the medications that fare up all the time. It is checking the medical record with the hand written prescriptions, grouping the varied medications and also the instrumentation for giving them, and ensuring all the patients safety measure are covered.
A pharmacist must check any medication that is administered to a patient. This is the
The rules and regulations surrounding dispensing errors in the UK are governed by the Medicines Act of 1968 ‘the Act’, and the Health Act 1999, which legislates the General Pharmaceutical Council (GPhC) through the Pharmacy Order 2010. The Act is an Act of Parliament which governs the control, manufacture and supply of medicines in the UK. It was introduced to help control the use of medicinal compounds and to increase patient safety, although much of it has been modernized and repealed. It also gives power to the courts to charge any dispensing mistakes as a criminal offence.
According to the Food and Drug Administration (FDA 2009), the wrong route of administrating medication accounts for 1.3 million injuries each year. An article published in September issue of the Journal of Patient Safety estimates there are between 210,000 and 400,000 deaths per year associated with medical errors. This makes medical errors the third leading cause of deaths in the United States, behind that comes heart disease and cancer. To prevent medical errors always follow the Three Checks and most importantly the Rights of Medication Administration. The “Rights of Medication Administration” helps to ensure accuracy when administering medication to a patient. When administering medication the administer should ensure they have the Right Medication, Right Patient, Right Dosage, Right Route, Right Time, Right Route, Right Reason, and Right Documentation. Also remember the patient has the right to refuse, assess patient for pain, and always assess the patient for signs of effects.
Medication errors are the leading cause of morbidity and preventable death in hospitals (Adams). In fact, approximately 1.5 million Americans are injured each year as a result of medication errors in hospitals (Foote). Not only are medication errors harmful to patients but medication errors are very expensive for hospitals. Medication errors cost America’s health care system 3.5 billion dollars per year (Foote).Errors in medication administration occurs when one of the five rights of medication administration is omitted. The five rights are: a) the right dose, b) the right medication, c) the right patient, d) the right route of administration, and e) the right time of delivery (Adams). Medication administration is an essential part of
rights, health, and safety of the patient.” This provision, identifying patients, medication safety are related because it is a nurse’s responsibility to protect the patient from harm and promote safety. Nurses are taught to use multiple checks before administering a drug and use two identifiers. These checks include checking the medication against the order when obtaining it, checking again when preparing the medication and the last check is done at the patient’s bedside prior to giving the medication. Also it is imperative to question any medication order that does not seem fit. The order should include a date, time, name of the medication, dosage strength, the route for
The person dispensing must also be appropriately trained, follow safe systems of work and understand the side effects of various drugs; be able to access appropriate information and understand when to access advice or further information
P3- explain relevant sections of key legislation associated guidelines with regard to the administration of medicines
Outcome measures assess whether the interventions to improve medication safety practice will be successful. During the interview of the new employee, competency evaluation related to medication administration will be applied first. In addition, during the orientation for these new employees, adequate training will be provided to ensure the importance of preventing medication errors. They will be given a list of similar and look-alike medications and will focus on medications that cause the most adverse reactions when errors may occur. Then, after training and when staff start working, they will be supervised during their first few months. When they are not supervised, they will be assessed and evaluated for any errors. During this process,
- The chemist’s role is to dispense the medication that is written on the prescription. It is his/ her responsibility to make sure that the items they give out are correct and are exactly the same as what is written on the prescription. If there are any mistakes then they should contact the doctor who prescribed the medication.
According to pharmacist T. Perryman, the errors he sees the most in the pharmacy setting “occurs when hospital made barcodes are being added to the medication rather than the medication having factory barcodes already present.” The process of standardizing all pharmaceutical drug
There are other pharmacy staff who also have roles in relation to the safe dispensing of medicines. A pharmacist is responsible for: Overall checking of a prescription to make sure that it is legal and written by a person qualified to do so, dispensing the right quantity of the correct medicine, ensuring that medicines are correctly labelled with the person’s name, the name of the medicine and the dosage, providing advice and treatment for minor illnesses, injuries and health concerns, providing a repeat prescription service in co-operation with GP
After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.
The National Patient Safety Agency (NPSA 2010), defines a drug error as ‘any preventable event that may cause or lead to inappropriate use of patient harm. Although not all drug errors have lead to patient harm it is important to recognise that if a mistakes has been