Pharmacy Compliance Monitoring
Posted: Tuesday, December 15, 2009
by Rose-Marie Chaperon
Chaperon Consulting, LLC
It is the responsibility of Hospital's pharmacy to conduct compliance and enforcement activities in accordance with this policy. The maintenance and enhancement of quality and safety is a responsibility that is shared among all employees of the pharmacy.
Compliance Monitoring
Hospital's conducts monitoring activities to assess the compliance of regulated pharmacies with the Act and its associated Regulations, in accordance with established policies and procedures. These proactive activities include a wide variety of fact gathering and assessment activities such as inspections, surveys and a product sampling program.
The risk to health and safety, including the absence of a purchase and sales
Compliance history of the drug manufacturers;
The degree of cooperation offered by drug manufacturers
The likelihood that the same problem will reoccur;
The likelihood of the enforcement action being effective;
The need to maintain public confidence in the programs administered by
Drug Recall
A recall is a method for removing a distributed regulated product, including its labeling, that violates the Act and/or its associated Regulations, or that may present a risk to the health of the consumer. Recalls of regulated products may be undertaken anytime, in response to a formal request by the Authority or on the initiative of regulated party to carry out the combined responsibility to ensure compliance with the legislation, and to protect the health of consumers (FDA, 2007) .
Hospital's Pharmacy will handle all recalls with the most care; all recalled medications will be considered dangerous and lethal. An inventory of patients' record who has received such medications will be reviewed or contacted to perform necessary test if warranted.
Voluntary Detention
A voluntary detention is an agreement between a regulated party to maintain control of a particular product. Hospital's will monitor the effectiveness of a detention and may take other enforcement action, e.g. disposal, as appropriate.
Voluntary Disposal
A voluntary disposal is an action by a regulated party to prevent further distribution of a non-compliant product, by actions such as disposal, destruction, or returning it to the manufacturer. In considering whether voluntary disposal is an appropriate compliance action, the pharmacy will consider the following factors:
The degree of cooperation offered by a regulated party on prior occasions;
That the product will be rendered non-saleable/usable.
Compliance, Verifications and Investigations
Where hospital is identified or is notified of a potential non-compliance, it takes steps to determine whether non-compliance has occurred. Potential non-compliance may be identified by consumer complaints, industry complaints, referrals from regional authorities and other regulatory agencies, international partners or the Authority's compliance monitoring activities and patients and employees (Ndomondo-Sigonda, 2006) .
Responses to non-compliance
Where non-compliance is brought to the attention of management, it is management's responsibility to take timely and appropriate action to comply with legislative and regulatory requirements. Compliance is normally achieved through a cooperative approach among all employees. However, a number of enforcement options are available if necessary, particularly when management is unable or unwilling to correct non-compliance.
Decision:
After the completion of a compliance violation investigation, Hospital's will follow the Human Resources policies and procedures on code of conduct. Sanctions will be as follows: 1 st violation write-up - 2 nd violations suspension 3 rd violations terminations
Depending on the severity of the violation, a decision may be made to terminate an employee who has violated the policy.
REFERENCESF
FDA. (2007). Pharmacy Compliance Monitoring. Atlanta: Fodd and Drug Administration.
Ndomondo-Sigonda, M. (2006). Compliance and Enforcement Policy. New York: TFDA.
This Article has been viewed 442 times. (Not updated in real-time.)
No comments yet.We want your comments! If you can read this, you don't have javascript enabled, so you can't use this comment system. Please enable javascript.