Importance of Compliance Procedures in Pharmacy

Many of the health care compliance policies about health care are developed by the United States Food and drug administration agency together with various professional boards.they are meant to protect and promote the health and well-being of all people through the implementation of various initiatives meant to promote public health. With respect to pharmacies, the main concern is ensuring patient safety through avoidance of any mistakes that could lead to adverse health outcomes on the patients. The agency for example is greatly involved in the regulation and supervision of prescription drugs, pharmaceutical drugs, and other products that are often considered to be of great significance to health like cosmetics. The agency is involved at almost all levels from manufacturing, drug testing, labeling, advertising, and marketing of medical drugs. Compliance procedures have been instituted in the pharmaceutical industry as a measure to foster professionalism in the practice of pharmacy and also to ensure public safety.

There are numerous compliance procedures that are meant to guide practice in the pharmaceutical industry and which can also be applied within a pharmacy department as well. Examples of these compliance procedures that are now commonly being used to protect the safety of the public and regulate the practice of pharmacy in the united states include; the statutory adherence to various laws enacted by the government, routine inspections of drug outlets and pharmacies, ensuring that the pharmacy has been issued with a license or a permit and ensuring that the people employed to work in the pharmacy like pharmacy technicians and pharmacists are licensed or registered to practice.

There exist also written procedures for receiving and addressing complaints received from the general populace and those that guide investigations and hearings against pharmacists and persons or firms granted permits to run business in the pharmaceutical industry. The main responsibility of the pharmacy department is to ensure that patients receive proper drug therapy for their conditions. In order to discharge this mandate, the department, through its staff members undertakes various duties like making orders for medications from different supplies and then distributing them to the patients who need them(Fred &American Society of Health-System Pharmacists,2005, p.1).

Financial management becomes an important factor worthy of consideration because the success of the department in meeting its mandate depends mainly on whether the financial matters within the department are prudently managed. Pharmacy managers are required to come up with budgets that are supportive of the overall objectives of the department and the organization as well. They are also required to monitor the financial performance of the department, perform financial audits and analyses if there is a need. All these assignments ensure that there is proper record management which is essential in capturing the income generated and the expenses incurred (American Society of Health-System Pharmacists, 2008, p.289-291).

Good financial management is very important for it ensures that patients can access the drug in a timely manner. This would save the department from the sanctions that come from centers for Medicare and Medicaid services which at the beginning of the year 1999 issued a sanction prohibiting WellPoint (a health benefits company located in Indianapolis) from enrolling new customers into its program. These sanctions not only tarnish the company’s image but also contribute considerably to lost revenue when the company cannot attract new customers (Montgomery, 2009, para.1).

It is important for the pharmacy department to comply with the billing requirements as set out in the agreement signed before a company can start providing medically related services to Medicare. Estrin (1990, p.807) explains that during the 1990s, such companies were required by Medicare not to bill patients for more than twenty percent of the total cost. This is because the company receives the larger percentage of payment (eighty percent) from the Medicare carrier. If the company contravenes this requirement, the consequence would be sanctions issued to the company. These sanctions come in the form of heavy fines, imprisonment, or both sanctions. If a company violates this agreement either willfully or unintentionally, it is subject to a civil penalty for every violation and it is eventually be barred completely from participating in the Medicaid or Medicare programs (Estrin, 1990, p.807).

In addition, all Medicaid programs restrict companies from billing medic aid beneficiaries for services or items which are covered within the state medic aid program. It s is a requirement that an excluded provider petitions to be reinstated in the programs again, very often the provider will not be paid for the service or goods they may have rendered during the exclusion period. Unbundling is considered fraud and is subject to similar sanctions as highlighted above. Unbundling involves making multiple bills to obtain more pay for a service or goods that should be submitted as a single bill (Institute of Medicine, U.S, Lohr & U.S Health care financing Administration, 1990, p.167).

Documentation within the department is of utmost importance in guiding the daily operations at the pharmacy department. Good documentation makes the management of records more easy and smooth. Of particular importance is the documentation of problems encountered in the process of carrying out various duties within the department. Records on how problematic situations in the past were handled can be used as a guide to help new employees to handle crisis situations in discharging their responsibilities. Careful documentation of records is useful in handling complaints that may be brought against the department in the future. Quick references can be made through the records when the old employees are no longer there and this can save the time that would be needed to trace them in order to provide the required information. Documentation also makes it easy to make stock inventories (Medina, 2003, p.267).

Prescription errors are the leading of the four commonly made medical mistakes. Prescription mistakes are in part mainly due to poor documentation. Documentation is important while dispensing prescription drugs because it’s through documentation that vital information relating to patient assessment, drug choice, dosing, and duration of treatment can be obtained. This information is very important in clinical decision-making. Failure to provide information about medical allergies, hypersensitivity, and related medical conditions could lead to the prescription of none beneficial medication or therapy. It is important that the writing used on prescriptions is not so ambiguous to avoid confusion when following on the history of the drug user (Varkey&American College of medical quality, 2010, p.50).

Efforts to control fraud by employees and encourage compliance to written down procedures should be enacted in workplace policies. These policies should contain explicit provisions on the ethical responsibilities and standards that are attached to certain positions in which fraud is likely to occur. These policies should be designed particularly to address conflicts of interest that many employees face when they are engaged in activities that are likely to impair the way they make impartial monetary decisions.firms should for example make it a requirement that employees m declare any business or material interests that could impair their ability to make impartial decisions (Barr &Eversole, 2003, p.109).

Firms can also consider separating authority and the duties of employees who occupy positions where the temptation to engage in fraud is most likely. Such a policy would require that decisions be made collectively and not individually. Enacting job-specific operational procedures is another important strategy that is used to minimize fraud and also ensure employee compliance to written workplace procedures. This can be effective for controlling fraud involving the delivery or supply of defective goods (Barr &Eversole, 2003, p.109).

Reference List

American Society of Health-System Pharmacists. (2008). Best Practices for Hospital and Health System Pharmacy 2008-09.Bethesda: American Society of Health –system Pharmacists.

Berry, R.A &Eversole, J. (2003).The fire chief’s handbook.6th Ed. Oklahoma: PennWell Books.

Estrin, N.F. (1990). The Medical device industry: science, technology, and regulation in a competitive environment. U.S.A: CRC Press.

Fred, L& American Society of Health-System Pharmacists. (2005). Manual for pharmacy technicians.3rd Ed.Bethesda: American Society of Health –system Pharmacists.

Institute of medicine, (U.S)., Lohr, K.N & U.S Health care Financing Administration.( 1990). Medicare: a strategy for quality assurance, Volume 1.Ed. Lohr Kathleen. Washington D.C: National Academies Press.

Medina, C. (2003). Compliance handbook for pharmaceuticals, medical devices, and biologics. : USA: Informa Health Care.

Montgomery, K. (2009). Medicare Sanctions WellPoint. Web.

Varkey, P. & American College of medical quality. (2010). Medical quality management: theory and practice.2nd Ed. U.S.A: Jones & Bartlett Learning.

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