Remove Definition Remove Documentation Remove Medical Records
article thumbnail

How to Successfully Employ External Comparator Arm Studies Using Real World Data

pharmaphorum

Therefore, to help contextualise study findings, external comparator arms (ECAs) can be employed, which compile data from external sources, such as patient registries and other medical records. However, methodological considerations must be undertaken to ensure the best conduct and minimise potential biases in ECA study designs.

article thumbnail

Medication Therapy Management in geriatric

FADIC

Medication Therapy  Review (MTR) ■ A list of suggested questions to use when conducting a medication therapy review in a geriatric patient. * What medication are prescribed by any specialists you may see? What medication do you take that do not require a prescription? 2014;11(4):329-337. doi:10.11909/j.issn.1671-5411.2014.04.008

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Adverse Drug Reactions

RX Note

However, this definition does not consider the following scenarios, all of which can also cause ADRs. Also, it is important to Document the ADR in the patient's medical record. What other medicines can be used instead? Whether a dose reduction is feasible or practical. The ability to successfully treat the side effect.

article thumbnail

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

FDA Law Blog: Biosimilars

In 1997, the Food and Drug Administration Modernization Act (FDAMA) amended the definition to make clear that substantial evidence could also be demonstrated by “one adequate and well-controlled clinical investigation and confirmatory evidence.” objective clinical outcomes in the context of detailed medical record collection).

article thumbnail

Sentinel Events Should Result In A Blameless Society — Not Make The Employee The Scapegoat

The Happy PharmD

These documents focused on why the sentinel event occurred. In this particular case, the physician folded the medication order when he placed it in the nurse’s bin. The nurse transcribed the medication order on the patient’s (nurse’s) record system. Blaming Employees For Sentinel Events. I was momentarily stunned.

article thumbnail

Antimicrobial MTM Case

FADIC

Personal Medication Record (PMR) Patients should be instructed to keep a record of all the medications they are prescribed, whether from the over-the-counter or as prescriptions. If possible, the patient can document the name and personal details of the physician who made the prescription. Pathway/ Protocol 5.