Inventory of Drug Samples in a Health Care Institution

11 Dec
2010

drugs samples

INTRODUCTION

The distribution of drug samples by the pharmaceutical industry and by physicians and certain other health care professionals is permitted, in certain situations, under Canadian and US federal laws. In Canada, under the Food and Drugs Act, the distribution of drug samples is generally banned, with certain exceptions allowing physicians, dentists, veterinarians, or pharmacists who are duly registered and authorized to practise their profession in a given province to request drug samples from manufacturers, by specifying the brand name, proper name or usual name, and quantity of a drug to be used as a sample. The pharmaceutical representative who receives such a request may distribute the drug as a sample to the physician, dentist, veterinarian, or pharmacist, if the drug is labelled in accordance with the regulations. In Canada, professional practice falls under provincial jurisdiction, such that the provincial bodies governing each profession may also govern the use of drug samples. In the province of Quebec, both the College des medecins du Quebec and the Ordre des pharmaciens du Quebec (the provincial regulatory bodies for physicians and pharmacists, respectively) condemn the inap­propriate use of samples, especially for resale to patients or for personal use, while recognizing their suitability for patients who could not otherwise afford the medications.

The distribution of drug samples is widespread in Canada and the United States. According to Intercontinental Medical Statistics Health (also known as IMS Health), expenditures for prescription drugs being promoted by the pharmaceutical industry in the United States doubled from US$12.4 billion in 1998 to US$25.3 billion in 2003, including US$16 billion in distributed drug samples. In a national survey of 3167 US physicians conducted in late 2003 and early 2004, 78% of respondents stated that they had received samples. In a similar survey in 2001, 92% of responding physicians indicated that they had received drug samples. In 2000, nearly 800 million drug samples were distributed in the United States, equivalent to 1500 samples per physician. In a descriptive study of 53 general practitioners in 18 offices, a total of 1588 patient visits were observed, 20% of which involved the distribution of drug samples. eriacta tablets

Many reasons are given for physicians distributing drug samples rather than writing prescriptions that would necessitate a visit to the pharmacy. According to physicians and other individuals polled (e.g., medical residents, nurses, pharmacists, participants in medical continuing education, pharmaceutical sale representatives), samples save the patient from having to go to the drugstore; reduce the cost of treatment; allow the patient to gain access to new treatments while allowing the physician to develop clinical experience and use new drugs that may not yet be covered by public or private plans; allow rapid initiation of therapy, which may be needed for clinical reasons; and allow the physician to verify short-term tolerance or efficacy before writing a prescription for the usual duration of therapy. The use of samples may even increase the patient’s level of satisfaction.

Distributing samples also has perceived disadvantages. For example, the distribution of drug samples may jeopardize the continuity of care, especially as the patient’s medication record at the retail pharmacy will be incomplete and the pharmacist is unlikely to meet the patient during the course of therapy with drug samples. These omissions can lead to unintended therapeutic duplication, allergic reactions, intolerances or interactions, doses that are too low or too high, use of contraindicated drugs, and missed opportunities to counsel patients. The use of samples by a patient who also has a prescription to be dispensed by a pharmacy can create confusion or may lead to unexpected clinical results or interruption or discontinuation of treatment before the planned course of therapy is complete. Documentation of the distribution of drug samples by physicians varies, with only 9% to 30% of drug samples being recorded in the patient’s chart, which makes it difficult to monitor and solve potential pharmacotherapy-related issues. When physicians or nurses distribute samples, they are unable to supply specific instructions to the patient, who may forget the individual dosage or other details about using the medication. Similarly, the packaging of certain samples is unsafe (e.g., can be opened easily by children or may have incomplete or illegible labelling), which may increase the risk of accidental ingestion. Although samples are intended for use by patients, studies have shown that 30% to 54% of samples are handed out to health care staff or are used by pharmaceutical representatives. Finally, there have been reports of disciplinary decisions against physicians who have engaged in the illegal practice of selling drug samples. levitra plus


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