Standards and regulations in health-care delivery — Part 3
The integrity of standards and regulations depend on uniform and transparent application of compliance regime.

IN our continuing series on health-care standards and regulations, we will look at how compliance with standards may be assessed and enforced. An important issue to consider is how societies may ensure that agreed industry standards are complied with in a transparent matter.

There are several mechanisms by which standards may be assessed and maintained. A key point to note is that the integrity of standards and regulations depend on uniform and transparent application of compliance regime.

Government regulatory agencies

Government regulatory agencies play an important role in ensuring safe and effective health-care delivery when appropriately deployed. The designing and functioning of these agencies, their remit and reporting requirements are different in various countries. A good example of government regulation in the health-care arena is when the area of medications is considered. It’s noteworthy that the regulation of access and use of medications appropriately employs one uniform standard for both public and private sector health-care operators in Jamaica. A similar standard is applied in other countries.

Many countries often impose regulation on the use and sale of medications within their borders. In Jamaica, this authority resides within the Ministry of Health and Wellness. In the United States, the Food and Drug Administration (FDA) is the responsible authority. From the FDA website “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation”.

From the perspective of the United States public, the FDA ensures that medications are safe and effective. Any company that wishes to sell pharmaceuticals in the United States is required to apply to the FDA for approval. The application process is lengthy and requires that the company to submit scientific studies which speaks to the drug’s pharmacologic properties, safety, and efficacy. There are many criticisms of the drug application process in the United States. The cost to get a drug approved often runs into hundreds of millions of dollars. The FDA process is by nature slow, making it difficult to quickly approve medication with significant potential. The tedious FDA processes sometimes makes it challenging to remove harmful medication from the market. Another criticism of the FDA relates to its use of advisory committees (external experts who assist in drug evaluation). Often these experts have links to pharmaceutical companies and may benefit from drug approval or rejection.

Despite its many imperfections, the pathway to getting a drug on the market in the United States is clear and unambiguous. Once a company is financially able to perform the studies, it can be assured that if criteria for safety and efficacy are met, the drug can be sold in the United States market. This clarity of process is what gives the process credibility. However, there are lingering concerns about how much transparency there is in the process of drug approval. Advisory committee meetings for drug approval must be published in the federal register 15 days in advance and these meetings are open to the public. Transcripts for these meeting are readily available within 30 days of meeting. Decision-making within the FDA itself is not as transparent, but FDA’s actions may be audited by the legislative branch (Congress) and they are directly answerable to the executive (the President). This provides necessary oversight.

An important role for the FDA is so called post marketing surveillance. This is the monitoring of medications currently on the market for signals of harm. It can be more difficult to be sure that a drug is dangerous but if clear signals of harm are seen, drugs have been removed from the market (examples: thalidomide, Vioxx), allowed to remain on the market but with so-called “black box” warnings or to have their use restricted to special populations.

Other apposite examples of government regulatory agencies which have standard enforcement as their remit include the Center for Medicare Services (CMS) and Occupational and Healthcare Services (OSHA) in the United States. CMS co-ordinates healthcare for most of the aged population in the United States. The agencies are mandated to examine the quality of care that is being delivered by hospitals and physicians. CMS often provide financial incentives for above standard care that is, physicians that have a history of above quality care can be paid at higher rates. They can also penalise physicians and hospital systems for care that does not meet usual standards of care. The Occupational Safety and Health Administration (OSHA) is a large regulatory agency of the United States Department of Labor. The Occupational Safety and Health Act was established by US Congress in 1970 to ensure safe and healthful working conditions for workers by setting and enforcing standards and by providing training, outreach, education, and assistance.

Non-governmental regulatory agencies

The maintenance of standards can exist outside of the government in the setting of non-profit or private agencies. An example of such an agency is the Joint Commission in the United States. This is a non-profit agency that was formed in 1951 with the goal of improving patient care in hospital. Today it evaluates more than 22,000 health-care facilities in the United States and worldwide. Health-care facilities are audited unannounced approximately every three years. The health-care facilities are assessed on knowledge of current standards and the policies and procedures that relate to these standards. If they are found not to be complying, then a remedial course of action is often required. Although they are a non-profit entity, US facilities that accept Medicaid and Medicare patients are required to have joint commission accreditation. There have been criticisms of the joint commission process including the fact that medical industry representatives serve on its board and that relatively low numbers of facilities fail the accreditation process suggesting conflict of interest. There is also the additional question of whether patient care can be demonstrated to be better at a joint commission accredited facility as opposed to a facility that is not accredited.

Other examples of standard assessment from the Non-profit/private sector include Intersocietal Accreditation Commission in the United States. This is a non-profit organisation that seeks to evaluate institutions in the appropriate utilisation, standardisation, and quality of diagnostic and interventional radiographic studies. Evaluations are performed every three years. Achieving IAC accreditation serves as a marker of quality. Medicare requires that advanced imaging (CT, MRI, and Nuclear Medicine) that take place outside of a hospital setting take place in an IAC accredited centre. The same rules apply for US government owned and operated facilities as with private profit or non-profit facilities. This uniformity ensures that all patients receiving care in facilities within the USA enjoy the same protection and access to quality care irrespective of social class or where they seek care. We should strive for the same equity in Jamaica.

Next week, we will look at the role of professional societies and the legal system in enforcing regulatory compliance.

Ernest Madu
Dr Paul Edwards

Dr Ernest Madu, MD, FACC and Dr Paul Edwards, MD, FACC are consultant cardiologists for Heart Institute of the Caribbean (HIC) and HIC Heart Hospital. HIC is the regional centre of excellence for cardiovascular care in the English-speaking Caribbean and has pioneered a transformation in the way cardiovascular care is delivered in the region. HIC Heart Hospital is registered by the Ministry of Health and Wellness and is the only heart hospital in Jamaica. Correspondence to info@caribbeanheart.com or call 876-906-2107

Dr Ernest Madu and Dr Paul Edwards

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