The U.S. health care policies on drug importation/re-importation relative to counterfeit drugs
Health care policy
This refers to a set of rules, standards, and regulations informing the operation, financing, and delivery of health care services.
Counterfeit Drugs
These are pharmaceutical products produced and sold with the intention of misrepresenting their active ingredients, efficacy, safety, and authenticity.
Imported Drugs
These are pharmaceutical products, which are produced inside and outside the U.S., and sold to local consumers.
Re-imported Drugs
These include the pharmaceutical products, which are produced and approved in the U.S.; exported to other countries, and then sold back to consumers in the United States.
Types of importation
There are two distinct types of importation in the U.S., which include personal importation (Internet orders and mail orders) and commercial importation (drug wholesalers and pharmacies).
Historical health care policies on drug importation/re-importation
In the United States, policies governing the production and sale of pharmaceutical products to local consumers have been effective for the past 100 years.
Therefore, the U.S. government ensures that the prescribed and over-the-counter drugs available in the U.S. market meet the required safety and efficacy standards.
Here, the Food and Drug Administration (FDA) plays a pivotal role in terms of ensuring that the drug policies are followed.
However, the policies governing drug importation/re-importation to curb drug counterfeiting can be traced back to 1938.
In 1938, the Food, Drug, and Cosmetics Act (FD&C Act) was established with the intention of regulating the manufacture and distribution of all types of drugs.
As a result, the FD&C Act gave FDA the following powers and responsibilities;
- Ensuring that all drug manufacturers verified the safety of the pharmaceutical products meant for human use.
- Ensuring that manufacturers provided proper and accurate labels showing how their products should be handled and used.
- Inspecting the manufacturing facilities to ensure that the information provided by the manufacturers regarding their products was accurate and credible.
In 1962, the Kefauver-Harris proposals to amend the FD&C Act ensured that FDA had the powers to compel drug manufacturers to verify not only the safety of their products but also drug effectiveness.
Therefore, with the above-mentioned regulations in place, the U.S. market is regarded as closed to the entry of counterfeit drugs from foreign countries.
However, to address the paramount need in terms of reducing drug counterfeiting at the global level, the U.S. government introduced the Prescription Drug Marketing Act(PDMA) in 1987.
The PDMA gave FDA the responsibility of ensuring that drug re-importation into the U.S. was carried out by the original manufacturer of the product.
As a result, foreign manufacturers were forced to allow FDA officers to inspect their products and facilities before they can be allowed into the U.S. market.
Unfortunately, the rising cost of prescription drugs in the U.S. forces the local consumers to seek alternative means of obtaining prescription drugs such as through the Internet.
The current health care policies on counterfeit drugs
To reduce the number of U.S. citizens exposed to counterfeit drugs through the internet, the government introduced the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) in 2003.
The MMA Act allows wholesalers and pharmacies to import FDA-approved prescription drugs from Canada and avail them to local consumers at a relatively lower price.
In addition, the MMA Act allows U.S. citizens to import a limited volume of prescription drugs from approved Canadian sources using their legitimate prescription forms.
Furthermore, the U.S. government has established the E-pedigree system, which collaborates with the global m-Pedigree platform for automatic drug detection.
These platforms require that all pharmaceutical products on transit should undergo automated inspection to curb the movement of counterfeit drugs in the global and local markets.
In addition, FDA collaborates with some online advertising companies such as Google to try and reduce the number of counterfeit drugs available through the internet.
The positive implications of the policy
With the regulations regarding drug importation/re-importation in place, the U.S. government through FDA ensures that the drugs available to U.S. citizens are safe, reliable, and effective.
Moreover, the FD&C Act ensures that the safety and effectiveness of drugs produced globally is maintained before marketing because it gives FDA the powers to inspect foreign drug manufacturing facilities relative to their compliance with the acceptable standards.
Additionally, the E-pedigree and the m-Pedigree platforms allow the global pharmaceutical market to keep vigilance on the movement of counterfeit drugs.
Furthermore, some regulations enacted by the U.S. government such as the MMA Act enables some foreign manufacturers producing high quality products at a cheaper price to expand their market into the U.S.
Overall, the MMA Act reinforces the global goal in drug research and development, which aims at developing new therapeutic products to treat emerging health complications at a relatively low cost.
Lastly, with the U.S. government’s move to partner with on-line advertising companies to oversee the global pharmaceutical advertising, it is apparent that there might be a reduction in the availability of counterfeit drugs through the Internet.
The negative implications of the policy
The strict rules regarding the sale and production of drugs in the United States do not only increase the global cost of prescription drugs, but they also delay the process of drug research and development.
In addition, some regulations such as the MMA Act encourage the sale of counterfeit drugs through the internet and across the borders because personal importation/re-importation is not clearly defined.
Furthermore, the MMA Act has accelerated the global movement of unapproved pharmaceutical products because some U.S. citizens are able to purchase counterfeit drugs elsewhere, and avail them in the local and global markets.
As a result, some inaccurately labeled drugs and controlled substances have found a favorable market in and outside the United States.
Additionally, the current regulations regarding the control of pharmaceutical advertising through the Internet are ineffective because the Internet is still a favorable market for pharmaceuticals, which are sold without valid prescription forms.
Overall, the emergence of legalized commercial and personal drug importation poses a possible danger to the future of drug research and development because of the issues regarding intellectual property protection.
The implications of the U.S. health care policy on counterfeit drugs for the nursing profession
The positive implications of the policy
The government’s policy regarding counterfeit products enhances the goals and mission of the nursing profession in terms of improving the patient outcome through ensuring that the safety and efficacy of prescribed drugs is guaranteed.
In addition, the nursing profession benefits from the current regulations regarding the production and clinical testing of new drugs because the regulations ensure that the FDA-approved drugs are safe and effective in addressing the emerging health complications.
Furthermore, FDA expands the accessibility of nursing professionals to essential generic medications, which are under clinical investigation.
Conversely, the regulations governing drug importation/re-importation play a major role in ensuring that the nursing professionals and patients are aware of unapproved medications, which can interfere with the intended health outcomes.
Overall, through legalized importation of essential drugs, which are under investigation in the U.S., the MMA Act ensures that the time and cost incurred in providing nursing care services and drugs decreases significantly.
Negative implications of the policy
The current regulations regarding drug importation/re-importation presents the nursing professionals with the problem of maintaining the desirable patient outcomes because there are several loopholes, which expose patients to unapproved medications.
In addition, legalized importation of prescription drugs allows the infiltration of several varieties of prescription drugs into the U.S. market thereby limiting the accuracy of nurses in prescribing effective drugs.
Moreover, the role of nurses and pharmacies in providing prescription drugs is undermined by some FDA regulations, which allow patients to import medications even without valid prescription forms.
Conversely, the nursing professionals face major challenges in terms of treating some emerging health complications, which are associated with wrong prescription or the use of the readily available counterfeit drugs.
Overall, the nursing professionals benefit less from some FDA regulations because they are aimed at reducing the overall cost of importing prescription drugs while undermining the desirable quality of prescription drugs and the desired patient outcome.
Conclusions
This presentation deals with the issues regarding the U.S. health care policy on counterfeit drugs.
Here, the presentation looks at various regulations regarding drug importation/re-importation relative to the issues regarding the global drug counterfeiting.
Subsequently, the discussions above present the global implications of the U.S. health care policy on counterfeit drugs.
In addition, the presentation looks at the overall implications of the U.S. health care policy on counterfeit drugs for the nursing profession.
Overall, the discussions above shows that the U.S. government has made several successful steps to control the movement of counterfeit drugs both in the local and global pharmaceutical markets.
However, more needs to be done because the Internet and other entry points prove to be the most lucrative marketplaces for counterfeit drugs.
In addition, there is the need for the U.S. government to take drastic measures to ensure that the same regulations, which are used to control drug counterfeiting locally are extended to the global arena.
References
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