Pharmacovigilance System

Goal three by the National Patient Safety Goal for 2014 is to use medicines safely. Many errors occur regularly with medications which is why communication is so important with the doctors, nurses and patients. One process that Joint Commission requires in accredited HCO’s is medication reconciliation “creating the most accurate list possible off all medications a patient is taking, including drug name, dosage, frequency, and route, and comparing that list against the physician’s admission, transfer, and/or discharge orders with the goal of providing correct medications to the patients at all transition points within the hospital (Finkelman & Kenner, 2012, p. 388)”. Ensuring medication reconciliation to the patient, health providers and any new consults that are

A pharmacist must check any medication that is administered to a patient. This is the

Each year, roughly 1.5 million adverse drug events (ADEs) occur in acute and long-term care settings across America (Institute of Medicine [IOM], 2006). An ADE is succinctly defined as actual or potential patient harm resulting from a medication error. To expound further, while ADEs may result from oversights related to prescribing or dispensing, 26-32% of all erroneous drug interventions occur during the nursing administration and monitoring phases (Anderson & Townsend, 2010). These mollifiable mishaps not only create a formidable financial burden for health care systems, they also carry the potential of imposing irreversible physiological impairment to patients and their families. In an effort to ameliorate cost inflation, undue detriment, and the potential for litigation, a multifactorial approach must be taken to improve patient outcomes. Key components in allaying drug-related errors from a nursing perspective include: implementing safety and quality measures, understanding the roles and responsibilities of the nurse, embracing technological safeguards, incorporating interdisciplinary collaborative efforts, and continued emphasis upon quality control.

1. In the workplace there is a generic Medication Management Policy and Procedures for Adult Services (Issue 10, 2012) document. This is kept to hand in a locked cupboard, readily available to read. It requires that all Healthcare Staff are given mandatory training and refreshers are provided. Legislation which surrounds the administration of medication includes The Medicines Act 1968, The Misuse of Drugs Act 1971, The Data Protection Act 1998, The Care Standards Act 2000 and The Health and Social Care Act 2001

I also work closely with local pharmacies and doctors around the changing of a person’s medication. It’s important that we work closely together to ensure that the service user is having the correct medication at all times.

Due to the large number of consumers being prescribed multiple medications, and the complexity of managing those medications, it is of a major safety concern that systems are in place for clinicians to reconcile patients medications to resolve any discrepancies in what the patient is using, or should be using, and newly added ones.

The nurse must verify the physician’s medication order, including the dose and time, and then the pharmacy is responsible for their own checks and balances via the BCMA system in order to complete the dispensing phase of the medication (Gooder, 2011). The nurse enters the BCMA system with a login and password and is able then to see a list of the virtual due list for a specific patient. The computer on wheels is then taken to that patient’s room and the five rights of medication administration begin. As nurses, we are taught to use the five rights of drug administration are (1) right patient (2) right medication (3) right dose (4) right route and (5) right time. By scanning the barcode on the patient’s hospital identification band, the nurse then asks for the patient to verbally state their name and date of birth, which can be verified by the nurse on the virtual due list and then choses the medication that are due for administration at that time. The medication is dispensed and the nurse is able to scan the barcode on the medication, the scanning triggers the automatic documentation of the medication given (Kelly, 2012).

Medication errors are focused on: terms and definitions; incidence of and harm; risk factors; avoidance; disclosure, legalities & consequences (Wittich, Burkle & Lanier, 2014). Medication errors categories have been developed by the American Society of Health-System Pharmacists (ASHP). Examples of these categories are based on prescribing, omitting drugs not administered, timing, unauthorized drug, wrong dosage, wrong preparation, expired drug, not using laboratory data to monitor toxicity (Wittich, Burkle & Lanier, 2014). Additionally, this article examines in depth common causes leading to medication errors, drug nomenclature, similar sounding drugs, unapproved abbreviations and handwriting, medical staff shortages and manufacturer medication shortages. Even though this article provides an informative overview for physicians, other allied health personnel may benefit too. This is valuable knowledge for the health care professional not just physicians in order to provide safe care for their

One of the standards that has been implemented is Standard 4: Medication Safety. The Australian Commission implemented this standard with the intention of ensuring that competent clinicians safely prescribe, dispense and administer appropriate medicines to informed patients and monitor the effect. (Australian Commission on Safety and Quality in Health Care, 2012) In healthcare, one of the most common treatments is medication. As a result of this, there are many incidences of error, many more than any other healthcare interventions. According to the Patient Safety Network (PS Network, 2015) medication errors account for nearly 700,000 emergency department visits and 100,000 hospitalizations each year. Medication errors are often a result of the unsafe and poor quality practice of healthcare professionals or system errors. Medication errors are costly and many are avoidable. For this standard

For many patients the scariest part of being in the hospital is having to rely on other people to control your life changing decisions. One large part of this is the medications one is given while in our care. I can only imagine what it must be like for patients to have a stranger to come in and start administering drugs to me. This would be especially scary if I did not know what these medications did, or what negative effects could be caused by taking them. Unfortunately, the fear of medication errors that many patients have are not unfounded. Estimates range from 1.5 to 66 million patients a year have medication errors occur while they are in the care of health care professionals. Considering all of the technology we have at our

Additionally, the facility should have a system in place that alerts the staff regarding high dosages. One way to alert the pharmacist would be via a computerized system that monitors the dispensing of all medications. The system should contain an up to date database for referencing medications. Also, the computerized system should have parameters set for alerting pharmacy and nursing staff for all high dosages. When taking cost into consideration, the facility might not have the feasibility to implement an entire computerized dispensing system that provides dosage alerts and cross check off of medications. To maintain patient safety with limited funds, the facility should have remote access to a pediatric pharmacy where all pediatric medications can be cross-checked and verified. If the facility was unable to have a pediatric pharmacist on staff, the remote access would provide a safety net for pediatric medication dispensing. In addition to the pharmacy staff having access to a computerized system, the physician should as well. Had the physician had computer access and been required to enter medication orders, the tenfold error could have been noted and not reached baby Miguel.

As a student pharmacist, I am interested in medication errors and initiatives for their prevention. In response to the IOM’s report, the Food and Drug Administration (FDA) agency enhanced its error reduction strategies by implementing a new division dedicated to medication errors.3

These programs can be successful when applied but without a physician being required to participate they can be unuseful as it leads to lack of accurate information for public health records. Doctors and pharmacist should both have a legal obligation to check a drug monitoring database and participate further in drug monitoring programs. Doctors and pharmacies should also be investigated for prescribing large quantity of prescription medication resulting in legal action if perhaps they are found guilty of overprescribing. With legislators onboard to curb the misuse of prescription medication this problem can finally be

A physician could make mistakes in prescribing, the pharmacy could send the wrong medication, but who actually gave it to the patient is accountable for the consequences. For this reason, it’s our responsibility to implement change in our practice based on the evidence in order to ensure safe patient care.

PharMed International is one of the world’s largest pharmaceutical companies. It was established two years ago when ValMed and PharmCO merged. PharMed is obligated to keep detailed records of how its drugs perform by relying on sophisticated database such as the Vigilance which will be used by division employees around the globe. The core team responsible for designing and implementing Vigilance has three members in the United States: Frank Lanigan, Carol Reynolds, and Mike Powell; and four members based in France:Didier Amrani, Karine Bareaut, Merline Bucquet and Fabrice Lemaire. In addition to the core team, five subteams were formed. Overall, half of